STRATEGIC PLAN

MOVING INTO THE FUTURE 

WITH NEW DIMENSIONS 

AND STRATEGIES:

A VISION FOR 2020 FOR 

WOMEN’S HEALTH RESEARCH

OFFICE OF RESEARCH ON WOMEN’S HEALTH

NATIONAL INSTITUTES OF HEALTH

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES
The Honorable Barbara Mikulski, U.S. Senator, Maryland 

August 16, 2010 

“Fighting for women’s health has been one of my life-long priorities. For far too 

long, women’s health was ignored. When I first came to the Senate, women’s 

health wasn’t a national priority. Remember the famous study, take an aspirin a 

day to keep the heart attack away? That study was done on 10,000 men. Not one 

woman was included. In a study of the aging process, they told me women weren’t 

included because there wasn’t a ladies room available for study participants. Yet the 

results of these studies were being applied to men and women. I vowed to fix that. 

I helped establish the Office of Research on Women’s Health at the National 

Institutes of Health to make sure women were no longer being neglected. Through 

this office we have been able to increase women’s inclusion in clinical drug trials 

and to increase funding for breast cancer research by 700 percent since 1992. We 

now know that men and women have different symptoms before a heart attack. 

And there are many more biological differences that must still be studied and 

understood. I will continue to fight to make sure women’s health remains a priority 

in the federal checkbook and that women are not left behind when it comes to 

their health and survival.” 

The Honorable John Lewis, Congressman, Fifth District, Georgia 

Regional Strategic Planning Meeting—Emory University • February 17, 2010 

“Do something about the health needs of women. That is a must. That is our 

mission and it is our goal....In the area of health, we must do what we can to bring 

about a revolution of values, a revolution of ideas....We must have the capacity to 

stand up, to speak up and out, to organize and mobilize.” 

The Honorable Connie Morella, Member, U.S. House of Representatives, 1987-2003 

August 17, 2010 

“The legislation that established the Office of Research on Women’s Health 

represented not only a victory for women, but an important contribution to 

science. By specifically studying women’s health issues the entire realm of 

scientific inquiry is enriched and expanded, and science is made more relevant. But, 

the challenge continues. The work is not finished. Our legacy for future generations, 

and to ensure that new and important advances continue, requires us to dedicate 

our continued energy, enthusiasm, and resources for women’s health research.” 
STRATEGIC PLAN

MOVING INTO THE FUTURE 

WITH NEW DIMENSIONS 

AND STRATEGIES:

A VISION FOR 2020 FOR 

WOMEN’S HEALTH RESEARCH

OFFICE OF RESEARCH ON WOMEN’S HEALTH

NATIONAL INSTITUTES OF HEALTH

U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES

A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

TABLE OF CONTENTS

5 Message from the Associate Director for Research on Women’s Health 

9 Mission and Historical Overview 

13 Vision, Goals, and Objectives 

16 GOAL 1 Increase sex differences research in basic science studies 

17 GOAL 2 Incorporate findings of sex/gender differences in the 

design and application of new technologies, medical devices, and 

therapeutic drugs 

18 GOAL 3 Actualize personalized prevention, diagnostics, and 

therapeutics for girls and women 

19 GOAL 4 Create strategic alliances and partnerships to maximize 

the domestic and global impact of women’s health research 

20 GOAL 5 Develop and implement new communication and social 

networking technologies to increase understanding and appreciation 

of women’s health and wellness research 

21 GOAL 6 Employ innovative strategies to build a well-trained, 

diverse, and vigorous women’s health research workforce 

23 Major ORWH Programs 

27 Appendix A: Hosts and Working Group Cochairs of the Regional 

Scientific Meetings 

34 Appendix B: Advisory Committee on Research on Women’s Health 

35 Appendix C: Coordinating Committee on Research on Women’s Health, 

National Institutes of Health, 2010 

38 Appendix D: External Advisors on the NIH Women’s Health 

Research Agenda 

39 Appendix E: Office of Research on Women’s Health Staff 

3 

A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

5 

Vivian W. Pinn, M.D. 

MESSAGE FROM THE ASSOCIATE 

DIRECTOR FOR RESEARCH 

ON WOMEN’S HEALTH 

The Office of Research on Women’s Health 

(ORWH) was established in September 1990 

in response to congressional, scientific, and 

advocacy concerns that a lack of systemic 

and consistent inclusion of women in NIHsupported clinical research could result in 

clinical decisions being made about health 

care for women based solely on findings 

from studies of men—without any evidence 

that they were applicable to women. The 

establishment of the Office heralded earnest 

efforts by NIH to develop a research agenda 

addressing gaps in scientific knowledge 

about women’s health across the lifespan and 

to increase the number of scientists pursuing 

investigations with a scientific design that 

would reveal sex differences in outcomes. 

These aims were articulated in the first 

ORWH agenda-setting report, Report of the 

National Institutes of Health: Opportunities 

for Research on Women’s Health (commonly 

referred to as the Hunt Valley report). In 

1997, ORWH undertook a second systematic 

program of collaborative planning and 

convened a series of public hearings and 

scientific workshops that culminated in 

the publication of the Agenda for Research 

on Women’s Health for the 21st Century. 

That agenda expanded the vision for NIH, 

going “beyond Hunt Valley” to highlight the 

importance of promoting interdisciplinary, 

collaborative research; studying and 

addressing the health differences and needs 

of all populations of women; and increasing 

the diversity of the biomedical workforce. 

ACCOMPLISHMENTS 

Twenty years after the establishment of 

ORWH, significant progress has been 

achieved in four benchmark areas: (1) policies 

have been developed and implemented 

to ensure the inclusion of women in NIH 

clinical research; (2) women’s health and 

sex differences research has increased; (3) 

new programs have been implemented to 

prepare researchers to conduct women’s 

health research; and (4) there has been 

new focus on interdisciplinary career 

development and sex differences research 

across the research continuum. Consequently, 

reports on sex and gender-related factors 

in health and disease and analysis of 

clinical trials by sex of participants have 

steadily increased in the scientific literature. 

Over the years, the biennial reports of 

the Advisory Committee on Research on 

Women’s Health, in collaboration with the 

NIH Coordinating Committee on Research 

on Women’s Health, attest to the attention 

and greater appreciation that has developed 

for women’s health and sex differences 

research in the design of studies and the 

translation of findings into clinical practice. 

The growth of NIH-funded women’s health 
research addressing the expanded concept of 

women’s health across the lifespan—including 

more than just the reproductive years while 

continuing to explore understudied areas 

of reproductive health and the menopausal 

transition—has been impressive. Additionally, 

increasing numbers of investigator-initiated 

women’s health research studies in areas 

such as cardiovascular disease and stroke, 

musculoskeletal and immune disorders, and 

mental health and substance abuse, among 

many others, reflect enormous progress. 

As a result of the increased attention to 

women’s health research funded by the 

NIH institutes and centers, women’s health 

scientists, providers, and advocates have 

gained a strong sense of their capacity to 

effect change. Research on women’s health 

has become a tangible reality. Furthermore, 

women’s health, sex differences, and 

interdisciplinary women’s health research 

have become distinct research career 

paths in multiple fields, a testament to the 

success of two ORWH signature programs: 

Building Interdisciplinary Research Careers 

in Women’s Health (BIRCWH), established 

in 1999, and the interdisciplinary Specialized 

Centers of Research (SCORs) on Sex 

and Gender Factors Affecting Women’s 

Health, established in 2002. As of 2010, 

the BIRCWH program has supported the 

career development of almost 400 earlystage research scientists at major research 

institutions throughout the United States. The 

SCORs on Sex and Gender Factors Affecting 

Women’s Health support interdisciplinary 

research, from basic to translational to 

clinical investigations, by accomplished 

scientists; while a third program, Advancing 

Novel Science in Women’s Health Research 

(ANSWHR), established in 2007, further 

supports interdisciplinary research. In 2010, 

these three ORWH-initiated programs 

are flourishing and enjoy continuing 

cosponsorship from many of the NIH 

institutes, centers, and offices. 

THE FUTURE 

To build on past successes and determine 

future directions for the next generation of 

women’s health and sex/gender research, 

ORWH has once more updated the NIH 

women’s health research agenda in a third 

report, Moving Into the Future With New 

Dimensions and Strategies: A Vision for 2020 

for Women’s Health Research. The report 

is the culmination of a 2-year strategic 

planning process, involving more than 

1,500 leading scientists, women’s health 

advocates, public policy experts, health care 

providers, Federal, State, and local elected 

officials, and the general public in 5 regional 

scientific meetings. This Strategic Plan not 

only articulates new priorities, but also 

strongly reinforces existing areas, such as 

interdisciplinary and sex differences research. 

Unlike earlier reports, the current Plan is not 

disease specific. It encompasses diseasespecific research in a broader vision of 

women’s health that can benefit both women 

and men by increasing our understanding of 

the role of sex/gender factors in differential 

disease risk, vulnerability, progression, and 

outcome, as well as the effects of being 

female on health. 

Over the past 20 years, research has 

revealed that from single cells to multiple 

biological systems and mechanisms, sex 

differences exist—and these differences are 

not just hormone based. Sex differences 

research is needed not only in fields such 

6 as endocrinology and immunology, but 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

also in rapidly evolving science areas 

such as epigenetics, systems biology, and 

neuroscience; and new technologyenabled fields such as genomics, proteomics, 

and metabolomics. 

The health of women has a direct bearing 

on the health of their families and 

communities, and ultimately, the health of 

societies. In an increasingly interconnected 

world, the health of an individual or a 

community can, in some way, affect the 

health of all. Women’s health research 

must encompass global considerations and 

continue to seek ways to address the pressing 

health needs of women worldwide. 

Moving into the Future with New Dimensions 

and Strategies: A Vision for 2020 for 

Women’s Health Research reflects ORWH’s 

commitment to fostering innovations 

in women’s health research from bench 

to bedside, and from laboratories to 

communities. Our strategy for the NIH 

pledges us and our many partners to address 

opportunities, challenges, and health needs 

of future generations of girls and women. 

We continue to look to our many partners 

among scientific groups, the public, advocacy 

groups, and policy leaders, who played such 

a defining role in creating ORWH, to continue 

to extol women’s health research and to help 

us realize our shared vision. 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health 

Director of the Office of Research on Women’s Health 

Research on 

women’s health 

has become a 

tangible reality. 

7 

A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

9 

I MISSION AND 

HISTORICAL OVERVIEW 

The Office of Research on Women’s Health 

(ORWH) was the first Public Health Service 

office dedicated specifically to women’s 

health. The office was established at 

the National Institutes of Health (NIH) 

on September 10, 1990. The office was 

reaffirmed by statute in congressional 

legislation by the NIH Revitalization Act of 

1993 to serve as the focal point for women’s 

health research at the NIH, reporting 

directly to the NIH Director, and working in a 

collaborative partnership with the institutes, 

centers, and offices. Congress assigned a 

far-reaching leadership role to the ORWH 

Director by mandating that the Director be 

responsible for the following: 

1 Advise the NIH Director and staff 

on matters relating to research on 

women’s health. 

2 Strengthen and enhance research related 

to diseases, disorders, and conditions that 

affect women. 

3 Ensure that research conducted and 

supported by NIH adequately addresses 

issues regarding women’s health. 

4 Ensure that women are appropriately 

represented in biomedical and 

biobehavioral research studies supported 

by the NIH. 

5 Develop opportunities and support 

for recruitment, retention, reentry, 

and advancement of women in 

biomedical careers. 

6 Support research on women’s 

health issues. 
10 

Throughout its 20-year history, ORWH has 

worked in concert with the NIH institutes, 

centers, and offices and the biomedical, 

behavioral, health care, and advocacy 

communities to foster understanding in 

support of a comprehensive approach to 

women’s health research. During this interval, 

the office initiated two research agendasetting initiatives in 1991 and again in 1997. 

Each of these efforts included public hearings 

and scientific workshops in formulating 

the research agenda. The first initiative 

led to the publication of the Report of the 

National Institutes of Health: Opportunities 

for Research on Women’s Health, commonly 

known as the Hunt Valley report. The second 

report, Agenda for Research on Women’s 

Health for the 21st Century, was issued in 1998. 

In October 2008, ORWH embarked on a 

2-year process to plan the NIH women’s 

health research agenda for the next decade. 

The current Strategic Plan is the product of 

a collaborative planning process informed 

by five regional scientific workshops and 

public hearings anchored in leading academic 

and research institutions in St. Louis, San 

Francisco, Providence, Chicago, and Atlanta. 

Central to the approach of these meetings 

was a decision to seek the opinions of a 

wide range of individuals from both within 

the NIH and from external scientific and lay 

communities regarding the research agenda 

for the future of women’s health. As a result, 

the format of each of the regional scientific 

workshops was designed to promote an 

interactive discussion involving leading 

scientists and researchers from across the 

nation, women’s health advocates, public 

policy experts, healthcare providers and the 

general public in a mutually informative and 

collaborative strategic planning process. 

Participating in this process were more 

than 1,500 individuals, representing the 

full spectrum of academic institutions, 

professional associations, advocacy 

organizations, health care facilities, and 

science policy analysts interested in research 

on women’s health and sex/gender factors 

in health and disease. Thirty-seven scientific 

and career development working groups 

were cochaired by leading external and 

NIH scientists, representing 44 academic 

institutions and 19 NIH institutes, centers, and 

the Office of the Director. Participants in the 

meetings came from 33 states, Great Britain, 

and Australia. Nearly 400 recommendations 

emerged during the course of 5 regional 

meetings. Public and written testimony was 

received from 141 advocacy and academic 

organizations, as well as from individuals 

presenting their personal health stories. 

The concerns and issues highlighted by the 

public testimony brought to the forefront 

remaining gaps in knowledge and unmet 

needs in women’s health care, and served to 

underscore the ultimate goal of the research 

agenda, to improve the health of women. 

In finalizing this document, the review 

process involved three different levels: (1) 

a review by the Advisory Committee on 

Research on Women’s Health; (2) a Strategic 

Plan review group consisting of external 

scientists, some of whom also served as 

cochairs of various working groups at the 

regional meetings; and, finally, (3) an internal 

NIH review. The entire process is presented in 

three printed volumes and is also available 

to the public on the ORWH homepage 

http://orwh.od.nih.gov. 

The benefit and purpose of the Strategic 

Plan are to identify a forward vision 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

that can further stimulate and continue 

scientific endeavor across and within all 

NIH institutes, centers, and offices and with 

an appreciation and understanding of the 

importance of conducting women’s health 

and sex differences research. Such research 

will ensure that science continues to be 

vigorous and dynamic and public health 

is well served. The Strategic Plan is also a 

tool for energizing partnerships across NIH, 

academia, the advocacy communities, and 

the world of public policy, leading to a better 

understanding of women’s health research 

and improving its benefits for human 

health worldwide. 

11
Elizabeth H. Blackburn, Ph.D. 

2009 Nobel Laureate 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

13 

II VISION, 

GOALS, AND OBJECTIVES 

A CHANGING VISION OF 

WOMEN’S HEALTH 

The mission of NIH is to seek fundamental 

knowledge about the nature and behavior of 

living systems and to apply that knowledge 

to enhance health, lengthen life, and 

reduce the burdens of illness and disability. 

ORWH works in partnership with the NIH 

institutes, centers, and offices to ensure 

that women’s health research is part of the 

scientific framework. Since the establishment 

of ORWH in September 1990, the field 

of women’s health research has greatly 

expanded in scope from a primary focus on 

reproductive health to a multifaceted area 

of research. Health outcomes are influenced 

by biological sex, gender identity, as well as 

developmental, cultural, environmental, and 

socioeconomic factors. The scope of women’s 

health research not only encompasses clinical 

studies, but a full spectrum of scientific 

investigations, such as molecular and 

genetic, other basic and laboratory studies, 

healthy lifestyle and behavior, risk reduction 

and disease prevention. It also includes 

studies to design clinical interventions and 

newly confirmed hypotheses to improve 

public health. There are striking sex/gender 

differences in prevalence, progression, and 

outcome of numerous conditions, including 

diabetes, obesity, cardiovascular diseases, 

substance abuse disorders, depression and 

brain disorders, infectious diseases, lupus and 

other autoimmune diseases, and cancer. 

NIH has greatly expanded its portfolio of 

women’s health and sex/gender differences 

research. Because of the continuum of 

women’s lifespan transitions and roles, 

research on puberty, childbirth, and 

menopause are required considerations in 

the NIH women’s health research agenda. 

For the last decade, four overarching themes 

have guided NIH research on women’s health: 
lifespan, sex/gender distinctions, health 

disparities/differences and diversity, and 

interdisciplinary research. 

MAJOR CROSS-CUTTING THEMES, 

GOALS, AND OBJECTIVES 

The current Strategic Plan encompasses 

disease-specific research in a broader vision 

of women’s health, with the goal of increasing 

understanding of the major diseases and 

conditions that disproportionately affect 

women’s overall quality of life. It is important 

to note that the research priorities identified 

in this Plan will benefit not only women, but 

men, by increasing our understanding of the 

role of sex/gender factors in disease risk, 

vulnerability, progression and outcomes. 

The Plan envisions how women’s health 

research can enrich the biomedical 

landscape. The following key research 

themes provide additional context for the 

goals and objectives in this plan. 

ADVANCING UNDERSTANDING 

OF BIOLOGICAL SEX DIFFERENCES 

IN HEALTH AND DISEASE 

Over the next decade, the exploration of 

biological sex differences at multiple levels, 

from genes to hormones to complex systems, 

will be greatly accelerated. Research will fall 

far short of its promise to usher in an era of 

personalized medicine unless the contribution 

of biological sex to the diversity of health 

outcomes is better understood and this 

knowledge applied in the development of 

the next generation of interventions and 

medical technologies. 

EMERGING NEW SCIENTIFIC 

FIELDS AND TECHNOLOGIES CAN 

PROVIDE UNIQUE OPPORTUNITIES 

TO MAXIMIZE RESEARCH 

The emergence of new fields of interdisciplinary science and the application of new 

technologies and analytic methodologies 

(e.g., high-throughput screening, modeling, 

bioinformatics) to fundamental and translational research can provide unprecedented 

future opportunities for understanding biological sources of variance in human health and 

disease. Advances in science and technology 

hold the promise of identifying causative 

disease susceptibility genes and disease biomarkers, understanding the totality of physiological systems, and providing targeted and 

personalized sex appropriate therapeutics. 

In an age emphasizing analytic strategies 

(e.g., mapping, data mining, meta-analysis), 

new enabling technologies will be able to 

take full advantage of information in data repositories, population datasets, observational 

studies, and clinical trials. 

14 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

FOSTERING PARTNERSHIPS TO IMPROVE 

THE TRANSLATION AND DISSEMINATION 

OF HEALTH INFORMATION 

Biomedical research ultimately serves human 

health by contributing to improved health 

care, reduction of morbidity and mortality, 

and enhanced health-related quality of life. 

In the next decade, NIH and ORWH will 

continue to provide leadership in forging links 

to further research along the translational 

spectrum toward community health and 

health services. By including academic 

partners from fields such as economics and 

ethnography as well as public and private 

partners, interdisciplinary research can also 

have significant impact on community health, 

health care delivery, and public policy. 

The Plan identifies six major goals to 

advance women’s health research and 

represents a synthesis of almost 400 

recommendations that emerged from five 

regional planning meetings. 

15
GOAL 

1 INCREASE SEX DIFFERENCES RESEARCH 

IN BASIC SCIENCE STUDIES 

Over the past two decades that ORWH has promoted women’s health research, 

most studies of sex differences have been in clinical research. Looking forward, 

and ensuring that scientific knowledge continues to advance, an expanded 

conceptual framework is needed that explores variations due to sex as an integral 

part of the search for knowledge across the entire research spectrum, beginning 

at the most basic laboratory level. This should encompass research in diverse 

fields, including genetics, immunology, endocrinology, developmental biology, 

cell biology, epidemiology, microbiology, biochemistry, and toxicology, as well 

as in behavioral and social sciences. Advances in these fields will be further 

strengthened by emerging technologies such as high-throughput sequencing, 

data acquisition, bioengineering, and bioinformatics, and on new modeling 

and data analytic techniques. This convergence of information presents an 

opportune time to expand what is known about the effects of biological sex on 

normal development and the structure and function of cells, tissues, and organs. 

Therefore, the identification of sex of origin of cells, tissues, and animal model 

systems, as appropriate, can lead to improved clinical diagnosis and health care 

based on accurate, sex-specific data. 

OBJECTIVES

1.1 Encourage genetic and epigenetic studies to 

identify sex differences in gene expression. 

1.2 Explore sex differences in the structure and 

function of male and female cells (including stem cells), 

tissues, organs, and physiological systems. 

1.3 Study sex differences using a systems biologybased approach. This will include research based on new 

technology platforms such as microbiomics, genomics, 

phenomics, proteomics, and metabolomics. 

1.4 Include sex parameters in the design of 

experiments using animal models. 

1.5 Promote neuroscience research to study sex/ 

gender differences in vulnerability to and clinical course of 

neurological, psychiatric, and substance abuse disorders. 

1.6 Increase basic and translational research on sex/ 

gender differences in the pathobiology, prevention, and 

treatment of diseases including HIV/AIDS, urinary tract 

and sexually transmitted infections. 

1.7 Investigate the actions of steroid hormones 

and hormone-mimicking environmental agents on 

gene expression, cells, tissues, and organs. Apply this 

knowledge to sex differences in disease prevalence, 

symptoms, management, and outcomes in conditions 

such as lupus and cardiovascular diseases and to 

predominantly sex-specific diseases such as breast 

cancer and uterine fibroids. 

1.8 Further understanding of sex/gender differences in 

fundamental mechanisms and patterns of behavioral and 

social functioning relevant to health and well-being. 

1.9 Incorporate sex/gender considerations into 

discussions in scientific conferences and meetings. 

16 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

GOAL
�

2 

INCORPORATE FINDINGS OF SEX/GENDER DIFFERENCES 

IN THE DESIGN AND APPLICATION OF NEW TECHNOLOGIES, 

MEDICAL DEVICES, AND THERAPEUTIC DRUGS 

Improvements in research methodology, instrumentation, and technology have 

dramatically accelerated progress in the biomedical sciences. As a result of new 

technologies in the last decade, human DNA can now be sequenced in a matter of 

hours versus years, therapeutic small molecules can be accurately synthesized by 

robots under highly controlled conditions, and brain functions can be noninvasively 

imaged. In clinical medicine, the availability of new medical devices as well as 

advances in bioimaging, genetics, and biochemistry have revolutionized models of 

disease diagnosis and management. 

In developing and utilizing new research technologies and clinical applications, 

it is important that sex/gender differences be part of their design and utilization. 

Some currently used technologies are not as applicable to women as to men 

because their development and standardization have been based primarily 

on study of males. Sex differences in biological response to drugs remain an 

underexplored area. 

OBJECTIVES 

2.1 Encourage the development of technologies that 

will address sex-based differences at all scales of detail, 

from the nanometer to the whole person. 

2.2 Develop novel animal, in vitro, and computational 

(virtual) models to study sex differences in diseases 

and conditions. 

2.3 Develop the information systems needed for 

collecting, sharing, and comparing clinical data for 

diseases and conditions of women and girls. 

2.4 Develop computational models that will utilize 

multiple levels of analyses to address both qualitative 

and quantitative outcomes of clinical research related 

to women. 

2.5 Work toward devising minimally invasive technologies for rapid and accurate screening, diagnosis, and 

treatment of diseases and conditions of women and girls. 

2.6 Exploit high-resolution bioimaging technologies 

to provide structural and functional imaging of sex 

differences in a variety of areas such as pain, brain 

activity, metabolism, infectious diseases, inflammation, 

and drug delivery. 

2.7 Design drugs, biologics, and devices to diagnose, 

prevent, and treat diseases and conditions affecting 

women and girls. 

2.8 Consider the sex and age of the patient in the 

development of engineered medical products, cell-based 

therapeutics, and regenerative procedures. 

2.9 Encourage collaborative interactions among 

clinicians, bioethicists, and technologists regarding 

accessibility of new technologies, drugs, and other 

interventions relevant to women’s health. 

17 
18 

GOAL 

3 

ACTUALIZE PERSONALIZED PREVENTION, 

DIAGNOSTICS, AND THERAPEUTICS 

FOR GIRLS AND WOMEN 

A major goal of biomedical research is to create knowledge that will lead to more 

accurate strategies for diagnosis, and preventive and therapeutic interventions, 

thereby ushering in a new era of personalized medicine. Personalized medicine 

considers individual differences in genetics, morphology, behavior, and health 

history. A comprehensive approach to personalized medicine must take into 

account biological sex, age, and factors such as social and cultural influences. 

NIH research has provided a wealth of biomedical scientific knowledge about 

women’s health across the lifespan, placing strong emphasis in recent years on the 

importance of speeding the translation of basic research into clinical applications. 

But efforts to translate clinical knowledge into interventions, services, and policies 

with measurable public health impact have had mixed success. To truly affect 

women’s health, translational research must go beyond “bench to bedside” by 

pursuing opportunities for dissemination and community uptake and involvement, 

including advocacy and policy development. Achieving 

this goal will require interdisciplinary collaboration and 

communication among basic science researchers, 

clinical researchers, behavioral scientists, public health 

researchers, clinicians, the community, and policymakers. 

Sex differences research can increasingly make 

major contributions to the goals of individualized 

medicine and improved public health. 

OBJECTIVES 

3.1 Conduct developmental and developmentally 

framed research to understand the role of hormones, 

hormonal changes, and reproductive transitions on conditions affecting women and girls throughout the lifespan. 

3.2 Study sex/gender differences in embryonic 

development, including epigenetic changes.

3.3 Encourage research on safe and effective 

interventions for conditions affecting pregnant women.	�

3.4 Expand research on pregnancy-related conditions 

such as preeclampsia, diabetes, and hypertension on the 

subsequent health of women and their offspring. 

3.5 Identify and validate sex-specific biomarkers for 

disease risk and prognosis across the lifespan. 

3.6 Study sex/gender differences in the aging process.
�

3.7 Explore differences in response to therapeutic 

interventions among samples of elderly women, including 

those with comorbid conditions. 

3.8 Conduct research on aging women with emphasis 

on prevention of frailty, promotion of healthy lifestyles, 

maintenance of independent living, self-management 

of symptoms, preservation of cognitive functions, and 

health-related quality of life. 

3.9 Examine health disparities among women 

stemming from differences in such factors as race 

and ethnicity, socioeconomic status, gender identity, 

and urban-rural living, as they influence health, 

health behaviors, and access to screening and 

therapeutic interventions. 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

GOAL 

4 

CREATE STRATEGIC ALLIANCES AND PARTNERSHIPS 

TO MAXIMIZE THE DOMESTIC AND GLOBAL IMPACT 

OF WOMEN’S HEALTH RESEARCH 

Strategic alliances and partnerships with women’s health stakeholders, 

including NIH institutes, centers, and offices; other Federal agencies; academia; 

advocacy groups; foundations; and industry are imperative to furthering women’s 

health research. Collaborations resulting from these alliances can help advance 

improvements in women’s health, leverage resources among public and private 

entities, help advance public health, and enhance public knowledge. Effective 

partnerships will also promote increased attention to women’s health research 

issues and ORWH’s role as a national and global leader in this arena. 

In an increasingly interconnected world, the health of an 

individual or a community can, in some way, affect the 

health of all. Women’s health research must encompass 

global considerations and continue to seek ways to 

address the pressing health needs of women worldwide. 

OBJECTIVES 

4.1 Convene futuristic thinkers from many fields of 

science, engineering, business, and the humanities to 

assist in devising implementation strategies for women’s 

health research. 

4.2 Establish new ventures and initiatives with 

a wide cross-section of partners, including NIH 

institutes, centers, and offices; academia; other Federal 

agencies; international organizations; private foundations; 

and industry. 

4.3 Promote an environment that uses multiple avenues 

and technologies to facilitate continuing input from 

partners committed to improving women’s health and 

promoting research. 

4.4 Create solid partnerships by engaging in scientific 

briefings and ad hoc meetings with policymakers, elected 

officials, and advocacy groups. 

4.5 Partner with professional societies to include 

women’s health research issues in national scientific 

meetings and conferences, including issues involving 

career training and development. 

4.6 Expand global strategic alliances and partnerships 

aimed at improving the health of women and girls 

throughout the world, particularly in developing countries. 

19
GOAL 

5 

DEVELOP AND IMPLEMENT NEW COMMUNICATION AND SOCIAL 

NETWORKING TECHNOLOGIES TO INCREASE UNDERSTANDING AND 

APPRECIATION OF WOMEN’S HEALTH AND WELLNESS RESEARCH 

Advances in all areas of science must be shared with diverse audiences. Effective 

communication can improve health outcomes for women and girls, both for their 

own sake and because women throughout the world play a central role in the 

health of their families and communities. Communications, policy development, 

and implementation science must be linked effectively to achieve these outcomes. 

Moreover, because of cultural and racial/ethnic diversity in national and 

international societies and communities, information about women’s health 

research and related issues must be disseminated in culturally appropriate ways. 

Multiple media strategies, along with the latest communication technologies, 

should be considered in communications research to determine how to best reach 

diverse audiences. 

The NLM-ORWH Web portal, Women’s Health Resources 

(http://womenshealthresources.nlm.nih.gov), provides 

information about the latest NIH-funded research in a 

centralized location for consumers, health providers, and 

researchers. The portal provides research literature, videocasts 

of NIH presentations, podcasts, videos, fact sheets, and other 

formats with health information. The portal also uses social 

media to connect with the public for awareness campaigns. 

OBJECTIVES 

5.1 Serve as a key informational resource for Federal 

and State agencies, elected representatives, the media, 

health and advocacy organizations, and the public on 

women’s health research issues. 

5.2 Expand collaboration with other NIH institutes and 

centers and Federal agencies in outreach activities on 

issues related to women’s health. 

5.3 Expand strategic alliances and partnerships with 

key national and international organizations to maximize 

the communication and impact of women’s health research. 

5.4 Convene leaders in communication sciences to 

explore and identify optimum messages and messaging 

to benefit women’s health research. 

5.5 Support research to explore and evaluate the 

ability of women and men of different ages to access, 

process, and act on health-related information. 

5.6 Build a central portal of information for women’s 

health research findings suitable for the specific needs 

of researchers, health care practitioners, patients, and 

their families. 

20 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

GOAL

6 

EMPLOY INNOVATIVE STRATEGIES TO BUILD 

A WELL-TRAINED, DIVERSE, AND VIGOROUS

WOMEN’S HEALTH RESEARCH WORKFORCE 

The research workforce serves as the foundation for scientific progress and must 

reflect the brightest talent equipped with essential scientific knowledge and 

exceptional training. Although women are well represented in early career phases 

of the life sciences, there is a well-recognized underrepresentation or absence of 

women in senior research leadership positions. It is therefore essential to learn 

from and expand upon successful efforts and develop and implement innovative 

programs and policies that will attract, retain, and advance women throughout 

their scientific careers. ORWH assumes a large-scale view of these challenges and 

extends career outreach efforts to include a focus on girls in secondary education 

settings, particularly among underserved populations. To advance women’s health 

research, it is also critical to prepare researchers with the interdisciplinary training 

and knowledge to evaluate and improve all aspects of women’s health. 

OBJECTIVES 

6.1 Connect and empower scientists across career 

stages by developing a central career advice/ 

development resource that includes contact with 

knowledge-rich people at the NIH. 

6.2 Lead the way in encouraging institutions to 

recognize mentoring as an essential component of 

building career success in their training programs; 

encourage evaluation of mentoring practices. 

6.3 Address the organizational, institutional, and 

systemic factors that impede recruitment, retention, and 

advancement of women in science, and modify practices 

that impede the careers of biomedical scientists. 

6.4 Evaluate the challenges and successes of part-time 

research careers and explore strategies to allow parttime faculty to remain involved in their fields of science. 

6.5 Promote recognition and understanding of 

women’s health among future health professionals and 

scientists by informing the design of curricula with upto-date research findings for use in educational materials 

for medical, dental, nursing, and other professional training. 

21 
Jeffrey Henderson, M.D., Ph.D.

Instructor of Medicine, 

Washington University School of Medicine

“This program [BIRCWH] has helped me tremendously 

as I begin the transition from mentored research 

toward an independent research career. Through this, 

I have obtained protected time to establish a research 

track record and have established a helpful mentoring 

relationship with several successful and established 

researchers. It has also helped me to better 

understand women’s health and the outstanding 

questions in this area.” 

Clay Semenkovich, M.D. 

Professor, Washington University 

“....the [BIRCWH] program provides 

salary support for the Scholars that 

enables each Scholar to devote a 

majority of their efforts to developing 

their own independent research 

program. This support comes at a 

pivotal time in the development 

of the Scholar and is essential 

for fostering their careers as 

biomedical researchers in the 

area of women’s health.” 

Valerie Flaherman, M.D., M.P.H. 

UCSF 

“My relationship with my BIRCWH 

mentors and advisors has allowed 

me to move forward much more 

rapidly on the path to independent 

clinical research.” 

Joan Riley, Ph.D. 

Instructor, Washington University 

“I hope that one day I can help 

shape the career of young scientists 

the way that....the members of my 

BIRCWH advisory committee have 

shaped mine.” 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

23 

III

MAJOR ORWH PROGRAMS 

INTERDISCIPLINARY PROGRAMS 

Because many factors influence women’s 

health, a comprehensive and interdisciplinary 

approach to conducting research in this area 

is fundamental. Interdisciplinary research 

facilitates the integration and synergy 

of basic science, clinical, translational, 

population, behavioral, social, and outcomes 

research. Women’s health research is best 

served by integrating this extensive variety 

of disciplines and fields. With increasing 

understanding of the interrelatedness and 

complexity of disease, the nature of scientific 

investigations has increasingly shifted to 

an interdisciplinary, collaborative approach. 

Interdisciplinary research provides an 

opportunity not just for medical specialists 

but also for researchers in dentistry, 

pharmacy, nursing, biotechnology, social 

sciences, anthropology, genetics, and other 

disciplines representing different perspectives 

and areas of expertise to work together in a 

mutually beneficial collaboration. Broadening 

this approach to encourage collaboration 

among research scientists in academia, 

private industry, and Federal settings 

provides expanded access to the latest 

scientific tools and technologies. 

ORWH, with the support of 23 NIH institutes, 

centers, and offices, the Agency for 

Healthcare Research and Quality (AHRQ), 

and the Food and Drug Administration 

(FDA) developed the following programs, 

beginning in 1999, to enhance collaboration 

and encourage interdisciplinary research. It 

was a prescient undertaking. The concept 

has not only been critical to the development 

of women’s health research at the NIH, but 

it also served as a template for what could 

be accomplished through interdisciplinary 

approaches throughout the NIH. 

BUILDING INTERDISCIPLINARY 

RESEARCH CAREERS IN 

WOMEN’S HEALTH 

The Building Interdisciplinary Research 

Careers in Women’s Health (BIRCWH) 

program is a novel, NIH-mentored research 

career development program (K12) for men 

and women junior faculty that is based upon 

three components: (1) career development, 

(2) strong mentoring, and (3) interdisciplinary 

research. BIRCWH supports the training of 

junior faculty in an interdisciplinary mentored 

environment by pairing junior researchers 

with senior investigators in women’s health. 

Mentors are established researchers in 

their respective fields. Each scholar has an 

interdisciplinary mentoring team comprising 

at least two mentors from different 

disciplines. The BIRCWH program is a bridge 

to research independence as scholars learn 

not only research techniques, but also the 
skills to become independent investigators 

and mentors. A key goal of BIRCWH is to 

promote sustained independent research 

careers. Scholar research areas cover a 

variety of topics including mental health, 

diabetes, cardiovascular health, neurological 

disorders, trauma, health disparities, 

reproductive health, menopausal hormone 

therapy, substance abuse, cancer, and 

arthritis/musculoskeletal health. 

The success of the program is impressive. 

Since its inception in 1999, 63 BIRCWH 

career development programs have been 

established at 41 institutions, with 27 

programs currently active. To date almost 

400 individuals have participated in the 

program as BIRCWH scholars, of whom 80% 

have been women. These scholars will further 

advance and support the interdisciplinary 

team approach to science and health care, 

providing valuable knowledge in overcoming 

the fragmentation of women’s health care 

delivery. Support for the BIRCWH program 

comes from ORWH; multiple institutes, 

centers, and offices at the NIH; and AHRQ. 

ORWH INTERDISCIPLINARY RESEARCH 

AND CAREER DEVELOPMENT PROGRAMS 

BIRCWH—29 Programs 

SCOR—11 Centers 

24 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

SPECIALIZED CENTERS 

OF RESEARCH ON SEX AND 

GENDER FACTORS AFFECTING 

WOMEN’S HEALTH 

The Specialized Centers of Research (SCOR) 

on Sex and Gender Factors Affecting Women’s 

Health program consists of 11 currently funded 

P50 centers that conduct interdisciplinary 

research focused on major medical problems 

affecting women and examine the influence 

of sex/gender on health and disease. A 

SCOR consists of at least three individual 

but interrelated research projects, each 

with high scientific merit and clear research 

objectives and, in the aggregate, devoted 

to a specific major health area. Basic, 

translational, and clinical research must be 

included. Each center has an administrative 

core to coordinate the research program, 

providing intellectual leadership as well as 

basic management functions. Many programs 

include one or more core resources, defined 

as a resource shared by multiple investigators 

that enhances research productivity and 

increases the functional capacity of the 

SCOR. Collaboration and sharing of scarce 

resources among institutions is encouraged 

within any given SCOR. 

The currently funded SCOR programs 

are interdepartmental, intercollegiate, 

and interinstitutional, covering research 

on depression, pain, urinary tract health, 

reproductive issues, substance abuse, and 

osteoporosis. With a focus on sex/gender 

research, the SCOR program hopes to 

improve the lives of girls and women through 

research that examines how health or disease 

may differ between women and men, as well 

as how such differences affect diagnosis, 

progression, and treatment of diseases 

across the lifespan. By integrating sex 

differences research into broad experimental 

methodologies and scientific approaches, 

SCORs ensure that new therapies and diagnostic 

tools will be developed that will ultimately 

improve the future practice of health care. 

Support for the SCOR program comes 

from ORWH; multiple institutes, centers, 

and offices at the NIH; and the FDA. 

ADVANCING NOVEL SCIENCE 

IN WOMEN’S HEALTH RESEARCH 

Established in 2007, the Advancing Novel 

Science in Women’s Health Research 

(ANSWHR) program is aimed at stimulating 

new approaches to women’s health research 

using a 2-year R21 grant mechanism. The 

program solicits investigator-initiated, 

innovative, interdisciplinary research that 

will advance new concepts in women’s 

health research and the study of sex/ 

gender differences. Since its inception, 

the ANSWHR program has partnered with 

most of the institutes and centers at the 

NIH to support research in multiple areas of 

science, including cancer, human genetics, 

drug and alcohol abuse, heart diseases, 

immune disorders, lupus, infectious diseases, 

mental health, pain, obesity, pulmonary 

dysfunction, pregnancy, ovarian dysfunction, 

and stress. Prevention research is one of the 

areas of special emphasis for the ANSWHR 

program. Such research spans the continuum 

from the most basic biological studies to 

understanding the basis and effects of 

risk behaviors across the lifespan and the 

interventions to change them, including a 

focus on wellness and healthy behaviors. The 

program is highly competitive and between 

80 and 165 applications are received annually. 

25 
RESEARCH ENHANCEMENT 

AWARDS PROGRAM 

ORWH developed a trans-NIH Research 

Enhancement Awards Program (REAP) in 

the mid-1990s as a mechanism to facilitate 

cofunding of NIH institute and center peer 

reviewed research that might otherwise not 

be funded. The REAP program spans basic, 

clinical, behavioral, and translational research. 

The program offers 1 year of support for 

meritorious research in women’s health that 

has just missed the payline for funding by 

an institute or center at the NIH. The “out 

year” funds are provided by the primary 

NIH institute or center. This program was 

developed to increase the number of new 

research studies of women’s health and the 

study of sex/gender factors by collaborating 

with the NIH institutes, centers, and offices 

to identify and cofund meritorious research 

grants. The REAP program broadens and 

enhances the NIH women’s health research 

portfolio by supporting a wide range of 

scientific areas. 

ORWH BUDGET 

The ORWH was established in 1990 with 

a budget that covered staff requirements 

and minor programmatic activities. As 

increases took place, ORWH developed the 

programmatic initiatives that would have 

a major influence on women’s health and 

career development and training. Early 

planning in 1999, coupled with increases in 

the budget between 2001 and 2002, led to 

the development and implementation of the 

BIRCWH and SCOR programs. An additional 

increase in the 2007 budget facilitated the 

development of the ANSWHR program. The 

following graphic shows the budget history 

of ORWH since its founding. 

ORWH FUNDING HISTORY 

$50,000,000

$37,500,000

$25,000,000

$12,500,000

$0

FY 1991FY 1992FY 1993FY 1994FY 1995FY 1996FY 1997FY 1998FY 1999FY 2000FY 2001FY 2002FY 2003FY 2004FY 2005FY 2006FY 2007FY 2008FY 2009FY 2010

26 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

27 

APPENDIX A: HOSTS AND WORKING GROUP 

COCHAIRS OF THE REGIONAL SCIENTIFIC MEETINGS 

WASHINGTON UNIVERSITY IN ST. LOUIS SCHOOL OF MEDICINE 

ST. LOUIS, MISSOURI • MARCH 4–6, 2009
�

HOST: Scott Hultgren, Ph.D., Helen L. Stoever Professor in Molecular Microbiology 

and Director, Center for Women’s Infectious Disease Research
�

BLADDER AND PELVIC FLOOR 

DISORDERS 

Jeanette Brown, M.D. 

Professor of Obstetrics, Gynecology, and 

Reproductive Sciences; Epidemiology and 

Biostatistics; and Urology 

Director, Women’s Continence Center 

University of California, San Francisco 

San Francisco, California 

Kimberly S. Kenton, M.D., M.S., FACOG 

Associate Professor, Department 

of Obstetrics and Gynecology and 

Department of Urology 

Director, Female Pelvic and 

Reconstructive Surgery 

Fellowship Program 

Loyola University Medical Center 

Maywood, Illinois 

Chris Mullins, Ph.D. 

Director of Basic Cell Biology Programs in 

Urologic and Kidney Disease 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Estella Parrott, M.D., M.P.H. 

Medical Officer 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

BRAIN AND 

PSYCHIATRIC DISORDERS 

Nancy L. Desmond, Ph.D. 

Associate Division Director 

Division of Neurosciences and Basic 

Behavioral Science 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

Jill M. Goldstein, Ph.D. 

Professor of Psychiatry 

Director of Research for Women’s Health 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Rajita Sinha, Ph.D. 

Professor of Psychiatry 

Director, Yale Stress Center 

Yale University 

New Haven, Connecticut 

CHRONIC PAIN SYNDROMES 

Leslie J. Crofford, M.D. 

Professor of Internal Medicine 

Chief, Division of Rheumatology 

University of Kentucky 

Lexington, Kentucky 

Emeran A. Mayer, M.D. 

Director, UCLA Center for Neurobiology 

of Stress 

University of California, Los Angeles 

Los Angeles, California 

Chris Mullins, Ph.D. 

Director of Basic Cell Biology Programs in 

Urologic and Kidney Disease 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Linda I. Porter, Ph.D. 

Program Director, Extramural Research 

Program 

National Institute of Neurological 

Disorders and Stroke 

National Institutes of Health 

Bethesda, Maryland 

EATING DISORDERS 

Mark Chavez, Ph.D. 

Associate Director for Research Training 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

B. Timothy Walsh, M.D. 

Professor of Psychiatry 

College of Physicians and Surgeons 

Columbia University 

New York, New York 

Denise E. Wilfley, Ph.D. 

Professor 

Departments of Psychiatry, Medicine, 

Pediatrics, and Psychology 

Washington University in St. Louis School 

of Medicine 

St. Louis, Missouri 

GENETICS AND MICROBIAL 

COMMUNITIES (METAGENOMICS/ 

MICROBIOME) 

Larry Forney, Ph.D. 

Professor, Biological Sciences 

University of Idaho 

Moscow, Idaho 

Maria Y. Giovanni, Ph.D. 

Assistant Director for Microbial Genomics 

National Institute of Allergy and 

Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Jacques Ravel, Ph.D. 

Associate Professor 

Institute for Genome Sciences 

University of Maryland School of Medicine 

Baltimore, Maryland 

INFECTIOUS DISEASES OF 

THE URINARY AND 

REPRODUCTIVE TRACTS 

Carolyn Deal, Ph.D. 

Branch Chief 

Sexually Transmitted Disease Branch 

National Institute of Allergy and 

Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Eve M. Lackritz, M.D. 

Division of Reproductive Health 

Centers for Disease Control 

and Prevention 

Atlanta, Georgia 
28 

Uma M. Reddy, M.D., M.P.H. 

Medical Officer 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Craig Rubens, M.D., Ph.D. 

Executive Director, Global Alliance to 

Prevent Prematurity & Stillbirth 

Seattle Children’s Hospital/University 

of Washington 

Seattle, Washington 

OBESITY 

Graham A. Colditz, M.D., Dr.P.H. 

Niess-Gain Professor of Surgery, 

Professor of Medicine 

Washington University in St. Louis School 

of Medicine 

St. Louis, Missouri 

Samuel Klein, M.D. 

Chief, Division of Geriatrics and 

Nutritional Science 

Director, Center for Human Nutrition 

Washington University in St. Louis 

School of Medicine 

St. Louis, Missouri 

Charlotte A. Pratt, Ph.D., RD 

Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

WOMEN IN 

BIOMEDICAL CAREERS 

Phoebe S. Leboy, Ph.D. 

President, Association for Women 

in Science 

Professor Emerita of Biochemistry 

University of Pennsylvania School of 

Dental Medicine 

Narberth, Pennsylvania 

Walter Schaffer, Ph.D. 

Senior Scientific Advisor for 

Extramural Research 

Office of Extramural Research 

National Institutes of Health 

Bethesda, Maryland 

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO (UCSF) 

SAN FRANCISCO, CALIFORNIA • MAY 27–29, 2009 

HOSTS: Linda C. Giudice, M.D., Ph.D., M.Sc., Robert B. Jaffe. M.D. Endowed Professor and Chair,
�

UCSF Obstetrics, Gynecology & Reproductive Sciences • Nancy Milliken, M.D., Vice Dean of the UCSF 

School of Medicine & Director of the UCSF National Center of Excellence in Women’s Health
�

GLOBAL WOMEN’S HEALTH 

Kirsten Bibbins-Domingo, M.D., Ph.D., 

M.A.S. 

Associate Professor of Medicine and of 

Epidemiology and Biostatistics 

UCSF Center for Vulnerable Populations 

at San Francisco General Hospital and 

Trauma Center 

University of California, San Francisco 

San Francisco, California 

Warner C. Greene, M.D., Ph.D. 

Director and Professor 

Gladstone Institute of Virology 

and Immunology 

University of California, San Francisco 

San Francisco, California 

Gray Handley, M.S.P.H. 

Associate Driector for International 

Research Affairs 

National Institute of Allergy and 

Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Amy J. Levi, Ph.D., CNM 

Associate Clinical Professor 

University of California, San Francisco 

San Francisco, California 

Lynne M. Mofenson, M.D. 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Paula Tavrow, Ph.D. 

Director and Assistant Professor 

Bixby Program in Population and 

Reproductive Health 

UCLA School of Public Health 

University of California, Los Angeles 

Los Angeles, California 

Linda L. Wright, M.D. 

Deputy Director 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

STEM CELLS 

Susan J. Fisher, Ph.D. 

Professor, Oral Biology; Professor 

of Pharmaceutical Chemistry; 

Professor of Anatomy 

Faculty Director, Biomolecular 

Resource Center 

University of California, San Francisco 

San Francisco, California 

Nadya L. Lumelsky, Ph.D. 

Program Director 

Division of Extramural Research 

National Institute of Dental and 

Craniofacial Research 

National Institutes of Health 

Bethesda, Maryland 

Pamela Robey, Ph.D. 

Craniofacial and Skeletal Diseases Branch 

National Institute of Dental and 

Craniofacial Research 

National Institutes of Health 

Bethesda, Maryland 

Zena Werb, Ph.D. 

Professor and Vice Chair, Department 

of Anatomy 

University of California, San Francisco 

San Francisco, California 

WOMEN’S HEALTH & THE 

ENVIRONMENT 

Lawrence H. Kushi, Sc.D. 

Associate Director, Division of Research 

Kaiser Permanente 

Oakland, California 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

Estella Parrott, M.D., M.P.H. 

Program Director 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Eveline Shen, M.P.H. 

Executive Director 

Asian Communites for 

Reproductive Justice 

Oakland, California 

Kristina Thayer, Ph.D. 

Staff Scientist 

National Institute of Environmental 

Health Sciences, National 

Toxicology Program 

Center for the Evaluation of Risks to 

Human Reproduction 

National Institutes of Health 

Durham, North Carolina 

Deborah Winn, Ph.D. 

Deputy Director 

Division of Cancer Control and 

Population Sciences 

National Cancer Institute 

National Institutes of Health 

Bethesda, Maryland 

Tracey Woodruff, Ph.D., M.P.H. 

Associate Professor and Director 

Program on Reproductive Health 

and the Environment 

University of California, San Francisco 

Oakland, California 

HIV/AIDS AND WOMEN 

Anissa Brown, Ph.D. 

Office of AIDS Research 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

Ruth Greenblatt, M.D. 

Professor of Clinical Pharmacy 

University of California, San Francisco 

San Francisco, California 

Susan Plaeger, Ph.D. 

Director, Basic Sciences Program 

Division of AIDS 

National Institute of Allergy and 

Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Dawn K. Smith, M.D., M.S., M.P.H. 

Associate Chief for Science, 

Epidemiology Branch 

Division of HIV/AIDS Prevention 

Centers for Disease Control 

and Prevention 

Atlanta, Georgia 

INFORMATION TECHNOLOGY 

Irene Sue Dubman, M.A. 

Senior Director, Standards & Architecture 

Genzyme 

Cambridge, Massachusetts 

Laura J. Esserman, M.D., M.B.A. 

Director, Carol Franc Buck Breast 

Care Center 

University of California, San Francisco 

San Francisco, California 

Barbara A. Rapp, Ph.D. 

Chief, Office of Planning and Analysis 

National Library of Medicine 

National Institutes of Health 

Bethesda, Maryland 

WOMEN IN SCIENCE AND 

HEALTH CAREERS 

Elena Fuentes-Afflick, M.D., M.P.H. 

Professor of Pediatrics, Epidemiology, 

and Biostatistics 

San Francisco General Hospital 

University of California, San Francisco 

San Francisco, California 

J. Taylor Harden, Ph.D. 

Office of the Director 

National Institute on Aging 

National Institutes of Health 

Bethesda, Maryland 

Joan Y. Reede, M.D., M.P.H., M.B.A. 

Dean for Diversity and 

Community Partnership 

Harvard Medical School 

Boston, Massachusetts 

Joan P. Schwartz, Ph.D. 

Assistant Director 

Office of Intramural Research 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

THE WARREN ALPERT MEDICAL SCHOOL OF BROWN UNIVERSITY 

AND WOMEN & INFANTS HOSPITAL OF RHODE ISLAND
�

PROVIDENCE, RHODE ISLAND • SEPTEMBER 21–23, 2009
�

HOSTS: Joanna M. Cain, M.D., Chace/Joukowsky Professor and Chair, Obstetrics and Gynecology;
�

Assistant Dean for Women’s Health • Constance A. Howes, J.D., President, Women & Infants Hospital
�

PRENATAL, INFANCY, AND 

CHILDHOOD YEARS 

Gilman Grave, M.D. 

Endocrinology, Nutrition, and 

Growth Branch 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Melissa Jo Kottke, M.D., M.P.H. 

Cochair 

Emory University School of Medicine 

Atlanta, Georgia 

Louise E. Wilkins-Haug, M.D., Ph.D. 

Division, Director, Maternal-Fetal 

Medicine and Reproductive Genetics 

Brigham and Women’s Hospital 

Boston, Massachusetts 

ADOLESCENT YEARS 

Christine A. Bachrach, Ph.D. 

Acting Director 

Office of Behavioral and Social 

Sciences Research 

National Institutes of Health 

Bethesda, Maryland 

29 
Michelle Berlin, M.D., M.P.H. 

Vice Chair, OB/GYN & Director 

OHSU Center of Excellence in 

Women’s Health 

Oregon Health & Science University 

Portland, Oregon 

Sandra A. Carson, M.D. 

Medical Director of Women & Infants’ 

Center for Reproduction and Infertility 

Director of the Division of Reproductive 

Endocrinology and Infertility 

Women & Infants Hospital of 

Rhode Island 

The Warren Alpert Medical School of 

Brown University 

Providence, Rhode Island 

REPRODUCTIVE AND 

MIDDLE YEARS 

Robert Barbieri, M.D. 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Alan DeCherney, M.D. 

Program Head 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Valerie C. Montgomery Rice, M.D. 

Executive Director, CWHR 

Meharry Medical College 

Nashville, Tennessee 

Cynthia Casson Morton, Ph.D. 

Professor 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

PREGNANCY 

Alicia Y. Armstrong, M.D., MHSCR 

Associate Fellowship Director, 

Reproductive Endocrinology Fellowship 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Walter Reed Army Medical Center 

Bethesda, Maryland 

Lucia Larson, M.D. 

Director, Division of Obstetric and 

Consultative Medicine 

Women & Infants Hospital of 

Rhode Island 

The Warren Alpert Medical School of 

Brown University 

Providence, Rhode Island 

Donald R. Mattison, M.D. 

Senior Advisor 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Errol R. Norwitz, M.D., Ph.D. 

Professor 

Yale University School of Medicine 

New Haven, Connecticut 

Chairperson, Obstetrics and Gynecology Katharine Wenstrom, M.D. 

Director, Maternal-Fetal Medicine Division 

Women & Infants Hospital of 

Rhode Island 

Providence, Rhode Island 

MENOPAUSAL TRANSITION 

Paul A. DiSilvestro, M.D. 

Principal Investigator for Gynecologic 

Oncology Group 

The Warren Alpert Medical School of 

Brown University 

Women & Infants Hospital 

Providence, Rhode Island 

Andrew A. Monjan, Ph.D., M.P.H. 

Scientist Consultant 

National Institute on Aging 

National Institutes of Health 

Columbia, Maryland 

Robert W. Rebar, M.D. 

Executive Director 

American Society for 

Reproductive Medicine 

Birmingham, Alabama 

Jacques E. Rossouw, M.D. 

Branch Chief 

Women’s Health Initiative 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Marcia L. Stefanick, Ph.D. 

Professor of Medicine and Professor 

of OB/GYN 

Stanford Prevention Research Center 

Stanford University 

Stanford, California 

ELDERLY, FRAIL ELDERLY, 

AND HEALTHY AGING 

Richard Besdine, M.D. 

Professor of Medicine 

Director of the Center for Gerontology 

and Health Care Research at 

Brown University 

Director of the Division of Geriatrics in 

the Department of Medicine 

Chief of Geriatrics for Lifespan 

Greer Professor of Geriatric Medicine 

The Warren Alpert Medical School of 

Brown University 

Providence, Rhode Island 

Stefan Gravenstein, M.D., M.P.H., CMD, 

FACP, AGSF 

Clinical Director, Quality Partners 

of Rhode Island 

Division of Geriatrics, Department 

of Medicine 

The Warren Alpert Medical School 

of Brown University 

Providence, Rhode Island 

Stacy Tessler Lindau, M.D., M.A.P.P. 

Assistant Professor 

University of Chicago 

Chicago, Illinois 

Susan M. Resnick, Ph.D. 

Senior Investigator 

National Institute on Aging 

National Institutes of Health 

Baltimore, Maryland 

Bernadette Tyree, Ph.D. 

Health Scientist Administrator 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases 

National Institutes of Health 

Bethesda, Maryland 

ORAL HEALTH AND 

SYSTEMIC CONDITIONS 

Jane C. Atkinson, D.D.S. 

Director, Center for Clinical Research 

National Institute of Dental and 

Craniofacial Research 

National Institutes of Health 

Bethesda, Maryland 

Raul Garcia, D.M.D., M.M.Sc. 

Professor and Chair 

Henry M. Goldman School of 

Dental Medicine 

Boston University 

Boston, Massachusetts 

30 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

Brenda Heaton, M.P.H. 

Investigator 

Henry M. Goldman School of 

Dental Medicine 

Boston University 

Boston, Massachusetts 

Michelle M. Henshaw, D.D.S. 

Assistant Dean 

Henry M. Goldman School of Dental 

Medicine 

Boston University 

Boston, Massachusetts 

CAREERS IN DENTISTRY, 

BIOENGINEERING, AND OTHER 

NON-M.D. DISCIPLINES 

Paula K. Friedman, D.D.S., M.S.D., M.P.H. 

Associate Dean for Strategic Initiatives 

Henry M. Goldman School of 

Dental Medicine 

Boston University 

Boston, Massachusetts 

therine K. KaC uo . , Ph.D

sor esoft PrtansisAs

Biomedical Engineering 

y siterufts UnivT

ts tsachused, MasorMedf

Brenda Korte, Ph.D. 

Program Director 

National Institute of Biomedical Imaging 

and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging 

and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Valerie Wilson, Ph.D. 

Associate Provost and Director of 

Institutional Diversity 

Brown University 

Providence, Rhode Island 

NORTHWESTERN UNIVERSITY FEINBERG SCHOOL OF MEDICINE,
�

NORTHWESTERN MEMORIAL HOSPITAL
�

CHICAGO, ILLINOIS • OCTOBER 14–16, 2009
�

HOST: Andrea Dunaif, M.D., Charles F. Kettering Professor of Medicine; 

Chief, Division of Endocrinology, Metabolism, and Molecular Medicine 

UNDERSTUDIED AND 

UNDERREPRESENTED 

POPULATIONS 

Vickie M. Mays, Ph.D., M.S.P.H. 

Department of Health Services 

University of California, Los Angeles 

School of Public Health 

Los Angeles, California 

Gloria Sarto, M.D., Ph.D. 

Professor, Department of 

Obstetrics & Gynecology 

Co-Director, Center for Women’s 

Health Research 

University of Wisconsin–Madison 

Madison, Wisconsin 

UNDERSTUDIED AND 

UNDERREPRESENTED 

POPULATIONS SUBGROUP 1: 

MINORITIES, URBAN, RURAL, 

AND ISSUES OF POVERTY 

Pamela K. Brown, M.P.A. 

Associate Director, Mary Babb Randolph 

Cancer Center 

Past Chair, Intercultural Cancer Council 

Morgantown, West Virginia 

Rebecca L. Clark, Ph.D. 

Extramural Program Staff 

Demographic & Behavioral 

Sciences Branch 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Naomi Lynn Gerber, M.D. 

Director, Center for the Study of Chronic 

Illness and Disability 

George Mason University 

Fairfax, Virginia 

Celia J. Maxwell, M.D. 

Assistant Vice President for 

Health Sciences 

Howard University Hospital 

Washington, D.C. 

Anne E. Sumner, M.D. 

Investigator 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Derrick Tabor, Ph.D. 

Centers of Excellence Program, Office of 

Scientific Programs 

National Center on Minority Health and 

Health Disparities 

National Institutes of Health 

Bethesda, Maryland 

UNDERSTUDIED AND 

UNDERREPRESENTED 

POPULATIONS SUBGROUP 

2: LESBIAN, BISEXUAL, 

TRANSGENDER, AND INTERSEX 

ISSUES 

Christine A. Bachrach, Ph.D. 

Acting Director 

Office of Behavioral and Social 

Sciences Research 

National Institutes of Health 

Bethesda, Maryland 

Judith Bradford, Ph.D. 

Professor, Institute for Women’s Health 

Virginia Commonwealth University 

Co-Chair, The Fenway Institute, 

Fenway Health 

Boston, Massachusetts 31 
Tonda L. Hughes, Ph.D. 

Research Director, Professor, 

Department Head 

National Center of Excellence in 

Women’s Health 

College of Nursing 

University of Illinois at Chicago 

Chicago, Illinois 

Alicia Matthews, Ph.D. 

Associate Professor, Department of 

Health Systems Science 

University of Illinois at Chicago 

Chicago, Illinois 

Diane Abbe Sabin, D.C. 

Executive Director 

Lesbian Health & Research Center 

University of California, San Francisco 

San Francisco, California 

CLINICAL AND 

TRANSLATIONAL RESEARCH 

Mary A. Foulkes, Ph.D.
�

Research Professor, Department 

of Epidemiology and Biostatistics, 

Department of Health Policy 

The George Washington University
�

Washington, D.C.
�

Stacie E. Geller, Ph.D.
�

Professor, Department of Obstetrics 

and Gynecology
�

Center for Research on Women 

and Gender
�

University of Illinois at Chicago
�

Chicago, Illinois 

Martha Hare, Ph.D., RN
�

Health Scientist Administrator/
�

Program Director
�

National Cancer Institute 

National Institutes of Health
�

Bethesda, Maryland
�

Carole Ann Heilman, Ph.D.
�

Director, Division of Microbiology and 

Infectious Diseases 

National Institute of Allergy and 

Infectious Diseases
�

National Institutes of Health
�

Bethesda, Maryland
�

Kwame Osei, M.D.
�

Professor of Medicine

The Ohio State University
�

Columbus, Ohio
�

NEW TECHNOLOGIES/ 

BIOENGINEERING/IMAGING 

John O. De Lancey, M.D. 

Professor, Department of Obstetrics 

and Gynecology 

University of Michigan 

Ann Arbor, Michigan 

Guoying Liu, Ph.D. 

Program Director 

National Institute of Biomedical Imaging 

and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging 

and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Teresa K. Woodruff, Ph.D. 

Professor of Obstetrics and Gynecology 

Professor of Biochemistry, Molecular 

Biology, and Cell Biology 

Northwestern University 

Chicago, Illinois 

GENETICS AND EPIGENETICS 

Geoff Hayes, Ph.D. 

Assistant Professor, Endocrinology 

Northwestern University 

Chicago, Illinois 

Kathryn Sandberg, Ph.D. 

Professor of Medicine 

Director, Center for the Study of 

Sex Differences 

Georgetown University 

Washington, D.C. 

Susan Taymans, Ph.D. 

Program Director 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

SEX HORMONES AND DISEASE 

Louis V. DePaolo, Ph.D. 

Chief, Reproductive Sciences Branch 

Eunice Kennedy Shriver National Institute 

for Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Andrea Dunaif, M.D. 

Professor and Chief, Division of 

Endocrinology, Metabolism and 

Molecular Medicine 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

David A. Ehrmann, M.D. 

Professor of Medicine 

Associate Director, University of Chicago 

Clinical Research Center 

Director, University of Chicago 

Center for PCOS 

University of Chicago 

Chicago, Illinois 

NEUROSCIENCE 

Jon E. Levine, Ph.D. 

Professor, Department of Neurobiology 

and Physiology 

Northwestern University 

Evanston, Illinois 

Cheryl L. Sisk, Ph.D. 

Director, Neuroscience Program 

Michigan State University 

East Lansing, Michigan 

WOMEN IN SCIENCE CAREERS 

Molly L. Carnes, M.D., M.S. 

Professor and Center Director 

University of Wisconsin–Madison 

Madison, Wisconsin 

Sandra Kazahn Masur, Ph.D. 

Director, Office for Women’s Careers 

Department of Ophthalmology 

Mount Sinai School of Medicine 

New York, New York 

Rodney E. Ulane, Ph.D. 

Director, Division of Scientific Programs 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

University of Colorado Denver 

School of Medicine 

Aurora, Colorado 

32 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

EMORY UNIVERSITY SCHOOL OF MEDICINE 

ATLANTA, GEORGIA • FEBRUARY 16–17, 2010 

HOST: Nanette K. Wenger, M.D., Professor of Medicine (Cardiology)
�

PREGNANCY AND 

CARDIOVASCULAR DISEASE 

RESEARCH AND ETHICAL 

CONSIDERATIONS 

Janet W. Rich-Edwards, M.P.H., Sc.D. 

Director of Developmental Epidemiology 

Division of Women’s Health, Department 

of Medicine 

Brigham and Women’s Hospital 

Boston, Massachusetts 

Catherine Y. Spong, M.D. 

Chief, Pregnancy and Perinatology 

Branch 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Robert N. Taylor, M.D., Ph.D. 

Professor and Vice Chair for Research 

Gynecology and Obstetrics 

Emory University School of Medicine 

Atlanta, Georgia 

CARDIOVASCULAR DISEASE 

IN ELDERLY AND FRAIL 

ELDERLY WOMEN: OPTIMAL 

MANAGEMENT AND RESEARCH 

Elizabeth O. Ofili, M.D. 

Professor of Medicine, Chief of 

Cardiology, and Associate Dean of 

Clinical Research 

Clinical Research Center 

Morehouse School of Medicine 

Atlanta, Georgia 

Jacques E. Rossouw, M.D. 

Chief, Women’s Health Initiative Branch 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Viola Vaccarino, M.D., Ph.D. 

Professor of Medicine (Cardiology) 

Emory University School of Medicine 

Atlanta, Georgia 

MICROVASCULAR DISEASE, 

BIOMECHANICS, AND 

APPLICATION OF NEW 

TECHNOLOGIES TO 

CARDIOVASCULAR RESEARCH 

Barbara D. Boyan, Ph.D. 

Professor 

Biomedical Engineering 

Georgia Institute of Technology 

Atlanta, Georgia 

Gary Gibbons, M.D. 

Director, Cardiovascular Research 

Institute 

Professor, School of Medicine 

Cardiovascular Research Institute 

Morehouse School of Medicine 

Atlanta, Georgia 

George Sopko, M.D., M.P.H. 

Medical Officer and Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

STEM CELLS, PROGENITOR 

CELLS, AND THE VISTA 

OF CARDIOVASCULAR 

REGENERATIVE MEDICINE 

Martha Shauck Lundberg, Ph.D. 

Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Robert Nerem, Ph.D. 

Parker H. Petit Distinguished Chair for 

Engineering in Medicine 

Institute Professor 

Georgia Institute of Technology 

Atlanta, Georgia 

Arshed A. Quyyumi, M.D., FRCP 

Professor of Medicine, Division 

of Cardiology 

Emory University School of Medicine 

Atlanta, Georgia 

UNMET NEEDS IN DIAGNOSTIC 

TESTING FOR WOMEN WITH 

CARDIOVASCULAR DISEASE 

Patrice Desvigne-Nickens, M.D. 

Medical Officer 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Leslee Shaw, Ph.D. 

Professor 

Department of Cardiology 

Emory University School of Medicine 

Atlanta, Georgia 

ISSUES OF CARDIOVASCULAR 

PREVENTION ACROSS 

THE LIFESPAN WITH AN 

EMPHASIS ON GENDER AND 

UNDERSERVED POPULATIONS 

Jane L. Harman, D.V.M., Ph.D., M.S. 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Catherine (Cay) Loria, Ph.D., M.S. 

Nutritional Epidemiologist 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Peter W.F. Wilson, M.D. 

Professor of Medicine 

Medicine/Cardiology 

Emory University School of Medicine 

Atlanta, Georgia 

Jackson T. Wright, Jr., M.D., Ph.D. 

Professor of Medicine 

Nephrology and Hypertension/Medicine 

Case Western Reserve University 

Cleveland, Ohio 

WOMEN’S CAREERS IN THE 

BIOMEDICAL SCIENCES 

Nakela Cook, M.D., M.P.H. 

Medical Officer 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

University of Colorado Denver School 

of Medicine 

Aurora, Colorado 

33 
APPENDIX B: ADVISORY COMMITTEE ON RESEARCH 

ON WOMEN’S HEALTH • FY 2010–2011 

Vivian W. Pinn, M.D., Chairperson 

Associate Director for Research on 

Women’s Health 

Director, Office of Research on 

Women’s Health 

National Institutes of Health 

Joyce Rudick, Executive Secretary 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Francisco Garcia, M.D., M.P.H. 

Distinguished Outreach Professor 

of Obstetrics and Gynecology and 

Public Health 

Director, Center of Excellence in 

Women’s Health 

The University of Arizona 

Margery L.S. Gass, M.D. 

Executive Director 

North American Menopause 

Society (NAMS) 

Ronald S. Gibbs, M.D. 

Professor, Department of 

Obstetrics & Gynecology 

Associate Dean, Continuing 

Medical Education 

University of Colorado Denver 

School of Medicine 

Linda C. Giudice, M.D., Ph.D. 

The Robert B. Jaffe, M.D., Endowed 

Professor and Chair 

Department of Obstetrics, Gynecology 

and Reproductive Sciences 

University of California, San Francisco 

Ronda S. Henry-Tillman, M.D. 

Practice Director, Ladies’ Oncology Clinic 

Director, Cancer Control 

Winthrop P. Rockefeller Cancer Institute 

University of Arkansas for 

Medical Sciences 

Constance A. Howes, J.D. 

President and Chief Executive Officer 

Women & Infants Hospital of 

Rhode Island 

Scott J. Hultgren, Ph.D. 

Helen L. Stoever Professor of 

Molecular Microbiology 

Director of the Center for Women’s 

Infectious Disease Research 

Department of Molecular Microbiology 

Washington University School of 

Medicine 

Paula A. Johnson, M.D., M.P.H. 

Executive Director, Connors Center for 

Women’s Health and Gender Biology 

Chief, Division of Women’s Health 

Brigham and Women’s Hospital 

Karen Kim, M.D., M.S. 

Associate Professor of Medicine 

The University of Chicago 

Nancy H. Nielsen, M.D., Ph.D. 

Immediate Past President, American 

Medical Association 

Senior Associate Dean 

SUNY at Buffalo School of Medicine and 

Biomedical Sciences 

Office of Medical Education 

SUNY at Buffalo 

Nancy Norton 

Founder and President, International 

Foundation for Functional 

Gastrointestinal Disorders 

Chairperson, Digestive Disease 

National Coalition 

Mary Beth O’Connell, Pharm.D., 

BCPS, FASHP, FCCP 

Associate Professor, Wayne 

State University 

Eugene Applebaum College of 

Pharmacy & Health Sciences 

Mary I. O’Connor, M.D. 

Chair, Department of Orthopedic Surgery 

Department of Orthopedics, Mayo Clinic 

Eugene P. Orringer, M.D. 

Executive Associate Dean for Faculty 

Affairs and Faculty Development 

School of Medicine 

University of North Carolina, Chapel Hill 

Claire Pomeroy, M.D., M.B.A. 

Vice Chancellor, Human Health Sciences 

Dean, School of Medicine 

Professor of Internal Medicine and 

Microbiology/Immunology 

University of California, Davis 

Sally Rosen, M.D., M.F.S. 

Founding Director, Center for Women’s 

Health Research, Leadership 

and Advocacy 

Temple University 

Jeanne Craig Sinkford, D.D.S., Ph.D. 

Professor and Dean Emeritus 

Howard University College of Dentistry 

Associate Executive Director and Director, 

Center for Equity and Diversity 

American Dental Education Association 

Susan P. Sloan, M.D. 

Program Director, Internal Medicine 

Drexel University College of Medicine 

Farida Sohrabji, Ph.D. 

Associate Professor and Associate 

Department Head 

Department of Neuroscience and 

Experimental Therapeutics 

Texas A&M System Health Science Center 

College of Medicine 

Gary E. Striker, M.D. 

Professor 

University of Miami School of Medicine 

Paul F. Terranova, Ph.D. 

Vice Chancellor for Research 

Senior Associate Dean for Research 

& Graduate Education 

The University of Kansas Medical Center 

School of Medicine 

Debra Toney, Ph.D., RN 

President, TLC Health Care Service 

President, National Black Nurses 

Association 

Barbara Yee, Ph.D. 

Professor and Chair 

Department of Family and 

Consumer Sciences 

University of Hawaii at Manoa 

34
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

APPENDIX C: COORDINATING COMMITTEE 

ON RESEARCH ON WOMEN’S HEALTH 

NATIONAL INSTITUTES OF HEALTH • 2010 

Margaret V. Ames, Ph.D 

Acting Director 

Office of Science Planning 

and Assessment 

National Cancer Institute 

Jane C. Atkinson, D.D.S. 

Director, Center for Clinical Research 

National Institute of Dental and 

Craniofacial Research 

Sanja Basaric 

Program Analyst 

National Human Genome 

Research Institute 

Gina M. Brown, M.D. 

Director, Women and Girls Section 

Office of AIDS Research 

Office of the Director 

John T. Burklow 

Director, Office of Communications 

Office of the Director 

Sheila Caldwell, Ph.D. 

Program Officer 

National Center for Complementary and 

Alternative Medicine 

Victoria A. Cargill, M.D., M.S.C.E. 

Director of Minority Research and 

Clinical Studies 

Office of AIDS Research 

Office of the Director 

Deborah F. Cohen 

Director, Summer and Postbac 

IRTA Programs 

Office of Intramural Training 

and Education 

Office of the Director 

Deborah Dozier-Hall, M.S.W. 

Assistant Chief 

Social Work Department 

Warren Grant Magnuson Clinical Center 

Gale A. Dutcher, M.L.S., M.S. 

Head 

Office of Outreach and 

Special Populations 

National Library of Medicine 

Paula Flicker, Ph.D. 

Program Director 

National Institute of General 

Medical Sciences 

Eleanor F. Hoff, Ph.D. 

Health Science Policy Analyst 

Office of Scientific Program and 

Policy Analysis 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

Tanya Hoodbhoy, Ph.D. 

Program Director 

Office of Strategic Coordination 

Division of Program Coordination, 

Planning, and Strategic Initiatives 

Office of the Director 

Bonnie Kalberer 

Contractor 

Office of Science Policy 

Office of Science Education 

Linda E. Kupfer, Ph.D. 

Deputy Director 

Division of International Science Policy, 

Planning, and Evaluation 

John E. Fogarty International Center 

Tamara E. Lewis Johnson, M.P.H., M.B.A. 

Women’s Health Program Manager 

Office of Special Populations and 

Research Training 

National Institute of Allergy and 

Infectious Diseases 

Padma Maruvada, M.D. 

Health Scientist Administrator 

Division of Research Infrastructure 

National Center for Research Resources 

Barbara R. Marzetta, M.S. 

Deputy Director 

Office of Science and Technology 

National Heart, Lung, and Blood Institute 

Kate Nagy, M.A. 

Program Analyst 

National Institute on Aging 

Lisa A. Neuhold, Ph.D. 

Program Director for Retinal Diseases 

National Eye Institute 

Sheila A. Newton, Ph.D., M.S. 

Director 

Office of Policy, Planning, and Evaluation 

National Institute of Environmental 

Health Sciences 

Wendy J. Nilsen, Ph.D. 

Health Scientist Administration 

Office of Behavioral and Social Sciences 

Research 

Office of the Director 

Kathleen M. O’Leary, M.S.W. 

Deputy Chief, Women’s Programs 

National Institute of Mental Health 

Karen L. Parker, M.S.W. 

Senior Health Science Analyst 

Office of Science Planning 

and Assessment 

National Cancer Institute 

Mary Frances A. Picciano, Ph.D. 

Senior Nutrition Research Scientist 

Office of Dietary Supplements 

Linda Porter, Ph.D. 

Program Director 

Systems and Cognitive 

Neuroscience Cluster 

Division of Extramural Research

 and Training 

National Institute of Neurological 

Disorders and Stroke 

35
Svetlana Radaeva, M.D. 

Program Director 

Division of Metabolism and Health Effects 

National Institute on Alcohol Abuse 

and Alcoholism 

Mona Rowe, M.C.P. 

Associate Director 

Science Policy Analysis and 

Communication 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

Lana O. Shekim, Ph.D. 

Director 

Voice and Speech Program 

National Institute on Deafness and Other 

Communication Disorders 

Derrick C. Tabor, Ph.D. 

Program Official 

Centers of Excellence 

National Center on Minority Health and 

Health Disparities 

Xenia Tigno, Ph.D., M.S. 

Program Director 

National Institute of Nursing Research 

Bernadette Tyree, Ph.D. 

Program Officer 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases 

Cora Lee Wetherington, Ph.D. 

Women and Sex/Gender Differences 

Research Coordinator 

National Institute on Drug Abuse 

Denise G. Wiesch, Ph.D. 

Scientific Review Officer 

Epidemiology of Cancer Study Section 

Center for Scientific Review 

CCRWH ALTERNATES 

Diane Adger-Johnson 

Minority Health and Research 

Training Analyst 

National Institute of Allergy and 

Infectious Diseases 

Marin P. Allen, Ph.D. 

Deputy Director 

Office of Communications 

Anissa J. Brown, Ph.D. 

Office of AIDS Research 

Paul Cotton, Ph.D. 

Program Director, Division of 

Extramural Programs 

National Institute of Nursing Research 

Anthony Demsey, Ph.D. 

Director, Extramural Policy 

National Institute of Biomedical Imaging 

and Bioengineering 

Phyllis Frosst, Ph.D. 

Head, Policy and Program Analysis 

National Human Genome 

Research Institute 

Mary M. Gant, M.S. 

Interagency Liaison 

National Institute of Environmental 

Health Sciences 

Jodi Gilman, Ph.D. 

Health Policy Analyst 

National Institute of Neurological 

Disorders and Stroke 

Ruth S. Grossman, D.D.S. 

National Institute of Biomedical Imaging 

and Bioengineering 

Mary C. Hanlon, Ph.D. 

Health Science Policy Analyst 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

Walter Jones 

Deputy Director for Management and 

Diversity Operations 

Warren Grant Magnuson Clinical Center 

Karin L. Kolsky 

Writer-Editor 

National Institute on Aging 

Donna Krasnewich, M.D., Ph.D. 

Program Director 

National Institute of General 

Medical Sciences 

Natalie Kurinij, Ph.D. 

Health Scientist Administrator 

National Eye Institute 

Anita M. Linde, M.P.P. 

Director, Office of Program Planning 

and Evaluation 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases 

Lonnie L. Lisle 

Office of Health Communication 

and Public Liaison 

National Institute on Deafness and Other 

Communication Disorders 

Sheila A. McClure, Ph.D. 

Health Scientist Administrator 

National Center for Research Resources 

Sharon L. Milgram, Ph.D. 

Director, Office of Intramural Training 

and Education 

Office of Intramural Training 

and Education 

Walter Mitton 

Community Relations Specialist 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

Samia D. Noursi, Ph.D. 

Deputy Coordinator, Women and 

Gender Research 

National Institute on Drug Abuse 

Ruth E. Nowjack-Raymer, Ph.D. 

Program Director, Health 

Disparities Research 

National Institute of Dental and 

Craniofacial Research 

Estella C. Parrott, M.D., M.P.H. 

Program Director, Reproductive 

Sciences Branch 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

Rose E. Pruitt 

Federal Women’s Program Manager 

Office of Equal Opportunity and 

Diversity Management 

Deidra Roach, M.D. 

Health Scientist Administrator 

National Institute on Alcohol Abuse 

and Alcoholism 

Catherine A. Roca, M.D. 

Contractor 

National Institute of Mental Health 

Louise Rosenbaum, Ph.D. 

Science Policy Analyst 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases 

36 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

Jacques Rossouw, M.D. 

Project Officer, Women’s Health Initiative 

National Heart, Lung, and Blood Institute 

Milagros Ruiz 

Program Analyst/Contractor 

John E. Fogarty International Center 

Joan P. Schwartz, Ph.D. 

Assistant Director 

Office of Intramural Research 

Susan Scolnik 

Program Analyst 

National Heart, Lung, and Blood Institute 

Elaine Sierra-Rivera, Ph.D. 

Scientific Review Administrator/ 

Deputy Chief 

Oncology Sciences Integrated 

Review Group 

Center for Scientific Review 

Lana R. Skirboll, Ph.D. 

Acting Director 

Division of Program Coordination, 

Planning, and Strategic Initiatives 

Nathaniel Stinson, M.D. 

National Center on Minority Health and 

Health Disparities 

Susanne S. Strickland, M.S. 

Chief, Strategic Coordination Branch and 

Women’s Health Center 

National Cancer Institute 

Stacy Wallick 

Public Health Analyst 

National Institute of Biomedical Imaging 

and Bioengineering 

37 
APPENDIX D: EXTERNAL ADVISORS ON THE NIH 

WOMEN’S HEALTH RESEARCH AGENDA 

Francisco Garcia, M.D., M.P.H. 

Distinguished Outreach Professor 

of Obstetrics and Gynecology and 

Public Health 

Director, Center of Excellence in 

Women’s Health 

The University of Arizona 

Jill M. Goldstein, Ph.D. 

Director of Research, Connors Center for 

Women’s Health and Gender Biology 

Division of Women’s Health 

Brigham and Women’s Hospital 

Scott J. Hultgren, Ph.D. 

Helen L. Stoever Professor of 

Molecular Microbiology 

Director of the Center for Women’s 

Infectious Disease Research 

Department of Molecular Microbiology 

Washington University School 

of Medicine 

Paula A. Johnson, M.D., M.P.H.
�

Executive Director, Connors Center for 

Women’s Health and Gender Biology
�

Chief, Division of Women’s Health 

Brigham and Women’s Hospital 

Linda M. Kaste, D.D.S., Ph.D., M.S.
�

Associate Professor
�

University of Illinois at Chicago, 

College of Dentistry
�

Phoebe S. Leboy, Ph.D.
�

President, Association for 

Women in Science
�

Professor
�

University of Pennsylvania
�

Jon E. Levine, Ph.D.
�

Professor, Neurobiology and Physiology
�

Northwestern University
�

Valerie C. Montgomery Rice, M.D. 

Senior Vice President for Health Affairs 

Dean, School of Medicine 

Meharry Medical College 

Nancy H. Nielsen, M.D., Ph.D. 

Senior Associate Dean, SUNY at Buffalo 

School of Medicine and 

Biomedical Sciences 

Office of Medical Education 

SUNY at Buffalo 

Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

General Internal Medicine/Cardiology 

University of Colorado-Denver School 

of Medicine 

Janet W. Rich-Edwards, M.P.H., Sc.D. 

Director of Developmental Epidemiology 

Division of Women’s Health/ 

Department of Medicine 

Brigham and Women’s Hospital 

38 
A VISION FOR 2020 FOR WOMEN’S HEALTH RESEARCH 

APPENDIX E: ORWH STAFF 

Vivian W. Pinn, M.D., 

Associate Director for Research on Women’s Health 

Director, Office of Research on Women’s Health 

Janine Austin Clayton, M.D., Deputy Director 

Lisa Begg, Dr. P.H., R.N., Director, Research Programs 

Joyce E. Rudick, Director, Programs & Management 

Angela C. Bates, M.B.A., Program Analyst 

Gerald Boston, Contractor 

Nida H. Corry, Ph.D., AAAS Science & Technology Policy Fellow 

Mary A. Foulkes, Ph.D., 

Under an Intergovernmental Personnel Act Agreement 

between George Washington University and the NIH 

Sharon E. Gist, Program Specialist 

Charlie Hampp Jr., Administrative Technician 

Eleanor Z. Hanna, Ph.D., Associate Director,

 Special Projects and Centers 

Dorie A. Hightower, Communications Director 

Sharron Jernigan-Jones, Program Support Assistant 

Indira P. Jevaji, M.D., Medical Officer 

Teresa R. Kendrix, Administrative Officer 

Joslyn Yudenfreund Kravitz, Ph.D., Program Analyst 

Kimberly S. Kurilla-Gray, Secretary to the Director 

Mary G. Lawrence, M.S., Contractor 

Dennis F. Mangan, Ph.D., Health Scientist Administrator 

Suzanne Medgyesi-Mitschang, Ph.D., Consultant 

Joan Davis Nagel, M.D., Medical Officer 

Maya W. Peterson, Contractor 

Marc L. Stern, Consultant 

Charles A. Wells, Ph.D., Senior Advisor to the Director 

ACKNOWLEDGEMENTS 

The Office of Research on Women’s Health wishes to acknowledge the contributions of the working group co-chairs, 

the many scientists, advocacy representatives and members of the public who participated in the five regional scientific 

meetings. A note of thanks also goes to the graduate and post-graduate students, and fellows at the various academic 

institutions who volunteered to assist the working group co-chairs in capturing the discussions of the individual working 

groups. A special thanks to Mary Blehar, Ph.D. and Barbara Lynch, Ph.D. for their work as the overall science writers for 

this effort, with a further acknowledgement to Dr. Blehar for her assistance to ORWH staff in developing this volume. 

39 
40

NIH Publication No. 10-7606 

Moving Into the Future With New Dimensions and Strategies: 

A Vision for 2020 for Women’s Health Research 

Office of Research on Women’s Health 

National Institutes of Health 

VOLUME II 

REGIONAL SCIENTIFIC REPORTS 

I
U.S. Department of Health and Human Services, Public Health Service, National Institutes 

of Health, Office of Research on Women’s Health. (2010). Moving Into the Future With New 

Dimensions and Strategies: A Vision for 2020 for Women’s Health Research, Volume II— 

Regional Scientific Reports. Bethesda, MD: National Institutes of Health. 

NIH Publication No. 10-7606-B 

Copies of this report and other publications of the Office of Research on Women’s Health 

are available at no charge from: 

Office of Research on Women’s Health 

National Institutes of Health 

6707 Democracy Blvd., Suite 400, MSC 5484 

Bethesda, Maryland 20892-5484 

Fax: 301-402-1798 

Voice: 301-496-8176 

http://orwhpubrequest.od.nih.gov 

II
Acknowledgments 

The Office of Research on Women’s Health (ORWH) wishes to acknowledge the many people who served on committees and contributed their collective expertise to the creation of 

Moving Into the Future With New Dimensions and Strategies: A Vision for 2020 for Women’s 

Health Research. 

Advisory Committee on Research on Women’s Health 

FY 2009–2011 

Vivian W. Pinn, M.D., Chairperson 

Associate Director for Research on Women’s Health 

Director, Office of Research on Women’s Health 

National Institutes of Health 

Joyce Rudick, Executive Secretary 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Francisco Garcia, M.D., M.P.H. 

Distinguished Outreach Professor of Obstetrics and Gynecology and Public Health 

Director, Center of Excellence in Women’s Health 

The University of Arizona 

North American Menopause Society 

Executive Director 

Margery L.S. Gass, M.D. 

Ronald S. Gibbs, M.D. 

Professor, Department of Obstetrics & Gynecology 

Associate Dean, Continuing Medical Education 

University of Colorado-Denver School of Medicine 

Linda C. Giudice, M.D., Ph.D. 

The Robert B. Jaffe, M.D., Endowed Professor and Chair 

Department of Obstetrics, Gynecology and Reproductive Sciences 

University of California, San Francisco 

Ronda S. Henry-Tillman, M.D. 

Practice Director, Ladies’ Oncology Clinic 

Director, Cancer Control 

Winthrop P. Rockefeller Cancer Institute 

University of Arkansas for Medical Sciences 

III
Constance A. Howes, J.D. 

President and Chief Executive Officer 

Women & Infants Hospital of Rhode Island 

Scott J. Hultgren, Ph.D. 

Helen L. Stoever Professor of Molecular Microbiology 

Director of the Center for Women’s Infectious Disease Research 

Department of Molecular Microbiology 

Washington University School of Medicine 

Paula A. Johnson, M.D., M.P.H. 

Executive Director, Connors Center for Women’s Health and Gender Biology 

Chief, Division of Women’s Health 

Brigham and Women’s Hospital 

Karen Kim, M.D., M.S. 

Associate Professor of Medicine 

The University of Chicago 

Nancy H. Nielsen, M.D., Ph.D. 

Senior Associate Dean 

SUNY at Buffalo School of Medicine and Biomedical Sciences 

Office of Medical Education 

SUNY at Buffalo 

Nancy Norton 

Founder and President, International Foundation for Functional Gastrointestinal Disorders 

Chairperson, Digestive Disease National Coalition 

Mary Beth O’Connell, Pharm.D., BCPS, FASHP, FCCP 

Associate Professor, Wayne State University 

Eugene Applebaum College of Pharmacy & Health Sciences 

Mary I. O’Connor, M.D. 

Chair, Department of Orthopedic Surgery 

Department of Orthopedics, Mayo Clinic 

Eugene P. Orringer, M.D. 

Executive Associate Dean for Faculty Affairs and Faculty Development 

School of Medicine 

University of North Carolina, Chapel Hill 

Claire Pomeroy, M.D., M.B.A. 

Vice Chancellor, Human Health Sciences 

Dean, School of Medicine 

Professor of Internal Medicine and Microbiology/Immunology 

University of California, Davis 

IV
Sally Rosen, M.D., M.F.S. 

Founding Director, Center for Women’s Health Research, Leadership and Advocacy 

Temple University 

Jeanne Craig Sinkford, D.D.S., Ph.D. 

Professor and Dean Emeritus 

Howard University College of Dentistry 

Associate Executive Director and Director, Center for Equity and Diversity 

American Dental Education Association 

Susan P. Sloan, M.D. 

Program Director, Internal Medicine 

Drexel University College of Medicine 

Farida Sohrabji, Ph.D. 

Associate Professor and Associate Department Head 

Department of Neuroscience and Experimental Therapeutics 

Texas A&M System Health Science Center 

College of Medicine 

Gary E. Striker, M.D. 

Professor 

University of Miami School of Medicine 

Paul F. Terranova, Ph.D. 

Vice Chancellor for Research 

Senior Associate Dean for Research & Graduate Education 

The University of Kansas Medical Center 

School of Medicine 

Debra Toney, Ph.D., R.N. 

President, TLC Health Care Service 

President, National Black Nurses Association 

Barbara Yee, Ph.D. 

Professor and Chair 

Department of Family and Consumer Sciences 

University of Hawaii at Manoa 

V
External Advisors on the NIH Women’s Health Research Agenda 

Jill M. Goldstein, Ph.D. 

Director of Research, Connors Center for Women’s Health and Gender Biology 

Division of Women’s Health 

Brigham and Women’s Hospital 

Francisco Garcia, M.D., M.P.H. 

Distinguished Outreach Professor of Obstetrics and Gynecology and Public Health 

Director, Center of Excellence in Women’s Health 

The University of Arizona 

Scott J. Hultgren, Ph.D. 

Helen L. Stoever Professor of Molecular Microbiology 

Director of the Center for Women’s Infectious Disease Research 

Department of Molecular Microbiology 

Washington University School of Medicine 

Paula A. Johnson, M.D., M.P.H. 

Executive Director, Connors Center for Women’s Health and Gender Biology 

Chief, Division of Women’s Health 

Brigham and Women’s Hospital 

Linda M. Kaste, D.D.S., Ph.D., M.S. 

Associate Professor 

University of Illinois at Chicago, College of Dentistry 

Phoebe S. Leboy, Ph.D. 

President, Association for Women in Science 

Professor, University of Pennsylvania 

Jon E. Levine, Ph.D. 

Professor, Neurobiology and Physiology 

Northwestern University 

Valerie C. Montgomery Rice, M.D. 

Senior Vice President for Health Affairs 

Dean, School of Medicine 

Meharry Medical College 

Nancy H. Nielsen, M.D., Ph.D. 

Immediate Past President, American Medical Association 

Senior Associate Dean 

SUNY at Buffalo School of Medicine and Biomedical Sciences 

Office of Medical Education 

SUNY at Buffalo 

VI
Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

General Internal Medicine/Cardiology 

University of Colorado-Denver School of Medicine 

Janet W. Rich-Edwards, M.P.H., Sc.D. 

Director of Developmental Epidemiology 

Division of Women’s Health/Department of Medicine 

Brigham and Women’s Hospital 

Coordinating Committee on Research on Women’s Health (CCRWH) 

National Institutes of Health 

2010 

Margaret V. Ames, Ph.D. 

Acting Director 

Office of Science Planning and Assessment 

National Cancer Institute 

Jane C. Atkinson, D.D.S. 

Director, Center for Clinical Research 

National Institute of Dental and Craniofacial Research 

Sanja Basaric 

Program Analyst 

National Human Genome Research Institute 

Gina M. Brown, M.D. 

Director, Women and Girls Section 

Office of AIDS Research 

Office of the Director 

John T. Burklow 

Director, Office of Communications & Public Liaison 

Office of the Director 

Sheila Caldwell, Ph.D. 

Program Officer 

National Center for Complementary and Alternative Medicine 

Victoria A. Cargill, M.D., M.S.C.E. 

Director of Minority Research and Clinical Studies 

Office of AIDS Research 

Office of the Director 

VII
Deborah F. Cohen 

Director, Summer and Postbac IRTA Programs 

Office of Intramural Training and Education 

Office of the Director 

Deborah Dozier-Hall, M.S.W. 

Assistant Chief 

Social Work Department 

NIH Clinical Center 

Gale A. Dutcher, M.L.S., M.S. 

Head 

Office of Outreach and Special Populations 

National Library of Medicine 

Paula Flicker, Ph.D. 

Program Director 

National Institute of General Medical Sciences 

Valery Gordon, Ph.D. 

Senior Extramural Policy Officer 

Office of Research Administration 

National Institute of Biomedical Imaging and Bioengineering 

Eleanor F. Hoff, Ph.D. 

Health Science Policy Analyst 

Office of Scientific Program and Policy Analysis 

National Institute of Diabetes and Digestive and Kidney Diseases 

Tanya Hoodbhoy, Ph.D. 

Program Director 

Office of Strategic Coordination 

Division of Program Coordination, Planning, and Strategic Initiatives 

Office of the Director 

Bonnie Kalberer 

Contractor 

Office of Science Policy 

Office of Science Education 

Office of the Director 

Linda E. Kupfer, Ph.D. 

Deputy Director 

Division of International Science Policy, Planning, and Evaluation 

John E. Fogarty International Center 

Tamara E. Lewis-Johnson, M.P.H., M.B.A. 

Women’s Health Program Manager 

Office of Special Populations and Research Training 

National Institute of Allergy and Infectious Diseases 

VIII
Padma Maruvada, M.D. 

Health Scientist Administrator 

Division of Research Infrastructure 

National Center for Research Resources 

Barbara R. Marzetta, M.S. 

Deputy Director 

Office of Science and Technology 

National Heart, Lung, and Blood Institute 

Kate Nagy, M.A. 

Program Analyst 

National Institute on Aging 

Lisa A. Neuhold, Ph.D. 

Program Director for Retinal Diseases 

National Eye Institute 

Sheila A. Newton, Ph.D., M.S. 

Director 

Office of Policy, Planning, and Evaluation 

National Institute of Environmental Health Sciences 

Wendy J. Nilsen, Ph.D. 

Health Scientist Administration 

Office of Behavioral and Social Sciences Research 

Office of the Director 

Kathleen M. O’Leary, M.S.W. 

Deputy Chief, Women’s Programs 

National Institute of Mental Health 

Karen L. Parker, Ph.D., M.S.W. 

Senior Health Science Analyst 

Office of Science Planning and Assessment 

National Cancer Institute 

Mary Frances A. Picciano, Ph.D. 

Senior Nutrition Research Scientist 

Office of Dietary Supplements 

Office of the Director 

(Deceased August 2010) 

Linda Porter, Ph.D. 

Program Director 

Systems and Cognitive Neuroscience Cluster 

Division of Extramural Research and Training 

National Institute of Neurological Disorders and Stroke 

IX
Svetlana Radaeva, M.D. 

Program Director 

Division of Metabolism and Health Effects 

National Institute on Alcohol Abuse and Alcoholism
�

Mona Rowe, M.C.P. 

Associate Director 

Science Policy Analysis and Communication 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Lana O. Shekim, Ph.D. 

Director 

Voice and Speech Program 

National Institute on Deafness and Other Communication Disorders 

Derrick C. Tabor, Ph.D. 

Program Official 

Centers of Excellence 

National Institute on Minority Health and Health Disparities 

Xenia Tigno, Ph.D., M.S. 

Program Director
�

National Institute of Nursing Research
�

Bernadette Tyree, Ph.D. 

Program Officer 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

Cora Lee Wetherington, Ph.D. 

Women and Sex/Gender Differences Research Coordinator 

National Institute on Drug Abuse 

Denise G. Wiesch, Ph.D. 

Scientific Review Officer 

Epidemiology of Cancer Study Section 

Center for Scientific Review
�

CCRWH Alternates 

Diane Adger-Johnson 

Minority Health and Research Training Analyst
�

National Institute of Allergy and Infectious Diseases
�

Marin P. Allen, Ph.D. 

Deputy Director
�

Office of Communications & Public Liaison
�

Office of the Director
�

Anissa J. Brown, Ph.D. 

Health Scientist Administrator
�

Office of AIDS Research
�

Office of the Director
� X
Paul Cotton, Ph.D. 

Program Director, Division of Extramural Programs 

National Institute of Nursing Research 

Anthony Demsey, Ph.D. 

Director, Extramural Policy 

National Institute of Biomedical Imaging and Bioengineering 

Phyllis Frosst, Ph.D. 

Head, Policy and Program Analysis 

National Human Genome Research Institute 

Mary M. Gant, M.S. 

Interagency Liaison 

National Institute of Environmental Health Sciences 

Jodi Gilman, Ph.D. 

Health Policy Analyst 

National Institute of Neurological Disorders and Stroke 

Ruth S. Grossman, D.D.S. 

Scientific Review Administrator 

National Institute of Biomedical Imaging and Bioengineering 

Mary C. Hanlon, Ph.D. 

Health Science Policy Analyst 

National Institute of Diabetes and Digestive and Kidney Diseases 

Walter Jones 

Deputy Director for Management and Diversity Operations 

NIH Clinical Center 

Karin L. Kolsky 

Writer-Editor 

National Institute on Aging 

Donna Krasnewich, M.D., Ph.D. 

Program Director 

National Institute of General Medical Sciences 

Natalie Kurinij, Ph.D. 

Health Scientist Administrator 

National Eye Institute 

Anita M. Linde, M.P.P. 

Director, Office of Program Planning and Evaluation 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

Lonnie L. Lisle 

Office of Health Communication and Public Liaison 

National Institute on Deafness and Other Communication Disorders 

XI
Sheila A. McClure, Ph.D. 

Health Scientist Administrator 

National Center for Research Resources 

Sharon L. Milgram, Ph.D. 

Director, Office of Intramural Training and Education 

Office of Intramural Research 

Office of the Director 

Walter Mitton 

Community Relations Specialist 

National Institute of Diabetes and Digestive and Kidney Diseases 

Samia D. Noursi, Ph.D. 

Deputy Coordinator, Women and Gender Research 

National Institute on Drug Abuse 

Ruth E. Nowjack-Raymer, Ph.D. 

Program Director, Health Disparities Research 

National Institute of Dental and Craniofacial Research 

Estella C. Parrott, M.D., M.P.H. 

Program Director, Reproductive Sciences Branch 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Rose E. Pruitt 

Federal Women’s Program Manager 

Office of Equal Opportunity and Diversity Management 

Office of the Director 

Deidra Roach, M.D. 

Health Scientist Administrator 

National Institute on Alcohol Abuse and Alcoholism 

Catherine A. Roca, M.D. 

Contractor 

National Institute of Mental Health 

Louise Rosenbaum, Ph.D. 

Science Policy Analyst 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

Jacques Rossouw, M.D. 

Project Officer, Women’s Health Initiative 

National Heart, Lung, and Blood Institute 

Joan P. Schwartz, Ph.D. 

Assistant Director 

Office of Intramural Research 

Office of the Director 

XII
Susan Scolnik 

Program Analyst 

National Heart, Lung, and Blood Institute 

Elaine Sierra-Rivera, Ph.D. 

Scientific Review Administrator/Deputy Chief 

Oncology Sciences Integrated Review Group 

Center for Scientific Review 

James M. Anderson, M.D., Ph.D. 

Director 

Division of Program Coordination, Planning, and Strategic Initiatives 

Office of the Director 

Nathaniel Stinson Jr., M.D., Ph.D., M.P.H. 

National Institute on Minority Health and Health Disparities 

Susanne S. Strickland, M.S. 

Chief, Strategic Coordination Branch and Women’s Health Center 

National Cancer Institute 

Stacy Wallick 

Public Health Analyst 

National Institute of Biomedical Imaging and Bioengineering 

ORWH also wishes to thank the cochairs of the scientific working and discussion groups, 

credited in this volume at the beginning of each individual regional scientific meeting report. 

In addition, the more than 1,500 individuals listed in the Appendices of this volume who participated in the public hearings and scientific workshops provided invaluable input to the 

strategic planning process. 

XIII
XIV
 
Table of Contents 

ACKNOWLEDGMENTS III 

INTRODUCTION 1 

REGIONAL SCIENTIFIC MEETINGS 

St. Louis, Missouri—March 4–6, 2009 

Agenda 4 

Working Group Cochairs 9 

Introduction 13 

Summary of Plenary Presentations 13 

Scientific Working and Discussion Groups 

Bladder and Pelvic Floor Disorders 22 

Brain and Psychiatric Disorders 27 

Chronic Pain Syndromes 32 

Eating Disorders 36 

Genetics and Microbial Communities (Metagenomics/Microbiome) 41 

Infectious Diseases of the Urinary and Reproductive Tracts 48 

Obesity 52 

Women in Biomedical Careers 57 

San Francisco, California—May 27–29, 2009 

Agenda 64 

Working Group Cochairs 67 

Introduction 71 

Summary of Plenary Presentations 71 

Scientific Working and Discussion Groups 

Global Women’s Health 78 

Stem Cells 87 

Women’s Health and the Environment 91 

HIV/AIDS and Women 100 

Information Technology 107 

Women in Science and Health Careers 115 

Providence, Rhode Island—September 21–23, 2009 

Agenda 123 

Working Group Cochairs 128 

Introduction 133 

Summary of Plenary Presentations 133 

XV
Scientific Working and Discussion Groups 

Prenatal, Infancy, and Childhood Years 138 

Adolescent Years 146 

Reproductive and Middle Years 151 

Pregnancy 159 

Menopaual Transition 167 

Elderly, Frail Elderly, and Healthy Aging 173 

Oral Health and Systemic Conditions 180 

Careers in Dentistry, Bioengineering, and Othr Non-M.D. Disciplines 187 

Chicago, Illinois—October 14–16, 2009 

Agenda 192 

Working Group Cochairs 196 

Introduction 201 

Summary of Plenary Presentations 201 

Scientific Working and Discussion Groups 

Understudied and Underrepresented Populations: 

 Minorities, Urban, Rural, Disabilities, and Issues of Poverty 206 

Understudied and Underrepresented Populations: 

 Lesbian, Bisexual, Transgender, and Intersex Issues 215 

Clinical and Translational Research 220 

New Technologies/Bioengineering/Imaging 225 

Genetics and Epigenetics 229 

Sex Hormones and Disease 233 

Neuroscience 237 

Women in Science Careers 242 

Atlanta, Georgia—February 16–17, 2010 

Agenda 246 

Working Group Cochairs 250 

Introduction 253 

Summary of Plenary Presentations 253 

Scientific Working and Discussion Groups 

Pregnancy and Cardiovascular Disease Research and 

 Ethical Considerations 258 

Cardiovascular Disease in Elderly and Frail 

 Elderly Women—Optimal Management and Research 264 

Microvascular Disease, Biomechanics, and Application of 

 New Technologies to Cardiovascular Research 268 

Stem Cells, Progenitor Cells, and the Vista of 

 Cardiovascular Regenerative Medicine 274 

Unmet Needs in Diagnostic Testing for Women with 

 Cardiovascular Disease 280 

Issues of Cardiovascular Prevention across the Lifespan with 

 an Emphasis on Gender and Underserved Populations 288 

Women’s Careers in the Biomedical Sciences 3 29

XVI
APPENDICES 

A. Testimony Providers 302 

B. Meeting Participants 312 

INDEX 386 

XVII
XVIII
Introduction

The Office of Research on Women’s Health (ORWH) was established in September 1990 in 

response to congressional, scientific, and advocacy concerns that a lack of systemic and consistent inclusion of women in NIH-supported clinical research could result in clinical decisions 

being made about health care for women based on findings from studies of men—without evidence that they were applicable to women. The Office was further established in statute in the 

NIH Revitalization Act of 1993 (Public Law 103–43). Congress codified the Office’s mission and 

included directives that expanded its leadership role in identifying and promoting research on 

women’s health. 

Since that time, the Office has been the focal point for guiding the national research effort on 

women’s health issues and is responsible for ensuring that women’s health research priorities 

are integrated into the wider NIH research agenda. The mission of ORWH is to: 

1. advise the NIH Director on matters relating to research on women’s health; 

2. strengthen and enhance research related to diseases, disorders, and conditions that 

affect women; 

3. ensure that research conducted and supported by NIH adequately addresses issues 

regarding women’s health; 

4. ensure that women are appropriately represented in biomedical and biobehavioral 

research studies supported by NIH; 

5. develop opportunities for and support recruitment, retention, reentry, and advancement 

of women in biomedical careers; and 

6. support research on women’s health issues. 

To advance a robust research agenda to guide women’s health research at the NIH, ORWH previously initiated two intensive planning initiatives, one beginning in 1991 and a second one in 

1997. ORWH called upon experts in the fields of basic and clinical sciences, practitioners interested in women’s health, and representatives of professional and women’s organizations to develop 

specific and workable recommendations to advance research activities on behalf of the diversity of women and define the research priorities for women’s health research at the NIH. The first 

research agenda from 1991, The Report of the National Institutes of Health: Opportunities for Research on Women’s Health redefined the parameters of women’s health to encompass the life 

span going beyond the reproductive system and to better understand sex and gender differences between women and men in development, health, and disease. It also brought attention to 

the need to focus on populations of women that had been underrepresented in clinical research. 

The 1997 report, Agenda for Research on Women’s Health for the 21st Century, expanded upon 

the initial scientific agenda for women’s health research and emphasized the relevance of the 

full spectrum of research from basic to clinical research, epidemiological and population studies, translation into clinical applications and health outcomes, with continued emphasis on sex 

1
and gender comparisons and the introduction of an emphasis on interdisciplinary research on 

women’s health. 

Science is dynamic and evolving at a remarkable pace with emerging knowledge from results of 

investigations and from new concepts of health and disease based on new technologies and approaches to research endeavors. Each decade has brought new discoveries, new understanding 

of the intricacies of molecular contributions to health and the workings of the totality of the human body, and new opportunities to leverage the knowledge from science to improve human 

health and, specifically, women’s health. The first two reports ensured that women’s health rose 

to prominence within the national psyche, as well as within the research environment. The next 

10 years can bring new research advances with improved therapeutics based on sex differences 

with an expansion of the evidence based clinical application to women’s health care. Achieving 

new dimensions and innovative strategies for research is an important element of the NIH women’s health research agenda for the future. 

Moving Into the Future With New Dimensions and Strategies: A Vision 

for 2020 for Women’s Health Research 

Ten years after the last women’s health research agenda was updated, the ORWH launched a 

series of five regional scientific workshops and public hearings to ensure that research on women’s health continues to be on the cutting edge of science, based upon the most advanced 

techniques and methodologies. Four of the five regional scientific workshops were held during 

2009, and the final was in 2010. The meetings were hosted by five universities: 

1. Washington University, St. Louis, Missouri, March 4–6, 2009 

2. University of California, San Francisco, May 27–29, 2009 

3. Women and Infants Hospital/Brown University, Providence, Rhode Island, September 

21–23, 2009 

4. Northwestern University, Chicago, Illinois, October 21–23, 2009 

5. Emory University, Atlanta, Georgia, February 16–17, 2010 

The format of each of the regional scientific workshops was designed to promote an interactive discussion involving leading scientists from across the nation, women’s health advocates, 

public policy experts, health care providers, and the general public. Individuals representing 

the full spectrum of academic institutions, professional associations, advocacy organizations, 

health care facilities interested in biomedical and behavioral research on women’s health and 

sex/gender issues, or those wishing to present their personal opinions on these issues were encouraged to provide both written and public testimony at each of the regional meetings. In 

each of the meetings, the ORWH Director challenged conference attendees to think beyond traditional women’s health issues in defining the women’s health research agenda of the future. 

Participants were asked to give attention to new areas of scientific application, innovative technologies, and sex differences research in basic and laboratory investigations. Clinical questions 

for which documented answers are still not evident were to be considered in determining research priorities, recognizing the importance of new health care and research paradigms that 

will be facing the Nation in the years ahead. 

2
A total of 37 scientific and career development working groups were cochaired by research scientists representing 44 academic institutions and 19 NIH Institutes, Centers, and the Office of 

the Director. Participants came from thirty-three states, and scientists from Great Britain and 

Australia also contributed to the discussions. Scientific panels and concurrent workshops addressed a wide range of topics, from the interplay of research and health care to specific areas 

of research, resulting in nearly 400 recommendations. The working group reports and recommendations are found in the companion Volume II to the ORWH Strategic Plan. 

A key element of each of the regional meetings was the time devoted to receiving public testimony. From its earliest establishment, ORWH has actively welcomed input from advocacy 

organizations, health and disease interest groups, health care providers, and the general public. Over the years, public testimony has served as an important reality gauge to inform the 

research agenda-setting process. During the course of the five meetings, 141 organizations and 

individuals presented written and public testimony, always on the first day of the meeting. The 

testimonies from the meetings are found in Volume III of the ORWH Strategic Plan. 

At the conclusion of the five regional workshops, the working group reports and recommendations were synthesized by ORWH staff and the resulting document (Volume I) was reviewed 

by three separate groups: (1) the Advisory Committee on Research for Women’s Health (the 

non-Federal advisory committee to the Director of ORWH); (2) an outside group of experts in 

women’s health research convened April 14, 2010 at the NIH; and (3) the Coordinating Committee on Research on Women’s Health Research/NIH (composed of NIH Institute and Center 

directors or their designees). The final document, entitled Moving Into the Future With New 

Dimensions and Strategies: A Vision for 2020 for Women’s Health Research, represents the 

conclusion of an intensive 2-year national planning discussion. This new Strategic Plan for research and career development opportunities to guide efforts towards the year 2020 is being 

unveiled on September 27, 2010 as part of the 20th anniversary celebration of the establishment of the ORWH at the NIH. 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health and 

Director, Office of Research on Women’s Health 

National Institutes of Health 

3
A Vision for 2020 for Women’s Health Research: 

Moving into the Future with New Dimensions and Strategies 

Washington University in St. Louis School of Medicine 

St. Louis, Missouri 

March 4–6, 2009 

DAY 1—PUBLIC HEARING 

Location: Eric P. Newman Education Center 

12:00–2:00 p.m. Registration 

2:00–2:15 p.m. Welcome 

Scott Hultgren, Ph.D. 

Helen L. Stoever Professor of Molecular Microbiology and 

Director, Center for Women’s Infectious Disease Research, 

Washington University in St. Louis 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health, Director, 

Office of Research on Women’s Health (ORWH), National 

Institutes of Health (NIH) 

2:15–3:30 p.m. OPENING PANEL: A Common Goal— 

Engaging the Public, Nonprofit Organizations, and Scientists in the Future of 

Research on Women’s Health 

Susan Wood, Ph.D. 

Associate Professor, The George Washington University 

School of Public Health 

Valerie C. Montgomery Rice, M.D. 

Sr. Vice President of Health Affairs and Dean, Meharry 

Medical College 

Susan Scanlan 

President, Women’s Research and Education Institute 

Perspectives from Washington University School 

of Medicine 

Kenneth Polonsky, M.D. 

Chair, Department of Medicine 

Alan Schwartz, Ph.D., M.D. 

Chair, Department of Pediatrics 

4
Victoria Fraser 

M.D., Co-Director, Infectious Disease Division, Department 

of Medicine 

Jeffrey F. Peipert, M.D., Ph.D. 

Robert J. Terry Professor and Vice Chair of Clinical Research 

Department of Obstetrics and Gynecology 

3:30–6:00 p.m.	� PUBLIC HEARING 

Interested individuals presented oral testimony to a panel of 

scientists, clinicians, and NIH representatives. 

DAY 2—SCIENTIFIC WORKSHOPS 

Location: Eric P. Newman Education Center 

7:00–8:00 a.m. Registration 

8:00–8:15 a.m. Welcome and Opening Remarks 

Samuel L. Stanley, Jr., M.D. 

Vice Chancellor for Research, Washington University 

in St. Louis 

8:15–8:45 a.m. Realizing the Vision: Advancing Research 

on Women’s Health in the 21st Century 

Vivian W. Pinn, M.D. 

8:45–9:15 a.m. Keynote Address: Women’s Health 

Research Must Be Part of the National 

Research Strategy 

Nancy H. Nielsen, M.D., Ph.D. 

President, American Medical Association 

9:30–10:15 a.m. PANEL: Unmet Medical Needs and the 

Future of Women’s Health: Identifying 

Opportunities for Women’s Health Research 

Moderator: Gail H. Cassell, Ph.D. 

Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company 

Third World Statistics in the USA: What Keeps 

the Health Commissioner Awake at Night 

Judy Monroe, M.D. 

Indiana State Health Commissioner 

5
Research in Women’s Health Viewed Through 

the Lens of Health Care Reform 

Eve E. Slater, M.D. 

Senior Vice President of Worldwide Policy, Pfizer, Inc. 

Unmet Needs and Sex and Gender 

Differences Research 

Phyllis Greenberger, M.S.W. 

President and CEO, Society for Women’s Health Research 

10:15–10:30 a.m. BREAK 

10:30–11:00 a.m. PANEL: A Paradigm for Enhancing 

Interdisciplinary Science in Women’s 

Health—Research on the Urogenital Tract 

Remarks by Griffin Rodgers, M.D. 

Director, National Institute of Diabetes and Digestive and 

Kidney Diseases 

Scott Hultgren, Ph.D. 

Helen L. Stoever Professor of Molecular Microbiology and 

Director, Center for Women’s Infectious Disease Research, 

Washington University in St. Louis 

Jeanette Brown, M.D. 

Professor, Obstetrics, Gynecology, and Reproductive Sciences, 

Epidemiology and Biostatistics, and Urology, Director, Women’s Continence Center, University of California, San Francisco 

11:00–11:30 a.m. Audience Questions and Discussion 

11:30–11:45 a.m. Working Group Charge 

Vivian W. Pinn, M.D. 

11:45 a.m.–3:15 p.m. Lunch and Concurrent Working Groups: 

Drafting of Recommendations by Area 

• Bladder and Pelvic Floor Disorders 

• Brain and Psychiatric Disorders 

• Chronic Pain Syndromes 

• Eating Disorders 

• Genetics and Microbial Communities (Metagenomics/ 

Microbiome) 

• Infectious Diseases of the Urinary and Reproductive Tracts 

• Obesity 

• Women in Biomedical Careers 

6
3:15–3:30 p.m. BREAK 

3:30–5:30 p.m. PANEL: Narrowing the Focus—Applying 

Emerging Concepts in Science to Women’s 

Health Research 

Moderator: Mary Woolley, M.A. 

President, Research!America 

Microbes, Genomics, and Premature Labor 

and Delivery 

David Relman, M.D. 

Professor of Medicine, Infectious Diseases, Microbiology, 

and Immunology, Stanford University 

Biological Engineering Approaches for 

Women’s Health 

Pamela Kreeger, Ph.D. 

Assistant Professor of Biomedical Engineering, University 

of Wisconsin–Madison 

The Human Microbiome Project: Exploring the 

Microbial Side of Ourselves 

Jeffrey Gordon, M.D. 

Dr. Robert J. Glaser Distinguished University Professor, 

Director, Center for Genome Sciences, Washington 

University in St. Louis 

5:30–6:30 p.m. Audience Questions and Discussion 

6:30–8:00 p.m. Reception 

DAY 3—SCIENTIFIC WORKSHOPS 

Location: Eric P. Newman Education Center 

8:00–8:30 a.m.	� Welcome and Opening Remarks 

Vivian W. Pinn, M.D. 

8:30–9:00 a.m.	� Keynote Address: Retaining Women 

in Academic Medicine 

Phoebe S. Leboy, Ph.D. 

President, Association for Women in Science 

7
9:00–10:30 a.m. Concurrent Working Groups: Finalizing 

of Reports 

10:30–10:45 a.m. BREAK 

10:45 a.m.–12:15 p.m. PANEL: Working Group Results, Audience 

Questions, and Feedback 

Moderator: Gail H. Cassell, Ph.D. 

12:15–12:45 p.m. Audience Questions and Discussion 

12:45–1:00 p.m. Closing Remarks 

Vivian W. Pinn, M.D. 

8
Washington University in St. Louis School of Medicine 

St. Louis, Missouri 

March 4–6, 2009 

WORKING GROUP COCHAIRS 

BLADDER AND PELVIC FLOOR DISORDERS 

Jeanette Brown, M.D. 

Professor of Obstetrics, Gynecology, and Reproductive Sciences; Epidemiology 

and Biostatistics; and Urology 

Director, Women’s Continence Center 

University of California, San Francisco 

San Francisco, California 

Kimberly S. Kenton, M.D., M.S., FACS, FACOG 

Associate Professor, Department of Obstetrics and Gynecology and Department of Urology 

Director, Female Pelvic and Reconstructive Surgery Fellowship Program 

Loyola University Medical Center 

Maywood, Illinois 

Chris Mullins, Ph.D. 

Director of Basic Cell Biology Programs in Urologic and Kidney Disease 

National Institute of Diabetes and Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Estella Parrott, M.D., M.P.H. 

Medical Officer 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

BRAIN AND PSYCHIATRIC DISORDERS 

Nancy L. Desmond, Ph.D. 

Associate Division Director 

Division of Neurosciences and Basic Behavioral Science 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

Jill M. Goldstein, Ph.D. 

Professor of Psychiatry 

Director of Research for Women’s Health 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Rajita Sinha, Ph.D. 

Professor of Psychiatry 

Director, Yale Stress Center 

Yale University 

New Haven, Connecticut 

9
CHRONIC PAIN SYNDROMES 

Leslie J. Crofford, M.D. 

Professor of Internal Medicine 

Chief, Division of Rheumatology 

University of Kentucky 

Lexington, Kentucky 

Emeran A. Mayer, M.D. 

Director, UCLA Center for Neurobiology of Stress 

University of California, Los Angeles 

Los Angeles, California 

Chris Mullins, Ph.D. 

Director of Basic Cell Biology Programs in Urologic and Kidney Disease 

National Institute of Diabetes and Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Linda I. Porter, Ph.D. 

Program Director, Extramural Research Program 

National Institute of Neurological Disorders and Stroke 

National Institutes of Health 

Bethesda, Maryland 

EATING DISORDERS 

Mark Chavez, Ph.D. 

Associate Director for Research Training 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

B. Timothy Walsh, M.D. 

Professor of Psychiatry 

College of Physicians and Surgeons 

Columbia University 

New York, New York 

Denise E. Wilfley, Ph.D. 

Professor 

Departments of Psychiatry, Medicine, Pediatrics, and Psychology 

Washington University in St. Louis School of Medicine 

St. Louis, Missouri 

10
GENETICS AND MICROBIAL COMMUNITIES 

(METAGENOMICS/MICROBIOME) 

Larry Forney, Ph.D. 

Professor, Biological Sciences 

University of Idaho 

Moscow, Idaho 

Maria Y. Giovanni, Ph.D. 

Assistant Director for Microbial Genomics 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Jacques Ravel, Ph.D. 

Associate Professor 

Institute for Genome Sciences 

University of Maryland School of Medicine 

Baltimore, Maryland 

INFECTIOUS DISEASES OF THE URINARY AND 

REPRODUCTIVE TRACTS 

Carolyn Deal, Ph.D. 

Branch Chief 

Sexually Transmitted Disease Branch 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Eve M. Lackritz, M.D. 

Division of Reproductive Health 

Centers for Disease Control and Prevention 

Atlanta, Georgia 

Uma M. Reddy, M.D., M.P.H. 

Medical Officer 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Craig Rubens, M.D., Ph.D. 

Executive Director, Global Alliance to Prevent Prematurity & Stillbirth 

Seattle Children’s Hospital/University of Washington 

Seattle, Washington 

11
OBESITY 

Graham A. Colditz, M.D., Dr.P.H. 

Niess-Gain Professor of Surgery, Professor of Medicine 

Washington University in St. Louis School of Medicine 

St. Louis, Missouri 

Samuel Klein, M.D. 

Chief, Division of Geriatrics and Nutritional Science 

Director, Center for Human Nutrition 

Washington University in St. Louis School of Medicine 

St. Louis, Missouri 

Charlotte A. Pratt, Ph.D., R.D. 

Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

WOMEN IN BIOMEDICAL CAREERS 

Phoebe S. Leboy, Ph.D. 

President, Association for Women in Science 

Professor Emerita of Biochemistry 

University of Pennsylvania School of Dental Medicine 

Narberth, Pennsylvania 

Walter Schaffer, Ph.D. 

Senior Scientific Advisor for Extramural Research 

Office of Extramural Research 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

12
INTRODUCTION 

This report summarizes the first strategic planning meeting, held at the Washington University 

School of Medicine, St. Louis, Missouri, March 4–6, 2009. The agenda included public hearings, 

four panels, two keynote speakers, and a presentation in which the ORWH Director provided the charge to eight scientific breakout working groups. Public hearings with testimony were 

held the first day, and 39 representatives of advocacy and professional organizations, as well 

as clinicians and private citizens, provided verbal and written statements to a panel of scientists, clinicians, and NIH representatives. On the second and third days of the meeting, working 

groups addressed scientific challenges, gaps, and opportunities for women’s health in breakout 

sessions on specific areas, which ranged from brain and psychiatric disorders to metagenomics and microbial communities. The recommendations of the working groups, summarized in 

individual reports, constitute the major portion of this document. Highlights of the panels and 

presentations are summarized briefly here. 

The panels were designed to challenge the audience to think “outside the box” of their discipline, scientific research, clinical specialty, or advocacy interest. The themes ranged from public 

health, health policy, and health services to models of interdisciplinary research and a vision for 

the potential application of leading-edge science and technology to women’s health. Recurrent 

themes were the importance of behavioral and societal factors in health and disease and the 

need to translate science from the research setting to the community setting. 

SUMMARIES OF PLENARY PRESENTATIONS 

OPENING PANEL: A COMMON GOAL—ENGAGING THE PUBLIC, 

NONPROFIT ORGANIZATIONS, AND SCIENTISTS IN THE FUTURE 

OF RESEARCH ON WOMEN’S HEALTH 

The theme of the opening session emphasized common ground among the diverse participants in the audience. Speakers addressed the interplay among biomedical science, public 

health, and public policy. Panelists included: 

Susan Wood, Ph.D. 

Associate Professor, The George Washington University, School of Public Health and 

Health Services 

Dr. Wood discussed the many policy implications and challenges facing NIH as the research 

strategy in women’s health is developed. The challenges include bringing research from bench 

to bedside and moving clinically relevant findings to the appropriate level of widespread use. 

Policy mechanisms for promoting interdisciplinary research are also critical, and it is important 

to evaluate whether these mechanisms have been used to promote women’s health research 

and have led to increased interdisciplinary research in women’s health in the past and envision 

their impact over the next decade. Likewise, effective communication of NIH research activities 

and findings on women’s health both to the public and to policymakers is critical. The public 

understanding of both the promise and limitations of NIH-funded research requires proactive 

outreach and partnerships for success. Reaching women facing health concerns in their daily 

lives who do not actively seek NIH information requires expanding existing programs and developing new and innovative approaches and partnerships. Finally, as policymakers at the State 

13
and national levels begin to implement health care reform, providing them with relevant data 

and information stemming from NIH research on women’s health will give them the tools they 

can use for decisions in establishing health policy. 

Valerie Montgomery Rice, M.D. 

Senior Vice President for Health Affairs, Dean School of Medicine, Meharry Medical College 

Dr. Montgomery Rice addressed the special challenges facing women of color in their access to 

the health care system, health status, and health outcomes. She demonstrated the urgency of 

health disparity issues by sharing the changing demographics of the United States, which project that women will make up 51 percent of the population in 2050, with population increases 

of 188 percent in Latinos, 213 percent in Asian-Americans, 71 percent in African Americans, and 

only 7 percent in Caucasians. Dr. Montgomery Rice presented compelling data related to diseases that impact health disparities, racial differences in access to health care innovations and 

resource allocation, and the underrepresentation of minorities in health professions. She cautioned that the exclusion of women from clinical studies, or inclusion of women in numbers 

too small to detect gender differences or to support subgroup analyses, may result in a “male 

model” of medical treatment that is inappropriate for women. Dr. Montgomery Rice proposed 

three approaches to eliminate disparities in women’s health, including 1) channeling funding 

and resources to research diseases that disproportionately impact women of color; 2) directing 

funding to study the social determinants that contribute to health disparities; and 3) increasing 

the number of women investigators, particularly women of color. She emphasized that, beyond 

improving access to health care, the benefits of scientific advances and innovations must be 

equally diffused into all communities. Further health outcomes and the achievement of milestones should be measured indications of success in eliminating health disparities. 

Susan Scanlan 

President, Women’s Research and Education Institute 

Ms. Scanlan provided a historical retrospective, beginning in 1977, of the role of the Women’s 

Health Caucus in influencing policy decisions. She aptly characterized the challenges facing legislators in her opening comment that in “Washington, DC, where the decisions get made, you’re 

either at the table or on the menu!” Aided by external advocates and informed by health statistics, dedicated and determined women in Congress—Senators Barbara Mikulski and Olympia 

Snowe and Congresswomen Lindy Boggs, Yvonne Burke, Martha Keys, and Gladys Noon Spellman, to name a few—awakened a sense of urgency in their congressional colleagues about 

women’s health issues. With a series of historical anecdotes, Ms. Scanlan demonstrated the 

effectiveness of the Women’s Health Caucus in drawing attention to inequities, such as the comparative lack of funding for women’s health issues and diseases and the disjuncture between the 

public health impact of diseases like breast cancer and the NIH investment in researching such 

diseases. From 1977 onward, the Caucus succeeded in bringing about major changes in funding 

and legislation that benefited women’s health. The Breast and Cervical Cancer Mortality Prevention Act and the Mammography Quality Standards Act are examples of how biomedical science, 

joined with public health data, can be translated into public policy of far-reaching impact. 

14
PERSPECTIVES FROM WASHINGTON UNIVERSITY SCHOOL 

OF MEDICINE 

Kenneth Polonsky, M.D. 

Chair, Department of Medicine 

Dr. Polonsky provided a perspective on women’s health research using the incidence and impact of bone health as an example. One focus of the Washington University Department of 

Medicine is understanding basic bone biology and developing novel approaches to preventing 

and treating metabolic bone disease—an area of research addressed by only a few departments 

of medicine nationally. The research is informed by strong interactions with the departments of 

orthopedics and pathology. Dr. Polonsky discussed some of the most exciting basic molecular 

findings in osteoporosis, including some promising research on the inhibition of notch signaling 

to stimulate bone formation with the potential of reversing osteoporosis. Dr. Polonsky also outlined the research philosophy that characterizes all research conducted by his department and 

ensures that women’s health research continues to flourish. These strategies involved choosing 

research that is relevant to human health; selecting diseases that are common and have a large 

impact—or that are relatively rare, but important scientifically; emphasizing the underlying basic 

science; facilitating the translation of basic findings to applications at the bedside; and promoting training and career development. 

Alan Schwartz, M.D., Ph.D. 

Chair, Department of Pediatrics 

Dr. Schwartz noted that the 750,000 U.S. teens who become pregnant each year are more likely to give birth prematurely and their babies are at greater risk for health problems, long-term 

disabilities, and death. The consequences can extend to later life, according to the Barker Hypothesis, which holds that reduced fetal growth can increase the risk of developing diseases 

such as cardiovascular disease and type 2 diabetes in adulthood. 

Victoria Fraser, M.D. 

Co-Director, Infectious Disease Division, Department of Medicine 

Dr. Fraser charted the increasing number of women in biomedical research, but noted that it 

will require a massive effort to achieve equality. Among the challenges are the disproportionate attrition of women, who leave at double to triple the rate of men. It is important to find out 

why women leave research and what can be done to keep them. Among her suggestions: have 

dual PIs for research, use team-based science, develop reentry programs for women who have 

taken a career break, and develop mentoring programs. 

Jeffrey F. Peipert, M.D., Ph.D. 

Robert J. Terry Professor and Vice Chair of Clinical Research, Department of Obstetrics 

and Gynecology 

Dr. Peipert discussed the use of the dual contraceptive method as a way to prevent unplanned 

pregnancy and sexually transmitted diseases (STDs). This requires pairing a long-acting, reversible contraception (such as an IUD or subdermal implant), which effectively prevents pregnancy, 

with a barrier method (a condom), which effectively prevents STDs. Dr. Peipert also described 

his ongoing research, the Contraceptive Choice Project, which will provide no-cost, long-acting 

contraceptives to 10,000 women for 3 years. Among the aims: to determine whether removing 

15
the financial barrier to obtaining contraceptives could increase their use, decrease teen pregnancy, and reduce repeated abortions. Eighteen months into the project they have found 

significantly increased use of the contraceptives. 

KEYNOTE ADDRESS: WOMEN’S HEALTH RESEARCH MUST BE PART 

OF THE NATIONAL RESEARCH STRATEGY 

Nancy Nielsen, M.D., Ph.D. 

President, American Medical Association (AMA) 

Dr. Nielsen, a member of the ORWH Advisory Committee on Research on Women’s Health, 

addressed the St. Louis meeting participants and attendees by video because her in-person 

attendance at the White House at a Health Care Summit convened by President Obama prevented her from attending the St. Louis meeting. In her presentation she identified several areas 

that needed to be a part of the thinking and the discussion during the St. Louis meeting. For 

example, when identifying the gaps in basic and biomedical research—the traditional purview of 

NIH—meeting attendees were urged also to consider other knowledge gaps. Dr. Nielsen noted 

that even effective dissemination of health information does not guarantee that desired behavior change will occur. She expanded on two examples—obesity and heart disease in women. 

Obesity remains a major epidemic and a major contributing factor to multiple conditions such as 

diabetes, coronary heart disease and cancers despite widely disseminated information of its risk 

and ways to reduce weight through diet and exercise. Clearly, behavior change will require new 

strategies. With heart disease, sometimes clinicians do not behave as they should when women 

present with atypical symptoms. This represents a gap in care. There are other gaps that need 

attention—for example, violence against women. This is usually viewed as a societal problem, 

yet it has significant negative impacts on the health of women, children and families. Research 

into its causes and strategies for prevention should be included in a comprehensive national research agenda on women’s health. Finally, Dr. Nielsen emphasized that the AMA has been in the 

forefront of advocating for increased funding for research on women’s health, as well as urging 

medical and scientific journals to publish research on women’s health issues and insisting that 

research data be analyzed by sex/gender differences. 

PANEL: UNMET MEDICAL NEEDS AND THE FUTURE OF WOMEN’S 

HEALTH: IDENTIFYING OPPORTUNITIES FOR WOMEN’S HEALTH 

RESEARCH 

A second panel was moderated by Gail H. Cassell, Ph.D., Vice-President, Scientific Affairs and 

Distinguished Lilly Research Scholar for Infectious Diseases. In her opening remarks, Dr. Cassell noted that the St. Louis meeting was the beginning of another round of strategic planning 

that would further women’s health nationally and globally, and that women’s health was an 

important barometer of the health of families and communities. Science has a key role in this 

enterprise, as does the continuing work of public health officials and women’s health advocates. Panelists included the following: 

Judy Monroe, M.D. 

Indiana State Health Commissioner 

Dr. Monroe highlighted public health problems such as infant mortality and preterm births 

that remain at unacceptably high levels in some parts of the United States and among certain 

16
populations. In two counties in Indiana, for example, infant mortality among Black infants is 

30 per 1,000 live births, a rate that is comparable to rates in some developing countries. Smoking, obesity, and sexually transmitted diseases among women are also greater than national 

norms in some U.S. regions. Disparities will not be resolved until public health officials and 

researchers “drill down” to the local level in databases so they can identify where health indicators fall short of optimal norms. Public health practitioners should work more closely with 

basic science and clinical researchers to find ways to close the gap between their knowledge 

of science and population-level health outcomes that continue to fall short of what the United 

States is capable of achieving. Translation of research is needed across all levels and all communities, with information technology serving as an important conduit. 

Eve E. Slater, M.D. 

Senior Vice President of Worldwide Policy, Pfizer, Inc. 

Viewing American Recovery and Reinvestment Act funds from the perspective of women’s 

health, Dr. Slater said researchers should assess gender, racial, and ethnic differences as they 

pertain to comparative effectiveness. With respect to investment in health information technology, she recommended that tools to assess quality and outcomes be incorporated in all systems. 

An important health problem is noncompliance in taking medication; Dr. Slater advocated more 

extensive use of health information technology, for example, to remind patients to get prescription refills or to make a doctor’s appointment. 

Phyllis Greenberger, M.S.W. 

President and CEO, Society for Women’s Health Research 

Ms. Greenberger provided a retrospective presentation that looked at how 20 years ago, advocacy, informed by health statistics, moved women’s health research forward at the NIH. She 

cited the 2001 IOM report Exploring the Biological Contributions to Human Health: Does Sex 

Matter? as pivotal in emphasizing the need to carefully evaluate sex-based differences in medical research and incorporate these differences into clinical practice. Ms. Greenberger noted that 

despite recognized differences, women at risk continue to face uneven care or are not referred 

for diagnostic testing that would be standard for men. She concluded her presentation by presenting six issues that need to be addressed to change the face of sex differences research and 

to improve health care for all women: (1) physicians need to be trained and educated in medical 

school, residencies and in continuing medical education about sex difference in order to communicate the information effectively to their patients; (2) physicians need to be alert to possible 

“physician bias” in diagnosis and treatment in favor of men; (3) women need to be informed and 

empower themselves to ask for sex-specific information when consulting physicians or dealing with the health care system; (4) sex should be included as a variable in all basic and clinical 

research design; the analysis and reporting of results by sex, age, race and ethnicity must be a 

fundamental requirement; (5) there is a need for a strong patient-centered comparative clinical 

effectiveness research emphasis that will add value to understanding biologic and physiologic 

differences that affect disease prevention, diagnosis and treatment; and (6) research and innovation into new diagnostics and imaging tools is critical to our health care system’s ability to 

address new and emerging diseases and illnesses. 

17
PANEL: A PARADIGM FOR ENHANCING INTERDISCIPLINARY 

SCIENCE IN WOMEN’S HEALTH—RESEARCH ON THE UROGENITAL 

TRACT 

Interdisciplinary research is a model paradigm for achieving progress toward understanding 

the interplay of biomedical and biopsychosocial factors that influence women’s health. Consequently, a third panel highlighted two ORWH-funded interdisciplinary research centers focused 

on women’s urogenital health. Panelists included the following: 

Griffin Rodgers, M.D. 

Director, National Institute of Diabetes and Digestive and Kidney Diseases 

Dr. Rodgers opened this session by asserting that interdisciplinary approaches to research on 

the urogenital tract can serve as a model for future research in women’s health, and he noted 

the special features of this research—powerful interdisciplinary and multidisciplinary approaches, translational research, and prevention-oriented research tailored to patient needs. To help set 

the stage for the presentations by Drs. Hultgren and Brown, Dr. Griffin provided some thoughts 

on past successes and future opportunities for research in women’s health, making the following five points. (1) A major element in the success of women’s health research at NIH has 

been the leadership role of ORWH and its “vigorous” director, Dr. Vivian Pinn. The office has 

brought women’s health research to the forefront of science by identifying, articulating, and 

providing funding for critical research priorities. ORWH has been strategic in designing collaborations across NIH, and NIDDK has been fortunate to be one of those research partners. (2) The 

Women’s Health Initiative (WHI) provided critical information, based on research, that women 

receiving estrogen plus progestin to treat menopausal symptoms had increased risk for cardiovascular disease. Beyond these specific findings, WHI cast an intense spotlight on women’s 

health research and the need for additional studies in the field. (3) As a result of the NIH policy requiring the inclusion of women in clinical trials and analysis for sex and gender differences, 

women’s health research has become a central element of NIH research efforts. (4) Women’s 

health research has benefited from a range of new technologies that permit more rapid and 

precise scientific investigation. Of particular note are the new approaches of functional genomics, proteomics, and metabolomics. (5) The emphasis on interdisciplinary and multidisciplinary 

research has led to a veritable explosion in scientific knowledge and new technologies. More scientists are now working together toward common goals, and women’s urologic health is an 

excellent example of this emphasis upon team science. 

Scott Hultgren, Ph.D. 

Helen L. Stoever Professor of Molecular Microbiology and Director, Center for Women’s 

Infectious Disease Research, Washington University in St. Louis 

Dr. Hultgren, a member of the ORWH Advisory Committee on Research on Women’s Health, 

described the multiple approaches and disciplines represented in his laboratory and among 

his collaborators in his ORWH-sponsored Specialized Centers of Research (SCOR) on Sex and 

Gender Factors Affecting Women’s Health to study urinary tract infection (UTI) in women at all 

levels from the clinical to the molecular. The work of Dr. Hultgren and his colleagues is changing 

the way UTIs are evaluated and spawning the development of novel vaccines and antimicrobial 

therapeutics to diagnose, treat and/or prevent UTIs and their sequelae. Using his interdisciplinary team as an example, Dr. Hultgren emphasized the great strides that are possible by 

18
examining conditions from many angles simultaneously. He noted that discovery of disease 

etiology and novel therapeutics are facilitated by a combined approach utilizing clinical samples directly from women, animal models of disease, and basic molecular science. Dr. Hultgren 

ended by applauding the ORWH for its pivotal role in championing this interdisciplinary and applied scientific approach at the NIH through its SCOR, Advancing Novel Science in Women’s 

Health Research (ANSWHR) and Building Interdisciplinary Research Careers in Women’s Health 

(BIRCWH) programs. 

Jeanette Brown, M.D. 

Professor, Obstetrics, Gynecology, and Reproductive Sciences, Epidemiology and Biostatistics, 

and Urology; Director, Women’s Continence Center; University of California, San Francisco 

Dr. Brown spoke about the SCOR program at UCSF, which focuses on lower urinary tract function in women. The SCOR model promotes collaboration between basic science and clinical 

researchers, encouraging more rapid translation of research findings to patient care. Obesity and 

diabetes mellitus are risk factors for urinary incontinence (UI), and the work to study the molecular mechanisms of the condition continues, Dr. Brown said. Losing weight and preventing 

diabetes can reduce episodes of incontinence. The public health implications are that women 

may be motivated to lose weight, control diabetes, or to control hyperglycemia as a way to 

alleviate incontinence. 

PANEL: NARROWING THE FOCUS—APPLYING EMERGING CONCEPTS 

IN SCIENCE TO WOMEN’S HEALTH RESEARCH 

A fourth panel highlighted ways in which fundamental science advances and cutting-edge 

scientific technologies may be used to benefit women’s health research. Panelists included 

the following: 

Mary Woolley, M.A. 

President, Research!America 

Ms. Woolley moderated the panel. Her opening comments reminded the scientists in the audience that no matter how technical or esoteric their research, they must effectively communicate 

to the public how their research benefits public health. Research saves lives, provides better 

quality of life, can make health care less costly, and can foster economic growth. Helping the 

public and legislators see these benefits is critical to building support for biomedical research. 

David Relman, M.D. 

Professor of Medicine, Infectious Diseases, Microbiology, and Immunology, Stanford University 

Dr. Relman discussed his research showing that previously unrecognized intra-amniotic infections caused by cultivation-resistant microbes play a role in preterm births. Molecular methods 

can detect, characterize, and quantify microbes independently of traditional culture techniques. However, molecular studies on a scale needed to define the diversity and abundance 

of microbes invading the amniotic fluid were not possible until genomics revolutionized 

microbiology. The evolving field of bacterial typing and genomic technologies will enable 

comparative analysis of multiple genomes and the metagenomes of complex microbial 

environments, and help address problems such as the microbial contribution to risk for 

preterm birth. 

19
Pamela Kreeger, Ph.D. 

Assistant Professor of Biomedical Engineering, University of Wisconsin–Madison 

Dr. Kreeger discussed the potential contributions of biological engineering to biomedical research on women’s health. Biological engineering includes tissue engineering; biomechanics; 

and the “omics” (e.g., genomics, proteomics, metabolomics) used to identify and characterize biomarkers for disease. Examples of potential applications to women’s health include the 

development of neuroengineering devices to monitor pain, biomechanical approaches to the 

study of male-female differences, bioimaging tools to better image breast and bone, and systems engineering to create models of estrogen crosstalk with signaling pathways. She also 

noted an impediment in narrowing the focus of biomedical advances to problems in women’s 

health—there are very few women engineers, particularly in academic settings. 

Jeffrey Gordon, M.D. 

Dr. Robert J. Glaser Distinguished University Professor and Director, Center for Genome Sciences; 

Washington University in St. Louis 

Dr. Gordon discussed advances in metagenomics as applied to the study of the microbial composition of the human body. Recently, scientists have come to appreciate that humans are a 

composite of microbial and human cells—a “supraorganism.” In adults, it is estimated that microbial cell populations outnumber human cells by nearly 10 times. The genetic landscape of a 

human is the sum total of genes in the human genome and the genomes of the microbial partners that inhabit our bodies (the microbiome). Human metabolic features are an amalgam of 

human and microbial traits. To understand fully human genetic and physiologic diversity, the 

factors influencing health and illness and the structure and functions of human microbiota and 

the microbiome need to be characterized. 

KEYNOTE ADDRESS: RETAINING WOMEN IN ACADEMIC MEDICINE 

Phoebe Leboy, Ph.D. 

President, Association for Women in Science 

Dr. Leboy gave the keynote address on the challenges of and potential solutions for retaining women in academic medicine. Dr. Leboy informed the audience that despite earning over 

40 percent of the M.D. and Ph.D. degrees in the biomedical sciences in the last 15 to 20 years, 

women are seriously underrepresented among medical and biomedical faculty. She presented 

striking findings regarding the predominantly male associate-professor status across clinical 

and tenure-track positions, as well as the disproportionately low application rates of women for tenure-track faculty positions in basic science departments. Dr. Leboy noted that the 

relative absence of women among medical school faculty is reflected in NIH grant data, with 

women receiving more NIH-mentored scientist (K) awards than research (R) awards. However, she pointed out that this finding appears to be a result of fewer applications submitted 

by women rather than lower success rates. Dr. Leboy outlined several possible factors that 

contribute to the poor retention of women clinician-scientists and biomedical researchers in 

academic medicine. These included a culture, which is extremely competitive and focused on 

very high productivity, demanding 24/7 professional effort, with an increasing emphasis on 

quantity rather than quality of research. She emphasized the link between large numbers of 

high-quality trainees and increased publication rates and suggested that lower professional prestige is a key factor leading to lower research productivity among women scientists. Dr. 

20
Leboy recommended a three-pronged approach to tackle these issues: 1) acknowledge that 

existing policies and practices disadvantage women in academic biomedical careers, 2) initiate efforts to change those practices that are particularly unfriendly to women, and 3) provide 

targeted grant funding for those institutions committed to transforming both their climate and 

their culture. 

CHARGE TO THE WORKING GROUPS 

Prior to breaking out into their science working groups, participants were given their charge 

by Dr. Pinn. NIH women’s health research priorities, she noted, must be comprehensive and interdisciplinary. They should include the full spectrum of research, from molecular and genetic 

studies and translational research to prevention, behavioral, clinical, and outcomes research. 

A comprehensive National Research Agenda should include the following multiple elements: 

• The identification of continuing gaps and emerging science about women’s health and 

sex/gender factors 

• The application of new technologies to women’s health science 

• A program of research that moves from basic science to clinical translation and ranges 

from molecular to societal factors 

• The translation of advocacy concerns to science-based initiatives 

• The advancement and sustainability of the careers of women in science and engineering 

The working groups were charged with developing recommendations in these areas, which 

would move women’s health research and career development forward, and which also anticipated future cutting-edge women’s health research. Reports of the working groups follow. 

21
SCIENTIFIC WORKING AND DISCUSSION GROUPS 

BLADDER AND PELVIC FLOOR DISORDERS 

Cochairs:
�

Jeanette Brown, M.D.
�

University of California, San Francisco 

Kimberly Kenton, M.D., M.S. 

Loyola University Medical Center 

NIH Cochairs: 

Chris Mullins, Ph.D. 

National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) 

Estella Parrott, M.D., M.P.H. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers:
�

Ashley Nenninger, Ph.D.
�

Washington University in St. Louis 

Lorry Blath 

St. Louis Breast Cancer Coalition 

Introduction 

The three primary pelvic floor disorders (PFDs) are urinary incontinence (UI), pelvic organ prolapse (POP), and fecal incontinence. These conditions are common among women, with nearly 

one quarter of all women reporting one or more PFD according to a recent prevalence study.1 

This prevalence results in a significant national burden in the form of health care costs, lost 

productivity, and decreased quality of life. Despite this prevalence, relatively few studies are 

conducted on PFDs. Although some PFD risk factors are well described, such as increased age, 

parity, and weight, a substantial lack of knowledge or progress remains for many key issues, 

including the following: 

• Comparative effectiveness trials of surgical procedures and therapies, including types 

and methods of procedures, materials used, and the timing of repair 

• Development of new therapies, including regenerative therapy 

• Elucidation of the biological mechanisms that lead to dysfunction 

• Identification of additional risk factors and biological markers to improve diagnosis, 

prevention, and therapy 

• Development and efficacy of prevention strategies 

• Dissemination of information to clinicians and the community to increase awareness 

and to create a common language 

The discussions began with brief oral presentations based on prepared statements from experts in the fields of urogynecology, urology, translational/basic science, and primary care. Each 

speaker highlighted areas of need, with the goal of advancing the understanding and treatment 

22
of PFD. Presentations were followed by questions, comments, and discussion from working 

group participants. The resulting recommendations fall into four areas of research: basic science, T1 translational research, clinical studies, and T2 translational research. 

Summary of the Discussion 

Group consensus was that numerous reliable epidemiologic studies consistently report both 

high prevalence and symptom bother from PFDs, and that future efforts should be directed 

away from epidemiologic studies and toward identifying risks, treatments, and prevention strategies for PFDs. This was addressed in a September 2008 report in the Journal of the American 

Medical Association about the prevalence of symptomatic pelvic floor disorders in U.S. women. 

In this report, PFD prevalence was found to be substantial, with at least one PFD being reported by nearly 24 percent of all women and nearly 50 percent of women 80 years or older, using 

conservative estimates. Prevalence was found to increase with age, number of children a woman 

has delivered, and weight.1 Given the aging population and the probable underestimates of current prevalence due to conservative study design, considerable effort is needed to address the 

many other knowledge gaps about PFD to better care for these patients. 

Biological Mechanisms of PFDs 

Although the risk factors for PFDs are known, the biological mechanisms that result in PFDs 

are less clear. Certain PFDs are associated with maternal changes during pregnancy and delivery. A better understanding of the biological mechanisms associated with these changes may 

lead to preventive or reparative therapies that promote or accelerate pelvic floor healing to 

prevent or minimize later development of PFDs. 

One potential biological mechanism underlying PFDs is neuromuscular dysfunction. Neuromuscular changes associated with secondary damage to pelvic floor muscles were described in 

women with UI and POP over two decades ago; these changes are believed to be major contributors to the etiology and pathogenesis of UI and POP. However, few clinician-investigators have 

explored the impact of neuromuscular dysfunction on disease progression or on symptomatic outcomes after surgery. It is quite plausible that the degree of neuromuscular injury predicts 

or is associated with development of pelvic floor symptoms with aging or incomplete symptom resolution after reconstructive surgery. Recent advances in neuroregenerative neuroscience, 

such as application of electrical stimulation, gonadal steroids, or nerve growth factors, could be 

useful as adjunct preventive or perioperative interventions aimed at symptom improvement. 

Future studies should not only quantify neuromuscular differences in parous and nulliparous 

women with and without pelvic floor symptoms across ages, but should identify neural targets 

at which to direct concomitant therapies. This may have important implications for preventing 

pelvic floor symptoms with aging, maximizing surgical outcomes, and preventing recurrences. 

The following overall research strategies for this area were identified during the discussion. 

• Conduct translational and basic research to identify the basic biological processes by 

which risk factors lead to development of PFDs. 

• Conduct translational and basic research to supplement or boost the processes of healing after delivery followed by clinical testing of these treatments. For example, can an 

23
easily administered treatment with nominal side effects be developed for administration 

to women identified diagnostically to be at greatest risk? 

• Conduct translational and basic research to develop neuroregenerative techniques (e.g., 

electrical stimulation or nerve growth factors) that could be used instead of or in addition 

to conventional treatments and reconstructive surgery. 

• Based on knowledge of the biological processes, conduct translational and basic research 

to develop a diagnostic test for identifying women at greatest risk for PFD, followed 

by clinical testing of this test in longitudinal clinical studies as a predictor of PFD and as a 

way to track a woman’s response to treatment. 

Needs in Clinical Care 

Significant gaps remain in the understanding of numerous aspects of clinical care for patients 

with PFDs, such as comparative effectiveness of different PFD treatments, factors that predict 

adherence and response to treatment, an understanding of “normal” pelvic floor function, and 

standardization of care across clinical specialties. 

In particular, improvements are needed in the efficacy and safety of surgical treatments and 

surgical devices. Reconstructive pelvic surgery is common, with one in nine women undergoing surgery for POP or UI in her lifetime, many women reporting new or persistent symptoms, 

and 30 percent requiring additional surgery.2 Similarly, regardless of the procedure, less than 80 

percent of stress incontinence surgeries have positive outcomes.3

 Research on surgical treatment efficacy is still lacking, although both the UTI Network and PFD Network are attempting to 

fill these gaps. Also, there has been a significant increase in new medical devices cleared by the 

U.S. Food and Drug Administration (FDA) and commonly used for POP and UI, despite minimal 

safety or efficacy data. Strategies that enable clinical testing of promising devices in a timely 

fashion are critical to ensure both patient safety and access to new, effective treatments supported by data. Furthermore, the development of better data and resource sharing may allow 

more timely insight into complications of new medical devices. Collaboration between the UTI 

and PFD Networks, thought leaders, trial design experts, industrial collaborators, and various 

Federal agencies can help to standardize treatment assessments of new and promising medical, 

minimally invasive, and surgical treatments. 

The following additional research strategies needed in this area were identified during 

the discussion. 

• Compare effectiveness trials to evaluate UI and POP treatments, including design methods to further our understanding of disease mechanism and predict treatment response. 

• Determine the optimal timing and method for initial treatment of uterovaginal prolapse, 

with or without concomitant stress urinary incontinence. 

• Assess the indications for hysterectomy (total or subtotal) and for augmenting surgical 

materials at the time of surgical treatment of uterovaginal prolapse. 

• Advance our understanding of urethral function in women with all types of UI: innovative methods should be incorporated to quantify urethral function (e.g., neurophysiologic 

24
testing and imaging) to enhance the understanding of UI pathophysiology and to 

predict success. 

• Improve the POP–Q system so that the condition of prolapse can be better described, 

and establish a baseline of “normal” pelvic anatomy/function across groups. 

• Increase precision in patient-reported outcomes, which may help to detect small, but 

significant, differences between interventions. 

• Improve patient-physician communication by developing a common language regarding 

PFD to avoid inconsistencies between surgical expectations and goals. 

• Standardize care across geographic and specialty variation for women with PFD. 

• Develop more sensitive and specific tests to quantify disease severity, follow disease 

progression, and predict treatment outcomes. 

• Identify factors that determine whether women adhere to, and benefit from, pharmacologic and behavioral therapies for incontinence, to guide clinicians in choosing the 

optimal strategy for symptom management. 

Risk Factors and Prevention 

The current understanding of risk factors (including potentially modifiable risk factors) that 

contribute to the development, progression, and/or recurrence of PFD is incomplete. No primary 

or secondary preventive strategies for PFD have been proven. Research is needed to determine 

whether risk factor modification may prevent or delay disease development, decrease the severity of these conditions, or improve treatment outcomes. Identifying risk factors that may 

exacerbate these conditions after the primary occurrence (i.e., risk factors of recurrence) is also 

important, and may help improve the specificity of treatments and decrease the number of 

women requiring multiple procedures. 

Concomitant Diseases 

Other important factors to consider are comorbidities that may influence the development and 

severity of PFD, such as obesity, diabetes, and depression, and whether clinical interventions 

directed at improving these modifiable risk factors can also improve women’s urinary tract and 

pelvic floor symptoms. This goal could be achieved through clinical trials or through ancillary 

studies in which urinary and pelvic floor symptom assessment measures are incorporated into 

ongoing studies of clinical interventions to address these comorbid problems. 

Biological disease mechanisms of PFD may differ due to these comorbidities. For instance, 

whereas it is known that incontinence is more common in women with diabetes, mechanisms by 

which type 2 diabetes may contribute to its development or severity are not well understood. A 

likely etiology for incontinence is microvascular damage, similar to the disease process involved 

in development of retinopathy, nephropathy, and peripheral neuropathy. Also, clinical outcomes 

of common treatments for lower urinary tract dysfunction in women with prediabetes and 

diabetes have not been critically examined, and randomized controlled trials are needed to 

assess the efficacy and safety of conservative, pharmacologic, and surgical treatments in the 

25
diabetic population as well as the nondiabetic population because outcomes may vary across 

these groups. 

Incontinence might also be used as a diagnostic marker for diabetes. Recent findings of a similarly high prevalence of incontinence among women with prediabetes and those with diabetes 

suggests that incontinence may be an earlier and more common consequence of hyperglycemia than other microvascular complications. As the population ages, diabetes and lower 

urinary tract dysfunction will markedly increase in prevalence. Physicians should be alert 

for lower urinary tract dysfunction because it is often unrecognized and therefore undertreated among women with diabetes and prediabetes. 

Finally, PFD symptoms may be a barrier to treatment of potentially life-threatening conditions that are well recognized, such as heart disease and obesity. For example, a woman with 

urge incontinence may be less likely to comply with diuretic therapy for underlying heart disease. An obese patient may avoid exercise because of stress incontinence or prolapse. Without 

advanced understanding of the consequences and optimal treatment strategies for PFD, it is 

possible that other important areas of women’s health will advance more slowly. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Comparative effectiveness trials of surgical and adjuvant treatments 

to determine optimal methods, materials/devices, indications, timing, and combinations of 

treatment to improve patient outcome. 

Recommendation 2: T1 translational research to develop methods, including the application 

of stem cells, cytokines, gonadal steroids, and other neurotrophic factors, to promote regeneration and repair of damaged nerves, muscles, and connective tissue after pelvic floor injury. 

Recommendation 3: Clinical research to identify modifiable risk factors; characterize “normal” 

pelvic floor function and anatomy across age, parity, weight, race/ethnicity; and identify factors that predict adherence and response to given treatments. 

Recommendation 4: Basic science aimed at understanding the biologic processes and pathophysiology underlying PFD to improve diagnostic, therapeutic, and preventive strategies. 

Recommendation 5: T2 translational research to raise awareness and create a common language for improved communication, treatment, and understanding of PFD in the community. 

References 

1. Nygaard, I., Barber, M.D., Burgio, K.L., Kenton, K., Meikle, S., Schaffer, J., Spino, C., ... 

Pelvic Floor Disorders Network. (2008). Prevalence of symptomatic pelvic floor disorders in US women. Journal of the American Medical Association, 300(11), 1311–1316. doi: 

10.1001/jama.300(11)1311–1316 

26
2. Olsen, A.L., Smith, V.J., Bergstrom, J.O., Colling, J.C., & Clark, A.L. (1997). Epidemiology 

of surgically managed pelvic organ prolapse and urinary incontinence. Obstetrics and 

Gynecology, 89(4), 501–506. 

3. Harding, C.K. & Thorpe, A.C. (2008). Surgical treatment for stress urinary incontinence. 

International Journal of Urology, 15, 27–34. 

BRAIN AND PSYCHIATRIC DISORDERS 

Cochairs:
�

Jill M. Goldstein, Ph.D.
�

Harvard Medical School 

Rajita Sinha, Ph.D. 

Yale University 

NIH Cochair:
�

Nancy L. Desmond, Ph.D.
�

National Institute of Mental Health 

Science Writers: 

Megan Straiko, Ph.D. 

Washington University in St. Louis 

Mary O’Brien Uhlmansiek, M.A. 

Washington University in St. Louis 

Introduction 

The global burden of psychiatric disorders is substantial. According to the World Health 

Organization, four of the top six leading causes of “years lived with disability” are due to neuropsychiatric disorders: depression, substance use disorders (including nicotine, alcohol, and illicit 

drug abuse), schizophrenia, and bipolar disorders. The costs of these disorders, including health 

care costs, economic and individual productivity, and family burden, exceed $650 billion per 

year in the United States.1,2 Psychiatric disorders are comorbid with nearly every chronic 

medical disease, multiplying the burden substantially. 

There are sex and gender differences in prevalence, expression, and treatment responses regarding depression, anxiety disorders (including post-traumatic stress disorder or PTSD), eating 

disorders, alcohol and drug-related substance use disorders, schizophrenia, autism, and Alzheimer’s disease. New technologies provide novel capabilities for understanding processes 

that may explain sex/gender differences in ways that were not previously possible. Furthermore, 

it is important to take a lifespan perspective to identify etiologic mechanisms during fetal development, puberty, adulthood, and aging, with special consideration to time periods specific 

to women such as childbearing years, perimenopause, and menopause. Time periods in which 

there are major changes in the hormonal milieu are critical periods for research on vulnerability 

for developing sex differences in psychiatric disorders. Research findings must be translated into 

27
effective clinical and population-based strategies that meet the needs of women with diverse 

backgrounds, including those who are underserved and have limited access to health care. 

Progress in research on sex and/or gender differences has been impeded by a number of 

challenges. They include methodological attention to designing studies focused on sex/gender differences, not just separating data by sex/gender after data collection. Two examples of 

methodological attention include selection issues related to ascertainment of women and men 

in population studies or in treatment studies and controlling for hormonal status, which is important for both human and animal investigations. Thus, there is a need for methodological 

development that considers the complexity of the domains of sex and gender in the initial design of the study. Second, there is a need to educate the scientific community that data analyses 

by sex/gender reflect quality science and that the findings can enhance the understanding of 

neurobiology and its implications for clinical medicine. This understanding should underlie the 

training of the next generation of leaders in women’s mental health. Furthermore, education regarding the importance of sex and gender differences in clinical medicine is important not only 

for the scientific community, but also for policymakers and the public, if funding of these important arenas is to be sustained. 

Summary of the Discussion 

Invited investigators and clinicians presented observations to the working group, and a discussion followed. The following are the major concepts that emerged from the discussion. 

1. Regarding genes and psychiatric disorders, it is important to do the following: 

• Determine the genetic contribution to sex differences in psychiatric illnesses. 

• Understand the function of genes associated with psychiatric illnesses, how these 

genes are regulated, and the relationship between gene expression in the brain and the 

disease state. 

• Consider that genes on sex chromosomes may play key roles in generating sex differences in brain structure and function beyond their role in gonadal determination. 

2. Sex differences in psychiatric illnesses, even when they develop in adulthood, are likely to 

be the result of brain development during the fetal and postnatal periods. Thus, to understand developmental antecedents to sex differences in adult-onset psychiatric disorders, 

it is critical to understand the following: 

• What are the sex differences in the development of the healthy human brain? 

• How do they go awry differentially in the female and male brain given specific 

risk factors?
�

• How can research on sex differences in the human brain be integrated with the long history of, and continued work on, preclinical studies of brain sexual differentiation? 

3. The onset of many sexually dimorphic disorders occurs during periods of endocrine 

transitions (e.g., depression and schizophrenia after puberty or pregnancy). Puberty, perimenopause, menopause, and postmenopause can influence the trajectory of a 

woman’s mental health significantly with regard to clinical outcomes. Factors affecting 

28
outcomes (e.g., endocrine states, inflammatory factors, vascular status) need to be 

better understood. 

4. In understanding sex and gender differences in the vulnerability to phenotypic expression 

of psychiatric disorders, an enhanced appreciation of gene-environment interactions in 

the expression of psychiatric disorders in women would be critical. Environmental factors 

would necessarily include those that are intrafamilial, but would also extend to sociocultural factors, exposure to environmental chemicals and neurotoxins, and psychoactive drugs 

and medications that might enhance or diminish vulnerability. Environmental endocrine 

disruptors may also differentially influence males and females as they transition through 

puberty, even after normal fetal development. 

5. The impact of sex/gender on the brain through etiologic mechanisms discussed above is 

shared with other organs and tissues. It is important to understand shared mechanisms for 

understanding sex/gender biology and pathology across organs and tissues (e.g., heart 

and brain) to fully understand the mental health of women and men. These shared mechanisms may involve hormones, genes, inflammatory pathways, growth factor signaling, 

vasculature factors, cell cycle and proliferation, and neuropeptides. 

6. It is important to translate clinical and preclinical knowledge of sex differences in the 

brain into development of sex- and gender-specific treatments and prevention strategies. 

Sex-specific treatment and prevention strategies for psychiatric disorders must be rigorously tested for efficacy and effectiveness, with focused investigation on mediators and 

moderators of outcome. 

7.	�Education of the scientific community and the public is an important component of 

improving women’s mental health. An understanding of sex differences in the brain and 

how this contributes to sex and gender differences in psychiatric illnesses will lead to the 

development of, and demand for, sex-specific treatments and prevention strategies for 

psychiatric disorders. 

8. Mental health policies are needed at the State and Federal levels that are informed about 

sex and gender differences in psychiatric disorders, both in underlying predisposing 

factors to disease as well as differences in treatment response. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Develop New Knowledge: Visualize and manipulate in vivo cellular 

function and communication in the nervous system in humans and animal models to explain 

sex differences in the pathophysiology of psychiatric disorders. The dream of neuroscience 

is to see the brain in action: not as a black box, but as vital and functioning in the world. The 

real world imposes limits on our ability to do this, but the limits are being broken down continuously. Visualization can refer to anything from functional magnetic resonance imaging in 

29
live people to mapping of molecular entities in live tissue slices or postmortem fixed-tissue 

sections. This recommendation looks forward broadly with an eye toward future innovations. 

However, the following steps can be initiated now. 

• Expand existing brain banks and atlases with a focus on sex differences in normal 

brain structure and functional processes from development through aging. 

• Within these atlases, compare postmortem human tissue, in vivo human imaging, 

and animal postmortem tissue and imaging. 

• Create standards for open access of these atlases and the quality of collected brain 

tissue, including the requirement that all banks/atlases include tissue/images from male 

and female brains. 

• Determine the neural basis of behavior change in treatment outcome research (i.e., use 

these visualization tools to understand the neural basis of behavior, affect, and cognition 

and apply this knowledge to understanding individualized treatment outcomes). 

Recommendation 2: Develop New Knowledge: Identify biomarkers of sex-specific vulnerabilities in psychiatric disorders. Determining the genetic contribution to sex differences in 

psychiatric illnesses is important. With the successful mapping of the human genome and increasing molecular knowledge ranging from genomics to proteomics and other emerging 

disciplines, we are at a new point in time to identify molecular and genetic variability that 

may be linked to specific psychiatric disorders. It is important to understand the function of 

specifically linked genes, how these genes are regulated, and the relationship between gene 

expression in the brain and the disease state. It is also important to integrate populationlevel studies with preclinical and other clinical studies to advance our knowledge of 

sex-specific psychiatric disorder biomarkers. For example, 

• Identify biosignatures, including behavioral phenotypes, to account for individual differences in risk and resilience, including the interplay of biological factors (including genes, 

molecular and cellular signaling cascades, race/ethnicity, developmental stage) and environmental variables (including diverse social contexts and health disparities, stress, 

coping resources). 

• Identify the molecular bases for cellular communication and determine if the bases 

are different for males and females. 

• Combine the power of genetics with new tools for phenotyping (e.g., imaging, 

proteomics) to explain sex differences in variability of psychiatric disorders. 

• Develop and validate sex-specific animal models of critical brain processes implicated 

in the pathophysiology of sex differences in psychiatric disorders. 

Recommendation 3: Develop New Knowledge: Exploit neuroengineering approaches to 

manipulate brain function using viral and/or transgenic approaches, stem cells, or medical devices to understand healthy brain function and treat mental disorders in women and 

men. Engineering is a discipline that applies technical and scientific knowledge in the context 

of natural laws and physical resources to design and implement specific outcomes. Neuroengineering applies this approach to problems of nervous system function and disorder. New 

30
tools range from the world of computer science and nanotechnology to the integration of new 

cellular and genomic material into animal models or humans. For example, 

• Antidepressants may alter neurogenesis. Methods are needed to ask whether this occurs in 

humans (and if so, is there a difference by sex), while using animal models to determine 

detailed mechanisms to explain sex differences. 

• Electrical stimulation of the peripheral and central nervous system may influence psychiatric function. Understanding of the medical device/human-animal interface is needed and, 

in particular, whether there are differential implications for women and men. 

• Stem cells are being proposed as solutions for brain dysfunction. We need to understand 

the integration and function of such cells in living individuals; the visualization of such 

cells in situ will greatly enhance their utility. 

Recommendation 4: Translation to the Clinic: Use the new knowledge obtained from visualization, biomarker identification, and neuroengineering to develop and evaluate novel, sex-specific 

treatments (including pharmacologic and behavioral) in diverse populations and community 

contexts. Taking a treatment from the bench to the bedside adds a level of complexity. Animal 

models show behavior, but they do not communicate mental processes as humans do. Some 

animals do not experience menopause. As new technologies are developed that provide an 

ability to look at brain function in live individuals, it may be possible to better match the 

expectations of the bench to the realities of the bedside. For example, 

• Brain treatment targets can be identified by visualizing molecular or activity-based changes. 

• Molecular processes as drug targets can be identified as biosignatures unique to 

selected psychiatric disorders. 

• Novel treatments (e.g., stem cells) can be developed by using neuroengineering approaches. 

• These studies must test for the specificity of treatment efficacy by sex/gender and 

hormonal status and compare treatment strategies. 

Recommendation 5: Translation to the Community: Develop and test innovative models of 

health care delivery for women that provide integrated prevention and treatment for mental 

and physical disorders, emphasizing wellness through the lifespan and including issues of diversity. Integration throughout the health care universe is a desirable goal, but a difficult mission. 

New strategies are needed that range from arranging physical locations (proximity) to sharing 

medical records (paper in the past and present to more digital in the future). The emphasis should 

be on designing ways to test whether these changes improve health outcomes for women in 

diverse contexts, including those facing health disparities and a variety of social challenges. This 

integrated approach will replace the fragmented system experienced by most women seeking 

care for physical and mental health, which is important given the substantial comorbidity of 

psychiatric disorders with chronic medical diseases. For example, 

• Compare outcomes in integrated interdisciplinary practice settings (not just colocalization of disciplines) with standard settings. Incorporate tests of comparative 

treatment effectiveness.
�

31
• Develop and evaluate integrated assessment and treatment protocols for sex-specific, 

comorbid conditions in psychiatric disorders (e.g., substance use disorders with eating 

disorders, psychoses, and/or depression) and comorbid psychiatric and physical health 

conditions (e.g., depression or substance use disorders or psychoses with obesity, 

diabetes, cardiovascular disease, cancer). 

• Increase effectiveness studies of safer sex skills in at-risk women (e.g., women with substance use disorders, depression, PTSD) to decrease transmission of HIV through risky 

sexual behaviors. 

References 

1.	� U.S. Department of Health and Human Services. (1999). Mental health: A report of 

the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, 

Substance Abuse and Mental Health Services Administration, Center for Mental Health 

Services, National Institutes of Health, National Institute of Mental Health. 

2. Murray, C. J., & Lopez, A. D. (Eds.). (1996). The global burden of disease: A comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 

and projected to 2020. Cambridge, MA: Harvard University Press. 

CHRONIC PAIN SYNDROMES 

Cochairs:
�

Emeran Mayer, M.D.
�

University of California, Los Angeles 

Leslie J. Crofford, M.D. 

University of Kentucky 

NIH Cochairs: 

Linda Porter, Ph.D. 

National Institute of Neurological Disorders and Stroke 

Chris Mullins, Ph.D. 

National Institute of Diabetes and Digestive and Kidney Diseases 

Science Writer: 

Ann Marie Stowe, Ph.D.
�

Washington University in St. Louis 

Introduction 

At the outset, the working group decided that the focus would be on “chronic functional pain” 

syndromes including, but not limited to, fibromyalgia, chronic fatigue syndrome, irritable bowel 

syndrome, interstitial cystitis/painful bladder, pelvic pain syndromes, vulvodynia, temporomandibular disorder, and headache disorders. The rationale for this decision was twofold: These 

conditions are more prevalent in women than in men, and the conditions are not well addressed in clinical settings or by the categorical structure of the NIH institutes. 

32
The discussion then focused on the following areas to assist with formulation of recommendations. 

• Identifying areas of progress in research, with acknowledgment that advances both in 

the understanding of chronic pain syndromes, as well as in sex and gender differences of 

chronic pain, is limited. Participants provided summaries for recent advances in preclinical 

and clinical research, and presented patient advocate and industry perspectives. 

• Recognizing major obstacles to making progress in future work, participants placed particular emphasis on a general lack of crosstalk between important stakeholders (e.g., between 

investigators and clinicians, between preclinical and clinical investigators, between investigators from different disciplines, and between patient advocacy organizations representing 

different syndromes and investigators). 

Summary of the Discussion 

In discussing the state of pain research, the working group concluded that the lack of a generally accepted organizing hypotheses, or conceptual models, for chronic pain is partly because of 

a lack of basic understanding of the clinical disease, and specifically how it relates to sex and 

gender. Several related questions were raised. 

• Does chronic pain have a cortical dimension (e.g., cognitive, attentional) not affected by 

treatments directed at peripheral pain-processing pathways that differs between male and 

female patients? Cortical dimensions cannot be modeled effectively in rodents; therefore, a 

more complete understanding of this dimension in humans may be critical for developing 

effective treatment. 

• Can sex or gender differences be organized into a single hypothesis? 

• Do sex or gender differences with regard to sleep, diet, enteric microbiota, and anatomy 

contribute to differences of prevalence among women? 

• Are there prepubescent differences between the sexes with respect to pain processing 

or clinical pain? 

• How do culture and society influence the etiology and treatment of chronic pain, including 

the perceived negative impact on women in both acknowledging chronic pain and seeking 

necessary medical interventions? If women seek health care at a lower threshold of pain, 

are they still considered “excessive health care seekers,” and would the development of 

unbiased biomarkers (e.g., prefrontal imaging) ameliorate this social or cultural issue? 

The group discussed how pain research focuses on putative end-organ pathologies or is pursued 

by respective subspecialties, fragmenting research design to the detriment of crosstalk between 

interdisciplinary investigators. The future of pain research should move away from categorical 

syndrome-focused research and move toward the development of neurobiological and neuropsychological endophenotypes. Discussion on this topic led to identification of key needs in both 

clinical and preclinical research. Problems identified with regard to current and future clinical 

research of chronic pain include the following: 

• A lack of rigor in studies in which, because of the higher prevalence of women with 

chronic pain, an insufficient or unrepresentative male sample affects the assessment 

of sex and gender differences in the treatment of pain. 

33
• Clinical trials that do not accurately represent the diversity of symptoms within chronic pain. Several reasons were given for this, including (1) presentation of the mean 

data without outliers; (2) no broad survey of symptoms to transcend an end organ/subspecialty analysis; and (3) lay vocabulary that is both difficult to use to convey pain 

accurately, and even more difficult to translate into quantifiable data. 

• A heightened biological redundancy during chronic pain in humans as compared to laboratory animals. Although not well understood, this biological redundancy is evidenced 

by the failure of several high-profile, single-target chemical candidates to show efficacy 

in clinical trials that previously demonstrated great preclinical promise (e.g., failure of 

recent clinical trials with antagonists for the substance P and the CRF1 receptor). 

• Major variations in placebo rates, ranging between 25 and 60 percent, that have been 

detrimental to the continuation of several clinical trials into chronic pain pharmacotherapeutics. The variations in placebo may result from the lack of understanding of the true 

diversity of symptoms, as addressed above. 

In addition, the working group brought forth several issues with regard to preclinical animal 

studies, as follows: 

• Use of animal models in chronic pain research presents several inherent problems, related to poor face, construct, and predictive validity. These include (1) a general lack of 

models for common chronic pain syndromes, including irritable bowel syndrome, fibromyalgia, and migraine; (2) lack of relevant outcome measures of pain, particularly with 

regard to spontaneous versus evoked pain models, and with regard to reflexive outcome 

measures versus operant models; (3) the unsuccessful translation of therapeutic targets 

in knockout/transgenic animals to efficacy in the clinic; and (4) an inability to model social factors that modulate pain perception and efficacy of treatment in the clinic. 

• A lack of significant focus on sex and gender differences in chronic pain because the 

majority of the animal models of pain use male animals only. This situation is, in large 

part, due to the increased cost of studying sex-related differences, and to the technical 

challenges in controlling for cyclical hormonal variations in female animals. 

• Better rodent models of spontaneous pain and better methods to assess associated 

pain behaviors are needed. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Focus research on identifying shared mechanisms among different pain 

syndromes with trans-NIH effort, to support collaborative inquiry into commonalities and 

differences in chronic pain syndromes. One successful example is NIDDK’s Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network approach for head-to-toe 

phenotyping (clinical as well as biological), using a collaborative effort to identify systemic disease with comorbidity while moving away from an organ-centric approach. One logical area of 

research, spanning several subspecialty areas, should be sex differences in the central nervous 

34
system that may underlie the observed greater prevalence of chronic pain syndromes in women 

(including sex differences in cognitive, attentional, and affective mechanisms, and sex differences underlying the lower threshold in women for seeking health care). 

Recommendation 2: Encourage the study of clinical programs that promote societal support 

for individuals, especially women of all socioeconomic and cultural groups, in seeking out 

and receiving treatment for chronic pain. For example, in positive portrayals of women, a lower 

threshold in women for seeking medical care for persistent pain should be presented as reflecting an adaptive biological mechanism, that enhances chances for survival of women and their 

offspring, rather than as a psychological weakness. 

Recommendation 3: Encourage funding initiatives that address the issue of the transition of 

acute into chronic pain, specifically: Does it occur? In which subset of patients does it occur? 

What are the vulnerability factors for such a transition to occur—such as physical trauma (e.g., 

infection, injury) and psychological trauma (e.g., traumatic brain injury, rape, stress)? How do 

psychological factors interact with genetic and other vulnerability factors to influence the development and progression of chronic pain? Preventive programs, starting in childhood, should be 

designed that focus on early support for vulnerable individuals following acute injury in an effort 

to minimize the development of chronic pain. 

Recommendation 4: Encourage funding initiatives that develop a more “universal” impact 

scale for chronic pain across endophenotypes, similar to the Patient-Reported Outcomes Measurement Information System (PROMIS) network. PROMIS is a network of NIH-funded primary 

research sites and coordinating centers working together to develop tools to reliably and 

validly measure patient-reported outcomes. The development of a similar questionnaire, 

with an emphasis placed on gender specificity, could be encouraged in all NIH-funded 

chronic pain research. 

Recommendation 5: Undertake an evaluation and subsequent overhaul of clinical trial 

designs for chronic pain and include advocacy and industry representation. 

• Investigate more than one pathology instead of the evidence-based single pathology 

approaches currently in use. 

• Support an environment for chronic pain clinical trials that is not a “one and done” approach. An accepted industry standard is for 10 trials to be undertaken with respect to 

antidepressant drugs, with only 4 to 5 of these clinical trials showing efficacy. Because 

chronic pain spans a spectrum of disorders, with high incidence of comorbidity, this 

approach may be necessary to truly establish efficacy for a particular endophenotype. 

• Require the reporting of the full spectrum of results, not just the mean data. This will 

be particularly beneficial to outliers who may benefit from the drug in question. 

• Encourage the exploration of combinations of treatments (combinations of drugs, or 

combination of a drug with cognitive behavioral approaches). 

35
• Minimize the wide range of placebo effects in current chronic pain clinical trials by incorporating the effective methodology currently used in pediatric trials, including lead-in 

studies or randomized withdraw. 

• Promote the concept of flex dosing, which is not currently used in chronic pain clinical 

trials, but is used in clinical psychiatry trials with excellent effects. 

Recommendation 6: Because of the prevalence of chronic pain in the United States, there 

should be a call for increased funding for functional pain research to better understand the 

disease mechanisms in humans, appropriate treatments, and possible preventive measures. 

This funding initiative should include research of chronic pain across gender and socioeconomic 

and cultural strata, with emphasis on how life experience modulates resilience and recovery. 

As a long-range objective, advances in understanding the human etiology of chronic pain, via 

genetics, biomarkers, neuroimaging, etc., can promote the development of relevant animal models that would more accurately predict the clinical efficacy of therapeutics (reverse translation). 

Recommendation 7: Encourage the development and management of repositories for painrelevant clinical and biological information that spans current end-organ subspecialties. Such 

repositories could include a centralized database for structural and possibly functional magnetic resonance imaging data. To spearhead the rapid development of this repository, there should 

be an international call to industry to share clinical data, particularly with regard to failed clinical 

trials in the area of chronic pain. This should be presented as an ethical and moral imperative, to 

minimize superfluous experimentation into compounds that are not efficacious, and to promote 

the possible combination of FDA-approved drugs that may show efficacy in treatment for specific syndromes. 

Recommendation 8: Encourage individual fellowships that support a 1-year grant for basic 

science researchers to work in a clinical setting. With particular regard to chronic pain, understanding how pain presents in the clinic could aid the rapid development of animal models by 

basic researchers that more accurately reflect the disease. 

EATING DISORDERS 

Cochairs:
�

Denise E. Wilfley, Ph.D.
�

Washington University in St. Louis 

B. Timothy Walsh, M.D. 

Columbia University 

NIH Cochair:
�

Mark Chavez, Ph.D.
�

National Institute of Mental Health 

Science Writers:
�

Dorothy J. Van Buren, Ph.D.
�

Washington University in St. Louis 

36
Anna L. Vannucci 

Washington University in St. Louis 

Introduction 

The cochairs of the Eating Disorders Working Group presented a review of the current state of 

research on eating disorders and summarized input from experts they consulted on the gaps 

in knowledge in the field and needs for future research. The working group discussed research 

progress to date and current gaps in knowledge regarding the etiology, prevention, and treatment of eating disorders across the lifespan. 

Summary of the Discussion 

Eating disorders currently recognized in the DSM-IV include anorexia nervosa, bulimia nervosa, and “eating disorders not otherwise specified,” which includes binge eating disorder. Eating 

disorders are among the top 10 mental disorders that cause disability among women and are a 

significant source of morbidity and even mortality.1,2 For example, morbidity from anorexia nervosa is the highest of all mental disorders, with a 50-fold increase in the relative risk of death 

from suicide.3 Common psychiatric comorbidities of eating disorders include depression, anxiety, 

substance abuse, and impaired social functioning. Serious medical complications include cardiovascular problems (e.g., bradycardia, low blood pressure), electrolyte imbalance, neurological 

problems (e.g., seizures, disordered cognitions), hormonal changes (e.g., lower estrogen, higher 

stress hormones), and problems with bone health. 

Observations on Anorexia Nervosa 

Anorexia nervosa (AN) affects .3 percent to .6 percent of Americans—as many as 1.8 million 

people—in their lifetime, and 90 percent of the cases are among women.4,5,6 The disorder presents as a failure to maintain a minimally normal body weight, intense fear of weight gain, and 

disturbances in the perception of body shape or size. It typically begins during adolescence 

and is associated with profound, even life-threatening, physiological abnormalities. It can have 

a variable (e.g., full recovery after a brief episode, chronic illness lasting years, death), but often 

chronic, course. 

The state of current research on AN is the following. 

• Evidence suggests that genetic and environmental factors play important roles in the 

etiology of AN (e.g., studies comparing brain circuitry of normal individuals and individuals with AN have found that although eating produces a calming effect for most people, 

it elicits anxiety for individuals with AN). However, clear evidence-based etiology and 

pathophysiology have not been established. 

• A small amount of research indicates that the most effective intervention for adolescents 

with AN is a family-based approach, and several studies of this approach are currently 

underway.7 However, no specific treatment, either pharmacological or psychological, 

has been shown to be consistently effective for adults with AN.8 

Observations on Bulimia Nervosa 

Bulimia nervosa (BN) affects 1 percent of Americans in their lifetime—approximately 3 million 

people—and occurs primarily among women with body weights that are within normal limits.4,5,8 

37
The disorder is characterized by recurrent binge eating (the consumption of an abnormally 

large amount of food in a discrete period of time), followed by the use of inappropriate compensatory behaviors, particularly self-induced vomiting, to avoid weight gain. It generally 

begins during adolescence or early adulthood and may be accompanied by potentially serious medical complications, largely as a result of self-induced vomiting or other forms of 

inappropriate compensatory behaviors, and frequent psychosocial morbidity. 

The state of current research on BN is the following. 

• The detailed etiology and pathophysiology of BN are not well established, although existing data support the important role that biologic and psychosocial factors play in the 

development and persistence of this disorder (e.g., research indicates the frontal lobes of 

individuals with BN exert less inhibitory control than those of normal individuals).9 

• Significant progress has been made in the last 20 years in the development of several effective psychological and pharmacologic treatment interventions for BN. However, 

continued progress in treatment development is clearly needed because as many as 50 

percent of women treated for BN are resistant to available interventions.10 

• Although BN often begins in the early teenage years, controlled treatment studies of 

adolescents with BN are just now getting underway. 

Observations on Binge Eating Disorder 

Binge eating disorder (BED) affects 2.8 percent of Americans—approximately 8.4 million 

people—in their lifetime. The majority of cases are women.5 The disorder is characterized by recurrent binge eating without other frequent inappropriate compensatory behaviors (i.e., binge 

eating without purging). It develops in adolescence and early adulthood, but treatment seeking 

does not typically occur until middle age. It is typically associated with obesity and significant 

psychosocial morbidity. 

The state of current research on BED is the following. 

• Extensive research has demonstrated the clinical significance and validity of BED, with 

studies demonstrating that BED is distinct from other eating disorder diagnoses (i.e., AN, 

BN) and non-BED obese populations.11 

• BED appears to aggregate in families and to have a significant genetic component, 

though the etiology and pathophysiology is unclear.11 It is notable that genetic and 

biological research on BED has lagged behind that of AN and BN. 

• Treatment interventions, such as cognitive behavior therapy and interpersonal psychotherapy, have been shown to achieve long-term reductions in binge eating and have 

resulted in weight stabilization, with a subset of patients obtaining clinically significant 

weight loss.12 

In addition, individuals with clinically significant eating disorder symptoms who do not meet 

the full diagnostic criteria for AN, BN, or BED are commonly seen for treatment in outpatient 

settings. However, the diagnostic validity and clinical utility of these other symptom presentations (e.g., purging disorder, night eating syndrome) are not yet well understood. 

38
Recommendations 

The working group, consistent with responses by members of the Eating Disorders Research Society (EDRS), believed that the most pressing issue confronting the field is the establishment of 

the significance of eating disorders as a major public health problem for women. (EDRS is an international organization of researchers in the field of eating disorders interested in AN, BN, BED, 

and obesity.) Additional issues include advances needed in basic research, intervention/prevention research, and training the next generation of eating disorders scientists. The concern 

regarding research training is common across many research areas, but the small number of 

researchers of eating disorders warrants heightened concern. 

The following are specific research gaps identified by the working group. The recommendations 

proposed may help to provide guidance to health administrators, clinicians, scientists and the 

public as to areas of investigation that merit greater research. 

• The development and testing of effective treatments for persistent AN. For example, 

there are many barriers to conducting controlled clinical trials with this population given 

the relative rarity of this disorder and the egosyntonic nature of the symptoms (e.g., recruitment and retention of individuals with AN to clinical trials is even more difficult and 

costly than is typical, often requiring multiple treatment sites, which further increases the 

cost and complexity of conducting research with this population). These challenges are 

exacerbated by the paucity of clinical research scientists working with AN in particular, 

and in the field of eating disorders in general. 

• The genetics and pathophysiology of eating disorders and how biological factors interact with behavioral and environmental factors and vice versa, particularly in view of the 

increasing cost effectiveness of genetic testing and continuous improvements in neuroimaging techniques. For example, studies of brain circuitry regarding reward and emotion 

regulation, research on temperament, and research into the differential maturation rates 

of various brain structures during adolescence and early adulthood are needed to learn 

more about why some individuals, especially youth, are at risk for developing eating disorders. 

• The roles that gender and life stages play in the development, course, and responsiveness to treatment of eating disorders. For example, do genetic or hormonal mechanisms 

contribute to the disproportionate expression of eating disorders in women, but not 

men? How do events such as pregnancy and menopause affect the development or 

course of eating disorders? 

• The development of effective methods for early identification, intervention, and prevention of eating disorders. For example, efficient screening methods need to be 

developed for identifying individuals most at risk for eating disorders (e.g., women with 

high weight and shape concerns, with other comorbid psychiatric symptoms, and with 

loss-of-control eating), and targeted prevention programs need to be developed. 

• The intersection of the fields of obesity and eating disorders research. For example, 

obesity prevention programs that emphasize the adoption of healthy lifestyle behaviors 

(e.g., regular eating patterns) may prevent eating disorders by modifying the unhealthy 

dieting and dysregulated eating behaviors in which individuals with eating disorders 

39
often engage. Additionally, obesity prevention programs that encourage the adoption of 

regular, moderate physical activity are associated with improvements in mood and sleep 

cycles, which may help with body-image enhancement and emotion regulation in overweight individuals and thus may decrease their risk for developing eating disorders. 

• The development of more potent treatments for eating disorders by examining the mediators and moderators of treatment effects, determining the degree of recovery or of 

symptom change that is necessary to prevent relapse in these often chronic and recurring disorders, and by using basic and laboratory research findings to help personalize 

treatments for eating disorders. 

Furthermore, a “disconnect” exists between proven treatments for eating disorders, such as BN 

and BED, and their use by the general treatment community. For example, more than half of the 

training programs for psychologists and social workers do not require training in evidence-based 

psychotherapies. More specifically, few formal training opportunities exist at the doctoral level for instruction and practice in providing evidence-based treatments to individuals with eating 

disorders. In addition, clinical research in the area of eating disorders is most often conducted in 

specialty clinics within medical school departments of psychiatry. As a result, when women seek 

treatment for an eating disorder in the community, the treatment they receive is likely to be inconsistent and not necessarily based on evidence. 

Intervention designs need to consider the perspectives of consumers and stakeholders (e.g., patients, providers, family members) from the outset so that the most effective interventions can 

be implemented in “real world” settings in a timely and cost-effective manner. Along these lines, 

innovative training paradigms need to be explored to allow for training scientists and clinicians 

to work as part of interdisciplinary teams in order to design studies that evaluate, test, and treat 

eating disorders across multiple levels (e.g., the biological/genetic, interpersonal, and cultural) 

and to ensure that the most effective interventions available are provided to women across 

the age spectrum. 

References 

1. Murray, C.J.L. and Lopez, A.D. (Eds.). (1996) The global burden of disease: a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 

and projected to 2020. Cambridge, MA: Harvard University Press. 

2. Sullivan, P.F. (1995). Mortality in anorexia nervosa. American Journal of Psychiatry, 

152(7),1073–1074. 

3. Keel, P.K., Dorer, D.J., Eddy, K.T., Franko, D.L., Charatan, D,. & Herzog, D.B. (2003). 

Predictors of mortality in eating disorders. Archives of General Psychiatry, 60, 170–183. 

4. Hoek, H.W. & van Hoeken, D. (2003). Review of the prevalence and incidence of eating 

disorders. International Journal of Eating Disorders, 34, 383–396. 

5. Hudson, J.I., Hiripi, E., Pope, H.G., & Kessler, R.C. (2007). The prevalence and correlates 

of eating disorders in the National Comorbidity Survey replication. Biological Psychiatry, 

61, 348–358. 

40
6. Gidwani, G. P., & Rome, E. S. (1997). Eating disorders. Clinical Obstetrics and Gynecology, 

40(3), 601–615. 

7. le Grange, D., & Eisler, I. (2009). Family interventions in adolescent anorexia nervosa. 

Child and Adolescent Psychiatric Clinics of North America, 18(1), 159-173. doi:10.1016/j. 

chc.2008.07.004 

8. U.S. Department of Health and Human Services, National Institutes of Health, National 

Institute of Mental Health. (2007). Eating disorders (NIH Publication No. 07-4901). 

Retrieved from http://www.nimh.nih.gov/health/publications/eating-disorders/nimheatingdisorders.pdf 

9. Fischer, S., Smith, G.T., & Anderson, K.G. (2003). Clarifying the role of impulsivity in 

bulimia nervosa. International Journal of Eating Disorders, 33(4), 406–411. 

10. Steinhausen, H. C., & Weber, S. (2009). The outcome of bulimia nervosa: Findings from 

one-quarter century of research. The American Journal of Psychiatry, 166(12), 1331-1341. 

doi:10.1176/appi.ajp.2009.09040582 

11. Hudson, J. I., Lalonde, J. K., Berry, J. M., Pindyck, L. J., Bulik, C. M., Crow, S. J., McElroy, 

S. L., Laird, N. M., Tsuang, M. T., Walsh, B. T., Rosenthal, N. R., & Pope, H. G.,Jr. (2006). 

Binge-eating disorder as a distinct familial phenotype in obese individuals. Archives 

of General Psychiatry, 63(3), 313-319. doi:10.1001/archpsyc.63.3.313 

12. Vocks, S., Tuschen-Caffier, B., Pietrowsky, R., Rustenbach, S. J., Kersting, A., & Herpertz, 

S. (2010). Meta-analysis of the effectiveness of psychological and pharmacological 

treatments for binge eating disorder. The International Journal of Eating Disorders, 

43(3), 205-217. doi:10.1002/eat.20696 

GENETICS AND MICROBIAL COMMUNITIES 

(METAGENOMICS/MICROBIOME) 

Cochairs: 

Larry Forney, Ph.D.
�

University of Idaho 

Jacques Ravel, Ph.D. 

University of Maryland 

NIH Cochair: 

Maria Giovanni, Ph.D.
�

National Institute of Allergy and Infectious Diseases 

Science Writers: 

Linda A. Landon, Ph.D.
�

Research Communiqué 

Sarah Van Vickle-Chavez, Ph.D. 

Washington University in St. Louis 

41
Introduction 

The Genetics and Microbial Communities Working Group discussed strategies and approaches for applying metagenomics technologies to stimulate progress in basic science and clinical 

research related to women’s health. Research on the human microbiome—the sum of those 

microbial communities found in and on the human body—can be used to define the healthy 

and diseased states of women throughout life and to better understand women’s responses to diseases, medical therapies, and technologies. The most important potential benefit of 

these studies is an increased understanding of the healthy and diseased states of women and 

differences among individuals that arise from the interaction of genetic, physiological, socioeconomic, environmental, and other variables. An increased understanding of the healthy 

human state will enable early disease recognition and prediction, novel therapeutic targets, 

optimal nutrition, and an increased understanding of drug action. 

As a background for the working group discussion, the cochairs presented extensive information about the nature of the human microbiome, the NIH Human Microbiome Project, and 

research technologies and methodologies for studying the microbiome. Human microbiome 

research is poised to make significant advances, and considerable preliminary data are available. In addition, rapid progress is being made in the development and application of technical 

tools for the study of interactions between human hosts and their microbiomes. For example, a 

current major initiative for microbiome research is the Human Microbiome Project, part of the 

National Institutes of Health Roadmap for accelerating biomedical research. 

The goal of the NIH Human Microbiome Project is to characterize the microbes that inhabit the 

human body and examine whether changes in the human microbiome can be related to health 

and disease. Specific goals of the project include (1) sequencing 1,000 microbial reference 

genomes; (2) performing metagenomic analysis of human clinical samples from five human 

body sites (vagina, nose, mouth, skin, and gastrointestinal tract) in more than 250 healthy individuals; (3) demonstrating the feasibility of metagenomics to correlate changes in the human 

microbiome with health or disease phenotypes; and (4) developing new and improved technologies and bioinformatic tools specifically applicable to metagenomic research. 

The Human Microbiome Project also supports a reagent repository and a data analysis and coordination center located at the University of Maryland School of Medicine to give the scientific 

community rapid access to reagents, datasets, and other resources generated by the project. 

In addition, an International Human Microbiome Consortium has been formed that will internationally coordinate human microbiome initiatives and generate a shared resource of human 

microbiome data and protocols, coordinate international efforts to reduce redundancy, and 

provide a venue for international communication of results and strategies. 

Summary of the Discussion 

The working group discussion centered on four broad issues: (1) investigation of the human microbiome to explore mutualistic relationships that occur with the host, with a focus on health 

to provide insights into disease; (2) the need to be inclusive in clinical research to understand 

these interactions as they occur throughout women’s lifespans; (3) technical challenges faced 

in studies of the human microbiome; and (4) the need to recruit and retain women in research 

42
to understand the role of the human microbiome in women’s health. Subsequently, the working 

group developed five broad recommendations for genetics and human microbiome research. 

Mutualistic Relationships Between Hosts and Their Microbiomes 

The human body has remarkable homeostatic mechanisms that ensure the stability of bodily 

functions and the survival of individuals; as a result, most humans are healthy most of the time. 

Understanding these mechanisms, particularly with regard to the mutualistic relationships that 

exist between the human host and its microbiomes, should receive increased attention so that 

strategies for the maintenance of human health and the prevention of disease can be improved. 

Furthermore, it should be recognized that the microbiomes of healthy individuals are in dynamic 

equilibria, and a certain degree of variability in structure and function over time should be expected. However, changes that exceed certain limits could either increase the risk for disease or 

be associated with disease symptoms, and this possibility warrants exploration. Thus, there is a 

need to better understand the temporal dynamics of these systems. This effort should include 

changes in the host and human microbiome that occur over a human’s lifespan. Such studies 

must be interdisciplinary and must address all three domains of the ecological triad—host, 

microbiome, and environment. 

The recognition that mutualism exists among the hosts, their microbiota, and the environment presents new avenues toward learning about the maintenance of health in individuals. 

By not simply focusing on disease states, one could envision studies in which microbiomes 

were deliberately perturbed to explore their resiliency and to better understand the processes, community members, and relationships that are key to homeostasis and the maintenance 

of health. Such human-provoked perturbations might arise from changes in lifestyle, behavior, 

pregnancy, diet, birth control practices, or various other habits and practices. However, these 

perturbations might also occur following chemotherapy, use of antibiotics, and use of other 

drugs. These studies might also assess whether different microbiota communities are functionally equivalent, determine if new alternative equilibria are established following specific 

perturbations, or identify indicators of pathology. 

Inclusiveness in Clinical Research 

Expanding Clinical Research to Include a Woman’s Lifespan. Studies on women’s health must 

encompass the entire lifespan. Until recently, there was a dearth of information concerning 

women of nonreproductive age, and many clinical studies in the past excluded women of childbearing age or who were nursing or pregnant. Information is needed about all stages of life to 

define the normal progression of acquiring microbiota, to define differences in microbiota that 

occur independently of reproductive status, to define the roles of interpersonal variation in 

microbiota composition, and to define the interaction between the human host and the microbiota. Such studies will provide insight about how the host’s age affects interactions between the 

microbiome and a woman’s body at all stages and states of a woman’s life. Such studies should 

be extended beyond the cross-sectional studies to include longitudinal studies that accurately 

reflect the variations in microbial communities that occur in healthy individuals over time. 

Examples of age-specific issues that warrant further investigation are described briefly below. 

43
Pregnancy. For both the infant and the mother, microbiome changes during and after pregnancy offer a unique opportunity to study changes in host status on microbiome structure and 

function and to study the effects of those changes on women’s health. Such studies might address potential differences in the microbiome before, during, and after pregnancy and during 

lactation. There are likely to be multiple deterministic and stochastic effects on the acquisition 

of microbiota and community assembly during the pre- and postpartum periods that are influenced by the mode of childbirth (vaginal versus C-section delivery); the prophylactic use of 

antibiotics during pregnancy or prior to delivery; breastfeeding; and medical interventions to 

improve infant health in the short term. This acquisition may be especially important to the 

development of the microbiome in neonatal intensive care units that could be influenced by 

the numbers and types of organisms to which infants are exposed and by medications that 

are administered. 

Correlation of health status with factors such as reproductive age, medical interventions during 

delivery, and normal versus abnormal pregnancy will shed light on the healthy state in women and newborn children. For example, correlation of perinatal effects (C-section, predelivery 

antibiotic administration, early administration of broad-spectrum antibiotics, health care worker interactions with the infant, etc.) with microbiome structure and function will provide insight 

into the long-term consequences of these interventions on microbiome. 

Adulthood. Gaining information about women across the globe who live in different environments and cultural settings will shed light on how these factors influence the microbiomes of 

women. Moreover, mapping changes in the microbiome over time, throughout menstrual cycles, 

and in various anatomic sites will provide information on variation in microbiome structure and 

function over time. Finally, studies on the effects of medical interventions on women’s health 

should be expanded to include the human microbiome. 

Older women. Older women are likely to experience multiple perturbations of the host-environment interaction because of comorbidities and polypharmacy. These perturbations may 

contribute to adverse effects on a woman’s health and susceptibility to additional disease, and 

alter her response to treatments. These possibilities should be explored through detailed monitoring of the microbiome in the presence of pharmaceuticals and comorbidities, especially in 

older women. 

Policy Barriers to Clinical Research on Women’s Health. Changes to current research practices 

and funding mechanisms are needed to facilitate the long-term longitudinal studies required to 

address all stages of life, and to study interpersonal variations and behavioral parameters. Such 

studies to relate the structure and function of the microbiome to women’s health must be interdisciplinary and designed to address the host, the microbial communities, and the environment 

in an integrated manner. 

Several policies limit studies of women’s health over the lifespan. Research funding and approvals for using human subjects currently focus on time-limited, cross-sectional studies; 

thereby, longitudinal, intergenerational, and long-term data gathering are largely precluded. The necessity of conducting lifespan research over multiple funding periods conflicts with 

44
current prohibitions against contacting study participants after the end of a study period. 

Thus, changes to the scientific and funding environment are needed to facilitate recruitment 

for lifespan studies and to ensure accessibility to samples across multiple funding periods. 

Novel protocols and methods will be needed to identify, recruit, and retain women who are 

willing and able to participate in studies over extended periods. Adequate funding will be required to create sampling protocols that allow data collection on individuals over multiple 

funding periods and that will produce samples that adequately represent the tremendous 

interpersonal variation inherent to human populations. Funding should exist that can support 

long-term studies, including interdisciplinary studies. 

Regulatory Barriers to Research on Women’s Health. A change in regulations regarding the use 

of existing women’s cohorts and databases (including electronic health records and associated 

health care information) would facilitate multiple contacts with study participants and the use of 

existing samples for additional studies. Existing cohorts might provide a valuable source of serial samples (data) to correlate microbiome dynamics with healthy states and help increase the 

understanding of the role and dynamics of microbial communities in women of all ages. These 

data would enable wide-ranging multifactorial correlation analyses of the interactions among a 

woman’s body, the microbiome, and the environment. Such retrospective analyses would also 

enable the development of predictive models for future health predicaments. Access to such 

cohorts and databases has major implications for the protection of a woman’s confidentiality, 

and addressing ethical issues associated with patient privacy and consent is requisite to the 

use of existing cohorts and data. 

Changes to regulatory control of clinical studies will be required to support studies of the microbiome over a woman’s lifespan. These studies must start before birth, which raises specific 

ethical questions. Standardizing data and specimen collection procedures across institutions 

and improving the sharing of information among researchers might ease interactions with institutional review boards (IRBs). Uniform standards, such as those of the NIH best practices 

model program, could provide templates for standardized protocols that will be acceptable 

for approval by IRBs and other regulatory bodies. 

Educating IRBs on such studies will be required. The composition of the IRB is outlined in 

the Code of Federal Regulations and, historically, has been most concerned with issues of 

risk management. The concern with liability is so great that it often excludes women of reproductive age, children, and infants from clinical research in spite of NIH directives to include 

women of all ages. Furthermore, there is no advocate for women or minorities in the codified 

composition of the IRB. Lifespan research will be facilitated by better communication between 

IRBs and researchers as well as women themselves. This, coupled with broader representation 

and increased input to IRB decisions by all parties, particularly ethnic minority communities, 

will be necessary. 

Ethical Issues Affecting Women’s Health Research. Former interpretations of ethical issues 

create barriers to the participation of women, children, and infants in lifespan research, including research before birth. Paternalistic attitudes about who can and cannot participate in 

45
clinical research effectively prevent women at all life stages from participating in important clinical studies. Some researchers and review boards have misconceptions that certain population 

groups, such as minority women, are not interested in participating in clinical research. Adding 

members, such as community advocates or bioethicists who specifically represent the interest 

of women and communities, to IRBs might increase the IRBs’ fundamental knowledge of women’s health and community attitudes. These members would have a nonvoting status because 

of the codified composition of IRBs. 

Community Education. There is remarkable receptivity among the lay public for women’s 

health research. This is important because their involvement and support is essential to promote lifespan research. To promote research on the human microbiomes of women, the lay 

public must come to understand that the microbiome is a normal, beneficial part of body, 

important to each individual. Behavioral research and educational programs must target specific groups of women and must focus on the family in order to communicate why women’s 

health research is important and that clinical research is a tool for community progress. Educational programs and materials must target the community and potential study participants. 

Researchers should use these educational tools and can take advantage of existing community-based infrastructures to disseminate and use these educational tools. Experience has shown 

that all truly effective communication is locally based and engages the community. Communication must be established between members of the community and scientists. To further 

community education, increased support is necessary for those people who know both the 

science and clinical aspects of women’s health research and can also interact effectively 

with the community. 

Technical Challenges to Microbiome Research 

Critical technical issues that limit microbiome research must be overcome, such as separating microbial DNA from human DNA. In addition, novel bioinformatic and computational 

approaches will be required to mine existing and emerging datasets and sources, including 

electronic health records, pharmacotherapy, comorbidities, and others, while respecting the privacy of participants. Technologies and bioinformatic algorithms must be developed to correlate 

health or disease with microbiome community characteristics. These studies might remedy the 

current limited clinical ability to diagnose diseases such as vaginitis or to develop new and improved diagnostics for known etiologic agents. 

Career Opportunities in Women’s Health Research 

Women’s health research is an expansive field of study with broad opportunities and a great 

need for scientists with expertise in a broad range of disciplines. Young students must be 

encouraged to choose women’s health research as a career. Specifically, educational opportunities and training grants for the next generation of researchers must be targeted specifically 

to women and, most importantly, to women of color. Financial commitments will be required 

to support the infrastructure necessary at the university level to implement the needed career 

training in women’s health research. 

46
Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Examine the relationships among host, microbiome, and environment. 

• Host: Define genotypically or phenotypically well-defined controls and cohorts. Analyze 

other effects on the host that include, but are not limited to, the effects of socioeconomic status on health. 

• Microbiome: Correlate microbial community structure and function with the occurrence 

of disease. Identify appropriate controls and reference microbiomes. Develop advanced 

technological tools for genome sequencing, data analysis, and translation of microbiome 

findings to point-of-care applications. 

• Environment: Determine the influences of environmental factors on immune status, unintentional effects (e.g., diet), stochastic variation, extremes of health, and behaviors that 

are generally regarded as safe (e.g., methods of birth control). 

Recommendation 2: Develop new strategies for community outreach and behavioral 

research and develop educational materials to increase clinical trial registration and 

the general public’s knowledge of health and the microbiome. 

• Disseminate and translate information to the public, K–12 teachers, health care 

professionals, and the scientific community.
�

• Interact with communities to improve acceptance of research and to enhance 

participation in longitudinal genomics research.
�

• Develop models of preclinical trial preparation to encourage community participation, 

addressing health care disparities between different racial and ethnic groups. 

Recommendation 3: Advance women’s health research by addressing lifespan, logistical, 

and bioethical issues. 

• Facilitate longitudinal studies throughout a woman’s lifespan through the development 

of new funding models and institutional review board mechanisms. 

• Ensure opportunities for special populations, including infants, children, adolescents, 

older adults, and underrepresented ethnic groups, to participate in longitudinal studies. 

• Encourage open discussion of bioethical issues associated with recruiting populations 

that have been excluded previously from studies. 

Recommendation 4: Apply new technologies to clinical care. 

• Address both technical and ethical issues of linking databases on microbial communities 

to other data sources, including electronic health records and associated health care information, to enhance the understanding of interactions that occur in the host-microbial 

community-environment triad. Promote the use of emerging information technologies to 

facilitate transmission of data in real time. 

• Encourage the translation of findings into point-of-care applications to facilitate 

personalized medicine in women’s health and wellness. 

47
• Develop software and hardware for database integration. 

Recommendation 5: Promote career training of future scientists, especially women, in 

genomics and bioinformatics. 

• Focus on recruitment and training of women and underrepresented minorities. 

• Encourage interdisciplinary research training that includes ecology, genomics, 

systems biology, information technologies, and clinical science. 

INFECTIOUS DISEASES OF THE URINARY AND 

REPRODUCTIVE TRACTS 

Cochairs:
�

Craig Rubens, M.D., Ph.D.
�

Seattle Children’s Hospital 

Eve Lackritz, M.D. 

Centers for Disease Control and Prevention 

NIH Cochairs: 

Carolyn Deal, Ph.D. 

National Institute of Allergy and Infectious Diseases 

Uma Reddy, M.D., M.P.H. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers: 

Victoria Brown-Kennerly, Ph.D. 

Washington University in St. Louis 

Patricia Fogertey, RN, M.S.N., M.B.A. 

Washington University in St. Louis 

Introduction 

The Infectious Diseases of the Urinary and Reproductive Tracts Working Group focused on 

four areas of women’s genitourinary health: 

1. Urinary tract infections 

2. Reproductive tract infections 

3. Preterm birth as a consequence of urinary and reproductive tract infections 

4. Global impact of women’s reproductive and genitourinary tract infections 

For each of the four areas, the discussion below provides an overview of the current state of 

the field and emerging technologies recently developed at the bench that must be integrated into clinical studies and patient care; ways to make disease prevention messages, disease 

treatments, and health services delivery more efficient by quantifying the impact of the cur48
rent methodologies, and then using the feedback to modify research focus as well as clinical 

practices; and future work that will be critical for continued progress in these disciplines. 

Summary of the Discussion 

Urinary Tract Infections 

Urinary tract infections are common in women, yet poorly understood. Persistent urinary tract 

infections can progress to ascending infections, causing disseminated disease (including maternal and neonatal sepsis). However, the determinants of progression are poorly understood. 

Recent work has overturned classic models of infection by showing that acute, recurring, and 

chronic infections are part of a continuum of pathophysiology and may provide a new paradigm 

for infectious diseases of the urinary tract. The growing problem of widespread antimicrobial 

resistance underscores the importance of developing novel therapeutic strategies. 

Basic research has illuminated the involvement of microbial biofilms in disease. New methods have been developed for rapid pathogen-sequencing methods and culture-independent 

methods for pathogen identification. The challenge now lies in translating these advances into 

clinical methods for point-of-care screening and individualized therapy. Basic and translational research is needed (1) to enable early, rapid identification of pathogens and drug sensitivity 

profiles and to identify the type of infection (acute, recurrent, or chronic); and (2) to develop 

efficient translational therapeutics, for example, biofilm inhibitors and vaccines, with a strong 

emphasis on more prudent use of antimicrobials, including use of combination therapy to 

prevent further development of antimicrobial resistance. 

Reproductive Tract Infections 

Significant progress has been made in detecting and treating reproductive tract infections, for 

example, urine screening to detect sexually transmitted diseases (STDs), Group B streptococcal screening and prophylaxis, human papillomavirus genotyping and vaccine development, and 

highly active antiretroviral therapy to reduce mother-to-child HIV transmission. In spite of this, 

the basic etiology and pathogenesis of most STDs remain poorly understood. Antimicrobial resistance has become a critical public health challenge. Major unexplored questions remain. Does 

the endogenous (benign) vaginal flora affect STD acquisition? Do various contraceptive methods affect STD acquisition and disease progression? More studies are required to (1) advance 

genetic/genomic studies of microbial communities in the reproductive tract, and use microbial 

“omic” data (proteomic, metabolomic, other) to develop point-of-care screening for early, rapid identification of the pathogen, its drug resistance profile, and women at risk; and (2) develop 

critically needed, novel antimicrobial agents for STD and pelvic inflammatory disease (PID) 

prophylaxis and treatment, including natural products and immunobiologics. 

STDs and PID are occurring at epidemic frequencies among U.S. teens and minorities. Accompanying the unabating problem of sexually transmitted infections in teens is the problem of 

unintended teen pregnancy, particularly among minority populations. Teen pregnancies account 

for about 750,000 live births per year and are often complicated by urinary tract infections and 

STDs.1 Current advances in this field include development of long-acting reversible contraceptives (LARCs) and Plan B contraception. Focused effort is required to (1) advance research to 

49
more accurately quantify the risk of PID and STDs associated with intrauterine devices and other 

LARC use; (2) promote dual protection methods, including use of LARC and barrier contraception to prevent both pregnancy and STDs; and (3) develop more effective methods to promote 

sexual health through better dissemination of information regarding disease and pregnancy prevention. These goals will require multidisciplinary projects that emulate the NIH’s Specialized 

Centers of Research (SCOR) on Sex and Gender Factors Affecting Women’s Health program, 

and projects that strive to include populations that are underserved due to racial, ethnic, 

cultural, or educational disparities. 

Preterm Birth 

Urinary tract and reproductive tract infections during pregnancy significantly increase the risk 

for preterm birth. Preterm birth is the leading cause of infant mortality and long-term disability 

in the United States, disproportionately affecting African-American and Native American women. Social factors, such as poverty and lower education, also increase a woman’s risk of preterm 

birth. Health care costs for treatment of preterm labor and delivery and subsequent infant care 

are estimated at $26 billion per year in the United States alone.2 Little progress has been made 

in the past decade in the prevention of preterm birth and preterm-related mortality. 

Use of 17-hydroxyprogesterone caproate therapy for the prevention of preterm birth in women 

at high risk and antenatal steroids to promote infant lung maturation represent advancements 

in the field. Increased use of assisted reproductive technologies for treatment of infertility, often due to chlamydia or other preventable causes, has resulted in increased multiple gestation 

pregnancies and risk for preterm delivery. Moving forward in this field will require (1) basic research to understand the contribution of genitourinary infections and inflammatory processes 

that affect risk of preterm birth based on a fundamental understanding of the biology of pregnancy from implantation to delivery; and (2) development of methods to detect women at risk 

early in pregnancy, such as screening for biomarkers of genetic risk factors, immunologic determinants, and infections that contribute to preterm birth. Advancing these goals will lead 

to new methods for early detection and prevention of preterm birth and improvement of 

infant outcomes. 

Global Health Burden of Women’s Reproductive Tract Infections 

The working group came to the consensus that there is an unacceptable gap in the knowledge of the burden of genitourinary infections among women in resource-restricted countries. 

In the developing world, there is a dearth of projects to assess the epidemiology or etiology of 

female genitourinary and reproductive tract infections, and few statistics for teen pregnancy, 

preterm birth, stillbirth, and maternal and infant mortality. Addressing women’s health issues in 

the developing world is directly relevant to women’s health care in the United States, particularly regarding women of lower socioeconomic status and immigrant populations. More clinical 

studies of these populations will provide a universal understanding of women’s urinary and 

reproductive infections as they relate to maternal/fetal health and infant outcomes. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

50
Recommendation 1: Promote multidisciplinary projects that create linkages between medical fields and newer disciplines, such as computational biology and bioengineering to develop 

cutting-edge tools for clinical applications; biomarker-assisted risk assessment; early diagnostics; and point-of-care pathogen screens, drug-resistance profiling, and infection classification 

(acute, recurrent, chronic). 

Recommendation 2: Use emerging technologies and develop animal models to understand 

the normal and diseased states of the female urinary and reproductive systems, including 

during pregnancy. Collect the resulting data in a centralized, open-access database that correlates prospective cohorts with data on patient phenotype, treatment strategy, and outcome 

with descriptions of the relevant animal models and basic research findings (molecular data) 

germane to the disease. The database should be structured to support prospective, longitudinal studies of clinical conditions using either human cohorts or animal model systems along with 

properly collected, processed, and stored specimens collected at appropriate times during 

clinical assessments and followup, such as during antenatal care. 

Recommendation 3: Foster public-private partnerships that use multiethnic cohorts to develop more vaccines and critically needed, novel antimicrobials—such as biofilm inhibitors, 

chemoprophylactics, natural products, and immunobiologics—against infectious diseases of 

the female urinary and reproductive tracts. New products must be evaluated for safety during 

pregnancy and early infancy in humans and relevant animal models. 

Recommendation 4: Create a smoother pipeline among basic research, T1 (lab to clinic), and 

T2 (clinic to community) translational research to more effectively link research findings from 

bench to bedside. This can be achieved by funding cross-disciplinary projects and centers that 

combine basic research, translational research, and public health application research. Currently there are significant barriers to effective translation of basic biologic discovery to clinical 

application at critical points, including invention technology transfer, preclinical development 

and testing, meeting regulatory (FDA) requirements, and capacity for clinical trials. In addition, 

attention should be paid to monitoring and evaluation to guide technical refinement and 

successful implementation and scale-up of new interventions (see pipeline diagram below). 

51
Model: “Pipeline of Discovery to Delivery”—Pipeline priorities dependent on global burden of 

a particular disease or condition 

Feedback loops promote refinement and new science

Recommendation 5: Measure the public health impact of the current strategies used in health 

education regarding pregnancy prevention and acquisition of genitourinary infections. Measure the impact of current treatment strategies for infections of the female genitourinary tract. 

Use feedback to improve the effectiveness of current strategies by refining the focus of basic 

research and modifying clinical research practices, with a strong emphasis on the prudent use 

of antimicrobials by both clinician and patient. 

References 

1. Guttmacher Institute. (n.d.). Facts on American Teens’ Sexual and Reproductive Health. 

Retrieved from http://www.guttmacher.org/pubs/FB-ATSRH.pdf 

2. Institute of Medicine. (2006). Preterm Birth: Causes, Consequences, and Prevention. 

Washington, DC: The National Academies Press. 

OBESITY 

Cochairs: 

Graham Colditz, M.D., Dr.P.H.
�

Washington University in St. Louis 

Samuel Klein, M.D. 

Washington University in St. Louis 

52
NIH Cochair:
�

Charlotte Pratt, Ph.D., R.D.
�

National Heart, Lung, and Blood Institute 

Science Writers: 

Katie Duggan, M.P.H., M.S., R.D.

Washington University in St. Louis 

Courtney Caruso 

Washington University in St. Louis 

Introduction 

Obesity has become a major health problem in the United States because of its high prevalence, causal relationship to serious medical illnesses, and economic impact of more than 

$100 billion per year in direct (health care expenses) and indirect (lost productivity) costs.1 

The working group identified three primary areas for which targeted research could have a 

high clinical impact. 

• Community-based prevention and treatment of obesity. Special focus was placed on behavior lifestyle change, ethnic and racial disparities, issues specific to children and adults, 

and community issues. 

• The cellular, organ, and whole-body physiological mechanisms responsible for (1) obesity-related cardiometabolic disease, with particular interest in the mechanisms responsible 

for metabolic differences between men and women and ethnic and racial groups; and (2) 

the beneficial metabolic effects of weight loss. 

• The developmental factors that affect weight status, with specific consideration of factors 

in utero and during infancy that influence childhood and adult body weight. 

Summary of the Discussion 

Community-based Prevention and Therapy of Obesity 

Dr. Gary Bennett of Duke University presented background information to start the discussion in the working group. The most recent National Health and Nutrition Examination Survey 

data show a 40-year disparity in the prevalence of obesity, which has plateaued in white women, but continues to rise in African-American women and children.2

 This discrepancy cannot be 

adequately explained by socioeconomic status alone. Sociocultural influences may be an important factor to consider; for example, African Americans have a higher acceptance of larger 

body size than Whites and often demonstrate common misconceptions regarding the health 

risks associated with obesity. In fact, the few randomized controlled trials of weight loss that 

have been conducted with African Americans have had limited success, perhaps because they 

did not address such sociocultural influences. 

The working group began by discussing what steps are required to translate what has been 

learned in academic centers to the community. The group discussed whether future studies 

should focus on implementation research or on effective interventions, especially given the 

fact that some highly controlled trials have shown successful outcomes. The following is a list 

of the major discussion points and observations of the working group: 

53
Community Interventions 

• When considering the best age to intervene, effective models of interventions for 

children that should be taken into account include Planet Health and Coordinated Approach to Child Health (CATCH). Planet Health is a curriculum that helps middle school 

teachers guide students in learning about nutrition and physical activity while building 

skills in language arts, math, science, and social studies; understanding how health behaviors are interrelated; and choosing healthy foods, increasing physical activity, and 

limiting TV and other screen time. CATCH is an evidence-based, coordinated school 

health program to promote physical activity and healthy food choices, and to prevent 

tobacco use in children, preschool through grade 8. 

• Long-term studies, greater than 2 years, are needed to track maintenance of weight loss. 

• Given the difficulty of losing weight in an obesogenic environment, there should be a 

stronger focus on implementing an ecological intervention model that would coordinate 

interventions at multiple social levels. These would include the individual, familial, communal, academic, working, and policy levels. Women strongly influence familial lifestyle 

choices by purchasing food, preparing meals, and serving as family caretakers. Because 

childhood obesity tracks into adulthood and women potentially play an important role in 

managing their children’s health, there is a need to develop multigenerational research 

that examines family interventions. Ideally, these interventions would harness women’s 

roles as family caretakers in order to facilitate healthy familial and personal lifestyle decisions. Furthermore, there is limited information on what specifically motivates women 

to lose weight. Some suggest that women experience increased incentive to lose weight 

when they become pregnant, but additional research is warranted. Furthermore, the 

many roles women take on in the family frequently impede their efforts to lose weight. 

• White or wealthy women are more likely to breastfeed than Black or poor women. This 

has potentially large implications that merit further exploration.3 

• Information is lacking on how physiologic (e.g., hormonal) and behavioral changes, 

which occur during transitional phases of female development (menarche, pregnancy, menopause), relate, alone and in combination, to increases in rates of obesity. Why 

do 60 to 70 percent of American women exceed weight gain recommendations during 

pregnancy, and how can this trend be countered?4 

The Physiological Mechanisms Responsible for Obesity-Related 

Cardiometabolic Disease 

The obesity working group concluded that cardiovascular and metabolic (cardiometabolic) 

disease should be a major focus of future research initiatives regarding obesity because these 

are the most common complications associated with obesity and habitually result in considerable morbidity, decreased quality of life, and increased mortality. However, other important 

adverse consequences of obesity in women should also be addressed, specifically reproductive 

dysfunction and certain cancers. Some key questions that should be addressed by future 

research follow: 

• Why does excess body fat cause metabolic and other chronic diseases in some, but not 

all, obese persons? 

54
• What mechanisms are responsible for the association between obesity and dysfunction 

or disease in organ systems that are of particular importance to women, including endocrine function; reproductive system; and cancer (breast, uterus, cervix)? 

• Why is the relative risk of certain obesity-related diseases, such as type 2 diabetes and 

heart failure, greater in women than men? 

• What cellular, organ system, and whole-body mechanisms are responsible for metabolic 

improvements associated with weight loss in obese persons? What are the mechanisms 

responsible for the metabolic benefits of bariatric surgery? Are there weight-lossindependent effects? 

The Developmental Effects of Obesity in Utero and During Infancy 

In research studies, high-fat diets fed to mice during pregnancy led to a transgenerational effect—the babies developed glucose intolerance and a propensity to become obese. Are effects 

on preconception human oocytes related? Are they reversible? What are the long-term effects 

and how can these studies be translated to humans? Discussion points and specific research 

questions include the following. 

• What types of childcare settings or institutional and parental feeding skills predispose 

infants to obesity? Do large babies, stressful life circumstances, or excessive crying 

correlate with the incidence of obesity? 

• There is currently a gap in research knowledge regarding epigenetic changes, and studies 

have rarely focused on in utero factors. 

• Because the field lacks information about how nutritional patterns and changes affect 

oocyte metabolism, more research should be conducted to answer these questions as 

well as an additional focus placed on preconception nutritional counseling for women. 

There should be identifiable ways of communicating to women the increased risk of 

obesity derived from specific preconception and pregnancy exposures. 

• The following environmental health issues may increase the risk of obesity: exposure to 

tobacco smoke and antiestrogens showing transgenerational effects on male spermatogenesis and oocytes. Additional research on environmental health issues (e.g., Bisphenol 

A, plastics) would be useful in identifying the existence of and degree of further risks. 

Currently, research efforts regarding pregnant women are often highly constrained by inadequate guidelines from IRBs. IRBs should recognize the importance of studies gleaned from 

pregnant participants and should change guidelines to allow for research on pregnant women. 

Guidance is needed for institutions on how basic, clinical, and epidemiologic research can be 

safely and effectively conducted in this way. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Use multilevel (i.e., ecological model) and multigenerational (e.g., family) interventions for obesity prevention and treatment. The specific levels to be considered are 

55
the individual level, such as determining motivators unique to women, as well as intrapersonal, 

interpersonal, family, community, societal, institutional, and policy levels. Multigenerational interventions should harness women’s status as family gatekeepers and caretakers. 

Recommendation 2: Develop a comprehensive, rather than a piecemeal, understanding of the 

metabolic consequences of excess body fat, by conducting transdisciplinary research (basic, 

clinical, and public health science) to examine obesity’s effects on multiple organ systems simultaneously. The use of animal models is important to provide research directions in humans and 

to provide a better understanding of the mechanisms responsible for effects observed in humans. Most importantly, advanced clinical and translational research involving collaborations 

between basic and clinical scientists is urgently needed to make clinically relevant advances 

in the field. 

Recommendation 3: Understand reproductive and further factors during pregnancy that 

affect obesity-related disease and maternal and fetal obesity. Their immediate and long-term 

effects also should be considered. 

Overall, the working group believed the field would benefit from funding mechanisms, such 

as was done with the Transdisciplinary Research on Energetics and Cancer (TREC) centers at 

the National Cancer Institute, which give incentives to researchers conducting related work at 

different levels (cellular, animal, human) and different phases of translation (bench, bedside, 

community) to work together to translate findings. 

Other research goals are relevant to community-based prevention and therapy of obesity. 

• Establish when in specific life-course stages (preconception, in utero, childhood, adolescence, adulthood) interventions are most effective at interrupting disparate obesity 

trajectories. This research should particularly focus on the female developmental time 

periods of menarche, pregnancy, and menopause. 

• Develop interventions that lead to sustained weight loss and improvements in metabolic 

parameters and health outcomes. This research may include the evaluation of communities with low prevalences of overweight and obesity. 

• Develop interventions that prevent weight gain and determine the relative importance of 

diet and physical activity. 

• Implement obesity intervention programs that recognize and study socioeconomic, 

geographic (e.g., urban/rural), and ethnic/racial disparities with consideration of research 

findings regarding sociocultural influences. 

• Determine the most effective and sustainable methods of implementing, translating, and 

disseminating evidence-based interventions to communities. Possible methods may include public education programs, use of new technologies such as social networking, 

and tailored messages. 

Other research goals relate to physiological mechanisms responsible for obesity-related 

cardiometabolic disease. 

56
• Understand the cellular, organ system, and whole-body mechanisms responsible for the 

metabolic consequences of obesity. These studies should be directed to provide an understanding of (1) why excess body fat causes metabolic and other chronic diseases; 

(2) why some obese persons are resistant to the adverse metabolic effects of obesity; 

(3) how obesity affects different organ systems; and (4) why the relative risk of certain 

obesity-related diseases is different in men and women, particularly type 2 diabetes 

and heart failure. 

• Determine the cellular, organ system, and whole-body mechanisms responsible for metabolic improvements associated with weight loss in obese persons. In addition, provide a 

better understanding of why these improvements are seen with moderate 5–10 percent 

weight loss despite the persistence of obesity. 

• Other research goals relate to developmental obesity. 

• Concentrate on the postpartum health and weight trajectory of women. 

• Determine what level of intervention before (e.g., oocyte level, in utero) and during 

pregnancy is required to prevent obesity/metabolic syndrome in infants and how these 

conditions track into adulthood. 

• Develop effective educational programs highlighting the importance of prepregnancy 

planning (e.g., planned pregnancy, preconception diet, and diet during pregnancy). 

• Determine causes of and remedies for racial/ethnic disparities in pregnancyrelated outcomes.
�

References 

1. Wellman, N.S. & Friedberg, B. (2002). Causes and consequences of adult obesity: 

health, social and economic impacts in the United States. Asia Pacific Journal of Clinical 

Nutrition, 11(Suppl 8), S705–S709. 

2. Ogden, C.L., Carroll, M.D., Curtin, L.R., McDowell, M.A., Tabak, C.J., & Flegal, K.M. (2006). 

Prevalence of Overweight and Obesity in the United States, 1999–2004. Journal of the 

American Medical Association, 295(13), 1549–1555. 

3. Forste, R., Weiss, J., & Lippincott, E. (2001). The Decision to Breastfeed in the United 

States: Does Race Matter? Pediatrics, 108, 291–296. 

4. Institute of Medicine. (2009). Weight Gain During Pregnancy: Reexamining the 

Guidelines. Washington, DC: The National Academies Press.
�

WOMEN IN BIOMEDICAL CAREERS 

Cochairs:
�

Phoebe Leboy, Ph.D.
�

Association for Women in Science 

57
NIH Cochair:
�

Walter Schaffer, Ph.D.
�

Office of the Director 

Science Writers: 

Deborah J. Frank, Ph.D. 

Washington University in St. Louis 

Samantha Savarese 

Washington University in St. Louis 

Introduction 

The participants of the Biomedical Careers Working Group recognized that women today are 

well represented in life science fields. They have earned more than 40 percent of medical and 

biomedical doctorates since 1995. By 2006, approximately 50 percent of the new recipients of 

M.D. and biomedical Ph.D. degrees in the United States were women.1,2 However, women are underrepresented in positions of research leadership. During the past 5 years, approximately 25 

percent of principal investigators (PIs) on NIH research grants have been women and the data 

suggest that this percentage is increasing, however slowly.3 The problem, as identified by the 

working group, is not one of a lack of talent and credentials, but rather one of a non-level playing field.4 The goal of the discussion, therefore, was to understand why this is the case and 

what can be done to improve the situation. 

Summary of the Discussion 

The following were the major issues identified regarding women in biomedical careers. 

• Although women have a success rate similar to men in obtaining their first grants, they 

are less successful in securing subsequent funding.3 

• Women M.D.s leave academia at a twofold higher rate than men M.D.s.5,6 

• Women Ph.D.s apply for faculty positions at medical schools in smaller numbers than 

would be expected by their availability in the Ph.D. and postdoctoral populations.7 

Initial discussion focused on the reasons for this situation. The following were among the 

points made. 

• Academic health centers undervalue the importance of retaining highly skilled scientists, 

regardless of gender. 

• Tenure and promotion decisions are primarily based on numbers of publications 

and “weighing the CV” rather than acknowledging the many other ways that 

scientists contribute. 

• The climate in medical schools often leaves women faculty feeling isolated 

and unwelcome.
�

• The current structure of academia is not designed for faculty with family responsibilities. 

• Researchers who have left academia for a number of years have difficulty regaining a 

fulltime scientist position. 

58
• Mentoring in medical schools is inadequate and undervalued. 

• Many of these problems cannot be corrected simply by NIH actions because they are 

created and maintained by academic institutions. 

During lively discussion, the group returned repeatedly to the five main themes below. 

Changing the culture: There is a need for institutional transformation at 

medical schools and other biomedical institutions. 

Efforts must be focused on “changing the game” versus teaching everyone how to play the old 

game. The group strongly concurred that the culture of academic institutions should change.4 

NIH encourages the development of a diverse workforce at all levels through a variety of programs, including entry programs, but can clearly do more in terms of supporting studies and 

encouraging institutional transformation. This transformation must be directed toward both 

increasing equity and improving work-life balance. 

Colleges and universities are the biggest players and are directly responsible for the environment in which most biomedical scientists work. Tenure and promotion decisions should not 

be so heavily based on the number of publications and “weighing the CV,” but rather should 

consider other ways that women contribute, such as team building and participation in collaborative projects. Evaluation mechanisms should emphasize quality rather than quantity. 

The world of academia appears to undervalue employee retention, whereas businesses recognize the value of retaining trained people.8 The need for facilitating career reentry for academic 

physicians also was discussed, and it was noted that data are needed on how many researchers 

want to reenter academia. Academia should adopt the attitude of businesses, especially considering the time and resources devoted to predoctoral, doctoral or medical, and postdoctoral or 

fellowship training. 

Family-friendly policies are needed at academic institutions and at NIH. 

Policies at academic institutions, as at NIH, should continue to strengthen efforts to promote 

support for childbearing responsibilities for graduate students, postdoctoral fellows, and medical residents; in the absence of such supportive policies, women may feel compelled to delay 

this important life choice until they start an academic appointment.9

 Other suggestions included extensions of funding for PIs with children, such as the no-cost extensions that are already 

available on NIH grants, implementation of part-time faculty positions in medical schools, and, 

when possible, more flexible grant application deadlines, which might be more convenient for 

researchers who have family care responsibilities. 

There was strong agreement about the importance of institutions and universities providing and 

subsidizing onsite day care. The group believed the lack of affordable day care is not simply a 

women’s issue or even a biomedical career issue, but truly is a workforce issue of importance to 

the entire United States. Possible initiatives at the national level were (1) grassroots advocacy for 

congressional bills that support subsidized day care, and (2) a White House summit on work-life 

balance. Focusing on biomedical research, the working group reached a consensus that childcare costs should be covered by grants as fringe benefits or indirect costs, and each institution 

59
should be responsible for implementing this. A broader awareness of these Federal policies is 

needed to help assist them in designing their family-friendly policies. 

The group also raised the possibility that day care and K–12 education could be directly associated with universities and health professional schools to improve both work-life balance 

and educational quality. The group did not define what kinds of educational relationships 

between elementary education and universities should be built, but these ideas might be 

explored further. 

Mentoring programs within research and teaching institutions need to 

be evaluated. 

There is a need for mentor training, clarity of expectations for both mentor and mentee, and 

assessment of mentoring methods. Mentors should not only help women identify strategies 

to advance their careers, but also address issues such as work-life balance. While there was 

strong consensus that systems need to be in place that promote good mentoring practices 

and ways of rewarding mentors, whether or not mentoring programs should be mandated remained controversial. One suggestion was that PIs be required to increase their effort on a 

grant by approximately 5 percent if they have graduate students, postdoctoral fellows, or 

fellows funded on the grant. 

A disputed topic was whether grant scores should take into account the family-friendly policies 

(or lack thereof) of an applicant’s institution. Concerns were that this would be burdensome to 

study sections or that this could have a negative impact on researchers at a “nonenlightened” 

institution. Although there might not be an acceptable way to do this in grant applications, 

nonetheless, there was broad agreement that some kind of mechanisms should be in place that 

recognize and reward institutions with exemplary mentoring and work-life balance practices. 

Level the playing field and promote the prestige of women scientists. 

The working group expressed the common belief that because women scientists have a decreased probability of gaining tenure, are PIs on fewer grants, publish less often, and do not 

receive as many invitations to give lectures as their male peers, ambitious graduate students 

frequently conclude that men may be better thesis advisers. The result is that most women 

biomedical faculty do not train as many of the best graduate students as men, leading to 

a self-fulfilling prophecy: women having fewer publications, fewer grants, and less prestige. 

What is good for women is good for everyone. 

Programs with a gender-neutral approach are more accepted by institutions and are thus more 

likely to be sustained. 

60
Recommendations 

The group envisions a future in which the proportion of women holding academic positions 

and receiving NIH grant funding is equivalent to the proportion of women in the postdoctoral medical and biomedical community. All researchers should experience a productive work-life 

balance. None should feel that work pressures force them to delay or abandon having a family. 

Furthermore, the tenure decision process should value the quality of contributions, not just the 

quantity of publications. This will become increasingly important as projects become more collaborative and interdisciplinary. The culture of academia should move away from “survival of 

the fittest” toward a “rising tide lifts all boats.” 

To bring about these changes, the working group identified the following recommendations 

to provide guidance to academic institutions and administrators, the health professions, clinicians, and scientists. 

Recommendation 1: Funding agencies should develop funding programs for institutional 

transformation grants, similar to and building upon the information from the NIH Request for 

Applications, RFA-GM-09-012, “Research on Causal Factors and Interventions that Promote 

and Support the Careers of Women in Biomedical and Behavioral Science and Engineering.” 

These grants would support research into best practices that promote work-life balance in 

institutions engaged in biomedical research and would support initiatives within those institutions to accomplish changes in the culture, climate, and practices of both clinical and basic 

science departments. 

Recommendation 2: There is a need to change the culture of academic institutions so that 

they recognize the value of retaining highly trained personnel. The current tenure and promotion processes at many health professional schools rely heavily on the dollar value of grants 

an investigator has received and the number of papers she has published. These criteria fail to 

take into account other ways in which investigators contribute to their field, such as participation in interdisciplinary work, mentoring, advocacy, and education. Furthermore, the traditional 

approach forces many to make the unpalatable choice between working longer hours and 

spending time with their families or on personal pursuits. 

Recommendation 3: Individuals, professional organizations, and funding agencies should 

support mentoring and faculty development. The “leaky pipe” problem is manifested in a 

disproportionate loss of women at two critical stages. Many women focused on a career in 

biomedical research are lost in the transition from postdoctoral status to an independent faculty position. One major reason is the perception that the chance of career success for women 

in junior faculty positions is unacceptably low, but research is needed to analyze the causes 

and solutions to this phenomenon. NIH should also expand institutional K awards that provide 

mentoring and bridging support to physician-scientists as they move between completion of 

clinical or postdoctoral training and an independent research career. 

61
The second stage in which a disproportionate number of women leave biomedical careers occurs after a woman attains an assistant professor position and a first R01. The women who do 

achieve faculty positions have as favorable a chance of attaining their first NIH research grant 

as comparably employed men. However, the odds of receiving a second and third grant decline 

for women, as do the chances of faculty promotion. Better mentoring of junior faculty can reduce these losses. NIH should expand mentor training programs and should develop programs 

to evaluate mentors and mentoring systems. 

Recommendation 4: Institutions should be more aware of the need for subsidized child care. 

Many young researchers avoid having children during their training period due to an inability 

to pay for child care. Some find that they must make a financial choice between staying in academia and starting a family. They are effectively forced to wait until a time when they receive 

a sufficient salary to afford care for their children. This is a problem plaguing all researchers, 

not just women. Providing subsidized onsite child care would go a long way toward promoting 

work-life balance in the lives of researchers, both men and women. 

References 

1. Hoffer, T. B., Hess, M.,Welch, V., Jr., & Williams, K. (2007). Doctorate recipients from 

United States universities: Summary report 2006. Chicago: National Opinion Research 

Center. (The report gives the results of data collected in the Survey of Earned Doctorates, conducted for six Federal agencies, NSF, NIH, USED, NEH, USDA, and NASA, 

by NORC.) 

2. Leadley, J., Magrane, D., Lang, J., & Pham, T. (2009). Women in U.S. academic medicine. 

Statistics and benchmarking report, 2007–2008. Washington, DC: Association of American Medical Colleges. 

3. U.S. Department of Health and Human Services, National Institutes of Health. (2010). 

NIH data book, fiscal year 2009. Retrieved from http://www.report.nih.gov/nihdatabook/ 

Default.aspx?catid=15 

4. National Academies. (2007). Beyond bias and barriers: Fulfilling the potential of women 

in academic science. Washington, DC: The National Academies Press. 

5. Leboy, P. S., & Lowery, B. (2001). The gender equity report. Almanac, 48(14). Retrieved 

from http://www.upenn.edu/almanac/v48/n14/GenderEquity.html 

6. Leboy, P. S. (2008). Fixing the leaky pipeline. The Scientist, 22, 67–70. 

7.	� Perez, L. (2008). The disappearing biomedical faculty women. AWIS Magazine, 37, 

28–30. 

8. U.S. Department of Health and Human Services, National Institutes of Health, Office of 

Research on Women’s Health. (2009). Women in biomedical research: Best practices for 

sustaining career success (NIH Publication No om hed frvtriee366). R7. 09- omw/:/tpt -

eninscience.nih.gov/bestpractices/docs/BestPracticesReport.pdf 

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9. Willett, L.L., Wellons, M.F., Hartig, J.R., Roenigk, L., Panda, M., Dearinger, A.T., Allison, J., 

& Houston, T.K. (2010). Do women residents delay childbearing due to perceived career 

threats? Academic Medicine, 85(4), 640–646. 

63
A Vision for 2020 for Women’s Health Research: 

Moving into the Future with New Dimensions and Strategies 

University of California, San Francisco (UCSF) 

San Francisco, California 

May 27–29, 2009 

DAY 1 – PUBLIC HEARING 

Location: Mission Bay Conference Center 

12:00–1:00 p.m. Registration 

1:00–1:15 p.m. Welcome 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health, Director, 

Office of Research on Women’s Health (ORWH), National 

Institutes of Health (NIH) 

Linda C. Giudice, M.D., Ph.D., M.Sc. 

Professor and Chair, Department of Obstetrics, Gynecology, 

and Reproductive Sciences, UCSF 

Video Welcome 

The Honorable Jackie Speier 

Congresswoman, 12th District, California 

1:15–2:00 p.m. OPENING PANEL: Shaping the Future 

of Women’s Health Research—Two 

Perspectives 

Moderator: Nancy Milliken, M.D. 

Professor and Vice Dean, UCSF 

Sally A. Shumaker, Ph.D. 

Professor & Associate Dean, Research, Wake Forest University 

Surina Khan 

Vice President of Programs, Women’s Foundation of California 

2:00–6:00 p.m. PUBLIC HEARING 

Moderator: Linda C. Giudice, M.D., Ph.D., M.Sc. 

Receiving Public Testimony: Members of the ORWH 

Advisory Committee and governmental officials and staffers 

64
DAY 2 – SCIENTIFIC WORKSHOPS 

Location: Mission Bay Conference Center 

8:30–8:45 a.m. Welcome and Opening Remarks 

Vivian W. Pinn, M.D. 

8:45–9:30 a.m. Keynote Address: Why So Slow— 

The Advancement of Women in Science 

and Medicine 

Virginia Valian, Ph.D. 

Distinguished Professor, Psychology and Linguistics, Hunter 

College and CUNY Graduate Center 

9:30–10:15 a.m. PANEL: Telomeres and Aging: A Women’s 

Health Issue 

Elizabeth H. Blackburn, Ph.D. 

Morris Herzstein Professor of Biology and Physiology, 

Department of Biochemistry and Biophysics, UCSF 

Jue Lin, Ph.D. 

Assistant Research Biochemist, Department of Biochemistry 

and Biophysics, UCSF 

10:15–10:30 a.m. Working Group Charge 

Vivian W. Pinn, M.D. 

10:30–10:45 a.m. BREAK 

10:45 a.m.–3:15 p.m. Lunch and Concurrent Working Groups: 

Drafting of Recommendations by Area 

• Global Women’s Health 

• Stem Cells 

• Women’s Health and the Environment 

• HIV/AIDS and Women 

• Information Technology 

• Women in Science and Health Careers 

3:15–3:30 p.m. BREAK 

3:30–5:00 p.m. PANEL: Role of Community-Based 

Participatory Research (“T3”) 

Moderator: Cynthia A. Gómez, Ph.D. 

Founding Director, San Francisco State University Health 

Equity Initiatives 

65
Elena Rios, M.D. 

President & CEO, National Hispanic Medical Association 

Karen Pierce, J.D. 

Coordinator, Bayview Hunters Point Health and Environmental 

Assessment Program 

Caitlin Ryan, Ph.D., M.S.W. 

Director, Adolescent Health Initiatives, Cesar Chavez Institute 

at San Francisco State University 

Marj Plumb, Dr.P.H., M.N.A. 

Coach, Consultant and Trainer, Plumbline Coaching and 

Consulting, Inc. 

Ngina Lythcott, Dr.P.H., M.S.W., R.N. 

Associate Dean for Students, Boston University School of 

Public Health 

5:00–6:00 p.m. Conference Reception 

DAY 3 – SCIENTIFIC WORKSHOPS 

Location: Mission Bay Conference Center 

8:30–8:40 a.m. Welcome and Opening Remarks 

Vivian W. Pinn, M.D. 

8:40–9:15 a.m. New Pathways for Translational Research: 

How Science Can Advance Women’s Health 

Moderator: Linda C. Giudice, M.D., Ph.D., M.Sc. 

Claire Brindis, Dr.P.H. 

Director, Philip R. Lee Institute for Health Policy Studies, UCSF 

Deborah Grady, M.D., M.P.H. 

Director, Women’s Health Clinical Research Center, UCSF 

9:15–10:45 a.m. Concurrent Working Groups: Finalization 

of Recommendations 

10:45–11:00 a.m. BREAK 

11:00 a.m.–12:30 p.m. Working Group Presentations 

Moderator: Nancy Milliken, M.D. 

Presentations by individual Working Group co-chairs 

and discussion of Working Group results 

12:30–12:45 p.m. Closing Remarks 

Vivian W. Pinn, M.D. 

66
University of California, San Francisco (UCSF) 

San Francisco, California 

May 27–29, 2009 

WORKING GROUP COCHAIRS 

GLOBAL WOMEN’S HEALTH 

Kirsten Bibbins-Domingo, M.D., Ph.D., M.A.S. 

Associate Professor of Medicine and of Epidemiology and Biostatistics 

UCSF Center for Vulnerable Populations at San Francisco General Hospital and Trauma Center 

University of California, San Francisco 

San Francisco, California 

Warner C. Greene, M.D., Ph.D. 

Director and Professor 

Gladstone Institute of Virology and Immunology 

University of California, San Francisco 

San Francisco, California 

Gray Handley, M.S.P.H. 

Associate Driector for International Research Affairs 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Amy J. Levi, Ph.D., C.N.M. 

Associate Clinical Professor 

Department of Family Health Care Nursing 

University of California, San Francisco 

San Francisco, California 

Lynne M. Mofenson, M.D. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Paula Tavrow, Ph.D. 

Director and Assistant Professor 

Bixby Program in Population and Reproductive Health 

UCLA School of Public Health 

University of California, Los Angeles 

Los Angeles, California 

67
Linda L. Wright, M.D. 

Deputy Director 

Center for Research for Mothers & Children 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

STEM CELLS 

Susan J. Fisher, Ph.D. 

Professor, Oral Biology; Professor of Pharmaceutical Chemistry; Professor of Anatomy 

Faculty Director, Biomolecular Resource Center 

University of California, San Francisco 

San Francisco, California 

Nadya L. Lumelsky, Ph.D. 

Program Director 

Division of Extramural Research 

National Institute of Dental and Craniofacial Research 

National Institutes of Health 

Bethesda, Maryland 

Pamela Robey, Ph.D. 

Craniofacial and Skeletal Diseases Branch 

National Institute of Dental and Craniofacial Research 

National Institutes of Health 

Bethesda, Maryland 

Zena Werb, Ph.D. 

Professor and Vice Chair, Department of Anatomy 

University of California, San Francisco 

San Francisco, California 

WOMEN’S HEALTH AND THE ENVIRONMENT 

Lawrence H. Kushi, Sc.D. 

Associate Director, Division of Research 

Kaiser Permanente 

Oakland, California 

Estella Parrott, M.D., M.P.H. 

Program Director 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Eveline Shen, M.P.H. 

Executive Director 

Asian Communities for Reproductive Justice 

Oakland, California 

68
Kristina Thayer, Ph.D. 

Staff Scientist 

National Institute of Environmental Health Sciences, National Toxicology Program 

Center for the Evaluation of Risks to Human Reproduction 

National Institutes of Health 

Durham, North Carolina 

Deborah Winn, Ph.D. 

Deputy Director 

Division of Cancer Control and Population Sciences 

National Cancer Institute 

National Institutes of Health 

Bethesda, Maryland 

Tracey Woodruff, Ph.D., M.P.H. 

Associate Professor and Director 

Program on Reproductive Health and the Environment 

University of California, San Francisco 

Oakland, California 

HIV/AIDS AND WOMEN 

Anissa Brown, Ph.D. 

Health Scientist Administrator 

Office of AIDS Research 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

Ruth Greenblatt, M.D. 

Professor of Clinical Pharmacy 

University of California, San Francisco 

San Francisco, California 

Susan Plaeger, Ph.D. 

Director, Basic Sciences Program 

Division of AIDS 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Dawn K. Smith, M.D., M.S., M.P.H. 

Associate Chief for Science, Epidemiology Branch 

Division of HIV/AIDS Prevention 

Centers for Disease Control and Prevention 

Atlanta, Georgia 

69
INFORMATION TECHNOLOGY 

Irene Sue Dubman, M.A. 

Senior Director, Standards & Architecture 

Genzyme 

Cambridge, Massachusetts 

Laura J. Esserman, M.D., M.B.A. 

Director, Carol Franc Buck Breast Care Center 

University of California, San Francisco 

San Francisco, California 

Barbara A. Rapp, Ph.D. 

Chief, Office of Planning and Analysis 

National Library of Medicine 

National Institutes of Health 

Bethesda, Maryland 

WOMEN IN SCIENCE AND HEALTH CAREERS 

Elena Fuentes-Afflick, M.D., M.P.H. 

Professor of Pediatrics, Epidemiology, and Biostatistics 

San Francisco General Hospital 

University of California, San Francisco 

San Francisco, California 

J Taylor Harden, Ph.D. 

Assistant to the Director for Special Populations 

National Institute on Aging 

National Institutes of Health 

Bethesda, Maryland 

Joan Y. Reede, M.D., M.P.H., M.B.A. 

Dean for Diversity and Community Partnership 

Harvard Medical School 

Boston, Massachusetts 

Joan P. Schwartz, Ph.D. 

Assistant Director 

Office of Intramural Research 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

70
INTRODUCTION 

This report summarizes the second regional strategic planning meeting, held May 27-29, 2009, 

at the University of California, San Francisco (UCSF). The meeting format included welcoming 

remarks from the ORWH Director and the University sponsor, a video welcome by California 

Congresswoman Jackie Speier, a keynote address on the advancement of women in science 

and medicine, public testimony from 45 participants, a charge to participants by the ORWH 

Director, and six breakout working groups. The groups addressed scientific challenges, gaps, 

and opportunities for women’s health in six areas: global health, HIV/AIDS, careers, environmental risk factors, information technology, and stem cells. Below are highlights from the 

plenary presentations. 

SUMMARIES OF PLENARY PRESENTATIONS 

OPENING PANEL: SHAPING THE FUTURE OF WOMEN’S HEALTH RESEARCH—TWO PERSPECTIVES 

The opening panel speakers highlighted the progress that has been made in women’s health 

research but noted that there is still much more to do. They called for new research approaches to ensure the equitable representation of underserved populations of women in clinical 

research. The challenges and potential benefits of community-based participatory research 

were also discussed. 

Nancy Milliken, M.D. 

Professor and Vice Dean, University of California, San Francisco 

Dr. Milliken moderated the panel and introduced the presenters as leaders committed to communication between academia and the community. She characterized this dialogue as a way 

to identify the important questions that merit further research and to educate providers to the 

needs of patients. In addition, such communication can help make leadership positions a possibility for academics and community members who are working on women’s health. 

Sally A. Shumaker, Ph.D. 

Professor and Associate Dean, Research, Wake Forest University 

Dr. Shumaker traced the progress of women’s health research using the example of the Women’s Health Initiative (WHI), the NIH study that began in 1991. At the time, some expressed 

skepticism that women would participate in clinical studies; others said a hormone trial was 

not needed because the outcomes were already known. The WHI successfully enrolled large 

numbers of women, has a retention rate of more than 90 percent, and has produced a number of unexpected findings. In addition, the WHI continues to generate hundreds of papers, 

new hypotheses, and new ancillary studies on the health of older women; and it opened the 

door for a large number of women scientists who have become engaged in and are leaders in 

the biomedical sciences. Although much progress has been made in women’s health research, 

important challenges remain, such as increasing diversity among health researchers and decisionmakers. Research is still needed to address health disparities, women’s health issues across 

the lifespan, and cultural and international differences in women’s health. Creative new models 

are needed to overcome the multiple barriers facing diverse and underrepresented groups. 

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Surina Khan 

Vice President of Programs, Women’s Foundation of California 

Ms. Khan discussed the important role of community participation in health care research. 

The traditional central role of women as decisionmakers for the health care of families means 

that efforts to engage women in research will yield dividends in the improved health of family 

members. She said that individuals and communities that are most impacted by health disparities are in the best position to help develop solutions. Among the communities she mentioned 

were elder women, women of color, low-income women, lesbians, women in the military, and 

women in military families. Among the areas of research Ms. Khan said needed greater attention were environmental health, including women’s exposure to workplace toxins; the effect 

of economic insecurity on the health of elder women; lesbian health; causes and prevention 

of child sexual abuse; and the effect of trauma on women’s health, including from domestic 

violence, human rights violations, or exposure to HIV. Researchers also need to take into consideration what it takes for communities that experience health disparities to fully participate, 

including access to childcare and transportation. 

KEYNOTE ADDRESS: WHY SO SLOW—THE ADVANCEMENT OF 

WOMEN IN SCIENCE AND MEDICINE 

Virginia Valian, Ph.D. 

Distinguished Professor, Psychology and Linguistics, Hunter College and CUNY Graduate Center 

Overt discrimination against women has all but disappeared from academic biomedical 

research settings, and, with a few exceptions, gender equity now exists in hiring for most entrylevel biomedical fields. However, women continue to lag behind men in the uppermost rungs 

of most biomedical academic career ladders. Dr. Valian cited research suggesting that genderrole “schemas” are cognitive barriers to the attainment of leadership positions among women. 

Schemas of women as helpers and nurturers are consistent with gender roles but inconsistent 

with the prevailing schemas of the ideal qualities of scientific leaders and innovators, which 

are more likely to be attributed to men. Furthermore, women who act in ways that are consistent with leadership schemas (and not consistent with helper-nurturer schemas) may risk 

being viewed negatively by academic decisionmakers and colleagues. The persistence of gender-based schemas leads to an “accumulation of advantage” for men over time. Institutional 

efforts to reduce structural barriers to women’s career advancement will likely not be enough 

to eliminate inequalities. To achieve that end, efforts are needed to heighten awareness among 

members of the research community of the effects of schemas on their behavior toward and 

perceptions of more junior faculty, as these influence their decisionmaking. 

PANEL: TELOMERES AND AGING—A WOMEN’S HEALTH ISSUE 

Elizabeth H. Blackburn, Ph.D. 

Morris Herzstein Professor of Biology and Physiology, Department of Biochemistry and 

Biophysics, University of California, San Francisco 

Dr. Blackburn presented evidence that variations in telomere length are influenced by modifiable environmental factors, and hence may provide a new model for studying environmental 

influences on aging and age-related diseases. She explained that although telomeres do not 

contain genes, they play a role in chromosomal replication. They also shorten with repeated cell cycles, so that telomere length is a biomarker for cellular aging. Recent studies have 

72
found a relationship between telomere length and longevity in human samples. While telomere 

length appears to be highly heritable, there is also evidence that it can be influenced by environmental factors. 

Jue Lin, Ph.D. 

Assistant Research Biochemist, Department of Biochemistry and Biophysics, UCSF 

Dr. Lin discussed reports of telomere shortening in two samples with high psychosocial stress, 

with one consisting of mothers caring for chronically ill children, and the other of family caregivers of dementia patients. This area of research could lead to the development of new biological 

and behavioral interventions to promote longevity and ameliorate age-related illnesses. New 

high-throughput methods for examining telomere lengths on a large scale are available and 

should facilitate this line of research in human samples. 

PANEL: THE ROLE OF COMMUNITY-BASED 

PARTICIPATORY RESEARCH (“T3”) 

Cynthia A. Gómez, Ph.D. 

Founding Director, San Francisco State University Health Equity Initiatives 

Dr. Gómez opened the panel by saying that community-based participatory research (CBPR) 

can reduce the distance between the people who produce scientific research and the people 

who use the results. CBPR is an extension of multidisciplinary research and attempts to create 

mutually beneficial relationships between scientists and the community. The outcomes are better science and increased interest and knowledge of research from the public. 

Elena Rios, M.D. 

President and CEO, National Hispanic Medical Association (NHMA) 

Dr. Rios emphasized that CBPR relies on coalition building. She explained how her organization 

has been building coalitions to improve the health of the Hispanic community, which, according to the 2006 National Healthcare Disparities Report, has the most problems with disparities 

in health care of any ethnic group in the United States. New challenges will arise as the Nation’s 

demographics change. The new America will consist of populations that face severe lack of access to health care, lack of trust and knowledge, and are low-income, poorly educated, with 

strong cultural and family values, limited English proficiency, and living mainly in urban areas. 

They suffer from high rates of obesity, diabetes, infectious and chronic diseases, and demand 

health care reform. To address these problems, the NHMA brought together 100 people from 

disparate organizations—medical schools, foundations, insurance companies, unions, schools, 

community clinics, Hispanic chambers of commerce, and government—to talk about improving 

health care for the community. Dr. Rios detailed the recommendations that resulted, broadly 

falling under the categories of improving access to care and preventing obesity and diabetes. 

Karen Pierce, J.D. 

Coordinator, Bayview Hunters Point Health and Environmental Assessment Program 

Ms. Pierce discussed some of the challenges that can make CBPR more difficult and timeconsuming than traditional research. Her program addresses the impact that environmental 

contaminants have had on the health of the Bayview Hunter’s Point community of San Francisco, a predominantly African-American community. One particular challenge was developing a 

73
survey instrument that not only included the key factors that researchers wanted to assess, but 

also framed questions in a way that community members could understand and to which they 

could give substantive responses. Translational challenges arose in another project that sought 

to involve community members with basic science research. The partners in the study continue 

to examine how the community voice might directly influence the way research is conducted, how to interpret the research findings, and who should be involved in that interpretation. 

Finding solutions to such challenges takes time and commitment to true collaboration. When 

applying for funding, researchers should take into account the amount of time that is needed 

to complete a CBPR project. Ms. Pierce also recommended that funding organizations require a 

copy of the principles of collaboration agreed upon by all parties as part of all funding applications. In addition, funders should more strongly encourage partnerships between researchers 

and the community. To encourage dissemination into the community, scientists should consider publication of study results in popular media a respectable goal, and continue to work 

together with community members to formulate recommendations from their findings. 

Caitlin Ryan Ph.D., M.S.W. 

Director, Adolescent Health Initiatives, Cesar Chavez Institute at San Francisco 

State University 

Dr. Ryan outlined the benefits of CBPR by describing her research on how family behavior affects the mental health of lesbian, gay, bisexual, and transgender (LGBT) adolescents. 

The Family Acceptance Project uses a participatory research approach to engage community members, health and mental health providers, social workers, teachers, families, and youth 

in planning and implementation. Results are being used to develop culturally competent interventions to strengthen families, improve health and mental health outcomes for LGBT youth, 

and improve the quality of care they receive. The community groups and the participants were 

instrumental in identifying the 106 family behaviors (positive and negative) that were most important to mental health outcomes. The CBPR method also helped connect the researchers to 

communities such as farm workers and non-English speakers. 

Marj Plumb, Dr.P.H., M.N.A. 

Coach, Consultant and Trainer, Plumbline Coaching and Consulting, Inc. 

Dr. Plumb highlighted the successes of the community research collaboration (CRC) awards 

funded by the California Breast Cancer Research Program (CBCRP) and discussed some of the 

important lessons learned. Community research collaborations produce outcomes that benefit the community, the researcher, and the science. In evaluations of more than 60 CRC projects, 

CBCRP found that the program encouraged women affected by breast cancer to participate in 

the research process and fostered the inclusion of diverse participants (including disabled women, lesbians, rural women, Samoans, Koreans, Hmong, Guam immigrants, and hard-of-hearing 

women). When technical assistance was provided by CBCRP, it was regarded as important and 

valued. To facilitate successful outcomes, community research teams should focus on fully collaborating through all steps of the research process. Funders must become active participants, 

providing technical assistance, outreach, and support to both community members and researchers. Thoughtfully written agreements are required to ensure full collaboration throughout 

all phases of the research process and to reduce barriers to community participation. 

74
Ngina Lythcott, Dr.P.H., M.S.W., R.N. 

Associate Dean for Students, Boston University School of Public Health 

Dr. Lythcott emphasized the role of CBPR in giving the community a sense of control and providing community members with a chance to develop new skills. Funding organizations should 

expect researchers to use CBPR in most population-based research, taking into account the 

additional time needed to truly engage a community in participatory research and the costs 

associated with these efforts. Dr. Lythcott also recommended that researchers partner with existing community-based organizations to empower community members to take on formal 

and informal leadership roles. Research funding should support the establishment of a community coalition board to serve in an advisory capacity. Researchers should directly involve 

community members in the conduct of the research by training them to identify a hypothesis 

and collect and interpret data. To ensure that the research results provide the maximum benefit to the community, researchers should write a “lay” abstract of the research and community 

members should be encouraged to help disseminate the findings. 

PANEL: NEW PATHWAYS FOR TRANSLATIONAL RESEARCH: 

HOW SCIENCE CAN ADVANCE WOMEN’S HEALTH 

A translational research panel focused on the potential for systems biology research to make 

possible dramatic advances in women’s health research. 

Linda C. Giudice, M.D., Ph.D., M.Sc. 

Professor and Chair, Department of Obstetrics, Gynecology, and Reproductive Sciences, UCSF 

Dr. Giudice defined systems biology as a discipline at the intersection of biology, mathematics, 

engineering, and the physical sciences. It integrates experimental and computational approaches to study and understand biological processes in cells, tissues, and organisms. The field is 

holistic and integrative, as opposed to more traditional reductionist scientific paradigms. Its 

progress has been greatly facilitated by advances in high-throughput technology, computer science, and bioinformatics. Systems biology uses whole-system methods, such as genomics 

(study of the whole set of genes of a biological system), proteomics (study of the entire set of 

proteins expressed in a system), transcriptomics (study of the set of RNA transcripts of a system), and metabolomics (study of the set of metabolites in a biological process). Applied to 

human health, systems biology holds the potential to predict the physiological behavior of a 

complex system in response to natural and artificial perturbations, and thereby contribute to the 

understanding of the etiology of disease as well as to the development of new diagnostic and 

prognostic technologies and identification of new treatments. 

Systems biology approaches are applicable to a wide range of conditions and disorders of 

importance in women’s health research. These include breast and gynecological cancers, endometriosis, developmental and regenerative medicine, and systemic diseases, such as immune 

disorders, cardiovascular disease, and diabetes. A goal for the future is to apply systems biology to the development of personalized medicine. A current example of a personalized 

medicine application of systems biology is found in the development of MammaPrint, which 

yields a 70-gene breast cancer expression signature to predict which early-stage breast cancer 

patients may in fact be at risk for metastasis or recurrence. Challenges to advances in systems biology as applied to women’s health include the tasks of identifying and modeling the 

75
biologic, genetic, and hormonal diversity of women. Career development in this highly interdisciplinary field is of the utmost importance. There are dual challenges: to prepare women’s 

health researchers with skills needed to work collaboratively on systems biology problems, and 

to stimulate increased interest in systems biology approaches to women’s health research. 

Deborah Grady, M.D., M.P.H. 

Director, Women’s Health Clinical Research Center, University of California, San Francisco 

At a time when comparative effectiveness research is being emphasized, the biomedical research enterprise must consider how to maximize its potential contribution to inform clinical 

best practices. Dr. Grady noted that it is unrealistic to expect that even large-scale clinical trials 

will be adequately powered to provide answers to questions of effectiveness for different population subgroups. There is a need to design new models of clinical research to provide more 

information on effectiveness, and to implement strategies to utilize results from varied and 

multiple sources. Meta-analysis provides one such standard method for studying effectiveness, 

and its impact could be enhanced if researchers were to provide more uniform data elements 

and information about the characteristics of subjects in their studies. Other methods include 

advanced statistical modeling and repeated measures meta-analysis. Propensity scores may be 

derived from observational studies to assess causal effects. The combined use of observational and clinical trial designs within one study has merit for yielding more information than could 

be obtained from stand-alone studies. The next generation of clinical trials will include Webbased recruitment, advanced electronic data collection and management, and access to and 

pooling of data from multiple clinical sources. ORWH should consider funding methodological 

research on alternative methods to randomized clinical trials. In its interdisciplinary training and 

career development programs, it should also consider enhanced efforts to recruit individuals 

from fields needed to advance data mining and clinical study design, such as information technology and biostatistics. 

Claire Brindis, Dr.P.H. 

Director, Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco 

Dr. Brindis discussed how rapid technological change contributes to information overload, 

leading to important questions. For example, what is the best method for communicating 

complex health findings? How can researchers ensure that communication not only is understood but also results in behavior change? Dissemination—that is, the uptake of information—is 

the communication challenge of the 21st century. For this process to be successful, many partners must be involved, including the media, health care providers, policymakers, and consumer 

educators. The latter group, in particular, may provide a means of “narrowcasting” messages 

more effectively to communities experiencing health disparities. Funding organizations could 

support this process by funding research on implementation science. Likewise, in educating 

the next generation of scientists, training in core communication competencies may arguably 

be as important as basic sciences education for maximizing the impact of the biomedical

 research enterprise. 

76
CHARGE TO THE WORKING GROUPS 

Before meeting participants broke out into working groups, the ORWH Director noted that, “if 

everything is a priority, then nothing is a priority.” She urged members to undertake the hard 

work necessary to narrow their focus to the most pressing women’s health issues, while at the 

same time identifying, within that focused scope, new opportunities for cutting-edge science 

and technology applications. Finding this intersection of public health needs and science 

opportunity is what ORWH seeks to achieve as it prepares to update its strategic plan. 

77
SCIENTIFIC WORKING AND DISCUSSION GROUPS 

GLOBAL WOMEN’S HEALTH 

Cochairs: 

Paula Tavrow, Ph.D.
�

University of California, Los Angeles 

Amy Levi, Ph.D., C.N.M. 

University of California, San Francisco 

Warner Greene, M.D., Ph.D. 

University of California, San Francisco 

Kirsten Bibbins-Domingo, M.D. 

University of California, San Francisco 

NIH Cochairs: 

F. Gray Handley, M.S.P.H. 

National Institute of Allergy and Infectious Diseases 

Linda Wright, M.D. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Lynne M. Mofenson, M.D. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers:
�

Simran Sabherwal, M.H.S.
�

Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco 

Pratheepa Sivaswarupan, M.S. 

University of California, San Francisc 

Megan Hutchko, M.D., M.P.H. 

University of California, San Francisco 

Carinne Meyer, M.P.H. 

University of California, San Francisco 

Introduction 

Even though 85 percent of excess disability and mortality occurs in the developing world, less 

than 4 percent of research funding is devoted to identifying the factors and mitigating the 

conditions that underlie the global disease burden. Biological, social, political, and economic 

factors combine to put women, especially those in the developing world, at risk for disease, injury, and death across their life course. Pregnancy and childbirth can be life-threatening events 

for women in developing countries: more than one-half million women die of preventable causes 

related to pregnancy and childbirth every year, 99 percent of whom are in developing countries. 

For every woman who dies, another 30 are estimated to suffer long-term disabilities related to 

maternal reproductive causes. Women in low-resource countries also suffer disproportionately 

from malnutrition, some infectious diseases, gender-based violence, certain chronic conditions 

78
(such as depression and longevity-related diseases), and unwanted pregnancies. In many cases, 

women’s ill health and death could be avoided through simple, effective, and cheap interventions that are already known, but are not accessible or affordable to women. 

The group began by reviewing sex and gender disparities in disease and injury in each stage of 

women’s lives in developing countries, beginning in utero and ending in old age. Gender disparities were identified in the areas of health risks (women have less opportunity to enjoy good 

health); health needs (women have greater needs due to childbearing and longevity); and organization of health care (women may have more responsibilities in providing health services, but 

the power resides with men). The session highlighted specific areas where global disparities are 

particularly acute, such as in maternal mortality, unsafe abortion, and maternal disability. Participants also took note of health conditions that almost exclusively affect women in developing 

countries, such as female genital mutilation, obstetric fistula, chronic conditions (and deaths) 

associated with indoor cooking fires, and the interaction of infectious diseases like malaria 

with pregnancy.1 

Summary of the Discussion 

Before the conference, it was decided that the Global Women’s Health Working Group would 

be split into three subgroups: (1) maternal, sexual, and reproductive health, (2) chronic diseases, and (3) infectious diseases. Each subgroup was asked to answer the following questions. 

What should be the priorities for research in this area? How should the priorities be set? And, 

how could research be structured to achieve maximum impact on women’s health in developing countries? Because the first subgroup had more than 40 participants, it was further 

divided into two discussion groups—maternal health and sexual/reproductive health—and 

brought together again to develop priority recommendations. 

Maternal, Sexual, and Reproductive Health Subgroup 

This subgroup’s guiding principles were to focus the research agenda on areas where women in 

the developing world have a disproportionate burden of disease or disability, and on neglected topics where research to date has been limited. The subgroup unanimously agreed that the 

greatest disparities globally are in the areas of maternal morbidity and mortality. More than 

500,000 women die from childbirth and pregnancy complications each year, 99 percent of 

whom are in developing countries. Millions more suffer debilitating conditions related to pregnancy, unsafe abortion, and postdelivery complications.2,3 

To address maternal mortality and morbidity effectively, it is important that research address 

not just tertiary prevention, such as access to quality obstetrical care, but also primary and 

secondary prevention, including nutrition, effective use of fertility control measures, safe abortion, and maternal health education.4,5,6 The subgroup noted that the Eunice Kenney Shriver 

National Institute of Child Health and Human Development (NICHD) Global Women’s and Children’s Health Network focuses mainly on the tertiary prevention of maternal mortality and on 

approaches to improve child outcomes. It gives insufficient attention to primary and secondary 

prevention as well as to the role of health systems strengthening.7,8 

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The subgroup also stated that the sexual and reproductive health of female children and adolescents in developing countries should be a research priority, since sexual and reproductive 

health is cumulative and has effects across the lifespan. Moreover, inadequate attention has 

been given to improving the health of girls and young women in developing countries, particularly those who are poor, marginalized, and unmarried. Sociocultural issues that can have 

profound effects on women’s later health—female genital mutilation, child sexual abuse, sex 

trafficking, early marriage, unwanted pregnancies, sexually transmitted diseases, and gender violence (including teen dating violence)—have been under-researched in developing 

countries.9-13 Little research exists on their etiology and epidemiology, as well as on effective 

interventions to mitigate these practices in children and young women. It is imperative that 

local researchers be included in these studies, and that the research be culturally sensitive 

and responsive. 

The subgroup noted that renewed attention needs to be given to family planning and contraception, particularly in sub-Saharan Africa and South Asia. The AIDS epidemic had drawn 

attention away from ongoing needs in this area.14,15 Specifically, a wider range of contraceptives 

needs to be developed that can be used by men, can be used postcoitally by people who have 

infrequent or unplanned sex, and that are entirely under the woman’s control (without the 

need for a provider as intermediary). There also need to be easier and cheaper ways to assess 

fertile times of the month for women and to achieve menstrual regulation. 

The subgroup concluded that the most pressing research priorities were to reduce maternal 

mortality and disability, improve children and adolescents’ reproductive health, and develop 

more effective and wide-ranging contraception methods particularly suited to conditions 

in developing countries. In addition, there is a strong need to build global women’s healthresearch-and-implementation capacity, especially in terms of female researchers, policymakers, and managers. The group lamented that funding is lacking in areas of health where global 

disparities are greatest. For example, no global fund exists for maternal health, although one 

exists for AIDS, malaria, and tuberculosis. Current research grant opportunities through the 

NIH Fogarty International Center programs do not address women’s issues specifically, and 

the scope of the activities of the Global Network for Women’s and Children’s Health Research 

needs to be broadened to include barriers specific to maternal and reproductive health. 

The subgroup also discussed the research process. They noted that researchers need to test 

interventions that take into account the values, beliefs, and traditions of communities with respect to maternal and reproductive health. Participation of religious, community, and youth 

leaders can help ensure that data gathering and interventions are designed and implemented 

in culturally sensitive ways. Not only will culturally appropriate research yield better results, but 

research can help suggest alternative modalities to traditional practices that may be harmful 

to women. For example, the implementation of low-emission stoves in Guatemala has improved 

infant and child health outcomes while preserving traditional indoor cooking practices.16 

Participants agreed that interdisciplinary and interprofessional research can address the 

complexities of maternal, sexual, and reproductive health in developing countries by taking into 

account ethnicity, culture, and biology. New modalities of problem identification and service 

80
delivery may need to be tested to better assist specific populations, such as displaced women, 

orphans, and disabled women in resource-constrained settings. NIH grants that foster this 

type of interdisciplinary research will facilitate innovation in cross-cultural biomedical and 

sociomedical research methods. 

Because global women’s health researchers often work in isolated regions or are testing interventions targeted to specific groups, it would be valuable to them to have a single repository 

of comparative effectiveness research—including validated instruments, recommended methodologies, and data. The NIH could play a central role in the development of such a repository 

that would be freely accessible. 

Because of liability and ethical concerns, pregnant and lactating women have often been excluded from drug effectiveness research. However, the subgroup felt that creative approaches 

need to be developed to include these women in drug studies, such as using a registry or a 

postmarketing surveillance model. Drugs that are available in developed countries may not 

have the same applicability in developing countries because of differences in nutrition, availability of refrigeration, and acceptability of administration. Research that examines traditional 

healing practices in the context of currently available pharmacologic regimens can help identify the best approach to introducing medications in developing countries. 

Lastly, the subgroup discussed how best to build research capacity and promote women’s leadership in health care. More attention needs to be paid to creative approaches for increasing 

capacity in developing countries, such as ongoing support for women educated abroad who return to their home countries, opportunities for women leaders to share experiences with one 

another, and gender diversification in the workplace. Furthermore, translational research models 

need to be developed for diverse settings in order to accelerate the use of bench science to direct patient care. Currently, translational research often assumes that women’s experiences are 

universal and that scientific investigation from industrialized countries will translate in similar 

ways, not recognizing that context and resources can matter greatly. 

Chronic Diseases Subgroup 

This subgroup expressed dissatisfaction with the universal neglect of research into chronic diseases and women globally, even though most chronic disease is found in the developing 

world. For middle-income countries, chronic diseases are rivaling infectious diseases in importance.17 The subgroup noted that managing chronic conditions among women is particularly 

challenging because of their caregiver roles, the costs of chronic disease treatment, and 

women’s natural longevity, which makes them more vulnerable to chronic disease. 

Women are disproportionately affected by particular risk factors and chronic disease manifestations, such as stroke, blindness, depression, and exposure to household air pollutants and 

cooking fuels. The group noted that focusing on women was essential to improving the health 

of the entire population because of the central role that women play in family health. 

The subgroup was large and diverse. Participants included individuals new to chronic disease; individuals who had worked on other women’s health topics and who were aware of 

81
the increasing burden of these illnesses among women; and others with expertise in specific 

common and neglected chronic illnesses globally, including diabetes, chronic obstructive 

pulmonary disease, and mental health. A brainstorming session allowed all participants to 

contribute ideas for the final report. 

During the second half of the brainstorming session, participants identified major emerging 

themes and sought to frame these in the language and interests of NIH and ORWH. The subgroup noted that unhealthy diet, sedentary lifestyles, and tobacco use underlie most chronic 

diseases. However, much remains to be learned about the potentially differential impact of 

these risk factors on women, and whether there are certain risk factors that solely relate to 

women. Moreover, in developing countries, factors associated with poverty, the environment, 

and women’s unequal status may also be influential. The determinants of chronic depression 

among women in developing countries have been particularly neglected. 

Participants identified the following as essential components of research in women’s chronic 

disease. 

1. Understand environmental factors and physical factors contributing to chronic disease 

burden in women: (1) early events and exposures (including in utero), (2) genderbased factors, (3) family events, and (4) mechanisms of action. Such studies would 

have a longer time horizon (e.g., 10 years) and would include novel designs (e.g., intergenerational, multilevel). Ideally, such studies would also attempt to understand the 

bidirectional impact of factors on developing countries and recognize the effects of 

immigration and multinational global influences. 

2. Identify and measure social and cultural factors that influence chronic disease uniquely 

in women: (1) women’s role or status, (2) the impact of men on women’s health, (3) 

the impact of the family, (4) cultural or societal expectations, (5) the work or domestic 

environment, (6) norms and behavioral expectations, (7) aging, and (8) social determinants of health/social class. Such studies would also have a longer time horizon and 

be focused on mechanisms of action. Because these studies are focused uniquely on 

women, the potential exists in this area to use existing infrastructures to study and 

deliver care in areas of maternal and reproductive health to expand and collect data 

of relevance regarding mechanisms of chronic disease in women. 

3. Assess, transfer, and develop interventions to prevent and treat chronic disease 

globally. The focus in this area would include evaluating interventions known to work in 

developed countries and translating them to other settings, as well as developing 

appropriate interventions in less developed settings. The focus is on comparative effectiveness and translation of appropriate interventions, but the timeline is much shorter, 

recognizing the need to get appropriate interventions to appropriate settings quickly 

and in an effective manner. Such work should be bilateral and focus on the implementation of global successes in the United States and in developing countries, with bilateral 

exchanges of ideas and innovation. Such work would also integrate organizations and 

institutions outside of the traditional health care sector (e.g., schools). 

4. Expand chronic disease research capacities in developing countries: (1) increase 

personnel (clinical researchers and health workers in residency) and funding oppor82
tunities (the Fogarty International Center or the Building Interdisciplinary Research 

Careers in Women’s Health [BIRCWH] program); (2) institutions; and (3) patient advocacy. Such work recognizes that a major threat to effectively addressing chronic disease 

in developing countries is the lack of infrastructure to deal with the long-term impact of 

such illness. Research capacity should address local solutions, improve the ability for 

bilateral exchange of ideas, and ideally be integrated into the public health and health 

care delivery infrastructures as well. 

The major barrier to achieving these research goals is a failure to recognize chronic disease as 

the primary contributor to morbidity and mortality globally, particularly among women. A focus on chronic disease is central to improving the health of women globally, and the issues 

raised by chronic disease will only continue to grow over time. ORWH can play a major role in 

overcoming these issues by (1) continuing to emphasize this area as a focus in addition to the 

more traditional areas of maternal and reproductive health, and (2) creating opportunities to 

use the existing infrastructure for the study of issues in maternal and reproductive health to 

expand research into chronic disease and associated risk factors in women. 

Infectious Diseases Subgroup 

This subgroup considered the main infectious diseases that cause excess disease and mortality 

burden in developing countries, specifically the “gang of four”: malaria, tuberculosis, neglected 

tropical diseases, and HIV/AIDS. The group noted that women bear a disproportionate burden 

regarding these diseases. Women, children, and individuals living in remote areas and urban 

slums are most vulnerable to the consequences of neglected tropical diseases.18 The cochairs 

led a discussion about the need for biomedical research focused on the roles of sex and gender in health and disease. Many felt that this area of research had only been recognized in the 

past few decades as the differences between the biochemistry and physiology of men and 

women became more fully appreciated.19 The group agreed that recent efforts to fill the gap 

in women’s health research are starting to mobilize the scientific community in new directions 

but that more research in this area is urgently needed. 

Within the discussion, priorities were set by assessing various infectious diseases and gauging 

their selective impact on women’s health. Prioritization emerged as a result of consensual decision making within the group. The group felt that since malaria in pregnancy is a major risk 

factor for maternal mortality, particularly in Africa, it should be a priority research area. In addition, tuberculosis is responsible for approximately 9 percent of all deaths in women ages 15 

to 44 years, and deserves more examination. Finally, more than half of HIV infections in subSaharan Africa occur in women, because of physiological, economic, and sociocultural factors. 

HIV in women in developing countries is another important and essential area of emphasis, 

particularly due to its contribution to the global burden of disease.1 

Current barriers discussed include a relative lack of funding for gender-specific studies, 

particularly of infectious processes occurring in the developing world. Additional barriers 

include diminished access to health care by women in many developing countries. 

83
Discussion then turned to possible avenues of innovation for research in infectious disease, including the biological, behavioral, and hormonal causes of disease and disease susceptibility; 

and the need to explore women’s particular susceptibility to other diseases beyond HIV. Participants agreed that a transdisciplinary and translational approach would be needed to fully 

understand and treat these often intractable infections.19 It was suggested that it would be 

valuable for NIH to develop Requests for Applications (RFAs) to fund research in different disciplines, such as genomics, where new technologies and sciences are generating important 

perspectives and new evidence for gender studies. In addition, more efforts to identify the 

institutions necessary for the implementation of interventions specific to women would create 

sustainable and long-term benefits for women’s health. 

In considering critical research gaps, the subgroup focused on three main areas: (1) understanding the dynamics of disease transmission, and why women are more susceptible to certain 

infectious diseases; (2) considering the special case of breast milk, and developing approaches 

to mitigate diseases passing from mother to infant; and (3) researching effective strategies 

to prevent infectious diseases, particularly when women are pregnant and most vulnerable. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Implementation science. Support is needed for innovative, translational 

research to facilitate the application of evidence-based and sustainable interventions in developing countries to improve women’s health (particularly reducing maternal morbidity and 

mortality) and reduce barriers to care. Research should focus on the following: 

• Preventive strategies that aim to reduce risk for reproductive, chronic, and 

infectious disease 

• The development of standards of practice for how to conduct culturally sensitive research 

Recommendation 2: Sexual/Reproductive health. Research is needed on the determinants, 

long-term consequences, and effective strategies for eliminating or reducing the following understudied issues that affect female children and adolescents in developing countries: early 

sexual trauma, female genital mutilation, exploitation and trafficking, coerced sex, genderbased violence, and early marriage. Longitudinal studies to determine cumulative effects on 

women across the lifespan should be instituted. Another area in need of increased research 

is unwanted pregnancy, particularly among the young, marginalized, and poor. Support is 

needed for the following: 

• The development and evaluation of new and improved contraceptives—particularly male, 

postcoital, and female self-administered contraceptives—that are appropriate and 

sustainable for developing countries 

• Behavioral research required to understand the factors underlying the expanded use 

of contraceptives in developing countries 

Recommendation 3: Mechanisms of chronic disease risk across the life course. Research on 

the biological, environmental, behavioral, and physical factors that contribute to or protect 

84
against chronic diseases (including mental illness) in women, as well as research that explores 

their mechanisms of action, is needed. Recognizing the effects of poverty, the environment, 

and women’s unequal status, it is recommended that research focus on the following: 

• Early events and exposures (including in utero) 

• Family and intergenerational causes 

• Lifestyle factors that uniquely affect women 

Because chronic depression among women in developing countries has been particularly neglected, we recommend research that identifies both protective and risk factors for depression 

among these women. Best practices for prevention and treatment within various cultural, 

political, and economic contexts need to be determined. 

Recommendation 4: Infectious diseases. Research is needed to understand the increased susceptibility of women in the developing world to various infections, including malaria, HIV, HPV, 

and sexually transmitted infections (STIs). The following research should be funded: 

• The pathways (basic science) of behavioral and hormonal changes across the menstrual cycle and lifespan that can influence infectious diseases. This will lead to a better 

understanding of how women are affected differently, thereby contributing to better 

prevention and treatment. 

• Pregnant women and/or women with compromised nutritional status. (These two 

conditions affect millions of women and place them at increased risk.) 

• The physiologic mechanisms of transmission of HIV and other infectious diseases 

through breast milk, since breastfeeding is so important for children’s health and 

well-being in resource-constrained environments. 

Recommendation 5: Capacity building in developing countries. The brain drain of health 

researchers, medical practitioners, and program managers is a serious problem in most developing countries. To help slow or reverse this trend, we recommend enhancing research 

capacity in developing countries through the following: 

• Mentorship programs 

• Research training programs 

• Leadership development of women 

• Building supportive institutional environments (including those in nonhealth sectors) 

Using models of female capacity building and career development in the United States, we 

recommend that similar efforts be undertaken in developing countries. 

In addition, we recommend the development of a repository of information technology, standardized definitions, recommended methodologies, and data on women’s health, which can 

be easily accessed and shared. This would enhance research among many disparate areas and 

populations around the globe. 

85
References 

1.	� Buvinić, M., Médici, A., Fernández, E., & Torres, A. C. (2006). Gender differentials in 

health. In D. Jamison et al. (Eds.), Disease control priorities in the developing world 

(2nd ed., pp. 195–210). Washington, DC: IBRD. 

2. Melah, G. S., Massa, A. A., Yahaya, U. R., Bukar, M., Kizaya, D. D., & El-Nafaty, A. U. 

(2007). Risk factors for obstetric fistulae in north-eastern Nigeria. Journal of Obstetrics 

and Gynaecology, 27(8), 819–823. 

3. Fawcus, S. R. (2008). Maternal mortality and unsafe abortion. Best Practice & Research. 

Clinical Obstetrics & Gynaecology, 22(3), 533–548. 

4. Freedman, L. P., Graham, W. J., Brazier, E., Smith, J. M., Ensor, T., Fauveau. V., ... Agarwal, 

K. (2007). Practical lessons from global safe motherhood initiatives: Time for a new 

focus on implementation. Lancet, 370(9595), 1383–1391. 

5. Fauveau, V., & de Bernis, L. (2006). “Good obstetrics” revisited: Too many evidencebased practices and devices are not used. International Journal of Gynaecology and 

Obstetrics, 94(2), 179–184. 

6. Murray, S. F., & Pearson, S. C. (2006). Maternity referral systems in developing countries: Current knowledge and future research needs. Social Science & Medicine, 62(9), 

2205–2215. 

7.	� Maine, D. (2007). Detours and shortcuts on the road to maternal mortality reduction. 

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developing countries. New England Journal of Medicine, 356(14), 1395–1357.
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22(4). 

STEM CELLS 

Cochairs: 

Susan Fisher, Ph.D.
�

University of California, San Francisco 

Zena Werb, Ph.D. 

University of California, San Francisco 

NIH Cochairs: 

Nadya Lumelsky, Ph.D.
�

National Institute of Dental and Craniofacial Research 

Pamela Robey, Ph.D. 

National Institute of Dental and Craniofacial Research 

Science Writers: 

Erika Ilagan 

University of California, San Francisco 

Evelin Szakal, Ph.D. 

University of California, San Francisco 

Carinne Meyer, M.P.H. 

University of California, San Francisco 

Introduction 

The working group conducted a roundtable discussion led by the cochairs, with input from 

participants representing industry, the basic science community, clinician-scientists, and medical practitioners. By exploring the exciting potential of using stem cells in groundbreaking 

basic science research and clinical applications, the group defined key research priorities with 

direct relevance to women’s health, keeping racial and ethnic considerations at the fore: 

87
• Sex-related differences in stem cell functions 

• Role of stem cells in cancer biology 

• Regenerative medicine approaches for targeting female-specific diseases 

• Public education, advocacy, and science policy 

These topic areas reflect the cutting edge in stem cell research and put at the forefront the areas in which investigations into the sex of a stem cell is becoming an essential component for 

combating disease. Sex differences in stem cell function and the impact of these differences on recipients may have important implications for understanding the way disease works in 

the body. Recent reports of the presence of estrogen and testosterone receptors on stem cells 

suggest that hormones may modify the function of cells. For example, researchers have found 

that muscle-derived stem cells transplanted into dystrophic mice efficiently regenerate skeletal muscle, but they could not obtain a male subfraction with a regeneration capacity similar 

to that of their female counterparts.1

 These and other findings have persuaded researchers to 

identify cell sex, a largely unexplored variable, and to consider the implications of relying on 

cells of one sex. 

Achieving a more in-depth understanding of the molecular, biochemical, and functional characteristics of cancer stem cells and their sex differences may lead to the development of more 

effective and precisely targeted treatments. Stem cell research is also making groundbreaking advances in cancer research. Researchers have already been able to identify the molecular 

mechanisms that control self-renewal of cancer stem cells, which could ultimately lead to the 

prevention of tumor formation.2 Furthermore, some scientists suspect that cancer stem cells 

may be the cells most responsible for resistance to the drugs currently used to treat cancer, 

and that sex differences in these stem cells influence outcomes. The development of drugs 

that target the tiny proportion of cancer cells with self-renewing properties is likely to have 

long-term benefit for many women’s cancers, such as breast and ovarian cancer. 

Finally, researchers are discovering aspects of stem cells that may allow scientists to create 

pluripotent cells (stem cells that have the potential to differentiate into any of the three germ 

layers), and this achievement could serve as a critical tool in cell replacement therapies and 

regenerative medicine.3

 The ability to manufacture pluripotent cells holds the promise of developing patient-specific therapies for many degenerative diseases and for designing new 

tools with which to study human development and disease progression for many diseases, 

including those that are specific to women. 

All of these developments need to be translated into science policy through partnerships with 

academic and research institutions and leaders in research, business, advocacy, finance, law, 

and ethics. These parties must come together to create an influential advocacy strategy in 

order to chart the future of sex-related differences in stem cell investigations, stem cell 

cancer research, and regenerative medicine. 

88
Summary of the Discussion 

The group began by discussing important core concepts regarding possible sex-related differences in stem cells. This neglected variable may partly underlie the varying degrees of 

pluripotency observed in stem cells from different sources (e.g., embryonic or adult). Another 

important consideration is the potential for genetic/epigenetic differences between male and 

female stem cells—differences that could become amplified as a function of time in culture and/ 

or donor age. For example, compared to other gender combinations, female donor/male recipient transplants are associated with increased graft-versus-host disease and transplant-related 

mortality for patients treated with allogeneic hematopoietic stem cell transplantation.4 The 

group emphasized that the sex of stem cell transplants and recipients is not given appropriate 

consideration in current research or clinical applications, and that this omission could have 

serious repercussions for the future success of stem cell therapies. 

In general, it was noted that a sophisticated and detailed characterization of existing stem cell 

lines is lacking, which is one reason why information about sex-related functional differences is as yet somewhat obscure. As a remedy to this problem, high-throughput technologies 

(e.g., proteomics, transcriptomics, metabolomics) could be used immediately to establish and 

document quality control measures for assessing phenotypic drift due to interlaboratory differences in culture conditions and other standard practices. It was also stressed that the data 

obtained from “-omics” technologies should be correlated with findings from functional assays of self-renewal, pluripotency, differentiation potential, tumorigenicity, and other stem 

cell properties. 

In relation to cancer biology, sex differences have received very little attention given the potential importance of this variable. Researchers should explore how the physiology of the two 

sexes (in particular, the hormonal milieu) affects all stages of the disease process. For example, investigators need to know if there are sex-related differences in tumor-initiating cells that 

affect their stem cell-like properties; such differences could influence the response to therapy 

and, thus, remission and recurrence rates. Other unanswered questions concern the role of environmental agents and endocrine disruptors in the biology of sex-specific cancers (e.g., breast 

and prostate). Research on tumor-initiating or cancer stem cells will require robust standard 

laboratory practices to derive, propagate, and characterize these cells. Understanding the nature of tumor-initiating cells may improve the safety of stem cell therapies by preventing the 

development of tumors that may result from these therapies. 

The working group agreed that regenerative medicine approaches offer great potential for 

treating diseases, including those that are specific to women, but that these approaches also 

raise important questions. For example, is there a difference in transplant success attributable 

to sex match or mismatch of grafts? Existing studies could be reviewed, and the scientific community, together with the FDA, could consider the possible effects of sex-related differences 

on the success of regenerative medicine approaches in terms of both the transplant and the 

recipient. The question of sex differences of donors and recipients in regenerative medicine 

could also be addressed through another approach, which could be readily implemented with 

current technologies. Male and female stem cells could be systematically studied in the highthroughput screening of potential pharmaceutical compounds. 

89
Working group participants envisioned many exciting stem cell approaches to the treatment 

of female-specific diseases and conditions. In the future, regenerative medicine applications 

using stem cell science may improve the outcomes of assisted reproductive procedures. Candidate female-specific diseases include Asherman’s syndrome (scarring of the uterine lining), 

which may be amenable to therapies involving mesenchymal stem cells. Because the female 

reproductive organs contain tissues that are highly malleable (as illustrated by pregnancy), 

with a high rate of turnover (as illustrated by menstruation), a stem cell-focused perspective 

may be key to understanding the biology of diseases in which these processes go awry. 

Endometriosis is only one example. 

Working group participants noted that resident stem cells may be important therapeutic targets that could be exploited in regenerative medicine approaches. Potential treatments include 

fertility preservation and restoration. To this end, stem cell reconstitution of ovarian function 

in mice has been successful. Given the profound variations in the hormonal milieu of women 

over time, the group reiterated how difficult it is to approximate human sex-specific differences using animal models. Mice lack these variations, and the ethics and cost of using nonhuman 

primates create significant barriers. Thus, the development of cost-effective animal models that 

mimic the impact of female sex hormones on stem cell-based therapies should be a priority. 

Finally, the group also underscored the importance of education, advocacy, and science policy in creating realistic expectations regarding regenerative medicine therapies and setting the 

national agenda for stem cell research. As a relatively new area that has basic science, translational, and clinical components, the stem cell field needs dedicated campaigns and advocacy 

groups that focus on education of the public. Communication with the lay public and the media 

via town hall meetings and at the national level will be crucial for increasing patients’ willingness 

to participate in clinical trials (which is currently low) and for supporting nationwide funding for 

stem cell research that will deliver on the promises of regenerative medicine approaches. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Explore sex-related differences in stem cell functions. Use multidisciplinary “-omics” technologies and systems biology approaches to fully explore sex-related 

differences in stem cell biology and transplant success (historically and prospectively). 

Recommendation 2: Explore the role of stem cells in cancer biology. Determine if there are 

sex-related differences in tumor initiation/progression/recurrence that involve tumor-initiating 

or cancer stem cells and that could, in turn, be exploited for therapeutic purposes. 

Recommendation 3: Examine regenerative medicine approaches for targeting femalespecific diseases. Consider the XX chromosome complement as a variable in all stages of 

the pipeline that leads to regenerative medicine therapies and other stem cell applications, 

such as high-throughput screening to identify pharmaceutical compounds with harmful 

or therapeutic effects. 

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Recommendation 4: Conduct public education, advocacy, and science policy. Educate the 

public, policymakers, and the media about stem cell-related issues, which will help create 

realistic expectations of the national research agenda and improve patients’ willingness 

to participate in clinical trials. 

References 

1.	� Deasy, B. M., Lu, A., Tebbets, J. C., Feduska, J. M., Schugar, R. C., Pollett, J. B.,...Huard, J. 

(2007). A role for cell sex in stem cell–mediated skeletal muscle regeneration: Female 

cells have higher muscle regeneration efficiency. Journal of Cell Biology, 177, 73-86. 

2. Betschinger, J., Mechtler, K., & Knoblich, J. A. (2006). Asymmetric segregation of the tumor suppressor brat regulates self-renewal in Drosophila neural stem cells. Cell, 124(6), 

1241–1253. 

3. Geijsen, N. & Jones, D. L. (2008). Seminal discoveries in regenerative medicine: Contributions of the male germ line to understanding pluripotency. Human Molecular Genetics, 17(R1), R16–R22. 

4. Stern, M., Brand, R., de Witte, T., Sureda, A., Rocha, V., Passweg, J., ...Gratwohl, A. 

(2008). Female-versus-male alloreactivity as a model for minor histocompatibility antigens in hematopoietic stem cell transplantation. American Journal of Transplantation, 

8(10), 2149–2157. 

WOMEN’S HEALTH AND THE ENVIRONMENT 

Cochairs: 

Tracey J. Woodruff, Ph.D., M.P.H.
�

University of California, San Francisco 

Lawrence H. Kushi, Sc.D. 

Kaiser Permanente 

Eveline Shen, M.P.H. 

Asian Communities for Reproductive Justice 

NIH Cochairs: 

Kristina Thayer, Ph.D. 

National Institute of Environmental Health Sciences 

Estella Parrott, M.D., M.P.H. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Deborah Winn, Ph.D. 

National Cancer Institute 

Science Writers:
�

Michael C. Velarde, Ph.D.
�

University of California, San Francisco 

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Annemarie Charlesworth, M.P.H. 

University of California, San Francisco 

Introduction 

The cochairs began the session by presenting current insights on trends regarding adverse 

women’s health outcomes, such as reduced fecundity, decreasing age at puberty, and the relatively high prevalence of certain female reproductive conditions, such as uterine fibroids and 

endometriosis.1,2 It was also noted that there are racial and ethnic disparities in the distribution of a number of these conditions.3,4 Environmental influences, defined as chemicals present 

in the environment, can affect women’s health during development and various stages of life 

(e.g., impact of environmental chemicals on early onset of puberty, endometriosis).5,6 They also 

noted that people in the United States are exposed to a large number of environmental chemicals, some of which have been measured in women.7 Finally, it was noted that environmental 

chemicals are one of multiple environmental factors, which also include nutrition, stress, and local environments that influence women’s health independently or in interaction with each other.4 

The importance of further understanding the disproportionate burden of these environmental 

factors on certain racial and ethnic groups and low-income communities was emphasized.4 

A brainstorming session followed, with participants being encouraged to list their main areas 

of concerns and recommendations for the women’s environmental health research agenda. 

Participants identified the following five areas for further exploration and discussion in 

smaller groups: 

1. Influence of chemical exposures on disease etiology and healthy human development 

2. Tools needed for assessment and research 

3. Sources of exposure 

4. Research translation and intervention, including health policies 

5. Community-based participatory research 

At the conclusion of the session, the small groups were charged with brainstorming research 

recommendations in their area, identifying emerging themes, and prioritizing the top three to 

five areas. The cochairs, science writers, and a member of the community-based participatory 

research subgroup synthesized the recommendations, identifying overlap among groups and 

broader recommendation themes. The synthesis process, resulting working group recommendations, and justification for the recommendations were then shared with the larger group for 

comment. Finally, it should be noted that extensive effort was made to reflect participant comments and concerns, and participants were actively included in the development of the final 

five recommendations. 

Summary of the Discussion 

The working group discussed the definition of “environment.” Materials distributed to the working group suggested that the scope of the discussion regarding the environment be focused 

primarily on “environmental toxicants,” defined as “chemicals, metals, and physical agents, such 

as ultraviolet radiation, that women may be exposed to in their daily environment, their work 

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place, and throughout their lives that may affect their health.”6 However, many participants expressed concern that “environment” was too narrowly defined, and that the working group 

should also address broader social and institutional factors (e.g., built environment, stress, violence, racism, unemployment, and social inequities) that are also aspects of the environment in 

which women live, and that may have important health effects.8 

Several of the working group discussions emphasized the centrality of environmental exposures, 

however defined, in determining health status and disease outcomes. Although much recent 

biomedical research has focused on the promise of genomic and other technologies and their 

potential application to health, working group members felt strongly that environmental factors must remain a central focus of NIH research. While genetic factors may influence disease 

susceptibility, environmental factors play a critical role in determining whether a disease may 

manifest. Understanding the role of environmental factors, therefore, is key to developing 

personal, clinical, and public health strategies to improve health. 

The working group agreed that the new frontier for research is the role of the environment 

in propelling our understanding of, and ultimately improving, the health of women. As such, 

the group agreed that research efforts should focus on the role of environmental chemicals in influencing women’s health, particularly during critical windows of susceptibility (e.g., 

periconception, prenatal, early childhood, puberty, perimenopausal), and include additional 

environmental concerns that impact women’s health, such as the built environment, stress, 

violence, racism, unemployment, and social inequities. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

1.	� Understand the effects of chemical and other environmental exposures on disease 

etiology in women, including a major focus on developmental programming of adult 

diseases and syndromes. 

2. Expand the capacity and invest in the development and application of new technological tools to revolutionize our ability to measure efficiently, cheaply, and accurately 

environmental sources and exposures, chemical toxicity (particularly early markers of 

disease), and the human/environment interaction; and to allow us to conduct research 

in human populations. 

3. Pioneer research efforts that will identify and eliminate the negative effects of 

environmental factors and sources of exposures on women’s health.
�

4. In partnership with the communities most impacted, dramatically enhance women’s 

health by strategically undertaking the synthesis, dissemination, and translation of 

evidence to better use environmental health science to improve clinical care, policy, 

and community health. 

5. Develop innovative partnerships that include interdisciplinary approaches and 

community participation.
�

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These five main areas are described in greater detail below, along with additional suggestions 

for research directions. 

Recommendation 1: Explore the influence of chemical exposure on disease etiology and 

healthy human development. The working group agreed that the effects of chemicals and other environmental exposures on disease etiology in women is generally not well understood, and 

that research efforts should focus on the influence of chemical and other environmental exposures on disease etiology and healthy human development. A comprehensive research agenda 

that would better explore these effects would include the following: 

• Developing appropriate animal and cell culture models for studying and understanding developmental programming of adult disease and the etiologies of diseases over the 

lifespan of women, including epigenetic causes; acute, chronic and multiple exposures; 

genetic susceptibility; chemical doses; and biomarkers predictive of disease outcomes. 

• Translating these animal models and identifying crucial windows of susceptibility, beginning prenatally and continuing throughout all life stages in women, which increase the 

risk of disease through direct and/or transgenerational mechanisms and are affected by 

ethnic and other disparities. (The identification of human studies that may have stored 

biospecimens from longitudinal studies where health outcomes have been assessed 

many years later would complement the animal studies, and availability of such studies 

should be promoted.) 

• Understanding the biological and pathophysiological mechanisms by which such epigenetic, genetic, cellular, molecular, metabolic, nutritional, immunologic, and environmental 

factors interact in women to increase the risk of disease through direct and/or transgenerational mechanisms, including investigation of disease syndromes. 

• Understanding the complex interaction between reproductive and metabolic functions 

and how this is influenced by environmental exposures (e.g., reactions of insulin and 

how it affects female reproduction, especially during critical periods). 

• Understanding the impact of the environment on the disease itself, including the 

whole trajectory of the disease. 

• Developing better indicators of diseases and life stages (e.g., biomarkers and 

non-invasive tools) to study the impact of chemical exposures on disease etiology 

and developmental programming of adult disease syndromes, as well as on 

normal development. 

• Developing innovative methodologies that consider lifecourse events and 

periconception/preconception in studying environmental impacts.
�

• Maximally utilizing genomics, proteomics, metabolomics, and genome-wide association 

study (GWAS) databases to study environ-“ome” and disease-“ome” interactions. 

• Developing experimental models that will address interventions and the prevention 

of diseases attributable to environmental exposures. 

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• Understanding the role of the microenvironment in the context of diseases and treatment, e.g., nutrition and menopause in the U.S. population. (For example, in Africa, 

women do not report experiencing hot flashes and mood swings. It has been theorized 

that diet makes a difference, especially white yams.) 

• Expanding the design of existing or soon to be initiated studies to incorporate 

environmental factors as confounders or modifiers.
�

• Identifying occupational exposures, especially among poor women, and identifying 

interactions of multiple factors that impact health (e.g., nutrition, SES). 

Recommendation 2: Support the development of tools needed for assessment and research. 

To maximize researchers’ ability to accurately measure environmental sources and exposures, understand how they interact with women’s health, and conduct research with women, 

expanded capacity and new technological tools are needed for assessment and research, 

focusing on the following: 

• Enhancing our ability to leverage epidemiologic studies by using existing longer term 

cohorts to add an environmental dimension (e.g., Women’s Health Initiative, Framingham Heart Study, Study of Women’s Health Across the Nation, National Children’s Study), 

such as linking through geographic information systems (GIS) or evaluating stored biological specimens for environmental chemicals. 

• Using GIS and personal sensors of exposure to improve exposure assessment. 

• Enhancing the collection and banking of biological samples in ongoing studies to facilitate studies of environmental exposures and genetic susceptibility. (Repositories must be 

easily identified and proper cataloging of samples must be available to fully maximize 

tissue sharing and coordination across various research groups.) 

• Developing new methods to measure chemicals, such as noninvasive biological 

samples (e.g., saliva) and lower concentrations in biological tissue and exposure sources 

(e.g., products, plants, animals, air), more efficiently and cost-effectively. 

• Developing high-throughput methods and expanding capacity to conduct these assays 

to facilitate application of exposure measurement tools for population studies. 

• Developing new rapid screening tools to identify chemical toxicity, identifying those that 

can be used now (e.g., hormones) and those that are still needed (e.g., stem cells), focusing on the most effective tools for identifying early indicators of disease. 

• Revolutionizing the recruitment and followup of study participants using new technologies (e.g., text messaging, social networking). (However, privacy/HIPAA infrastructure 

issues would need to be addressed, and NIH-approved guidelines for collection and 

storage of samples would need to be developed.) 

• Improving registry of data and tracking of health trends. 

Recommendation 3: Identify and eliminate sources of exposure. The working group emphasized that research efforts were especially needed to identify and eliminate the negative 

95
effects of environmental factors and sources of exposures on women’s health, focusing on 

the following: 

• Identifying a broad spectrum of underexplored environmental factors that impact women’s health across the lifespan (e.g., chemical exposures, stress, violence, unemployment, 

lack of health care, built environment, racism), with particular attention being paid to key 

windows of susceptibility (e.g., in utero, placental influences, breast milk, infancy, prepubescent, postmenopausal). 

• Better understanding disproportionately exposed subpopulations, for example, occupational groups, geographically-based groups (e.g., residents near hazardous waste sites 

or industrial zones) and how environmental factors might interact with one another and 

genetics in exposed populations. 

• Identifying leading sources of exposure commonly found in women. 

• Improving the understanding of personal susceptibility factors, such as the influence 

of body characteristics, behaviors, and interventions (e.g., obesity, alcoholism) on the 

behavior of a chemical in the body, and the potential health impacts of exposure. 

• Understanding the impact of hazardous waste and pharmaceuticals throughout the 

lifespan, especially in regard to women’s cognitive functioning and aging. 

Recommendation 4: Support research translation and intervention, including health policies. 

The working group discussed the critical role of information synthesis and the translation of 

scientific evidence to dramatically improve clinical care, policy, and community health. The following strategies were suggested: 

• Developing strategies and conducting evidence synthesis in partnership with communities to determine whether and what action is warranted (i.e., what strategies are 

most appropriate for different arenas, such as general education, clinical care, special 

populations, community groups, public health policy); identify exposures, windows of 

susceptibility, outcomes, modifiers of effect; and establish environmental health 

proficiency among clinicians and policy decisionmakers. 

• Conducting comparative effectiveness research to identify best strategies to prevent 

or mitigate the negative effects of the environment on women’s health. 

• Developing best practices to empower stakeholders to act on this knowledge (e.g., 

social marketing). 

• Funding health policy related research that evaluates how public policies can address 

environmental influences on women’s health. This could include examining how the 

implementation of health policies (local vs. State vs. national) influences health, and 

evaluating which are most effective in preserving/improving public health. Comparisons with international policies also could be useful. 

• Funding research that identifies gaps in knowledge, training, and critical assessment skills 

across health care disciplines, in women’s health and the environment. This should include research on the development of educational programs and materials to address 

these gaps. 

96
• Funding research to develop the most effective tools and methods for assessing chemical 

toxicity and more effectively evaluating the data, and reviewing the scientific literature to 

inform decisionmaking for clinical practice and policy development. 

• Funding basic and applied research that identifies safer alternatives to widely recognized 

harmful exposures. Green chemistry, basic and applied research that identifies harmful 

exposures, should be prioritized. 

• Funding new studies and supplements on occupational exposures. 

• Creating a bioinformatics grid for health outcomes related to environmental exposures, 

and incorporating information relevant for clinical decisionmaking. 

• Utilizing Web-based technologies for multidisciplinary collaborations. 

• Incorporating clinical and community impact in research projects (as part of the original 

project or as a supplement). 

• Identifying gaps in training and knowledge regarding environmental issues, research, etc. 

• Developing effective training models for providers (e.g., CMEs). To the extent possible, 

training should be open source and Web-based. 

• Evaluating methods for training physicians, nurses, and others in women’s health and the 

environment, identifying clinical knowledge and practice gaps that inhibit incorporating reproductive health science into practice. (For example, what clinicians need to know 

both from content and critical appraisal perspective and how clinicians can understand 

science derived from animal data and apply it to humans). 

• Including social marketing and communication research on messaging that is most 

effective in the environmental arena. 

• Evaluating fast track research to inform chemical policy reform and develop interagency 

collaboration to lead to implantation of chemical policy reform. 

• Researching appropriate criteria for women’s health related information to be 

collected in large public health registries, similar to Surveillance Epidemiology 

and End Results (SEER). 

• Synthesizing complex scientific information and bringing it to various groups (e.g., 

clinicians, public, decisionmakers). 

Recommendation 5: Support community-based research. The working group concluded that 

three elements are necessary to conduct the innovative and revolutionary women’s health research described above. This research advances the state of knowledge and makes the findings 

useful to clinicians, policymakers, and the community. The group said it was essential for researchers to take an interdisciplinary approach, develop innovative partnerships, and actively 

include local communities. The following were specifically recommended: 

• Increasing NIH resources and support for community-based participatory research as a 

fundamental component of women’s environmental health research, as it identifies new 

environmental factors, increases the quality and usability of research, and builds capacity 

97
among researchers and members of the community that will result in effective solutions 

that prevent and mitigate negative environmental impacts on women’s health. 

• Increasing NIH resources and support for a range of interdisciplinary approaches that 

are critical to conducting research that addresses the multidimensional interactions 

between women’s health and the environment. These approaches include examining 

complex interactions (e.g., between disease and race/SES or between genetic susceptibility to exposures and disease), creating multi-disciplinary partnerships (e.g., 

between biology and social studies), and forging unrealized relationships (e.g., partnering with technology innovators, such as Google, to adapt new tools to address 

environmental issues). 

• Increasing patient education to avoid remorse from underinformed patients (e.g., 

women who missed their window of receptivity, awareness of environmental hazards). 

• Enlisting other nontraditional partners in the conduct and dissemination of research, 

such as community colleges, which are less intimidating and more intimate learning 

environments, are able to engage impacted communities, and are good places to 

disseminate research. 

• Evaluating ecological and geographical approaches where accumulated risk could be 

established (e.g., communities near freeways, homes with elevated lead), and tracking 

accumulated risk factors in affected communities. 

• Encouraging community participation in research (e.g. developing questions, 

implementing research, systemic change), to create unique opportunities for 

community contributions. 

• Enlarging the interdisciplinary approach spectrum that goes from basic science to 

clinical to community and back. 

• Identifying differences between women’s reproductive health and women’s health 

and the environment, and the need to research broader environmental health factors 

that impact women’s health. 

• Stressing the quintessential importance of community participation in developing 

research questions, implementing research, disseminating findings, and moving 

towards systemic change. 

• Increasing the range of community involvement. 

• Encouraging the use of The California Endowment’s “Places” initiative as a model for engaging and focusing on community needs (defined by them), realizing that this requires 

a long-term investment (e.g., 10 years). 

• Promoting compensation, recognition, and additional resources. For example, 

anti-tobacco was successful because of additional resources for social marketing 

in the community. 

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• Encouraging the community to provide data and new knowledge, expanding dialogue 

about community involvement, expanding funding incentives (e.g., publication in community media is critical), increasing resources and NIH support for incentives (e.g., 

money, time), and recognizing that community-based research can take a longer time. 

• Identifying the most critical women’s environmental health factors, such as stress, violence, unemployment, racism, lack of childcare, substandard housing, access to healthy 

foods and food insecurity, access to parks and natural environments, transportation, work 

environment (no living wage, no health care), lack of social capital, lack of quality educational institutions, access to health care, and chronic disease (e.g., caregiving, community 

impact). This includes identifying the most critical environmental factors and stressors 

that impact women’s health across the lifespan. 

References 

1. Crain, D.A., Janssen, S.J., Edwards, T.M., Heindel, J., Ho, S.M., Hunt, P.,... Guillette, L.J. Jr. 

(2008). Female reproductive disorders: The roles of endocrine-disrupting compounds 

and developmental timing. Fertility and Sterility, 90(4), 911–940. 

2. Euling, S.Y., Selevan, S.G., Pescovitz, O.H., & Skakkebaek, N.E. (2008). Role of environmental factors in the timing of puberty. Pediatrics, 121(Suppl 3), S167–171. 

3. Herman-Giddens, M.E. (2006). Recent data on pubertal milestones in United States children: The secular trend toward earlier development. International Journal of Andrology, 

29(1), 241–246; discussion 286–290. 

4. Morello-Frosch, R. & Shenassa, E.D. (2006). The environmental “riskscape” and social 

inequality: Implications for explaining maternal and child health disparities. Environmental Health Perspectives, 114(8), 1150–1153. 

5. Diamanti-Kandarakis, E., Bourguignon, J.P., Giudice, L.C., Hauser, R., Prins, G.S., Soto, 

A.M.,...Gore, A.C. (2009). Endocrine-disrupting chemicals: An Endocrine Society scientific statement. Endocrine Reviews, 30(4), 293–342. 

6. Woodruff, T.J., Carlson, A., Schwartz, J.M., & Giudice, L.C. (2008). Proceedings of the 

Summit on Environmental Challenges to Reproductive Health and Fertility: Executive 

summary. Fertility and Sterility, 89(2 Suppl), e1–e20. 

7. U.S. Department of Health and Human Services, Centers for Disease Control and 

Prevention, National Center for Environmental Health. (2005). Third National report on 

human exposure to environmental chemicals (NCEH publication no. 05-0570). Atlanta, 

GA: National Center for Environmental Health. 

8. Morello-Frosch, R. & Lopez, R. (2006). The riskscape and the color line: Examining the 

role of segregation in environmental health disparities. Environmental Research, 102(2), 

181–196. 

99
HIV/AIDS AND WOMEN 

Cochairs:
�

Ruth Greenblatt, M.D.
�

University of California, San Francisco 

Dawn Smith, M.D., M.P.H., M.S. 

Centers for Disease Control and Prevention 

NIH Cochairs: 

Anissa Brown, Ph.D. 

Office of the Director 

Susan Plaeger, Ph.D. 

National Institute of Allergy and Infectious Diseases 

Science Writers:
�

Yvette Cuca, M.P.H., M.I.A.
�

University of California, San Francisco 

Nancy Robbins, M.S.W. 

University of California, San Francisco 

Evelin Szakal, Ph.D. 

University of California, San Francisco 

Introduction 

Almost three decades after HIV/AIDS was first identified, the disease has spread throughout 

the United States and the world to become a significant health issue. The Centers for Disease 

Control and Prevention (CDC) estimates that someone in the United States becomes infected 

with HIV every 9.5 minutes.1

 Approximately 1 million people in the United States are currently living with HIV/AIDS, and more than 15,000 women were newly infected in 2007, mainly 

through sexual contact and injection drug use.2 Women currently account for approximately 27 percent of cases of HIV/AIDS in the United States and more than half of these women are 

African-American.2

 Worldwide, the United Nations Program on HIV/AIDS reports that in 2007, 

33.2 million people were living with HIV, and almost half (15.4 million) were women. Over the 

past decades, HIV/AIDS has shifted from a disease that affected mainly gay men and injection 

drug users in the United States to one that currently affects all groups of people and all 

countries of the world. 

The HIV/AIDS epidemic has changed substantially from the time it was first identified. In the 

United States, the disease was originally associated with white men who have sex with men and 

with intravenous drug users, and the disease was fatal. HIV/AIDS now reaches into all segments 

of the U.S. population, and increasingly affects women, particularly women of color. Furthermore, since the advent of antiretroviral (ARV) medications, HIV/AIDS has been transformed from 

an acute into a chronic illness.3 For both women and men, highly active antiretroviral therapy 

(HAART) allows them to live longer and healthier lives after an HIV diagnosis. 

100
Despite the advances in treatment for people living with HIV, the demographic shifts require 

new thinking on the part of researchers and program managers. The prevention and treatment 

paradigms that for so long focused on gay men and drug users may not be appropriate and/or 

effective among women. In the context of HIV/AIDS, women may differ substantially from men 

in all areas, from basic biological factors affecting transmission to behavior and sociological 

and structural factors that place them at risk and influence their ability to access prevention, 

treatment, and care services. 

The vast majority of basic science and other HIV research has been conducted on men, but 

because of shifts in the demographics of those affected by the disease, researchers and policymakers must pay much greater attention to issues faced by women. Scientists in the field have 

already identified a number of gaps, including, for example, the need for research on the basic 

science on biological differences between women and men, as well as on biological differences 

across a woman’s lifespan; interdisciplinary research; the examination of assisted reproduction 

in serodiscordant couples; and research on specific populations (e.g., girls and women across 

the lifespan, women of color, transgender individuals, immigrants). 

The working group discussed these known issues, as well as other issues that affect women in 

the United States and worldwide. 

Summary of the Discussion 

Working group participants represented the spectrum of those working in the area of HIV/ 

AIDS, as did the information and comments they presented. In addition, a number of people living with HIV/AIDS actively participated in the working group. Four overarching themes 

emerged from the discussions: the need for female-specific care, the need to address gaps in 

the current research process, the need to take into account the entire lifespan of women, and 

the need for innovative funding mechanisms. 

Prevention, treatment, and care in the United States have been based largely on models for 

and research on white men who have sex with men. These models often do not sufficiently take into consideration women’s specific contexts and biology or ethnicity. As more women 

become infected, there is a need to conduct a wide spectrum of research focused specifically 

on women and HIV/AIDS, from basic science to comparative effectiveness research. For example, HIV/AIDS studies should ensure the adequate enrollment of women and minorities in order 

to have enough power to analyze data by these groups. 

Beyond the topics of specific studies, changes are needed in the research process itself. 

Research should be more interdisciplinary and integrated, linking behavioral with biological aspects, and employing mixed methods (quantitative and qualitative) to explore new hypotheses 

and to develop a deeper understanding of social context and other factors. In addition, research 

models need to be more dynamic so that results quickly reach those who need the information, 

and so that they are understandable not only to scientists and researchers, but also to program 

managers, policymakers, people living with the disease, and their family and friends. 

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Innovative funding mechanisms are needed to support a broader spectrum of research, including mechanisms to support more resource-intensive and comprehensive studies, and to 

encourage better use of existing data (e.g., funding for secondary analyses, which may be 

more cost-effective than collecting new data). As an example, women and girls are affected by 

HIV throughout the lifespan, and they have very different issues, needs, and concerns from one 

phase of the lifespan to another. In particular, longitudinal and long-term followup research is 

needed to address emerging issues among females infected in the perinatal period, as they develop, and, in particular, as they enter their reproductive years. There is a need to facilitate the 

establishment of healthy behaviors in HIV-positive children, rather than waiting to intervene 

later. Included in this group are individuals who are aging out of pediatric care into adult care. 

Likewise, specific lifespan considerations need to enter into research on HIV/AIDS infections in 

reproductive age and post-reproductive-age women. What are the behavioral issues among 

older women that place them at risk? Long-term research is needed to study the cumulative 

effects of chronic HIV medications on women. These studies need to be complemented by 

lifespan research to understand more clearly biological differences between girls, women of 

reproductive age, and older women, as these relate to the treatment, course, and outcome of 

HIV infection. 

Research is needed to examine a range of specific populations. Research involving people living 

with HIV (“prevention with positives”) should examine reasons for nonadherence, whether these 

reasons vary by gender, and whether gender-tailored interventions improve adherence. In this 

same way, research is essential to understand how adherence and quality of care vary among 

women of color. In the transgender community there are many people with HIV/AIDS who are 

not currently being studied in the context of men. These patients should be studied in the context of women. For serodiscordant couples, research and care should address prevention as well 

as childbearing issues. For undocumented immigrants, who are often disenfranchised and 

experience social stigma, research on how to maximize access to services is necessary. 

The working group’s major recommendations address women and HIV, as related to behavioral and biologic prevention, health services and policy, reproductive health, pathogenesis and 

genetics, total disease burden, clinical trials, and pharmacology. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Research should develop new methods for understanding the concept of 

women’s HIV/AIDS “risk,” both behavioral and biologic. Current models often rely on research 

with white men who have sex with men, and may not apply to women. 

• Research should look broadly at structural factors that differentially affect women and 

men, such as social and economic inequalities, homelessness, and violence. 

• Studies should examine the contexts of women’s lives and relationships, for example, 

stable relationships versus other types of relationships in which sex occurs. This would 

102
include addressing the issue of women’s autonomy and ability to make decisions about 

relationships, as well as the impact of drug and alcohol use in those relationships. 

• A greater understanding of risk will require research on the best strategies for 

testing women for HIV, and on women-controlled protective methods other than 

the female condom. 

• More in-depth research is needed on the changes in risk—both behavioral and 

biologic—across a woman’s lifespan.
�

• Research must also examine issues of gender, race and ethnicity, culture, and stigma. 

Recommendation 2: There is a need to develop new models of HIV/AIDS prevention, both 

behavioral and biologic, specifically for women. This may include both primary prevention 

and prevention efforts targeting HIV-positive women. 

• The existing harm and risk reduction models were developed for white men who have 

sex with men, and may not be appropriate for women, considering the context of their 

risks and vulnerabilities. Therefore, new models need to be developed and tested. 

• Researchers must also evaluate the extent to which preventive interventions and models 

are working. 

Recommendation 3: New and integrated ways of conducting research on women and HIV/ 

AIDS should be explored, looking at issues such as the relationship between behavioral and 

biomedical prevention, use of both qualitative and quantitative methodologies, and new ways 

to effectively disseminate research findings. 

• Innovative research linking behavioral and biologic issues, such as the effect of medications on emotions and subsequent risk behaviors, can further our understanding of HIV/ 

AIDS among women. 

• The use of mixed methods (qualitative and quantitative) either simultaneously or sequentially, to research the link between the behavioral and the biologic should be encouraged. 

Use of mixed methods can deepen our understanding of HIV/AIDS issues among women. 

• Investigators should include more definitive outcome measures (e.g., HIV incidence, 

biomarkers), which may require research on a much larger scale than has been 

conducted to date. 

• Efforts to develop a more dynamic research model for more rapid turnaround in science—getting results to researchers, clinicians, and the public as quickly as possible, 

and in ways that are understandable to all—should be intensified. This may include 

encouraging collaborations and interdisciplinary research, as well as developing and 

continually updating annotated literature reviews of results. 

Recommendation 4: Communities of interest to researchers should collaborate as full partners 

in the research process. Such participation can increase buy-in and mutual respect, improve 

research questions and techniques, enhance dissemination of results, and improve use of results 

in program development. 

• Effective research must involve community-based organizations, not only as volunteers, 

but also as paid partners and experts. These groups already work closely with women at 

103
risk and women living with HIV, and have a better understanding of what is happening 

in their communities to place women at risk. They may also be more effective at disseminating information and at using that information to implement prevention, treatment, 

and care programs. 

Recommendation 5: Methodological studies of biologic markers for women should be 

strongly encouraged. Such studies will create a more nuanced understanding of women’s 

physical risk and resilience, and of changes and differences across their lifespan. 

• Biologic research should examine such issues as how women’s upper and lower reproductive tracts are affected differently throughout the lifespan and in the various stages 

of HIV/AIDS; the effects of mucosal immunology, virology, pharmacology, and hormones 

on HIV/AIDS; sex differences in the efficacy and safety of existing ARV drugs (given that 

an effective HIV vaccine is not likely to be available within the next decade); the gap 

between reproductive endocrinology and HIV research; and potential sex differences in 

treatment adherence. 

• Investigators should also consider the specific needs of special populations including 

presexual adolescents, HIV-positive adolescents, women over 50, transgendered persons, 

drug addicts, and the chronically ill. 

Recommendation 6: There should be a collaborative effort to encourage health services and 

policy research to identify and address barriers to women’s participation in research; access 

to health care services, including mental health care services; and continued presence in the 

health care system. 

• Research should examine issues specific to women of various ethnicities and socioeconomic status regarding the types of service delivery that provide the best quality care 

at the least expense. 

• Operations research may increase our understanding of the relationship between HIV 

prevention and referral services and reproductive health services, leading to improvements in prevention, treatment, and care. This may include a review of contraceptive 

counseling practices, referrals for care, cross-training of internists and obstetricians/ 

gynecologists, best practices for testing for women, and the capacity of women’s organizations to provide health services and to use science to improve their programs. 

• ORWH should encourage analysis of the effectiveness of outcome trials across various 

populations, including women of various ethnicities and/or races. 

• Investigators should be encouraged to conduct secondary data analyses across disciplines in order to use resources more effectively. These may include, for example, using 

the HIV Cost and Services Utilization Study data, or updating the study by adding 

questions looking specifically at gender and race and ethnic disparities. 

• The methodology and design in implementation science must be strengthened, rather 

than simply applying previously effective programs across disparate populations. 

Recommendation 7: Research is needed into the extent of childbearing among HIV-positive 

women, reproductive intentions, and methodologies for safe reproduction. 

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• Many people living with HIV want and do bear children. Research is needed regarding reproductive intentions and behaviors among HIV-positive women and their partners, and 

across race/ethnicity. 

• Comparative effectiveness research may also look at various reproductive technologies 

that allow for pregnancy but may reduce the risk of HIV transmission (e.g., IVF, timed 

coitus, postexposure prophylaxis, preexposure prophylaxis, uterine insemination). 

• Cost-effectiveness research is also needed. 

Recommendation 8: Research on genetics and pathogenesis should use heterogeneous 

populations and employ better definitions of gender, race, and ethnicity. 

• Pathogenesis and genetic research studies so far have primarily been conducted in white 

homosexual men. There is a need either to test and validate these findings in women, or 

to conduct new studies using heterogeneous populations. 

• Because phenotypic sex is an inadequate proxy for biologic sex in the majority of clinical 

research studies, new studies must include women in order to examine evidence for sex 

differences in areas such as viremia, inflammatory response, and the immune system. 

• Sex and gender differences can be biochemical, physiological, XY-chromosome related, 

or hormonal (sex steroids), and thus may affect genetic risk factors by sex on several 

levels. Study of such differences could lead to novel treatments. 

• Race and ethnicity definitions should be reviewed. Genetic markers of heritage are 

important, but current categories do not adequately address this. 

Recommendation 9: New clinical research on women and HIV is needed, as prior research on 

men may not be applicable. 

• There is an overarching need to develop and validate research methodologies for different population groups by gender, race and ethnicity, nationality, etc. Such methodologies 

need to be disseminated to researchers. 

• Research is needed to evaluate strategies to prevent long-term complications specific 

to women (e.g., cumulative effect of medications). For example, studies of underlying genetic markers may be done on a small scale, which is more cost effective than 

large-scale studies. 

• Clinical research is needed to examine the intersection of HIV with other chronic illnesses, 

mental health, and other areas. 

Recommendation 10: Research on biomarkers for precancer screening, therapy, and therapeutic vaccines needs to be encouraged. Such research should also examine lower cost options for 

low-resource countries. 

• There are fundamental differences in the immune systems of women and men. Hence, 

research is needed to understand the differential effects of comorbidities that may accelerate or increase vulnerability to HIV (e.g., cancers and coinfections, inflammation due to 

HIV infection, mucosal immunology, reproductive aging, the menstrual cycle, expression 

of receptors, neuropathogenesis, dementia, liver damage, cardiovascular disease, obesity, 

autoimmune diseases, and migraines). 

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• Additional nondisease factors may also accelerate or increase vulnerability to HIV, and 

thus should be studied. For example, smoking and nutrition may interact in significant 

ways with HIV and vulnerability. 

• New therapies are needed to prevent and treat HIV and comorbidities in order to address 

the increasing disease burden around the world. 

Recommendation 11: HIV clinical trials research needs to address the growing population of 

HIV-infected women, ensuring that sufficient numbers are included in research to allow for 

analysis by sex and designing research that addresses the specific needs of women. 

• Most research proposals include plans for recruiting women and minorities but, in many 

cases, not enough are recruited to allow analytical power for subgroup comparisons. 

Researchers should be encouraged to fulfill their targeted enrollment plans. 

• Pregnant women must be included in HIV clinical trials in order to gain a better 

understanding of risks and benefits.
�

• Operations research is needed for the development of improved informed consent 

language for HIV research studies. Much of the language currently used in consent 

documents is not comprehensible to participants, implying that true informed consent 

does not always occur. 

• Research is also needed regarding biomarkers of reproductive aging in chronically ill 

women. Studies should also examine the full reproductive tract for prevention of 

pathogenesis and coinfections. 

Recommendation 12: Research is needed in the area of pharmacology to inform new 

treatments, address medication adherence, and focus on issues specific to women. 

• There is no gold standard measure of treatment adherence. Research is needed to examine the determinants of adherence, the relationship of adherence to age, sex, autonomy, 

and other variables. 

• Dosage studies are needed to understand whether dosing and toxicity to ARVs are 

related to body mass, gender, age, or pharmacogenomics (e.g., slow metabolizers). 

Such research will inform optimal treatment regimens. 

• There is a need for methodologies for predicting drug interactions in early phase 

screening in pilot studies, so that not all drugs need to be studied individually. 

• Research is needed in the area of novel methods for administration of drugs. HIV researchers can learn from other areas, such as contraception (e.g., patch, implant, IUD). 

• Little is known about drug interactions and cumulative toxicity in combination therapy in 

women (e.g., preexposure prophylaxis with microbicides, hormone replacement therapy 

and ARVs, or different types of progesterone in combined contraceptives). 

• Population diversity, especially in early phase clinical trials, is necessary in order to 

determine how sex differences affect a drug’s efficacy. 

• Research on new HIV drug treatment must address issues specific to women, such as 

drug metabolism, pharmacodynamics, pregnancy, breastfeeding (exposure to breast-fed 

106
infants), drug interaction with contraceptives, aging (adolescence, premenopausal, 

postmenopausal), toxicities to drugs, penetration of target tissue, and comorbidities. 

References 

1. Centers for Disease Control and Prevention. (2009). HIV/AIDS Surveillance Report, 2007. 

Vol. 19. Atlanta: U.S. Department of Health and Human Services, Centers for Disease 

Control and Prevention. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ 

2. U.S. Department of Health and Human Services, Centers for Disease Control and 

Prevention. (2008). CDC HIV prevalence estimates—United States, 2006. Morbidity 

and Mortality Weekly Report, 57(39). 

3. Gifford, A. L., & Groessl, E. J. (2002). Chronic disease self-management and adherence 

to HIV medications. Journal of Acquired Immune Deficiency Syndromes, 31(Suppl 3), 

S163–S166. 

INFORMATION TECHNOLOGY 

Cochairs:
�

Laura Esserman, M.D., M.B.A.
�

University of California, San Francisco 

Sue Dubman, M.A. 

Genzyme 

NIH Cochair: 

Barbara Rapp, Ph.D. 

National Library of Medicine 

Science Writers:
�

Nancy Oliva, Ph.D., M.P.A., R.N.
�

University of California, San Francisco 

Eve Harris 

University of California, San Francisco 

Carinne Meyer, M.P.H. 

University of California, San Francisco 

June-Ho Kim 

University of California, San Francisco 

Introduction 

Current information technology (IT) can contribute substantively to the clinical research 

process, and future advances in IT promise to further accelerate progress in women’s health 

research. For example, novel IT can improve women’s participation in clinical research by facilitating early and rapid screening of eligible participants to improve recruitment and retention, 

automating reminders and scheduling to facilitate study compliance, and providing immediate 

107
reporting of events and increasing access to this information, among other benefits. The ability 

to share information across the health care system and between health care organizations, the 

community, and the research enterprise will enhance collaborative decisionmaking. Advances 

in IT have the potential to affect all stages of the clinical research process, ultimately improving 

outcomes in women’s health.1,2 

The Working Group on Information Technology started its meeting with a discussion of the 

great promise of advances in biologic and information science for improving women’s health 

outcomes. In order to take full advantage of these advances, the group felt that the health 

community must radically alter its system of care delivery. The Institute of Medicine (IOM) has 

repeatedly reported the need to address systemic issues, such as quality of care, coordination 

of information and services, safety, and quality improvement.3 However, the current system of 

care is fragmented and relies on inaccessible, nonstandard, noncomputable, and nonportable 

information about patients. In addition, there is no mechanism to facilitate and improve care 

across providers and institutions—resulting in a disconnection in delivery of care, clinical outcomes, and research for women’s health. 

The group based its discussion on the understanding that single, isolated advances do not 

achieve change, and that any new technology must be connected to larger systems of care 

and research. For example, electronic medical record (EMR) systems have not provided the 

panacea that some hoped—they simply make medical charts available in the form of electronic 

text files. These records do not allow for the storage and reuse of data for the multiple purposes of care and research. In addition, the information from these records is not available across 

institutions, or even within most systems of care delivery. In order to merge research with care, 

we must develop and implement systems that enable us to collect critical data automatically 

as a byproduct of care in order to improve quality.4,5 This approach would dramatically improve 

research efficiency and leapfrog the challenges of getting more women into trials. It would 

also serve to reduce the redundancy created by repeated manual entry of clinical information 

by research coordinators and then again by third parties for each clinical trial. Finally, the integration of common electronic data at intake and along the care continuum would significantly 

reduce cost, labor, and inefficiency. A virtual cycle of improvement results when standards are 

adopted, high volumes of information are exchanged, and proprietary software and equipment 

are eliminated. 

In addition to systems improvements, using IT to access medical information and education is 

an important area that deserves more emphasis. Women of all income levels are increasingly interested in using the Internet to research their treatment options and manage their care.6,7,8 

According to the Pew Internet and American Life Project, about 8 million Americans search 

the Internet daily for health information.9

 In addition to addressing the disconnect between research and care delivery, the failure to heavily invest in surrogate markers (biomarkers), and 

the failure to adopt standards, improvements in IT can harness the unprecedented power of 

the Internet for the benefit of women and the personal management of their health.10,11 

The working group acknowledged that some progress has already been made. Access to highquality health information by the lay public has been achieved through the Internet as well as 

108
through electronic educational modalities. Telemedicine (distance learning for clinicians and 

consultations for patients far from medical care) has been used with success in some areas of 

women’s health. For clinicians, continuing medical education and calendars of educational opportunities regarding women’s health have been made available online. Creative new uses of 

IT have been developed by the Centers of Excellence in Women’s Health. These modalities are 

only the beginning, and building on early success as well as facilitating innovation is crucial to 

creating real and sustainable improvements in women’s health outcomes through IT. 

Summary of the Discussion 

The working group agreed on a basic understanding of IT, which includes software, hardware, 

and user behavior as it relates to software and hardware. Health IT includes infrastructure— 

tools and applications that are integral to the wide range of activities associated with research 

and clinical care. IT plays an important role in analysis, management, exchange, and integration of information across a wide range of disciplines, including clinical research, clinical care, 

molecular biology, genomics, proteomics, imaging, pathology, and epidemiology, among others. 

Invaluable Role of IT in the Health Care System 

The working group discussed the types of IT that have specific applications to health. 

Discussion points included the topic of informatics, an overarching term that applies to 

the gathering, manipulating, storing, retrieving, and classifying of recorded information. 

Within informatics, specialized areas include clinical or medical informatics, translational 

informatics (the application of both informatics theory and methods to translational research), bioinformatics, biomedical text informatics (e.g., natural language processing), 

imaging informatics (e.g., content-based image retrieval), computational biology (e.g., 

models), and information dissemination. 

The working group agreed that the fundamental value driving health IT decisions was the creation of an evidence base for the continuous improvement of clinical care. As mentioned in 

Barack Obama’s Plan for a Healthy America, “Comparative effectiveness [research] studies provide crucial information about which drugs, devices and procedures are the best diagnostic and 

treatment options for individual patients.”12 IT improvements should be aimed at the development of personalized and evidence-based medicine, individualized treatment, and quality care. 

The group stated that health IT systems need to be interoperable, exchangeable, and mineable for information. There is a need to transform the process of clinical care and integrate data 

across settings and clinicians. Notions of where data come from (e.g., cell phone-based biophysical monitoring; patient-generated content online) need to be broadened. Population data 

should be used in a shared, interoperable way, not through a traditional “owned” registry model. 

Defining the Data Needs of Women, Clinicians, and Researchers 

The group agreed that the data gathered by new and improved systems must be interoperable 

across systems and platforms to be meaningful, useful, interpretable, exchangeable, and accessible. One issue that came up in the discussion was that ownership of data must be resolved, and 

that a commitment to sharing will improve knowledge and options for care and prevention. 

109
Participants agreed that IT has immense value to health care because it provides an interconnected web of tools and applications that link participants in the health care ecosystem, 

including patients, providers, and researchers. Patient data are a valuable but currently underutilized resource. There is a need for rapid access to clinical effectiveness information as well 

as interdisciplinary data access across diverse communities of providers. Information dissemination is already challenging, as evidenced by the 4.2 billion Web pages indexed by Google. 

Thus, patients and clinicians need help to evaluate and distill accurate information through 

easy-to-use, portable, and integrated systems. 

Investment in novel uses of IT to promote women’s health and wellness is needed. New applications specific to women’s needs for managing illness will change the way women engage 

with their health and health care. To improve health outcomes, research should focus on the 

range of information needed for clinical decisionmaking, managing and monitoring chronic 

conditions, motivating behavior change, empowering women, and enabling health and wellness-promoting activities such as coaching and self-care decision support. 

Improvements in IT can result in increased collection and use of women’s health data and, 

therefore, improved outcomes. There is a need to use clinical care data from systems of care 

for data mining and research applications. Clinical care databases can be used and adapted for research, which will serve to enhance the inclusion of women in research designs and 

processes by allowing their health information to be used in research without requiring their 

participation in a clinical trial. In that way, personal health records represent an opportunity 

both to integrate information into research and to educate patients about their own health. 

Patients can efficiently provide the critical followup information to enable evaluation of clinical 

care outcomes. Data must move quickly within a real-time adaptive design to effect changes in 

clinical care, rather than lag by 3 years as is common today. 

Finally, an essential aspect of any new system is to create processes that provide for diversity. The wide variety of needs of women from different backgrounds must be factored into 

the ways science is communicated to consumers, and patients/consumers need to be educated about their roles in health care decisionmaking. Women from every background need to 

be able to build trust and have a level of comfort with online systems, and providers and researchers need to be aware that a “digital divide” still places the poor, older consumers, and 

immigrants at a disadvantage. 

A Vision for the Future of Health Informatics 

The goal of the second half of the discussion was “to define a research agenda that will facilitate the creation of systems that provide the right information, in the right format, to the 

right person, at the right place, and at the right time to improve health care decisions and 

outcomes.” The cochairs established that priority research aims were to increase connectivity, productivity, and learning by use of technology. Expanding on this idea, group members 

agreed that there was an absolute need to rectify current inadequacies by engineering new 

data processes to help create a 21st century “knowledge economy” and a vision to frame 

clinical practice as a learning system. 

110
The group acknowledged the need to identify existing barriers that may hinder improvements in 

IT for health care and research, and to address them. Although an integrated system is the ideal 

way to collect patient information, current academic researchers face disincentives to sharing 

information and data. One incentive for researchers and academics would be to examine data 

sharing through a lens of comparative effectiveness. This could demonstrate how improved information sharing allows learning from patient information—a currently underutilized resource 

that potentially holds answers to questions of health and disease. 

Other barriers include privacy issues and the need to protect patient information and confidentiality. New systems must instill confidence in individual patients that all personal information 

will be kept safe and anonymous. The promise of a more personalized medical experience may 

reduce patients’ fears—by allowing broader use of their personal data, patients can receive 

superior health care that is tailored to their individual health profile. In the evolving realm of 

personalized medicine, the unwillingness of systems and organizations to change presents another barrier. To overcome it, clinicians will need to adopt a model of continuous learning and 

change. In order to tailor treatment to individual biology, preferences, and consequences, such 

barriers must be overcome to ensure that research can be integrated into clinical care through 

IT-enabled processes. 

Women’s Input into Health IT 

Group discussion led to the elaboration of IT issues specific to women’s health. First, researchers 

and health informatics specialists must base their research on a broader definition of health that 

comes from women themselves, including aspects such as the environmental, sensory (visual 

and hearing), dental, and psychosocial domains. In addition, the group stressed the importance 

of educating women about the value of participating in clinical research and their central role in 

the success of trials. Despite sobering statistics about the low level of clinical trial participation, 

the tone of the discussion was optimistic—in some cases, passionate—that the process of clinical 

care can be reengineered to simultaneously generate the information required to improve care 

and conduct research. By doing this, the health care system can enhance the inclusion of women in research designs and processes, with the end goal of improving health outcomes for 

all women. 

Next Steps: The Future 

The cochairs then asked the group, “What do we need to do in terms of research and funding 

to facilitate the next step?” The group determined that demonstration projects were the best 

way of studying the multifaceted aspects of ways IT should transform the processes of clinical 

care and research. Through demonstration projects, stakeholders (e.g., female patients, clinicians, and researchers) can work collaboratively to contribute to and create an IT infrastructure 

that supports interoperable data exchange for clinical and research use. The output from such 

demonstration projects can be an understanding of best practices and research methods in 

order to create a learning culture (evidence-based management), while also identifying missing components and spurring development. This will best move us forward together towards 

meeting the vision and goals identified earlier. 

111
Demonstration projects can show how to use IT connectivity to advance learning and care. 

There should be an explicit policy to encourage experimentation that encompasses care delivery, wellness, and research. In the end, demonstration projects can facilitate the beginning of 

changes in the culture of health care organizations, research organizations, and funders, 

including the Federal government. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Ensure that scientific findings from research inform best practices that 

are linked to data collection at other points of care, such as codes of patient conditions, 

clinician treatments, and reimbursements. 

• Women’s health variables and issues should be brought into data modeling 

and collection.
�

• Informatics initiatives should be encouraged to produce research-ready, standards-based 

clinical data at the point of care. These efforts should be IT-enabled with a focus on engineering new data collection processes. IT has to be designed and deployed to support 

quality improvements, including risk assessment and detailed feedback on the characteristics of care processes. These initiatives should also use IT to integrate evidence into 

care processes, continuously monitor and collect relevant data, and produce performance 

feedback. This information will help researchers and clinicians determine which women have a high risk of developing certain serious diseases and learn how to reduce their 

morbidity and mortality. 

• A strong commitment should be made to common data standards, vocabularies, and 

terminologies, so that data and information can be easily shared and understood across 

disciplines. There is a need to collaborate with other public and private initiatives aimed 

at gaining consensus and harmonization of standards for the benefit of research on 

women’s health. 

• Research and evaluation on the nature and value of clinical and quality-of-care indicators 

should be funded. The option of including a requirement for clinical answers as well as 

scientific answers in all funded Phase III trials should be explored. 

• Clinician and researcher collaborations should be encouraged to design products that 

model data elements essential for providing good care, effective clinical research, and 

evaluation of care processes and outcomes. 

Recommendation 2: Invest in research on transforming information into knowledge. 

• Focus research agendas on producing, distributing, and presenting useful information to 

different groups of stakeholders. 

• Match new technology to specific contexts and conditions—e.g., distributing effective 

and appropriate data and tools to patients with basic literacy to help them manage their 

chronic diseases. 

112
• Invest in research on building integrated processes that will fully link complex but relevant data. For example, various databases in external and internal contexts could be 

integrated with pollution control and environmental data to inform population health and 

clinical care beyond antiquated models of linear knowledge development. Considerations 

here include modeling necessary data and improving the capacity of EMR products to 

collect and report research-ready, standards-based data. 

Recommendation 3: Support and lead the extension of data standards in therapeutic areas of 

special interest to women (e.g., STIs, female cancers, pregnancy, aging). 

• Data standards should be developed through demonstration projects that will serve as 

a strategy for improving health care IT adoption and applications. For example, one can 

study and test the reengineering of processes for data collection and integration, the 

transformation of data into knowledge, and the impact on effecting change in care. 

• Researchers need to model novel systems for IT-integrated women’s health care delivery 

using demonstration projects to evaluate models. 

Recommendation 4: Invest in the education of women on the importance of creating 

and sharing their information for research and using their information to promote health 

and wellness. 

• Encourage women to participate in clinical trials (women have the lowest enrollment 

in such trials) and to permit the use of their personal health records. 

• Address how individuals can benefit from participation in large-scale clinical research 

trials. For example, there are now millions of cancer survivors whose quality of life is impacted by pain and depression. Many of these patients can be helped—how do we collect 

this information from patients and treatment systems? 

• Empower patients to act as critical data providers in the 21st century knowledge economy. For example, there is a need to merge data on tumor biology, treatment, quality 

of life, complications, and followup. Much of this information can be provided by the 

patients themselves. 

Recommendation 5: Promote policies and capabilities that ensure patient information is safe 

and de-identified, yet accessible for research purposes. 

• A critical question is, “Who owns data?” Ownership “silos” can impede access to patient 

information. Health information “banking” is one option, with patients controlling access. 

• Data efficacy and safety should be top priorities in developing the best health IT. 

Recommendation 6: Support initiatives that enable integration and sharing of clinical, 

molecular, imaging, and other information (e.g., population, environmental), and promote 

collaboration across multiple disciplines. 

• Research is needed on how best to engineer information so that it can be communicated 

and actionable to a range of different stakeholders. 

• There is a need to integrate data from literature and resources; there is a large body of 

knowledge that can be accessed and applied. 

113
• Education and training are needed to promote information sharing and knowledge 

transfer among health care systems. This includes education and training for patients, 

providers, and researchers. There is a need to change the way information is acquired, 

transformed, and used to deliver care. Patients need training to learn to provide information and access information sources that they help generate. Providers need training 

to learn to use patient-generated information, and participate in transforming and 

improving care by integrating information and feedback at the point of care. 

• Borrowing methods and strategies from other industries can help speed information access and use, as well as modeling and development of applications. Examples include 

online access to services and information (e.g., financial industry products, online 

reading, and music product markets). 

References 

1. Pinn, V.W., Roth, C., Bates, A., Wagner, R., & Jarema, A. (2009). Monitoring adherence to 

the NIH policy on the inclusion of women and minorities as subjects in clinical research: 

Comprehensive report – tracking of human subjects research as reported in Fiscal Year 

2007 and Fiscal Year 2008. Bethesda, MD: National Institutes of Health. Retrieved from 

http://orwh.od.nih.gov/inclusion/2009AnnualTrackingInclusionComprehensiveRpt.pdf 

2. Ford, J. G., Howerton, M. W., Bolen, S., Gary, T. L., Lai, G. Y., Tilburt, J.,...Bass, E. B. 

(2005). Knowledge and Access to Information on Recruitment of Underrepresented 

Populations to Cancer Clinical Trials (AHRQ Publication No. 05-E019-2). Rockville, MD: 

Agency for Healthcare Research and Quality. 

3. Institute of Medicine. (2001). Crossing the quality chasm: A new health system for the 

21st century. Washington, DC: The National Academies Press. 

4. Berwick, D. (2004). Escape fire: Designs for the future of health care. San Francisco, CA: 

Jossey-Bass. 

5. Wachter, R., & Shojania, K. (2004). Internal bleeding: The truth behind America’s 

terrifying epidemic of medical mistakes. New York, NY: Rugged Land.
�

6. Bundorf, M., Wagner, T. H., Singer, S. J., & Baker, L. C. (2006). Who searches the Internet 

for health information? Health Services Research, 41(3 Pt 1), 819–836. 

7.	� Ferris, N. (2007). The un-health record. Government Health IT, 2(3), 16–20. 

8. Madden, M., & Fox, S. (2006). Finding answers online in sickness and in health. Pew 

Internet and American Life Project. 

9.	�Detwiler, J. (2008) Paging Dr. Google. Fitness, 96. 

10. Pearl, R. M., & Burgelman, R. (2004). Better medicine through information technology. 

Stanford, CA: Stanford Graduate School of Business. 

11.	�Taking the pulse v 5.0: Physician and emerging information technologies. (2005). 

Retrieved June 7, 2007, from http://www.manhattanresearch.com/thepulse2005.htm 

114
12. Obama for America. (2008). Barack Obama’s plan for a healthy America: Lowering 

health care costs and ensuring affordable, high-quality health care for all. Retrieved 

from http://www.barackobama.com/pdf/HealthPlanFull.pdf 

WOMEN IN SCIENCE AND HEALTH CAREERS 

Cochairs: 

Elena Fuentes-Afflick, M.D., M.P.H.
�

University of California, San Francisco 

Joan Reede, M.D., M.P.H., M.B.A. 

Harvard Medical School 

NIH Cochairs: 

J Taylor Harden, Ph.D.
�

National Institute on Aging 

Joan P. Schwartz, Ph.D. 

Office of the Director 

Science Writers: 

Holly A. Garriock, Ph.D.
�

University of California, San Francisco 

Rebecca A. Howsmon, Ph.D. 

University of California, Berkeley 

Meridithe Mendelsohn, M.P.A. 

University of California, San Francisco 

Introduction 

To achieve goals in women’s health research, it is critical to champion the interests and support 

the career advancement of women in science, technology, engineering, and math, across 

all disciplines and sectors of the health professions. This working group was charged with 

defining strategies and approaches that will break down barriers and create opportunities to 

ensure that women in these fields can achieve their full potential. The group examined the 

ideas and recommendations of the Working Group on Women in Science and Health Careers 

convened in March 2009, at the conference at Washington University in St. Louis, and extended and prioritized them. 

As part of this effort, the working group also addressed the particular career advancement issues facing women of color and women in nonmedical disciplines, including, but not limited to, 

women with Ph.D.s and with degrees in pharmacy, dentistry, nursing, psychology, engineering, 

and mathematics. 

115
Summary of the Discussion 

The working group included women and men from a wide range of disciplines and ethnicities. 

All participants identified important topics for future programmatic development and research, 

particularly research to address the multiple factors that influence the advancement of women 

in science careers. 

The discussion began with each participant sharing personal perspectives on future directions 

to address barriers to recruitment, retention, reentry, and advancement of women in science 

at all stages of their careers. Specific attention was given to the many types of diversity within 

the realm of women scientists, including differences in sexual orientation, disabilities, race/ethnicity, and urban or rural residence. Participants addressed the need for increased funding for 

women scientists, and underscored the importance of changes in the institutional and organizational culture within academia to address specific barriers to the advancement of women 

in biomedical professions. Among the working group participants was Dr. Virginia Valian, who 

referenced the “gender schema,” she had discussed in her keynote address at this meeting 

(see page 72). 

Before breaking into two subgroups, the NIH cochairs provided the participants with a progress 

report on a variety of programs and policies that are in place or being addressed at the NIH. The 

working group endorsed five themes and recommendations from the St. Louis meeting: 

• Institutional transformation 

• Family-friendly policies 

• Mentoring programs and evaluation 

• Leveling the playing field and promotion 

• “What is good for women is good for everyone” 

While family-friendly policies and mentoring programs were identified as important topics, 

these types of issues were not included in the final report of this working group since these 

issues were highlighted in the recommendations from the St. Louis report. 

The remaining three themes and recommendations from the St. Louis meeting—institutional 

transformation, leveling the playing field and promotion, and “what is good for women is good 

for everyone”—served as conceptual building blocks that allowed the San Francisco group to 

advance similar thoughts but not duplicate work already accomplished. The larger group then 

separated into subgroups to discuss and develop recommendations addressing two specific 

areas: cross-disciplinary issues and women of color. Subsequently, the cochairs refined the list 

of issues and recommendations into five categories that served as the focus of the final recommendations. These areas were: 

• Pipeline 

• Representation/leadership 

• Research topics 

• Training and education 

• Transparency 

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The full working group reconvened and finalized the list of recommendations. 

Pipeline 

The working group discussed a number of concepts that evolved from individual concerns regarding the “pipeline” to a larger context involving institutional concerns and “transparency.” 

It was noted that over a decade ago and under similar circumstances, Dr. Pamela Marino, 

Ph.D., National Institute of General Medical Sciences, developed a pathways model for career 

progression of women in science1 as a frame for discussion of pipeline and career progression issues (see Figure 1). The model addresses the dynamics of the rates of career progression, 

exit, and reentry to the career path from high school to independent investigator. The model 

includes the potential for assessing dynamic rates of progression, as well as points to leverage 

and/or recover losses. 

Figure 1. Pathways Model 

SOURCE: Office of Research on Women’s Health. (2000). AXXS ’99. Achieving XXcellence 

in science: Advancing women’s contributions to science through professional societies (NIH 

Publication No. 00-4777). Bethesda, MD: National Institutes of Health. 

Within this model, one can situate issues related to the need to engage elementary school 

and college level students early in the science and research enterprise. One specific need is to 

develop better ways of communicating opportunities and support mechanisms, such as programs like Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) and NIH 

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reentry opportunities, to postdoctoral fellows and junior faculty members, who become discouraged and/or change career plans, resulting in leaks from the pipeline pathway. Within 

this context, clear information is needed on causal factors contributing to the leakage, such as 

family and maternity leave concerns, lack of insurance, difficulty in securing Federal funding, 

and effects of current NIH policies on institutional policies. Additionally, and throughout the 

pathways, there is both the challenge and the opportunity to address the role of mentors, particularly in providing advice on how to effectively achieve work-life balance. In terms of career 

maintenance, the group felt that there could be more support for the opportunity to go back 

and forth between academia and industry. 

At all points in the pathways model, women of color are lost at a disproportionate rate relative 

to majority women. The sense of the group was that the number of minority women funded 

by the NIH is small. Critical issues include the need to enhance their entrance into the pipeline, 

and to determine at which steps in the pathways model women of color in biomedical sciences leave and how to ensure that they reach the academic track, successfully compete for NIH 

funding, and achieve leadership positions in science. The administrative supplements for providing summer research experiences for students and science educators, which was funded by 

the American Recovery and Reinvestment Act (NOT-OD-09-060) in 2009 and 2010, should 

be continued with emphasis on youth from disadvantaged backgrounds and on ethnic and racial groups underrepresented in the sciences. Greater use of the NIH Research Supplements to 

Promote Diversity in Health Related Research (PA-08-190) at all career levels may be a means 

to provide science experiences for youth of color, as well as among junior and more experienced academicians. 

The discussion on the pipeline concluded with an emphasis on encouraging professional students to enter the pipeline by reducing the barriers that women, particularly women of color 

and lesbian women, face. Many gay youth and youth of color cannot imagine a future in the 

sciences because their mentors are few and not always in decisionmaking positions. Lesbian and minority women should be provided opportunities to do research on issues that affect 

them specifically. Factors that help women of all backgrounds to take on leadership and decisionmaking positions include formal mentoring programs, a strong linked pipeline from 

university to graduate or health professional school, and programs such as evidence-based 

parenting (education programs that have been studied in both controlled, clinical trials and 

community settings, and have demonstrated specific, expected outcomes) for pregnant or 

parenting faculty and postdoctoral fellows. In addition, women should be encouraged to 

become interested in conducting research in women’s health at an earlier age, which will 

require new mechanisms and pathways starting in elementary school. 

Transparency 

Working group participants felt that there was opportunity for broader institutional change 

and enhanced transparency based on gender schema and issues related to women of color, 

disabled women, and lesbian women. One model to follow is the LCME/ACGME accreditation, 

which requires a report card on diversity from each specific program. One way to enhance this 

model would be to include consequences for failing to create a comprehensive diversity policy and results. 

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Participants felt that the current organizational culture does not do enough to encourage 

gender and racial diversity. There is a need to ensure that NIH-funded institutions put in place 

family-friendly policies, such as policies addressing spousal hiring, maternity and paternity 

leave (including leave for adoption), parents of children with disabilities, and families with ill 

partners or aging parents. Institutions should identify mechanisms that enable better visibility 

of the institutional contributions of women. Finally, universities should ensure clarity about 

on-ramps for academic careers, especially for those in their childbearing years and those 

caring for aging parents. 

Training and Education 

In the area of training and education, participants agreed that curricula in health professional 

schools currently lack material on sex and gender issues relevant to human physiology and 

human disease across the lifespan. Faculty are not sufficiently trained to address these questions and the national curricula do not require health care professions to examine sex and 

gender issues related to health across the lifespan. In addition to curriculum changes, mentor-development programs should be established that would provide mentoring, not only to 

students but also to midcareer to early senior career-level academics. The NIH could fund 

programs to develop tools that would enable faculty to mentor across gender lines. 

Programs are also needed to address retention of those who have a support role in grant submission by providing training and education, tuition assistance and loan forgiveness, and 

competitive salaries. The Midcareer Investigator Award in Patient-Oriented Research (Parent 

K24), which provides protected time, training, and mentoring in clinical research, could be 

expanded to include Ph.D.s, particularly in fields such as the pharmaceutical sciences. 

Research Topics 

The discussion included development of a list of research topics not yet prioritized but 

important to advancing women’s health. The following topics were discussed: 

• Sex differences 

• Physiology of menopause 

• Interdisciplinary research on women’s physiology 

• Women’s neurology 

• Work and family issues, including families with older children and adolescents 

• Organizational culture and change 

Representation/Leadership 

Discussion of concerns related to representation and leadership centered on developing an 

understanding of how some women gain prominent leadership roles in biomedical sciences 

while others reach a ceiling at lower level positions. The group was very supportive of the 

recent Request for Applications (RFA) for Research on Causal Factors and Interventions that 

Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering (RFA-GM-09-012). The aims of the initiative were to support: 1) research on causal 

factors explaining the current patterns observed in the careers of women in biomedical and 

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behavioral science and engineering, and 2) evaluation of the efficacy of programs designed 

to eliminate sex/gender disparities and promote the careers of women in these fields. Areas 

of interest included, but were not limited to, the following: 

• Individual characteristics, including family and economic circumstances 

• Institutional/departmental environment 

• Organizational structure 

• Disciplinary cultures or practices 

• Special populations, such as women of color 

• Features of the broader social and cultural context 

The group supports reissuing this RFA. 

The challenge of getting women into senior leadership positions and ensuring visibility of 

their accomplishments in science can, in part, be addressed by implementing significant 

award programs at local and national levels. The group felt strongly that institutions should 

be held accountable for any underrepresentation of women in leadership positions. Tools can 

be developed to address everyday issues such as how to discuss gender disparities, and funding for research in this area would be useful. 

Based on the above rationale, the working group developed recommendations through an 

iterative process of discussion and refinement. The group identified four overarching themes. 

• Include women of color in all deliberations regarding training, career development, 

research, and leadership representation. 

• Address the organizational, institutional, and system factors that influence/limit the 

advancement of women in science (e.g., evaluation biases). 

• Develop new and enhance existing communication strategies to inform constituencies 

about opportunities and research findings. 

• Evaluate the effectiveness and implications of specific programs or policies prior 

to expansion. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Pipeline/Pathway 

• Focus on pipeline/pathway issues along the career continuum and address issues of 

entry, transition, advancement, and retention, including issues that affect women at 

the senior level, particularly women of color. 

• Identify, assess, and communicate best practices that address pipeline/pathway issues. 

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Recommendation 2: Transparency 

• Increase environmental capacity. Funding agencies should ask for data on race/ethnicity 

and gender of faculty and leadership, as well as faculty development efforts at the institutional level. 

• The NIH should amend the research grant application to add an “impact statement” that 

will address the benefit of the proposed work to the applicant’s institution (science, education, training enterprise, particularly as it relates to women and people of color). 

• Any NIH career development or training grant should include a section describing activities that will be undertaken to enhance the talent and career development of trainees on 

the grant. 

• Institutions should be made aware that they may negotiate funding for faculty development efforts and work-life balance programs into their indirect funding rates. 

Recommendation 3: Training and Education 

• Advocate for the requirement of a Collaborative Institutional Training Initiative (CITI)-like 

training module that addresses gender and racial schemas for PIs. 

• Ensure that salaries are comparable across K training awards. 

• Advocate for the development of an equivalent K24 mechanism for midcareer basic 

scientists, including research on gender/sex and health disparities. 

• Expand communication strategies related to transition and reentry awards. 

Recommendation 4: Research Topics 

• Increase emphasis/priority of research topics that address sex/gender, LBTI, and health 

disparities in women, as well as biomarkers for diseases that differentially affect women. 

• Work with other professions and disciplines to identify best practices and research findings that foster organizational change and determine their applicability, synthesis, and 

translation to the biomedical community. 

• Extend research on work-life factors that impact women scientists/clinicians’ career success and advancement (e.g., elder parents, adolescents, disabled family members, etc.). 

Recommendation 5: Representation and Leadership 

• Professional organizations and funding agencies should develop ways to recognize 

institutions’ achievement in the advancement of women and minorities in science. 

• Consider the development of a MERIT* -like program in women’s health that would 

recognize leadership activities in promoting women and minorities in science. 

• Develop an extramural mentoring award for extraordinary accomplishments 

in mentoring.
�

• Initiate a community dialogue on “losing” senior-level women and minority faculty. 

* The MERIT (Method to Extend Research in Time) Award provides principal investigators up to 10 years of research support in two 

5-year segments without the need to renew the application after 5 years. 

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References 

1. Office of Research on Women’s Health. (2000). AXXS ’99. Achieving XXcellence in science: 

Advancing women’s contributions to science through professional societies (NIH Publication 

No. 00-4777). Bethesda, MD: National Institutes of Health. 

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A Vision for 2020 for Women’s Health Research: Moving into 

the Future with New Dimensions and Strategies 

The Warren Alpert Medical School of Brown University 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

September 21–23, 2009 

DAY 1—PUBLIC HEARING 

Location: Women & Infants Hospital of Rhode Island Conference Center 

11:00 a.m.–12:00 p.m.	� Registration 

12:00–12:30 p.m.	� Welcome 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health, 

Director, Office of Research on Women’s Health (ORWH), 

National Institutes of Health (NIH) 

Edward Wing, M.D. 

Dean of Medicine and Biological Sciences, Frank L. Day 

Professor of Biology, Brown University 

Constance A. Howes, J.D. 

President, Women & Infants Hospital 

12:30–2:00 p.m.	� Women’s Health Research and Researchers: 

Setting the Stage for the Nation’s Health 

through the Lifespan 

Perspectives from Policymakers/Legislators 

The Honorable Jim Langevin 

Congressman, Second District, Rhode Island 

Governor Donald L. Carcieri 

First Lady Suzanne “Sue” Carcieri 

Lieutenant Governor Elizabeth Roberts 

David Gifford, M.D., M.P.H. 

Director, Rhode Island Department of Health 

Frank T. Caprio 

State Treasurer 

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Translational Research in Women’s Health, from 

Basic Science to Bedside to Community 

Maureen G. Phipps, M.D., M.P.H. 

Associate Professor of Ob/Gyn and Community Health, The 

Warren Alpert Medical School of Brown University, Division 

Director of Research, Women & Infants Hospital 

Translational Research in Public Health 

Terrie Fox Wetle, Ph.D. 

Associate Dean of Medicine for Public Health and Public 

Policy, Brown University 

2:00–5:00 p.m. PUBLIC HEARING 

Moderator: Joanna M. Cain, M.D. 

Chace/Joukowsky Professor and Chair, Ob/Gyn, Assistant 

Dean for Women’s Health, Brown University 

Receiving Public Testimony: Members of the ORWH 

Advisory Committee and Conference Committee 

DAY 2 —SCIENTIFIC WORKSHOPS 

Location: Women & Infants Hospital of Rhode Island Conference Center 

7:30–8:30 a.m. Registration 

Moderator: Agnes B. Kane, M.D., Ph.D. 

Professor and Chair of the Department of Pathology 

and Laboratory Medicine, Brown University 

8:30–9:00 a.m. Welcome and Opening Remarks 

Vivian W. Pinn, M.D. 

Clyde Briant, Ph.D. 

Vice President for Research, Brown University 

9:00–9:45 a.m. Keynote Address: Policy Gaps that Identify 

Research Gaps in Women’s Health 

JudyAnn Bigby, M.D. 

Secretary of Health and Human Services, Commonwealth 

of Massachusetts 

9:45–10:30 a.m. PANEL: Lifespan Implications of Maternal 

Adaptation to Pregnancy 

Moderator: Joanna M. Cain, M.D. 

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Michelle Hladunewich, M.D., M.Sc. 

Assistant Professor, Divisions of Nephrology and Critical Care, 

University of Toronto 

Margaret Miller, M.D. 

Assistant Professor of Medicine and Obstetrics and 

Gynecology, Department of Medicine, The Warren 

Alpert Medical School of Brown University 

Caron Zlotnick, Ph.D. 

Director of Behavioral Medicine Research, Women & 

Infants Hospital, The Warren Alpert Medical School of 

Brown University 

10:30–10:45 a.m. Working Group Charge 

Vivian W. Pinn, M.D. 

10:45–11:00 a.m. BREAK 

11:00 a.m.–3:15 p.m. Concurrent Working Groups: Drafting of 

Recommendations by Area 

Across the Lifespan 

• Prenatal, Infancy, and Childhood Years 

• Adolescent Years 

• Reproductive and Middle Years 

• Pregnancy 

• Menopausal Transition 

• Elderly, Frail Elderly, and Healthy Aging 

• Oral Health and Systemic Conditions 

• Careers in Dentistry, Bioengineering, and Other 

Non-M.D. Disciplines 

3:15–3:30 p.m. BREAK 

3:30–5:00 p.m. Special Populations 

Moderator: Susan Cu-Uvin, M.D. 

Professor of Medicine and Ob/Gyn, Director of the Women 

& AIDS Core, Center for AIDS Research, The Warren Alpert 

Medical School of Brown University 

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Disparities in Women’s Health Research: 

Oncology Examples Across the Lifespan 

Wendy R. Brewster, M.D., Ph.D. 

Professor, Gynecologic Oncology, University of North Carolina 

Addiction to Nicotine: A Lifespan and Diversity 

Perspective on Women’s Health 

Bess H. Marcus, Ph.D. 

Professor, Department of Community Health and Department 

of Psychiatry and Human Behavior, Brown University 

Beyond the Barker Hypothesis: Lifespan 

Implications of Intrauterine Environment 

James Padbury, M.D. 

Oh-Zopfi Professor of Pediatrics and Perinatal Research, 

The Warren Alpert Medical School of Brown University 

Barry Lester, Ph.D. 

Professor of Psychiatry & Human Behavior and Pediatrics, 

Director, Brown Center for the Study of Children at Risk, 

The Warren Alpert Medical School of Brown University 

Carmen Marsit, Ph.D. 

Assistant Professor of Medical Science, Department of 

Pathology and Laboratory Medicine, The Warren Alpert 

Medical School of Brown University 

5:30 p.m. Taking Research to the Environment/ 

Building Level 

Tours and Discussion of Environmental Design 

to Impact Neurodevelopment 

6:00–7:30 p.m. Conference Reception 

DAY 3—SCIENTIFIC WORKSHOPS 

Location: Women & Infants Hospital of Rhode Island Conference Center 

8:00–8:15 a.m. Welcome and Opening Remarks 

Janine Austin Clayton, M.D. 

Deputy Director, Office of Research on Women’s Health, NIH 

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8:15–9:00 a.m. Creating the Future—Careers in Research 

in Biomedicine 

Shirley M. Malcom, Ph.D. 

Head, Education and Human Resources, American 

Association for the Advancement of Science 

9:00–10:45 a.m. Concurrent Working Groups: Finalization of 

Reports by Area 

10:45–11:00 a.m. BREAK 

11:00 a.m.–12:30 p.m. Working Group Results and Discussion 

12:30–1:00 p.m. Audience Feedback 

1:00–1:15 p.m. Closing Remarks 

Vivian W. Pinn, M.D. 

127
The Warren Alpert Medical School of Brown University 

and Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

September 22–23, 2009 

WORKING GROUP COCHAIRS 

PRENATAL, INFANCY, AND CHILDHOOD YEARS 

Gilman Grave, M.D. 

Endocrinology, Nutrition, and Growth Branch 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Melissa Jo Kottke, M.D., M.P.H. 

Assistant Professor 

Obstetrics & Gynecology 

Emory University School of Medicine 

Atlanta, Georgia 

Louise E. Wilkins-Haug, M.D., Ph.D. 

Division, Director, Maternal-Fetal Medicine and Reproductive Genetics 

Brigham and Women’s Hospital 

Boston, Massachusetts 

ADOLESCENT YEARS 

Christine A. Bachrach, Ph.D. 

Acting Director 

Office of Behavioral and Social Sciences Research 

National Institutes of Health 

Bethesda, Maryland 

Michelle Berlin, M.D., M.P.H. 

Vice Chair, OB/GYN & Director 

OHSU Center of Excellence in Women’s Health 

Oregon Health & Science University 

Portland, Oregon 

Sandra A. Carson, M.D. 

Medical Director of Women & Infants’ Center for Reproduction and Infertility 

Director of the Division of Reproductive Endocrinology and Infertility 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown University 

Providence, Rhode Island 

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REPRODUCTIVE AND MIDDLE YEARS 

Robert Barbieri, M.D. 

Chairperson, Obstetrics and Gynecology 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Alan DeCherney, M.D. 

Program Head 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Valerie C. Montgomery Rice, M.D. 

Executive Director, Center for Women’s Health Research 

Meharry Medical College 

Nashville, Tennessee 

Cynthia Casson Morton, Ph.D. 

Professor 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

PREGNANCY 

Alicia Y. Armstrong, M.D., M.H.S.C.R. 

Associate Fellowship Director, Reproductive Endocrinology Fellowship 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Lucia Larson, M.D. 

Director, Division of Obstetric and Consultative Medicine 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown University 

Providence, Rhode Island 

Donald R. Mattison, M.D. 

Senior Advisor 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

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Errol R. Norwitz, M.D., Ph.D. 

Professor of Obstetrics, Gynecology & Reproductive Sciences 

Yale University School of Medicine 

New Haven, Connecticut 

Katharine Wenstrom, M.D. 

Director, Maternal-Fetal Medicine Division 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

MENOPAUSAL TRANSITION 

Paul A. DiSilvestro, M.D. 

Principal Investigator for Gynecologic Oncology Group 

The Warren Alpert Medical School of Brown University 

Women & Infants Hospital 

Providence, Rhode Island 

Andrew A. Monjan, Ph.D., M.P.H. 

Scientist Consultant 

National Institute on Aging 

National Institutes of Health 

Columbia, Maryland 

Robert W. Rebar, M.D. 

Executive Director 

American Society for Reproductive Medicine 

Birmingham, Alabama 

Jacques E. Rossouw, M.D. 

Branch Chief 

Women’s Health Initiative 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Marcia L. Stefanick, Ph.D. 

Professor of Medicine and Professor of OB/GYN 

Stanford Prevention Research Center 

Stanford University 

Stanford, California 

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ELDERLY, FRAIL ELDERLY, AND HEALTHY AGING 

Richard Besdine, M.D. 

Professor of Medicine 

Director of the Center for Gerontology and Health Care Research at Brown University 

Director of the Division of Geriatrics in the Department of Medicine 

Chief of Geriatrics for Lifespan 

Greer Professor of Geriatric Medicine 

The Warren Alpert Medical School of Brown University 

Providence, Rhode Island 

Stefan Gravenstein, M.D., M.P.H., CMD, FACP, AGSF 

Clinical Director, Quality Partners of Rhode Island 

Division of Geriatrics, Department of Medicine 

The Warren Alpert Medical School of Brown University 

Providence, Rhode Island 

Stacy Tessler Lindau, M.D., M.A.P.P. 

Assistant Professor 

University of Chicago 

Chicago, Illinois 

Susan M. Resnick, Ph.D. 

Senior Investigator 

National Institute on Aging 

National Institutes of Health 

Baltimore, Maryland 

Bernadette Tyree, Ph.D. 

Health Scientist Administrator 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

National Institutes of Health 

Bethesda, Maryland 

ORAL HEALTH AND SYSTEMIC CONDITIONS 

Jane C. Atkinson, D.D.S. 

Director, Center for Clinical Research 

National Institute of Dental and Craniofacial Research 

National Institutes of Health 

Bethesda, Maryland 

Raul Garcia, D.M.D., M.M.Sc. 

Professor and Chair, Department of Health Policy and Health Services Research 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

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Brenda Heaton, M.P.H. 

Investigator, Department of Health Policy and Health Services Research 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Michelle M. Henshaw, D.D.S., M.P.H. 

Assistant Dean for Community Partnerships and Extramural Affairs 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

CAREERS IN DENTISTRY, BIOENGINEERING, AND OTHER 

NON-M.D. DISCIPLINES 

Paula K. Friedman, D.D.S., M.S.D., M.P.H. 

Associate Dean for Strategic Initiatives 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Catherine K. Kuo, Ph.D. 

Assistant Professor 

Biomedical Engineering 

Tufts University 

Medford, Massachusetts 

Brenda Korte, Ph.D. 

Program Director 

National Institute of Biomedical Imaging and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Valerie Wilson, Ph.D. 

Associate Provost and Director of Institutional Diversity 

Brown University 

Providence, Rhode Island 

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INTRODUCTION 

This report covers the third strategic planning meeting, held September 21–23, 2009 at Brown 

University’s Women & Infants Hospital of Rhode Island. The meeting format included welcoming 

remarks from the ORWH Director, University sponsors, the Governor of Rhode Island and several 

other legislators and policy makers; 19 public testimony presentations; 10 scientific presentations during the plenary session, including a keynote address from the Massachusetts Secretary 

of Health and Human Services; a charge to participants from the ORWH Director; and 8 breakout working groups. The value of developmental lifespan research on women’s health provided 

the primary scientific organizing principle of the meeting; a major crosscutting perspective was 

the need for more rapid translation of biomedical research findings into information, community interventions, organizational changes, and policies to improve the public health of diverse 

populations of women. Plenary presentations that provided public health perspectives were 

complemented by presentations on special populations of women and on the lifespan health 

implications of maternal adaptations to pregnancy and of the fetal intrauterine environment. 

Below are highlights from the plenary presentations. 

TRANSLATIONAL RESEARCH IN WOMEN’S HEALTH 

Maureen G. Phipps, M.D., M.P.H. 

Associate Professor of Ob/Gyn and Community Health, The Warren Alpert Medical School of 

Brown University, Division Director of Research, Women & Infants Hospital 

Dr. Phipps gave an overview of the goals of translational research, identifying gaps and opportunities for interdisciplinary translational research to improve women’s health. NIH research has 

provided a wealth of biomedical scientific knowledge about women’s health across the lifespan, placing strong emphasis in recent years on the importance of speeding the translation of 

basic research into clinical applications. But efforts to translate clinical knowledge into interventions, services, and policies with measurable public health impact have had mixed success. 

To truly make an impact on women’s health, translational research must go beyond “bench to 

bedside” by pursuing opportunities for dissemination, community uptake and involvement, including advocacy and policy development. Achieving this goal will require interdisciplinary 

collaboration and feedback between basic science researchers, clinical researchers, behavioral 

scientists, public health researchers, clinicians, the community, and policymakers. 

Terrie Fox Wetle, Ph.D. 

Associate Dean of Medicine for Public Health and Public Policy, Brown University 

Dr. Wetle continued the discussion of translational research from the perspective of public health, describing the potential of using public health strategies in translational research to 

improve women’s health. To effectively move newly discovered clinical interventions into the 

community, translational public health research is needed to provide the evidence base from 

which to design effective community intervention and dissemination strategies. Opportunities include applying public health expertise to designing clinical and behavioral research that 

will develop and test new interventions; assessing and monitoring the health of communities 

and at-risk populations to identify health problems and set priorities; designing community and population-based interventions to prevent disease and promote health; formulating 

new policies and practices to address local and national health problems; and assuring that 

133
all have access to appropriate and cost-effective care, including health promotion and disease prevention services. Scientists, whose research has created the knowledge base for these 

activities, need to become key participants. To accomplish this, dissemination and communication skills should be elevated to the status of core competencies in women’s health scientific 

career and leadership development programs. Individuals planning a career in translational 

public health research will need scientific preparation that not only provides a broad interdisciplinary perspective, but also helps them to develop highly technical competencies in areas 

such as the analysis of large linked population databases as well as model building that 

integrates genomic, epidemiological, and exposure data. 

KEYNOTE ADDRESS: POLICY GAPS THAT IDENTIFY RESEARCH 

GAPS IN WOMEN’S HEALTH 

JudyAnn Bigby, M.D. 

Secretary of Health and Human Services, Commonwealth of Massachusetts 

Dr. Bigby reviewed the current status of women’s health based on key public health indicators. She noted that women have greater disability associated with chronic disease than do 

men. This pattern is due in part to women’s greater longevity, but it also stems from gender 

differences in income levels and patterns of health care coverage. Furthermore, among different populations of women, disparities exist in health care coverage, use of services, and health 

outcomes. Since 2006, when health care reform was enacted in Massachusetts, coverage in the 

State has increased for previously underinsured groups. In the next few years, this expanded 

coverage should permit determination of the impact of removing financial barriers to access 

on women’s public health indicators, such as disparities in receipt of adequate care during 

pregnancy and rates of preterm birth. 

Nonetheless, even universal access will not solve problems posed by fragmentation of women’s 

health care. Gestational diabetes mellitus (GDM) and its followup demonstrate this fragmentation. GDM increases risk for type 2 diabetes, with 35 to 60 percent of women who have GDM 

developing type 2 diabetes within 10 years. Despite a need for continuity in monitoring, postpartum glucose screening is still not routinely done for GDM women, nor is information about their 

GDM status routinely provided to their primary care physicians. New integrative models of 

services delivery for women should recognize lifespan health risks and concerns. 

LIFESPAN IMPLICATIONS OF MATERNAL ADAPTATION 

TO PREGNANCY 

Michelle Hladunewich, M.D., M.Sc. 

Assistant Professor, Divisions of Nephrology and Critical Care, University of Toronto 

Severe preeclampsia leading to preterm birth is a major cause of maternal and fetal morbidity and mortality. Recent epidemiological findings have challenged a long-held view that 

preeclampsia is inconsequential for later health. Now it is recognized as an early indicator 

of a woman’s risk for later vascular disease—hypertension, myocardial infarction, stroke, 

and renal disease. 

Animal models of preeclampsia provide insights into its pathogenesis as well as the 

shared mechanisms that underlie its association with later vascular disease. COMT 

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(catechol-O-methyltransferase) is the principal enzyme in the conjugation pathway for estradiol. Both COMT and 2-methoxyoestradiol (2-ME) are significantly lower in women with 

preeclampsia. A mouse model of the preeclamptic phenotype, produced in COMT knockout 

(-/-) pregnant mice, was rescued by administration of 2-ME. 2-ME also suppressed placental 

hypoxia and antiangiogenic factors that have been linked to placental pathology and pregnancy-related hypertension. Clinical applications of this research may include the use of 2-ME as 

a diagnostic risk marker for preeclampsia or as a therapeutic supplement to prevent or treat 

the condition. Translational research should continue to increase fundamental understanding 

of the mechanisms linking pathological syndromes of pregnancy to later disease and to provide new therapeutic and preventive targets. 

Margaret Miller, M.D. 

Assistant Professor of Medicine and Obstetrics & Gynecology, Department of Medicine, 

The Warren Alpert Medical School of Brown University 

Dr. Miller described the move away from viewing women’s health primarily in terms of its importance for pregnancy outcomes, citing an emerging paradigm that views pregnancy as having 

important lifespan implications for women’s health. Pregnancy may unmask chronic disease, 

pregnancy outcomes may predict future disease, and pregnancy may provide an opportunity to identify health risks and disease. Normal changes in pregnancy present a picture of a 

“metabolic syndrome,” with insulin resistance, hyperlipidemia, increased coagulation factors, 

upregulation of the inflammatory cascade, and increased white blood cells. Most women 

tolerate these changes with no problems, but others develop diseases such as GDM and 

venous thromboembolism. 

Caron Zlotnick, Ph.D. 

Director of Behavioral Medicine Research, Women &Infants Hospital, The Warren Alpert Medical 

School of Brown University 

Dr. Zlotnick discussed what is currently known about perinatal depression and future research 

directions. Depression is a lifelong recurrent disorder, and females have twice the risk of being diagnosed with depression as do males. Depression during the perinatal period, defined 

as pregnancy and postpartum, raises a number of special issues. Some women have increased 

vulnerability to new-onset or recurrent depression at this time. Perinatal depression also raises unique treatment issues. Studies of antidepressant exposure in pregnancy have suggested 

increased risk for poorer infant outcomes, but medication discontinuation is also associated 

with higher rates of maternal depression relapse. Maternal perinatal stress has been associated with poorer offspring outcomes, impaired mother-infant bonding, and later child behavioral 

problems. Many women indicate a preference for psychosocial interventions for perinatal depression, but few such interventions, tailored to their special issues, are currently available. 

SPECIAL POPULATIONS 

Wendy R. Brewster, M.D., Ph.D. 

Professor, Gynecologic Oncology, University of North Carolina 

Dr. Brewster’s presentation focused on health disparities in cancer. As the population ages, 

cancer rates are expected to increase proportionately. Because women on average live longer than men, cancer will increasingly become a woman’s health issue. The elderly are 

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underrepresented in cancer clinical trials due to the presence of complicating medical comorbidities. To more adequately address geriatric cancer and its treatment, geriatric and cancer 

clinical researchers need to develop strong interdisciplinary, collaborative models of training, 

research, and care. Health disparities in cancer exist among different populations of women, as 

is the case for breast cancer. This type of cancer is more prevalent in White women, but causes 

higher mortality in Black women. Recent research indicates that the mortality disparity may 

persist even when screening and treatment are comparable for both groups of women. New 

research aimed at understanding this disparity is currently also examining the role of factors 

related to tumor biology in the disproportionate occurrence of an aggressive, early-onset 

form of breast cancer in Black women. 

Bess H. Marcus, Ph.D. 

Professor, Department of Community Health and Department of Psychiatry and Human Behavior, 

Brown University 

Dr. Marcus discussed the numerous gender differences that have been identified in addiction 

prevalence, course, relapse risk, and treatment. Males are more likely to smoke, drink, and use 

drugs than are females, but trends indicate that the gender gap may be closing. Dependence 

on a substance, once use has started, is greater for females than males. “Telescoping” of the 

course of addiction occurs in females, who begin regularly self-administering substances at 

lower doses than males, become addicted faster, and enter treatment after fewer years of use. 

Females are at greater risk for relapse following abstinence, and their risk factors are different 

than those of males. For example, concern over weight gain is a major cause of relapse from 

smoking cessation in women. In a Commit to Quit smoking cessation trial specifically tailored 

to women smokers, participants were randomized either to an intervention of cognitive behavior therapy (CBT) to address weight gain concerns along with vigorous exercise or to CBT with 

control staff time. Those in the CBT and exercise arm had twice the quit rate as the CBT group 

alone. Those who exercised gained 6 pounds versus 12 pounds in the other group. Attention to 

gender differences in risk factors and concerns can affect substance abuse treatment outcomes. 

LIFESPAN IMPLICATIONS OF THE IN UTERO ENVIRONMENT: 

BEYOND THE BARKER HYPOTHESIS 

James Padbury, M.D. 

Professor of Pediatrics, The Warren Alpert Medical School of Brown University 

Carmen Marsit, Ph.D. 

Assistant Professor, Pathology and Laboratory Medicine, The Warren Alpert Medical School of 

Brown University 

Barry Lester, Ph.D. 

Professor of Psychiatry and Pediatrics 

Center for the Study of Children at Risk, Women & Infants Hospital of Rhode Island, 

The Warren Alpert Medical School of Brown University 

The Barker hypothesis is a theory that links disturbed intrauterine growth to the later development of cardiovascular disease. The original hypothesis was based on epidemiological 

findings that low-birth-weight offspring, whose mothers were severely malnourished during 

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the third trimester, had increased risk as adults for cardiovascular disease. This nutritionaladaptation hypothesis has been expanded to explain increased risk in adult life for a range 

of cardiovascular system outcomes such as diabetes, hypertension, and hypercholesterolemia. 

A more general extension of the hypothesis—to include other environmental stresses in utero—has also gained scientific currency. A plenary presentation provided evidence to support 

the conceptualization of maternal cocaine use during a critical period in fetal development as 

a stressor that downregulates the placental norepinephrine transporter system (NET). In this 

model, cocaine exposure in utero triggers a chain of events, leading from increased fetal exposure to catecholamines and altered fetal neuroendocrine activity to changes in the epigenetic 

expression of key genes. Changes in epigenetic programming provide the developmental link 

between prenatal risk exposure and later behavioral outcomes: activity rhythm dysregulation 

in infancy; poor inhibitory control and emotion regulation in childhood; and behavioral phenotypes that confer vulnerability to substance use in adolescence. 

CHARGE TO THE WORKING GROUPS 

Dr. Vivian M. Pinn delivered the charge to the working groups. Women’s health research, she 

emphasized, must be comprehensive and must include the entire spectrum of research activities, from basic science to community dissemination. She noted that women’s health research 

is an inherently interdisciplinary endeavor; those who would undertake it must bring to bear 

perspectives such as lifespan, sex/gender determinants, and health disparities and diversity. In 

her concluding remarks, she urged participants to think outside their disciplinary silos and to 

move beyond their current research or advocacy agendas to anticipate and envision the next 

generation of women’s health research. 

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SCIENTIFIC WORKING AND DISCUSSION GROUPS 

PRENATAL, INFANCY, AND CHILDHOOD YEARS 

Cochairs: 

Melissa Jo Kottke, M.D., M.P.H.
�

Emory University 

Louise Wilkins-Haug, M.D., Ph.D. 

Brigham and Women’s Hospital 

NIH Cochair: 

Gilman Grave, M.D. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers:
�

Suzanne M. de la Monte, M.D., M.P.H.
�

The Warren Alpert Medical School of Brown University 

Fusun Gundogan, M.D. 

The Warren Alpert Medical School of Brown University 

Introduction 

The Working Group on Prenatal, Infancy, and Childhood Years identified four main topics for 

forward-looking research. Obstetric care represents a critical window of health care during the 

reproductive lifespan of women. Four topics were chosen because they represented situations 

or conditions occurring during pregnancy that have far-reaching effects on the developing 

child. The four topics chosen were 1) the molecular basis for developmental origins of health 

and disease—childhood onset; 2) the placenta as a functional endocrine and transport organ; 

3) prenatal exposures to environmental toxins, inflammatory cytokines, drugs, and socioeconomic stressors; and 4) fetal therapy. 

Summary of the Discussion 

Molecular Basis for Developmental Origins of Health and Disease— 

Childhood Onset 

The important concept known as fetal programming emphasizes that the intrauterine environment and the mother’s prenatal exposures and experiences can have long-term effects on the 

health of the offspring. For example, epidemiologic studies show that aberrant fetal growth 

rate is a major risk factor for later development of chronic diseases such as coronary artery 

disease, stroke, type 2 diabetes mellitus, and hypertension. However, the etiologic factors for 

these relationships are not known.1

 In addition, these and other chronic diseases are more 

prevalent among minority races than Whites and among males than females. 

Further analyses are needed of a broad range of prenatal conditions and stresses that could 

have long-term consequences on health and disease. Existing examples include the following: 

• Gender differences in susceptibility to low birthweight as well as myocardial infarction. 

• Impaired thyroid hormone function and brain development. 

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• Prenatal caffeine exposure, growth rates in preterm infants, and increased body fat later 

in life. 

The underlying mechanisms are likely to be multifactorial and will require interdisciplinary 

approaches, including molecular studies to identify biomarkers. The identification of the developmental and molecular bases of sexual dimorphism should be included in this research. 

Specific Examples of Fetal Programming Research 

Roles of Insulin Resistance in the Pathogenesis of Obesity. One working hypothesis for fetal programming is that stressors and environmental toxins promote insulin resistance, which 

changes gene expression due to DNA methylation and alters protein expression in the brain. 

For unknown reasons, these factors contribute to chronic diseases during adulthood and likely contribute to disorders of childhood, including obesity. Research is needed to examine how 

the prenatal brain is influenced by differential gene expression. Equally important is an assessment of how differential gene expression occurs and is triggered. Molecular and biochemical 

approaches should be used. Novel methods are needed to detect early exposures and to track 

their later effects and identify individuals at risk. For example, the cause of the childhood obesity epidemic may be multifactorial, and consideration should be given to the pathogenic roles 

of maternal hyperglycemia, maternal weight gain, alcohol misuse, infant feeding practices 

(breastfeeding), and the effect of prematurity on the infant’s weight gain early in the postnatal 

period. This approach could lead to the development of public health measures to prevent 

exposures in the future and has global relevance. 

One study has shown strong associations between maternal plasma glucose levels (at lower 

levels than the standard criteria for a diagnosis of diabetes) and increased birthweight and increased cord blood serum C-peptide levels.2

 These findings indicate that research is needed to 

better identify mothers and fetuses at risk of becoming overweight newborns and the factors 

contributing to these problems. 

Hypothalamic-Pituitary-Adrenal (HPA) Axis Overdrive. Fetal adaptation to stress in utero is an 

important concept. The cause of intrauterine stress is probably multifactorial and cumulative. 

Stress pushes the HPA axis into overdrive, causing excess production and release of cortisol 

by the adrenal glands. Then, in the context of later exposure to obesogenic diets, the primed 

individuals gain weight rapidly and develop insulin resistance and type 2 diabetes mellitus 

in their teenage years or early 20s.3

 Importantly, rapid weight gain during the first 2 years of 

life increases the rates of myocardial infarction many years later. However, the specific role of 

the adrenal glands was put in doubt by the finding that loss of both adrenal glands does not 

modify mortality from cardiovascular disease. Remaining to be investigated, however, is the 

common thread of altered fetal programming with obesity and chronic disease risk as a result. 

Innovative methods are needed for assessing allostatic load and critical window exposures 

and stressors that go beyond the HPA axis in relation to effects on childhood, adult, and gender-biased diseases. Attention should be focused on growth and sexual dimorphisms, mood 

disorders, depression and appetite regulators, and addictive disorders. Racial disparities are 

quite critical because, controlling for socioeconomic status and education, race remains a key 

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risk factor for low birthweight and infant mortality. In this regard, it could be postulated that 

allostatic load more effectively activates the HPA axis, leading to stress responses that are 

more sustained in Blacks than in Whites. This would constitute a greater degree of preterm 

stress and could contribute to preterm delivery and low birthweight. 

Finally, other conditions and exposures during pregnancy likely will be found to influence fetal 

programming with effects on childhood neurodevelopmental disorders, autoimmune diseases, 

inflammatory disorders, addictive disorders, and precocious puberty. Research should be directed toward basic science approaches as well as mechanisms for translating research into clinical 

practice. This effort will require services beyond those provided by physicians, particularly given the prevalence of diabetes and obesity. Health care extenders such as nurse practitioners 

and physician’s assistants could provide care, management, and followup of patients with 

obesity, type 2 diabetes, and related or secondary diseases during pregnancy and the interconception windows. 

Placenta as a Functional Endocrine and Transport Organ 

The vital role the placenta plays in the health of the fetus, and how impairments in its structure 

and function may facilitate fetal exposure to drugs, stressors, toxins, etc., are largely unknown, 

despite clear evidence that significant abnormalities in placental structure and function are 

associated with intrauterine growth restriction. An overarching concept for enabling studies of placental functions is the establishment of a placental biobank. It would make possible a 

systematic collection of data and sharing of reagents and data among multiple investigators, 

including globally. Besides placentas, biobanked specimens should include umbilical cord 

blood, amniotic fluid, meconium, DNA, and RNA. In terms of extending the investigations to 

clinical outcomes in children, adolescents, and adults, breast milk could serve as a vehicle for 

perinatal exposure to drugs, toxins, inflammatory mediators, and other substances. 

Establishing a placental biobank would facilitate large-scale investigations that could perform 

the following: 

• Lead to the identification of novel biomarkers of individuals at risk for becoming obese 

and developing significant and life-threatening cardiovascular, cerebrovascular, hypertensive, arteriosclerotic small-vessel disease, and type 2 diabetes mellitus later in life. 

• Examine the effects of toxin, microbial, and drug exposures on development, behavior, 

and diseases, including obesity and type 2 diabetes. 

• Investigate the mechanisms of placental transport of nutrients and drugs on molecular, 

biochemical, and functional levels. 

• Track the effects of early prenatal exposures leading to epigenetic changes that have 

long-term consequences for health and disease. 

• Determine drug (licit and illicit) effects on the fetus, child, and mother, and for examining 

transporter physiology or pathophysiology. 

• Create models for studying multiple drug/toxin exposures on the fetus, newborn, mother, 

and child, as well as gender effects. 

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New technologies are needed to access placental function from maternal circulation. Free fetal 

nucleic acids circulating in maternal blood could be used to track health status, detect disease, 

and monitor effects of treatment. We already know that more than 100 genes are turned on or 

off based on their parent of origin, the imprinted genes; however, we have not yet constructed 

profiles of gene expression that correlate with healthy and disease states. Future studies should 

include the development and analyses of biomarkers, substrate and drug transport studies, and 

epigenetics and imprinting during critical windows. Apart from gene expression studies, proteomics should be used as complementary approaches, particularly because proteins are the 

ultimate mediators of cell signaling and function. 

A very exciting and strategically important area of research will be to understand how shifts in 

gene expression early in life have lifelong consequences on health and disease. Mechanistically, 

a process known as “gene imprinting” occurs when genomic DNA gets methylated, resulting in 

lifelong silencing of gene expression. Examining patterns of DNA methylation in placenta, fetus, and offspring during different stages of development or critical windows could advance 

the understanding of molecular mechanisms of disease proneness, and thereby explain unexpected correlations such as the overlapping prevalence rates of low birthweight/small for 

gestational age and subsequent increased risk for cardiovascular death. This concept could 

be relevant to many adult diseases that have familial, but no apparent genetic, linkages. Factors influencing DNA methylation in utero most likely include stresses from various sources, 

including nutrient deficiencies, insulin resistance, poverty, violence, drug exposures, poor living 

conditions, and numerous unknowns. Consideration must also be given to modifiers that serve 

as “second” or “third” hits in propagating disease proneness. For example, prenatal stress 

combined with obesogenic and nutrient-deficient diets may play a large role in the growing 

pandemic of insulin-resistance diseases, including obesity, type 2 diabetes, and secondary 

effects that include cardiovascular disease. Therefore, this concept has global relevance. 

Other concepts were raised. Dynamic models are needed to study placental function and 

drug/toxin transport. Rodent models have limited use, and subhuman primate models are 

generally unacceptable. Instead, the working group proposed that safe and well-controlled 

obstetrical-pharmacological centers be established for studying drug delivery, nutrients, and 

toxins across the placenta. Perhaps an artificial placenta could be developed and used for 

similar investigations, or perhaps to help sustain normal growth and development of atrisk fetuses. 

Prenatal Exposures 

Environmental toxins, inflammatory cytokines, drugs, and socioeconomic stressors influence 

fetal neurodevelopment and can adversely affect later-life function and biobehavioral diseases, 

as in the following examples. 

Toxins 

• Maternal, fetal, and early childhood exposures to toxins such as Bisphenol A and 

phthalates, which contaminate plastics, may lead to obesity because of their 

endocrine-disrupting effects. 

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• DDT exposure affects girls under age 13 by predisposing them to develop aggressive 

forms of breast cancer later in life. Because this relationship does not occur in older 

girls, understanding exposures within and outside of critical windows of development 

is important. 

• Puberty is occurring earlier, particularly in girls; this trend began 20 to 30 years ago, 

along with the obesity/type 2 diabetes/insulin resistance epidemic. Is this phenomenon related to gene imprinting or differential silencing/activation of certain genes 

during prenatal development? We know that more than 500 genes are differentially 

expressed by gender. The effects of environmental toxins that could influence the 

estrogen-receptor activity or cause endocrine disruption have not been investigated. 

How do early exposures to toxins and endocrine disruptions result in changes in 

gene expression and function that predispose girls to undergo early puberty? 

Inflammation 

• Inflammation and cytokine activation mediate or contribute to many diseases, including 

intrauterine growth restriction, preeclampsia, and preterm delivery. 

• Placental inflammation during the first trimester of pregnancy has been reported to 

increase the rate of schizophrenia, and IL6 has been implicated. 

• An important avenue of research is to understand how inflammatory mediators influence 

in utero brain development and function, and predispose the offspring to develop neurobiological and behavioral diseases during adolescence and early adulthood. Do in utero 

inflammatory mediators alter critical genes responsible for neuropsychiatric function? 

Drugs 

• Development of novel biomarkers that detect drug exposures and the effects on the 

placenta, fetus, and child would lead to an understanding of how drugs change the 

developing organism. 

• Tools are needed to identify mothers at risk for using addictive drugs during pregnancy that could result in physical, neurological, psychiatric, developmental, or behavioral 

abnormalities in the offspring. In addition, tools should be developed for assessing morbidity associated with addictive drug exposure and withdrawal in both mother and child. 

• Many policies associated with detecting addictive drugs have punitive consequences 

with respect to maternal-child relationships. The policies across different States should 

be examined and the data used to restructure the paradigms for managing and treating 

mothers at risk. 

• An additional line of investigation would be to examine the long-term effects of perinatal 

addiction, and to identify social determinants, access to treatment, and methods of translating the results into clinical practice. For example, assessing the effects of exposure to 

addictive drugs on patterns of child abuse, maternal stress, parenting difficulties, depression, smoking, and differential gender responses in the children are important goals. 

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Socioeconomic Stressors 

• Antenatal and postpartum stress can also adversely affect childhood development, and 

persistent maternal stress interferes with and adversely affects parenting. Ample animal 

research shows that poor parenting has epigenetic effects on development. Maternal 

stress from the antenatal period to childhood results in significant development of childhood stress, thereby creating a closed circuit. Biomarkers and psychosocial markers of 

different types of stress are needed to detect and intervene in this cycle. 

• Stress caused by racism, depression, and social determinants, such as poor housing, 

food insecurity, and family status, could represent chronic exposures that influence 

pregnancy outcomes and the health and welfare of the offspring. In the Adverse Childhood Experiences Study, which included 19,000 self-report questionnaires, it was found 

that long-term outcomes from chronic exposure to stressors were dose dependent and 

had stepped effects.4 This retrospective study demonstrated relationships between 

long-term health effects and a series of adverse events, including smoking, substance 

abuse, obesity, chronic obstructive pulmonary disease, liver problems, mental health, 

suicide, sexually transmitted diseases, and teenage pregnancy. Higher proportions of 

heart disease and other conditions could be explained by cumulative adverse events 

that primarily center on violence. 

No one factor or exposure could be responsible for the subsequent development of complex 

syndromes. For example, the pathogenesis of neurodevelopmental diseases, such as autism, 

should be considered in relation to adverse event stress, as well as stress caused by agent exposures, including toxins, environmental substances (e.g., mold, bugs, lead, licit and illicit drugs), 

addictive drugs, herbals, nutrients, and supplements. Autism has a large sex dimorphism that 

may correlate with high testosterone levels, raising the question as to whether hyperandrogenized brains or congenital adrenal hyperplasia predispose infants to become autistic. The 

potential role of endocrine-mediated neurobiobehavioral syndromes is reinforced by the fact 

that individuals with Cushing’s disease have increased rates of neuropsychiatric disorders. 

Thus, a systems approach to data analysis with consideration of multiple potential causes of 

stress in pregnant women and their fetuses will be required. Research should address the impact of cumulative adverse events, timing (critical window), thresholds, and interactions with 

addictive drug exposures on pregnancy and later life health, and track their effects with respect 

to age, gender, and race. Due to its complexity, the research will likely have to be interdisciplinary and use mathematical models such as the Granger causality analysis to pinpoint causality. It 

is unlikely that we will ever be able to isolate independent variables to determine how each one 

impacts pregnancy, fetal development, and later life disease profiles. 

Another consideration for research is to design approaches for therapeutic intervention and 

prevention. Longitudinal studies should examine outcomes with respect to interconception 

reduction of allostatic stress load, and through improved monitoring and detection of at-risk individuals. The expectation is that these measures will help prevent generational drug and other 

substance abuse that stem from maternal and/or fetal stress. Design of preventive and therapeutic intervention measures should use collaborative efforts across various centers, such as 

medical, obstetric, psychiatric, and public health. Use of teams and community health workers to 

143
improve outcomes will be important for overall outcomes. The study designs should be interdisciplinary and include agendas that cross various disciplines (e.g., medical obstetric, psychiatric, 

and public health) to promote the health of communities beyond hospitals and health centers. 

In addition, public-private partnerships need to be developed to encourage communities to 

remain committed to the overall goals. 

Fetal Therapy 

Today, fetal therapy is considered niche medicine and is not a public health priority. However, as 

the approaches are increasingly less invasive and with fewer maternal and fetal complications, 

the concept is growing in importance. Moreover, in utero repair of a few congenital defects has 

become a clinical reality. 

One disease that can be successfully treated is fetal aortic stenosis, which in severe cases leads 

to hypoplastic left heart syndrome. Alleviating aortic stenosis early in gestation can prevent 

the subsequent development of hypoplastic left heart syndrome in some, but not all, fetuses. 

The pathogenesis of fetal aortic stenosis is not understood, but the 90 percent male occurrence rate may provide a clue. 

Advancing the field of fetal therapy requires a better understanding of the pathophysiological basis of the conditions that potentially could be treated, for example, twin-twin transfusion 

syndrome. Currently, fetal surgery is used to treat this condition. However, little is understood 

about the mechanism of the condition, though it is known that virtually the same vascular 

connections exist between identical twins who do not develop the syndrome. 

The explosion in the past decade in the number of treatment centers providing fetal surgical 

approaches around the world is worrisome because guidelines for treatment have not been established; there is no credentialing of practitioners and no oversight. Efforts should be made to 

address these issues and help elevate these procedures to evidence-based therapies. Considerations for clinical trials include whether control and sham procedures should be performed in 

determining the effectiveness of various fetal surgical approaches. The rationale for conducting 

controlled trials is the need to prioritize which procedures are effective and therefore worthwhile, and which, based on outcomes, should not continue. 

The ever-growing access to fetuses via imaging, analysis of amniotic fluid, cells, fetal tissues, 

blood, and physiology has begun to inform the science about abnormal development and how 

to deal with diseases prior to birth. The changing field of ultrasound lends itself to earlier diagnosis and potential for early intervention. Major benefits from the improved access to fetuses for 

diagnostics include disease prevention by treating a condition that has secondary consequences 

on later organ development and function. In addition, better imaging and tissue analysis of fetuses will provide the opportunity to gain a better understanding about sex differences in fetal 

diseases requiring surgical or nonsurgical therapy. 

To take advantage of these recent technologies in research applications, establishing a fetal 

therapy network is critical. This network, if modeled similar to the MFMU (Maternal Fetal Medicine Unit Network funded by the Eunice Kennedy Shriver National Institute of Child Health and 

144
Human Development), would enable sharing of resources (materials, tissues, ideas) and provide 

much-needed guidelines, criteria, and benchmarks, and stimulate collaborative research about 

disease mechanisms. A fetal therapy network would make it feasible to study dysmorphologies 

that are rare in any one institution or setting. Both surgical and nonsurgical treatments could be 

used to treat otherwise fatal or debilitating conditions such as diaphragmatic hernia, hemaglobinopathies, cystic fibrosis, and possibly TORCH (toxoplasmosis, other, rubella, cytomegalovirus, 

herpes simplex virus) infections. Gene or stem cell therapeutic approaches could lead to prenatal prevention of sickle cell disease or thalassemia. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Investigate the molecular basis for developmental origins of child-onset 

health and disease. Research should focus on the molecular alterations during pregnancy that 

underlie the fetal programming that informs childhood development and growth. Because 

childhood obesity is epidemic and global, it should be a priority for research. 

• Advance research at a molecular level starting with existing avenues of epidemiologic research, which include maternal hyperglycemia, insulin resistance, maternal weight 

gain, maternal obesity, infant feeding practices, and infant weight gain, especially in 

premature infants. 

• Further expand the research of fetal programming and the molecular mechanisms of 

disease by supporting investigation of neurodevelopmental disorders, autoimmune diseases, inflammatory disorders, addictive disorders, precocious puberty, and diseases 

that have a sexually dimorphic phenotype. 

Recommendation 2: Support research of the placenta as a functional endocrine and transport 

organ. Establish an interdisciplinary placental biospecimen banking mechanism to enhance 

research on antenatal antecedents to childhood health with a focus on the following: 

• Functional studies 

• Biomarker development 

• Substrate and drug transport 

• Epigenetics and imprinting during critical windows 

• Development of technologies to access placental function from the maternal circulation, 

for example, free fetal nucleic acid 

• Innovations toward development of an artificial placenta 

Recommendation 3: Examine a range of prenatal exposures (addictive drugs, environmental 

toxins, stressors, nutrient intake) and their relationship to preterm delivery/low birthweight. 

Multidisciplinary approaches in clinical and translational research are needed to address the 

wide range of agents that could affect birth outcomes. The following is a brief, and not conclusive, list of potential exposures to be evaluated: 

• Appraise the birth outcomes of licit or illicit addictive drugs. 

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• Develop innovative approaches/biomarkers for identifying exposures and effects. 

• Expand screening efforts to move from research to practice. 

• Evaluate the effect of multiple drugs and toxins (polydrug exposure) during critical windows of development. 

• Propose and evaluate the effects of interconception substance abuse interventions. 

• Perform comprehensive research on effects and measurements of antenatal and postpartum stressors and their impacts on parenting and child development by gender. 

• Evaluate other prenatal exposures (e.g., environmental toxins, prescription drugs, 

over-the-counter drugs, herbs, and nutrients) and their relationship to birth outcomes. 

Recommendation 4: Create and support a national multicenter network for fetal therapy and 

for translational research that brings together the basic science and clinical disciplines. Incorporate stem cell and gene therapy into the network’s areas of study and treatment. Minimally 

invasive fetal therapies that will allow for antenatal treatment have become a reality and there 

is a need to share limited resources and expertise, minimize duplication, and use scientific approaches. 

References 

1 Barker, D. J., Osmond, C., Kajantie, E., & Eriksson, J. G. (2009). Growth and chronic 

disease: Findings in the Helsinki Birth Cohort. Annals of Human Biology, 36, 445–458. 

2 Landon, M. B., Spong, C. Y., Thom, E., Carpenter, M. W., Ramin, S. M., Casey, B., . . . 

Anderson, G. B.; Eunice Kennedy Shriver National Institute of Child Health and Human 

Development Maternal-Fetal Medicine Units Network. (2009). A multicenter, randomized trial of treatment for mild gestational diabetes. New England Journal of Medicine, 

361, 1339–1348. 

3 Bose, M., Olivan, B., & Laferrere, B. (2009). Stress and obesity: The role of the 

hypothalamic-pituitary-adrenal axis in metabolic disease. Current Opinion in Endocrinology, Diabetes, and Obesity, 16(5), 340-346. 

4 Dube, S. R., Felitti, V. J., Dong, M., Giles, W. H., & Anda, R. F. (2003). The impact of 

adverse childhood experiences on health problems: Evidence from four birth cohorts 

dating back to 1900. Preventive Medicine, 37, 268–277. 

ADOLESCENT YEARS 

Cochairs:
�

Sandra Carson, M.D.
�

The Warren Alpert Medical School of Brown University, 

Women & Infants Hospital of Rhode Island 

Michelle Berlin, M.D., M.P.H. 

Oregon Health Services University 

146
NIH Cochair: 

Christine Bachrach, Ph.D.
�

Office of Behavioral and Social Sciences Research 

Science Writers:
�

Rebecca H. Allen, M.D, M.P.H.
�

The Warren Alpert Medical School of Brown University 

Marybeth Sutter 

Brown University 

Introduction 

The Working Group on Adolescent Years addressed research priorities among adolescents and 

young adults, ages 10 to 24 years. Following an overview of the demographic characteristics 

of the U.S. adolescent population and the major causes of morbidity and mortality in this age 

group, each working group participant contributed ideas about the status of current research 

and innovative ideas for the future. After a discussion of these ideas, the working group 

generated a list of recommendations for future research. 

Summary of the Discussion 

Current data about health characteristics of adolescents and young adults in the United States 

include the following:1 

• In 2006, there were 63.3 million adolescents and young adults, with 55.2 percent White, 

16.5 percent Hispanic, 13.6 percent Black, 3.9 percent Asian/Pacific Islander, 0.9 percent 

American Indian/Alaskan Native, and 9.9 percent other. Ten percent were immigrants or 

foreign born. 

• Much of the morbidity in adolescence and young adulthood stems from behaviors rather 

than intrinsic disease. 

• Nearly 5 percent of young adults have a disabling chronic condition. 

• In 2005, about 7 in 10 deaths among persons ages 10 to 24 were caused by motor 

vehicle accidents, homicide, and suicide. 

• Unintentional deaths and violence impact non-White males disproportionately. Depression is the highest reported psychiatric disorder among teens, with the highest rates 

among Hispanic females, and suicide attempts are higher for girls than for boys. 

• Rates of substance use are decreasing for binge drinking and daily cigarette use, including smoking half a pack; however, small increases in marijuana use and changes in “drugs 

of choice” have occurred, with more use of prescription drugs. 

• Recently, adolescent and young adult birth rates have slightly increased. 

• Sexually transmitted infections continue to increase and disproportionately affect 

Black females. 

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• Rates of overweight and obese adolescents nearly doubled from the mid-1990s to the 

mid-2000s. Rates of exercise and rates of fruit and vegetable consumption have not 

changed, however. 

• Most females enter the health care system for reproductive health services. Males are 

seen more often in the emergency department. 

• Although most adolescents and young adults saw a clinician and dentist in the past 

year, only 40 percent of adolescents have time alone with a provider. 

More knowledge is needed about adolescent development in normal, healthy teenagers. Despite 

disadvantaged circumstances, some adolescents in every community are successful, but others 

fall into risk-taking behaviors. The working group discussed the following topics as candidates 

for research in order to elucidate protective factors that contribute to healthy behaviors and 

improve asset building* among adolescents: 

• Breastfeeding by adolescent mothers 

• First and repeat teen pregnancy 

• Access to contraception and family planning 

• Postpartum depression 

• Eating disorders 

• Substance abuse, particularly tobacco and alcohol use 

• Inadequate physical activity 

• Adequate nutrition 

• Intimate partner violence 

Participants said they believed little is understood about how culture and community influence 

the psychosocial development of adolescents in areas that include the following: 

• Gender identity, roles, and formation 

• Trends in sexuality among adolescents and young adults, including members of the 

lesbian, gay, bisexual, and transgender communities 

• Early puberty transition and its role in risk-taking behaviors 

• The changing structure of immigrant families and its role in gender formation 

• International differences in gender formation and roles 

Further understanding is needed on how the transition into and out of adolescence affects existing chronic disease, onset of new disease, and treatment. Areas of research might include 

the following: 

• Adaptation of adolescents with chronic diseases across key life transitions, including 

changes in the clinical manifestations and treatment of asthma, allergies, and diabetes 

• How the transition into adolescence will affect individuals with genetic and congenital 

disorders, such as children with autism 

* Developmental assets are the positive relationships, opportunities, values, and skills. 

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• Chronic diseases that first appear in adolescence, including autoimmune diseases, vulvar 

diseases, and chronic pain disorders 

• Identification of diseases that are at a crucial period for intervention in adolescence, 

including obesity and mental health disorders 

• Additionally, research on the effects of pharmaceuticals and of biological states on 

adolescents is important, including the following: 

• Comparative analysis of the long-term effects of different contraceptive methods 

used by adolescents 

• The long-term effects of teen pregnancy on health and disease 

• The impact of adolescent breastfeeding on future health outcomes 

• The effect of environmental stressors on the adolescent’s biological and psychological 

health and well-being 

Emerging genetic tools and other diagnostic tools may also be useful for studying adolescents’ 

health. For example, adolescents’ heightened addiction to tobacco has been documented 

through magnetic resonance imaging. 

The working group acknowledged the need for translational research that will affect the 

community in a significant way. To reach adolescents, new strategies must be used to foster bidirectional communication between adolescents and their communities. One approach might 

be to incorporate adolescents in participatory research and peer education, including possibly 

forming a “Teen Advisory Board” that would keep up with the most current health trends. Adolescents could also play a role in identifying research questions that reflect emerging issues 

of concern to them and their peers, and, with appropriate training, supervision, and support, 

adolescents could have a role in data collection, data analyses, and presentation of results to 

community stakeholders, including policymakers and peers. 

Research to improve the delivery of health care services to adolescents and young adults 

is a priority. Current delivery models have substantial gaps in terms of prevention, screening, 

referral, and early intervention with behaviors. These gaps often place these populations at 

increased risk for current and future negative outcomes. Research could determine the best 

methods to improve the adoption of new guidelines and provider adherence to guidelines, especially concerning cervical cancer screening, colposcopy, and human papilloma virus (HPV) 

vaccine distribution. Academic detailing, or face-to-face education of providers by providers 

using evidence-based information, is one method that needs further research. 

Uninsured adolescents and young adults probably do not receive the care they need. They, 

as well as the insured, might best be served through access to a stable “medical home” that 

would have a multidisciplinary team of providers and could be in an ideal setting, such as 

school-based or community-based clinics. The medical home should offer strong counseling 

and education components, especially teaching that is aimed at reducing the stigma 

surrounding reproductive health. 

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A potentially important tool for influencing adolescent behavior is social marketing through 

new media technologies, including Twitter, Facebook, text messaging, video games, etc. These 

technologies could be used to generate educational programs and support for healthy behaviors, such as adolescent male involvement in family planning and parenting, as well as new 

campaigns for smoking cessation and increased compliance with medications. 

The following overarching themes should be incorporated into all future research projects: 

• Inclusion of all groups that are underserved and impacted by health disparities, including 

different ethnic and cultural groups; immigrants; individuals with special needs; members 

of the lesbian, bisexual, gay, and transgender communities; and parenting teens 

• Consideration of the impact of health policies on adolescents and young adults 

• Use of a variety of research methodologies, including community-based participatory 

research and comparative effectiveness research 

• Interrelationships of the adolescent with family, school, community, and social environments and the bidirectional impact of each on adolescent health, safety, and well-being 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: As a basis for developing interventions to empower adolescents to engage in health-promoting behaviors that make them resilient, 1) identify protective factors 

in individuals and the environment that promote and sustain healthy behaviors across cultural 

groups; 2) describe gender formation, identity, and roles from cultural, societal, and biological 

viewpoints; and 3) identify factors that improve asset building among adolescents. 

Recommendation 2: To understand how the transitions from childhood to adolescence and 

adolescence to young adulthood affect normal function, disease, and treatment, 1) conduct 

comparative research on a variety of issues, including the long-term health effects of pregnancy, 

different contraceptive methods, various models designed to reduce body mass index and increase physical activity, various HIV and sexually transmitted infection prevention models, etc.; 

and 2) increase the use of mixed methodologies, including community-based participatory 

research, when conducting research among adolescents. 

Recommendation 3: To improve diffusion and uptake of new knowledge by adolescents and 

their health care providers, 1) involve adolescents and groups of interdisciplinary providers 

(e.g., primary care providers in the “medical home,” other providers in other community-based 

settings) in not only conducting research/peer education, but also in developing communication channels for distributing new knowledge in ways that are more readily adopted by 

adolescents, their families, and providers; 2) examine the effectiveness of social marketing to 

influence adolescent behavior, including use of new technologies; and (3) conduct research 

on the uptake of new technologies, guidelines, and provider adherence, such as in the case 

of cervical cancer screening. 

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References 

1. Mulye, T. P., Park, M. J., Nelson, C. D., Adams, S. H., Irwin, C. E., & Brindis, C. D. (2009). 

Trends in adolescent and young adult health in the United States. Journal of Adolescent 

Health, 45, 8–24. 

REPRODUCTIVE AND MIDDLE YEARS 

Cochairs:
�

Robert Barbieri, M.D.
�

Harvard Medical School, Brigham and Women’s Hospital 

Cynthia Morton, Ph.D. 

Harvard Medical School, Brigham and Women’s Hospital 

Valerie C. Montgomery Rice, M.D. 

Meharry School of Medicine 

NIH Cochair:
�

Alan DeCherney, M.D.
�

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers:
�

Colleen Renee Kelly, M.D.
�

Women & Infants Hospital of Rhode Island 

Tanya Ratcliff, Ph.D. 

The Warren Alpert Medical School of Brown University 

Introduction 

The Working Group on Reproductive and Middle Years focused on three topics related to 

reproduction—infertility, fibroids, and endometriosis—because of their serious impact on women’s health during the reproductive years and the paucity of peer-reviewed research in these 

areas. Each cochair provided background information for the discussion and the development 

of recommendations by the group participants. 

Summary of the Discussion 

Infertility 

Infertility is defined as the inability to conceive a child after 1 year of trying (or 6 months for 

women over 35) or, in some cases, the inability to remain pregnant. According to the Centers for 

Disease Control and Prevention, about 10 percent of women ages 15–44 have difficulty becoming or remaining pregnant.1

 Causes of infertility in females include ovulation disorders, fallopian 

tube damage or blockage, uterine abnormalities, and hormonal or genetic factors. Other disorders, such as fibroids and obesity, may also contribute to infertility. Causes of infertility in males 

are impaired sperm count or motility, or impaired ability of the sperm to fertilize the egg. In 

some cases, a combination of factors may play a role. 

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State of the Current Basic and Clinical Sciences on Infertility 

Most infertility research studies focus on ovulatory disorders and on male factors. Major current NIH funding for infertility research is focused on fertility preservation research (in patients 

with cancer undergoing chemotherapy) and the role of adipose tissue. Significant gaps exist in 

current knowledge about the role of hormonal, genetic, and environmental factors, and of ovulatory dysfunction. For Black women, the high incidence of obesity and reproductive disorders, 

such as fibroids, might affect their ability to become pregnant. Many of these potential 

research areas have not yet been peer-reviewed or funded by the NIH. 

Regarding medical assistance for individuals with conditions of infertility and impaired fecundity, there are significant racial, financial, health, and social disparities. The literature shows 

that little demographic difference exists among those who seek medical care for infertility, 

but there are large differences among those who use care and receive treatment, and in the 

outcomes of pregnancies. For example, the racial disparities in outcomes for in vitro fertilization are unexplained. 

Opportunities for Advancing Basic and Clinical Sciences on Infertility 

The issue of prevention is key to the future of infertility research and includes primary, 

secondary, and tertiary strategies. 

Primary prevention should emphasize health education and promotion. Chlamydia affects 3 to 

5 percent of reproductive-age women and can result in infertility.2

 Because the disease is often 

asymptomatic, funds to increase community-based screening are important. Developing rapid “point of care” to test for sexually transmitted diseases (STDs) in high-risk populations (e.g., 

male and female prisoners) may be an important approach to increasing screening rates. Other 

areas for study include the following: 

• Brief interventions to modify and decrease risk-taking behavior 

• Determining the efficacy and feasibility of partner-notification programs 

• Development of a chlamydia vaccine 

• Identification and remedy of social and cultural barriers to primary prevention 

Communities should have access to education programs that are culturally specific in addressing 

preconception care. One goal of such programs would be to ensure that culturally sensitive information would be disseminated broadly enough to have an effect on behavior change. These 

education programs may help reduce infertility by providing health materials to educate women before they even consider having children (preconception counseling). These materials would 

include medical, psychological, and behavioral information about screening and interventions 

related to intimate partner violence. 

The foundation for these education programs should be community-based research that addresses how to most effectively influence behaviors related to modifiable causes of infertility 

(e.g., STDs, tobacco use, nutrition, and physical activity). In addition, further studies are needed on epigenetics and the impact of the environment and various exposures on fertility. 

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Secondary prevention strategies are interventions for the early detection and prevention of 

disease progression. Development of these approaches requires additional knowledge and 

new technology to study the mechanistic pathophysiology of infertility. Multiple processes may 

be related to reproductive endocrinopathy, including infectious, immunologic, and psychiatric elements. Research focused on vaginal physiology (the only female-specific mucosal site) is 

also important. 

Tertiary prevention involves reducing the negative impact of a disease. Research is needed 

to better identify biochemical and morphologic characteristics of oocytes and embryos that 

predict successful implantation and birth of a healthy child. Improving options for special populations (e.g., people with HIV, cancer survivors, those with genetic disorders) who seek assisted 

reproductive technology should be the focus of continued clinical research. Other areas for 

tertiary prevention research are as follows: 

• Chronic pelvic pain, which is common and has a major impact on fertility3 

• The mechanisms of chronic pelvic pain and improved therapies 

• The impact of infertility treatment on the future health of the mother and infant 

• Long-term sequelae of infertility treatment 

• Social and psychological issues related to infertility treatment, such as multiple births, 

adoption, and barriers to care 

Overall, treating the woman as a whole being is important, and such research should focus on 

evidence-based gender topics covering biological, environmental, psychological, behavioral, 

spiritual, and economic aspects of women’s health. 

Fibroids 

Uterine fibroids are the most common gynecologic neoplasm. Though benign, fibroids often 

result in symptoms such as pelvic pressure and pain, abnormal uterine bleeding, urinary difficulties, constipation, or infertility. Fibroids result in a decreased quality of life for women and 

are the leading diagnostic indication for hysterectomy in the United States. Currently, $2.1 billion is spent annually in the United States for treatment of uterine fibroids.4 Black women are 

at particular risk for symptomatic fibroid disease, with a three- to nine-fold increase in frequency and severity compared with non-Blacks. Effective alternatives to invasive treatment 

are few. 

State of the Current Basic and Clinical Sciences on Fibroids 

The pathogenesis of uterine fibroids is unknown. Prevalence data, twin studies, and familial aggregation studies indicate a genetic basis. Hormonal factors are also clearly involved; estrogen 

has long been known to stimulate growth of fibroids. How these hormonal factors result in the 

phenotype is unclear. Studies have shown that the growth rate of tumors is variable with variable response to gonadotropin-releasing hormone (GnRH) therapy. Genomewide association 

studies (GWAS) have provided a method to identify risk variants, and the future use of these 

risk variants in personalizing medical treatment, though unproven, is viewed with great optimism. Furthermore, although there are management steps to take now based on family history, 

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obtaining an accurate and complete family history of fibroids to optimize patient care is still not 

widely used in medical practice. 

Fibroids have traditionally been classified by location (intramural, submucosal, subserosal, 

cervical), though this method may not be optimal for predicting tumor behavior. A standardized classification system for fibroids (similar to the Bethesda system for reporting cervical or 

vaginal cytologic diagnoses) is being developed and should improve the biological basis for 

classifying uterine fibroids. This evidence-based system includes pathology, magnetic resonance imaging (MRI), and genetics. 

The Eunice Kennedy Shriver National Institute of Child Health and Human Development, in 

collaboration with ORWH, has established a national fibroid tissue bank.5

 Tissue samples are 

collected from women during fibroid surgery, including samples from patients with unusual 

variants of fibroid disease such as hereditary leiomyomatosis, renal cell carcinoma, and benign 

metastasizing leiomyomatosis. This repository of well-characterized, well-preserved leiomyoma 

tissues will provide investigators in basic and translational research on fibroids with the opportunity to study the condition. The tissue bank is anticipated to strengthen the science base, 

improve the understanding of how uterine fibroids develop and grow, and provide clues to 

more effective conservative management of fibroids. 

Though rare, malignant transformation of fibroids can occur. Mutations in the fumarate 

hydratase gene predispose to multiple cutaneous and uterine leiomyomatosis and renal cell carcinoma. Different histologic subtypes appear to predict different biological characteristics (e.g., 

size, growth rate, benign vs. malignant, perhaps bleeding, impact on fertility, etc.), but it is not 

known how often these various subtypes may progress to malignant counterparts. Disseminated peritoneal leiomyomatosis is a rare condition that has been reported after minimally invasive 

surgical treatment of fibroid disease. Though preference is increasing for these minimally 

invasive treatments, the frequency of these severe sequelae has not yet been determined. 

Opportunities for Advancing Basic and Clinical Sciences on Fibroids 

One hypothesis is that while most women develop uterine fibroids, a smaller number have 

symptoms or complications from them. There have been no long-term studies to follow women 

with fibroids from an early or asymptomatic stage to determine the frequency of various outcomes. A large cohort study of a high-risk population, ideally using MRI or ultrasound, would 

be useful in describing the natural history of this disease. Such a study would also help determine whether earlier intervention or treatment would improve outcomes. Early intervention 

and increasing access to health care are important issues in the current movement for health 

care reform. 

Large cohort studies are needed to assess environmental factors and to provide large datasets 

with phenotype and genotype information that would help identify risk alleles. Creation of a 

database would enable researchers to collect a large amount of patient information over time. 

These data would include family medical history and could incorporate biomarkers from urine 

or serum, which would be valuable in the search for a target to inhibit the growth of fibroids. 

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Widespread public participation in a fibroid database is crucial. Enrolling women in the database will require their trust. Contacting potential participants through primary care physicians 

and patient advocacy groups is one way to reach large numbers of women with fibroid disease. The Internet is another vehicle that could be used to contact large numbers of potential 

participants. A possible model is the “Army of Women,” an online resource for recruiting women to participate in breast cancer research. In this model, women interested in participating as 

research subjects may voluntarily enroll in a database. They may then be notified about clinical 

studies in which they are eligible to participate. Innovative incentives should be developed for 

women for participating in a national health database. 

The 1,000 Genomes Project is an international effort to produce a publicly available catalog 

of human genetic variation.6 The catalog can be used for association studies relating genetic 

variation to disease and could ultimately lead to use of a patient’s genome analysis for 

prediction of risk, diagnosis, and drug and dosage selections. 

Women with fibroid disease often experience symptoms, such as severe menorrhagia, which can 

be socially embarrassing and can limit their quality of life. The stigma of such medical conditions 

should be reversed through public education so that those afflicted will seek treatment. Increasing public health literacy about fibroids is important. The Internet can be a source of valid health 

data, and most patients would benefit from being directed to the best sources of online health 

information. NIH is in a unique position to be the “public face” of medicine. In that role, NIH 

could develop “information prescriptions” for health care providers to give to patients. The “prescriptions” would specify sources of trusted health care information (e.g., Medline Plus) to help 

patients better understand their conditions. Informing the public about the results of research 

funded by the NIH through materials written for the lay public (e.g., NIH Medline Plus magazine) 

would improve the public’s scientific literacy. 

Endometriosis 

Endometriosis is a condition in which endometrial-like cells appear and flourish outside of 

the uterine cavity. Endometriosis may cause significant dysmenorrhea, chronic pelvic pain, 

dyspareunia, and gastrointestinal and urinary symptoms, and may contribute to infertility. It 

is estrogen dependent and thus typically occurs during the reproductive years in 5 to 10 percent of women.7 While the exact cause of endometriosis is unknown, proposed theories for 

its development implicate multiple factors, including anatomic, genetic, and hormonal 

factors; the immune system; and the environment. 

State of the Current Basic and Clinical Sciences on Endometriosis 

Current understanding of the pathophysiology of endometriosis is limited. Twin and family studies suggest a genetic basis for endometriosis. Many more studies have looked at the 

role of the environment. In one animal model, stress exacerbated the development of endometriosis activity. Dioxins have been shown to disrupt the action of estrogen in reproductive 

tissues, resulting in progesterone resistance and the disruption of progesterone-mediated regulation of matrix metalloproteinase (MMP). Environmental phytoestrogens and xenoestrogens 

(e.g., genistein, bisphenol A) exhibit hormonal activity and may contribute to the development 

155
of endometriosis. Nuclear antioxidants can regulate the growth of endometrial cells and may 

have clinical potential in the medical management of endometriosis. 

Immunologic mechanisms and factors related to inflammation are also likely to be important to 

the pathophysiology of the disease. Current studies are examining loss of complement protective CD55 expression, which may contribute to increased MMP expression and promote the 

ability of endometrial fragments to rapidly invade the peritoneal surface, acquire vasculature, 

and establish the disease. An NIH-funded translational study is looking at the effect of the immunomodulator rosiglitazone on concentrations of peritoneal fluid cytokines in women 

with endometriosis; concurrent laboratory experiments to explore fetal DNA microchimerism 

as a cause for the chronic immune response seen with endometriosis may provide a novel 

pathophysiologic mechanism for the disease. 

Recently published studies of the in vivo analysis of the impact of the adoptive transfer of human immune cells into immunocompromised mice receiving autologous human endometrium 

suggests that a robust immune system is protective against development of the disease.8

 Ongoing studies of inflammatory factors such as CRP, IL-12, IL-6, sTNFR1, sTNFR2, and IR are also 

looking at mechanisms and potential diagnostic biomarkers and treatments. Another recent 

study showed that the inflammatory environment that occurs in the endometrium of patients 

with disease results in high tissue factor (TF) expression, which, in turn, signals via PAR-2 to 

further produce inflammatory cytokine or chemokine production and macrophage recruitment, 

suggesting that TF might be a target for therapeutic intervention.9 Inflammatory factors 

related to endometriosis may increase risk for some types of ovarian cancer. 

Complex hormonal factors play a role and are the focus of ongoing research. Aromatase, an 

estrogen-synthesizing enzyme, produced by the implants themselves, have provided evidence on why and how the disease persists after menopause. This research indicates that the 

endometriosis lesions can produce estrogen, creating a microenvironment conducive to their 

continued growth. Endometriosis has also been associated with reduced responsiveness to 

progesterone, which may be a factor contributing to endometriosis-associated infertility. 

The influence of exercise, obesity, and lactation on endogenous estrogen biosynthesis is 

another area of intense research. 

Improved technology and tools for noninvasive diagnosis are another focus of research: circulating biomarkers (CA-125, circulating antibodies), menstrual fluid biomarkers, advanced imaging 

techniques (such as ultrasound or MRI technology), and biologic probes. Treatment studies have 

recently examined norethindrone acetate as well as oral contraceptives vs. leuprolide. An oral 

GnRH antagonist is in Phase III trials. Also, hysterectomy is a potential treatment. 

Little is known about how to prevent endometriosis. Lactation may be protective, but the 

precise biologic mechanism for this is not known; therefore, additional studies are necessary. 

Opportunities for Advancing Basic and Clinical Sciences on Endometriosis 

Prevention of endometriosis should be an important goal for future research. Preventing the disease, however, depends on more knowledge about earlier detection. Epidemiologic studies of 

156
adolescents are needed in order to understand the natural history of the disease, identify risk 

factors, and determine optimal treatment approaches to clinical practice. Currently, the only way 

to reliably diagnose endometriosis is by laparoscopy. Identification of biomarkers (e.g., CA-125, 

genetic markers, or circulating antibodies) in the serum or menstrual fluid would make noninvasive diagnosis easier and potentially enable earlier detection. 

To facilitate basic research, repositories are needed that contain tissue specimens from women 

with endometriosis. A complete GWAS with a significant number of subjects to detect associations might reveal a unique target for the pathogenesis of endometriosis. Continued efforts 

to develop good animal models for endometriosis are also important. 

Not all endometriosis is symptomatic. Additionally, the amount of pain a woman feels is not 

necessarily related to the stage of endometriosis; there may be several disease processes involved in chronic pelvic pain. Continued efforts to investigate the mind-body link between pain 

syndromes are important. Studies that are designed to look specifically at the natural history of primary dysmenorrhea might also be valuable in this regard. There is significant overlap 

among chronic pain syndromes (e.g., pelvic pain, fibromyalgia, irritable bowel syndrome). Elucidating the connection of depression and a history of victimization or traumatic events with 

functional pain syndromes is an important issue to consider for basic and clinical research. 

Current antiprogestins have side effects and can cause endometrial growth. GnRH analogs 

are expensive, and long-term treatment has been shown to cause significant decreases in 

bone mineral density. Continued effort should be directed at developing other options for 

medical treatment. 

Many women with endometriosis suffer from autoimmune inflammatory diseases, hypothyroidism, fibromyalgia, chronic fatigue syndrome, allergies, and asthma. Further efforts should 

be directed toward finding a common underlying mechanism that influences the development 

of these conditions. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Create a prospective, longitudinal cohort study of adolescents and women to study factors that affect reproduction and wellness. The study should be designed with 

access to genetic, environmental, and psychosocial information and linkage to longitudinal 

medical records, including the following: 

• Physical exam 

• Family/medical/social history 

• History of victimization/traumatic events 

• Initial blood and urine samples 

• Tissue samples and baseline imaging 

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• Validated questionnaires of quality-of-life/psychological status 

The outcomes might include incidence and progression of benign gynecologic disease, 

biomarkers for disease, and tissue signature. 

Recommendation 2: Coordinate data from past and current cohort studies that have involved adolescents and women. Coordination of cohort data would enable researchers to 

add focused questions that might not have been relevant at the time the earlier studies were 

designed. Researchers could also request additional material from study participants for genetic and molecular analyses. Additional analyses of previously collected material would 

also be possible. 

Recommendation 3: Similar to the model of the Gynecologic Oncology Group, establish a 

national registry in which practitioners can enroll patients with specific diseases so that data 

can be more readily shared among researchers who might also collaborate on future randomized trials. This multidisciplinary, multi-institutional, prospective approach would facilitate 

state-of-the-art research in diseases that affect reproduction and wellness in women. 

Recommendation 4: Coordinate large mechanistic studies around a disease. In a multicenter 

effort focused on prediction of risk, disease prevention, and identification of targets for personalized therapies, study diseases that affect the reproductive health and wellness of women, 

including fibroids, endometriosis, chronic pelvic pain, infertility, autoimmune diseases, and 

pelvic floor relaxation. GWAS offers the potential for understanding basic biological processes 

and for identifying further targets for molecular (including epigenetic) analysis. 

Recommendation 5: Expand existing tissue banks and develop a National Tissue Repository. 

Expand existing tissue banks to include tissues from the gynecologic system and urinary tract 

of normal women by establishing a national registry (partnering with trauma centers and the 

National Disease Research Interchange).10 Enhance the current repositories to encourage more 

widespread participation from practitioners, patient advocacy groups, and members of the 

community. These repositories would provide the essential materials for studies to develop 

new technologies and therapies for diseases that affect women. 

References 

1. U.S. Department of Health and Human Services, Centers for Disease Control 

and Prevention. (2010). Infertility FAQs. Retrieved from http://www.cdc.gov/
�

Reproductivehealth/Infertility/index.htm

2. Miller, W.C., Ford, C.A., Morris, M., Handcock, M.D., Schmitz, J.L., Hobbs, M.M., ...Udry, J.R. 

(2004). Prevalence of chlamydial and gonococcal infections among young adults in the 

United States. Journal of the American Medical Association 291(18), 2229–2236. 

3. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2010). Pelvic Inflammatory Disease – CDC Fact Sheet. Retrieved from http:// 

cdc.gov/std/PID/STDFact-PID.htm 

158
4. Flynn, M., Jamison, M., Datta, S., & Myers, E. (2006). Health care resource use for uterine 

fibroid tumors in the United States. American Journal of Obstetrics and Gynecology, 

195(4), 955–964. doi:10.1016/j.ajog.2006.02.020 

5. Dixon, D., Parrott, E. C., Segars, J. H., Olden, K., & Pinn, V. W. (2006). The second 

national institutes of health international congress on advances in uterine leiomyoma research: Conference summary and future recommendations. Fertility and Sterility, 86(4), 

800–806. doi:10.1016/j.fertnstert.2006.02.116 

6. 1000 Genomes Project. (2007). Meeting Report: A Workshop to Plan a Deep Catalog of Human Genetic Variation. Retrieved from http://www.1000genomes.org/ 

files/1000Genomes-MeetingReport.pdf 

7.	� U.S. Department of Health and Human Services, National Institutes of Health, Eunice 

Kennedy Shriver National Institute of Child Health and Human Development. (n.d.). Fast 

facts about endometriosis. Retrieved from http://www.nichd.nih.gov/publications/pubs/ 

endometriosis/ 

8. Bruner-Tran, K. L., Carvalho-Macedo, A. C., Duleba, A. J., Crispens, M. A., & Osteen, K. 

G. (2010). Experimental endometriosis in immunocompromised mice after adoptive 

transfer of human leukocytes. Fertility and Sterility, 93(8), 2519–2524. doi:10.1016/j.fertnstert.2009.05.076 

9. Krikun, G., Schatz, F., Taylor, H., & Lockwood, C. J. (2008). Endometriosis and tissue 

factor. Annals of the New York Academy of Sciences, 1127, 101–105. doi:10.1196/annals.1434.008 

10. National Disease Research Interchange. (2008). NDRI research brief - Fall 2008. Retrieved from http://www.ndriresource.org/SiteData/docs/Research-Brief-online/7abb03 

8fd6c0446dddb3d0ed1f7e322a/Research-Brief-online.pdf 

PREGNANCY 

Cochairs:
�

Katharine Wenstrom, M.D.
�

The Warren Alpert Medical School of Brown University, Women & Infants Hospital of 

Rhode Island 

Lucia Larson, M.D. 

The Warren Alpert Medical School of Brown University, Women & Infants Hospital 

of Rhode Island 

Errol Norwitz, M.D. 

Yale University 

NIH Cochairs:
�

Donald Mattison, M.D.
�

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

159
Alicia Armstrong, M.D., M.H.S.C.R. 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers: 

Katharine Wenstrom, M.D. 

The Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island 

Kenneth Chen, M.D. 

The Warren Alpert Medical School of Brown University, Women & Infants Hospital of Rhode Island 

Introduction 

As an introduction to their discussion about potential research avenues on pregnancy, the participants of the Working Group on Pregnancy acknowledged a number of underlying issues. In 

many ways, pregnant women are an underserved population, in part because major clinical and 

research areas pertaining to pregnancy have been neglected or deliberately avoided, possibly 

because of discomfort with pregnancy in general or the disadvantage of pregnant women and 

nonobstetric health care providers. The following examples illustrate neglected research areas: 

• Little pharmacologic data exist on drug metabolism and safety in pregnancy, with 

the result that many practitioners discontinue their patients’ needed medications 

during pregnancy, and many women do not receive optimal drug therapy because 

they are pregnant. 

• The available data on the normal physiology of pregnancy are dated, having been obtained from small numbers of patients with now-obsolete technology, before accurate 

monitoring techniques became available. Importantly, existing physiologic data may not 

be relevant to the third (or more) of pregnant women who are obese or morbidly obese. 

• A wide range of providers care for pregnant women in the United States and worldwide, 

representing a wide range of knowledge, skill, and experience. Some of these providers may not provide optimal care for pregnant women. The fact that no system currently 

exists to effectively provide continuing obstetric education to such providers may contribute to the well-recognized racial and socioeconomic disparities in obstetric outcomes 

observed in this country. 

• Unlike other clinical groups, obstetric patients themselves are often uninformed and 

unable to advocate for themselves. 

Summary of the Discussion 

The working group discussed the following five potential areas of obstetric research: 

• Development of an obstetric research infrastructure. 

• High-impact pregnancy complications. 

• Preventive care to optimize pregnancy outcomes and maternal and child health. 

• Optimal prenatal, intrapartum, and postpartum-interpregnancy care. 

• Patient and provider education. 

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These five areas were discussed in the context of the following four themes: 

• Pregnancy complications with important implications for public health, and factors 

increasing risk for complications. 

• Pregnancy’s effect on preexisting maternal medical conditions and provision of 

appropriate care.
�

• Pregnancy as a “stress test” revealing vulnerability to the future development of 

chronic disease, and ways to interrupt disease progression.
�

• Fetal “programming,” or pregnancy’s influence on the health of the adult that the 

fetus will become. 

Development of an Obstetric Research Infrastructure 

The working group participants concurred that research on pregnancy complications ideally should be coordinated to target basic, translational, and clinical aspects of each disease and 

its treatment, and that this kind of comprehensive research endeavor cannot be accomplished 

without an informatics infrastructure. A national pregnancy database and tissue bank is needed, containing blood samples from the child and both parents as well as amniotic fluid and 

placental samples when available, along with detailed family and personal medical histories, 

social and economic data, environmental exposures, and infant/child outcomes. Banking specimens from pregnancies with common complications (e.g., preterm labor or preeclampsia), as 

well as more rare disorders (e.g., acute fatty liver), would accomplish the following goals: 

• Enable researchers to perform a variety of investigations ranging from detailed genetic 

or proteomic studies to epidemiologic analyses. 

• Support studies that are more statistically powerful than can currently be done. 

• Enable the development of new genetic tests and the discovery of new biomarkers. 

• Facilitate collaboration among research groups. 

• Facilitate the collection of powerful intergenerational data, enabling study of the vertical transmission of risk factors as well as providing a better understanding of the concept 

of fetal programming. This kind of complete prospective data collection would support 

both hypothesis-driven and observational research, and would make retrospective studies more valuable by ensuring complete, unbiased, and prospective data collection. 

The working group participants strongly recommended that the database be attached to the 

infrastructure being developed for the National Children’s Study (NCS), a congressionally mandated interagency study designed to examine the effects of environmental influences on the 

health and development of more than 100,000 children across the United States, following them 

from before birth until age 21.1 Because the NCS already plans to collect a great deal of information about the parents and prenatal course of each enrolled child, a fairly complete pregnancy 

database could be created by adding more specific pregnancy-related data fields and ensuring the collection of tissue samples. This would allow a valuable informatics infrastructure 

to be created at a reduced cost, compared to creating such an infrastructure de novo. The database should be kept flexible at the beginning and reviewed regularly, and more data fields 

could be added as necessary with regular review. Ideally, women consenting to participate in 

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the database should be followed for several years after pregnancy, both to enable the study of 

recurrent risk and to facilitate research on the development of chronic adult-onset diseases 

that are heralded during pregnancy, an association proposed by the Barker hypothesis.2 

The working group also believed that new, valuable obstetric research databases could be created inexpensively by providing funding to obtain followup information from subjects who have 

already participated in a study that created an obstetric research database. Ideal databases 

would be those that collected metabolic data during pregnancy because obtaining followup of 

those women and their infants would enable studies of fetal programming as well as pregnancy 

determinants of adult-onset disease. An example of such a database was created for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal 

Medicine Units Network randomized trial of treatment for mild gestational diabetes. This study 

enrolled nearly 1,000 women and collected detailed dietary information in addition to standard 

prenatal data, but was not funded to permit followup of the children born to study mothers.3 

High-Impact Pregnancy Complications 

The United States has a high perinatal mortality—6.9 per 1,000 live births—compared to industrialized European countries. The United States currently ranks 30th, behind Singapore, Poland, 

the Czech Republic, and other countries with far fewer resources. Although this rate is largely 

attributable to the high rate of preterm births in this country, the U.S. mortality for infants born 

at 37 weeks of gestation or more is also higher than in most European countries.4 In the United States, perinatal deaths result in large part from common pregnancy complications, such 

as spontaneous preterm birth, indicated preterm birth for complications such as preeclampsia, 

and other hypertensive complications at term. Although many preterm infants now survive because of advances in neonatal care, many survivors suffer neurologic and other organ system 

damage and require considerable medical support for the rest of their lives. These pregnancy 

complications seriously affect not only the offspring of such pregnancies, but also society. Examples of high-impact pregnancy complications with the highest personal and societal effects 

and their relevant research questions include the five below. Each of these five major 

complications should be studied from the following four key perspectives: 

• Implications for public health, and factors that increase risk for the complication. 

• Effect on preexisting maternal medical conditions and practitioners’ ability to provide 

appropriate care. 

• Maternal vulnerability to the future development of chronic disease as revealed by the 

complication, and ways to interrupt disease progression. 

• Effect on fetal “programming,” or pregnancy’s influence on the health of the adult that 

the fetus will become.2 

Preterm Birth 

What are the maternal and fetal factors that contribute to preterm birth, and how can these 

factors be modified? Current data suggest that oral health, genetics, environmental exposures, 

and stress all play roles, but none of these factors has been fully evaluated. Importantly, these 

factors have not been evaluated in an integrated way, which is essential because preterm birth 

is a multifactorial disease. 

162
Preeclampsia 

What causes preeclampsia and how can it be prevented? If it is a marker for susceptibility to 

the later development of maternal cardiovascular disease, by what mechanism does this occur 

and how can this progression of disease be averted? 

Infection 

What factors increase susceptibility to maternal and fetal infections? How does infection 

contribute to other complications such as preterm birth, and can susceptibility be altered 

or decreased? 

Obesity 

What factors predispose women to obesity? How does obesity cause or predispose women 

to have pregnancy complications such as stillbirth, preterm birth, and hypertension? What 

is the relationship between obesity-related sleep apnea and adverse pregnancy outcomes? 

How do obesity-related pregnancy complications influence the later development of adultonset disease? 

Mental Health/Depression 

Does pregnancy increase a woman’s susceptibility to psychiatric disease? How does maternal psychiatric disease affect the course of pregnancy and fetal development? How does 

this disease concurrent with pregnancy influence long-term outcomes for both the child 

and the mother? 

In addition, a process should be developed to provide expedited funding to study unexpected health care crises affecting pregnant women and pregnancy outcomes. For example, the 

H1N1 influenza pandemic is expected to cause disproportionate morbidity and mortality among 

pregnant women. It would provide a unique opportunity to study immune changes and function 

during pregnancy to determine the physiologic changes of pregnancy that put women most 

at risk, and to study the effects of this virus on both the mother and the developing fetus. The 

effects of hurricane Katrina on the Gulf region afforded a missed opportunity to study the effects of different kinds of stress on the course and outcomes of pregnancy. Unfortunately, 

current protocols for obtaining research funding are too cumbersome to allow for the rapid 

funding that would be required to support such research. 

Preventive Care to Optimize Pregnancy Outcomes and Maternal and 

Child Health 

Studies of Maternal Physiology 

For various reasons, many women receive substandard care during pregnancy. Existing data 

on normal pregnancy physiology was obtained years ago with obsolete techniques and equipment, and are therefore incomplete or even inaccurate. Some aspects of maternal physiology 

have never been studied, with the result that high-risk pregnancy management—especially 

critical care, intraoperative, and anesthetic management—cannot always be evidence based. 

Importantly, despite the epidemic of morbid obesity in this country, particularly among women 

of reproductive age, knowledge of how obesity affects maternal physiology is so limited that it 

163
cannot be used to make informed management decisions. Decisions regarding anesthesia and 

surgical options for such women are particularly fraught because they must be based on data 

extrapolated from nonpregnant obese patients and pregnant women of normal weight— 

neither of which is likely to be completely relevant. Because maternal obesity is also an 

important factor contributing to the development of a variety of pregnancy complications 

as well as fetal and neonatal morbidity, understanding the physiology of obesity during 

pregnancy is vital to research in these other areas. A comprehensive study of maternal 

physiology, and especially of obesity during pregnancy, is needed. 

Drug Metabolism in Pregnancy 

The most egregious pregnancy-related information gap concerns drug metabolism and safety 

in pregnancy. Few pharmacologic studies have included pregnant women, and even fewer have 

been designed specifically to investigate drug metabolism and safety in pregnancy. As a result, 

many women discontinue or are told to discontinue their medications when pregnancy is diagnosed, often with disastrous results. Furthermore, many women who ordinarily would be treated 

pharmacologically for diseases that become apparent during pregnancy do not receive such 

therapy because many physicians are reluctant to initiate drug treatment in the absence of data. 

Consequently, if pregnant women receive drug treatment at all, many of them are treated with 

drugs that have been on the market for a long enough time that experience with their performance during pregnancy has been acquired over many years. This results in pregnant women 

being treated with medications that have been on the market for 20 years or more rather than 

newer, more effective agents, and many receive the wrong medicine or the wrong dose. Thus, 

the lack of pregnancy-related pharmacologic data results in suboptimal obstetric care. A 

small, four-center Obstetric-Fetal Pharmacology Research Units Network,5 funded by NICHD, 

has recently been established to study drugs in pregnancy—a good, but insufficient, start. 

Nevertheless, experience gained from this research network could be used to design and 

fund additional networks so that more drugs can be studied efficiently and effectively 

during pregnancy. 

Nutrition 

The current unprecedented epidemic of obesity in this country disproportionately affects 

women of reproductive age. Previously unknown factors that contribute to obesity have recently been recognized, but have not been adequately studied. Fetal programming appears to 

be one of the most important factors contributing to overweight, and appears to affect disadvantaged women disproportionately. For example, impoverished women are at increased risk 

for growth-restricted infants as a result of suboptimal diet, coexistent medical conditions such 

as hypertension and diabetes, unhealthful habits such as smoking or drug abuse, and living in 

a high-stress environment. Available data suggest that the growth-restricted infants of such 

women are at a significantly increased risk of becoming morbidly obese adults.2 Adult obesity predisposes an individual to hypertension and diabetes, thus putting the next generation 

at risk and perpetuating the cycle of adverse obstetric outcomes leading to adverse adult 

health.6 This situation is believed to be a major contributor to the disparity in adverse 

obstetric outcomes currently evident in this country, and has tremendous personal 

and societal consequences. 

164
Psychological Stressors 

Large racial and socioeconomic disparities exist in pregnancy outcomes, particularly with 

regard to common, but serious, pregnancy complications, such as preterm birth and hypertension. Evidence is now accumulating to show that many adverse pregnancy outcomes have 

multifactorial etiologies, with environmental factors and maternal stress playing important, 

but largely unspecified, roles. Focused research is needed to identify important psychological stressors during pregnancy, including social issues, violence, and mental health problems; 

to define the physiologic effects of these stressors on both mother and fetus; and to identify 

ways to lessen or nullify the effects of such stressors on pregnancy. 

Optimal Prenatal, Intrapartum, and Postpartum-Interpregnancy Care 

Current standards for prenatal, intrapartum, and postpartum-interpregnancy care are based 

largely on tradition rather than sound scientific evidence. For example, the optimal number and 

content of antenatal visits, the best strategies for monitoring the fetus during labor and delivery, 

and the most appropriate method for postpartum-interpregnancy screening for and treatment 

of chronic diseases are all largely unknown. Simultaneously, obstetricians across the country 

are facing a professional liability crisis, with the result that every aspect of the care they provide during pregnancy has the potential to be scrutinized, criticized, or blamed for an adverse 

outcome. Thus, research is needed to investigate basic aspects of pregnancy care as well as to 

develop creative new ways to provide prenatal care more efficiently and cost effectively. 

Patient and Health Care Provider Education 

Another factor contributing to the large disparity in pregnancy outcomes is the disparity in the 

quality of the health care and patient information provided by different practitioners during 

pregnancy. Effective strategies for educating and updating health care providers and their patients are desperately needed. Some of the most important research topics in this area include 

developing optimal strategies for pregnancy planning; screening for a variety of maternal and 

fetal abnormalities; and counseling and pre-, intra-, and postpartum management of patients 

with gestational diabetes, hypertension, and other chronic conditions, such as thyroid disease 

or seizure disorder. The most effective strategies for patient education must also be developed. 

For educating both the provider and the patient, projects that use information technology are 

needed. Centralized electronic medical records, which will be in place nationwide in the near 

future, could provide support for providers through a variety of mechanisms—such as providing prompts for the optimal schedule and content of prenatal visits, information for maternal 

counseling, standards for prenatal testing, and strategies for fetal evaluation. Informational 

Web sites could also be commissioned to provide up-to-date information to the general public. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Develop an effective obstetric research infrastructure that includes a 

national pregnancy database and a tissue bank. Serious consideration should be given to attaching the database to the infrastructure being developed for the National Children’s Study. 

165
Also, the value of obstetric databases that have already been established can be enhanced by 

additional funding to collect followup information from database participants. 

Recommendation 2: Identify and study the top five high-impact pregnancy complications 

that account for the major portion of perinatal mortality, and study those in the context of 

the following four perspectives: 

• Implications for public health, and the factors increasing risk for the complication. 

• Effect on preexisting maternal medical conditions and the practitioners’ ability to provide 

appropriate care. 

• Maternal vulnerability to the future development of chronic disease as revealed by the 

complication, and ways to interrupt disease progression. 

• Effect on fetal “programming,” or pregnancy’s influence on the health of the adult that 

the fetus will become.2 

Potential complications include preterm birth, preeclampsia, infection, obesity, and mental 

health, including depression. In addition, a funding mechanism should be established to enable 

rapid funding for the study of crisis-related acute health issues in pregnant women. 

Recommendation 3: Support research to develop preventive care that optimizes pregnancy 

outcomes and maternal and child health, especially with the following approaches: 

• Funding for the comprehensive study of maternal physiology, and especially for the 

study of obesity during pregnancy. 

• Use of experience gained from the Obstetric Pharmacology Research Units Network 

to design and fund additional networks so more drugs can be studied efficiently and 

effectively during pregnancy. 

• Research on nutrition during pregnancy and its effect on the intrauterine environment 

and fetal programming. 

• A focused research effort to identify important psychological stressors during pregnancy—including social issues, violence, and mental health problems— to define the 

physiologic effects of these stressors on both mother and fetus, and to identify ways 

to lessen or nullify the effects of such stressors on pregnancy. 

Recommendation 4: Determine standards for optimal prenatal, intrapartum, and postpartum-interpregnancy care and management, as well as new and creative ways to provide 

prenatal care more efficiently and cost effectively. 

Recommendation 5: Fund demonstration projects using electronic medical records, the Internet, and other venues for provider education and support, and for patient information transfer. 

References 

1. National Children’s Study. (n.d.) What is the National Children’s Study? Retrieved from 

http://www.nationalchildrensstudy.gov 

166
2. Barker, D.J.P. (1997). Maternal nutrition, fetal nutrition, and disease in later life. Nutrition, 

13, 807. 

3. Landon, M. B., Spong, C. Y., Thom, E., Carpenter, M. W., Ramin, S. M., Casey, B., . . . 

Anderson, G. B.; Eunice Kennedy Shriver National Institute of Child Health and Human 

Development Maternal-Fetal Medicine Units Network. (2009). A multicenter, randomized trial of treatment for mild gestational diabetes. New England Journal of Medicine, 

361, 1339–1348. 

4. MacDorman, M. F., & Mathews, T. J. (2009). Behind international rankings of infant mortality: How the United States compares with Europe. NCHS data brief (No. 23). Atlanta, 

GA: Centers for Disease Control and Prevention. 

5. U.S. Department of Health and Human Services, National Institutes of Health, Eunice 

Kennedy Shriver National Institute of Child Health and Human Development. (2006). 

Obstetric-Fetal Pharmacology Research Units Network. Retrieved from http://www. 

nichd.nih.gov/research/supported/opru_network.cfm 

6. U.S. Department of Health and Human Services, National Institutes of Health, National 

Institute of Diabetes and Digestive and Kidney Diseases. (2010). Statistics related to 

overweight and obesity. Weight-control Information Network. Retrieved from http:// 

www.win.niddk.nih.gov/statistics/index.htm 

MENOPAUSAL TRANSITION 

Cochairs:
�

Robert W. Rebar, M.D.
�

American Society for Reproductive Medicine 

Paul DiSilvestro, M.D. 

The Warren Alpert Medical School of Brown University, Women & Infants Hospital 

Marcia L. Stefanick, Ph.D. 

Stanford University 

NIH Cochairs:
�

Jacques Rossouw, M.D.
�

National Heart, Lung, and Blood Institute 

Andrew Monjan, Ph.D., M.P.H. 

National Institute on Aging 

Science Writers: 

Gil Abramovici 

The Warren Alpert Medical School of Brown University 

Monica Bertoia 

Brown University 

167
Introduction 

The Working Group on Menopausal Transition agreed to distinguish the effects of aging that 

both women and men experience through the “middle years” from those unique to the menopausal transition. The timespan of the menopausal transition is defined as ages 40–59, and 

postmenopausal as ages 60–69, with further recognition that aging follows a continuum from 

the decades before and after this 30-year range. The menopausal transition is that period in 

life beginning with variation in menstrual-cycle length in a woman who has elevated folliclestimulating hormone (FSH) levels and ending with the final menstrual period. The transition 

lasts approximately 4–5 years.1,2 

Summary of the Discussion 

To begin the discussion, the three cochairs highlighted current research findings on the physiology of the menopausal transition; on current recommendations for the use of menopausal 

hormones; and on health issues and causes of death for women in their middle years, with a 

focus on cardiovascular and bone health, and cancer. The normal menstrual cycle of young reproductive-age women was compared with that of older middle-age women, whose cycles 

are more likely to be anovulatory and/or characterized by higher FSH levels, variable estradiol levels, lower progestin, and lower dehydroepiandrosterone sulfate (DHEAS) levels.3 The 

DHEAS levels vary by ethnic/racial group, with decreases being particularly apparent in African-American women.4 Androgen levels, however, decrease only slightly, with substantial 

amounts continuing to be secreted by the postmenopausal ovary. Nearly all common menopausal symptoms are believed to result from decreasing estrogen and reports have included 

hot flashes, paresthesias, palpitations, cold hands and feet, headache, vertigo, irritability, anxiety, nervousness, depression, fatigue, weight gain, insomnia, night sweats, and forgetfulness. 

The majority of women complain of mild and moderate symptoms; however, a small percentage experience severe symptoms, with hot flashes and vaginal discomfort generally appearing 

before the final menstrual period, whereas bladder symptoms appear later. Chronic diseases 

appear more than a decade later. 

The concept that women are protected from heart disease until menopause, after which they 

lose this protection as estrogen levels decline, has been challenged by an analysis of British data 

(which closely resembles U.S. data) of sex differences in coronary heart disease (CHD) by age. 

In the study, there was no suggestion of a change in rates associated with menopause.5 Furthermore, death rates for adults hospitalized for myocardial infarction were higher for middle-age 

women than men, whereas they were similar from age 70 onward.6 This difference arises in part 

because of gender-related bias in medical practice, including differences in the recognition and 

treatment of CHD. There are also physiological differences between women who experience 

CHD in the middle years compared with those who are much older and constitute the majority 

of CHD patients. 

In contrast to what appears to be a steady age-related increase in heart disease death rates for 

women, breast cancer death rates decrease at menopause.7

 Bone mineral density, which shows 

a similar, steady decline in both men and women starting at about age 30, shows an accelerated decrease during the 3- to 5-year menopausal transition, after which the rate of decline 

again resembles the rate of loss in men.8 

168
Other health status observations from studies include the following: 

• Body weight and waist circumference appeared to increase at a greater rate after the final menstrual period over a 6-year period of observation, whereas skeletal muscle mass 

was unchanged.9 

• Total body weight increased in early postmenopausal women ages 50–59 over 7 

years; however, weight was relatively stable in those 60–69 and decreased in those 

70 and older.10 

• The percentage of men and women who have suboptimal levels of sleep was the same 

during the middle or later years, though the percentage increased in all age groups of 

both sexes from 1985 to 2004.11 

Lung cancer deaths have increased dramatically in women over the past decade, whereas breast 

and colorectal cancers have decreased.12 Breast cancer incidence is higher in White versus Black 

women, particularly from age 50 and over, whereas death rates from breast cancer are higher in 

Black versus White women across the age spectrum.13 

The group discussion emphasized two key points: 1) knowledge is lacking about the fundamental biological processes underlying and associated with menopause, despite its impact on 

the quality of life of many women; and 2) during midlife, women may begin to experience major chronic illnesses that affect their health in later years. Therefore, it is important to determine 

how and why risk factor profiles change during midlife and to identify prevention strategies 

that may effectively reduce morbidity prior to, during, and after the menopausal transition. 

The working group participants discussed different types of menopause and were interested 

in the range and variation of the experience, differences in rate of changes, and associations 

with health outcomes. Research on specific symptoms and temperature physiology in women 

was considered to be too limited. There was considerable interest in utilizing new technologies to study the physiology of menopause, as well as mathematical modeling in distinguishing 

between aging and the menopausal transition. Research on sex differences in chronic diseases and aging, in general, was strongly endorsed. Specific stressors affecting women in their 

middle years include the “sandwich generation” burden of having to care for both children 

and older parents. The middle-year period also includes an increasing number of women who 

have delayed first pregnancies. There was considerable enthusiasm for studying women from 

in utero through their lifespan, ideally as a long-term cohort study, but more practically as a 

set of current cohorts combined with some new cohorts recruited to fill in the gaps. It was acknowledged that age cohorts vary substantially across generations and that the health issues 

of women in the current and future population differ from those of the past generations for a 

large number of reasons. 

The discussion also addressed how to take advantage of electronic medical charts to improve 

health care of women and reduce costs. Participants noted that some available databases can 

already be linked; for example, the Surveillance, Epidemiology, and End Results (SEER) Cancer Registry14 can be linked to the Centers for Medicare and Medicaid Services (CMS) database. 

Other health concerns included improving CMS screening modalities, promoting prevention, 

169
and improving access to care, particularly in medically underserved women. Research on 

specific biomarkers for detecting tumors, targeted therapies, and new strategies for treating 

cancer was encouraged. There was interest in the physiologic impact of microchimerism, that 

is, the presence of embryonic stem cells from a woman’s offspring that have been found to be 

circulating in the mother three to four decades later. Epigenetics was considered an important 

emerging concept that should be utilized to study the remaining questions about menopause. 

Recommendations 

The overall goal of the recommendations is to distinguish the physiologic changes and 

chronic disease risks associated with the changes occurring at the menopausal transition 

from those arising as a result of aging—and place them in proper perspective. In this regard, 

comparison with the changes occurring in men, in oophorectomized women, and in women 

with premature ovarian failure should be instructive. It is still true that the causes of menopause are unknown in women, and safe and effective therapy for signs and symptoms of 

menopause remains to be established. 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Conduct research toward distinguishing changes related to aging from 

those related to the patterns associated with the menopausal transition (e.g., early/late onset, 

prolonged/short symptoms, biochemical/cellular/genetic profiles). This research could answer 

the following types of questions: 

• Are there genetic and epigenetic differences and/or influences? 

• Are there physiologic differences between symptomatic and asymptomatic women? 

• Do women in whom symptoms persist differ from those in whom symptoms 

quickly disappear?
�

• Does the menopausal transition have distinct and separate patterns? 

• Are there differences in women in whom menopause begins early compared 

with those in whom it begins late?
�

• Is quality of life affected by patterns, symptoms, and treatment? 

• Does cellular aging play a significant role? 

Recommendation 2: Enhance research on the basic physiology of changes associated with 

menopause, emphasizing a systems biology approach and translation into safe and effective 

management. This research would clarify the roles of the central and autonomic nervous systems and the neuroendocrine system in the changes observed (e.g., temperature regulation; 

pulse rate and blood pressure; sleep, mood changes, weight changes, and distribution of fat; 

urogenital, dermatologic, and bone changes), and strategies for short- and long-term safe and 

effective management of signs and symptoms. 

170
Recommendation 3: Develop and assess new technologies and communication tools (e.g., 

portable devices, imaging, biological profiling on microchips) for their impact on individual and 

public health outcomes during the years of the menopausal transition. It should be possible to 

identify and/or develop the following: 

• Innovations in bioengineering and materials science that can be used to manage symptoms of the menopausal transition (e.g., vasomotor symptoms by heat dissipation via 

engineered clothing). 

• New analytic models, using statistical and mathematical tools and simulations, to 

interpret the complex interactions among aging, the menopausal transition, multiple 

biological systems, and chronic disease. 

• Large databases to study comparative effectiveness and outcomes in midlife services 

and treatments (e.g., SEER, Kaiser, Intermountain Health). 

• New tools (e.g., portable digital devices, imaging, biological profiling) to facilitate 

diagnosis and personalize health care. 

• New information technology (e.g., social networking) that can be used to educate 

the public to change behavior and improve health outcomes via validated sources. 

• Information about changes during the middle years that can be used to reduce 

health care costs by developing accurate risk assessment tools.
�

Recommendation 4: Promote research that uses and follows cohorts of women from different generations over time to determine what chronic diseases develop in the context of their 

reproductive lives, patterns of menopausal transition, culture, environment, and genomes. Investigators should be encouraged to take the following actions: 

• Use (existing and/or new) cohorts of women for whom expression profiles (e.g., genome, 

proteome, and environmental factors) are characterized to document the development of 

chronic disease and influence on the patterns of the menopausal transition. 

• Examine how past reproductive function and history (e.g., menarche, use of oral 

contraceptives, and parity) affect menopause and subsequent chronic disease.
�

• Identify how interactions among comorbidities (e.g., obesity, diabetes, hypertension, 

cardiovascular disease) influence the menopausal transition. 

• Study the effects of environment and culture. 

• Determine if epigenetic changes in one generation influence the menopausal transition, 

aging, and chronic disease in subsequent generations. 

References 

1. Soules, M. R., Sherman, S., Parrott, E., Rebar, R., Santoro, N., Utian, W., & Woods, N. 

(2001). Executive summary: Stages of reproductive aging workshop (STRAW). Fertility 

and Sterility, 76(5), 874-878. 

171
2. Harlow, S. D., Crawford, S. L., Sommer, B., & Greendale, G. A. (2000). Self-defined 

menopausal status in a multi-ethnic sample of midlife women (SWAN) . Maturitas, 

36(2), 93–112. 

3. Cumming, D. C., Rebar, R. W., Hopper, B. R., & Yen, S. S. (1982). Evidence for an influence 

of the ovary on circulating dehydroepiandrosterone sulfate levels. Journal of Clinical 

Endocrinology and Metabolism, 54, 1069–1071. 

4. Crawford, S., Santoro, N., Laughlin, G. A., Sowers, M. F., McDonnell, D., Sutton-Tyrrell, K., . 

. . Lasley, B. (2009). Circulating dehydroepiandrosterone sulfate concentrations during the menopausal transition. Journal of Clinical Endocrinology and Metabolism, 94, 

2945–2951. 

5. Tunstall-Pedoe, H. (1998). Myth and paradox of coronary risk and the menopause. Lancet, 351, 1425–1427. 

6. Vaccarino, V., Parsons, L., Every, N. R., Barron, H. V., & Krumholz, H. M. (1999). Sex-based 

differences in early mortality after myocardial infarction. New England Journal of Medicine, 341, 217–225. 

7. Barrett-Connor, E. (2003), Clinical review 162: Cardiovascular endocrinology 3: an 

epidemiologist looks at hormones and heart disease in women. Journal of Clinical 

Endocrinology and Metabolism, 88(9), 4031–4042. 

8. Rosen, C. (2008). Osteoporosis. In L. Goldman, & D. Ausiello (Eds.), Cecil medicine (23rd 

edition, pp. 1879–1888). Philadelphia, PA: Elsevier. 

9. Sowers, M., Zheng, H., Tomey, K., Karvonen-Gutierrez, C., Jannausch, M., Li, X., . . . 

Symons, J. (2007). Changes in body composition in women over six years at midlife: 

Ovarian and chronological aging. Journal of Clinical Endocrinology and Metabolism, 

92(3), 895–901. 

10. Howard, B. V., Manson, J. E., Stefanick, M. L., Beresford, S. A., Frank, G., Jones, B., . . 

. Prentice, R. (2006). Low-fat dietary pattern and weight change over 7 years: The 

Women’s Health Initiative Dietary Modification Trial. Journal of the American Medical 

Association, 295, 39–49. 

11. U.S. Department of Health and Human Services, Centers for Disease Control, National 

Center for Health Statistics. (2004). National Health Interview Survey 1985–2004 [Data 

File and Documentation]. Retrieved from http://www.cdc.gov/nchs/nhis.htm 

12. Edwards, B.K., Ward, E., Kohler, B.A., Eheman, C., Zauber, A.G., Anderson, R.N... Ries, 

L.A. (2010). Annual report to the nation on the status of cancer, 1975–2006, featuring 

colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer 116(3), 544–573. 

13. U.S. Department of Health and Human Services, National Institutes of Health, National 

Cancer Institute. (2008). SEER cancer statistics review, 1975–2005. Tables I-20 & I-25. 

Retrieved from http://seer.cancer.gov/csr/1975_2005/results_merged/topic_race_ethnicity.pdf 

172
14. U.S. Department of Health and Human Services, National Institutes of Health, National 

Cancer Institute. (2010). Surveillance epidemiology and end results [data file]. Retrieved 

from http://seer.cancer.gov 

ELDERLY, FRAIL ELDERLY, AND HEALTHY AGING 

Cochairs:
�

Richard Besdine, M.D.
�

The Warren Alpert Medical School of Brown University 

Stefan Gravenstein, M.D., M.P.H. 

The Warren Alpert Medical School of Brown University 

Stacy Tessler Lindau, M.D., M.A.P.P. 

University of Chicago 

NIH Cochairs:
�

Susan Resnick, Ph.D.
�

National Institute on Aging 

G. Bernadette Tyree, Ph.D. 

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

Science Writers:
�

Anita Kestin, M.D., M.P.H.
�

The Warren Alpert Medical School of Brown University 

Carolina Abuelo, M.D., M.Sc. 

The Warren Alpert Medical School of Brown University 

Introduction 

The Working Group on Elderly, Frail Elderly, and Healthy Aging was given the task of identifying the most promising and important avenues for research on the health and health care of 

older women. Both the absolute number of women 65 and older and the percentage of elderly women in the population are projected to increase substantially during the first half of the 

21st century. These population trends are attributable to the aging of the Baby Boomer Generation and to the longer life expectancy for women than for men.1

 Furthermore, unlike men, 

the majority of women will live their later years and die without their life partner as a caregiver. 

For example, an NIH-funded 2005–06 study of social relationships and aging, using a nationally representative probability sample of community-residing adults ages 57–85, found that 

49.8 percent of women ages 75–85, but only 18.3 percent of men, were widowed. Fewer than 

40 percent of women, but 72 percent of men, in that age group were married or living with a 

partner.2

 The demographic shift outlined above has critical implications for women—for their 

health, quality of life, and the experiences of late-life illness and dying.3 

The working group posited four principles that should be used in evaluating and recommending potential research strategies aimed at improving the health of elderly women: a broader 

173
scope of the research approach, effectiveness studies in the approach, focus on the whole 

person in health care delivery, and comprehensive use of existing information sources. 

For the purposes of this report, we have defined the elderly as 65 and older. Human development continues until the end of the life course, and there are differences within the age group 

after 65; thus, it is no longer acceptable to designate this as one analytic group. 

Scope of the Research Approach 

• Much of the research on the health of elderly individuals has been notable for a focus 

on single-disease processes commonly found in the elderly. In contrast, the working 

group considered a new approach to research strategies for women’s health aimed at 

the following: 

• Understanding the effect of multiple concurrent morbidities on the health of elderly 

women 

• Fostering the promotion of wellness (biological, psychological, and social) in elderly 

women, recognizing that vitality in old age has important antecedent predictors that 

operate throughout the lifespan 

• Selecting research germane to the needs of women of different characteristics, including 

diverse ethnicity and race, physical conditions and abilities, cognitive and mental 

conditions and abilities, sexual orientations, and gender perspectives 

• Addressing the health not only of individual women, but also of communities 

Effectiveness Studies in the Research Approach 

The working group decided that the most important criterion for recommending a research 

strategy to the ORWH is that the strategy should have the potential to lead to meaningful improvements in health, health care, or health outcomes. The group emphasized the importance 

of translational research at the levels of bench-bedside and population-patient. The group articulated the belief that the next decade of interventional research on elderly women’s health 

should move from efficacy to effectiveness. This shift (i.e., to an emphasis on effectiveness) will 

require expansion of therapeutic trials and public health interventions to include older women, 

many of whom have multiple medical conditions and are using multiple medications (i.e., prescription, over-the-counter, and vitamins/nutritional supplements).4 

A Focus on the Whole Person in Health Care Delivery 

The working group expressed the opinion that the current quality of care of elderly women is diminished by a health care delivery system that is fragmented, focused on disease processes, and 

reactive. In contrast, the working group placed a high value on research focused on health care 

delivery models with the potential to shift the focus of care from organ systems to the whole 

person. A version of the advanced medical home tailored to needs of elderly women (and men) 

may be a model worthy of further exploration.5

 Implicit in the focus on the whole person is the 

need to provide elderly women with skills, support, and tools to evaluate the advantages and 

disadvantages of screening options, therapies, diagnostic tests, and the boundaries of care as 

decisionmakers for themselves and in the role of caregiver. 

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Comprehensive Use of Existing Information Sources 

A recurrent concern of the group was that, in designing future-oriented research strategies, the 

value of existing resources not be overlooked. The group emphasized that 1) existing data resources funded by NIH should be made more widely available to the research community, 2) 

ongoing cohort studies of aging should be evaluated for and leveraged to expand relevance for 

older women’s health issues, and 3) research should have the potential to culminate in studies of effectiveness (see section 2 above). The group pointed out that large NIH investments in 

population-based research on aging (e.g., the Health and Retirement Survey6 and several international comparative studies), if expanded to incorporate issues salient to older women (either 

through new data analysis or supplemental data collection), could serve as useful tools for investigating important questions that are currently unanswered. In addition, although some 

research questions have been explored in a robust fashion, large gaps remain regarding the implementation of the results of these studies. As an illustration, members of the group expressed 

the opinion that pelvic floor exercises (Kegel exercises) are efficacious for some women in treating and preventing urinary incontinence. Women can do such exercises at virtually no cost 

in their homes, yet most women who could benefit do the exercises improperly, or not at 

all. In view of the disconnect between theory and practice, the group expressed the opinion 

that further research on pelvic floor strengthening exercises and similar low-cost interventions 

should be directed at designing and evaluating the effectiveness of home-based and public 

health strategies for helping elderly women to incorporate Kegel exercises into their daily 

lives, rather than in reestablishing the efficacy of these exercises under highly controlled, 

experimental conditions. 

Summary of the Discussion 

The working group highlighted the following seven issues. 

The Impact and Relevance of Early and Midlife Events on the Health of 

Elderly Women 

In keeping with one of the themes of the conference, namely that pregnancy can be viewed 

as a window into a woman’s health throughout her lifespan, the group discussed methods for 

linking early and midlife events to the health of older women. For example, calcium intake by 

young girls is a key determinant of peak bone mass,7

 which in turn determines whether osteoporosis occurs in older women. A clearer understanding of the connections between early and 

midlife events could result in improved strategies for preventing illness; promoting health (biological, psychological, and social); and empowering women to make more informed choices 

regarding their health. 

Given the barriers to performing the ideal study for elucidating the connections between early and midlife events and the health of elderly women (e.g., longitudinal studies with 90-year 

followup periods), new kinds of interdisciplinary research teams and new analytic methods are 

needed that could exploit existing data sources to elucidate these connections. New study designs could combine minimally invasive biological and physiological measurements (many can 

be done in the home) with gold-standard survey research methods for population-based research on aging and elderly women’s health.8 

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The Challenge of Meaningful Inclusion of Individuals With Multiple Medical 

Conditions and Complex Medication Regimens in Research Studies 

Elderly women are likely to have multiple concurrent medical conditions and to use a large 

number of medications. Recent population-based data indicate that among people ages 57– 

65, women are more likely than men to be taking multiple medications.9

 Many research studies 

are designed to exclude individuals with complex medical profiles. Alternatively, model adjustment is done with overly simple methods that count the number of multiple morbidities 

or medications. As a result, many research studies disproportionately exclude elderly women 

from participation or use analytic strategies that diminish the relevance of study findings for 

these older women. Furthermore, the traditional focus on single-disease processes leaves unexplored the effect that multiple concurrent morbidities have on the health of the individual. 

Multidisciplinary efforts are needed that aim at (1) creating a uniform approach to multiple 

concurrent morbidities in order to include elderly women in research studies, (2) designing 

studies that are relevant to the health of elderly women, and (3) ensuring that study findings 

are relevant to elderly women. 

Defining the Usual Aging Process 

Although much is known about certain aspects of the aging process (e.g., bone density, cerebral morphology, memory), there are biological, psychological, and social aspects of aging that 

remain unexplored. Although a third of the life span, on average, is spent post menopause, research on older women typically groups together all those 60 or 65 and older. For example, 

more research is needed on age-related tissue degeneration that occurs in women. It is notable that a Medline literature search combining “vulva” with “aging” or “elderly” resulted in only 

a single reference that was germane to the topic.10 However, that reference described vulvar 

changes, but did not differentiate between changes found in “menopausal” women and those 

found in elderly women. There are also major gaps in knowledge about the social and relational contexts of women’s aging and the gender differences in these contexts, including sexual 

and intimate relationships, social networks, and ideal living arrangements.11 

Roles of Aging Women 

Older women’s lives often follow a different trajectory from those of older men.12–14 Women’s 

lives are often marked by intense periods of caregiving responsibilities for parents and partners. In particular, the fact that women spend their final years without the support of their life 

partners has economic, health, psychological, and sociological consequences.15–17 Women are 

more likely to spend their final years in health care facilities (rather than in their homes), often 

with economic constraints, and often without a caregiver who can serve as an advocate 

and companion. 

Personalized Medicine 

The working group explored personalized medicine through an age/gender lens and stated 

that it is important to provide women with information and tools, including technology literacy 

that would enable women to make informed choices throughout their lives and would ensure 

that their choices would be respected by caregivers. Given the importance of computers as a 

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health information resource, the lack of computer literacy among many older women is an 

important barrier to their health care decisionmaking processes and should be addressed. 

End-of-Life Care 

The working group identified end-of-life care as an area in particular need of attention, 

especially the following concerns: 

• End-of-life care and palliative care are often accessed far too late to be 

optimally beneficial.
�

• Staff in long-term care facilities often lack the ability to identify persons for whom 

palliative care might be appropriate. 

• Women’s wishes regarding end-of-life care are often ignored because they have no 

one to represent them or advocate for their preferences. 

• Large disparities exist and remain insufficiently addressed regarding end-of-life care, for 

example, monetary resources, access to a caregiver/partner, driving/mobility, partner in 

decisions about advance directives, and ability and supportive resources to stay in one’s 

own home vs. being institutionalized.18–20 

Critical Needs 

Given the changing demographics in the United States and the impending surge of elderly patients, the working group endorsed the opinions expressed by a number of prominent groups, 

such as the International Longevity Society and the MacArthur Foundation. For example, the 

Institute of Medicine report on Work Force Needs for an Aging Society states that the existing geriatric expertise within the current health care workforce is inadequate for the projected 

needs of the changing U.S. population and that the current health care delivery system is 

poorly designed to meet the needs of the oncoming wave of elderly people.21 

Recommendations 

Based on the principles selected by the working group and the subsequent discussion, the 

working group identified the following recommendations to provide guidance to health 

administrators, clinicians, scientists and the public as to areas of investigation that merit 

greater research. 

Recommendation 1: As a basis for developing and evaluating the effectiveness of strategies to 

promote physical and cognitive resilience in the elderly, support research designed to identify early and midlife factors that are determinants of later life resilience and disease, both at the 

individual and at the community/population level. These predictive factors could be biological, 

psychological, or social/environmental. 

Recommendation 2: To make research more relevant and applicable to broader populations 

of older women, develop new strategies designed to enable the integration of information on 

multiple morbidities and medications into research design and analysis. 

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Recommendation 3: To provide reference points for identifying opportunities for research, 

establish normative data and its variation in insufficiently explored areas of aging women’s 

bodies and functions, such as female genitalia and genital tract, balance, musculoskeletal integrity, and sexual function of older women. 

Recommendation 4: To empower elderly women to make optimal health decisions—for 

themselves and others—when faced with decisions involving screening programs, diagnostic 

tests, options for treatment, and end-of-life care; conduct research aimed at understanding 

how elderly women access, process, and act on health and health care-related information 

and needs for themselves and others. Conduct research designed to assist elderly women in 

accessing reliable health-related information, including technology-based resources. 

References 

1. He, W., Sengupta, M., Velkoff, V., & DeBarros, K. (2005). Current population reports: 

Special studies: 65+ in the United States: 2005. Washington, DC: U.S. Census Bureau. 

Retrieved from http://www.census.gov/prod/2006pubs/p23-209.pdf 

2. Lindau, S. T., Schumm, P., Laumann, E., Levinson, W., O’Muircheartaigh, C., & Waite, L. J. 

(2007). A study of sexuality and health among older adults in the United States. New 

England Journal of Medicine, 357, 762–774. 

3. Zaninotto, P., Falaschetti, E., & Sacker, A. (2009). Age trajectories of quality of life 

among older adults: Results from the English Longitudinal Study of Ageing. Quality 

of Life Research, 18, 1301–1309. 

4. Qato, D. M., Alexander, G. C., Conti, R. M., Johnson, M., Schumm, P., & Lindau, S. T. 

(2008). Use of prescription and over-the-counter medications and dietary supplements 

among older adults in the United States. Journal of the American Medical Association, 

300, 2867–2878. 

5. Blue Ribbon Panel of the Society of General Internal Medicine. (2007). Redesigning the 

practice model for general internal medicine. A proposal for coordinated care: A policy 

monograph of the Society of General Internal Medicine. Journal of General Internal 

Medicine, 22, 400–409. 

6. U.S. Department of Health and Human Services, National Institutes of Health, National 

Institute on Aging. (2007). Growing old in America: The health and retirement study 

(NIH Publication No. 07-5757). Retrieved from http://hrsonline.isr.umich.edu 

7. Javaid, M. K., & Cooper, C. (2002). Prenatal and childhood influences on osteoporosis. 

Best Practice and Research: Clinical Endocrinology and Metabolism, 16, 349–367. 

8. Lindau, S. T. (2009). Sexuality, sexual function and the aging woman. In J. B. Halter, 

J. G. Ouslander, M. E. Tinetti, S. Studenski, K. P. High, & S. Asthana (Eds.), Hazzard’s 

geriatric medicine and gerontology (6th ed., pp. 567–581). New York: The McGrawHill Companies, Inc. 

178
9. Qato, D. M., Alexander, G. C., Conti, R. M., Johnson, M., Schumm, P., & Lindau, S. T. 

(2008). Use of prescription and over-the-counter medications and dietary supplements 

among older adults in the United States. Journal of the American Medical Association, 

300, 2867–2878. 

10. Farage, M., & Maibach, H. (2006). Lifetime changes in the vulva and vagina. Archives 

of Gynecology and Obstetrics, 273, 195–202. 

11. Solomon, D. H., LoCicero, J., & Rosenthal, R. A. (2004). New frontiers in geriatrics 

research: An agenda for surgical and related medical specialties (pp. 235, 286, 289, 293). 

New York: American Geriatric Society. 

12. Allen, S. M. (1994). Gender differences in spousal caregiving and unmet need for care. 

Journal of Gerontology, 49(4), S187–S195. 

13. Katz, S. J., Kabeto, M., & Langa, K. M. (2000). Gender disparities in the receipt of home 

care for elderly people with disability in the United States. Journal of the American 

Medical Association, 284, 3022–3027. 

14. Navaie-Waliser, M., Spriggs, A., & Feldman, P. H. (2002). Informal caregiving: Differential 

experiences by gender. Medical Care, 40, 1249–1259. 

15. Katz, S. J., Kabeto, M., & Langa, K. M. (2000). Gender disparities in the receipt of home 

care for elderly people with disability in the United States. Journal of the American 

Medical Association, 284, 3022–3027. 

16. Navaie-Waliser, M., Spriggs., A., & Feldman, P. H. (2002). Informal caregiving: differential 

experiences by gender. Medical Care 40, 1249–1259. 

17. Roth, D. L., Perkins, M., Wadley, V. G., Temple, E. M., & Haley, W. E. (2009). Family caregiving and emotional strain: Associations with quality of life in a large national sample 

of middle-aged and older adults. Quality of Life Research, 18, 679–688. 

18. Rhodes, R., & Teno, J. M. (2009). What’s race got to do with it? Journal of Clinical Oncology, 27, 5496–5498. 

19. Shugarman, L. R., Decker, S. L., & Bercovitz, A. (2009). Demographic and social characteristics and spending at the end of life. Journal of Pain and Symptom Management, 38, 

15–26. 

20. Rhodes, R. L., Teno, J. M., & Connor, S.R. (2007). African American bereaved family 

members’ perceptions of the quality of hospice care. Journal of Pain and Symptom 

Management, 34, 472–479. 

21. Institute of Medicine. (2008). Retooling for an aging America: Building the health 

care workforce. Washington, DC: The National Academies Press. Retrieved from 

http://www.iom.edu/Reports/2008/Retooling-for-an-Aging-America-Building-theHealth-Care-Workforce.aspx 

179
ORAL HEALTH AND SYSTEMIC CONDITIONS 

Cochairs: 

Raul Garcia, D.M.D., M.M.Sc.
�

Boston University, Henry M. Goldman School of Dental Medicine 

Brenda Heaton, M.P.H. 

Boston University, Henry M. Goldman School of Dental Medicine 

Michelle Henshaw, D.D.S., M.P.H. 

Boston University, Henry M. Goldman School of Dental Medicine 

NIH Cochair:
�

Jane Atkinson, D.D.S.
�

National Institute of Dental and Craniofacial Research 

Science Writers: 

Stephanie R. Forschner 

University of Rhode Island 

Margaret E. Teasdale 

University of Rhode Island 

Introduction 

Prior to the discussion by the Working Group on Oral Health and Systemic Conditions, several 

speakers presented information addressing how to identify gaps in the current state of knowledge, the specific impact of oral health on women’s health, and future research needs. The 

presentation topics were as follows: 

• Oral health and systemic disease in women, with an emphasis on the oral–systemic links 

during the perinatal period 

• Early childhood caries 

• Sjögren’s syndrome 

• Temporomandibular disorders and chronic pain 

• Salivary diagnostics 

• Bisphosphonate-associated osteonecrosis of the jaw 

• Oral cancer 

To facilitate discussion about the lifespan, the group created a chart and divided it into five 

components representing the lifespan. An additional category was used for areas cross-cutting the lifespan. As the discussion progressed, topic areas and research ideas were recorded 

on the chart. 

* The cochairs gratefully acknowledge the premeeting assistance of the following individuals in providing concepts and preparing 

material on key topics in oral health: Kim Boggess, Christopher Engeland, Mark Heft, Linda Kaste, Stefanie Russell, Jeanne Sinkford, 

David Wong, and Athanasios Zavras. Their affiliations are included in the participant list. 

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The focus of the working group was the connection between oral health and systemic disease; therefore, discussions emphasized that the mouth is a window to a person’s general 

health status.1

 Two main themes emerged: 1) oral health is integral to general health, and the 

two should not be evaluated in isolation; and 2) oral–systemic relationships are bidirectional 

and extremely complex. 

Summary of the Discussion 

Oral Health and Pregnancy 

The working group elaborated on a theme that had been presented in the plenary session of 

the ORWH conference: Conditions unmasked during pregnancy, such as diabetes, could predict future chronic disease, such as cardiovascular disease. The group discussed the potential 

for oral conditions during pregnancy to also serve as a window to future oral conditions, such 

as periodontal disease. Additional discussion highlighted the following concepts: 

• The biology of pregnancy, including hormonal alterations, salivary changes, immunological changes, and changes in microbial community structure, have a demonstrated 

negative effect on oral health, including gingival health and periodontal disease, the 

effects of which may be clinically significant. 

• Sociological factors, such as gender roles, socioeconomic status, and psychological 

factors, likely contribute to oral health outcomes during pregnancy. 

• Pregnant women are less likely to visit the dentist than nonpregnant women, and 

evidence is lacking about the safety of treating women during pregnancy. 

• Despite the null results found in two randomized trials evaluating the effect of dental 

treatment in the second trimester on the prevention of adverse birth outcomes among 

women with periodontal disease, the trials resulted in several significant findings and implications for future research.2,3 Of particular importance was the finding that it was safe 

to provide standard periodontal therapy to pregnant women at that point. This finding 

alone will significantly contribute to the paucity of evidence regarding possible risks 

associated with treating women during pregnancy. 

Remaining unanswered questions regarding periodontal disease, its therapy during pregnancy, 

and its effect on improving birth outcomes include 1) whether the inflammatory response associated with periodontal disease is responsible for the observed adverse birth outcomes and, 

if so, 2) whether there is an ideal time in which periodontal therapy can be done at the lowest 

risk possible. 

During the discussions, additional areas of needed research were identified. These areas 

included the following: 

• Development of health policy based on empirical findings to improve access to and use 

of oral health care by women across their lifespan 

• Additional understanding of whether pregnancy promotes or accelerates dental disease, 

including periodontitis and dental caries 

• Exploring how oral health status during pregnancy might be a window to future disease 

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• Promoting positive health behaviors during the perinatal period that will improve the 

long-term health and oral health of women and their offspring 

Early Childhood Caries 

Early childhood caries (ECC) is the most common chronic disease in children, particularly 

those living in poverty who have limited access to dental care.4 ECC is increasing significantly 

in children ages 2 to 5, resulting in a larger number of fillings and increased overall cost 

for care, with large disparities of incidence in minority and poor populations. The mother is 

considered to be the “gatekeeper” to a child’s propensity to develop the disease in both 

biological and social contexts. 

To date, research has focused on the causes of ECC as the interactions among the oral microflora, the host dentition, and the substrate. Future research should also explore 1) the effects 

of family and social life, 2) maternal-child transmission, 3) understanding the determinants of 

ECC, 4) multimodal and curative interventions, and 5) comparative effectiveness research on 

ECC prevention. Furthermore, the development of salivary diagnostics may enhance detection 

of early risk for ECC and increase the understanding of bacterial colonization and virulence. 

Sjögren’s Syndrome 

As many as 3.1 million people suffer from Sjögren’s syndrome, and an estimated 90 percent are 

women. The risk of developing the disease increases significantly around the time of menopause.5 Currently, there are no accepted criteria or tools for diagnosing Sjögren’s syndrome, 

and no outcome criteria for trials testing the biological agents for treatment. The understanding of Sjögren’s syndrome is severely limited, with the following gaps commonly cited in the 

research literature: 

• Absence of universally accepted classification criteria resulting in a lack of good 

prevalence or incidence data in any population 

• Insufficient understanding of etiology and pathogenesis 

• Lack of clarification of differences in genetic predisposition for primary versus 

secondary cases
�

• Scarcity of studies establishing optimal dental treatment for those with salivary 

dysfunction as a result of Sjögren’s syndrome
�

• The role of sex hormones and their mechanism of action in the development of 

the disease
�

• The impact on quality of life 

Temporomandibular Disorders and Chronic Pain 

Temporomandibular disorders (TMDs) share common symptoms with other chronic autoimmune disorders, such as chronic fatigue syndrome and fibromyalgia. However, whether and 

how these diseases share common etiologies are not understood. Recent studies show that 

medical management is as effective as surgical intervention. Future research should center on 

the genetics of TMD, chronic pain, and autoimmune disorders and should explore the potential 

presence of common pathophysiologies between them. 

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Salivary Diagnostics 

Studies are underway to validate the ability of salivary diagnostics to identify biomarkers in 

the saliva for a few diseases (e.g., Sjögren’s syndrome, oral cancer). If embraced by practitioners, this technology may improve access to care, decrease health disparities, accelerate the 

diagnosis and treatment of a disease, and significantly affect global health.6 Research is still 

needed to understand the biological mechanism of the presence of biomarkers in the saliva 

for diseases affecting distant diseased organs, such as breast cancer.7 

Bisphosphonate-Associated Osteonecrosis of the Jaw 

Bisphosphonates (BPs) are drugs that prevent or treat bone resorption through selective inhibition of osteoclastic activity. More than 3 million American women receive oral BPs to control 

or prevent osteoporosis, and a smaller fraction receives intravenous BPs during cancer therapy to control bone metastases, bone pain, or hypercalcemia. Use of high doses of intravenous 

BPs, and on rare occasion low doses of oral BPs, has been associated with the development of 

osteonecrosis of the jaw (ONJ), a serious condition.8 Because the pathophysiology of bisphosphonate-induced ONJ is unclear, research is needed to understand the details about its etiology, 

prevention, and treatment. Similarly, methods are needed to predict who is susceptible to developing ONJ in order to allow population screening prior to BP initiation. Research is also needed 

on the oral health outcomes of long-term use of oral BPs, such as osteopetrosis of the jaw, especially as they relate to dental procedures such as surgical extractions, dental implant placement, 

and orthodontics. 

Oral Cancer 

Although oral cancer in the United States is typically thought of as a man’s disease, the annual incidence among women is substantial—similar to that of cervical cancer. The American 

Cancer Society estimates indicate that 11,270 new U.S. cases of cervical cancer and 10,480 new 

U.S. cases of oral cavity and pharynx cancer will be diagnosed in women in 2009.9

 Several regional studies have shown that awareness of oral cancer and its risk factors among the general 

population and the medical community is consistently low. The literature also indicates that 

although men and women with oral cancer share risk factors, their risk profiles are not identical. Similarly, for reasons not adequately understood, equal exposures to tobacco alone and 

tobacco combined with alcohol have been shown to lead to different risk levels for men and 

women, with the risk for women being greater. An understanding is needed of how hormones, 

nutrition, tissue wound response, and health behaviors of women affect oral cancer incidence 

because this area is largely understudied. In particular, future research should investigate a 

possible relationship between human papilloma virus (HPV) exposure, HPV oral infection, 

and oral cancer in women, and should monitor the impact of the HPV vaccine on rates of oral 

cancer in women. Equally interesting would be studies that explain the disparity in oral cancer rates among men (estimates for 2009 indicate 25,240 new cases) and women seen in the 

United States, but not as seen in the homelands of major immigrant groups to this country,10 

and to investigate whether interventions that decrease the incidence of oropharyngeal cancer 

in men are appropriate for or adaptable to women. 

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Recommendations 

The following research recommendations may help to provide guidance to health administrators, the health professions, clinicians, scientists, and the public as to areas of investigation 

that merit greater research. 

Recommendation 1: Salivary Diagnostics 

• Research the underlying biology of salivary diagnostics and its translation into research, 

clinical care, and population applications for diseases particularly affecting women’s 

health (Sjögren’s syndrome, breast cancer, ovarian cancer, diabetes mellitus type II). 

• Encourage genomic studies of oral diseases such as caries, periodontal diseases, 

and Sjögren’s syndrome using salivary diagnostics and evaluating the effectiveness 

of salivary biomarkers to predict diseases throughout the woman’s lifespan. 

Recommendation 2: Pregnancy and Oral Health 

• Continue research to clarify the relationship between periodontal disease and 

adverse birth outcomes.
�

• Conduct longitudinal studies that would lead to an understanding of whether changes 

unmasked during pregnancy predict future oral diseases (e.g., periodontal disease). 

• Promote behavioral interventions that would serve to increase access to and use of dental care for women during pregnancy. Explore whether women are more amenable to 

oral health behavioral change interventions during pregnancy in an effort to improve oral 

health for themselves or their offspring. 

• Encourage genetic and behavioral studies to evaluate maternal risk factors for offspring 

with craniofacial abnormalities. 

Recommendation 3: Chronic Disease and Oral Health 

• Encourage additional research on pathophysiology, genetics, systemic treatments, and 

evidenced-based treatments for chronic diseases with oral health sequelae, such as 

• Sjögren’s syndrome; 

• chronic facial pain syndromes such as temporomandibular disorders; 

• cancers of the oral cavity and pharynx; 

• eating disorders, depression, and HIV; and 

• diabetes. 

Recommendation 4: Impact of Systemic Disease Treatments on Oral Health 

• Research oral health outcomes of commonly used medications to treat systemic 

diseases, including the development of serious adverse effects. 

• Evaluate the pathophysiology of oral adverse effects, prevention, and optimal 

therapies of women receiving the following:
�

• Cancer chemotherapy (associated with mucositis and other conditions that might 

compromise the patient’s survivorship and well-being). 

184
• Bisphosphonates, either intravenous therapies to control cancer or oral medications 

to control or prevent osteoporosis (associated with osteonecrosis of the jaw and/ 

or osteopetrosis). 

• Stem cell transplantation (associated with a number of serious oral complications). 

• Radiation damage to head and neck tissue (associated with soft-tissue lesions 

and osteoradionecrosis). 

• Drug-induced xerostomia (associated with increased dental caries rates and 

reductions in quality of life). 

• Highly active antiretroviral therapy (suspected to be associated with effects on 

the oral health of offspring of HIV-positive mothers). 

Recommendation 5: Oral Cancer 

• Research the complex interactions among hormones, nutrition, tissue wound 

response, and behaviors of women across the lifespan, and how they affect oral 

cancer development. 

• Evaluate the potential link between HPV and oral cancer in women and include 

monitoring of oral cancer rates in women as HPV vaccine use increases. 

• Research behavioral change interventions to evaluate strategies for decreasing oral 

and pharyngeal cancer risk factors in women. 

Recommendation 6: Caries Prevention across the Lifespan 

• Encourage research to identify the maternal role in transmission and management 

of caries. 

• Support multimodal interventions that reflect the complex nature of the caries 

process in order to increase the effectiveness of prevention strategies.
�

• Establish best practices for interventions that address the oral health needs of the elderly. 

Recommendation 7: Pain 

• Conduct basic and clinical research to understand where, when, and why oral/facial/ 

cranial pain occurs. 

• Research the relationship between hormonal changes and increased incidence of 

temporomandibular disorders and other chronic pain syndromes. 

• Evaluate current and new treatment options for the management of chronic pain. 

Recommendation 8: Hormones across the Lifespan 

Encourage research to better understand the role of hormonal changes on oral health outcomes throughout a woman’s life, particularly the changes that accompany menopause and 

the menopausal transition. 

Recommendation 9: Longitudinal Studies 

• Continue and expand oral health measures in national population-based studies, including the Behavioral Risk Factor Surveillance System, National Health Interview Survey, and 

185
National Health and Nutrition Examination Survey; and integrate them into large, ongoing 

cross-sectional and prospective studies. 

• Communicate the value of women’s oral health and the need to include women in all 

clinical trials for data collection, interpretation, and outcomes. 

• Ensure that the “new science” (e.g., genomics, proteomics) includes oral components 

as major contributors to the understanding of general health and health treatment 

outcomes in the future. 

Recommendation 10: Update women’s health in medical and dental curriculum and other 

health profession studies as the foundation of knowledge required for the understanding of 

women’s health across a lifespan and for the training of future health professionals. 

Recommendation 11: Provide leadership training at the executive level so that global 

collaborations can be arranged that relate to women’s health initiatives across disciplines 

and populations. 

Recommendation 12: Provide mentored training programs such as Building Interdisciplinary 

Research Careers in Women’s Health that target health issues affecting women and girls. 

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A report of the Surgeon General (p. 10). Rockville, MD: U.S. Department of Health & 

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E., . . . Tschida, P. A. (2006). Treatment of periodontal disease and the risk of preterm 

birth. New England Journal of Medicine, 355, 1885–1894. 

3. Offenbacher, S., Beck, J. D., Jared, H. L., Mauriello, S. M., Mendoza, L. C., Couper, D. J., 

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3, c-erbB-2, epidermal growth factor receptor, cathepsin-D, and p53 in saliva among 

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8. King, A.E. & Umland, E.M. (2008). Osteonecrosis of the jaw in patients receiving 

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�

9. American Cancer Society. 2009. Cancer Facts & Figures 2009. Atlanta: American 

Cancer Society 

10. Garcia M, Jemal A, Ward EM, Center MM, Hao Y, Siegel RL, Thun MJ. 2007. Global Cancer 

Facts & Figures 2007. Atlanta, GA: American Cancer Society. 

CAREERS IN DENTISTRY, BIOENGINEERING, AND OTHER 

NON-M.D. DISCIPLINES 

Cochairs:
�

Paula Friedman, D.D.S., M.S.D., M.P.H.
�

Henry M. Goldman School of Dental Medicine, Boston University 

Valerie Wilson, Ph.D. 

Brown University 

Catherine K. Kuo, Ph.D. 

Tufts University 

NIH Cochairs: 

Belinda Seto, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

Brenda Korte, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

Science Writer:
�

Nicole M. Capezza, Ph.D.
�

The Warren Alpert Medical School of Brown University 

Introduction 

The charge to the Working Group on Careers in Dentistry, Bioengineering, and Other Non-M.D. 

Disciplines was to develop recommendations for advancing women in those disciplines over the 

next 10 years. Participants developed a list of topics for discussion: mentoring, reentry, retention, interdisciplinary research, part-time work, leadership, minorities, tenure and promotion, 

and unique obstacles to women’s careers. 

Group participants noted that many barriers for women in the workforce that exist today were 

there 30 years ago, and that the recommendations from the 1991 ORWH workshop on careers 

reflect some of the same issues that are of concern today, such as the lack of productive networking opportunities, mentoring, and reentry programs. Underlying the barriers to effective 

participation in advancing women’s health may be the apparent lack of prestige of the field 

of women’s health as a professional enterprise. 

187
Summary of the Discussion 

The discussion centered on several key issues that led to the group’s recommendations: career 

tactics and paths, training opportunities, and mentoring. 

Career Tactics and Paths 

The group observed that although men and women may end up at the same point in their careers, the career path may take different trajectories. Whereas a man’s career path typically 

might be linear, this is less likely to be the case for women. Women face several challenges, including meeting societal expectations and balancing family and work. Women in science and 

engineering positions continue to face unique pressures associated with stereotypes and social 

norms about women’s competence and ability to succeed in these fields. Such pressures often 

impact the career choices and opportunities of women. 

Women are more likely than men to make measured, calculated career decisions and to consider many factors in a three-dimensional matrix paradigm (e.g., family, childcare, and profession) 

when making career choices and considering promotion or leadership opportunities. The delicate and challenging balance between work and family is always a consideration and often 

creates unique workforce models that may include part-time work, lateral moves, career shifts, 

or extended leaves of absence for childcare or other family responsibilities. Research careers 

nearly always extend beyond an 8-hour workday, and women with children need resources to 

meet their family obligations. The option of part-time work is often rebutted by colleagues and 

supervisors, with the assumption that part-time workers are not successful; however, research 

has not been conducted to examine whether this assumption is accurate. One approach to addressing this part-time question might be to reconceptualize K awards (which provide support 

and “protected time” [3–5 years] for an intensive, supervised career development experience 

in the biomedical, behavioral, or clinical sciences leading to research independence) or create 

new awards to support part-time workers and evaluate their outcomes. 

To attract women to biomedical careers, more female representation and diversity within leadership positions is necessary. Female students often believe the stereotype that females are not 

competent in math and science, which leads them to choose other career paths. Female role 

models in these fields are needed to assure young girls that they can succeed in these fields. 

However, women are not offered leadership opportunities as often as men; thus, women risk 

failure more than men once women reach these positions. Women need to be given the opportunity for leadership positions and then must be trained and willing to take the risk once the 

opportunity arises. As women age, they are usually liberated from principal family obligations 

(children are out of the home) and are able to focus more on their career. Policymakers and 

researchers should consider how to reset the image of women so that they are considered 

for leadership positions and opportunities at every age, including when they are older. 

In discussion of models where women have achieved success and stature, the military was 

raised as an example of meritocracy. In seeking to identify what characteristics were unique to 

the military environment that might be modeled in other areas, participants honed in on what 

was necessary for advancement. Participants concluded that the rules for promotion in any 

188
work environment need to be clear, as they are in the military. However, this is not the case in 

some other sectors. In addition, the academy generally imposes unique time constraints and 

frameworks for advancement to award of tenure, meaning that if tenure is not achieved within 

a designated period, the opportunity is lost. In academia, this translates to the maxim “publish 

or perish.” But consideration should be given to stopping or adjusting tenure clocks to accommodate the unique characteristics of women’s career paths. 

The differences between industry and academic positions should be made clear to women. In 

industry, the corporate, and therefore common, goal is to increase the bottom line, which leads 

to more collaboration and teamwork. In turn, this tends to accommodate and provide resources 

for helping with family obligations (e.g., childcare). This is not the case in academia, where the 

environment is more one of individual competition. Childcare options and resources for faculty as well as postdoctoral fellows and graduate students are needed in many universities. 

What are the risks and myths associated with changing career paths? Women are often told 

that moving from one sector to another may ruin their careers (e.g., that they may be unable 

to reenter a research career once they leave). How can we change the stigma associated with 

changing career paths? How can we liberate women to feel free to pursue alternative career 

paths without fear of professional recriminations? Do we need to change the model of what 

constitutes a successful career? Women with Ph.D.s are often told that having a position at 

an R1 research university is the only way to be successful (R1 research universities offer a full 

range of baccalaureate programs, are committed to graduate education through the doctorate, 

give high priority to research, award 50 or more doctoral degrees each year, and receive annually $40 million or more in Federal support). Success is measured by publications and grants, 

but this may not be the best measure. Research is needed to address the best way to measure 

success. These measures will have clear implications for promotion and tenure decisions that 

are crucial for women’s advancement in academic and nonacademic careers. 

Training Opportunities 

Training opportunities, such as reentry and retraining, should be available to women throughout their careers. Refresher courses might be valuable for women trying to get back into a 

field after a break (e.g., taking time out to have children). Today, because of a lack of available 

academic positions (among other reasons), more women are choosing careers in smaller universities, which often makes them less viable candidates for R1 university positions or other career 

advancement opportunities. Yet, small liberal arts schools might provide a nurturing, supportive environment for women scholars, both in training and as faculty, an environment that could 

overcome barriers to career advancement if the colleges were given the resources to assist 

women researchers through mentoring and collaboration. 

Research is needed to examine the success of current training programs. For example, are the 

postdoctoral reentry programs and similar programs at NIH successful? Is better dissemination of these programs needed to increase applications? Do historically all-female colleges and 

universities provide an operational model that fosters collaboration and risk taking more than 

coeducational institutions? Do they provide more supportive entry and retraining points? 

189
Mentoring 

A central, nationwide mentoring network would benefit women throughout their careers as a 

central location to ask for advice and obtain deeper resources than those available at any individual institution. Women often need multiple mentors to address a wide range of issues, 

including current workplace expectations, family situations, research direction, and future career opportunities. A professional needs an adviser in her field to advise her about meeting 

career goals and finding career opportunities. In addition, some women could benefit from a 

coaching relationship (support, encouragement, and problem solving to help with life skills and 

family situations). A central mentoring network Web site would accommodate various types of 

mentoring and coaching on all facets of a woman’s career. It would also be a place to find 

opportunities for collaborations and interdisciplinary research, career positions, and advice. 

Women may need anonymous advice on how best to handle delicate work-related issues. 

Having a mentor outside of one’s institution offers the benefit, at least in theory, of a “politically safe” environment in which one may share information or ask candid questions without 

fear of local repercussions. A network would also broaden the professional expertise available to all junior faculty members, researchers, and trainees. 

Not everyone is suited to be a mentor or a mentee. Mentoring requires mutual trust and respect. Assigned mentors are generally not as effective as mentors chosen by the mentees. 

Effective mentorship generally requires training. Mentors should be trained in leadership skills 

(e.g., active listening, giving and receiving feedback, effective networking, constructive criticism, time management, budget skills). They should be informed about career options in all 

employment realms. Senior women in high-ranking positions might receive focused training on 

how to recruit junior women into a position and train them as replacements (succession planning). Such developmental opportunities for women are much more likely to be offered from 

other women than from men. 

A compilation of best mentoring practices is needed, as is timely dissemination of such information. A meta-analysis is needed to determine the effectiveness of various programs, such as 

child care centers; loan repayment programs; banks of donated leave time from which colleagues could draw, without need of repayment, for emergency personal leave needs; and 

principal investigator (PI) replacement programs for daily laboratory functioning (e.g., a lab 

manager to take over PI responsibilities in a PI’s absence). All of these programs affect women’s career paths. Having a central location where women can access information about such 

programs would assist them when making career choices. Having a compendium of research 

on these policies and programs also would be beneficial to institutions and organizations 

interested in establishing similar programs. 

Recommendations 

To meet current and future needs of women in biomedical careers, the working group 

identified the following recommendations to provide guidance to academic institutions and 

administrators, the health professions, clinicians, and scientists. 

190
Recommendation 1: Further Research 

• Evaluate the risk-taking behaviors and choices involved for girls and women to enter, 

remain in, and advance along the career continuum. 

• Fund pilot studies to learn more about part-time workers; specifically, the success 

of part-time workers and the challenges they face. 

Recommendation 2: Resource Development 

• Establish effective collaboration and networking nationwide by developing an Internetbased network of mentorship for all levels of careers that would provide connections 

for collaborations, career development, and job opportunities across disciplines. 

• Develop a compendium of best practices of factors that affect and support careers. 

• Develop new ways to measure success in academia, moving away from a focus 

primarily on publications. 

Recommendation 3: Training Needs 

• Develop flexible reentry/retraining programs for various careers across the professional 

lifespan beyond biomedical and behavioral research. 

• Encourage leadership training in all ORWH- and NIH-funded grants, with the goal of 

teaching mentors about multiple career pathway options, creating more diversity in 

leadership structures, and providing incentives for leadership training for women. 

191
A Vision for 2020 for Women’s Health Research: Moving 

into the Future with New Dimensions and Strategies 

Northwestern University Feinberg School of Medicine 

Northwestern Memorial Hospital 

Chicago, Illinois 

October 14–16, 2009 

DAY 1—PUBLIC HEARING 

Location: Feinberg School of Medicine, Robert H. Lurie Medical Research Center 

12:00–1:00 p.m.	� Registration 

1:00–1:15 p.m.	� Welcome 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health, 

Director, Office of Research on Women’s Health (ORWH), 

National Institutes of Health (NIH) 

Andrea Dunaif, M.D. 

Charles F. Kettering Professor of Medicine, Chief, Division of 

Endocrinology, Metabolism, and Molecular Medicine, Feinberg 

School of Medicine, Northwestern University 

1:15–2:30 p.m.	� OPENING PANEL: Diverse Populations 

and Disparities 

Moderator: Barbara (Bobby) W. K. Yee, Ph.D. 

Professor and Chair of the Department of Family and 

Consumer Sciences, College of Tropical Agriculture and 

Human Resources, University of Hawaii at Manoa 

Eleanor Hinton Hoytt, M.S., M.A. 

President and CEO, Black Women’s Health Imperative 

Nancy Woods, Ph.D., R.N. 

Dean, School of Nursing, University of Washington 

Francisco A. R. Garcia, M.D., M.P.H. 

Professor of Obstetrics & Gynecology and Public Health, 

Director, Center of Excellence in Women’s Health, University 

of Arizona 

Carolyn Stern, M.D. 

Physician and Partner, DeafDOC.org, Unity Health System 

192
2:30–2:45 p.m. Video Tribute by Tavis Smiley on Women’s 

Health Research 

Tavis Smiley 

PBS Broadcaster, Author, Advocate, and Philanthropist 

Introduced by: Vickie M. Mays, Ph.D., M.S.P.H. 

University of California, Los Angeles 

2:45–5:30 p.m.	� PUBLIC HEARING 

Moderator: Andrea Dunaif, M.D. 

Receiving Public Testimony: Members of the ORWH 

Advisory Committee, NIH Coordinating Committee, 

and host scientists 

DAY 2—SCIENTIFIC WORKSHOPS 

Location: Thorne Auditorium, Arthur Rubloff Building, Northwestern University, Chicago, IL 

7:30–8:30 a.m.	� Registration 

8:30–8:45 a.m.	� Welcome and Opening Remarks 

Vivian W. Pinn, M.D. 

Daniel I. Linzer, Ph.D. 

Provost, Northwestern University 

8:45–8:55 a.m.	� Welcoming Remarks 

Maggie Daley 

First Lady of the City of Chicago 

8:55–9:30 a.m.	� Keynote Address: 2009 H1N1 Influenza: 

Research Activities and Potential Impact 

on the Nation and its Women 

Carole Heilman, Ph.D. 

Director, Division of Microbiology and Infectious Diseases, 

National Institute of Allergy and Infectious Diseases 

193
9:30–10:15 a.m. PANEL: New Technologies—Overview and 

State of the Science 

Moderator: Colleen M. Fitzgerald, M.D. 

Assistant Professor, Feinberg School of Medicine, Northwestern University, Director, Women’s Health Rehabilitation 

Program, Rehabilitation Institute of Chicago 

Todd Kuiken, M.D., Ph.D. 

Associate Dean of Academic Affairs, Feinberg School of 

Medicine, Northwestern University 

Teresa K. Woodruff, Ph.D. 

Professor of Obstetrics & Gynecology, Feinberg School 

of Medicine, Professor of Biochemistry, Molecular Biology 

and Cell Biology, Weinberg College of Arts and Sciences, 

Northwestern University 

10:15–10:30 a.m. Working Group Charge 

Vivian W. Pinn, M.D. 

10:30 a.m.–3:15 p.m. Lunch and Concurrent Working Groups 

• Understudied and Underrepresented Populations: 

Minorities, Urban, Rural, Disabilities, and Issues of Poverty 

• Understudied and Underrepresented Populations: 

Lesbian, Bisexual, Transgender, and Intersex Issues 

• Clinical and Translational Research 

• New Technologies/Bioengineering/Imaging 

• Genetics and Epigenetics 

• Sex Hormones and Disease 

• Neuroscience 

• Women in Science Careers 

3:15–3:30 p.m. BREAK 

3:30–5:00 p.m. PANEL: Team Science at 

Northwestern University 

Moderator: Holly Falk-Krzesinski, Ph.D. 

Director of the Office of Research Team Support, 

NUCATS Institute and Office for Research Development, 

Office for Research 

Noshir Contractor, Ph.D. 

Director, Science of Networks in Communities (SONIC) and 

Professor, McCormick School of Engineering & Applied Sciences-Industrial Engineering and Management Sciences, School 

of Communication-Communication Studies, and Kellogg 

School of Management-Management and Organizations 

194
Brian Uzzi, Ph.D. 

Co-Director, Northwestern Institute on Complex Systems 

and Professor, Kellogg School of Management—Management 

and Organizations; Weinberg College of Arts & Sciences— 

Sociology; McCormick School of Engineering & Applied 

Sciences—Industrial Engineering and Management Sciences 

5:00–6:00 p.m. Conference Reception 

DAY 3—SCIENTIFIC WORKSHOPS 

Location: Plenary Session, Thorne Auditorium; Breakouts, Wieboldt Hall 

8:30–8:40 a.m. Opening Remarks 

Janine Austin Clayton, M.D. 

Deputy Director, Office of Research on Women’s Health 

8:40–9:15 a.m. Keynote Address: Retaining Women 

in Academic Careers 

Phoebe S. Leboy, Ph.D. 

President, National Association for Women in Science 

9:15–10:45 a.m. Concurrent Work Groups: Finalization 

of Recommendations 

10:45–11:00 a.m. BREAK 

11:00 a.m.–12:30 p.m. Working Group Presentations by Cochairs 

and Discussion of Working Group Results 

Moderator: Andrea Dunaif, M.D 

12:30–12:45 p.m. Closing Remarks 

Andrea Dunaif, M.D. 

Vivian W. Pinn, M.D. 

195
Northwestern University Feinberg School of Medicine 

Northwestern Memorial Hospital 

Chicago, Illinois 

October 15–16, 2009 

WORKING GROUP COCHAIRS 

UNDERSTUDIED AND UNDERREPRESENTED POPULATIONS 

Vickie M. Mays, Ph.D., M.S.P.H. 

Department of Health Services 

University of California, Los Angeles School of Public Health 

Los Angeles, California 

Gloria Sarto, M.D., Ph.D. 

Professor, Department of Obstetrics & Gynecology 

Co-Director, Center for Women’s Health Research 

University of Wisconsin–Madison 

Madison, Wisconsin 

UNDERSTUDIED AND UNDERREPRESENTED POPULATIONS SUBGROUP 1: MINORITIES, URBAN, RURAL, AND ISSUES OF POVERTY 

Pamela K. Brown, M.P.A. 

Associate Director, Mary Babb Randolph Cancer Center 

Past Chair, Intercultural Cancer Council 

Morgantown, West Virginia 

Rebecca L. Clark, Ph.D. 

Extramural Program Staff 

Demographic & Behavioral Sciences Branch 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Naomi Lynn Gerber, M.D. 

Director, Center for the Study of Chronic Illness and Disability 

George Mason University 

Fairfax, Virginia 

Celia J. Maxwell, M.D. 

Assistant Vice President for Health Sciences 

Howard University Hospital 

Washington, D.C. 

196
Anne E. Sumner, M.D. 

Investigator 

National Institute of Diabetes and Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Derrick C. Tabor, Ph.D. 

Centers of Excellence Program, Office of Scientific Programs 

National Institute on Minority Health and Health Disparities 

National Institutes of Health 

Bethesda, Maryland 

UNDERSTUDIED AND UNDERREPRESENTED POPULATIONS 

SUBGROUP 2: LESBIAN, BISEXUAL, TRANSGENDER, AND 

INTERSEX ISSUES 

Christine A. Bachrach, Ph.D. 

Acting Director 

Office of Behavioral and Social Sciences Research 

National Institutes of Health 

Bethesda, Maryland 

Judith Bradford, Ph.D. 

Professor, Institute for Women’s Health 

Virginia Commonwealth University 

Co-Chair, The Fenway Institute, Fenway Health 

Boston, Massachusetts 

Tonda L. Hughes, Ph.D. 

Research Director, Professor, Department Head 

National Center of Excellence in Women’s Health 

College of Nursing 

University of Illinois at Chicago 

Chicago, Illinois 

Alicia Matthews, Ph.D. 

Associate Professor, Department of Health Systems Science 

University of Illinois at Chicago 

Chicago, Illinois 

Diane Abbe Sabin, D.C. 

Executive Director 

Lesbian Health & Research Center 

University of California, San Francisco 

San Francisco, California 

197
CLINICAL AND TRANSLATIONAL RESEARCH 

Mary A. Foulkes, Ph.D. 

Research Professor, Department of Epidemiology and Biostatistics, Department of Health Policy 

The George Washington University 

Washington, D.C. 

Stacie E. Geller, Ph.D. 

Professor, Department of Obstetrics and Gynecology 

Center for Research on Women and Gender 

University of Illinois at Chicago 

Chicago, Illinois 

Martha Hare, Ph.D., R.N. 

Health Scientist Administrator/Program Director 

National Cancer Institute 

National Institutes of Health 

Bethesda, Maryland 

Carole Ann Heilman, Ph.D. 

Director, Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Kwame Osei, M.D. 

Professor of Medicine 

The Ohio State University 

Columbus, Ohio 

NEW TECHNOLOGIES/BIOENGINEERING/IMAGING 

John O. DeLancey, M.D. 

Professor, Department of Obstetrics and Gynecology 

University of Michigan 

Ann Arbor, Michigan 

Guoying Liu, Ph.D. 

Program Director 

National Institute of Biomedical Imaging and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging and Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

198
Teresa K. Woodruff, Ph.D. 

Professor of Obstetrics and Gynecology, Feinberg School of Medicine 

Professor of Biochemistry, Molecular Biology, and Cell Biology, Weinberg College of Arts 

and Sciences 

Northwestern University 

Chicago, Illinois 

GENETICS AND EPIGENETICS 

M. Geoffrey Hayes, Ph.D. 

Assistant Professor, Division of Endocrinology 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Kathryn Sandberg, Ph.D. 

Professor of Medicine 

Director, Center for the Study of Sex Differences 

Georgetown University 

Washington, D.C. 

Susan Taymans, Ph.D. 

Program Director 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

SEX HORMONES AND DISEASE 

Louis V. DePaolo, Ph.D. 

Chief, Reproductive Sciences Branch 

Eunice Kennedy Shriver National Institute for Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Andrea Dunaif, M.D. 

Professor and Chief, Division of Endocrinology, Metabolism and Molecular Medicine 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

David A. Ehrmann, M.D. 

Professor of Medicine 

Associate Director, University of Chicago Clinical Research Center 

Director, University of Chicago Center for PCOS 

University of Chicago 

Chicago, Illinois 

199
Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

University of Colorado-Denver School of Medicine 

Aurora, Colorado 

NEUROSCIENCE 

Jon E. Levine, Ph.D. 

Professor, Department of Neurobiology and Physiology 

Northwestern University 

Evanston, Illinois 

Cheryl L. Sisk, Ph.D. 

Director, Neuroscience Program 

Michigan State University 

East Lansing, Michigan 

WOMEN IN SCIENCE CAREERS 

Molly L. Carnes, M.D., M.S. 

Professor and Center Director 

University of Wisconsin–Madison 

Madison, Wisconsin 

Sandra Kazahn Masur, Ph.D. 

Director, Office for Women’s Careers 

Department of Ophthalmology 

Mount Sinai School of Medicine 

New York, New York 

Rodney E. Ulane, Ph.D. 

Director, Division of Scientific Programs 

Office of Extramural Research 

Office of the Director 

National Institutes of Health 

Bethesda, Maryland 

200
INTRODUCTION 

This report covers the fourth strategic planning meeting, held October 14–16, 2009 at Northwestern University’s Feinberg School of Medicine. Participants were welcomed by the Office 

of Research on Women’s Health and Northwestern cosponsors as well as by Maggie Daley, 

wife of Chicago Mayor Richard M. Daley. The format of the meeting included public testimony, 

a plenary session, and eight breakout groups. The plenary session included three panel presentations, two keynote addresses, and a charge from the ORWH director to meeting participants. 

Major themes of the plenary presentations were health disparities in understudied populations 

of women, the application of new technologies to women’s health, and multidisciplinary science teams of the future. Below are highlights from the plenary presentations. 

SUMMARIES OF PLENARY PRESENTATIONS 

OPENING PANEL: DIVERSE POPULATIONS AND DISPARITIES 

An opening panel of the plenary session called attention to health disparities in five special 

populations of women—urban women; those living on the U.S.-Mexico border, Deaf and Hardof-Hearing women; Black women; and Asian/Pacific Islander women. Below is brief synopsis 

of major points raised concerning each group. 

Nancy Woods, Ph.D., R.N. 

Dean, School of Nursing, University of Washington 

As of 2008, Dr. Woods explained, more than one-half of the world’s population was living in 

urban areas. For the foreseeable future, trends toward global urbanization will continue to 

shape urban environments as hubs of economic growth, particularly in emerging economies. 

Little scholarly literature, however, has addressed the needs of urban women. What is known 

about their health status? They are generally found to be healthier than rural women, but this 

statistic holds primarily for higher income women. It also masks subpopulation differences and 

is not sensitive to changing population dynamics. Urban environments are multidimensional and best broken down into dimensions for purposes of study. The benefits of this approach 

can be seen from a study of urban social environments and health. The study, carried out in 

several Philadelphia urban communities, found that higher Black racial composition and higher 

community social capital were both independently associated with lower all-causes Black mortality. The built environment also influences health behaviors. The Black Women’s Health Study 

found that high housing density was positively associated with utilitarian and exercise walking. 

Francisco A. R. Garcia, M.D., M.P.H. 

Professor of Obstetrics & Gynecology and Public Health, Director, Center of Excellence in 

Women’s Health, University of Arizona 

Dr. Garcia began by defining the U.S.-Mexico border as a 2,000-mile long strip extending inward about 62 miles on either side of the border. In 2009, more than 12 million people were 

living in the area, including, on the U.S. side, large numbers of Mexicans—both those with 

long ties to the area as well as recent immigrants—and members of American Indian tribes. 

These groups have lower educational levels and incomes than non-Hispanic whites. Higher rates of cervical cancer and obesity are two of the health disparities characterizing the 

groups. Addressing health disparities will require multidisciplinary approaches that consider 

201
the disparities in income, education, and culture and acculturation, as well as disparities in access to health care and in health behaviors. Not only should research attempt to identify risk 

factors, but also to determine those protective factors that confer resilience on some individuals in the community. 

Carolyn Stern, M.D. 

Physician and Partner, DeafDOC.org, Unity Health System 

Dr. Stern said that Deaf/Hard-of-Hearing (D/HH) status is the most common disability recognized by the Americans with Disabilities Act. It affects 1 in 10 Americans, with 1 in 100 

profoundly affected. Women born D/HH have profiles similar to English-language minorities, 

including limited socialization with the spoken-language community, lower educational attainment and socioeconomic status, lower health literacy, and less access to health services. Those 

who become D/HH later in life have poorer health and less frequent screenings and doctors’ 

visits. Communication is the major barrier to successful access to health care in the D/HH community. It limits not only women’s access to their own health care and information, but also 

family members’ health care because D/HH women serve as portals for their family’s entry into 

the health care system. Furthermore, there is not enough baseline information to characterize 

the health needs of D/HH women and their families. Community-based participatory research 

and recruitment are necessary to increase research pipelines needed to help D/HH women. 

Eleanor Hinton Hoytt, M.S., M.A. 

President and CEO, Black Women’s Health Imperative 

Ms. Hoytt said that, by most health measures, Black women have poorer outcomes than majority White women. Black women have the highest or near highest rates of most major chronic 

conditions (hypertension, diabetes, stroke, most cancers, glaucoma, arthritis, and lupus) and 

risk factors for poor health (obesity, sedentary lifestyles, drug dependence, tobacco use, depression, sexually transmitted diseases, low immunization rates, and partner violence). Health 

disparities largely reflect disparities in the social determinants of health, in access to therapies 

and prevention and differences in health behaviors. This complexity of risk factors calls for a 

shift from a strictly biomedical model to an interdisciplinary model. 

Barbara (Bobby) W. K. Yee, Ph.D. 

Professor and Chair of the Department of Family and Consumer Sciences, College of Tropical 

Agriculture and Human Resources, University of Hawaii at Manoa 

Dr. Yee noted that a widely held perception of Asian and Pacific Islanders is that they are a 

“model minority,” with Asian women having the longest life expectancy of any group in the 

United States. Nonetheless, subpopulations show health disparities, and disaggregated analysis is required to address these fully. For instance, in Hawaii, Pacific Islanders have diabetes 

twice as often as Whites. Hepatitis disproportionately affects some Asian subpopulations. Data 

disaggregation and analysis are needed to refine the identification of risk factors contributing 

to health disparities among subpopulations of Asians. 

202
KEYNOTE ADDRESS: 2009 H1N1 INFLUENZA: RESEARCH ACTIVITIES 

AND POTENTIAL IMPACT ON THE NATION AND ITS WOMEN 

Carole Heilman, Ph.D. 

Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and 

Infectious Diseases, NIH 

Dr. Heilman addressed special issues of the H1N1 epidemic for women. A 2009 New England 

Journal of Medicine report on H1N1 hospitalizations found that 73 percent of those hospitalized 

had at least one underlying medical condition. These conditions included asthma; diabetes; heart, lung, and neurologic diseases; and pregnancy. Because women have more asthma 

and chronic pulmonary diseases than men, this risk profile, in combination with obesity, raises special concerns for severe H1N1 complications in women. Pregnant women appear to be 

at increased risk for severe H1N1 complications. This increased vulnerability stems in part from 

pregnancy-related physiological changes in lung function and circulation. However, pregnancy is also a period of immune suppression, and hormones are critical factors in changes in 

maternal immunity. This is an area of translational and clinical importance that is also ripe for 

collaboration. 

PANEL: NEW TECHNOLOGIES—OVERVIEW AND STATE OF 

THE SCIENCE 

The panel on new technologies, moderated by Colleen M. Fitzgerald, M.D., Assistant Professor, 

Feinberg School of Medicine, Northwestern University and Director, Women’s Health Rehabilitation Institute of Chicago, discussed the potential of technological advances to improve 

health outcomes and quality of life, spur further innovations, and facilitate translation. 

Todd Kuiken, M.D., Ph.D. 

Associate Dean of Academic Affairs, Feinberg School of Medicine, Northwestern University 

Dr. Kuiken described a breakthrough innovation in neural-machine engineering that allowed an 

amputee to more precisely direct the movement of a prosthetic limb by his own thoughts. Noting that technology “should enable the human,” the presenter showed a video of Jesse, who has 

been called the first “bionic man.” A double amputee, Jesse can now use a prosthetic arm to 

shave, open bottles, and perform many other activities essential to independent living. The pioneering technique that made this possible is a muscle reinnervation, which takes an amputee’s 

own nerves and connects them to a healthy muscle. A myoelectric limb uses electrical signals 

from the muscle, activated by the user’s own thought-generated nerve impulses, to move. Such 

an example of a neural machine interface holds future hope that the brain can be harnessed to 

machines in other applications. In the future, perhaps paralyzed people will be able to use their 

thoughts to operate computers, wheelchairs, robots, and other mechanical devices. 

Teresa K. Woodruff, Ph.D. 

Professor of Obstetrics & Gynecology, Feinberg School of Medicine, Professor of Biochemistry, Molecular Biology and Cell Biology, Weinberg College of Arts and Sciences, Northwestern University 

Dr. Woodruff began with the hypothesis that the innovation of new technologies will drive the 

next generation of discovery research and lead to major health advances. Because technologies should drive innovation, but not create or increase health disparities, in a time of limited 

resources it is important to insist on the inclusion of women early in the process of device 

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development and technology design. Considering sex differences in basic research is important because science is on a continuum, with basic science providing the source of clinically 

relevant hypotheses. Such consideration has not always happened in the past—but sex differences are important, whether they are identified at the cellular or system levels, or in an animal 

model. As an example, recent research has shown that coronary artery plaque forms differently in women than in men, but most existing diagnostic technologies, designed on the male 

model, are better at detecting risk in men. 

Translational technologies have the potential to bridge basic science and clinical research 

translation. Among the top innovations that serve the greatest unmet needs to which an investment of resources is most likely to yield major benefits are the imaging technologies, 

biomaterials design, nanodiagnostic applications, self-assembling materials and regenerative 

medicine, and the assessment technologies—high throughput analytic methods, microscopy, 

proteomics, and bioinformatics. Encouraging translational scientists using these technologies 

to focus more on sex differences requires highlighting the scientific issue in unexplored areas 

and providing examples of scientific successes. 

PANEL: TEAM SCIENCE AT NORTHWESTERN 

The presentations in the team science panel provided an introduction to the field of social networking science and provided examples of the application of its methods to questions about 

the scientific impact of teams. 

Holly Falk-Krzesinski, Ph.D. 

Director of the Office of Research Team Support, NUCATS Institute and Office for Research Development, Office for Research 

Dr. Falk-Krzesinski, the panel moderator, noted the increased demand for collaboration in science and medicine, and a trend toward the multidisciplinary and interdisciplinary approach of 

team science. The Northwestern University Clinical & Translational Sciences (NUCATS) Institute 

aims to advance team-based, cross-disciplinary translational biomedical research and to focus 

on the empirical field of “the science of team science.” The Oncofertility Consortium, a program that has 10 linked grants at 6 institutions, provided an example of team science and its 

empirical evaluation. 

Brian Uzzi, Ph.D. 

Co-Director, Northwestern Institute on Complex Systems and Professor, Kellogg School 

of Management—Management and Organizations; Weinberg College of Arts & Sciences— 

Sociology; McCormick School of Engineering & Applied Sciences—Industrial Engineering 

and Management Sciences 

Dr. Uzzi assembled evidence that scientific breakthroughs are the result of individuals embedded in collaborative networks rather than solitary endeavors. Since the 1950s, teams have 

predominated in the physical sciences, with the biomedical sciences more recently also adapting 

that model. Team science, which has grown to include vast cross-university networks, has had 

a greater impact, as shown by citations in the published literature, than solo science. Furthermore, cross-organization teams tend to perform better in terms of impact than within-institution 

teams, despite claims that proximity and easier communication should be decisive benefits 

for the latter group. More impactful publications, as measured by journal citations, also result 

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from networks that periodically introduce new members into coauthorship, indicating that the 

infusion of new ideas by such members or the additional synergy they add to the existing 

publications networks may benefit scientific innovation. 

Noshir Contractor, Ph.D. 

Director, Science of Networks in Communities (SONIC) and Professor, McCormick School of Engineering & Applied Sciences—Industrial Engineering and Management Sciences, School of 

Communication—Communication Studies, and Kellogg School of Management—Management 

and Organizations 

Dr. Contractor continued by introducing the methods of social networking science and demonstrating how they can be applied to the design, diagnosis, and evaluation of social knowledge 

networks, using the Oncofertility Consortium as an example. The coevolution of knowledge networks science and methods along with advances in 21st-century cyberinfrastructure that better 

capture relational data has facilitated modeling of social knowledge networks and analysis of 

the effects of different network forms. The multidisciplinary field of oncofertility was the subject 

of a four-site social network clustering analysis, which showed dramatic increases from before to 

after the consortium’s establishment, both in intersite and interprofessional collaborations. Similar methodologies can be applied to evaluations of other multidisciplinary team science efforts. 

KEYNOTE ADDRESS: RETAINING WOMEN IN ACADEMIC CAREERS 

Phoebe S. Leboy, Ph.D. 

President, National Association for Women in Science 

Dr. Leboy discussed the problem of the underrepresentation of women M.D. and Ph.D. scientists in medical schools at progressive rungs of the career ladder. Although women M.D.s and 

Ph.D.s are at parity with men in the initial stages of careers, they show marked attrition from 

academic medicine at the associate and full professor levels. This attrition has been attributed 

to a number of causes, including family demands; the competitive academic environment of 

a 7-day workweek, which is incompatible with childrearing; and institutional bias in evaluation 

and reward. In addition to continued vigilance by institutions to the elimination of institutional barriers and bias within their own ranks, the NIH may also be able to make policy changes, 

such as changing the time commitment for mentoring on training and senior career grants or 

encouraging NIH-funded institutions to put family-friendly policies in place. 

CHARGE TO THE WORKING GROUPS 

Before the full group reconvened in smaller working groups, the ORWH Director provided 

them with their charge for their work efforts. Noting how exciting the plenary presentations 

had been, she asked the working groups to help the NIH chart the future direction of women’s 

health research. Specifically, she asked them to address a number of questions. What value 

does the ORWH add in the coming era of technological advances? What is the more for the 

women’s health research and career development enterprise that will not be done if the ORWH 

does not take the lead? What science and technologies are particularly innovative as well as 

addressed to critical women’s health needs? What science-based initiatives, falling within the 

mission of the NIH, are high priority? Is there a new scientific paradigm to be added to the 

Office’s approaches to women’s health to facilitate these initiatives? The working groups, she 

noted, are essential in shaping the product of the year-long planning process. She ended by 

underscoring what she hoped would emerge from the process: recommendations that anticipate new science rather than ones that merely recapitulate the status quo. 

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SCIENTIFIC WORKING AND DISCUSSION GROUPS 

UNDERSTUDIED POPULATIONS SUBGROUP 1: MINORITIES, URBAN, 

RURAL, DISABILITIES, AND ISSUES OF POVERTY 

Cochairs:
�

Vickie M. Mays, Ph.D., M.S.P.H.
�

University of California, Los Angeles 

Gloria Sarto, M.D., Ph.D. 

University of Wisconsin–Madison 

Subgroup Cochairs: 

Naomi Lynn Gerber, M.D. 

George Mason University 

Pamela Brown, M.P.A. 

West Virginia University 

Celia Maxwell, M.D. 

Howard University Hospital 

NIH Cochairs:
�

Rebecca L. Clark, Ph.D.
�

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Anne E. Sumner, M.D. 

National Institute of Diabetes and Digestive and Kidney Diseases 

Derrick C. Tabor, Ph.D. 

National Institute on Minority Health and Health Disparities 

Science Writers: 

Rebecca Martin 

Northwestern University 

Candace Tingen 

Northwestern University 

Introduction 

Women and girls in vulnerable societal statuses—minority women, immigrant women, women in urban and rural areas, disabled women, girls in the foster care system, women prisoners, 

veterans, and women living in poverty—experience special and sometimes unique health concerns in terms of disease risk, incidence, course, access to care, and disease-related disability. 

They are likely to fall below the national mean on general health and mental health status indices. Although the impact of disease-related disability is disproportionate in these women 

relative to the general population, they are often underrepresented in biomedical research, 

clinical trials, and natural history studies. Explanations for this underrepresentation are multifactorial and include lack of effective outreach, perceived difficulties in sustaining participation, 

mistrust of research, or lack of perceived benefit to others like them, language and communication barriers, or time demands as workers and caregivers. Women from these populations 

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may also have limited access to and knowledge of health resources and they often receive a 

different level of care when they do contact health care providers. The goals of the Understudied Populations Subgroup 1: Minorities, Urban, Rural, Disabilities, and Issues of Poverty 

Working Group were to identify the most significant health issues facing these women (hereafter referred to in this report as “understudied”) and the most promising research strategies to 

remedy the issues. The diversity of understudied groups and the unique configuration of risk 

and protective factors found in a particular population of women were acknowledged by the 

working group. However, their deliberations focused primarily on identification of crosscutting 

research issues and overarching themes that would be applicable to most—if not all—groups 

of understudied women. 

Summary of the Discussion 

The discussion of the working group began with a brief introduction by each member and a 

statement concerning a topic of interest to be considered when structuring research studies 

about women’s health. It quickly became apparent that the five initially identified understudied 

groups of women, based on the charge reflected in the title of this report, were not sufficiently comprehensive of those whose statuses result in vulnerability to their health. Other groups 

of women such as Asian Americans, Native Hawaiians, Native Americans or American Indians, 

foreign born, refugees/immigrants (particularly those without legal status), women veterans, 

incarcerated women, and girls in foster care were noted by the group as understudied. Despite 

this diversity, certain common cross-cutting concerns were identified. 

The first and most significant cross-cutting concern identified by the group was the role 

of trauma in the health of the understudied groups of women. The definition of trauma is 

complex, and it can include both institutional and relational experiences; acute and chronic trauma; and ongoing and remote trauma. Some questions that arise are whether there is a 

gendered nature to trauma; how trauma affects women’s health over the lifespan; and how it 

impacts the intergenerational health of women’s children and grandchildren. Trauma can be 

viewed as a continuum, from sustained stresses to acute insults/injuries. For example, poverty 

constitutes a chronic stress rather than acute stress. Trauma can also be classified as historical (institutional) or relational. Instances of historical traumas include those experienced by 

such groups as American Indians, African-American slave descendants, and other groups who 

have experienced longstanding institutional discrimination. The legacy of eugenics policies 

and institutionalization of the disabled presents another example of historical trauma. The effects of such histories can impact group members’ motivation to participate in clinical trials. 

Women from underrepresented and understudied populations are at greater risk of relational traumas throughout their lives. These traumas can include intimate partner violence, elder 

mistreatment, homelessness, unintended pregnancy, involvement in sex work, sex trafficking 

(especially of young girls), hostile work environments, and natural disasters. Relational traumas 

can not only affect current and long-term health outcomes of the individual, but they also can 

have intergenerational impact. Multidisciplinary approaches, including the collaboration of medical practitioners, basic researchers, and historians, are well suited to addressing the impacts 

of trauma(s) on understudied populations of women. The group saw trauma as a paradigm 

approach to thinking about its role in women’s health in general and, in particular, for those 

most vulnerable understudied women. 

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A second cross-cutting concern was the dearth of health studies based on an integrative 

model of health, such as a biopsychosocial model. The biopsychosocial model attempts to be 

integrative in its scope. It has as its goal the inclusion of contextual as well as individual factors, and the bridging of disciplines such as medicine, public health, economics, and social 

and behavioral sciences. In the past, research has tended either to address biomedical issues 

or social/behavioral issues, but not integrate these issues in a research protocol, with resultant limitations in understanding the complex contextual influences and social interactions 

that contribute to disease, disorders, and syndromes. Biomedical research, the major activity 

of the NIH, could benefit from increased conceptualization of health issues in terms of a biopsychosocial model, with attention not just to the individual, but also to family, neighborhood, 

community, and larger societal contributions to negative health outcomes in vulnerable women. As an example, disability versus independence in elderly women can be discussed in terms 

of the model. Independence in old age is the end result of numerous physical, social, and environmental factors over the lifespan. All too often, in later years of a woman’s life, she may 

suffer significant physical disability that impacts independent aging in place. As a biomedical issue, disability in aging can be considered in terms of sarcopenia or the infiltration of muscle by 

fat. From a biopsychosocial perspective, sarcopenia can be seen as leading to loss of mobility, 

self-care, social functions, and overall health; these consequences in turn are associated with increased hospitalization, falls, hip fracture, and shortened lifespan. Addressing these issues may 

also require addressing emotional and mental health issues in order to promote increased 

activity and self-care behaviors. 

Following discussion of crosscutting concerns for women in understudied populations, working 

group participants identified five overarching themes. They are: (1) access to/inclusion in biomedical research; (2) disaggregation of data; (3) the importance of place, space, and context 

in biomedical research; (4) developmental lifespan and intergenerational perspectives; and (5) 

communications. Within the framework of the special concerns and overarching themes identified, participants were asked to address future needs for research, and new methodologies, 

technologies, and approaches to identify and include previously understudied groups in 

biomedical research. Discussion is summarized below for each theme. 

1. Access to/inclusion in biomedical research. Women from understudied populations often have limited participation in health research, particularly when it is outside of the primary 

care setting. This is frequently a result of such factors as lack of effective recruitment/outreach to the women; lack of effective communication on how the research can benefit others 

like them; or research that poses a major time burden or lacks culturally tailored methods. 

Modes of research that continue to rely significantly on face-to-face interaction, landline telephones, or significant reading requirements result in lack of participation for large segments 

of underserved women because of geographic isolation, time commitments, or inability to fully participate because of lack of comprehension accommodations. Communication barriers 

include the use of recruitment and participation strategies that do not accommodate limited literacy, translation for non-English speakers, or effective communication methods for the 

sensory impaired. Physical barriers are also a problem in particular for women in isolated 

geographical locations, those with limited transportation access, and those who are physically 

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disabled and lack mobility. Several important points were made by working group participants 

concerning access/inclusion issues; bulleted highlights are given below: 

• The development of new data collection methods could address research issues for 

understudied populations of women. Data collection and reduction strategies need to 

be improved to capture data on the populations and to reduce the burden on participants. Use of emerging technologies (personal digital assistants, cell phones, electronic 

transmitters, Skype, etc.) would benefit outreach to underrepresented women. Research 

using telelinks should be explored to reach the populations. Use of telecommunications 

to interact with patients on reservations, in isolated locations, and the disabled could improve recruitment, participation, and maintenance in study cohorts. Electronic medical 

records would enable more effective work with populations that frequent emergency 

rooms rather than relying mainly on clinic populations. 

• New methods and devices are needed to enable noninvasive approaches to 

biospecimen/biomedical data collection. Development of new technologies is needed to monitor physiological health processes and psychological responses to trauma, 

so that early detection of indicators for poor or good physical, emotional, and functional outcomes is possible. These technologies should be able to distinguish biomarkers of 

both chronic and acute stress, and they should be able to capture data in real time. The 

development and implementation of noninvasive specimen collection (e.g., saliva collection, sweat patches, ankle bracelets, etc.) could improve data gathering of understudied 

women in remote locations or who do not frequent the health care system. For elderly women, the ability, for example, to measure fatty infiltration of muscle (sarcopenia), 

inexpensively and at low risk, will help identify those at risk for hospitalization, fall, and 

shortened lifespan. Muscle mass can be quantified using computerized tomography and 

skeletal attenuation models, but such approaches are expensive and have fairly high radiation exposure. There is a need to develop newer, less expensive imaging techniques 

that would help advance this area of investigation. For example, the use of ultrasound 

could be explored for such application. Metabolic studies about what promotes sarcopenia and studies of mechanisms for mobilizing fat from muscle and maintaining muscle 

function are needed for elderly women. The use of robotic and haptic technologies for 

providing interventions for the disabled, frail, and relatively immobile homebound and 

for rural women would provide newly accessible treatment options. 

• Efficiencies of scale may facilitate the participation of understudied populations of 

women in clinical research. Because the number of visits required for a study can be an 

impediment to women’s participation, there must be new efficiency as to what is brought 

into the community. Researchers from several institutions should consider collaborations 

so that a community is approached in a collaborative manner by researchers. This would 

potentially reduce research burden on participants as well as facilitate enrollment. Collaboration among health centers that serve smaller populations and larger universities 

would be beneficial in this regard. Again, the use of technologies such as specially 

designed cell phones and PDAs to capture needed ongoing biological measures 

should be explored to reduce travel and the burden of participation. 

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• Improvements are needed in the training of the research and biomedical workforce as 

well as in the diversity of researchers and health care providers. Individuals from understudied groups may be more likely to participate in research and to seek access to care 

if they are able to interface more frequently with doctors and researchers who offer 

culturally appropriate interventions and approaches. 

2. Disaggregation of data. Much currently available information on women’s health comes 

from data sources that are aggregated in larger racial/ethnic/socioeconomic status/geographic 

groups; average tendencies for the overall sample are often reported rather than for specific subpopulation groups. Even if results are presented in terms of gender, ethnic, racial, age, 

and socioeconomic categories, findings may lack the level of specificity needed to characterize problems in special populations of understudied women by allowing for several statuses 

simultaneously to be considered (e.g., age, race/ethnicity, socioeconomic status [SES], place). 

Current registries could be mined for analysis of disaggregated data; future registries and datasets should aim to include a fuller range of racial/ethnic, SES, sexual orientation, and age 

subpopulation groups and data points that allow for better contextual analyses (geographic 

information, e.g., neighborhood, region, census tract, the primary language spoken, and health 

services in regions). Consideration in planning analyses should be given to contextual and 

demographic factors, some of which are outlined in the first bullet below: 

•	�Current Office of Management and Budget definitions do not fully capture information 

needed for disaggregation. Study participants are often grouped together without full 

consideration of the impact of social, racial/ethnic, or legal status. Many characteristics 

of women play important roles in health over the lifespan. Among these are immigration and refugee status; age and generational status; disabilities; rural or urban location; 

education, income, occupation, and wealth; religion; veteran status; homelessness and 

incarceration history; self-identified race and ethnicity; and sexual orientation and 

gender identity. 

•	�Qualitative work is an important methodological task needed for appropriate measurement and disaggregation. Qualitative work may be done during interviews to allow 

participants to self-identify to the researchers and make known any barriers to access. 

Qualitative research may be particularly important for understudied groups of women 

because they are less likely to volunteer contextual information and because their culture may otherwise be defined by someone other than themselves, such as a husband 

or father. 

•	�Mental health status information should be studied in disaggregate groups. Acute, 

chronic, and chronic relapsing mental illnesses are important causes of functional disability; they also have significant impact on the course of general health conditions. 

Prevalence of mental disorders and risk and protective/resilience factors need to be 

identified in understudied populations as well as psychological distress and well-being. 

•	�A methodological development is needed to deal with statistical, reliability, and validity and interpretation issues that disaggregation poses. Methods for nonburdensome, 

reliable collection and the development of statistics for small samples are critical needs. 

Special consideration needs to be given to statistical significance and multiple testing 

in small-sample disaggregated groups because these issues may negatively impact the 

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validity and reliability of findings from small groups. To further address reliability and 

validity issues and to enhance interpretation, more robust statistical methods are needed 

for analyzing and modeling disaggregated data. 

• To facilitate comparison across datasets and subgroups, a core set of standard measures needs to be identified and implemented across studies. Because it may not be 

feasible to power all studies to address statistical significance in all subgroups of potential interest, meta-analysis based on a core set of measures may be an option. Where 

appropriate, existing well-validated population measures can be evaluated with regard to their psychometric performance in new populations and, as needed, they may 

be modified. New measurement instruments should also be developed for use in small 

groups with large variance and skewed distributions. 

• In designing new large-scale studies, sampling frames should enable study of the role 

of culture, race, and language on health outcomes. Plans for appropriate data disaggregation should be incorporated into a study’s framework, with sample size and 

sampling techniques considered a priori rather than left to post hoc analyses. Sampling considerations should include those of the stability and isolation of a population 

because these factors may create certain unique health implications. For example, the 

human papilloma virus, the major risk factor for cervical cancer, may have a distinctive 

transmission and oncologic potential in Appalachian women because of the long-term 

stability of that population. 

3. The importance of place, space, and context in biopsychosocial and biomedical research. Social context influences health and illness. The biopsychosocial model is needed to 

understand the causation of many conditions where biological (genetic and biochemical), sociological (stressors), and psychological (development and life experiences) factors interact to 

produce a health outcome. Women are often responsible for family cohesion and childcare. Research on their roles must be contextualized to the environments in which they are living and 

working. Therefore, their multiple roles in family and community should be studied with regard 

to setting (e.g., rural and urban) or family structure (e.g., single-parent or paired relationships). 

Transportation and isolation issues are also important to consider when addressing health research in these communities. Women in rural areas as well as urban areas are often affected by 

the time and distance to a clinical trial. Below are some bulleted issues that were specifically 

discussed with regard to this overarching theme: 

• Local study conditions must be conducive to participation of women in understudied 

groups. A study’s location must be achievable and nonthreatening. It must be welcoming and provide a sense of personal safety. Some examples might include community 

spaces such as schools, houses of worship, or community centers. There should be no 

fear of being turned away. Onsite child care should be provided if possible. Research 

should, when possible, be seamless in assessing health issues, but it should also provide 

women with information about access to health care and health tools that exist to intervene in their health problems. Space in which research is conducted must be accessible 

for the disabled. There should always be accessible entrances, readily available alternatives to stairs, and methods for participation that accommodate the differently abled 

whether their impairments are sensory, physical, or emotional. 

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• Geography might not always define a community, and this should be considered when 

choosing a clinical trial location. For example, a house of worship might be in a community, but not part of it. Furthermore, people may use health centers closer to work 

than to home. Place, although important, is often impacted by economic resources, and, 

therefore, definitions of place as community or neighborhood should be consistent with 

women’s self-defined context of place. 

• The physical context of a study is particularly important when conducting research involving underrepresented women. Vigilance about who else is in the room is important 

when conducting studies and interviewing. This may affect responses. Furthermore, research needs to embed people within their family or relational context and with regard 

to with whom they live and for whom they are responsible in their lives. 

4. Developmental lifespan and intergenerational perspective. A developmental lifespan perspective includes not only longitudinal considerations, but also consideration of the complex 

interplay of family factors on the health outcomes of women. The health of a young woman 

needs to be studied as an important issue in its own right, but also as an important influence 

on that woman’s health as she ages. Furthermore, due to their care giving and central family 

and social roles, the health of women across the lifespan has impact on families across generations. The following bulleted points received special emphasis with regard to developmental 

and intergenerational issues. 

• Caregiving has complex effects on women’s health and the health of families. Caregiving may provide caregivers with certain health benefits as well as health risks, and these 

benefits and risks need to be more fully understood in terms of context and the lifespan. 

Caregiving has potential intergenerational impact as well. 

• Aging and aging with disabilities have a significant impact on the individual and the 

family. This is true for children, nondisabled siblings, and other relatives. Conversely, the 

impact that chronic diseases most frequently affecting women have on independence is 

also poorly understood. 

5. Communication. Cultural sensitivity and awareness are core competencies for health researchers and health care providers seeking to work in communities of understudied women. 

Cultural competence means being aware of the needs of a specific population and training 

to approach the population in a way that enhances health outcomes. Further research is needed to determine relationships between cultural competence skills in the researcher/health care 

provider and health outcomes in the community. Such research is critical to the further development of policy on cultural competence training, for instance in curriculums for medical 

students and researchers. The following bulleted points were discussed specifically by working 

group members: 

• Community members should be fully involved in the design of studies. For clinical research to proceed and succeed, those with the disease or those at high risk of the 

disease—i.e., the community involved—should be taken into account in the design and 

conduct of studies and the reporting of results. Many clinical studies fail to reach any conclusions due to poor accrual, which suggests a disconnect between the research plan and 

that community. Research plan review at all levels, including local Institutional Review 

Boards, should assess the plan from the perspective of that community. The research 

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results should be conveyed back to the community to acknowledge their contribution 

and to disseminate the information derived. One example is the dissemination of the Diabetes Prevention Program (DPP) presentations back to the participants enrolled in DPP.1 

• Communication must be increased within study design. Simplification of consent forms 

will help communication between researcher and participant. Consent forms are currently designed mainly to protect the institution, not the individual. Consent forms that meet 

Federal standards for the protection of subjects, but also are comprehensible and acceptable to communities, are much needed. Translation services have increased the numbers 

of languages in which research materials and tools can be made available and should be 

incorporated into study designs to broaden participation of subpopulation groups. 

• Cultural sensitivity and subpopulation group knowledge must be increased in researchers through education and training. Because context is so important to all 

aspects of the research process, from recruitment of women in community-based 

participatory research to the design of meaningful research and the interpretation of 

findings, researchers and biomedical participants in the research process need to have 

professional acuity and cultural sensitivity to enhance their ability to interact and 

intervene effectively with members of the community. This training could be part of 

graduate education attached to NIH training grant participation, and other training can 

occur as a part of postdoctoral or continuing education efforts, which can be done in 

partnership with communities. Particularly for interactions with women research participants, competency training may include increased awareness of the role of mental 

health conditions, trauma, and resilience in general health outcomes. 

• In communicating with members of understudied groups, the definition of health 

should be expanded. It should be more expansive than pathology and medicine; it 

should include levels of functionality, well-being, and satisfaction. 

• New technologies are needed to address communication with the developmentally disabled, the elderly, and stroke victims. Film clips and interactive technologies can 

help low-literacy groups. Consideration needs to be given to technologies to enhance 

communication with low-vision groups and those with cognitive, hearing, sensory motor, or other disabilities and impairments that may affect ability to participate or provide 

research data in traditional ways. 

Recommendations 

The Working Group on Understudied Minorities, Urban, Rural, Disabilities, and Issues of 

Poverty offered the following recommendations for research, technology development and 

training. The following research recommendations may help to provide guidance to health 

administrators, clinicians, scientists, and the public as to areas of investigation that merit 

greater research. 

Recommendation 1: Increase participation and inclusion of understudied groups of women 

in biopsychosocial, biomedical, and other research designs. Examples of approaches and 

research needed to improve participation and inclusion are given below. 

• Develop new technologies and methodologies for remote data collection. 

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• Develop new measures, statistical approaches, and sampling methods in small samples to 

include understudied subpopulation groups of women. 

• Develop strategies to overcome time/distance/literacy/differently abled/ social role barriers in order to enhance and increase participation of understudied groups of women in 

various research designs. 

Recommendation 2: Studies of women’s health need to incorporate considerations of place 

space, and context. Effective research that is broadly translatable to diverse groups of women 

requires the conceptualization of women’s health issues in terms of a biopsychosocial model 

that attends to and integrates biological, social, mental health, societal and developmental 

factors as influences on health, disease, and well-being. 

• Increase measurement of specificity and detail in order to identify culturally 

contextual factors that distinguish the influential factors and risk details within 

groups (disaggregation). 

• Develop methods and data sources that provide attention to meaningful aspects of 

the cultural context of women’s lives, from the woman’s perspective. 

• Include studies throughout the lifespan, from girls to frail elderly women and 

across generations.
�

Recommendation 3: Integrate a focus on the role of trauma in health outcomes of understudied groups of women. A biopsychosocial research agenda for understudied women needs 

to encompass the role of trauma on health outcomes: 

• Identify commonalities in the experience of trauma and its consequences across 

diverse groups of women as well as special issues in particular groups (e.g., women 

with disabilities; women from immigrant groups). 

• Enhance focus on the “gendered” nature of trauma and the ways that women’s 

experiences of trauma influence lifespan and intergenerational outcomes. 

• Enhance the linkages of trauma intervention research findings to intervention systems 

in place so that there is sustainability after the studies are over. 

• Support the development of technologies to monitor real-time stress and trauma that 

can be used for research and for early interventions for stress. 

Recommendation 4: Improve health communication and literacy. Relatively little evidence is 

available to inform “best practices” for improving the health literacy levels of women from understudied subpopulation groups. 

• Identify how women access health and well-being information as a function of their 

different statuses (SES, geography, age, sexual orientation, differently abled). 

• To enhance participation in future NIH research designs, identify the reasons why participants have not been included in past or current research activities (e.g., lack of literacy in 

research designs in the areas of language, communication and/or cognitive barriers). 

• Examine and identify effective ways to use women’s existing social networks to disseminate health information and translational findings from NIH research. 

214
• Determine and investigate methods for the improvement of women’s and girls’ health 

literacy through use of public campaigns and activities, much the way that campaigns 

have been engaged to teach women about appropriate ages for screening and vaccination activities. Ensuring that women increase their health literacy will also improve 

health literacy for their children and other family members. 

• Design research to determine best practices for communication styles at both the patient and provider levels that enhance women’s experiences in health care interactions 

for the purposes of screening, treatment, and development of sustained health 

prevention-based health habits. 

• Determine and investigate best practice strategies for increasing: the level of knowledge 

of understudied subpopulation groups of women about health and health-habit behaviors; participation in health research and accessing research findings; and careers 

in health research. 

Reference 

1. Knowler, W. C., Barrett-Connor, E., Fowler, S. E., Hamman, R. F., Lachin, J. M., Walker, E. 

A., Nathan, D. M., & Diabetes Prevention Program Research Group. (2002). Reduction 

in the incidence of type 2 diabetes with lifestyle intervention or metformin. The New 

England Journal of Medicine, 346(6), 393-403. doi:10.1056/NEJMoa012512 

UNDERSTUDIED AND UNDERREPRESENTED POPULATIONS 

SUBGROUP 2: LESBIAN, BISEXUAL, TRANSGENDER, AND 

INTERSEX ISSUES 

Cochairs:
�

Vickie M. Mays, Ph.D., M.S.P.H.
�

University of California, Los Angeles 

Gloria Sarto, M.D., Ph.D. 

University of Wisconsin-Madison 

Subgroup Cochairs: 

Judith Bradford, Ph.D. 

Virginia Commonwealth University 

Tonda Hughes, Ph.D. 

University of Illinois at Chicago 

Alicia Matthews, Ph.D. 

University of Illinois at Chicago 

Diane Sabin, D.C. 

University of California, San Francisco 

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NIH Cochair:
�

Christine Bachrach, Ph.D.
�

Office of Behavioral and Social Sciences Research 

Science Writers: 

William Brugmann 

Northwestern University 

Carina Emery 

Northwestern University 

Introduction 

Lesbian health and health-related disparities were clearly documented in the 1999 Institute of 

Medicine (IOM) report on lesbian health.1 In the decade following the IOM report, a number of 

significant advances were made: improved methodological rigor and quality of research; expanded understanding of the health and health-related concerns of lesbian women; and a 

broadening of the scholarship to address the needs not just of lesbians, but also of bisexual, 

transgender, and intersex (LBTI) people. 

Stigma and discrimination, and accompanying stress, influence the health of sexual minorities, their families and friends, and may have greater impact on the most vulnerable sexual and 

gender minority groups. Two-thirds of lesbian, gay, bisexual, and transgender (LGBT) students 

report feeling unsafe at school because of their sexual orientation. Traumatic injury and death is 

a constant in transgender communities. In the first national survey of transgender people, more 

than two-thirds reported verbal harassment and nearly half reported having been victims of 

assault with a weapon, sexual assault or rape. Population-based data have demonstrated that 

lesbians and bisexual women have higher rates of alcohol use, mental disorders, and smoking. 

Data from prominent studies including the Massachusetts Behavioral Risk Factor Surveillance 

System and the Growing Up Today Study show that lesbians are more likely than heterosexual 

women to be obese or to have higher body mass index relative to heterosexual peers.2,3 Definitive data on cancer disparities are still unavailable, although community research has shown 

that lesbians with cancer have different needs and sources of support, findings of importance 

for tailoring interventions. 

Against this backdrop, working group cochairs and participants discussed the directions for 

research on the health of sexual and gender minority populations in the coming decade. 

Description of the Working Group Process 

Members of the Working Group on Understudied and Underrepresented Populations Subgroup: 

Lesbian, Bisexual, Transgender, and Intersex Issues included working group cochairs, invited investigators, clinicians, and community advocates. Collectively they engaged in a democratic and 

collaborative process and developed a set of research recommendations. To enhance discussion, 

an agenda was devised to assure incorporation of the diverse perspectives of the members. A 

preliminary set of recommendations was created following the public testimony and subgroup 

discussions. These recommendations were refined and finalized following extensive review from 

working group cochairs and participants. 

216
Summary of the Discussion 

Members of the working group identified several issues as central to advancing research 

during the next decade on the health of sexual and gender minority women. These include 

the need to accumulate appropriate data, to expand support for research and training, and to 

develop the breadth of research to advance the health of sexual and gender minority women. 

Need for Appropriate Data 

Research on the health status and needs of the sexual and gender minority women is greatly constrained by limitations in available data. Participants identified the failure to include sexual 

and gender minority identification in data systems of the U.S. Census Bureau and other Federal statistical agencies as a major impediment to research progress; another is the absence 

of routine measurement of sexual and gender identity in NIH-funded research. Working group 

members noted that while significant progress has been made in developing state-of-the-art 

measures appropriate to identifying and characterizing sexual and gender minority populations, 

these measures have not been widely disseminated or adopted. 

Participants also noted that further development and dissemination of research methodologies 

is needed to improve data on the health of sexual and gender minority women. For example, 

the identification of best practices for sampling, recruitment, and assessment of sexual and gender minority populations would help to inform the design of new studies. Methods research on 

dissemination would help increase access to data and develop a shared knowledge base. Participants noted research gaps and the unique challenges to studying these populations, including 

specific dissemination issues regarding protection of confidentiality when data are shared. 

Expanding Support for Research and Training 

Many existing NIH funding programs provide opportunities for researchers interested in studying sexual and gender minority women, but few initiatives actively draw attention to research 

gaps and opportunities in this area. There was some discussion about the IOM Panel on LGBT 

Health, which represents an important occasion to update and extend the findings of the 1999 

IOM report on lesbian health. Such a panel would review the state of the science and identify 

research gaps as well as best methodological practices from qualitative research to population-based research in representative samples. Participants emphasized the need for inclusion 

of each of the LBTI subpopulations in the IOM and other major research initiatives. 

Participants were concerned about the lack of inclusion of sexual and gender minority populations in discussions about health disparities. The current NIH definition of health disparities 

does not recognize LGBT and intersex populations. Inclusion of sexual and gender minority 

populations could greatly advance research on LBTI women. 

Expanded opportunities for training will be needed to complement new opportunities for research. There is a need not only to better equip researchers to address issues in the health of 

sexual and gender minority women, but also to institutionalize cultural competency training 

related to sexual and gender minorities for all health care practitioners. 

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Comprehensive Models for Research 

Research on the health of sexual and gender minority women builds on knowledge gained in 

stages, beginning with descriptive evidence on relative risks for health and disease outcomes 

in different populations, and progressing to research on mechanisms producing disproportionate risks and then to “best practices of intervention.” Participants noted that research is well 

advanced along this continuum for some outcomes, such as mental health and alcohol abuse, 

but for others even basic descriptive research is highly limited. Expanding the range of research on conditions and diseases that disproportionately affect sexual and gender minority 

women is an essential step in advancing the health of this population. 

Participants also believed an overemphasis on disease outcomes had served to limit potential 

advances. They noted that positive health is an important outcome in and of itself; that positive health is a continuum; and that understanding the sources of resilience and strength that 

contribute to positive health provides essential knowledge for understanding the development 

of adverse health outcomes. They agreed that only a “change in framework” that includes 

attention to wellness as well as disease will adequately advance research. 

Beyond the Individual: Need for a Holistic Perspective 

Health risks and health resiliency among sexual minority women are influenced by the interplay of sexual and gender identity, behavior, and feelings of attraction—that are in turn 

influenced by age, race, ethnicity, religion, geographical region, class, and disability status. 

Noting the broad span of influences that contribute to health and disease, working group 

participants stressed the importance of engaging interdisciplinary teams in research. Relevant expertise must be drawn from the biological sciences (e.g., on genetics and hormonal 

pathways), the psychological sciences (e.g., understanding personality and attitudinal factors), 

and the social sciences (e.g., research on the impact of stigma and discrimination, cultural 

meanings of gender, and the effects of public policies). The need to develop research strategies that can integrate methods and insights across scientific boundaries applies to all health 

research. Participants emphasized its particular importance in the case of research on the 

health of sexual and gender minorities, population groups for whom social and cultural 

stigma plays a large role in health-related processes. 

Intervention Research and Beyond 

Advancing basic research on the health of sexual and gender minority women is useful only 

if it contributes to improved health. Increased effectiveness may be achieved by broadening 

the scope of research. The working group strongly agreed that adequate attention be given 

to intervention research. Interventions can take multiple forms, from improving medical practice, to developing interventions to change risky behaviors, to changing policies that affect the 

health of sexual and gender minority populations. The development of interventions should be 

grounded in research on the multiple factors that affect health and disease outcomes in these 

populations. Targeted intervention research in these populations is needed to assess efficacy. 

Once effective interventions have been identified, mechanisms to disseminate them and 

ensure successful implementation will be another important target for research. 

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Concepts of Gender in Women’s Health Research 

Finally, the group identified a shared concern relating to the concepts of gender used in research on sexual and gender minority women’s health. Participants noted that the categories 

of gender identity and sexual orientation are complex and fluid; this complexity needs to be 

more clearly acknowledged as does the importance of distinguishing among diverse groups 

within this larger population. Research on the meanings and enactment of gender and sexual 

orientation, including the biological, psychological, and sociocultural processes that influence these, could significantly advance the understanding of the role that gender plays 

in all health research. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Sexual orientation and gender identity should be measured as core 

demographic variables in all federally funded national surveys. To achieve this goal, we 

recommend the development of a toolkit to assist researchers with the following: measurement of sexual orientation (identity, behavior, attraction) and gender identity (female, male, 

transgender, intersex); strategies to enhance the methodological rigor of research (e.g., sampling and recruitment); and assessment of the unique determinants of health outcomes 

(e.g., discrimination and minority stress). 

Recommendation 2: Expand support for interdisciplinary research and training related to the 

health of sexual- and gender-minority women. Research and training opportunities should be 

incorporated into existing research and training programs focused on women and gender (e.g., 

Building Interdisciplinary Research Careers in Women’s Health K–12) as well as those aimed 

at reducing health disparities among minority group populations (e.g., Minority Research 

Infrastructure Support Program). 

Recommendation 3: Support a comprehensive program of research on the health of sexual and gender minority women across the lifespan. Research programs focusing on sexual and 

gender minority women should include a continuum of research goals and methodologies 

including qualitative, community participatory, basic discovery, translational, and epidemiological research. 

Recommendation 4: Expand research on the determinants of health beyond the level of the 

individual (e.g., personality, risk behaviors). Encourage the use of multi-level theoretical and 

analytic models that examine biological, psychological, social and structural (e.g., public policy 

and institutionalized discrimination) determinants of health. 

Recommendation 5: Prioritize the development and evaluation of effective, culturally appropriate and methodologically rigorous clinical and community-based health promotion and 

prevention interventions. Best practices and findings of these intervention trials should be 

disseminated widely to funding organizations, to policymakers, and to the scientific, clinical 

and general communities. 

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Recommendation 6: Reframe the study of women’s health to include broad based multifaceted definitions of gender that go beyond male–female dichotomies or considerations 

of “social influences” on (biological) sex. Fund research that examines gender as a social 

construct that may or may not be tied to biological sex, thereby assisting the sciences to expand research on gender beyond current dualistic conceptualizations (i.e., many claim an 

understanding of the difference between sex and gender, but still use them synonymously in 

research practice). Future research on gender should include, but not be limited to, definitions 

and measurement of gender as a continuum rather than a binary concept among women and 

men; biological influences on gender identity and expression; cultural influences on interpretation of biological anatomy and gender expression; the social and psychological consequences 

of gender nonconformity; and the processes through which gender-based norms and beliefs 

affect all people’s health. 

References 

1. Solarz, A.L. (ed.). (2003). Lesbian health: Current assessment and directions for the future. Washington, DC: The National Academies Press. Retrieved from http://books.nap. 

edu/openbook.php?record_id=6109 

2. Massachusetts Department of Public Health. (2008). A Health Profile of Massachusetts 

Adults by Sexual Orientation Identity: Results from the 2001–2006 Behavioral Risk Factor 

Surveillance System Surveys. Boston, MA: Author. Retrieved from http://www.mass.gov/ 

Eeohhs2/docs/dph/health_equity/sexual_orientation_disparities_report.pdf 

3. Austin, S. B., Ziyadeh, N. J., Corliss, H. L., Haines, J., Rockett, H. R., Wypij, D., & Field, A. 

E. (2009). Sexual orientation disparities in weight status in adolescence: Findings from a 

prospective study. Obesity (Silver Spring, Md.), 17(9), 1776-1782. doi:10.1038/oby.2009.72 

CLINICAL AND TRANSLATIONAL RESEARCH 

Cochairs:
�

Stacie Geller, Ph.D.
�

University of Illinois at Chicago 

Kwame Osei, M.D. 

The Ohio State University 

NIH Cochairs:
�

Mary Foulkes, Ph.D.
�

The George Washington University 

Carole Heilman, Ph.D. 

National Institute of Allergy and Infectious Diseases 

Martha Hare, Ph.D., R.N. 

National Cancer Institute 

220
Science Writers: 

Monica M. Laronda 

Northwestern University 

Eileen Krepkovich, M.S. 

Rehabilitation Institute of Chicago 

Introduction 

Clinical and translational research can play a critical role in advancing women’s health. The reporting of clinical research, investigating potential sex/gender differences at every opportunity, 

can begin to address research questions where prior studies are equivocal. The translation of 

clinical research studies into practice and policy is also critical so that scientific findings can be 

used to fully benefit human health. Confirmatory studies in diverse populations would enhance 

the impact of clinical research on clinical practice. Women’s health, through clinical research, 

will improve as the following are optimized: augmenting investigators’ toolboxes for recruiting 

women and girls into both non-sex–specific and sex-specific research studies; more fully analyzing potential sex and gender differences in the available research data; using technological 

advances to disseminate results; and investing in future hypothesis generation and reanalysis 

by creating accessible data repositories. Participants in the Clinical and Translational Research 

Working Group were challenged to address how clinical and translational research can be enhanced and how the health of women and diverse populations will be advanced as a result of 

redefining the parameters within which research is conducted, and to identify far-reaching 

priorities with the greatest potential to advance women’s health. 

Summary of the Discussion 

The working group discussion was lively and varied across a number of topics. The group was 

well represented across institutions, professions, academics, NIH staff, community providers, 

and health consumers. A number of overarching issues related to clinical translational research 

in women’s health took priority in setting the working group’s agenda. Highlights of discussion 

of these issues are organized below under five major headings. 

Innovative Research Study Designs To Enhance the Conduct of Clinical 

Studies and the Translation of Findings 

In discussing the state of current clinical research, the working group highlighted several 

areas in which clinical study design could be improved to enhance both the conduct of the 

research as well as the translation of findings into the community. Participants discussed the 

importance of understanding the population of individuals who might directly benefit from a 

study. This can not only enhance recruitment of subjects into clinical studies, but also allow 

for straightforward dissemination and translation of findings into clinical practice. It was noted 

that new models for the conduct of research should include understudied populations such as 

the “older old” (defined as greater than 75 years of age); groups of women not normally studied (e.g., pregnant women and women in the military); underrepresented minorities (URMs); 

the lesbian, gay, bisexual, and transgender (LGBT) people; and underserved populations (e.g., 

remote and rural areas; inner city areas with poor transportation). 

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Questions related to different designs for clinical studies and the need to model “real- world” 

environments were raised. More real-world designs might translate better to actual clinical practice and adaptation to the community. Women, for example, report symptoms differently from 

men and their reported levels are interpreted differently by clinical investigators. Women may 

also use additional products to improve their well-being (i.e., holistic medicines) in addition to 

traditional medicines. The impact of these additional products may be independent, synergistic, 

or detrimental in the presence of traditional medicines. 

Working group participants discussed the importance of conducting more lifespan and intergenerational studies, such as the Study of Women Across the Nation (SWAN)*. SWAN focused 

on menopause but, in general, longitudinal designs could be very informative if done across the 

lifespan (e.g., Study of Adolescents Across the Nation). Such studies can help to evaluate the 

many facets of an individual’s lifestyle to understand better the onset of disease within various 

populations as well as the prevention of disease. These facets include diet, environmental 

factors, physical activity, and social environment, to name a few. 

New study designs may require scientists to think beyond the “gold standard” of the traditional 

randomized, placebo-controlled clinical trial. As appropriate, longitudinal observational studies 

can be considered to capture more “real-life” conditions of study participants. Studies such as 

these may be readily translated into practice. 

Lower Risk for Conducting Clinical Studies 

Working group participants discussed possible ways for the NIH to foster conversations with 

a diverse group of scientists, such as basic, clinical, bioethics, translational, and community-based researchers, on how to conduct research studies in vulnerable populations such as 

pregnant women, “older old” individuals, or those with comorbidities. These should involve 

discussions of how to address these issues with research Institutional Review Boards (IRBs) 

and ethics committees. Additionally, it was noted that the NIH should work to strengthen the 

policies and guidelines that address inclusion, analysis, and reporting on women involved in 

clinical studies. Discussions of these policies with other federal agencies, such as the Food 

and Drug Administration, Health Resources and Services Administration, and Centers for Disease Control and Prevention as well as with other non-Federal agencies and professional 

societies, are particularly important to ensuring that women and underrepresented minorities 

can be included in of clinical research studies and trials when it is appropriate. 

Clinical Studies/Trial Recruitment Strategies 

Working group participants discussed current clinical study/trial recruitment practices and 

several strategies for recruiting women and girls into both non-sex–specific and sex-specific 

research studies as well as ways to have broader, more inclusive recruitment of participants 

for clinical trials. Trial locations should be accessible to more potential participants. This will 

involve providing transportation, conducting studies using a mobile facility, conducting studies in clinics or hospitals outside the investigator’s primary facility, offering clinic visits at times 

outside the usual clinic days and hours, and providing childcare onsite. Understudied populations, such as individuals who live in rural areas, may have limited access to large hospitals 

* Study of Women Across the Nation (SWAN). More information is available online at http://www.nia.nih.gov/researchinformation/ 

scientificresources/SWANdescription.htm. 

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or universities where studies are generally held. Academic and community organizations as 

well as groups and networks should be encouraged to work together to increase participant 

engagement and recruitment. Several existing groups within most universities (e.g., women’s 

groups, underrepresented groups) could be enlisted in an effort to inform the public of past 

and ongoing studies and encourage individuals to participate in studies. 

Building Trust in Clinical Research 

Trust is a crucial element in subject participation in clinical trials, especially among underrepresented minorities. Educational efforts are needed to inform women and URMs about the 

process of research studies. Many women are unaware that medical research traditionally has 

been conducted in men, primarily white men, and the differences between sexes and genders 

and among races may lead to use of drugs, treatment, procedures, and practices that may be 

inappropriate for other groups (women and URMs). Additionally, much of the population is uninformed about how Federal funding goes into medical research, and the safeguards that exist 

for clinical trial participation such as IRBs, Health Insurance Portability and Accountability Act 

rules, and other ethical and privacy guidelines. Enhancing community awareness of the benefits of increased participation of women and underrepresented minorities in clinical research, 

along with providing information on the safeguards in place to ensure subject safety, will help 

to increase recruitment of these groups. 

New Strategies and Tools for Data Collection, Analysis, and Dissemination 

The working group discussed a number of strategies that could be applied to the collection, 

analysis, and dissemination of data obtained through clinical studies and clinical trials. The discussion of these tools focused on ways to improve access to new knowledge obtained through 

clinical studies to the scientific community to augment efficacy and effectiveness of future trials, as well as to the populace in general to improve their understanding of women’s health 

issues. For example, for studies that terminate due to unsuccessful recruitment or negative findings, information could be recorded detailing the conditions that may have contributed to lack 

of subject participation. This information would be valuable to future investigators who may encounter similar obstacles and who could benefit from understanding methods that have failed 

in the past. NIH programs and study sections could also benefit from this information. Negative 

findings offer valuable scientific information on the efficacy and safety of pharmaceuticals, 

therapies, and other interventions. 

New database technologies could be used for storing medical research information accessible 

to other researchers and enhance data exchanges across institutions and agencies. Database 

registries of this type would offer a number of potential uses, such as enabling investigators 

to find more subjects with a specific disease type and providing information on study techniques that are successful so that investigators do not have to reinvent their methodologies 

from scratch. 

The group also discussed the importance of analyzing sex and gender differences in research 

studies as well as retrospectively analyzing data from previous clinical trials where such analysis 

was neglected. The dissemination of these results is an important issue, and new and creative 

ways to translate findings to the provider and health consumer should be studied. 

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Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: To engage women and girls more fully in clinical studies, especially 

underrepresented communities, it is important to create the next generation of recruitment 

strategies and tools to assist researchers in reaching the maximum number of potential 

subjects. These include: 

• Research on new methodological techniques and tools, including creative approaches 

to research designs that address the needs of the participants (e.g., alternatives to 

standard RCTs); 

• Broader inclusion criteria that reflect the real-world population (e.g., diverse enrollment); 

• Culturally based communication, social networking, and social media to foster 

connections; and
�

• Research on informatics approaches to expand use of registries/shared databases 

for recruitment strategies. 

Recommendation 2: It is important to expand the value of NIH research and incorporate 

knowledge obtained from clinical studies into the community by moving beyond the “benchto-bedside” research model to one that emphasizes the next step of translating evidence-based 

science to community stakeholders, including providers, participants, insurance companies, and 

users of research findings. Ways to accomplish this include the following: 

Incorporate stakeholders in the development of the study design as well as the dissemination 

and translation of the findings. 

• Provide training and incentives for community-based clinicians and other stakeholders 

to engage in research. 

• Disseminate knowledge obtained from clinical studies into the community and 

incorporate knowledge into community practice. 

• Develop and use new tools and technologies (e.g., tracking use of new practice 

guidelines through electronic medical record).
�

• Encourage greater use of common measures among researchers. 

• Measure impact of dissemination and translation of study findings. 

Recommendation 3: The NIH should maximize the value and impact of current and future 

studies. This will promote research connectedness and allow for further dissemination of research results to the community as well as to other researchers. Among ways to accomplish 

this are the following: 

• Add substudies into larger studies, and encourage sharing of specimen collection. 

• Learn from all “nonsuccessful” studies (e.g., futility studies and negative findings). 

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• Develop and maintain large database registries of research methodologies, data, and 

research findings, and make them accessible to a variety of academic institutions as 

well as other research agencies. 

• Develop data repositories for sharing of data among researchers that can lead to future 

hypothesis generation and reanalysis. 

• Fund studies that are “real-world studies” with broad inclusion criteria that engage 

hard-to-study populations (e.g., pregnant women, “older old”) and understudied 

groups (e.g., racial/ethnic minorities, LGBT). 

Recommendation 4: Investigators and clinical centers can be uniquely positioned to address 

several barriers to lowering the risk for conducting future studies on higher risk or more vulnerable populations, such as studies on pregnant women. Approaches to reducing barriers 

include the following: 

• Build trust and research “connectedness” to the community. 

• Test new designs in research to involve hard-to-reach populations in underserved 

areas (e.g., rural “teleresearch”). 

• Engage and train community-based health care providers to participate in 

clinical research.
�

• Build on the global health research community engagement model. 

NEW TECHNOLOGIES/BIOENGINEERING/IMAGING 

Cochairs:
�

John DeLancey, M.D.
�

University of Michigan 

Teresa K. Woodruff, Ph.D. 

Northwestern University 

NIH Cochairs: 

Belinda Seto, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

Guoying Liu, Ph.D. 

National Institute of Biomedical Imaging and Bioengineering 

Science Writers: 

Alison Kim 

Northwestern University 

Pei-Hsuan Wu 

Northwestern University 

225
Introduction 

The development and application of new technologies has transformed the way diseases 

are diagnosed and treated in many fields. During the past decade, progress in basic science 

research, such as the development of in vitro tissue models and high-resolution imaging methods, has shown promise for a better outlook for understanding pathogenesis and treatment 

of numerous diseases prominent in women. In clinical medicine, advances in imaging and diagnostics have revolutionized disease diagnosis and management. Such benefits brought by 

existing technologies, unfortunately, have not reached women of all ages or social classes as 

intended. The working group discussed factors that prevent application of existing technologies and generation of new technologies for improvement of women’s health. Particularly 

important are the existing technologies that may be underexploited due to a lack of sex- and 

gender-based standardization, which limits their research and clinical use. Moreover, as new 

technologies are developed, we must ensure that potential sex differences in their application 

or output are considered. Furthermore, women are interested in affordable and accessible technology; thus, thinking about these issues at all stages is important, particularly in regards 

to design and manufacturing. 

Underexploited technologies are not applicable to all women because their development and 

standardization have been based primarily on studies conducted in male subjects and animals. The effect of sex on biological responses to drugs and disease treatment regimens is now 

clearer than ever. Many routinely performed medical technologies and procedures (e.g., cardiovascular disease imaging and joint replacements) were originally designed, tested, executed, 

and standardized using male models; this has become an issue demanding improvement due 

to increased awareness of physiological differences between the sexes. 

In light of current fragmentary knowledge of disease prevention and treatment in women and 

insufficient exploitation of existing technologies in sex-based research, discussion of the working group focused on several emerging technologies with great potential to impact women’s 

health. What ensued from the discussion was the identification of urgent and unique problems 

that present barriers to the improvement of women’s health as well as knowledge gaps and 

resource needs. The issues were discussed taking into consideration the powerful influences 

of society and communities on women and on sex-based research, and, as a correlated outcome, on women’s health. A synthesis of recommendations to address these issues followed. 

Among the recommendations was a call for change in the way that scientific research and clinical trials are carried out, and support for the dissemination of information about promising 

new technologies to improve women’s health. The synthesis of discussion in the following section describes the relevant technologies with emphasis given to the development of sex- and 

gender-based diagnosis and treatment for diseases, and improvement of access to and 

the affordability of these technologies. 

Summary of the Discussion 

Shortcomings in sex-based scientific research and medical applications were identified and 

became recurring themes in the working group’s discussion of new technologies as they impact women’s health. Several ways to address the shortcomings were discussed, as follows: 

226
1. Strongly promote interdisciplinary and cross-professional collaborations involving 

advanced technologies that aim to specifically address aspects of women’s health and 

sex-based studies. Such collaborations gather expertise, knowledge, and findings from 

various fields, which is essential considering the multifaceted nature of current issues 

on women’s health. Implementation of such collaborations should be encouraged 

and rewarded. 

2. Research should be conducted in both male and female animal models and human 

subjects. Inherent physiological differences between the sexes are rarely considered in 

research and development except in the obvious case of the reproductive system. There 

was consensus within the working group that most tissues display sex-dependent differences, but existing references and simulations are derived from male models and are 

therefore improperly applied to the understanding of female physiology. It was agreed 

that sex-based differences should be necessary considerations in the initial design 

of new models and prototypes, and that technologies should be exploited without 

hesitation to study these inherent differences. 

3. Disease diagnosis and treatment should be tailored to sex-specific needs and should 

evolve not only in design, but also in affordability. The newest, most powerful technologies often carry a high price tag and are therefore accessible only to institutions 

(and patients) with large budgets. Making an existing product or method affordable 

without sacrificing quality is a challenge in technological innovation. Currently, affordability of new technologies for those in need is typically not a prioritized consideration 

as early designs are refined and improved. 

4. Design and implementation of longitudinal studies are necessary on two fronts. First, 

there is an increasing need for all-in-one systems that can sustain the extended culture 

of cells or tissues in vitro while simultaneously allowing the researcher to observe these 

samples with minimal interference. Many long-term studies are currently done in “snapshot” style, wherein static images of a sample at a given time are acquired and threaded 

together to create a biological story with narrative gaps. Second, studies spanning the 

lifetime of an animal model or a human subject are difficult logistically and financially, 

though data on aging are absolutely necessary in a time where life expectancies continue 

to increase. Finally, data collection over the long-term requires new innovations in 

informatics for data storage, handling, and processing. 

5.	�Research teams, including those working in the development and application of 

advanced technologies, should anticipate translation of their results toward the improvement of health and the treatment of human diseases. This has been a particular 

concern in the academic community, where much of the scientific innovation occurs. 

Taxpayers largely support basic research via government agencies such as the NIH. 

Therefore, government-funded institutions have the responsibility to conduct research 

that is translatable and with the intent of benefiting the tax-paying citizens. 

6. Accessibility to technology should be enhanced for all women to include access to 

educational materials and health registries. From veteran scientists in academia to 

members of health-disparities communities, there is a common misperception that 

227
males and females are essentially biologically identical. The origin of this erroneous 

belief may be in the lack of public education regarding sex-based biological differences. 

Initiatives for increased awareness should be created and supported. 

Recommendations 

To reach out to women of all ages and social classes for education and research purposes, as 

well as to stress sex and gender-based differences in conducting research, the working group 

proposes two sets of recommendations. The first set of recommendations calls for immediate 

action and provides guidance to academic institutions and administrators, the health professions, clinicians, scientists, and the public. The second set of recommendations represents 

priorities in research or the development of new technologies. 

Agenda for New Technologies 

Recommendation 1: Advocate for a mandate to use male and female animals and human 

subjects in all appropriate research. Currently, there is only the requirement of the inclusion 

of women in NIH-funded studies. The working group recommends that this become an issue 

of national concern for both government and private funding agencies. 

Recommendation 2: Establish the new field of genderomics and national genderomics 

centers. No currently defined field of research is intentionally sex based. The working group 

recommends that the ORWH and NIH create the field of genderomics and delineate funding 

specifically for studies to identify critical differences in normal and diseased cells and tissues 

between males and females. Creating this field will not only bring attention to the necessity 

of sex-based studies, but also expressly encourage them via funding mechanisms. 

Recommendation 3: Develop a position statement on the application of new technologies 

for sex-appropriate research and clinical care. The working group recommends that the ORWH 

and NIH officially support the application of emerging technologies to sex-differences research 

studies and, as appropriate, to clinical care settings. 

Recommendation 4: Support a national repository for all clinical registries. Perhaps one of 

the most difficult aspects of clinical trials and surveys is the recruitment of participants who 

meet a given set of criteria. The working group recommends the creation of a central repository of existing local clinical registries that is accessible to all researchers. We anticipate that this 

will improve the pace and quality of studies that rely on patient information and participation. 

Computational and data management issues can be centralized and take advantage of the 

rapidly expanding information technology opportunities. 

Priorities in the Research and Development of New Technologies 

Recommendation 5: Specificity. A lingering biological challenge has been the identification 

and effective exploitation of molecular markers that unequivocally set one cell type apart 

from another. The working group recommends that the next generation of technological innovations be exploited to define sex-specific characteristics at multiple levels, from atoms 

to entire populations. Such knowledge will facilitate the development of new technologies 

for targeting and delivery of drugs and probes in a sex-appropriate manner. Finally, existing 

228
references and simulations in the laboratory and the clinic (e.g., phantoms) are largely derived from male models and generalized to both sexes. These should be updated to reflect 

the physiology of both sexes. 

Recommendation 6: Efficiency and efficacy. Point-of-care diagnostic tools have been instrumental in expanding health care management opportunities out of academic centers and into 

underserved areas. The working group recommends that fast, reliable, inexpensive, operatorindependent, and portable diagnostic methods continue to be developed. Additionally, many 

symptoms are common among multiple diseases, therefore requiring time and sometimes invasive procedures for a proper diagnosis, and perhaps even leading to misdiagnosis. Along with 

the identification of specific molecular markers, diagnostic tools should evolve to provide 

accurate differential diagnoses in an efficient and efficacious manner. 

Recommendation 7: Affordability and accessibility of research tools. The next generation of engineering innovations should make low-cost adaptations of existing, high-cost 

technologies that capture comparable levels of resolution and quality. The working group 

recommends that affordability and accessibility of new technologies be required as part 

of the development opportunity. 

Recommendation 8: Integration. Data analysis and interpretation are critical aspects of research, but this process can vary significantly depending on the operator and/or the platform. 

This is particularly true in the case of emerging technologies, where novel algorithms must be 

developed for operation and data collection. The working group recommends that such algorithms and methodologies be made to provide objective outcomes as early in development as 

possible. This way, data become easily transferable and uniformly interpretable among research groups as new technologies become widespread. This will also facilitate the creation 

of a national directory of databases and registries housing sex-specific information. 

Recommendation 9: Longitudinality. In a time where life expectancies steadily increase, there 

is scant knowledge about the process of aging, sex differences in aging, and how human physiology is inherently different at age 80 versus 20. The working group recommends that new 

technologies be able to accommodate long-term studies, not only of cells and tissues in a culture dish, but also of humans as they grow and age. This includes noninvasive imaging methods, 

development of reliable molecular markers as imaging probes and as biological targets, and 

computational innovations for data storage, handling, and manipulation. This may also include 

advances in the point-of-care devices that can track factors over time. In addition, new prototypes should be sensitive to and accommodate age-related changes in physiology. 

GENETICS AND EPIGENETICS 

Cochairs: 

M. Geoffrey Hayes, Ph.D. 

Feinberg School of Medicine, Northwestern University 

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Kathryn Sandberg, Ph.D. 

Georgetown University 

NIH Cochair:
�

Susan Taymans, Ph.D.
�

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers: 

Emily Crow 

Northwestern University 

Nance Seiple, M.Ed., R.N., C.R.N.A. 

Independent Consultant 

Introduction 

The session began with a discussion of the current state of research in genetics and epigenetics. We defined epigenetics as heritable traits not encoded in the genome, including 

histone methylation and acetylation, DNA methylation, and small RNAs. All participants emphasized the significance and challenges of the new technologies available to researchers, 

including genomewide association studies, the increased affordability of sequencing, and the 

emerging “-omics” fields, such as proteomics. The increasing availability of these technologies 

provides new opportunities to study women’s health issues and explore sex-based differences in biology and disease. Discussion focused on the importance of promoting awareness of sex 

differences in research models, enhancing communication and collaboration among women’s 

health researchers, and increasing the availability and reliability of data from current and 

future studies in women’s health. 

Summary of the Discussion 

The following major issues and areas of concern emerged from discussion within the 

working group. 

Accessibility of Current and Future Data, Both Published and Unpublished 

Researchers typically collect clinical samples with a focused purpose, based on their specific 

research interests. However, these samples potentially could be used for multiple studies if the 

origin of the tissue and its manner of collection were adequately documented and made available to other investigators. As epigenetics is an emerging field, it would be extremely useful 

to mine the data from previous experiments and publications, and perhaps reuse samples for 

epigenetic analysis. For genetics studies as well, the necessity of large cohorts makes it very 

useful to be able to use samples and/or data from previously collected datasets. For 

researchers to mine existing datasets, they need the following: 

• Extensive information about how the samples were collected and processed; 

• As much information as possible about the subjects from which they were collected; 

• Standard procedures for tissue collection; 

• A consistent metric for assessing subjective phenotypes; and 

• A thorough checklist of biographical criteria. 

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Standardization in these areas, as well as the establishment of a bioinformatics platform that is 

able to record and present these data in an accessible and comprehensive format, would maximize the usefulness and cost effectiveness of clinical studies, while still protecting the rights of 

the subjects. 

Necessity to Adjust Current Institutional Review Board (IRB) Procedures 

This step is needed to broaden the use of samples collected, particularly as new genetic and 

epigenetic analysis tools are developed. Again, the ability to reuse samples from current and ongoing clinical studies is extremely important for maximizing the usefulness of patient samples. 

One major challenge to a collaborative effort of this sort is the highly laboratory- and projectspecific nature of current IRB applications. An “umbrella” application or master form could be 

useful in streamlining the approval process for common or standard experimental designs. Further information required by a university or necessitated by an atypical experimental method 

could be added as supplementary forms. Most importantly, the working group suggests that an 

add-on consent form should be included for clinical studies, allowing patients to consent to the 

use of their samples for future IRB-approved research, even if that study is not specifically one 

for which they were recruited or sampled. This would lead to the development of an extensive 

database of well-annotated patient samples that could be used to explore genetics and epigenetics questions in women’s health, without the necessity of recruiting new cohorts of 

female subjects to explore each question. 

Need for Development of a Global Approach to Women’s Health 

This global approach should include an “-omics” approach and longitudinal studies. 

One important feature that distinguishes women’s health issues from men’s health issues is the 

wide range of hormonal changes that a woman experiences over her lifetime, including puberty, pregnancy, and menopause. In addition, the lifespan of women is typically longer than that of 

men, leading to additional health issues. The effect of these changing physiological conditions 

on disease progression, treatment effectiveness, and risk factors is not well reflected by current 

animal models or human studies. 

In female animal models of disease, it is important to account for a range of ages and different 

stages of development. Within human studies, it is important to sample multiple age groups, accounting for pre- and postmenopausal subjects. To obtain the most complete overview, it would 

be useful to develop multiple profiles whenever possible for female test subjects, including: 

• Genetic and epigenetic analyses; 

• Expression data; and 

• Proteomics, metabolomics, etc. 

Inclusion of Women in Clinical Trials and Female Animals in 

Experimental Models 

A significant deficit in the current experimental climate is the lack of emphasis on including 

female animals in trials. This is often because researchers are unwilling to deal with special 

considerations such as accounting for the reproductive hormonal cycling status in experimental animals. Other barriers include the high cost and technical difficulties of using female 

experimental animals, that could more accurately reflect human female physiology. 

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In human studies, sex is still too often a factor that is “corrected for;” instead of analyzing the 

results separately for male and female subjects, the results are pooled, eliminating potentially 

valuable information. For women’s health to be studied adequately and accurately, resources 

need to be devoted to developing new and promoting existing female animal models of 

disease, and emphasizing the requirement for female subjects in human studies. 

Need for Education of Health Care Providers and Collaboration Between 

Clinicians and Researchers 

Because genetics and epigenetics are relatively new fields, there is a gap between what researchers are able to discover and what health care professionals are able to implement. 

A specific lack of education exists in the medical school curriculum, which should prepare 

doctors to comprehend, communicate, and apply genetic data in their patients’ interests. Clinicians and researchers should communicate routinely about what genetic and epigenetic 

findings are important and relevant to health, and which patients can benefit most from this 

information. Interdisciplinary cooperation between genetics and epigenetics researchers and 

traditional women’s health researchers is essential in capitalizing on these new technologies 

to benefit women. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, and scientists as to areas of investigation that merit greater research. 

Recommendation 1: Catalog and harmonize genetic and epigenetic data in women and 

experimental models. 

• Standardize data collection. 

• Optimize/expand current medical databases. 

• Develop phenotype databases for experimental animal models (medical 

record surrogate).
�

Recommendation 2: Promote and facilitate collaborations among interdisciplinary scientists 

studying women’s health. 

• Improve the mechanisms for facilitating data collection and sharing; develop expeditious 

IRB processes among collaborating institutions and maximize use of existing data collections for future genetic and epigenetic studies while protecting subjects’ rights. 

• Broaden access to databases, including Government databases (e.g., Veterans 

Administration) and private insurance companies (e.g., Kaiser Permanente). 

• Expand tissue and biobanks; improve and standardize annotations. 

Recommendation 3: Develop new technologies to promote and facilitate analysis of 

“multiomic” datasets in women’s health and sex-based biology. 

• Determine which genetic and epigenetic information is critical. 

• Develop inexpensive and rapid assays for genetic and epigenetic analysis. 

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• Develop co-analysis tools to study interactions with peptidomics, proteomics, 

metabolomics, etc.
�

Recommendation 4: Develop experimental models of disease. 

• Exploit current and develop new animal models of disease to study the biology of 

sex differences. 

• Improve models for studying sex chromosome effects and their interactions throughout the lifespan. These include models of the effects of X-inactivation, escape from 

X-inactivation, and mosaicism. 

• Improve models for studying disorders of pregnancy (e.g., epilepsy). 

• Develop mechanisms to increase basic comparative research between male and 

female animals. 

• Improve education concerning the biology of sex differences, including Sex chromosome 

effects and developmental and activational effects of gonadal hormones. 

• Develop methods to train investigators in how to conduct sex-based biology. 

Recommendation 5: Promote new areas of research on genetics and epigenetics of 

women’s health. 

• Study pharmacogenetics in women across the lifespan and at transition points. 

• Conduct research on the interactions of small RNAs on phenotypes in women across 

the lifespan and at transition points. 

• Improve recruitment of women subjects. 

• Explore ways to increase the number and percentage of women entering and thriving 

in the fields of genetics and epigenetics 

SEX HORMONES AND DISEASE 

Cochairs:
�

Andrea Dunaif, M.D.
�

Feinbery School of Medicine, Northwestern University 

David A. Ehrmann, M.D. 

University of Chicago 

Judith G. Regensteiner, Ph.D. 

University of Colorado-Denver School of Medicine 

NIH Cochair:
�

Louis V. DePaolo, Ph.D.
�

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

233
Science Writers: 

Miranda L. Bernhardt 

Northwestern University 

Shailja P. Sharma, M.S. 

Northwestern University 

Introduction 

Sex hormones have broad effects on disease processes. They are major determinants of differences in the sex-specific prevalence of a number of disorders. The hormonal milieu differs in 

women across the lifespan and during pregnancy. Interested participants in the Working Group 

on Sex Hormones and Disease defined research priorities in basic studies and in translational 

and clinical studies of sex hormone actions in conditions such as cardiovascular disease, diabetes, and autoimmune disorders. Furthermore, innovative research possibilities with existing 

clinical datasets or new populations were suggested. 

Summary of the Discussion 

The discussion of the Working Group on Sex Hormones and Disease centered on identifying 

the gaps in research that have impeded advances in the diagnosis and treatment of major diseases affected by sex hormones. These diseases include cardiovascular disease, autoimmune 

disorders, type 2 diabetes, Alzheimer’s disease, metabolic bone disease, sleep disorders, obesity, and cancer. The working group was composed of investigators and clinicians who discussed 

observations and key issues in their areas of expertise. This discussion was informed by an initial 

update on the state of current knowledge of specific sex-hormone-dependent disease states, 

which was provided by cochair Dr. Andrea Dunaif. In addition, the working group focused on 

identifying gender disparities in the diagnosis, physiology, and pathophysiology of disorders 

that were identified as requiring further research. The following major concepts emerged from 

the discussion: 

1.	� In the field of sex hormones disease research, current gaps in knowledge need to be 

addressed. In addition, several emerging areas were discussed that have the potential to 

advance the frontiers of existing knowledge, improve diagnostic capabilities, and drive 

development of novel therapies. 

2. New technologies need to be developed to advance the field of sex hormone research. 

These technologies would include metabolomics, proteomics, and improved assays 

that would allow further refinement and understanding of the role of sex hormones 

in normal and abnormal development. 

3. Basic, clinical, and translational research ideally should be conducted with the 

purpose of resulting in improvements in direct patient care while at the same time 

considering the social context of the individual. The latter would include education, 

outreach/public involvement, and regulation of consumer safety through accessibility 

of information. A partnership among basic researchers, clinical scientists, and physicians 

needs to be fostered to promote an integrated “team science” approach as opposed 

to working in parallel. 

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4. With regard to specific disease categories involving sex hormones, many questions 

remain unanswered, including the following: 

• Cardiovascular disease. Is administration of sex-steroid hormone therapy beneficial to 

the vasculature? 

• Autoimmune disorders. Why are the majority of autoimmune disorders more common 

in women? How do sex-steroid hormones affect the progression of disease? Are gender 

differences present in the pathogenesis of diseases? 

• Diabetes. Why is the cardiovascular disease protection commonly present in premenopausal women lost when diabetes is present? Could estrogen receptor modulators 

prevent or modulate the natural history of diabetes? Are lower survival rates after 

myocardial infarction in women with diabetes related to sex hormones? 

• Metabolic bone disease. Are there sex differences in the action of hormones on bone? 

• Obesity. How do sex hormones regulate food intake in humans? What are the mechanisms involved in different responses to hormones of fat cells located in different depots? 

How do sex hormones influence the sympathetic nervous system? 

• Sleep disorders. Are the sex differences in the pathology of sleep disorders a 

consequence of differences in sex-steroid concentrations? 

• Alzheimer’s disease. Would early initiation of sex-steroid hormone therapy impact 

cognitive function? 

• Musculoskeletal system. How is estrogen involved in proprioreception? What role do 

endogenous androgens play in muscle mass in women? 

• Cancer. What role do sex hormones play in the pathology of hormone-dependent 

cancer and other forms of cancer? 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendation 1: Use a systems biology and integrative physiology approach to (a) perform a comprehensive inventory of sex-steroid-dependent disease states; (b) create databases 

of normative sex-steroid concentrations across the lifespan; and (c) identify model pathways 

and biological networks relevant to sex-steroid-dependent disease processes. The paucity of 

centralized resources containing information on sex differences has had a negative impact on 

the advancement of sex hormone disease research. To address this deficiency, it is proposed to 

take a systems biology approach to creating and disseminating information: 

• Catalog and create databases of structure, efficacy, and tissue specificity of endogenous sex steroids and pharmacological compounds and tissue expression patterns of 

receptors, coactivators, corepressors, and steroid metabolizers, with consideration of 

systems/connectivity. 

235
• Model pathways and identify biological networks by identifying molecules shared 

between networks, integrating networks, including direct and indirect effects of sex 

steroids, and implementing computer modeling. 

Recommendation 2: Focus on the impact of critical periods of development on health outcomes. It is becoming more apparent that physiologic/environmental influences at certain 

times during the lifespan have a significant impact on future health outcomes and disease. 

Therefore, it is of vital importance to decipher the role of sex hormones and other factors 

during critical windows of development and to understand how they affect future health 

outcomes. Important areas of potential for advancing these aims include the following: 

• Research into the role of sex hormones during fetal programming, the perinatal period, 

“minipuberty,” puberty, menarche, and menopause 

• Studies of the epigenetic effects of sex steroids and environmental endocrine disruptors 

• A focus on prevention and development of novel interventions to reduce disease burden 

• The creation of new datasets and the use of existing datasets from clinical trials and 

registries to maximize the impact of this research 

Recommendation 3: Investigate the chronobiological basis of sex-based disease. The fact 

that sleep architecture is different between men and women has been established.1 Investigating the relationship between sex hormones and sleep architecture is important. Areas of 

consideration for future research should include the following: 

• Causal relationships between sex steroids and circadian rhythms, and sleep/wake 

cycle differences 

• Intracellular “clock” genes and their regulation 

Recommendation 4: Examine the interaction between genetic sex and hormonal sex. Aside 

from the well-characterized differences in sex-steroid hormone levels between men and women, 

there are also inherent genetic differences. The following include topics for prospective research: 

• The role of sex steroids in modulating genotype/phenotype interactions 

• Differential effects of selective hormone receptor modulators (e.g., selective estrogen 

receptor modulators) 

Recommendation 5: Focus on local tissue metabolism beyond aromatase. Endocrine secretion of sex hormones is not the sole factor in determining cellular response. Local biosynthesis, 

secretion, and metabolism of hormones and their precursors must also be considered, and this 

continues to be an understudied area. To bridge the gaps in knowledge in this field, future 

research should include research on the following: 

• The influence of race and ethnicity on sex-steroid hormone biosynthesis, secretion, 

and metabolism as the basis for different disease prevalence rates and phenotypes 

• The prereceptor effects of prohormones and pharmaceuticals 

• The importance of nonclassical signaling pathways in the genesis of sex-steroid– 

based disease 

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Recommendation 6: Develop technological and pharmacological therapies tailored to sex 

hormone levels. The discovery and implementation of novel technologies could drive a more 

individualized approach to medicine. In addition, the development of new technologies could 

improve diagnostic capabilities and the ability to implement evidence-based medicine by 

overcoming current limitations on data acquisition. Focal points include the following: 

• Develop new diagnostic and research tools to improve sensitivity and detection limits of hormone assays; improve the efficacy, delivery methods, and cost effectiveness 

of current sex hormone therapies; and facilitate implementation of nanoscale and other 

emerging technologies. 

• Translate sex hormone research and pharmacogenomic studies into personalized 

patient care. 

References 

1. U.S. Department of Health and Human Services, National Institutes of Health, National 

Heart, Lung, and Blood Institute. (2003). National Sleep Disorders Plan (NIH Publication 

No. 03–5209). Retrieved from http://www.nhlbi.nih.gov/health/prof/sleep/res_plan/ 

index.html 

NEUROSCIENCE WORKING GROUP 

Cochairs: 

Jon E. Levine, Ph.D.
�

Northwestern University 

Cheryl Sisk, Ph.D. 

Michigan State University 

Science Writers: 

Cindy Danielson 

Northwestern University 

Adrienne Chen, Ph.D. 

Northwestern University 

Introduction 

Sex differences in brain development, structure, and function are well recognized. The best 

characterized of these are related to sexually differentiated reproductive behavior and neurohormone secretions. It is increasingly clear, however, that neuronal development and function 

are sexually differentiated in many other ways, such as stress responsiveness, body weight regulation, nocioception, mood and affect, and aspects of social behaviors and cognition. Basic 

science studies of these processes, however, remain largely focused on male animal subjects, 

and do not address adequately the specific neurobiological principles that govern the processes in females. In addition to sex differences in normal physiological and behavioral processes, 

there are differences in prevalence of and/or other aspects of many human neural disorders. 

237
Differences in prevalence are striking for some conditions (e.g., depression and eating disorders 

are more prevalent in women than men). For other conditions, such as epilepsy, drug abuse, and 

sleep disturbances, males and females have distinctive features. Basic studies show the female 

brain receives sex-specific endocrine signals from the ovaries that are quantitatively and qualitatively different from those conveyed by testicular hormones; sex differences arise in both the 

development and operations of a variety of neuronal circuitries. The mechanisms by which estrogens and progestins act in the brain and the peripheral nervous system are also thought to 

be key to understanding other female-biased pathophysiological conditions in humans such as 

multiple sclerosis and other neuroimmunological diseases. Conversely, the potential protective 

effects of ovarian hormones in the female brain are increasingly recognized, including the 

protective actions of estrogens in neurological injury and disease. 

Summary of the Discussion 

Participants in the Neuroscience Working Group were charged with helping to define priorities for basic science research on sexually differentiated brain function that could advance 

progress in understanding sex/gender differences in human psychiatric, neurological, neuroendocrine, neuroimmunological, and injury- and trauma-related neural disorders. A number of 

overarching general issues were raised by group participants. First, they noted that despite the 

substantial sex/gender differences in the prevalence, presentation, and response to treatment 

of a variety of diseases and disorders related to the brain, basic neuroscience research seldom 

focuses on sex differences and often ignores their relevance.† Second, they noted that lack of 

awareness of the pervasiveness of sex differences in the brain exists not only in the field of basic and clinical neuroscience research, but it also extends to the general public. The tendency 

of popular culture to sensationalize sex differences obscures the importance of their implications for understanding brain function and disease. When the public views the existence of sex 

differences in the brain as indicating inequality of the sexes and therefore as “politically incorrect,” researchers are often cautious about pursuing sex differences research and hence may 

minimize the consideration of the effects of sex differences on neurobehavioral health and disease. Third, working group participants noted that, even when sex differences of the brain are 

considered, a remaining impediment is the gap between basic research and clinical relevance. 

The nervous system is difficult to study experimentally, often requiring the use of invasive 

procedures. Although in-depth studies have been done in animal models, whether such basic information generalizes to humans remains unknown. Although neuroscience has shifted 

toward understanding how the interplay among genes, hormones, and experience influences behavior, animal models usually fail to incorporate sex as a variable, and it is more typical 

for researchers to ignore sex or dismiss it as too complicated to incorporate into experimental designs. Rather than continue to ignore sex differences, participants agreed that the culture 

of neuroscience research must change to acknowledge that sex differences in nervous system 

structure and function are normal and can be important. To better understand sex differences 

in the brain, both a shift in paradigm and a shift in methodology are needed. 

Basic Research Issues 

A major focus of the discussion was why sex differences are so often ignored in basic neuroscience research. Given the gender disparities that exist for human neurological and other brain 

† The 2003 Institute of Medicine report Exploring the Biological Contributions to Human Health: Does Sex Matter? notes the importance of distinguishing between sex and gender in order to sharpen research questions. Sex differences refer to biological based 

(e.g., genes, chromosomes, reproductive systems) differences between males and females and gender differences to a human being’s self-representation as male or female, or how that person is responded to by social institutions based on the individual’s 

gender presentation.. 

238
diseases, the avoidance of studying female phenotypes in animal models must be addressed. 

The group agreed that responsibility for this disparity lies with both the basic neuroscientist 

investigator and the study sections, who may provide discouraging or incomplete feedback. 

Factors relating to the investigator include the following: 

• Researchers are not aware of the pervasiveness of sex differences, nor of the proper 

subtleties inherent in studying them. 

• Investigators believe they must control all experimental factors, and accounting for variables such as cyclical differences in hormones creates an impossibly large experiment. 

• Experimental standards and phenotypes have been defined using male animals, making 

it difficult to evaluate behavior that may differ in females depending on the cycle. 

• There is a lack of emphasis on sex differences in the brain in graduate and medical school 

curriculums. When such differences are discussed, they are a short section at the end of 

the book rather than integrated into the rest of the curriculum. 

The lack of recognition of the importance of sex differences in brain function and disease within 

the broader scientific community also influences grant reviews and funding decisions. The group 

agreed that an important issue to address was the way in which studies proposing to investigate 

sex differences are evaluated. Some issues include the following: 

• When researchers interested in studying sex differences propose to include female 

animals, they are often criticized in study sections for not controlling for factors such 

as hormone fluctuation. 

• Many members of study sections do not have the expertise on sex differences or on 

the proper ways to evaluate variables such as estrous or menstrual cycling. 

• While clinical research now requires the inclusion of female subjects, a similar requirement has not been implemented in basic research. The working group believed that 

rather than mandating the inclusion of female animals in studies, the more important 

issue that must be addressed is changing the awareness of sex differences. 

Translational Research Issues 

Another major problem identified as part of the discussion was the lack of cross-talk between 

those doing basic neuroscience research and practicing clinicians working with human patients. This lack of bidirectionality has resulted in an uncertainty over the relevance of current 

basic neuroscience research to human health and brain disease, particularly with respect to sex 

differences. In particular, there was extensive discussion regarding the animal models currently 

being used in basic neuroscience research. Several issues identified include the following: 

• There is a lack of knowledge regarding whether the animal models used in the lab accurately reflect what is happening in the human brain and the resultant clinical outcomes. 

Thus, it has been difficult to translate findings on sex differences from rodent models to 

make assumptions about human neurophysiology, and there is a great need to validate 

the animal models that are being used to study sex differences in brain function. 

• There is a lack of understanding regarding which animal models are the best to use for 

the condition and/or disease state being studied. Often researchers use animal model 

systems that do not necessarily reflect the true physiological state being examined (e.g., 

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using ovariectomized young female rats to study menopause), and there is a need to 

develop better models for behavioral and disease research. 

• A major obstacle is the current inability to move beyond identifying correlations 

between structure and function in the brain to determining causes and effects; one 

example is determining the specific effect of signaling through a steroid receptor within a certain population of cells at a particular point in time on eventual disease outcome. 

This is partly because of the inherent complexity of the nervous system and partly 

because of the imperfect nature of the animal models of disease. 

• Interpreting and drawing definitive conclusions is difficult from studies using currently 

available genetic tools to manipulate animal subjects (e.g., knock-out and knock-in mice) 

due to a lack of cell specificity and direct targeting approaches. 

• There is a lack of understanding of fundamental questions such as the differential distribution between the sexes of steroid receptors within the human brain. There is also little 

knowledge as to whether the current information derived from rodent and primate 

models can be extrapolated to sex differences in human neurophysiology. 

Need for a New Research Paradigm 

A new paradigm is needed for basic and translational/clinical neuroscience studies of sex differences in brain and behavior. Over the years, the basic experimental paradigm in neuroscience 

has shifted from studying the effects of genes alone on the brain and/or behavior disorder, to 

studying the effects of both genes and hormones on the brain and/or behavior disorder. However, the effects of an individual’s experiences can also influence both gene expression and 

hormone levels, and vice versa. Thus, to fully understand sexually differentiated brain function 

and brain disorders, the following effects of experience, in addition to genes and hormones, all 

acting throughout the course of an individual’s lifespan, need to be integrated and considered: 

• Genes that are differentially expressed or modified in females and in males need to 

be identified. 

• The fact that males and females have different life experiences and exist in different social environments needs to be recognized, and feedback generated from these 

differences may alter gene expression or brain circuitry to ultimately affect their predisposition to certain disease states. For example, early onset of puberty results in 

different experiences for girls and boys, often being perceived as a negative 

experience for girls, but a positive experience for boys. 

• Environment includes learning, experience, and psychosocial variables, which are all determinants of health and disease states in humans. Current research tries to control for 

these variables, in addition to controlling for sex differences that influence hormones and 

their effects on learning and experience, instead of modeling them. 

• There is a lack of integration of dynamic events such as brain development, socialization, 

and brain plasticity that occur throughout the lifespan of an organism, and the ways in 

which they lead to the downstream expression of genes, which ultimately influence 

susceptibility to disease. 

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Recommendations 

The following research recommendations may help to provide guidance to research and health 

administrators, clinicians, and scientists as to areas of investigation that merit greater research. 

Recommendation 1: Promote the recognition and understanding among researchers of sex 

differences in brain function and brain disorders. 

• Integrate the study of sex differences into neuroscience graduate and medical school 

training curriculums. 

• Develop and disseminate didactic tools through professional organizations (e.g., Society 

for Neuroscience, Organization for the Study of Sex Differences). 

• Sharpen and clarify sex/gender definitions as a heuristic/means for focusing research 

questions that seek to understand differences between male and female subjects. 

Recommendation 2: Convene a panel of experts to make recommendations to NIH Peer Review administration on the inclusion of female animal subjects and/or the focus on sexually 

differentiated brain function and disease in basic neuroscience research. 

• Ensure that study sections understand sex differences research. 

• Ensure that the peer-review-process-intended plan for analysis by sex is honored in the 

final research design and tabulation of the analysis. 

Recommendation 3: Develop new animal research paradigms to study the epigenetic influences impacting development of neurological and psychiatric disorders. What determines 

sex-specific or sex-biased brain disease vulnerability, course, and/or response to therapeutics? 

• Develop experimental paradigms that model sex-specific or sex-biased experiential, hormonal, and psychosocial effects on gene expression, and intra- and intercellular signaling 

properties in the brain. 

• Develop and use high-throughput epigenomic approaches to characterize the large-scale 

epigenetic alterations associated with experience and related to sexually differentiated 

brain function and disease. 

Recommendation 4: Develop new molecular genetic approaches in animal models to study 

the impact of developmental stage, experience, hormones, and aging on sex-steroid hormone 

signaling in vivo, as well as new generations of transgenic and gene targeting approaches. 

Recommendation 5: Develop and support new approaches to define similarities and differences in sexually differentiated brain function and disease in humans and animal models; for 

example, through the use of comparative imaging (i.e., functional magnetic resonance imaging, 

or fMRI) of sexually differentiated brain function in order to both validate current animal models 

and to establish systems that are better models for specific conditions and/or disease states. 

Recommendation 6: Develop new methodologies in experimental animals for identification, 

targeted imaging of, and application of pharmacological agents to sexually differentiated 

cell populations in the brain. 

241
WOMEN IN SCIENCE CAREERS 

Cochairs:
�

Sandra Masur, Ph.D.
�

Mount Sinai School of Medicine 

Molly L. Carnes, M.D., M.S. 

University of Wisconsin–Madison 

NIH Cochair:
�

Rodney E. Ulane, Ph.D.
�

Office of the Director 

Science Writers: 

Jessica Reimer, Ph.D. 

Independent Consultant 

Eunji Chung 

Northwestern University 

Introduction 

The goal of the Women in Science Careers working group was to generate innovative approaches for the Office of Research on Women’s Health to take that would enhance the careers of 

women in basic, clinical, and other biomedical sciences. Working group participants were intimately familiar with the challenges faced by female clinicians and researchers at all stages 

of career development. They were a diverse group in various stages of their career, including 

graduate students, postdoctoral fellows, program directors, former presidents of national professional organizations, deans, and educators. This varied background helped focus discussion 

on not only retention of women in science careers, but also reentry of women into senior positions in the workforce, as well as what factors initially attract females to scientific professions. 

Given the charge of making short-term, achievable recommendations, the group discussed how 

several existing NIH career development mechanisms (e.g., Building Interdisciplinary Research 

Careers in Women’s Health and other K awards) could be useful for supporting effective 

mentoring or reentry of female scientists. 

The overarching theme identified by the group was that the biomedical enterprise has yet to 

address the paradox that, although significant economic, demographic, and social changes 

have occurred over the past several decades, there have not been parallel, significant adjustments made to the career paths and the workplace that optimize the ability of trainees to 

contribute to scientific excellence. Although these societal changes affect the entire workforce, 

given the known disparities between genders and among majority and underrepresented 

groups, the ORWH must continue to be an advocate and supporter of women and women’s 

health research. 

Summary of the Discussion 

By asking the working group participants to explain why they were attending this particular 

session and what they hoped to achieve, the following common concerns about careers 

for women in science were identified: 

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• Women often seem more likely than men to choose or be relegated to alternative or 

nontenure-track positions. 

• Talent is often not identified and therefore not nurtured. 

• Women rarely advance to leadership positions. 

• Focus needs to remain on attrition rates of women in science careers and 

productive interventions.
�

• Work-life balance and gender role collisions are of continuing concern, particularly 

regarding the absence of family-friendly environments at academic institutions (lack 

of lactation facilities, brief or unpaid maternity leave, overcrowded or inadequate child 

care availability, etc.). 

• Women’s health research is stigmatized as of lesser value or lower status than other 

areas of research. 

• There is a perception of gender-based pay inequity, possibly due to unconscious gender 

bias in hiring or choice of research fields. 

• There is greater potential for backlash against women leaders in the sciences. 

• There is a prominent role of female mentorship, yet a lack of recognition for mentoring. 

• Recognition of science careers outside of medicine (nursing, pharmacy, dentistry, etc.) 

is needed. 

The cochairs posed four questions to identify new strategies and to identify where existing 

programs for career development could be extended or strengthened in the next decade: 

1. How can the return on investment be optimized by identifying and developing all 

research talent? 

2. How can full career development be supported through alternative pathways and 

time frames? 

3. How can more women be advanced to top leadership and receive adequate support? 

4. How can available opportunities be more effectively publicized? 

The group noted that women now constitute more than 50 percent of college-aged students. 

To continue to attract the next generation, scientific curiosity needs to be identified and encouraged at a young age and developed throughout a woman’s undergraduate career. Substantial 

resources are invested in training women scientists. The group discussed ways to optimize return on that investment by focusing on women in graduate school and beyond. Clearly the 

support of mentors is critical not only for transition stages in a scientist’s career, but also for 

retention of women in academic careers and overall career development. The group was concerned that contributing time to mentoring could actually detract from associate or assistant 

professors’ ability to pursue research, further hindering their advancement into a leadership role 

in the future. Institutions must recognize the value of these activities and factor them into 

tenure and promotion decisions. Training was also proposed to help mentors use their time 

more effectively. Participants referenced successful mentor training programs at Vanderbilt 

University; University of California, San Francisco; and Baylor University. 

243
The next issue addressed was facilitating transitions of women in science careers, with an emphasis on understanding that publicizing alternative pathways and time frames may be effective 

in retaining and advancing women and preventing their dropping out. Implementing solutions 

to resolve the conflict between personal and professional goals is critical for supporting women 

who have taken time off from research or clinical practice for family responsibilities. The group 

identified two subsets of women who pursued alternative timeframes and/or pathways after 

having children: those who left early in their career and those who left senior positions. Several 

options were explored to provide ongoing career support for these women. The first is allowing women to “keep a thread” by maintaining a relationship with their laboratory or institution 

while on leave. This would aid in reentry because knowledge of current techniques and areas of 

study would remain up to date. In addition, extending eligibility of current funding options and 

providing support for mentors of late-career-stage women reentering the workforce would also 

be beneficial. Finally, encouraging institutions to foster a family-friendly environment for male 

and female staff is critical for retaining excellence in science. The group was aware that the NIH 

cannot mandate this, but suggested that it could incorporate questions into grant applications 

requesting that the institution describe its family-friendly policies. 

Keeping women in leadership roles and providing support to them is also critical for maintaining scientific excellence. The group recommended development of programming to fund and 

train senior women in leadership roles in conjunction with existing programs such as those of 

the Executive Leadership in Academic Medicine and the Association of American Medical Colleges. The importance of institutional or systems change regarding gender equity has been a 

recurrent theme in the regional ORWH workshops. It was suggested that the ORWH consider 

investing in organizational knowledge diffusion as a strategy to build on the research findings 

that will emanate from the 14 recently awarded (2009) NIH research grants focusing on factors 

that influence the careers of women in biomedical and behavioral science and engineering. 

Finally, the most easily remedied problem identified was the lack of publicity for funding opportunities, training, mentoring programs, and assistance with development of grant applications 

that have been pioneered by the ORWH. The group discussed ways to make information more 

accessible to women and women’s health researchers, allowing more scientists to take 

advantage of these opportunities. 

Recommendations 

The Women in Science Careers working group sees a sustained role for the NIH in supporting 

and advancing women and women’s health research agendas. The four recommendations 

provided below recognize the intrinsic value of existing NIH programs and suggest enhancements that promote their use in the future. These recommendations were developed to 

provide guidance to academic institutions and administrators, health professions, clinicians, 

and scientists as to areas of investigation that merit greater research. 

Recommendation 1: Aid in developing research talent and increasing return on investment: 

• Explicitly encourage awareness of unconscious bias in decisionmaking (“bias literacy”) 

that may impact hiring, promotion, and attainment of leadership roles. 

• Include financial support for mentors and Principal Investigators on training grants 

and career development awards, as was the case with Roadmap K12, and include a 

part in the application for a Mentor Development Plan. 

244
• Use existing mechanisms (e.g., K24 or K07) to support midcareer investigators both 

to encourage them to be mentors and to potentially develop curriculums relevant to 

women’s career advancement (e.g., mentor training). 

• Invest in Organizational Knowledge Diffusion to capitalize on existing and forthcoming 

research on women’s biomedical career development. 

• Provide funds in training and career development grants for program evaluation so that 

the most effective techniques could be publicized for others to adopt. 

Recommendation 2: Facilitate reentry of women into the scientific workforce: 

• Expand the target group of K grants to support mentored reentry of senior independent 

researchers and Principal Investigators. 

• Allow more flexibility of time distribution for research and nonresearch effort on 

K awards. 

• As part of the description of the environment in a proposal for training and career development awards, ask for information about institutional family-friendly policies. This 

could be viewed as “Organizational Knowledge Diffusion” and is similar in some ways to 

the National Science Foundation-funded Institutional Transformation awards. However, 

the main difference is in the fact that the award is not given to the institution explicitly 

for transformation, but to encourage implementation of family-friendly programs and 

to provide information to trainees about these policies. 

• Explore a “Keep a Thread” funding mechanism to allow part-time faculty to remain 

involved in their field of science or medicine to facilitate future reentry. 

Recommendation 3: Help women attain leadership positions and support those in 

leadership roles: 

• Explore providing funds for leadership training along with research training and/or career 

development (i.e., pre- or postdoctoral trainees) on R01 awards. 

• Cosponsor leadership training programs with professional societies. 

• Create a toolkit for leadership workshops. 

Recommendation 4: Publicize opportunities for funding and support: 

• Develop a central Career Advice platform that will provide the contact information 

of knowledge-rich people (e.g., an NIH Help Line) to assist with grant development 

and applications. 

• Develop a user-friendly Web site that consolidates information on funding and career 

development available at the NIH for supporting women from all backgrounds (including underrepresented minorities, individuals with disabilities, and individuals from 

disadvantaged backgrounds). Update this site regularly. 

• Highlight potential for partnerships between research-intensive and other institutions 

(e.g., nonresearch-intensive, teaching-focused, and minority-serving institutions). 

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A Vision for 2020 for Women’s Health Research: 

Moving Into the Future with New Dimensions and Strategies 

A Public Hearing and Scientific Workshop 

Emory University School of Medicine 

Atlanta, Georgia 

February 16–17, 2010 

DAY 1—SCIENTIFIC WORKSHOPS AND PUBLIC HEARING 

Location: James B. Williams Medical Education Building 

8:00–8:20 a.m. Welcome and Opening Remarks 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health, 

Director, Office of Research on Women’s Health (ORWH), 

National Institutes of Health (NIH) 

Nanette K. Wenger, M.D. 

Conference Chair, Professor of Medicine (Cardiology), 

Emory University School of Medicine, Chief of Cardiology, 

Grady Memorial Hospital 

Video Welcome 

The Honorable Lisa Murkowski 

U.S. Senator, Alaska 

8:20–8:30 a.m. Welcoming Remarks 

The Honorable Kasim Reed 

Mayor of Atlanta (Represented by Candace Byrd, 

Chief of Staff) 

8:30–8:40 a.m. Welcoming Address: The Role of the 

Medical School in Advancing Women’s 

Cardiovascular Health Research 

Thomas J. Lawley, M.D. 

Dean, Emory University School of Medicine 

8:40–9:45 a.m. OPENING PANEL 

Moderator: Jackson T. Wright, Jr., M.D., Ph.D. 

Professor of Medicine, Nephrology & Hypertension/Medicine, 

Case Western Reserve University 

246
Basic Science Vistas in Women’s Cardiovascular 

Health Research 

W. Robert Taylor, M.D., Ph.D. 

Director, Division of Cardiology and Professor of Medicine and 

Bioengineering, Emory University School of Medicine 

Pregnancy and Cardiovascular Health Research 

Sarah Berga, M.D. 

James Robert McCord Professor & Chairman, 

Reproductive Endocrinology & Infertility, Emory 

University School of Medicine 

The Health of Latino Women: Perspectives 

from the Hispanic Community Health Study— 

Study of Latinos 

Larissa Avilés-Santa, M.D., M.P.H. 

Medical Officer, Epidemiology Branch, Division of 

Cardiovascular Sciences, National Heart, Lung, and Blood 

Institute (NHLBI) 

Ethical Considerations in Advancing Women’s 

Cardiovascular Health Research 

Paul Root Wolpe, Ph.D. 

Asa Griggs Candler Professor of Bioethics; Raymond F. 

Schinazi, Distinguished Research Chair in Jewish Bioethics; 

Professor, Departments of Medicine, Pediatrics, and Sociology; 

Director, Center for Ethics, Emory University 

9:45–10:00 a.m.	� Audience Response 

10:00–10:15 a.m.	� BREAK 

10:15–10:30 a.m.	� Pregnancy History Predicts Cardiovascular 

Disease in Women: What More Do We Need 

To Know? 

Janet Rich-Edwards, Sc.D., M.P.H. 

Director of Developmental Epidemiology, Connors Center 

for Women’s Health and Gender Biology, Brigham and 

Women’s Hospital 

10:30–10:45 a.m.	� Welcoming Remarks 

James W. Wagner, Ph.D. 

President, Emory University 

247
10:45–11:00 a.m. NHLBI Perspective 

Patrice Desvigne-Nickens, M.D. 

Medical Officer, Heart Failure and Arrhythmias Branch, 

Division of Cardiovascular Sciences, National Heart, Lung, 

and Blood Institute 

11:00–11:30 a.m. Keynote Address: Women in Biomedical Careers—Implications for Advancing Women’s 

Cardiovascular Health Research 

Kathy Griendling, Ph.D. 

Professor of Medicine, Vice Chair for Faculty Development, 

Emory University 

11:30–12:45 p.m. PUBLIC HEARING 

Nanette K. Wenger, M.D. 

Receiving Public Testimony: Members of the ORWH 

Advisory Committee and Host Scientists 

12:45–1:00 p.m. Working Group Charge 

Vivian W. Pinn, M.D. 

1:00–1:15 p.m. BREAK 

1:15–5:00 p.m. Lunch and Concurrent Working Groups 

• Pregnancy and Cardiovascular Disease Research and 

Ethical Considerations 

• Cardiovascular Disease in Elderly and Frail Elderly 

Women—Optimal Management and Research 

• Microvascular Disease, Biomechanics, and Application 

of New Technologies to Cardiovascular Research 

• Stem Cells, Progenitor Cells, and the Vista of 

Cardiovascular Regenerative Medicine 

• Unmet Needs in Diagnostic Testing for Women with 

Cardiovascular Disease 

• Issues of Cardiovascular Prevention Across the Lifespan 

with an Emphasis on Gender and Underserved 

Populations 

• Women’s Careers in the Biomedical Sciences 

5:00–6:30 p.m. CONFERENCE RECEPTION 

248
DAY 2—KEYNOTE ADDRESSES AND WORKING GROUP 

PRESENTATIONS 

Location: James B. Williams Medical Education Building 

8:30–8:40 a.m. Welcome and Opening Remarks 

Janine Austin Clayton, M.D. 

Deputy Director, Office of Research on Women’s Health 

8:40–8:45 a.m. Perspective on Women’s 

Cardiovascular Disease 

Elizabeth Barrett-Connor, M.D. 

Distinguished Professor and Chief, Division of Epidemiology, 

University of California, San Diego 

8:45–8:50 a.m. Introduction to Keynote Speakers 

Nanette K. Wenger, M.D. 

8:50–9:15 a.m. Keynote: A View of the Legislative Role, 

Local and National, in Advancing Women’s 

Cardiovascular Research 

The Honorable John Lewis 

Congressman, 5th District, Georgia 

9:15–9:45 a.m. Keynote: Role of Public/Private Partnerships 

in Addressing Indigent Care: Implications for 

Women’s Cardiovascular Health Research 

Michael A. Young, M.H.A., FACHE 

President and Chief Executive Officer, Grady 

Memorial Hospital 

9:45–11:15 a.m. Concurrent Working Groups: Finalization 

of Recommendations 

11:15 a.m.–12:45 p.m. Working Group Presentations 

Moderator: Nanette K. Wenger, M.D. 

12:45–1:00 p.m. Closing Remarks 

Vivian W. Pinn, M.D. 

249
Emory University School of Medicine 

Atlanta, Georgia 

February 16–17, 2010 

WORKING GROUP COCHAIRS 

PREGNANCY AND CARDIOVASCULAR DISEASE RESEARCH 

AND ETHICAL CONSIDERATIONS 

Janet W. Rich-Edwards, M.P.H., Sc.D. 

Director of Developmental Epidemiology 

Division of Women’s Health, Department of Medicine 

Brigham and Women’s Hospital 

Boston, Massachusetts 

Catherine Y. Spong, M.D. 

Chief, Pregnancy and Perinatology Branch 

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Robert N. Taylor, M.D., Ph.D. 

Professor and Vice Chair for Research 

Gynecology and Obstetrics 

Emory University School of Medicine 

Atlanta, Georgia 

CARDIOVASCULAR DISEASE IN ELDERLY AND FRAIL ELDERLY 

WOMEN: OPTIMAL MANAGEMENT AND RESEARCH 

Elizabeth O. Ofili, M.D. 

Professor of Medicine, Chief of Cardiology, and Associate Dean of Clinical Research 

Clinical Research Center 

Morehouse School of Medicine 

Atlanta, Georgia 

Jacques E. Rossouw, M.D. 

Chief, Women’s Health Initiative Branch 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Viola Vaccarino, M.D., Ph.D. 

Professor of Medicine (Cardiology) 

Emory University School of Medicine 

Atlanta, Georgia 

250
MICROVASCULAR DISEASE, BIOMECHANICS, AND APPLICATION 

OF NEW TECHNOLOGIES TO CARDIOVASCULAR RESEARCH 

Barbara D. Boyan, Ph.D. 

Professor 

Biomedical Engineering 

Georgia Institute of Technology 

Atlanta, Georgia 

Gary Gibbons, M.D. 

Director, Cardiovascular Research Institute 

Professor, School of Medicine 

Cardiovascular Research Institute 

Morehouse School of Medicine 

Atlanta, Georgia 

George Sopko, M.D., M.P.H. 

Medical Officer and Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

STEM CELLS, PROGENITOR CELLS, AND THE VISTA OF 

CARDIOVASCULAR REGENERATIVE MEDICINE 

Martha Shauck Lundberg, Ph.D. 

Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Robert Nerem, Ph.D. 

Parker H. Petit Distinguished Chair for Engineering in Medicine 

Institute Professor 

Georgia Institute of Technology 

Atlanta, Georgia 

Arshed A. Quyyumi, M.D., FRCP 

Professor of Medicine, Division of Cardiology 

Emory University School of Medicine 

Atlanta, Georgia 

UNMET NEEDS IN DIAGNOSTIC TESTING FOR WOMEN WITH 

CARDIOVASCULAR DISEASE 

Patrice Desvigne-Nickens, M.D. 

Medical Officer 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

251
Leslee Shaw, Ph.D. 

Professor 

Department of Cardiology 

Emory University School of Medicine 

Atlanta, Georgia 

ISSUES OF CARDIOVASCULAR PREVENTION ACROSS 

THE LIFESPAN WITH AN EMPHASIS ON GENDER AND 

UNDERSERVED POPULATIONS 

Jane L. Harman, D.V.M., Ph.D., M.S. 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Catherine (Cay) Loria, Ph.D., M.S. 

Nutritional Epidemiologist 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Peter W.F. Wilson, M.D. 

Professor of Medicine 

Medicine/Cardiology 

Emory University School of Medicine 

Atlanta, Georgia 

Jackson T. Wright, Jr., M.D., Ph.D. 

Professor of Medicine 

Nephrology and Hypertension/Medicine 

Case Western Reserve University 

Cleveland, Ohio 

WOMEN’S CAREERS IN THE BIOMEDICAL SCIENCES 

Nakela Cook, M.D., M.P.H. 

Medical Officer 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

University of Colorado-Denver School of Medicine 

Aurora, Colorado 

252
INTRODUCTION 

This report covers the fifth strategic planning meeting, held February 16–17, 2010 at the Emory University School of Medicine. The topic of the meeting was cardiovascular disease (CVD), 

the leading cause of mortality among women in the United States. The format of this meeting, 

the only one of the five regional meetings to have a disease-specific focus, included plenary presentations, public testimony, and seven breakout sessions of the scientific working and 

discussion groups. The breakout groups were charged with developing recommendations for 

pregnancy and CVD research; CVD research focused on the elderly; applying new technologies 

to CVD; cardiovascular regenerative medicine; diagnostic testing for women; CVD prevention 

across the lifespan for women and underserved populations; and women’s careers in the biomedical sciences. The reports from the scientific working groups follow a brief summary of 

highlights of the plenary presentations. 

SUMMARIES OF PLENARY PRESENTATIONS 

The meeting opened with welcomes to participants. Vivian W. Pinn, M.D., director of the Office 

of Research on Women’s Health, noted that the establishment of a women’s health office at 

the National Institutes of Health in 1990 was motivated in large part by public concern over 

the exclusion of women from CVD clinical trials. Since the establishment of ORWH, mortality 

in women from CVD has fallen somewhat, but less so than in men. 

Nanette K. Wenger, M.D., the Emory meeting organizer, noted that symptoms of CVD in women 

continue to be underrecognized and undertreated by clinicians. Despite two decades of awareness of inequities in research on CVD in women, they continue to be underrepresented in clinical 

trials and incur greater mortality as a result of CVD than do men. Kasim Reed, Mayor of Atlanta, in a statement read by Candace Byrd, Chief of Staff, emphasized the link between improved 

public health and effective prevention and treatment of the number one killer of the nation’s 

women. Thomas L. Lawley, M.D., Dean of the Emory University School of Medicine, spoke of 

the need for medical schools both to partner with basic scientists to advance knowledge and 

to team with women’s health advocates to more effectively communicate the importance of 

research to professionals and the public. 

Senator Lisa Murkowski, Senate cosponsor, with Michigan Senator Debbie Stabenow, of the 

HEART for Women Act, welcomed participants in a video and commended them for undertaking such important work over the next two days. She spoke of the proposed legislation, 

which aims to raise awareness among women and their healthcare providers of heart disease and stroke and provide gender- and race-specific information about CVD to clinicians 

and researchers. The bill would also authorize the expansion to all 50 states of the Centers 

for Disease Control and Prevention (CDC)-funded WISEWOMAN program, which provides 

screening for low-income, uninsured women at risk for heart disease and stroke. 

OPENING PANEL 

The opening panel of the plenary session, moderated by Jackson T. Wright, Jr., M.D., Ph.D., Professor of Medicine at Case Western Reserve University, presented perspectives on basic 

253
science research in CVD, pregnancy and cardiovascular health research, underserved populations, and ethical considerations. 

W. Robert Taylor, M.D., Ph.D. 

Director, Division of Cardiology and Professor of Medicine and Bioengineering, 

Emory University School of Medicine 

Dr. Taylor began with an overview of sex differences in cardiovascular physiology and in biological risk factors. In men, the most common cause of a heart attack is a plaque rupture, resulting 

in coronary thrombosis. In premenopausal women, however, thrombosis is more likely to result 

from plaque erosion than rupture, and erosion is associated with higher mortality. Furthermore, 

women with myocardial infarction (MI) are less likely than men to have antecedent obstructions in their major coronary arteries. A significant portion of women suffer from another form 

of heart disease affecting the smaller arteries, the microvasculature, that delivers blood directly 

to heart muscle tissue. In addition to sex differences in initiating events, there are other sex 

differences in inflammatory processes, in the signaling pathways that mediate the responses 

of smooth muscle cells and endogenous vasoconstrictors, and in microvascular remodeling. 

Such differences contribute to the clinically manifest sex differences in MI, heart failure, 

atherosclerosis, and collateral vessel formation. 

Sarah Berga, M.D. 

James Robert McCord Professor and Chairman, Reproductive Endocrinology and Infertility, 

Emory University School of Medicine 

Dr. Berga highlighted maternal pregnancy effects on offspring CVD risk and pregnancy as a biological stress test—revealing vulnerability to later CVD in women who experience pregnancy 

complications such as preeclampsia and gestational diabetes. A growing body of literature indicates that maternal stress during pregnancy can alter the epigenetic expression of genes in 

offspring. For example, maternal malnutrition during pregnancy has been linked to an increased 

risk of diabetes and CVD in offspring when they reach adulthood. Psychological and social 

stresses also may alter gene expression in offspring by exposing the fetus to increased levels 

of adrenocortical hormones in the placenta. Maternal nutritional and social stress may alter 

metabolic function in offspring. 

Larissa Avilés-Santa, M.D., M.P.H. 

Medical Officer, Hispanic Community Health Study—Study of Latinos, National Heart, Lung, 

and Blood Institute 

Dr. Avilés-Santa described a recently initiated NHLBI study of risk and protective factors 

for CVD and pulmonary disease in Hispanic women. Collecting information on cohorts 

at multiple sites throughout the United States, the study will include data on ethnic and 

socioeconomic factors as well as measures of cognitive processing, emotional regulation, 

biological vulnerabilities, and health behaviors. The effort should provide a model of 

biopsychosocial vulnerabilities and resilience. 

Paul Root Wolpe, Ph.D. 

Director, Center for Ethics, Emory University 

Are pregnant women a vulnerable population for research? Is there a gender bias in clinical 

research? Dr. Wolpe’s presentation addressed these issues. In regulations promulgated in 1974, 

254
pregnant women, along with prisoners, children, and those with reduced cognitive capacity, were characterized as vulnerable populations whose recruitment and consent to research 

required a higher level of scrutiny. However, a pregnant woman who has a serious health condition and needs more information about its treatment is, in fact, fully able to provide informed 

consent and decide whether to participate in clinical research. Current wording of regulations 

may inhibit such research. 

Dr. Wolpe argued that devaluation of women’s health can be seen in the relatively low number of research publications that report analysis by sex of participant and in the failure of clinical 

medicine guidelines to incorporate gender-based findings. Gender bias is most emphasized in 

clinical trials, but there is also evidence for bias in other kinds of clinical research, e.g., epidemiology and health services. To overcome bias, steps should be taken to include gender-related 

issues in terms that provide the framework for scientific research searches. 

Janet Rich-Edwards, Sc.D., M.P.H. 

Director of Developmental Epidemiology, Connors Center for Women’s Health and Gender 

Biology, Brigham and Women’s Hospital 

Dr. Rich-Edwards discussed the role of preeclampsia and gestational diabetes as predictors of 

later risk for CVD, presenting some preliminary results from the Nurses’ Health Study II. These 

pregnancy complications appear to fall within the range of other early indicators of risk for CVD 

and could be useful predictors. There are many unanswered questions about the association of 

pregnancy outcomes and complications with the health of both parent and offspring. Dr. RichEdwards proposed examining cardiovascular risk factors as they emerge in mothers, fathers, and 

offspring. A longitudinal family cohort, recruited during pregnancy and followed up for several 

years, could yield several new research leads. A family cohort would allow researchers to explore 

the emergence of sex differences in cardiovascular risk in early life and thereby plumb some of 

the earliest origins of sex differences in CVD risk. One possible finding might be that pregnancy 

characteristics predict future CVD risk in mothers and children because they reveal subclinical CVD risk factors, like proinflammatory states or high risk angiogenic profiles. Such a study 

would enable researchers to get a step closer to understanding whether preventing or treating 

pregnancy complications might actually change the trajectory of mother and child. 

Patrice Desvigne-Nickens, M.D. 

Medical Officer, Heart Failure and Arrhythmias Branch, Division of Cardiovascular Sciences, 

National Heart, Lung, and Blood Institute 

Dr. Desvigne-Nickens highlighted NHLBI-funded resources and research priorities. Over the 

years, NHLBI has funded major cohort studies of CVD, from the Framingham Heart Study to 

the Women’s Health Initiative. These laid the groundwork for clinical trials of prevention and 

treatment and the development of risk indices. NHLBI has greatly expanded its investment in 

research infrastructure, technology development and biorepositories. Looking forward, major 

health advances may accrue from studies of healthy lifestyles and behavior change. Fundamental sex differences research offers the potential for insights into regenerative repair mechanisms. 

Study of sexually dimorphic patterns, whether in symptoms, plaque morphology and rupture, 

or in microvascular disease and molecular signatures will benefit both women and men. The 

ultimate goal of all this research will be the fine tuning of personalized medicine and improved 

health outcomes. 

255
KEYNOTE ADDRESS: WOMEN IN BIOMEDICAL CAREERS— 

IMPLICATIONS FOR ADVANCING WOMEN’S CARDIOVASCULAR 

HEALTH RESEARCH 

Kathy Griendling, Ph.D. 

Professor of Medicine and Vice Chair for Faculty Development, Emory University 

Dr. Griendling addressed the value of women conducting biomedical research on CVD. Women 

researchers bring talent equal to men, unique perspective and empathy, greater understanding 

of and interest in women’s health issues, and ownership of health issues. Women are entering 

academic medicine at rates comparable to men but their attrition is higher and they are underrepresented in leadership positions. To remedy this situation and to increase gender-focused 

CVD research, institutions need to address barriers to the retention of women, whether family-related or due to unrecognized bias. To address the dearth of women in leadership positions, 

more leadership training opportunities need to be made available to women. In addition, there 

should be gender-specific, high-quality mentoring and advising from the early stages of a 

woman’s career. 

KEYNOTE ADDRESS: A VIEW OF THE LEGISLATIVE ROLE, 

LOCAL AND NATIONAL, IN ADVANCING WOMEN’S 

CARDIOVASCULAR RESEARCH 

The Honorable John Lewis 

Congressman, 5th District, Georgia 

Congressman Lewis, a Civil Rights leader, began by noting that he is a member of the Congressional Health and Stroke Coalition, which is committed to raising awareness of CVD. He 

emphasized that medical research should be a national budget priority. Research done at 

Emory and other major research universities on CVD has been remarkable for men but unacceptable disparities exist for women with CVD. We should not rest until they are more fully 

acknowledged and addressed through research and research dissemination activities. 

KEYNOTE ADDRESS: ROLE OF PUBLIC/PRIVATE PARTNERSHIPS 

IN ADDRESSING INDIGENT CARE—IMPLICATIONS FOR WOMEN’S 

CARDIOVASCULAR HEALTH RESEARCH 

Michael A. Young, M.H.A., FACHE 

President and Chief Executive Officer, Grady Memorial Hospital 

Mr. Young spoke about the role of public-private partnerships in addressing indigent care. 

Grady Memorial is a public hospital that treats a disproportionate number of uninsured women. Uninsured adults receive fewer and less timely preventive and screening services and do 

not consistently receive care for chronic diseases. A few years ago, Grady was losing money 

and was unable to upgrade its physical plant and clinical facilities. Through partnerships with 

the business community and philanthropic organizations, the hospital has turned around. It 

is now a major trauma and HIV/AIDS center and boasts new cardiovascular (CV) testing and 

imaging facilities. Grady Memorial has improved patient care by using new communication 

technology to track patients, provide transportation to appointments, and promote communication among treating physicians. As a result, ER admissions are down and the hospital is 

able to control costs while providing better coordinated care to patients. 

256
CHARGE TO THE WORKING GROUPS 

Dr. Pinn provided a charge to meeting participants before they broke into groups. She asked the 

working groups to help the NIH chart the future direction of women’s health research. What science and technologies are most innovative? What are the highest priority issues in addressing 

women’s health needs? What new initiatives within the NIH mission are needed? What can the 

Office do to facilitate these initiatives? She ended by expressing her hope that working group 

recommendations would not summarize the status quo but anticipate new science needed over 

the next decade to advance women’s health. 

257
SCIENTIFIC WORKING AND DISCUSSION GROUPS 

PREGNANCY AND CARDIOVASCULAR DISEASE RESEARCH AND 

ETHICAL CONSIDERATIONS 

Cochairs:
�

Janet W. Rich-Edwards, M.P.H., Sc.D.
�

Brigham and Women’s Hospital 

Robert N. Taylor, M.D., Ph.D. 

Emory University School of Medicine 

NIH Cochair:
�

Catherine Y. Spong, M.D.
�

Eunice Kennedy Shriver National Institute of Child Health and Human Development 

Science Writers:
�

Neal Dickert, M.D., Ph.D.
�

Emory University School of Medicine 

Erin Galbraith, M.D. 

Emory University School of Medicine 

Introduction 

Any serious examination of women’s health issues must consider the implications of pregnancy and fertility. Pregnancy produces a unique and dynamic physiologic state that has numerous 

implications, particularly regarding CVD. Pregnancy can complicate the management of preexisting CVD, such as congenital heart disease, cardiomyopathy, and hypertension. Pregnancy 

also is associated with specific and well-known health problems such as postpartum cardiomyopathy, spontaneous coronary artery dissection, and pregnancy-related hypertensive disorders. 

Management of preexisting CVD and pregnancy-associated cardiovascular conditions has important immediate and long-term impact on the health of mothers and fetuses. Because of the 

unique state of interdependence that exists during pregnancy (i.e., the “maternal-fetal unit”), 

both the clinical treatment of pregnant women and clinical research involving pregnant women 

raise important ethical challenges. 

Mounting evidence suggests that some complications during pregnancy appear to be associated with long-term CVD. Data from large cohorts, including the Nurses’ Health Study II (NHS 

II), suggest that the presence of preterm delivery, pregnancy-induced hypertension (PIH), and 

gestational diabetes mellitus (GDM) appear to have important associations with long-term 

CVD. Indeed, these novel risk factors appear to be as important as other well-known CVD risk 

factors such as hyperlipidemia, family history, and overweight/obesity. Furthermore, evidence 

indicative of long-term vascular remodeling in women with complicated pregnancies points to 

a causative role in the development of long-term CVD. It is estimated that 25 percent of women who have given birth experienced at least one complication of pregnancy that may have 

CVD implications, making the public health impact of pregnancy complication-related 

cardiovascular risk potentially very large.1–4 

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The focus of this working group’s discussion was on the emerging science examining the relationships between pregnancy complications and CVD, and the ethical considerations raised by 

conducting clinical research in pregnant women. The principal goal was to identify priorities 

for future research that can further uncover the relationships between pregnancy complications and cardiovascular risk and identify potential avenues for assessment and prevention. 

Summary of the Discussion 

The discussion of the working group focused on the following major areas: (1) examination of 

associations between pregnancy history and CVD risk; (2) pathophysiologic evidence for causal relationships between pregnancy complications and CVD; (3) potential clinical implications 

of pregnancy-related CVD risk; (4) ethical considerations regarding the conduct of clinical cardiovascular research with pregnant women; and (5) identification of other potential priority 

areas for research related to pregnancy and CVD, such as preexisting CVD and primary cardiac 

complications of pregnancy. 

1. Examining Associations between Pregnancy History and CVD Risk 

How a woman “goes through pregnancy” appears associated with her cardiovascular status 

over time. An association between pregnancy complications and cardiovascular risk appears 

well-established. It may be that pregnancy functions as a “stress test” in that the cardiovascular and metabolic demands of pregnancy unmask clinically silent vascular dysfunction and 

disease. Pregnancy complications such as hypertension, GDM, and preterm delivery may be 

the manifestations of preexisting subclinical disease.1 Similarly, it has been suggested that 

women who do not suffer pregnancy complications may have the physiologic ability to handle the cardiovascular demands of pregnancy and thus are at lower risk of future CVD.2 Or, 

it may be that pregnancy complications actually cause cardiovascular injury and thus serve 

as an independent risk factor for CVD rather than a marker for potential CVD risk. Much of 

the subsequent discussion focused on potential ways to study these hypotheses and their 

potential clinical implications. 

Particular complications appear to have important links to cardiovascular disease. Data 

from several large cohorts have provided evidence of associations between GDM, preterm 

birth (PTB), PIH, and future CVD. GDM, for example, predicts future type 2 diabetes mellitus, an 

established CVD risk factor.3 NHS II findings indicate that PTB is associated with hazard ratios 

in the range of 1.6–2.3 for early CVD, with earlier delivery associated with greater risk. PIH 

has been associated with similarly increased risk. Furthermore, evidence suggests that the 

increased risk associated with these complications is additive; women with multiple 

complications have significantly greater long-term CVD risk.4,5,6 

Low birth weight (LBW) is another complication that has been associated with maternal CVD, 

with a 25 percent decrease in maternal CVD outcomes with 500 g increases in neonate body 

weight.7 However, recent data from the NHS II suggest that, when corrected for gestational 

length, LBW may not be as clearly associated with long-term CVD risk. Further studies should 

closely examine the long-term CVD implications for mothers who deliver offspring with evidence of fetal growth restriction at any gestational age, rather than relying on birth weight, 

which is a mixed outcome of both fetal growth and gestational length. 

259
Available data sources are limited. Existing data sources are limited with regard to examination of the relationships between pregnancy complications and CVD risk. Much of the evidence 

to date has been drawn from European linked vital statistics registries. However, these data 

sources lack information on lifestyle risk factors such as smoking, activity, or diet, as well as 

intermediate risk factors such as body mass index, hypertension, and hyperlipidemia. Another 

limitation is that they do not capture the diverse demographics of the U.S. population. The 

NHS II is one of few large U.S. cohorts to collect pregnancy history data. 

Another major limitation is that current CVD trials and cohorts do not adequately capture reproductive history, including details on pregnancy complications and outcomes and general 

fertility history. Conversely, most pregnancy-related cohorts, which typically end at delivery, do 

not capture CVD outcomes and data. A further limitation is the general inability of major records systems to link data from different clinical settings. As a result, data from delivery and 

other hospitalizations cannot be linked to primary care data. Such linkages are essential to understanding relationships between pregnancy and long-term CVD risk. Related, most existing 

records systems and research cohorts provide no way to link maternal and offspring data. As 

more is learned about the fetal and maternal genetic contributions to pregnancy complications, 

cohorts that collect biological samples from mother and child will be needed to determine the 

role of genes in the associations of pregnancy complications with maternal CVD. 

2. Pathophysiologic Evidence for Causal Relationships between Pregnancy 

Complications and CVD 

Cardiovascular alterations in pregnancy as potential causes of long-term CVD. In addition to 

the above-discussed epidemiologic evidence of associations between pregnancy complications and CVD risk, there are reasons to believe that complications of pregnancy may actually 

cause vascular changes that increase long term CVD risk. Working group participants noted that there are numerous cardiovascular changes found in pregnancy that may be associated 

with CVD risk. For example, there is evidence that placental microparticles and hormone/metabolic alterations significantly affect vascular cell function. In addition, pregnancy has been 

associated with resistance vessel remodeling and autoantigen production against angiotensin 

II receptors. 

Data also indicate that pregnancy complications associated with later CVD risk are associated 

with particular cardiovascular changes that may be responsible for long-term risk, particularly 

in preeclampsia. There is pathologic evidence of significant glomerular change in the kidneys of 

preeclamptic women. Changes in endothelin levels have been associated with pregnancy and 

the preeclamptic state. Preeclampsia has also been associated with acidification of albumin 

and the apparent loss of the protective function of more basic albumin, the presence of antibodies to the angiotensin II receptor, and significant arterial changes on the maternal side of 

the placenta. These observations offer support to the hypothesis that pregnancy complications 

(particularly preeclampsia) may actually play a causal role in long-term vascular change, 

particularly remodeling of resistance vessels. 

260
3. Potential Clinical Implications of the Links between Pregnancy 

Complications and CVD 

Risk Assessment. The association between some pregnancy complications and long-term 

maternal CVD appears to be as significant as many more well-established CVD risk factors 

currently included in risk assessment tools such as the Framingham risk score. One potential 

application of these data would be the explicit inclusion of pregnancy history as part of such 

CVD risk assessment tools. Similarly, if genetic associations emerge, genetic assessments may 

aid in CVD risk stratification. Furthermore, pregnancy history may be used to craft more specific screening schedules for women with a history of pregnancy complications. For example, 

recommendations for glucose screening after pregnancies complicated with gestational 

diabetes exist; similar schedules may be developed for hypertensive disorders of pregnancy. 

Clinical Interventions. In addition to risk stratification, pregnancy complication-related CVD 

risk may present a potential target for clinical intervention. Preventive education in postpartum weight management and lifestyle modification could be more precisely tailored and timed 

for women with pregnancy complications. Interventions might also include traditional therapy 

for CVD and CVD risk, such as statins, antihypertensive medications, etc. Alternatively, interventions might be directed at minimizing the complications during pregnancy, particularly if 

a causal relationship between such complications and long-term CVD risk can be established. 

Importantly, such interventions may be beneficial to pregnant women and to fetuses. 

4. Ethical Considerations in the Conduct of Cardiovascular Research 

with Pregnant Women 

Ethical implications of pregnancy for research vary. Working group participants noted that 

the maternal-fetal unit is conceptually complicated. As a result, research in pregnancy raises 

unique questions and challenges regarding risks and benefits, and pregnant women are often considered to be vulnerable subjects from a regulatory and ethical perspective. However, 

the extent to which pregnancy raises special considerations, and the extent to which pregnant 

women and their fetuses should be considered vulnerable, varies greatly based on the type of 

research conducted. Unlike many other sources of vulnerability, such as cognitive impairment, 

pregnancy does not necessarily have any implications with regard to decisionmaking. As a result, most observational studies that focus on risk prediction, genetic analysis, and other CVD 

outcomes raise few unique ethical issues. 

Clinical trials of intervention pose unique ethical considerations. Interventions during pregnancy can raise the potential for both risk and benefit to pregnant women and to fetuses, and 

analysis of maternal and fetal interests can be complex. Of particular challenge are intervention trials that may pose significant risks to both mothers and fetuses, such as in utero surgery 

trials. Careful analysis is also warranted regarding trials of interventions such as statins, diabetes regimens, and diet that may be directed toward reduction of maternal CVD risk. Finally, the 

group discussed the importance of ensuring that pregnant women are not arbitrarily excluded 

from trials in conditions affecting pregnant women and, when included, that they are adequately represented so the results will be generalizable to pregnant women as a population. 

261
5. Management of Other Pregnancy-related Cardiovascular 

Conditions and Preexisting CVD 

Primary cardiac complications of pregnancy. Although not the working group members’ 

area of expertise, the prevention and treatment of primary cardiac diseases emerging during 

and after pregnancy (e.g., postpartum cardiomyopathy, spontaneous coronary dissection, 

and myocardial infarction), was also discussed as an important issue warranting more 

in-depth evaluation and discussion by experts in management of these conditions. 

Management of existing CVD during pregnancy. The paucity of data regarding pharmacologic treatment options for preexisting cardiovascular risk factors in pregnant patients reflects the 

low numbers of pregnant women included in the large clinical trials for treatment of traditional 

CVD risk factors or myocardial infarction. The increasing age of women who bear children will 

result in larger numbers of women with underlying CVD and cardiovascular risk factors. This 

expanding patient population further pushes the need for studies evaluating the efficacy of 

treatment options in these women. The working group also discussed ethical issues surrounding treatments for pregnant patients with preexisting CVD. Working group members believed 

that this critical issue required extensive consideration by a group of individuals with special 

expertise related to the area. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, ethicists, and the public as to areas of investigation that merit 

greater research.
�

Recommendation 1: Assess the utility of pregnancy data for CVD prediction and prevention.
�

• Longitudinally follow pregnant women for emerging cardiovascular risk factors in a systematic and detailed way. Necessary data will include regular blood glucose and blood 

pressure checks in the postpartum years. Studies will also need to follow patients across 

clinical settings (labor and delivery and primary care), over the lifespan (prenatal period, 

delivery, and postpartum), and capture both maternal and child outcomes. 

• Ideal approach—Establish a large-scale longitudinal cohort beginning before 

pregnancy (ideally at birth). 

• More pragmatic approaches—Selectively follow historical cohorts. Include data necessary for cardiovascular risk assessment in pregnancy cohorts and trials (such as the 

National Collaborative Perinatal Project or other observational pregnancy cohorts that 

collect high quality pregnancy phenotypes). Include pregnancy history data in ongoing 

longitudinal chronic disease cohorts (such as the Framingham Heart Study, Women’s 

Health Initiative, and CARDIA). It is also critical to ensure that emerging records 

systems facilitate linkages of pregnancy history data with chronic disease data. 

• Develop and evaluate clinical protocols to predict and prevent CVD in women with pregnancy complications to assess whether the screening and followup are effective and to 

establish guidelines for clinical practice. 

• Develop educational materials for patients and clinicians regarding the risk of CVD after 

complex pregnancy. 

262
Recommendation 2: Elucidate mechanisms linking complex pregnancy to CVD. 

• Develop and validate noninvasive means of assessing vascular function and injury before, 

during, and after pregnancy. Assessment methods must be repeatable over time and ideally should be integrated into ongoing trials and observational studies. Critical to these 

studies will be the inclusion of preconception baseline data. 

• Clarify the role of pre- and postpartum psychosocial determinants and gene-environment 

interactions in both the development of complications and the development of CVD. 

• Use animal models to establish causal relationships. Animal models allow investigators 

to induce pregnancy complications, assess long-term maternal cardiovascular effects 

of complications, and assess the effects of treatment during and after pregnancy on 

maternal cardiovascular risk. 

Recommendation 3: Assess the impact of potential interventions on pregnancy-related 

CV risk. 

• Assess the effects of current treatments on maternal cardiovascular outcomes. Such 

assessments should include both traditional cardiovascular treatment (e.g., statins, beta 

blockers, and dietary modifications) as well as current clinical protocols for pregnancy 

complications such as GDM and preeclampsia. 

• Identify potential novel interventions designed explicitly to minimize maternal CV risk 

associated with pregnancy complications. Animal models may be particularly useful. 

Recommendation 4: Evaluate study-specific ethical implications of pregnancy for research. 

• Recognize that vulnerability is a context-specific concept. Pregnant women often are 

not vulnerable subjects. Many studies related to pregnancy history and CVD risk prediction do not raise special ethical concerns simply because the woman is pregnant, 

and concerns about vulnerability should not hinder such research. 

• Carefully evaluate the implications of intervention trials for mothers and children. Intervention trials to improve care are vitally important but can involve short and long-term 

risks to pregnant women and fetuses; thus, intervention trials raise particular challenges 

because of the ethical complexity of the maternal-fetal unit. Animal models may present 

valuable opportunities to minimize risks. 

References 

1. Sattar, N., Greer, I.A. (2002). Pregnancy complications and maternal cardiovascular risk: 

opportunities for intervention and screening? British Medical Journal, 325, 157–160. 

2. Chesley L. (2000). Recognition of the long-term sequelae of eclampsia. American Journal of Obstetrics and Gynecology, 182(1), 249–250. 

3. Shah, B.R., Retnakaran, R., & Booth, G.L. (2008). Increased risk of cardiovascular disease 

in young women following gestational diabetes mellitus. Diabetes Care. 31, 1668–1669. 

263
4. Irgens, H.U., Reisaeter, L., Irgens, L.M., Lie, R.T. (2001). Long term mortality of mothers 

and fathers after pre-eclampsia: population based cohort study. British Medical Journal, 

323(7323), 1213–7. 

5. Smith, G.C., Pell, J.P., Walsh, D. (2001). Pregnancy complications and maternal risk 

of ischaemic heart disease: a retrospective cohort study of 129,290 births. Lancet, 

357(9273), 2002–2006. 

6. Rich-Edwards, J. W. (2009). Reproductive health as a sentinel of chronic disease in 

women. Women’s Health (London, England), 5(2), 101-105. doi:10.2217/17455057.5.2.101 

7. Davey, Smith G., Hyppönen, E., Power, E., Lawlor, D.A. (2007). Offspring birth weight 

and parental mortality: prospective observational study and meta-analysis. American 

Journal of Epidemiology, 166(2), 160–169. 

CARDIOVASCULAR DISEASE IN ELDERLY AND FRAIL 

ELDERLY WOMEN 

Cochairs:
�

Elizabeth O. Ofili, M.D.
�

Morehouse School of Medicine 

Viola Vaccarino, M.D., Ph.D. 

Emory University School of Medicine 

NIH Cochair:
�

Jacques E. Rossouw, M.D.
�

National Heart, Lung, and Blood Institute 

Science Writers: 

Yolanda Hendley, M.D. 

Emory University School of Medicine 

Benjamin Mackie, M.D

 Emory University School of Medicine 

Introduction 

The U.S. Census Bureau projects that the population of U.S. residents aged 65 and older will increase from 39 million in 2008 to 88.5 million in 2050, representing growth from 13 percent to 

nearly 20 percent of the total U.S. population. The number of the oldest old (85 years and older) is expected to grow from 5.3 million in 2006 to nearly 21 million by 2050.1 In 2008, it was 

estimated that there were 73 men for every 100 women in the 65 and older group and only 48 

men per 100 women for the 85 and older group.1 

Approximately 60 percent of all cardiovascular disease (CVD)-related deaths in the United 

States occur in individuals 75 years or older, and most of them are women.2,3 Improved CVD 

prevention and management are therefore critical, not only to delay disease and mortality, 

264
but also to extend optimal function and quality of life. Elderly women are a unique group in 

terms of comorbidities, risks, and ethical considerations related to the testing of new interventions. Age-related changes occur in cardiovascular physiology (for example, decreased 

arterial compliance, increased cardiac afterload, and left ventricular diastolic dysfunction) and 

in drug metabolism. These changes are likely to affect treatment response and the probability of adverse reactions. CVD manifestations that are particularly prevalent among elderly 

women—specifically, heart failure with preserved systolic function and atrial fibrillation—are 

understudied. Very little is currently known of the pathophysiology, risk factors, clinical outcomes, and appropriate management of these conditions as they apply to elderly women. 

To date, most CVD trials exclude individuals older than 75 and those with comorbidities. Between 1991 and 2000, 25 percent of enrollees in U.S. acute coronary syndrome trials were 

women, despite the fact that they account for 43 percent of patients with myocardial infarction. 

CVD trial samples tend to be unrepresentative (i.e., healthier) of the population of affected individuals because those with comorbidities are excluded. Limited data from clinical trials, coupled 

with a perception of higher risk from treatments, can translate to suboptimal care for the elderly. Evidence-based recommendations that form the basis of clinical practice guidelines do not 

properly account for age-related differences in physiology, response to treatment, and susceptibility to adverse reactions. Outcome measures such as health-related quality of life and physical 

and mental functions are typically not captured in clinical practice or clinical trials. 

Measurements of independence and frailty are often neglected. The expected dramatic increase in the number of frail female octogenarians over the next two decades warrants much 

more attention to this area. Frailty is a term used to characterize elderly individuals (typically 

the oldest old) who have decreased function and increased vulnerability due to impairment in 

multiple organ systems. The pathophysiology of frailty is incompletely understood and is likely 

to be heterogeneous. The concept of frailty captures a vitally important aspect of functioning 

but despite its importance, assessments useful in clinical medicine are lacking, and available 

research and clinical data are inadequate to effectively direct patient care. This is especially 

true for elderly women with CVD. 

Summary of the Discussion 

General Framework 

Based on considerations summarized in the introduction and raised in the initial discussions, 

the working group identified the following general principles to inform future research on CVD 

in elderly and frail elderly women. 

1. Populations. There are two types of understudied populations that should be the focus 

of future research: a) elderly women (not necessarily frail), defined as those older than 

80 years of age; and b) frail elderly women, those with generalized decrease in function 

and increased vulnerability due to impairment in multiple systems. 

2. Context. Important areas of research include: a) prevention, with consideration of a 

broader set of outcome measures that are relevant to elderly persons (CVD events, 

functional decline, frailty); and b) management (of CVD, risk factors, etc.), considering 

risk and benefits that are relevant to this group. 

265
3. Methodology. Future studies should include a) new longitudinal, observational studies 

of older women; b) new clinical trials focused on elderly women; and c) creative use 

of existing resources, such as rigorous analyses of large clinical databases, and collaborations across existing or ongoing trials or cohort studies in order to gather larger 

numbers of elderly patients (similar to the Cohorts for Heart and Aging Research in 

Genomic Epidemiology [CHARGE] consortium). 

4. Themes. General thematic areas discussed include: 

• Need to better understand CVD disease processes that burden elderly women, such as 

atrial fibrillation and heart failure with normal systolic function. Many challenges are centered on diagnosis, prevention, and management of these conditions and understanding 

of sex differences. 

•	�Need to research effectiveness and safety in the prevention and management of 

CVD in elderly women, especially those with comorbidities. Perhaps the largest barrier to 

studying the elderly and frail elderly female population has been a lack of inclusion or underrepresentation in most clinical trials. The pooling of major cohorts already in existence 

represents an efficient way of gathering data. Moving forward, elderly patients should be 

included in clinical trials of new drugs and devices, and the safety of current interventions 

should be examined in the elderly and frail elderly population. An underappreciated clinical outcome that is especially relevant for the elderly and frail elderly is quality of life. 

To improve quality of life indicators, it is important to design behavioral interventions 

applicable to the frail elderly female population. 

• Need to rigorously define and assess frailty and to study its determinants, 

mechanisms, and treatments. Determinants and mechanisms include biological, socioeconomic, demographic, and genetic factors. Examples of proposed areas of study are: 

1) urban versus rural environment and the differing social structures that are beneficial 

or detrimental in relation to frailty; 2) social support, family structure, and other cultural 

factors; 3) biological variables such as muscle mass, muscle and fat composition, nutritional intake, and energy expenditure; and 4) adoption of new technologies in the study 

of frailty, such as microarrays, telomeres assessment, genetics, epigenetics, and proteomics. Novel interventions are needed, including nutritional, physical, pharmacologic, 

and behavioral interventions to prevent or delay frailty and improve outcomes in 

frail elderly. 

Recommendations 

The working group summarized its deliberations into four major recommendations to advance 

research and management of CVD and CVD risk factors in elderly and frail elderly women. The 

recommendations may help to provide guidance to health administrators, clinicians, scientists 

and the public as to areas of investigation that merit greater research. 

Recommendation 1: Support research on the prevention and management of common 

clinical manifestations of CVD in elderly women, such as heart failure with preserved 

systolic function and atrial fibrillation. 

266
Specific areas of management in need of further study include: Identification and diagnosis; 

etiology and physiology; and prevention and treatment. Below are examples of needed 

research/approaches: 

• Develop new cohorts and /or leverage populations and data from existing cohorts to 

obtain reasonably robust estimates. 

• Promote collaborations across existing cohort studies of older adults within the United 

States and internationally. 

• Design new clinical trials exclusively among older patients, or that include substantial 

numbers of older patients. 

• Promote the use of ancillary studies to existing trials involving the evaluation of patients 

80 years of age and older. 

• Encourage rigorous use of existing clinical databases such as large HMOs or Medicare as 

additional means to address these questions. 

Recommendation 2: Support research on the effectiveness and safety of prevention and 

management strategies for CVD in elderly women with comorbidities, including clinical trials 

and use of existing clinical databases to determine drug and/or device safety in the elderly. 

Specific examples include: 

• Studies of the role of comorbidities in triggering CVD. 

• Studies of the role of comorbidities in cardiovascular outcomes. 

• Studies of cost effectiveness and safety of guideline-based preventive interventions 

in this population (e.g., cardiovascular risk modification, automatic implantable 

cardioverter defibrillator use). 

Recommendation 3: Support research on the prevention and management of frailty among 

elderly women with CVD or CVD risk factors, and on the role of CVD as a determinant 

of frailty. 

Specific areas include: 

• Studies to formulate a universal and clinically applicable definition and assessment 

of frailty. 

• Studies of etiology/physiology/mechanisms. Encourage and support research to determine the underlying mechanisms of frailty, especially in relation to CVD, including 

approaches that exploit new technologies (microarrays, telomeres, genetics, epigenetics, 

proteomics, etc.). 

• Innovative clinical trials of the prevention and treatment of frailty. 

• Longitudinal studies examining frailty and CVD in the elderly female population, focusing 

on social and biological determinants. 

Recommendation 4: Support new measures and inclusion guidelines in order to obtain better 

data for the prevention and management of CVD in elderly and frail elderly women. 

• Include measurements relevant to older people in new clinical trials (physical and 

cognitive function, quality of life, independence). 

267
• Perform behavioral research to improve lifestyle and compliance using interventions 

relevant to elderly persons. 

• Advocate or mandate the inclusion of elderly persons in clinical trials to evaluate the 

efficacy and the safety of new devices and therapies. 

• Advocate or mandate safety assessment of new or existing interventions among elderly/ 

frail elderly prior to including such treatments in clinical practice guidelines. 

References 

1. Vincent, G.K. & Velkoff, V.A. (2010). The next four decades, the older population in the 

United States: 2010 to 2050 (Current Population Reports, P25-1138). Washington, DC: 

U.S. Census Bureau. Retrieved from http://www.census.gov/prod/2010pubs/p25-1138. 

pdf 

2. Lloyd-Jones, D., Adams, R.J., Brown, T.M., Carnethon, M., Dai, S., De Simone, G., ... WylieRosett, J. (2009). Heart disease and stroke statistics—2010 update. A report from the 

American Heart Association. Circulation, 121(12), e259. 

3. Heron, M.P., Hoyert, D.L., Xu, J., Scott, C., & Tejada-Vera, B. (2008). Deaths: Preliminary 

data for 2006. National Vital Statistics Reports, Vol. 56, No. 16. Hyattsville, MD: National 

Center for Health Statistics. 

MICROVASCULAR DISEASE, BIOMECHANICS, AND APPLICATION 

OF NEW TECHNOLOGIES TO CARDIOVASCULAR RESEARCH 

Cochairs:
�

Barbara D. Boyan, Ph.D.
�

Georgia Institute of Technology 

Gary Gibbons, M.D. 

Morehouse School of Medicine 

NIH Cochair:
�

George Sopko, M.D., M.P.H.
�

National Heart, Lung, and Blood Institute 

Science Writers: 

Roberto Hodara, M.D. 

Emory University School of Medicine 

Divya Gupta, M.D. 

Emory University School of Medicine 

268
Introduction 

Cardiovascular disease (CVD) is the leading killer of both women and men. Despite sex differences in CVD outcomes, relatively little is known about sex differences in the science of CVD, 

ranging from basic science inquiry to pathophysiological understanding, diagnostics, and therapeutics. The Institute of Medicine (IOM) published a monograph in 2001 exploring biological 

contributions to human health entitled Does Sex Matter?1

 The IOM report came up with three 

conclusions: 1) sex does matter and should be considered when designing and analyzing studies in all areas of health-related research; 2) the study of sex differences has been predominantly 

observational research, and the next step is study of mechanisms and therapies related to sex 

differences; and 3) barriers to the advancement of knowledge about sex differences in health 

and illness must be eliminated. For the purpose of the following discussions we define microvascular coronary heart disease as evidence of ischemia in the absence of macrovascular epicardial 

obstructions. The pathophysiology of microvascular ischemia continues to be better defined for 

targeting coronary reactivity, whether endothelium, or non–endothelium, dependent. The goal 

of this working group was to identify areas for future basic science research that will help 

understand the biological differences between sexes pertaining to CVD and frame the 

development of new, gender-targeted technologies. 

Summary of the Discussion 

The working group discussions centered on four broad issues: 1) understanding sex differences in vascular biology, pathophysiology, and biomechanics; 2) developing a bioinformatics 

network on “sexomics” in order to identify sex-related biomarkers in CVD; 3) developing new 

imaging techniques attuned to women’s CVD pathophysiology; and 4) implementing new 

gender-specific therapeutics. Major issues within each of the areas are summarized below. 

Focus Area 1: Sex Differences in the Vasculature 

There is significant evidence that the vasculature of men and women reacts differently to injury. 

For instance, women appear to have more diffuse atherosclerosis, less luminal stenosis, higher incidence of endothelial dysfunction, and a higher prevalence of microvascular dysfunction 

compared to men.2,3 The pathoanatomic substrate for coronary thrombosis also differs between 

men and women. In men, 80 percent of thrombi tend to occur due to plaque rupture, whereas in women, 20 to 40 percent of coronary thrombi occur on an intact atherosclerotic plaque 

with superficial athero-intimal erosion.4,5 This plaque erosion is a common finding in sudden 

cardiac death (SCD) in younger women who were smokers and postmenopausal women who 

are taking estrogens. Conversely, plaque rupture leading to thrombosis is relatively more common in men and older women. Plaques that tend to rupture are composed of a large lipid-laden 

core, have increased intimal and adventitial inflammation, and exhibit increased neovascularity. 

Inflammatory cells trigger death of smooth muscle cells through apoptosis and produce matrix-degrading enzymes which can induce depletion of the collagen framework leading to loss 

of collagen, thinning of the fibrous cap, and, eventually, rupture. Importantly, lipid-filled plaques 

have inflammatory cell-derived tissue factor (TF) that is a prototypical trigger for activating the 

clotting cascade. When a lipid-rich plaque ruptures, TF is immediately exposed to circulating 

blood, which, with other factors, stimulates the production of thrombin, leading to platelet-fibrin 

thrombus formation.6 Furthermore, it is unclear whether and when there is “a smooth transition” 

269
from microvascular pathology to macrovascular epicardial disease expression or whether these 

are two distinct processes, which share many of the triggers and some of the pathways. 

The mechanisms of sex differences in this process are not well understood. Enhanced endothelial apoptosis is associated with exposure of TF on the luminal side, and a higher prevalence 

of superficial endothelial erosions with increased sex-specific circulating coagulability.7,8 Additionally, systemic inflammatory processes increase anticardiolipin antibodies, which are more 

prevalent in women; and TF, which may not be originating from the plaque but from the circulation, may also create a prothrombotic state. Normally, cell-derived tissue factor remains 

contained within circulating leukocytes and is not available to trigger thrombosis. However, 

under certain conditions, circulating leukocytes can shed membrane microparticles, which 

have been shown by electron microscopy to be laden with TF.9

 Accordingly, these microparticles can be delivered to platelets and to other circulating leukocytes and the transfer of TF 

from circulating cells can occur at the site of endothelial erosion. This can cause thrombosis 

even though the plaque does not contribute TF. 

Spontaneous coronary artery dissection (SCD) is a rare clinical syndrome that is more prevalent 

in women than in men. In fact, 80 percent of cases occur in women, particularly in premenopausal women, often in the peripartum setting.10 Reproductive hormones may contribute to this, 

in that matrix metalloproteinases may be induced by hormonal alterations and may promote intimal disruption and dissection. The clinical presentation frequently is SCD and less commonly 

unstable angina, acute MI, heart failure, or shock. Interestingly, the left anterior descending coronary artery is more commonly affected in women, the right coronary is more commonly affected 

in men, and simultaneous multiple vessel dissections can also occur. 

Focus Area 2: Bioinformatics 

Most methods of noninvasive evaluation have been obtained via research done on majority 

male populations. It is an accepted concept that women present differently than men in many 

pathological states, including CVD. In order to understand what evaluations are needed to accurately diagnose a pathologic state in a female patient, we must first understand how women 

differ from men in their biologic and physiologic profiles and responses. A better understanding of the various biomarkers in women to evaluate cardiovascular health and illness needs to 

be obtained. These data, once obtained, need to be banked and analyzed in a timely manner 

so the data can be used for patient care. 

Focus Area 3: Improved Imaging Modalities 

Imaging modalities provide noninvasive means of anatomic and pathophysiologic evaluation. 

Optimally, they could also provide means for initiating and directing alternate therapeutic option. Improved data on the biologic markers and how they differ in women should improve 

both imaging modalities and optimize management capitalizing on the biologic differences 

between men and women. 

270
Focus Area 4: New Therapeutics 

Current therapy for CVD is based on studies that provide a general improvement in the population as a whole, but benefit at the individual level is less clear and may involve overutilization of 

resources and expensive management modalities for some but underutilization for others. Biomaterials have been created to attempt enhanced tissue and vascular regeneration, but none 

has been completely successful, whether it is due to failure of the device or incompatibility with 

the patient. We need to provide treatment targeting individual patients allowing for individualized medical care for people at high risk for CVD. In order to accomplish such a tall order, we 

need to obtain information that will lead to an improved understanding of differences in vasculature between men and women, using bioinformatics to better understand these differences 

on a microbiological level; and translating this personalized information into the provision of 

personalized medicine. 11 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendations for Focus Area 1: Sex differences in vasculature 

A better understanding of the mechanisms underlying sex differences in the vasculature 

is necessary to develop sex-specific diagnostic and therapeutic modalities. Research is 

recommended in the following areas: 

1. Biomechanics of the vasculature: 

• Analysis of extracellular matrix components in the vascular wall responsible for sex 

differences in vascular compliance and elasticity. 

• Sex differences in fluid dynamics and shear stress. 

• Cyclical differences in fluid and solid mechanics resulting from the menstrual cycle 

and gravid states. 

• The interplay of vascular biomechanics and the immune system. 

• The role of lymphatics and inflammatory mediators. 

2. Effects of sex hormones on: 

• Vascular extracellular matrix composition and vascular biomechanics. 

• The immune system response. 

• Vascular expression of receptors for vasoactive molecules. 

• Long-term effects of cyclical changes across the lifespan on vascular physiology. 

3. The role of sex differences in perivascular fat distribution as an influence on vascular 

function and structure. 

271
4. Sex differences in angiogenesis and collateral vessel development: 

• Sex differences in the number of circulating progenitor cells and their potential 

for differentiation to endothelial cells. 

• Sex differences in vascular smooth muscle and endothelial cell migration 

and proliferation. 

• The role of neural network/neurons in adventitia. 

5. Development of improved models to study the microvasculature. 

Recommendations for Focus Area 2: Bioinformatics 

1. Encourage the discovery of novel biomarkers to identify women at high risk for CVD 

in various areas of study: 

• Sexomics—Which biomarkers may be better for evaluating women, as opposed 

to men, and why 

• Genomics 

• Proteomics—Uncovering the protein differences that exist between women and men 

and using that data to improve the evaluation and treatment of women 

• Metabolomics 

• Epigenomics—Understanding the effects of epigenetic factors and the possible aberrant functions that can present in women so a better understanding of cardiovascular 

pathologic states can be obtained 

2. Encourage the development of high-throughput methods for data collection so 

information can be used and distributed in a timely manner. 

3. Encourage systematic data collection to allow for ease of organization and analysis. 

4. Collect all data into an NIH databank or database for modeling. 

Recommendations for Focus Area 3: Improved Imaging Modalities 

1. Optimize imaging on several levels. This will require better methods to enhance visualization of both microvasculature and macrovasculature and the development of novel 

markers to allow for alternate methods of visualization. Such improvements in imaging 

should optimize the evaluation and treatment of women, which at this time is lacking. 

The working group identified the following needs in this area: 

• Novel nano-based markers to evaluate microvascular density. 

• A method by which to merge metabolic states and the imaging of vessels and 

myocardium to better understand functionality in states of health and disease. 

• New biomechanical assessments of myocardium and vasculature to help gain an understanding of the physics involved and how they differ in cardiovascular health 

and disease. 

• Direct and accurate in vivo measurement and imaging of microvascular flow dynamics. 

272
• Imaging for sex specific disease characterization. 

• Improved modalities to provide a means of evaluating differences between men 

and women over a lifecycle. 

• Dynamic sex receptor modulation imaging to improve our understanding of the 

differences between men and women and how we may use these differences to 

enhance treatment. 

Recommendations for Focus Area 4: New Therapeutics 

1. Design tissue-engineered medical products to have an appropriate microvasculature 

and microenvironment with respect to sex. This microenvironment should consist of the 

extracellular matrix and its components (e.g., proteins), other vital cell types (e.g., inflammatory cells), intracellular and extracellular components, lymphatics, and innervations. 

2. Further investigate cell-based therapeutics with an understanding of the contribution 

of sex and age to this concept. 

3. Develop matrices that optimize regenerative processes to allow for biomaterials that 

are superior to those now available. 

References 

1. Institute of Medicine. (2001). Exploring the biological contributions to human health: 

Does sex matter? Washington, DC: National Academy Press. 

2. Shaw, L.J., Shaw, R.E., Bairey Merz, C.N., Brindis, R.G., Klein, L.W., Nallamothu, B., Douglas, P.S., Krone, R.J., McKay, C.R., Block, P.C., Hewitt, K., Weintraub, W.S., Peterson, E.D. 

(2008). Impact of ethnicity and gender differences on angiographic coronary artery 

disease prevalence and in-hospital mortality in the American College of CardiologyNational Cardiovascular Data Registry. Circulation, 117(14), 1787–1801. 

3. Bairey Merz, C.N., Shaw, L.J., Reis, S.E., Bittner, V., Kelsey, S.F., Olson, M., ...Sopko, G. 

(2006). Insights from the NHLBI-Sponsored Women’s Ischemia Syndrome Evaluation 

(WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with 

regard to gender-based pathophysiology of atherosclerosis and macrovascular and 

microvascular coronary disease. Journal of the American College of Cardiology, 47(3 

Suppl) S21–29. 

4. Burke, A.P., Farb, A., Malcom, G.T., Liang, Y., Smialek, J., Virmani, R. (1998). Effect of risk 

factors on the mechanism of acute thrombosis and sudden coronary death in women. 

Circulation, 97(21), 2110–2116. 

5. Farb, A., Burke, A.P., Tang, A.L., Liang, T.Y., Mannan, P., Smialek, J., Virmani, R. (1996). 

Coronary plaque erosion without rupture into a lipid core. A frequent cause of coronary 

thrombosis in sudden coronary death. Circulation, 93(7), 1354–1363. 

6. Shah, P.K. (2007). Molecular mechanisms of plaque instability. Current Opinion in 

Lipidology, 18(5), 492–499.
�

7. Sugiyama, S., Kugiyama, K., Aikawa, M., Nakamura, S., Ogawa, H., Libby, P. (2004) Hypochlorous acid, a macrophage product, induces endothelial apoptosis and tissue factor 

273
expression: involvement of yeloperoxidase-mediated oxidant in plaque erosion and 

thrombogenesis. Arteriosclerosis, Thrombosis, and Vascular Biology, 24(7), 1309–1314. 

8. Durand, E., Scoazec, A., Lafont, A., Boddaert, J., Hajzen, A.A., Addad, F., ...Mallat, Z. 

(2004). In vivo induction of endothelial apoptosis leads to vessel thrombosis and endothelial denudation: a clue to the understanding of the mechanisms of thrombotic plaque 

erosion. Circulation, 109(21), 2503–2506. 

9. Sambola, A., Osende, J., Hathcock, J., Degen, M., Nemerson, Y., Fuster, V., Crandall, J., 

Badimon, J.J. (2003). Role of risk factors in the modulation of tissue factor activity and 

blood thrombogenicity. Circulation, 107(7), 973–977. 

10. Kar, S., Shah, P.K. (2001). Acute coronary syndrome caused by coronary artery dissection mimicking acute plaque rupture. Reviews in Cardiovascular Medicine, 2(4), 215–219. 

STEM CELLS, PROGENITOR CELLS, AND THE VISTA OF 

CARDIOVASCULAR REGENERATIVE MEDICINE 

Cochairs:
�

Robert Nerem, Ph.D.
�

Georgia Institute of Technology 

Arshed A. Quyyumi, M.D., FRCP 

Emory University School of Medicine 

NIH Cochair:
�

Martha Shauck Lundberg, Ph.D.
�

National Heart, Lung, and Blood Institute 

Science Writers: 

Rebecca D. Levit, M.D. 

Emory University School of Medicine 

Ryan Jordan, M.D. 

Emory University School of Medicine 

Introduction 

Stem cells, regeneration, and repair are fundamental mediators of health and disease. These 

processes impact cellular structure and function in all organ systems. While many different 

types of stem and progenitor cells have been identified, each has positive and negative attributes in their potential for effecting myocardial and vascular repair. Which cell types will 

be most applicable to treatment of cardiovascular disease in humans is currently a subject of 

intense study. Very little is known on how (or if) sex-based differences will play a role in selection and preparation of cells, their ultimate potency, delivery methodology, and therapeutic 

effect. The goals for the Stem Cells, Progenitor Cells, and the Vista of Cardiovascular Regenerative Medicine Working Group were to assess the needs of the research community and to 

recommend scientific opportunities to further the understanding in this important field. 

274
Summary of the Discussion 

The working group identified five major areas for discussion. Each of these areas is also the 

subject of recommendations in the “Recommendations” section. Below is a summary of key 

points raised by participants for each of the areas. 

1. Burden of Cardiovascular Disease (CVD) in Women. Working group members noted 

that CVD imposes a heavy burden on women’s health and accounts for 25.6 percent of 

all deaths in U.S. women.1

 Current CVD management includes preventive therapies and 

lifestyle changes to ameliorate risk factors and secondary prevention for those with 

coronary artery disease, myocardial infarction, or heart failure. Revascularization approaches center on relief of ischemia and potentially on preservation of heart function. 

Since these treatments cannot repair or regenerate damaged myocardium and may 

not be feasible in the presence of unrevascularizable disease, ischemic cardiomyopathy 

may develop due to adverse remodeling. For the past 20 years, researchers have been 

exploring novel ways to restore and regenerate blood vessels and the myocardium. 

Until recently, however, research has often overlooked the crucial effect of sex on CVD 

and its related therapies. It is known that before menopause, women are better protected from coronary artery disease than age-matched male counterparts. However, by the 

age of 60, this cardiovascular protective effect is lost. Although some of the premenopausal protection is attributed to estrogens, estrogen replacement therapy does not 

abolish this increased risk in postmenopausal women. It has been hypothesized that 

this age-dependent susceptibility in women may be at least partly due to changes in 

regenerative capacity. Accelerated research into the specific mechanisms underlying 

sex differences in CVD risk and clinical manifestations is needed. 

2.	�Regenerative cells as biomarkers of cardiovascular health. A second area of intensive discussion by working group participants was the utility of regenerative cells as 

biomarkers of cardiovascular health. Studies on circulating progenitor cells suggest that 

their numbers and function correlate with cardiovascular health. It is likely that these 

rare but essential cells perform necessary functions to maintain vascular health. The 

number of circulating endothelial progenitor cells (EPCs) inversely correlates with death 

from cardiovascular causes2 and cardiovascular events.3 However, this early evidence 

has largely been gathered in men. Diseases such as metabolic syndrome, hypertension, 

and diabetes reduce circulating progenitors, as do many medications.4,5 The significance 

and mechanism of these effects on EPCs and other progenitor cell types are unknown. 

Clinical studies in relatively small numbers of subjects suggest that circulating progenitor cells also vary by age in women.6 Premenopausal women have higher circulating 

levels of EPCs compared to men, but their numbers are lower after menopause, similar 

in number to age-matched males. The number of progenitors increases by approximately 25 percent after hormone replacement therapy in postmenopausal women.7,8 

EPC-enriched populations vary during the menstrual cycle, with higher numbers during 

the luteal phase, and there is evidence for cyclic bone marrow progenitor cell mobilization. These cyclic effects during the menstrual cycle appear to be mediated by estrogen, 

vascular endothelial growth factor, and nitric oxide. Working group participants identified a pressing need for more fundamental biological research on stem cells, especially 

in relation to biological sex and hormonal influences. 

275
3. Clinical trials for cardiovascular regeneration—the relevance of sex. Various endogenous 

and transplanted cell types and bioengineered materials are under investigation for the 

treatment of heart diseases, but their value in men versus women remains largely undetermined. Progenitor and stem cells from various sources, including skeletal myoblasts, 

endogenous cardiac progenitor cells, and bone marrow mononuclear cells, are currently 

undergoing clinical evaluation.9–11 A variety of delivery approaches, devices, and clinical 

syndromes is being studied. One interesting subpopulation of bone marrow and circulating cells, EPCs, has been studied most extensively, largely because of their availability, 

safety, and reputed ability to enhance angiogenesis in the border zones of infarcts and in 

unrevascularizable tissue. The beneficial effect of EPCs is most likely due to their paracrine effects.12–14 The number of EPCs and their ability to form colonies and vessels in vitro 

and in vivo appear to be enhanced by estrogen.8,15–17 Despite this, the majority of subjects 

enrolled in clinical trials to date have been men, so the value of these therapies in women 

is not yet known. 

Considering that cell source is a critical issue for any type of cell-based therapy, there is 

early evidence that potency and availability is influenced by sex. Also, therapy in postmenopausal women may be different from that of premenopausal women depending 

on cell source. For example, human cardiac progenitor cells (c-kit and Islet-1 progenitors) are more often available from the right atrium in women than in men.18 However, 

mobilization capacity of bone marrow progenitors appears not to be sex dependent, 

although this has not been systematically studied. A recent report found that androgen 

receptors in female endothelial cells made them responsive to the angiogenic effects 

of testosterone. In male mice, castration impaired angiogenesis, an effect reversed by 

androgen treatment.19 

4.	�Pluripotent stem cells, gender, and estrogen. Embryonic stem cells and induced pluripotent stem (iPS) cells are capable of proliferating and differentiating into several cell 

types. Embryonic stem cells have enormous regenerative potential but their clinical applicability is restrained by ethical and immunological barriers. By contrast, iPS cells, first 

described in 2006, can be autologously generated from terminally differentiated tissues 

(skin, blood, adipose tissue, or fibroblasts) and then induced into pluripotency by activation of embryonic genes by viral vectors, plasmids, and proteins.20, 21 The basic biology 

as well as stringent definitions for iPS cells needs to be established in a sex-specific 

manner. This will allow for better comparison of data amongst research groups and the 

streamlining of cell advancement into clinical trials. How sex influences iPS cell generation efficiency, their dedifferentiation and redifferentiation, remains to be explored. For 

example, physiological concentrations of testosterone in men and premenopausal concentrations of estrogen in women have a positive effect on the chondrogenic potential 

of chondrocyte progenitor cells in vitro. Therefore, cell therapy approaches that may be 

potentially beneficial for the regenerative potential in late stages of human disease may 

be sex-specifically procured and expanded.22 

For example, estradiol accelerates reendothelialization and estrogen mobilizes bone 

marrow-derived EPCs.23, 24 Estrogen, via specific receptors, modulates the proliferation and survival of progenitor cells. Additionally, studies using cultured human EPCs 

276
from peripheral blood mononuclear cells disclosed consistent gene expression of the 

estrogen receptor. Under the physiologic concentrations of estrogen, proliferation and 

migration were stimulated, whereas apoptosis was inhibited in cultured EPCs.25 

5. Enabling Technologies. The field of regenerative cardiovascular medicine is very new 

and the technology to achieve the goals outlined above is not developed. Fundamental 

tasks such as identifying cells, characterizing their pluripotency, sorting them, and expanding them are imprecise and rudimentary. Evaluation of the secretome of cells with 

in vitro analysis, which removes the cells from their physiologic environment, may alter 

their function and products. Fluorescence-activated cell sorting is the fastest way to 

separate cells, but it relies on superficial surface marker expression that may or may not 

correlate with cell function and potential. Because the use of EPCs in clinical application has been limited by varying definitions of cells as well as the lack of reproducibility 

of experiments, it will be essential to develop new technologies to fully exploit the 

potential of EPCs and to develop other cell types for clinical use. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

1. Accelerate discovery of sex-specific differences related to CVD. Examples of needed 

research include efforts to: 

• Investigate whether the known reduced risk of coronary heart disease in premenopausal women is merely due to the effects of estrogen and progesterone, or due to 

differences in stem cell function before and after menopause. 

• Determine whether different mechanisms of CVD progression between sexes (e.g., 

erosions vs. plaque rupture), are related to differences in stem cells. 

• Develop regenerative cell therapy approaches for CVD as a priority in older women. 

• Improve understanding of how special populations of women, e.g., pre- vs. postmenopausal women, athletic women with amenorrhea, and women with premature CVD 

events, may benefit from regenerative medicine therapies. 

2. Develop new knowledge of the fundamental biologic mechanisms of stem and 

progenitor cells. 

• Improve understanding of how sex influences endogenous regenerative processes 

throughout the lifespan. 

• Determine sex-based mechanistic differences including genetic, epigenetic, molecular, 

proteomic, physiologic, and hormonal differences. 

• Investigate cell-associated “secretomes” at all stages of differentiation, including 

somatic, adult, embryonic, and iPS cells. 

• Evaluate how age and sex affect regenerative potential throughout the lifespan—in 

utero, infancy, childhood, puberty, adulthood, pregnancy, and after menopause. 

• Evaluate the effect of risk factors and disease on stem cell function. 

277
3. Exploit emerging knowledge about how sex differences influence therapeutic efficacy 

and whether optimal regenerative strategy is similar in men and women. 

• Investigate whether cell sources vary between sexes (e.g., bone marrow, adipose, 

heart, and non-autologous cells). 

• Foster the study of procurement bias. 

• Explore the importance of extracellular matrix and microenvironment in 

transplanted sites. 

• Develop preimplantation cell strategies that utilize sex-based advantage. 

• Develop different delivery methods. 

4. Integrate advances in the fundamentals of how sex differences influence iPS function. 

• Incorporate the relevance of sex and sex hormones in study of iPS cell 

dedifferentiation and redifferentiation. 

• Explore the feasibility of sex hormones as adjuncts to therapy with iPS cells 

(ex vivo treatment, dual delivery). 

5. Establish the required resources to enable comprehensive laboratory, preclinical, 

and clinical methodologies.
�

• Quantify fundamental biologic sex differences. 

• Facilitate procurement, process, and delivery. 

References 

1. U.S. Department of Health and Human Services, Centers for Disease Control and 

Prevention. (2010). Leading Causes of Death in Females United States, 2006. Retrieved 

from http://www.cdc.gov/women/lcod/ 

2. Werner, N., Kosiol, S., Schiegl, T., Ahlers, P., Walenta, K., Link, A., ... Nickenig, G. (2005). 

Circulating endothelial progenitor cells and cardiovascular outcomes. New England 

Journal of Medicine, 353(10), 999–1007. 

3. Schmidt-Lucke, C., Rossig, L., Fichtlscherer, S., Vasa, M., Britten, M., Kamper, U., ... Zeiher, 

A.M. (2005). Reduced number of circulating endothelial progenitor cells predicts future 

cardiovascular events: Proof of concept for the clinical importance of endogenous vascular repair. Circulation, 111(22), 2981–2987. 

4. Oliveras, A., Soler, M.J., Martinez-Estrada, O.M., Vazquez, S., Marco-Feliu, D., Vila, J.S., ... 

Lloveras, J. (2008). Endothelial progenitor cells are reduced in refractory hypertension. 

Journal of Human Hypertension, 22(3), 183–190. 

5. Grisar, J., Aletaha, D., Steiner, C.W., Kapral, T., Steiner, S., Seidinger, D., ... Smolen, J.S. 

(2005). Depletion of endothelial progenitor cells in the peripheral blood of patients with 

rheumatoid arthritis. Circulation, 111(2), 204–211. 

278
6. Bulut, D., Albrecht, N., Imohl, M., Gunesdogan, B., Bulut-Streich, N., Borgel, J., ... Mugge, 

A. (2007). Hormonal status modulates circulating endothelial progenitor cells. Clinical 

Research in Cardiology, 96(5), 258–263. 

7.	� Fadini, G.P., Albiero, M., Cignarella, A., Bolego, C., Pinna, C., Boscaro, E., ... Avogaro, A. 

(2009). Effects of androgens on endothelial progenitor cells in vitro and in vivo. Clinical 

Science, 117(10), 355–364. 

8. Fadini, G.P., de Kreutzenberg, S., Albiero, M., Coracina, A., Pagnin, E., Baesso, I., ... Avogaro A. (2008). Gender differences in endothelial progenitor cells and cardiovascular risk 

profile: The role of female estrogens. Arteriosclerosis, Thrombosis, and Vascular Biology, 

28(5), 997–1004. 

9.	�Smits, P.C., van Geuns, R.J., Poldermans, D., Bountioukos, M., Onderwater, E.E., Lee, C.H., 

... Serruys, P.W. (2003). Catheter-based intramyocardial injection of autologous skeletal 

myoblasts as a primary treatment of ischemic heart failure: Clinical experience with sixmonth follow-up. Journal of the American College of Cardiology, 42(12), 2063–2069. 

10. Hagege, A.A., Marolleau, J.P., Vilquin, J.T., Alheritiere, A., Peyrard, S., Duboc, D., ... Menasche, P. (2006). Skeletal myoblast transplantation in ischemic heart failure: Long-term 

follow-up of the first phase I cohort of patients. Circulation, 114(1 Suppl), I108–113. 

11.	�Mills, W.R., Mal, N., Kiedrowski, M.J., Unger, R., Forudi, F., Popovic, Z.B., ... Laurita, K.R. 

(2007). Stem cell therapy enhances electrical viability in myocardial infarction. Journal 

of Molecular and Cellular Cardiology 42(2), 304–314. 

12. Ziegelhoeffer, T., Fernandez, B., Kostin, S., Heil, M., Voswinckel, R., Helisch, A., & Schaper, 

W. (2004). Bone marrow-derived cells do not incorporate into the adult growing vasculature. Circulation Research 94(2), 230–238. 

13. Takakura, N., Watanabe, T., Suenobu, S., Yamada, Y., Noda, T., Ito, Y., ... Suda, T. (2000). 

A role for hematopoietic stem cells in promoting angiogenesis. Cell, 102(2), 199–209. 

14. Rehman, J., Li, J., Orschell, C.M., & March, K.L. (2003). Peripheral blood “endothelial progenitor cells” are derived from monocyte/macrophages and secrete angiogenic growth 

factors. Circulation 107(8), 1164–1169. 

15. Bolego, C., Rossoni, G., Fadini, G. P., Vegeto, E., Pinna, C., Albiero, M., ...Cignarella, A. 

(2010). Selective estrogen receptor-alpha agonist provides widespread heart and vascular protection with enhanced endothelial progenitor cell mobilization in the absence 

of uterotrophic action. The FASEB Journal : Official Publication of the Federation of 

American Societies for Experimental Biology, 24(7), 2262–2272. doi:10.1096/fj.09-139220 

16. Ruifrok, W.P., de Boer, R.A., Iwakura, A., Silver, M., Kusano, K., Tio, R.A., & Losordo, D.W. 

(2009). Estradiol-induced, endothelial progenitor cell-mediated neovascularization in 

male mice with hind-limb ischemia. Vascular Medicine, 14(1), 29–36. 

17. Foresta, C., Zuccarello, D., Biagioli, A., De Toni, L., Prana, E., Nicoletti, V., ... Ferlin, A. 

(2007). Oestrogen stimulates endothelial progenitor cells via oestrogen receptor-alpha. 

Clinical Endocrinology, 67(4), 520–525. 

279
18. Itzhaki-Alfia, A., Leor, J., Raanani, E., Sternik, L., Spiegelstein, D., Netser, S., ... Barbash, 

I.M. (2009). Patient characteristics and cell source determine the number of isolated 

human cardiac progenitor cells. Circulation, 120(25), 2559–2566. 

19. Sieveking, D.P., Lim, P., Chow, R.W., Dunn, L..L, Bao, S., McGrath, K.C., ... Ng, M.K. (2010). 

A sex-specific role for androgens in angiogenesis. The Journal of Experimental Medicine, 

207(2), 345–352. 

20.Takahashi, K. & Yamanaka, S. (2006). Induction of pluripotent stem cells from mouse 

embryonic and adult fibroblast cultures by defined factors. Cell, 126(4), 663–676. 

21. Takahashi, K., Tanabe, K., Ohnuki, M., Narita, M., Ichisaka, T., Tomoda, K., & Yamanaka, S. 

(2007). Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell, 131(5), 861–872. 

22.Koelling, S. & Miosge, N. (2010). Gender differences of chondrogenic progenitor cells in 

late stages of osteoarthritis. Arthritis and Rheumatology, 62(4):1077–1087. 

23.Iwakura, A., Luedemann, C., Shastry, S., Hanley, A., Kearney, M., Aikawa, R., ... Losordo, 

D.W. (2003). Estrogen-mediated, endothelial nitric oxide synthase-dependent mobilization of bone marrow-derived endothelial progenitor cells contributes to reendothelialization after arterial injury. Circulation, 108(25), 3115–3121. 

24.Iwakura, A., Shastry, S., Luedemann, C., Hamada, H., Kawamoto, A., Kishore, R., Zhu ... 

Losordo, D.W. (2006). Estradiol enhances recovery after myocardial infarction by augmenting incorporation of bone marrow-derived endothelial progenitor cells into sites 

of ischemia-induced neovascularization via endothelial nitric oxide synthase-mediated 

activation of matrix metalloproteinase-9. Circulation, 113(12), 1605–1614. 

25.Masuda, H., Kalka, C., Takahashi, T., Yoshida, M., Wada, M., Kobori, M., ... Asahara, T. 

(2007). Estrogen-mediated endothelial progenitor cell biology and kinetics for physiological postnatal vasculogenesis. Circulation Research, 101(6), 598–606. 

UNMET NEEDS IN DIAGNOSTIC TESTING FOR WOMEN WITH 

CARDIOVASCULAR DISEASE 

Cochair:
�

Leslee Shaw, Ph.D.
�

Emory University School of Medicine 

NIH Cochair:
�

Patrice Desvigne-Nickens, M.D.
�

National Heart, Lung, and Blood Institute 

Science Writers:
�

Maria Carolina Gongora, M.D.
�

Emory University School of Medicine 

280
Don O. Rowe, M.D. 

Emory University School of Medicine 

Introduction 

This report synthesizes the discussions of the working group on unmet diagnostic testing 

needs for women with cardiovascular disease (CVD). Consistent with the principles of comparative effectiveness research,1

 the working group focused on those areas where a research 

agenda could address and influence the greatest number of female lives. Moreover, the charge 

for this working group was to set forth a research agenda for the future that identified critical gaps in knowledge. This report will highlight relevant background material for each of three 

critical areas that were deemed sufficiently important for the improvement of the quality of 

care of women undergoing CVD diagnostic testing or imaging-based risk assessment. Importantly, early and precise recognition of atherosclerosis and heart disease is essential 

for the objective of improving women’s longevity and quality of life. 

Summary of the Discussion 

Topic 1: Pathogenesis of Myocardial Ischemia and Anatomic Correlates 

Considerable epidemiologic evidence supports a delay in the onset of CVD whereby women 

become symptomatic and are diagnosed with obstructive coronary artery disease (CAD) approximately 10 years later than their male counterparts.2

 Gender differences have also been 

frequently reported in higher rates of nonobstructive CAD in symptomatic women versus men 

across all adult deciles of ages, with the exception of the very elderly.3

 This signal of a differential atherosclerotic disease process has largely been ignored, with limited focused research 

efforts detailing the development and progression of atherosclerosis culminating in obstructive CAD. There are disparate pieces of information that describe a unique female-specific 

process which not only is differentially time related but also may result in an acute coronary 

syndrome presentation of varying etiology.4–6 Investigations led by Virmani and colleagues7–9 

detailed a greater frequency of plaque erosion in women (compared to plaque rupture occurring more often in men) with sudden cardiac death. This early evidence suggested a strong 

influence of gender and sex-related differences in plaque progression and notably may contribute to differential clinical presentation. Coupling this information with other sex differences in 

vascular biology, one starts to unfold an exploratory model on detecting the “vulnerable” 

female patient. 

The NIH-NHLBI-sponsored Women’s Ischemia Syndrome Evaluation (WISE) registry performed 

extensive testing on a sample of nearly 1,000 symptomatic women. This study forms the basis for much of our knowledge and thoughts on gender differences in CAD. An important focus 

of WISE was the delineation of at-risk women without obstructive CAD. Key findings in women 

with nonobstructive CAD include frequently documented nonobstructive atheroma by 

intravascular ultrasound as well as abnormal invasive coronary reactivity testing.10 

A more recent report explored mortality differences by gender in obstructive CAD extent and 

severity as well as nonobstructive plaque by coronary computed tomographic angiography 

(CCTA).11 Importantly, nonobstructive atherosclerosis was predictive of death in women but not 

men.11 These data reveal an ever-increasing prevalence of nonobstructive plaque for women 

281
as they age; a trend not seen for men. These data suggest that men may progress rapidly 

through stages of constrictive remodeling whereas women may linger within more extensive, 

expansive remodeling. 

A recent review12 has put forth a preliminary working model that the working group agreed 

could form the basis of a research agenda. That is, research is needed to understand genderspecific normative standards for plaque progression and composition and how they contribute 

to worsening clinical outcomes for women. The group prioritized this agenda as critical to 

formulating an understanding of a working hypothesis on plaque development and progression, including plaque composition, and the interplay between atherosclerosis with myocardial 

blood flow and vascular function as well as proatherogenic factors including traditional and 

novel CVD risk factors. 

Topic 2: Subclinical, Asymptomatic Women 

CVD remains the number one killer of women and men,13 despite focused public policy and 

clinical practice guidelines efforts aimed at primary prevention of traditional risk factors. The 

most recent statistics from the American Heart Association note that 432,700 women and 

398,600 men died from CVD in 2006.13 Although considerable declines have been reported 

over the past few decades, a detection gap remains that may form the basis for novel approaches to detection of at-risk women. Importantly, a recent evaluation of the NIH-NHLBI 

Atherosclerotic Risk in the Community (ARIC) study revealed marked declines in sudden 

cardiac death for men with only marginal trends for women.14 

For asymptomatic individuals, use of a global risk score (e.g., Framingham risk score [FRS]) is 

central to the initiation of preventive therapies and the designation of high risk status.15 Yet, the 

FRS is a poor estimator of 10-year CVD risk in women less than 70 years of age and in ethnic 

minorities.16,17 Efforts to improve the FRS have resulted in an adapted score that includes novel 

risk markers, such as high-sensitivity C-reactive protein and family history of CVD.18 LloydJones also put forth the concept allowing for a differentially lower near-term (i.e., 10 year) risk 

but focusing on the high lifetime CVD risk in women.19 More recent efforts have also examined 

improved classification of risk in women by employing direct atherosclerotic disease markers, 

such as coronary artery calcification (CAC).20–22 These reports importantly note that atherosclerotic disease markers, such as CAC, play a unique and additive role in risk assessment of 

women.23 Yet, none of these efforts have provided an exhaustive testing and validation of 

novel risk markers and how they result in net reclassification improvement in important 

CVD outcomes.24 

This working group supports a research agenda that would result in improved detection of 

asymptomatic women at moderate to high risk who may be candidates for more intensive 

lifestyle or risk factor modification strategies. 

Topic 3 - Symptomatic Women 

Women present more often for evaluation of chest pain including more frequent atypical 

symptoms that often include non-specific factors such as fatigue or shortness of breath.12, 25 

Historically, the presence of atypical symptoms in women has often been ignored or treated 

282
as non-cardiac in origin; more recent evidence supports an elevated CVD risk in symptomatic 

women regardless of its stated quality or characteristics.26–28 

Diagnostic testing in women is fraught with challenges that include strategies that rely on exercise testing in females with prevalent functional disability.29–31 The under-recognition on the 

part of clinicians of women who are functionally disabled and/or are unable to perform routine 

activities of daily living represents a significant and commonly missed opportunity to focus 

prevention efforts and identify women at risk for CVD.32 A second major limitation with current 

imaging modalities is the high rate of technical limitations or artifact challenges that diminish 

the accuracy of testing in women.33 For example, women who are often obese present major 

technical challenges in terms of imaging and for the morbidly obese, equipment weight limits 

may preclude testing. 

An additional major challenge is that current diagnostic testing strategies seek to define the 

woman with obstructive CAD, with much of the published literature focusing on the most 

sensitive and specific test.33 However, this type of strategy remains poorly optimized for 

women with non-obstructive CAD. Importantly, demonstration of ischemia in women is often categorized as a “false positive” test when co-occurring with non-obstructive CAD. Yet, 

evidence supports that the extent and severity of ischemia, as demonstrated on varied cardiac imaging modalities, is an effective risk stratifier of women.33, 34 This latter point is important 

because it signifies that ischemia, regardless of the underlying burden of obstructive CAD, is 

prognostically important. Moreover, the development of gender-optimized, ischemia-guided 

strategies of care, such as the optimal medical therapy strategy trials (e.g., VA-sponsored Clinical Outcomes Using Revascularization and Aggressive Drug Evaluation [COURAGE]) should aid 

in focusing anti-ischemic therapy to at-risk women.35 Moreover, in a recent substudy within the COURAGE trial, a serial testing strategy was put forth that focused optimal medical 

management toward ischemia resolution as a guide to improving patient outcomes.36 The 

development of serial medical management strategies may prove useful for women with 

chest pain and documented ischemia. 

Despite the fact that nearly 10 million women undergo diagnostic testing each year in the US, 

current guidelines are not supported by randomized trial evidence identifying an accurate and 

efficient strategy for improved detection and guided treatment of symptomatic women. The development of uniquely female trials oriented toward guiding anti-ischemic treatment strategies 

based on evidence of demonstrable stress-induced ischemia should be aggressively undertaken. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the public as to areas of investigation that merit greater research. 

Recommendations for Pathogenesis of Myocardial Ischemia and 

Anatomic Correlates 

1. Elucidate the sex-specific pathobiology of development and progression of microvascular 

and epicardial obstructive CAD, including the interplay between vascular dysfunction, 

nonobstructive atherosclerosis, and plaque composition. To date, the tools available 

283
to image and quantify microvascular abnormalities and plaque characteristics require 

further development for reliable, clinical (perhaps, noninvasive) application. 

2. Research in this area should lead to the development of a model which incorporates 

anatomic and functional parameters as well as accelerating factors such as hormonal, 

metabolic, and inflammatory influences which ultimately leads to timely and accurate 

detection of the vulnerable, high risk, female patient. Current diagnostic testing strategies 

that focus on obstructive CAD may require a paradigm shift to detecting gender-specific 

risk markers, including abnormalities within the microcirculation. 

Recommendations for Subclinical, Asymptomatic Women 

1. Develop highly accurate risk-based algorithms tailored to young and older women 

and men of different ethnic and racial backgrounds that incorporate and comparatively 

evaluate the effectiveness of standard risk assessment compared to strategies that 

include novel (e.g., imaging, biochemical, and physiologic) markers or factors that 

improve classification of at-risk women. A critical component to gender-optimized, 

population screening is the accurate detection of moderate-high risk women, 

necessitating long term risk prediction models. 

2. Incorporation of novel risk markers may require collaboration through biotechnology 

partnerships with the goal to provide clinically useful, inexpensive, reliable, and safe 

biomarkers. 

Recommendations for Symptomatic Women 

1. The development of “right test / right woman” diagnostic test strategies focusing on 

the development of novel, pretest risk scores incorporating symptoms and genderfocused risk factors and comorbidity, in clustering, that result in appropriate 

stratification of at-risk women. 

2. This research agenda should also incorporate comparative effectiveness research 

employing randomized trials of strategies centered on pre-catheterization, noninvasive as 

compared to invasive testing approaches. 

3. Central to these comparative effectiveness trials are the comparison of strategies incorporating functional, ischemia testing alone or in combination with anatomic approaches. 

4. Trial-specific aims must focus on identifying diagnostic testing strategies resulting in 

improved clinical outcomes, safety, and cost efficiency. 

5. Within this agenda is the focus on female-specific protocols (e.g., radial approaches to 

angiography, smaller catheters for diagnostic catheterizations, new radioisotopes for 

reduced breast tissue artifact in nuclear imaging) to improve quality imaging, reduce 

procedural risk, and employ radiation reduction strategies (whenever possible). 

References 

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Yancy, C.W. (2009). The American Heart Association’s principles for comparative effectiveness research: A policy statement from the American Heart Association. Circulation, 

119, 2955–2962. 

284
2. Shaw, L.J., Bairey Merz, C.N., Pepine, C.J., Reis, S.E., Bittner, V., Kelsey, S.F., ... Sopko, G. 

(2006). Insights from the NHLBI-sponsored Women’s Ischemia Syndrome Evaluation 

(WISE) study: Part I: Gender differences in traditional and novel risk factors, symptom 

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of Cardiology, 47, S4–S20. 

3. Shaw, L.J., Shaw, R.E., Merz,, C.N., Brindis, R.G., Klein, L.W., Nallamothu, B., ... Peterson, 

E.D. (2008). Impact of ethnicity and gender differences on angiographic coronary 

artery disease prevalence and in-hospital mortality in the American College of Cardiology-National Cardiovascular Data Registry. Circulation, 117, 1787–1801. 

4. Nabel, E.G., Selker, H.P., Califf, R.M., Canto, J.G., Cao, J.J., Desvigne-Nickens, P., ... Virmani, R. (2004). Women’s ischemic syndrome evaluation: Current status and future 

research directions: Report of the National Heart, Lung and Blood Institute workshop: 

October 2–4, 2002: Section 3: Diagnosis and treatment of acute cardiac ischemia: Gender issues. Circulation, 109, e50–52. 

5. Kolodgie, F.D., Gold, H.K., Burke, A.P., Fowler, D.R., Kruth, H.S., Weber, D.K., Farb, A., 

Guerrero, L.J., Hayase, M., Kutys, R., Narula, J., Finn, A.V., Virmani, R. (2003) Intraplaque 

hemorrhage and progression of coronary atheroma. The New England Journal of Medicine, 349, 2316–2325. 

6. Burke, A.P., Kolodgie, F.D., Farb, A., Weber, D.K., Malcom, G.T., Smialek, J., & Virmani, R. 

(2001). Healed plaque ruptures and sudden coronary death: Evidence that subclinical 

rupture has a role in plaque progression. Circulation, 103, 934–940. 

7. Virmani, R., Burke, A.P., & Farb, A. (1999). Plaque rupture and plaque erosion. Journal of 

Thrombosis and Haemostasis, 82 Suppl 1, 1–3. 

8. Arbustini, E., Dal Bello, B., Morbini, P., Burke A.P., Bocciarelli, M., Specchia, G., & Virmani, 

R. (1999). Plaque erosion is a major substrate for coronary thrombosis in acute myocardial infarction. Heart, 82, 269–272. 

9. Farb, A., Burke, A.P., Tang, A.L., Liang, T.Y., Mannan, P., Smialek, J., & Virmani, R. (1996). 

Coronary plaque erosion without rupture into a lipid core. A frequent cause of coronary 

thrombosis in sudden coronary death. Circulation, 93, 1354–1363. 

10. Pepine, C.J. (2006). Ischemic heart disease in women. Journal of the American College 

of Cardiology, 47, S1–3. 

11. Shaw, L.J., Min, J.K., Narula, J., Lin, F., Bairey-Merz, C.N., Callister, T.Q., & Berman, D.S. 

(2010). Gender differences in mortality associated with computed tomographic angiographic measurements of obstructive and nonobstructive coronary artery disease: an 

exploratory analysis. Circulation: Cardiovascular Imaging, 3(4), 473-81 

12. Shaw, L.J., Bugiardini, R., Bairey Merz, C.N. (2009). Women and ischemic heart disease: 

Evolving knowledge. Journal of the American College of Cardiology, 54, 1561–1575. 

13. Lloyd-Jones, D., Adams, R.J., Brown, T.M., Carnethon, M., Dai, S., De Simone, G., ... WylieRosett, J. (2009). Heart disease and stroke statistics—2010 update. A report from the 

American Heart Association. Circulation, 121(12), e259. 

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(2009). Trends from 1987 to 2004 in sudden death due to coronary heart disease: The 

atherosclerosis risk in communities (ARIC) study. American Heart Journal, 157, 46–52. 

15. Wilson, P.W., D’Agostino, R.B., Levy, D., Belanger, A.M., Silbershatz, H., & Kannel, W.B. 

(1998). Prediction of coronary heart disease using risk factor categories. Circulation, 97, 

1837–1847. 

16. Michos, E.D., Nasir, K., Braunstein, J.B., Rumberger, J.A., Budoff, M.J., Post, W.S., & Blumenthal, R.S. (2006). Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis, 184, 201–206. 

17. Nasir, K., Michos, E.D., Blumenthal, R.S., & Raggi, P. (2005). Detection of high-risk young 

adults and women by coronary calcium and National Cholesterol Education Program 

Panel III guidelines. Journal of the American College of Cardiology, 46, 1931–1936. 

18. Ridker, P.M., Buring, J.E., Rifai, N., & Cook, N.R. (2007). Development and validation of 

improved algorithms for the assessment of global cardiovascular risk in women: The 

Reynolds Risk Score. JAMA, 297, 611–619. 

19. Lloyd-Jones, D.M., Leip, E.P., Larson, M.G., D’Agostino, R.B., Beiser, A., Wilson, P.W., Wolf, 

P.A., & Levy, D. (2006). Prediction of lifetime risk for cardiovascular disease by risk factor burden at 50 years of age. Circulation, 113, 791–798. 

20.Raggi, P., Gongora, M.C., Gopal, A., Callister, T.Q., Budoff, M., & Shaw, L.J. (2008). Coronary artery calcium to predict all-cause mortality in elderly men and women. Journal of 

the American College of Cardiology, 52, 17–23. 

21. Raggi, P., Shaw, L.J., Berman, D.S., & Callister, T.Q. (2004). Gender-based differences in 

the prognostic value of coronary calcification. Journal of Women’s Health, 13, 273–283. 

22.Bellasi, A., Lacey, C., Taylor, A.J., Raggi, P., Wilson, P.W., Budoff, M.J., Vaccarino, V., & 

Shaw, L.J. (2007) Comparison of prognostic usefulness of coronary artery calcium in 

men versus women (results from a meta- and pooled analysis estimating all-cause 

mortality and coronary heart disease death or myocardial infarction). American Journal 

of Cardiology, 100, 409–414. 

23.Lakoski, S.G., Greenland, P., Wong, N.D., Schreiner, P.J., Herrington, D.M., Kronmal, R.A., 

Liu, K., & Blumenthal, R.S. (2007). Coronary artery calcium scores and risk for cardiovascular events in women classified as “low risk” based on Framingham Risk Score: The 

multi-ethnic study of atherosclerosis (MESA). Archives of Internal Medicine, 167, 2437– 

2442. 

24.Pencina, M.J., D’Agostino, R.B., Sr., D’Agostino, R.B., Jr., & Vasan, R.S. (2008). Evaluating 

the added predictive ability of a new marker: From area under the ROC curve to reclassification and beyond. Statistics in Medicine, 27, 157–172; discussion 207–112. 

25.Hemingway, H., Langenberg, C., Damant, J., Frost, C., Pyorala, K., & Barrett-Connor, E. 

(2008). Prevalence of angina in women versus men: A systematic review and metaanalysis of international variations across 31 countries. Circulation, 117, 1526–1536. 

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26.Gulati, M., Cooper-DeHoff, R.M., McClure, C., Johnson, B.D., Shaw, L.J., Handberg, E.M., 

... Merz, C.N. (2009). Adverse cardiovascular outcomes in women with nonobstructive 

coronary artery disease: A report from the Women’s Ischemia Syndrome Evaluation 

study and the St. James Women Take Heart Project. Archives of Internal Medicine, 169, 

843–850. 

27. Robinson, J.G., Wallace, R., Limacher, M., Ren, H., Cochrane, B., Wassertheil-Smoller, S., 

... Ko, M.G. (2008). Cardiovascular risk in women with non-specific chest pain (from the 

Women’s Health Initiative hormone trials). American Journal of Cardiology, 102, 693– 

699. 

28.Johnson, B.D., Shaw, L.J., Pepine, C.J., Reis, S.E., Kelsey, S.F., Sopko, G., ... Bairey Merz, 

C.N. (2006). Persistent chest pain predicts cardiovascular events in women without 

obstructive coronary artery disease: Results from the NIH-NHLBI-sponsored Women’s 

Ischaemia Syndrome Evaluation (WISE) study. European Heart Journal, 27, 1408–1415. 

29.Gulati, M., Pandey, D.K., Arnsdorf, M.F., Lauderdale, D.S., Thisted, R.A., Wicklund, R.H., AlHani, A.J., & Black, H.R. (2003). Exercise capacity and the risk of death in women: The 

St. James Women Take Heart Project. Circulation, 108, 1554–1559. 

30.Gulati, M., Black, H.R., Shaw, L.J., Arnsdorf, M.F., Merz, C.N., Lauer, M.S., ... Thisted, R.A. 

(2005). The prognostic value of a nomogram for exercise capacity in women. The New 

England Journal of Medicine, 353, 468–475. 

31. Mora, S., Redberg, R.F., Cui, Y., Whiteman, M.K., Flaws, J.A., Sharrett, A.R., & Blumenthal, 

R.S. (2003). Ability of exercise testing to predict cardiovascular and all-cause death 

in asymptomatic women: A 20-year follow-up of the lipid research clinics prevalence 

study. JAMA, 290, 1600–1607. 

32.Shaw, L.J., Olson, M.B., Kip, K., Kelsey, S.F., Johnson, B.D., Mark, D.B., ... Bairey Merz, C.N. 

(2006). The value of estimated functional capacity in estimating outcome: Results from 

the NHLBI-sponsored Women’s Ischemia Syndrome Evaluation (WISE) study. Journal of 

the American College of Cardiology, 47, S36–43. 

33.Mieres, J.H., Shaw, L.J., Arai, A., Budoff, M.J., Flamm, S.D., Hundley, W.G., ...Wenger, N.K. 

(2005). Role of noninvasive testing in the clinical evaluation of women with suspected 

coronary artery disease: Consensus statement from the Cardiac Imaging Committee, 

Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation, 111, 682–696. 

34.Shaw, L.J., Vasey, C., Sawada, S., Rimmerman, C., & Marwick, T.H. (2005). Impact of gender on risk stratification by exercise and dobutamine stress echocardiography: Longterm mortality in 4234 women and 6898 men. European Heart Journal, 26, 447–456. 

35.Boden, W.E., O’Rourke, R.A., Teo, K.K., Hartigan, P.M., Maron, D.J., Kostuk, W.J., ... Weintraub, W.S. (2007). Optimal medical therapy with or without PCI for stable coronary 

disease. The New England Journal of Medicine, 356, 1503–1516. 

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W.E. (2008). Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: Results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation, 

117, 1283–1291. 

ISSUES OF CARDIOVASCULAR PREVENTION ACROSS 

THE LIFESPAN WITH AN EMPHASIS ON GENDER AND 

UNDERSERVED POPULATIONS 

Cochairs:
�

Peter W.F. Wilson, M.D.
�

Emory University School of Medicine 

Jackson T. Wright, Jr., M.D., Ph.D. 

Case Western Reserve University 

NIH Cochairs:
�

Jane L. Harman, D.V.M., Ph.D., M.S.
�

National Heart, Lung, and Blood Institute 

Catherine (Cay) Loria, Ph.D., M.S. 

National Heart, Lung, and Blood Institute 

Science Writers: 

Juan Velasquez, M.D. 

Emory University School of Medicine 

Heather Westmoreland, M.D. 

Emory University School of Medicine 

Introduction 

Cardiovascular disease (CVD) is a major cause of morbidity and mortality in adult women 

across the United States and approximately one third of women are expected to develop cardiovascular disease in their lifetime.1 Underserved populations, especially African Americans, 

experience a disproportionate burden of cardiovascular disease; and a variety of reasons underlie these differences. “Underserved groups” include those with disabilities or disadvantages 

on the basis of their place of residence, geographic location, age, race, ethnicity, underlying 

chronic conditions, or social status.2

 These persons may also receive less healthcare because 

of economic, cultural, or linguistic factors. 

Summary of the Discussion 

The Working Group focused on differences between men and women in clinical aspects of 

cardiovascular disease development that deserve greater research attention. 

288
The sections that follow summarize discussions related to several key areas including: 1) education and provider tools; 2) better CVD risk profiling in women from underserved populations; 

3) clinical therapeutic gaps in knowledge; 4) basic science; and 5) clinical practice. In addition, 

the group encouraged further research related to medical records of insured minorities and 

investigation of the determinants of cardiovascular disease from such resources. 

1. Education and Provider tools 

Areas of research that merit special attention include: a) provider education; b) school-based 

interventions; c) workplace educational programs and interventions; and d) community-based 

interventions that could take place using community facilities and those provided directly to 

community members. 

Measures and Methods. The risk factors for cardiovascular disease are reasonably well understood and current evidence suggests these risk factors apply to women and to underserved 

populations. Risk factor reduction and improved healthcare performance measures for underserved women are important goals, and further research is needed to specifically identify the 

methods that are effective in women, who are more likely to be underinsured, have limited 

resources, reduced access to primary care and subspecialty providers, and modern facilities. 

Comparative Effectiveness Research. A variety of ways to improve care and access for women and underserved populations deserve research attention, and many of the opportunities 

would probably be characterized as comparative effectiveness research. Novel approaches 

could be compared to existing care models with either serial designs (before-after comparisons) or parallel designs (observations made at the same time and site specific interventions 

compared) designs. 

Different ways to deliver education and care should be evaluated to carry out these types of 

programs. Research on models of delivery might include comparisons of traditional clinical 

office-based medical care, use of health providers such as nurses, dietitians, physical activity experts, and disease specific specialists. Newer methods of assessment include quick tools 

such as risk assessment with easy-to-understand interpretations, and use of techniques that 

are easily understandable and accessible by patients and clients. The efficacy/effectiveness of 

financial incentives should also be considered when developing and evaluating programs 

including the incentives for clients, providers, and employers. 

2. Better Vascular Disease Risk profiling in women and underserved populations 

Metabolic Syndrome in African Americans. The diagnosis of metabolic syndrome is common, 

highly linked to obesity, and associated with increased CVD risk. However, the utility and implications of the diagnosis are less clear for African Americans.3 It is usually defined by the 

presence of three or more of the following: glucose intolerance, low HDL cholesterol, high triglycerides, elevated blood pressure, and increased abdominal adiposity. Despite higher rates of 

CVD, the tendency toward lower triglyceride levels and higher HDL cholesterol levels in African 

Americans may lead to a lower prevalence of this condition than would otherwise be expected. 

Further study on the determinants of metabolic syndrome risk in African Americans and the 

289
development of effective strategies to prevent or treat obesity in African Americans are 

greatly needed. 

Cardiovascular Disease Risk Profiling. Both Whites and African Americans are very likely to 

develop cardiovascular disease during adulthood. Most of the risk prediction algorithms were 

derived from White populations. Less is known concerning how well the risk algorithms can be 

applied to African American population groups and other underserved groups that were not 

well represented in the datasets that were used to develop the estimating equations.4 

Research concerning the accuracy and precision of cardiovascular disease risk assessment 

in women and underserved groups should include: a) evaluation of traditional risk factors; 

b) an improved definition of left ventricular hypertrophy by echocardiogram in African 

Americans; c) consideration of the role of novel markers in blood specimens; d) inclusion of 

inflammation biomarkers such as C-reactive protein; e) consideration of vitamin D levels, 

which are well-recognized to be lower in persons with darker skin pigmentation; f) genetics; 

and g) subclinical CVD assessment. There is also a question of the utility of calcium scoring in 

African Americans because this population group experiences high risk for vascular disease 

events but appears less likely to have lesions that are calcified prior to the development 

of the clinical vascular event.5, 6 

3. Clinical therapeutics gaps in knowledge 

Preserved systolic function heart failure: how to treat it in women. Heart failure is currently one of the most common clinical diagnoses made in American adults and is responsible for 

a very large number of hospitalizations. Non-invasive methods have been developed to assess 

heart failure, and it is possible to categorize individuals as having heart failure that has systolic, diastolic, or both systolic and diastolic abnormalities. Women and persons with diabetes 

mellitus are more prone to develop heart failure with preserved systolic function; and further 

research is needed to understand the pathophysiology of heart failure and its different presentations in women. 

Efficacy of defibrillator therapy in women with heart failure. Patients with heart failure and 

reduced cardiac output with diminished ejection fraction are candidates for defibrillator 

implantation. More research is needed about such placements in women. 

Nitric oxide enhancing therapy for primary prevention of heart failure. The results of a heart 

failure clinical trial showed that long-term oral nitrate therapy combined with hydralazine reduced the risk for secondary events in African Americans, especially among African American 

women. Further research into the mechanisms of benefit is needed particularly concerning 

whether it extends to the prevention of initial heart failure events. 

Are cardiovascular disease preventive therapies different in women vs. men? The efficacy 

of cardiovascular disease prevention strategies is often assumed to be the same for men and 

for women. Further sex-specific and minority-specific investigation into the role of cholesterol lowering, blood pressure therapy, antiplatelet therapy, minimally invasive interventions such 

as catheters, and cardiovascular surgery should be undertaken to improve understanding of 

290
the efficacy and side effect profiles of such treatment strategies in women and underserved 

minority groups. Part of this research should specifically investigate the role of metabolic and 

genetic factors that might underlie the differences between men and women. 

4. Basic Science 

Adult men and women are both very likely to develop cardiovascular disease in their lifetimes. 

Women experience greater longevity, extremely low risk for vascular disease events prior to 

menopause, and greatly increased vascular disease risk after the menopause. Investigation of 

human subjects and animals that are especially susceptible to atherosclerosis is needed to provide further information related to these differences. To better understand the differences in 

vascular disease risk in humans, studying non-human primates may be especially productive.7, 8 

A variety of reproductive health issues in women are of special interest related to vascular disease pathophysiology and risk, and would benefit from research, including studies of: 

(a) the link between CVD and age at menarche or age at menopause; (b) female animal 

models of CVD and the effects of estrogen preparations on the vascular system; (c) diastolic 

dysfunction and cardiac remodeling in women; (d) thrombosis risk in women; and (e) the pathophysiology of myocardial infarction and vascular function in women. 

5. Clinical practice 

Women who experience clinical cardiovascular disease are more likely to have worse outcomes 

than men.9 Investigations into the significance of preceding levels of risk factors, gender-related 

differences in treatments at the time of the vascular events, rehabilitation and convalescent care, 

and long-term care after the event are important considerations to improve our understanding 

of these differences. 

Specific areas of research that deserve attention include: a) women-centered cardiac rehabilitation; b) telemedicine for rural populations vs. usual care to manage patients; and c) ensuring 

adequate participation of women in secondary prevention studies. 

Recommendations 

The following research recommendations may help to provide guidance to health administrators, clinicians, scientists, and the population as to areas of investigation that merit greater 

research to identify women at increased risk for cardiovascular sequelae. 

1. New education and provider tools are needed, including: 

• New assessments of the comparative effectiveness of various methods of behavior 

change and assessments of determinants of response in children, adolescents, 

and adults. 

• Potential vehicles for interventions include health provider education, school-based 

interventions, workplace and community-based interventions, and interventions 

during pregnancy. 

291
• Methodological studies needed include comparisons of new versus traditional models 

of delivery and studies of the impact of financial incentives. 

2. Better vascular risk profiling in minority women and those from underserved 

populations is needed, including: 

• More research to provide better metabolic syndrome characterization in 

African American women and other minority groups.
�

• Better risk factor profiling of women from high risk groups, using 

• traditional risk factors; 

• blood pressure assessments and ECG-LVH; 

• novel markers in blood specimens, including inflammation and adiposity markers, 

vitamin D levels, and genetics; 

• subclinical CVD assessment; and 

• utility of calcium scoring in African Americans. 

3. Studies are needed to address clinical therapeutics gaps in knowledge for 

women including: 

• Treatment of diastolic heart failure. 

• Efficacy of defibrillator therapy in women with heart failure. 

• Nitric oxide enhancing therapy for primary prevention. 

• Shown in secondary prevention mostly in African-American women. 

• Determine whether this therapy is effective for primary prevention in 

African-American women and other groups. 

• Determine whether there are pharmacologic differences between women and 

men for CV-preventive therapies. 

4. Basic science research to address issues such as: 

• How do characteristics of menarche, timing of menopause, and quality of ovarian 

function relate to CVD?
�

• Female animal models to study estrogens and their preparations’ impact on CVD. 

• What is the importance of diastolic dysfunction and heart remodeling in women? 

• Why is risk of thrombosis/bleeding greater in women? 

• Pathophysiology of MI and vascular function in women. 

5. Clinical practice studies are needed, including: 

• Women-centered cardiac rehabilitation 

• Comparative effectiveness research for different medical strategies 

292
• Rural populations 

• Urban populations 

• Ensuring adequate participation of women in secondary prevention studies 

References 

1. Lloyd-Jones, D.M., Larson, M.G., Beiser, A., & Levy, D. (1999). Lifetime risk of developing 

coronary heart disease. Lancet, 353(9147), 89–92. 

2. Weitz, T.A., Freund, K.M., & Wright, L. (2001). Identifying and caring for underserved 

populations: experience of the National Centers of Excellence in Women’s Health. 

Journal of Women’s Health and Gender Based Medicine, 10(10), 937–52. 

3. Ford, E.S., Giles, W.H., & Dietz, W.H. (2002). Prevalence of the metabolic syndrome 

among US adults: findings from the third National Health and Nutrition Examination 

Survey. JAMA, 287(3), 356–9. 

4. D’Agostino, R.B., Sr., Grundy, S., Sullivan, L.M., & Wilson, P. (2001). Validation of the 

Framingham coronary heart disease prediction scores: Results of a multiple ethnic 

group investigation. JAMA, 286(2), 180–187. 

5. Bild, D.E., Folsom, A.R., Lowe, L.P. et al. (2001). Prevalence and correlates of coronary 

calcification in black and white young adults: the Coronary Artery Risk Development 

in Young Adults (CARDIA) Study. Arteriosclerosis, Thrombosis, and Vascular Biology, 5, 

852–857. 

6. Detrano, R., Guerci, A.D., Carr, J.J. et al. (2008). Coronary calcium as a predictor of coronary events in four racial or ethnic groups. New England Journal of Medicine, 358(13), 

1336–1345. 

7.	� Kaplan, J.R. & Manuck, S.B. (2008). Ovarian dysfunction and the premenopausal origins 

of coronary heart disease. Menopause, 4, Pt 1, 768–776. 

8. Adams, M.R., Williams, J.K., & Kaplan, J.R. (2004). Estrogens, progestins, and atherosclerosis. Arteriosclerosis, Thrombosis, and Vascular Biology, 24(11), e190–e191. 

9.	�Vaccarino, V., Parsons, L., Peterson, E.D., Rogers, W.J., Kiefe, C.I., & Canto, J. (2009). Sex 

differences in mortality after acute myocardial infarction: changes from 1994 to 2006. 

Archives of Internal Medicine, 169(19), 1767–1774. 

WOMEN’S CAREERS IN THE BIOMEDICAL SCIENCES 

Cochair:
�

Judith G. Regensteiner, Ph.D.
�

University of Colorado–Denver School of Medicine 

NIH Cochair:
�

Nakela Cook, M.D., M.P.H.
�

National Heart, Lung, and Blood Institute 

293
Science Writers:
�

Raquel Bennett-Gittens, M.D.
�

Emory University School of Medicine 

Charles Jackson, M.D. 

Emory University School of Medicine 

“For every bright mind that doesn’t reach her or his full potential, biomedical research loses a 

new idea, a new approach, or a new perspective.”1 

Introduction 

Over the past few decades, the number of women entering the field of biomedical research 

has steadily increased. However, the proportion of women in leadership positions has remained 

consistently low and women still lag behind their male counterparts in attaining positions of 

scientific leadership.2,3 

This problem is not unique to women with careers in biomedical science. In 2006, the American Association of University Professors conducted a study evaluating the role of women in 

higher education. The study included 1,445 colleges and universities and revealed that while 

women earn more than half of all Ph.D. degrees in the United States they comprised only 45 

percent of tenure-track faculty, 31 percent of tenured faculty and just 24 percent of full 

professorships in 2005-2006.4 

This pattern also applies to the area of academic medicine where women represent a substantial proportion of faculty positions but the numbers of women serving in leadership positions 

such as department chairs remain disproportionately low.3 In an effort to narrow the gender 

gap in science, medicine, and engineering, the National Institutes of Health (NIH) continues to 

explore the factors that interfere with the trajectory of women’s career paths and to devise 

interventions to minimize obstacles. In addition, the NIH has well-established programs 

designed to promote women’s careers in the biomedical sciences. 

Summary of the Discussion 

The working group, comprising clinicians, scientific investigators, engineers, pharmacists, 

and NIH representatives, discussed the current status of women in biomedical research and 

the factors that contribute to the gender gap in leadership positions. The majority of the discussion focused on methods whereby the NIH is involved in promoting career development 

of women in biomedical science to maximize their career potential and to enable their rise to 

higher positions in academia. The acronym “MILES (Mentoring, Institutional Transformation, 

Leadership, Educational Pipeline, and Support for Careers) Ahead” was chosen as representing the areas that needed focus to sustain and further the development of women’s careers 

in biomedical research. 

The following are the major concepts that emerged from the discussion: 

294
Mentoring 

The working group identified mentorship as a key component to a woman’s success in biomedical research. There are issues pertaining to both mentors and mentees that must be considered. 

Group members felt that a large percentage of mentors would benefit from formal mentorship 

training. They suggested that the NIH could devise and offer methods of training mentors in the 

development of skills required for good mentorship. This could take the form of workshops at 

NIH on mentoring, short-term courses at the NIH, and/or even virtual mentorship online courses. 

Mentees could also benefit from courses developed by the NIH explaining the key ingredients 

of a successful mentorship relationship and the role of the mentee in accomplishing this goal. 

The type of mentoring that works best for mentors and mentees could also be explored in such 

courses. Many NIH K (career development) awards feature a team mentorship approach which 

may include content as well as career mentors. 

Working group members also recognized that there needs to be a formal evaluation of mentors 

and the mentoring relationship. Mentors, mentees, and the leadership responsible for mentoring 

programs should take part in the formal evaluations. Mentees also need to receive appropriate 

and timely feedback. Appropriate multidimensional feedback for both mentors and mentees will 

optimize good practices and discourage practices that undermine the goals of mentorship. This 

may be fostered through the development of programs and other institutional methods 

evaluating the quality of mentoring at multiple career stages. 

One of the major obstacles that limit the ability of experienced scientists and clinicians to undertake the mentorship of junior colleagues is lack of funded time for mentoring. This could be 

addressed by developing and offering grants which support protected time for both the mentor 

and mentee. One current grant model that could be replicated or extended to funding mentoring programs for women is the NHLBI’s “Programs to Increase Diversity among Individuals 

Engaged in Health-Related Research” (PRIDE). This is a grant that funds research, education, 

and mentoring programs for minorities with a goal of increasing diversity in the biomedical sciences workforce. Another method that can potentially be used to assist with this effort involves 

expanding existing grant mechanisms such as the ORWH Building Interdisciplinary Research 

Careers in Women’s Health (BIRCWH) program, which is designed to provide mentoring for 

junior faculty (http://orwh.od.nih.gov/interdisciplinary/bircwhmenu.html). 

Additionally, participants discussed other mechanisms which would encourage or reward mentors. Including mentoring activities on biosketches would draw attention to their importance 

and would be another way of encouraging mentorship. These efforts to recognizing the value of mentoring could have long term benefits by encouraging and enabling scientists of the 

highest caliber to train and mentor the next generation of scientists. 

In addition to mentorship at one’s home institution or department, mentorship should also be 

encouraged across institutions and across disciplines. This would provide trainees at smaller institutions a more diverse and experienced pool of potential mentors and collaborators. 

Funding agencies and institutions could support programs utilizing novel mechanisms such 

as cross-institution, cross-disciplinary, or web-based mentorship opportunities that could pair 

mentees with mentors throughout the country. Such innovative forms of mentoring could 

295
provide support to mentees, mentorship training to mentors, and even opportunities to leverage existing funded research programs as opportunities for mentorship. Social networking 

Web sites and emerging technologies could be utilized to facilitate connections between 

mentees and mentors. 

Institutional Transformation 

Institutions need to equip women in biomedical science with the tools that will enable them to 

maximize their full potential and rise to positions of leadership. Looking “MILES ahead,” funding agencies and professional societies can play an exciting and key role in the development 

of women’s careers in the biomedical sciences by encouraging and rewarding transformational 

changes within institutions. This would potentially bring about greater retention and job 

satisfaction of female scientists and faculty. 

Institutional career development offices, which address the needs of postdoctoral fellows 

and faculty, as well as students, would aid in ensuring equal opportunities for career advancement across the sexes. Funding agencies may play a role in offering seed grants to such offices 

to develop and implement innovative programs and institutions should recognize and value 

their efforts. 

Many NIH institutional career development and training grants provide opportunities and 

incentives for institutions to leverage the resources of multiple departments to create interdisciplinary or translational programs. The BIRCWH and Clinical Translational Science 

Awards are examples of such programs, which can foster women’s careers by providing 

extensive mentoring, enhanced research infrastructure, and offering opportunities women 

to take on leadership roles. 

The issue of encouraging women surgeons to go into research while carrying out their mandated clinical duties was raised. There continues to be a need to facilitate research training for 

those in higher paying specialties and professions; however this cannot be addressed by current grant mechanisms while maintaining equitable salary scales for researchers in all fields. 

In addition, ensuring that allied health professionals, such as nurses, pharmacists, and physical therapists, have access to research and career development grants would generate research 

in novel areas and further diversify the scientific workforce. 

Leadership 

Another overarching goal identified by the working group was increasing the number of women in leadership roles within the biomedical sciences. This requires effective training of women 

in leadership skills. Programs such as Executive Leadership in Academic Medicine provide extensive year-long training, but tend to be relatively small, costly, and focused on specific career 

stages. The Association of American Medical Colleges (AAMC) also offers excellent leadership 

seminars for early- and mid-career women but access to these is also limited and demand often 

exceeds supply. Professional organizations offer an important opportunity for career development and advancement through their meetings and should be encouraged to provide leadership 

short courses, which could focus on junior-, mid- or senior-level faculty needs with specific training in leadership appropriate to that level, at their meetings. Organizations could partner with 

296
funding agencies on the planning, development, and execution of such programs which could 

be inexpensive, widely available, and would provide attendees with both the toolkit for leadership at their current level and a map for further advancement. People would likely be very 

drawn to such courses and the benefit could be widespread. 

In order to narrow the gender gap that exists in leadership positions in the field of biomedical sciences, awareness needs to be raised at the highest levels in institutions. Current statistics 

on women in leadership roles should be presented to the institutional leaders and discussions 

held to determine key strategies that would result in more women having opportunities to 

attain leadership positions. 

Leadership succession is also a major issue that must be addressed on an institutional level, 

and it provides opportunity for gender diversity in leadership as women are prepared and considered for these positions. Early planning regarding the transition of leadership of divisions, 

departments, laboratories, and major research projects with an attention to the distribution of 

women in such roles is needed. Funding agencies could require that leadership training be included in career development and training grants, such as NIH K awards. The group suggested 

that departments that have an active program for faculty development could potentially be 

recognized for their efforts by their institutions and professional societies. 

Recognizing the benefits of inspirational narratives of the journeys travelled by accomplished 

female leaders in biomedical science, it was thought that a collection of abbreviated biographies of such individuals should be made available to more junior women. These stories would 

also be enlightening to young women in high school and college, and could result in some of 

these young women exploring careers in biomedical sciences by providing new role models. 

The publication Women in Science at the National Institutes of Health, 2007–2008 could serve 

as a model.5

 Institutions and professional organizations should be encouraged to develop similar publications and to create exhibits, perhaps during Women’s History Month, to recognize 

and highlight women at those institutions or in those professions. 

Educational Pipeline 

Educating and exciting girls and young women about science and medicine increases the likelihood that they will choose educational paths that make these careers possible. One such 

example is the Jackson Heart Study in Jackson, Mississippi, where middle-school children are 

engaged to participate as health advocates in their communities. Career fairs where biomedical professionals explain their fields and the work that they do to middle or high school students 

were suggested. In this type of direct interaction, young people can see the passion that these 

adults have for their work and can ask questions about the steps they need to take to reach 

these goals. It would be especially powerful to young women if many of these demonstrators 

were women—as proof that women can achieve in any career. It is important to encourage girls 

and young women to pursue these professions before they make important decisions about 

their high school and college curriculum—such as number and type of science and math courses 

they should take. Working group participants also noted that many career opportunities are not 

apparent to women entering the work force. The biomedical careers that tend to be emphasized 

297
are physicians and researchers in academic practice. This ignores the vast number of positions 

in private industry and government, where valuable research and patient care are performed. 

Support for Careers 

For many women, their central role in the family results in career paths that do not follow the 

traditional timeline. Because some women choose to either leave their jobs temporarily or decrease their status to part time, programs and policies should be in place so that a woman’s 

career is not limited or ended by the need to attend to family or other caregiving responsibilities. There are currently reentry grants awarded by the NIH for scientists (men or women) 

returning from providing care for a family (http://grants.nih.gov/grants/guide/pa-files/PA-08-

191.html). Since many of the working group members were not aware of these grants, they 

recommended an effort to increase publicity. In addition, NIH grant applicants who have taken 

a hiatus from research may apply for an extension of their Early Stage Investigator status. 

This alone is not enough, however. There are many women who continue to work while caring 

for a family member, which can result in gaps in productivity. These women need an extended timeline for career goals, whether that means research deadlines, tenure track mileposts, or 

other metrics by which researchers are judged. NIH currently provides no-cost extensions on 

research grants and allows career award grantees to reduce their efforts to part-time for one 

year. The American Heart Association grant applications ask if there are gaps in productivity 

and the reasons for them. The NIH is currently exploring mechanisms to offer a similar 

opportunity on its grant applications. 

In addition to increased flexibility, working group participants also suggested that current 

NIH and professional society career development and mentoring programs be made available 

across career stages. This increased support will increase the number of women reaching more 

senior positions—positions of leadership where they in turn can effect change to increase the 

number of women who achieve research careers. 

Recommendations 

The following research recommendations may help to provide guidance to health academic 

institutions, administrators, clinicians, and scientists as to areas of investigation that merit 

greater research. 

1. Mentorship 

• Mentor training, in the form of short courses or workshops in conjunction with professional conferences or web-based courses, should be developed to help scientists learn 

and enhance the skills needed to be successful mentors. 

• Training for mentees on how to be effectively mentored and how to mentor others 

should be provided as part of career development and training grants. 

• Expand the availability of interinstitutional and interdisciplinary mentorship, using innovative mechanisms to increase the number and diversity of experienced individuals 

available to guide more junior women in science. 

298
2. Institutional Transformation 

• Academic and research institutions should be encouraged to have faculty development programs, which could be initiated with seed grants from funding agencies 

and professional societies. 

• Expand existing funding opportunities (such as the BIRCWH) where NIH support is likely 

to be leveraged by institutions. 

3. Leadership 

• Professional societies and funding agencies should partner to design and conduct leadership courses that focus on junior, mid-level, and senior faculty with specific training in 

leadership appropriate to each level.
�

• Create a role for addressing leadership succession in grants. Suggestions include incorporating leadership training or faculty development into career development awards. 

• Funding agencies and professional organizations should consider funding institutional 

faculty development offices which would promote women’s careers.
�

• Develop “Story Corps”-type narratives for women’s careers, which can serve as an 

inspiration for those more junior using the Women in Science at the National Institutes 

of Health 2007-2008 as a model.
�

4. Educational Pipeline 

• Institutions, professional societies, and funding agencies should sponsor career fairs 

encouraging girls and young women to pursue and remain in careers in the biomedical 

sciences, with an emphasis on having women professionals as presenters to serve as 

inspirational role models.
�

• Opportunities for partnership between public and private agencies to create a national 

curriculum on careers in the biomedical sciences for middle school and high school 

students should be developed.
�

• Highlight and share the experiences of accomplished women in biomedical research to 

provide more role models to young women and the future generation of scientists.
�

5. Support for Careers 

• Flexibility is needed in timelines for research projects for tenure-track for women who 

are primary caregivers. 

• The current reentry grant program should be continued and augmented with more 

publicity and funding. 

• Gaps in productivity due to family responsibilities should be noted on grant applications 

and reviewers should be educated on how to appropriately weigh these gaps into 

funding decisions. 

• A broader range of career development awards are needed throughout the spectrum of 

women’s careers—early, mid, and senior—to promote career development at all stages. 

299
References 

1. NIH News. (2008). NIH Helps Advance Women in Biomedical Research Careers. 

Retrieved from http://www.nih.gov/news/health/jul2008/od-14.htm 

2. Lenfant, C. (1993). Women in biomedical science: Through the looking glass. Circulation, 

88, 1409. 

3. Leadley, J. (2009). Women in U.S. Academic Medicine: Statistics and Benchmarking Report. Washington, DC: American Association of Medical Colleges. Retrieved from http:// 

www.aamc.org/members/gwims/statistics/stats09/wimstatisticsreport2009.pdf 

4. West, M. & Curtis, J.W. (2006). AAUP Faculty Gender Equity Indicators 2006. Washington, DC: American Association of University Professors. Retrieved from http://www. 

aaup.org/NR/rdonlyres/63396944-44BE-4ABA-9815-5792D93856F1/0/AAUPGenderEquityIndicators2006.pdf 

5. Office of Research on Women’s Health. (2009). Women in Science at the National 

Institutes of Health 2007–2008. Bethesda, MD: National Institutes of Health. 

300
301
 
APPENDIX A 

Public Testimony Providers 

WASHINGTON UNIVERSITY IN ST. LOUIS 

ST. LOUIS, MISSOURI 

MARCH 4, 2009 

Lynne Roney 

AAUW of Missouri 

Kristian Hurley 

American Autoimmune Related Diseases Association 

Cheryl Healton, Dr.P.H. 

American Legacy Foundation 

Donna Vallone, Ph.D. 

American Legacy Foundation 

Claire Saxton 

Bladder Cancer Advocacy Network 

Megan Whinery 

Endometriosis Association 

Susan Wood, Ph.D. 

The George Washington University School of Public Health and Health Services 

Diana Hankey Underwood, M.S.,WHNP-BC 

Grace Anatomy, Inc. 

Nancy Norton 

International Foundation for Functional Gastrointestinal Disorders 

Madeline Nolan 

LAM Foundation 

Lynne Matallana 

National Fibromyalgia Association 

Christin Veasley 

National Vulvodynia Association 

Paula Gianino 

Planned Parenthood of the St. Louis Region and Southwest Missouri 

302
Rino Aldrighetti 

Pulmonary Hypertension Association 

Mary Blades 

Scleroderma Foundation 

Phyllis Greenberger, M.S.W. 

Society for Women’s Health Research 

Sue Baebler 

St. Louis Breast Cancer Coalition 

Raul Artal, M.D. 

St. Louis University 

Rosemary B. Catanzaro M.S., R.D., C.D.E. 

Saint Louis University 

Lyse Norian, Ph.D. 

University of Iowa College of Medicine 

Susan Pfefferle, Ph.D. 

Washington University, George Warren Brown School of Social Work Research 

Ericka Hayes, M.D. 

Washington University Pediatric HIV Program 

Keith S. Garcia, M.D., Ph.D. 

Washington University School of Medicine 

Jeffrey Henderson, M.D., Ph.D. 

Washington University School of Medicine 

Raksha Jain, M.D. 

Washington University School of Medicine 

Catina O’Leary, Ph.D., M.S.W. 

Washington University School of Medicine 

Linda Peterson, M.D. 

Washington University School of Medicine 

Joan Riley, Ph.D. 

Washington University School of Medicine 

Gina Secura, Ph.D., M.P.H. 

Washington University School of Medicine 

Clay Semenkovich, M.D. 

Washington University School of Medicine 

303
William J. Ledger, M.D. 

Weill Medical College of Cornell University 

Jane Murray 

Women in Balance 

Missy Lavender, M.B.A. 

Women’s Health Foundation 

Maura Riordan 

Women Organized to Respond to Life-Threatening Diseases (WORLD) 

Claire Chosid 

Self 

Ellen Heislen, P.A.-C. 

Self 

Robert Kokenyesi 

Self 

Patricia Marsh 

Self 

Colleen McKee 

Self 

Diane Rubaii 

Self 

Aretha Webb 

Self 

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 

SAN FRANCISCO, CALIFORNIA 

MAY 27, 2009 

Debabrata Ghosh, Ph.D. 

All India Institute of Medical Sciences 

Cheryl Healton, Dr.P.H., M.P.A. 

American Legacy Foundation 

Lori Karan, M.D., PACP, FASAM 

American Society of Addiction Medicine 

Kathleen Besinque, Pharm.D., M.S. Ed. 

Association of Reproductive Health Professionals and USC School of Pharmacy 

304
Rivka Gordon, M.H.S., P.A.-C. 

Association of Reproductive Health Professionals 

Suzan Goodman, M.D., M.P.H. 

Association of Reproductive Health Professionals 

Joyce Bichler, M.S.W. 

Breast Cancer Action 

Kasha Ho 

California Healthy Nail Salon Collaborative/Breast Cancer Action 

Debra Bingham, Dr.P.H., R.N. 

California Maternal Quality Care Collaborative 

Heather Sarantis, M.S. 

Commonweal 

Kari Christianson 

DES Action USA 

Betsy Rassmussen 

Endometriosis Association 

Aspen Baker 

Exhale 

Danielle Thomas 

Exhale 

Janice Humphreys, Ph.D., R.N., N.P., FAAN 

Group of Concerned Nurse-Researchers 

Hugh Brown III 

HIV/AIDS Services for African Americans in Alaska 

Laura Mosier, B.S. 

Indiana State Department of Health 

Jennifer Pierce-Weeks, R.N., SANE-A, SANE-P 

International Association of Forensic Nurses 

Sue Goldstein 

International Society for the Study of Women’s Sexual Health 

Deb Levine, M.A. 

ISIS, Inc. (Internet Sexuality Information Services) 

Maria Cora, M.A. 

Lesbian Health & Research Center at the University of California, San Francisco 

305
Sarah Janssen, M.D., Ph.D., M.P.H. 

Natural Resources Defense Council 

Yali Bair, Ph.D. 

Planned Parenthood Affiliates of California 

Deborah Ortiz, J.D. 

Planned Parenthood Mar Monte 

Jane Honikman, M.S. 

Postpartum Support International 

Rhoda Nussbaum, M.D. 

Prevention International: No Cervical Cancer 

Roham Zamanian, M.D. 

Pulmonary Hypertension Association 

Elizabeth Arndorfer 

Reproductive Health Technologies Project 

Cathy Eddy 

Scleroderma Foundation Northern California Chapter 

Hassan Sallam, M.D., Ph.D., FRCOG 

The Suzanne Mubarak Regional Center for Women’s Health and Development 

Katie Gillespie, M.A. 

University of Arizona 

Vanessa Jacoby, M.D., M.A.S. 

University of California, San Francisco 

Purnima Madhivanan, M.D., Ph.D., M.P.H. 

University of California, San Francisco 

Patricia A. McDaniel, Ph.D. 

University of California, San Francisco 

Ruth Malone, Ph.D., R.N., FAAN 

University of California, San Francisco 

Elise Riley, Ph.D., M.P.H. 

University of California, San Francisco 

Paolo Rinaudo, M.D., Ph.D. 

University of California, San Francisco 

Patricia A. Robertson, M.D. 

University of California, San Francisco 

306
Tracey Woodruff, Ph.D., M.P.H. 

University of California, San Francisco 

Amy Levine, Ed.D. 

University of California, San Francisco 

Margaret Kristof , M.A. 

UCSF-Kaiser BIRCWH Program 

Valerie Flaherman, M.D., M.P.H. 

UCSF-Kaiser BIRCWH Program 

Yoshimi Fukuoka, Ph.D. 

UCSF-Kaiser BIRCWH Program 

Wendy B. Katzman, D.P.T.Sc., P.T., O.C.S. 

UCSF-Kaiser BIRCWH Program 

Alexandra Scranton, M.S. 

Women’s Voices for the Earth 

Loreen Willenberg 

Zephyr L.T.N.P. Foundation, Inc. 

Ken Chisholm 

Self 

Beverly Santos 

Self 

Lynn Shepler, M.D., J.D. 

Self 

THE WARREN ALPERT MEDICAL SCHOOL OF BROWN UNIVERSITY 

PROVIDENCE, RHODE ISLAND 

SEPTEMBER 21, 2009 

Sabrina McCormick, Ph.D. 

American Academy for the Advancement of Science, Fellow 

Scott L. Tomar, D.M.D., Dr.P.H. 

American Association of Public Health Dentistry 

Virginia T. Ladd, RT 

American Autoimmune Related Diseases Association 

Holly Kennedy, Ph.D., C.N.M., FACNM, FAAN 

American College of Nurse-Midwives 

307
Thomas C. Wright, Jr., M.D. 

American Society for Colposcopy & Cervical Pathology 

Rebecca Allen, M.D. 

Association of Reproductive Health Professionals 

Mimi Pomerleau, D.N.P., W.H.N.P.-BC, R.N.C.-OB 

Association of Women’s Health, Obstetric and Neonatal Nurses 

Deborah N. Pearlman, Ph.D. 

Brown University 

Michelle Cortes-Harkins 

Center for Hispanic Policy & Advocacy 

Dixie Mills, M.D. 

Dr. Susan Love Research Foundation/Army of Women 

Patricia Paluzzi, Dr.P.H., C.N.M. 

Healthy Teen Network 

Alessandra Rellini, Ph.D. 

International Society for the Study of Women’s Sexual Health 

Erin Boles, M.S.W. 

Massachusetts Breast Cancer Coalition 

Nancy Muller, M.B.A. 

National Association For Continence 

Liza Fuentes 

National Latina Institute for Reproductive Health 

Christin Veasley 

National Vulvodynia Association 

Stefanie Russell, D.D.S., Ph.D., M.P.H. 

New York University College of Dentistry 

Marlene McCarthy, H.L.D. 

Rhode Island Breast Cancer Coalition 

Katherine Silberman, J.D. 

Science & Environmental Health Network 

Julia Brody, Ph.D. 

Silent Spring Institute 

Rebecca Gasior Altman, Ph.D. 

Tufts University 

308
Maricel Maffini, Ph.D. 

Tufts University School of Medicine 

Cynthia Zembo, B.S.N., R.N., I.B.C.L.C. 

United States Breastfeeding Committee 

Christie Lancaster, M.D. 

University of Michigan 

Julia McQuillan, Ph.D. 

University of Nebraska-Lincoln 

William Burlingham, Ph.D. 

University of Wisconsin 

Francois Luks, M.D., Ph.D. 

The Warren Alpert Medical School of Brown University 

Sarah D. Fox, M.D. 

The Warren Alpert Medical School of Brown University 

NORTHWESTERN UNIVERSITY SCHOOL OF MEDICINE 

CHICAGO, ILLINOIS 

OCTOBER 14, 2009 

Kristian Hurley 

American Autoimmune Related Diseases Association (AARDA) 

Lydia Buki, Ph.D. 

American Psychological Association 

Dee Fenner, M.D. 

American Urogynecologic Society 

Nicole Perez, M.A. 

Amigas Latinas 

Emily Godfrey, M.D., M.P.H. 

Association of Reproductive Health Professionals (ARHP) 

Simone Koehlinger, Psy.D. 

Chicago Department of Public Health 

Pamela McCann, M.S. 

Chicago Department of Public Health 

309
Carolyn Stern, M.D. 

DeafDOC.org 

Susan Love, M.D., M.B.A., FACS 

Dr. Susan Love Research Foundation/Army of Women 

Naomi Lynn Gerber, M.D. 

George Mason University 

Amber Hollibaugh 

Howard Brown Health Center 

Jennifer McGuire, M.S., R.D. 

National Fisheries Institute 

Pauline Maki, M.D. 

North American Menopause Society (NAMS) 

Riley D. Johnson, M.A. 

Queer People’s Health Collective 

Colleen M. Fitzgerald, M.D. 

Rehabilitation Institute of Chicago 

Elizabeth Kissling, Ph.D. 

Society for Menstrual Cycle Research 

Annabelle S. Volgman, M.D., FACC 

WomenHeart: The National Coalition for Women with Heart Disease 

Lisa Martinez, J.D., R.N. 

The Women’s Sexual Health Foundation 

Kathie Duprey 

Self 

EMORY UNIVERSITY SCHOOL OF MEDICINE 

ATLANTA, GEORGIA 

FEBRUARY 16, 2010 

Yuling Hong, M.D., Ph.D, M.Sc. 

Centers for Disease Control and Prevention 

Frances Henderson, Ed.D., R.N. 

Jackson Heart Study 

Sharonne Hayes, M.D. 

Mayo Clinic and Foundation 

310
Diana Bitner, M.D. 

Michigan State University College of Human Medicine 

Elvan Catherine Daniels, M.D., M.P.H. 

Morehouse School of Medicine 

Virginia Miller, Ph.D. 

Organization for the Study of Sex Difference 

E. Clinton Lawrence, M.D. 

Pulmonary Hypertension Association 

Mary Blades 

Scleroderma Foundation 

Viviana Simon 

Society for Women’s Health Research 

Jay Kaplan, Ph.D. 

Wake Forest University School of Medicine 

Lisa M. Tate 

WomenHeart: The National Coalition for Women with Heart Disease 

311
APPENDIX B:
�

Participants in Regional Meetings
�

ST. LOUIS, MISSOURI 

MARCH 4–6, 2009 

PARTICIPANTS 

Elie D. Al-Chaer, Ph.D., J.D., M.S. 

Professor 

University of Arkansas for Medical Sciences 

Little Rock, Arkansas 

D. Craig Allred, M.D. 

Professor, Director of Breast Pathology 

Washington University School of Medicine/ 

Barnes-Jewish Hospital 

St. Louis, Missouri 

Jenifer Allsworth, Ph.D. 

Assistant Professor 

Washington University 

St. Louis, Missouri 

Shilpa H. Amin, M.D., M.B.Sc., FAAFP 

Medical Officer, Geriatrics and Women’s 

Health 

Agency for Healthcare and Research Quality 

Rockville, Maryland 

Beau Ances, M.D., Ph.D. 

Assistant Professor 

Washington University in St. Louis 

St. Louis, Missouri 

Lauren Anderson 

Medical Student/Writer 

Washington University 

St. Louis, Missouri 

Lauren Arnold, Ph.D., M.P.H. 

Postdoctoral Research Associate 

and Lecturer 

Departments of Surgery and Anthropology 

Washington University in St. Louis 

St. Louis, Missouri 

Raul Artal, M.D. 

Professor and Chair OB/GYN 

Department of OB/GYN and Women’s Health 

St. Louis University School of Medicine 

St. Louis, Missouri 

Christy Auston, M.A. 

Manager, Full Board Review 

Human Research Protection Office 

Washington University 

St. Louis, Missouri 

Sue Baebler 

President Emeritus 

St. Louis Breast Cancer Coalition 

St. Louis, Missouri 

Paula Ballew, M.Ed. 

Research Manager 

Washington University, George Warren 

School of Social Work, Institute of Public 

St. Louis, Missouri 

Thomas J. Baranski, M.D., Ph.D. 

Associate Professor 

Endocrinology 

Washington University 

St. Louis, Missouri 

Ana Baumann, Ph.D. 

Washington University in St. Louis 

Center for Latino Family Research 

St. Louis, Missouri 

Jill B. Becker, Ph.D. 

Professor of Psychology and Psychiatry 

Molecular and Behavioral Neuroscience 

Institute 

University of Michigan 

Ann Arbor, Michigan 

312
Lisa Begg, Dr.P.H., R.N. 

Director, Research Programs 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Gary G. Bennett, Ph.D. 

Associate Professor 

Duke University 

Durham, North Carolina 

David Berg 

Writer 

Kirkwood, Missouri 

Douglas E. Berg, Ph.D. 

Professor 

Department Molecular Microbiology 

Washington University Medical School 

St. Louis, Missouri 

Karen J. Berkley, Ph.D. 

Professor 

Florida State University 

Tallahassee, Florida 

Stephen M. Beverley, Ph.D. 

Professor & Head of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Teresa L. Bieg, M.B.A., B.S.N., R.N. 

Manager, Division of Clinical Research 

OB/GYN 

Washington University 

St. Louis, Missouri 

Ellen F. Binder, M.D. 

Associate Professor of Medicine 

Division of Geriatrics and Nutritional 

Sciences 

Washington University School of Medicine 

St. Louis, Missouri 

Stanley J. Birge, M.D. 

Associate Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Mary Blades 

President 

Scleroderma Foundation Missouri Chapter 

Springfield, Missouri 

Robert Blaine 

Medical Public Policy Specialist 

Washington University in St. Louis 

St. Louis, Missouri 

Lorry Blath 

Research Advocate; Board Member 

Secondary Scientific Writer 

St. Louis Komen Affiliate St. Louis Breast 

Cancer 

St. Louis, Missouri 

Samantha J. Books 

Special Assistant to the Directors 

Institute for Public Health 

Washington University 

St. Louis, Missouri 

Coco Bopp 

Research Coordinator 

Washington University in St. Louis 

St. Louis, Missouri 

Chas Bountra, Ph.D. 

Chief Scientist 

Structural Genomics Consortium 

Oxford, England 

Mikki C. Brewster, M.S.W. 

Board Member 

Komen for The Cure St. Louis Affiliate 

St. Louis, Missouri 

Carolyn B. Britton, M.D. 

President 

National Medical Association 

Washington, District of Columbia 

Jeanette Brown, M.D. 

Professor 

University of California, San Francisco 

San Francisco, California 

313
Victoria Brown-Kennerly, Ph.D. 

Instructor 

Department of Genetics, Center for Genome 

Washington University School of Medicine 

St. Louis, Missouri 

Linda Brubaker, M.D., M.S. 

Assistant Dean of Clinical and Translational Research 

Professor, Departments of Obstetrics/ 

Gynecology and Urology 

Loyola University Medical Center 

Maywood, Illinois 

Edward L. Bryant 

Director of Public Affairs 

Pfizer Inc. 

Chesterfield, Missouri 

Michael Caparon 

Professor of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Marilyn E. Carroll, Ph.D. 

Professor of Psychiatry and Neuroscience 

Department of Psychiatry 

University of Minnesota 

Minneapolis, Minnesota 

Yvette Carter, M.D. 

Cardiothoracic Surgery Research Fellow 

Dept of Surgery; Cardiothoracic Surgery 

Washington University in St. Louis 

St. Louis, Missouri 

Courtney Ann Caruso 

Washington University in St. Louis 

St. Louis, Missouri 

Gail H. Cassell, Ph.D. 

V.P., Scientific Affairs and Distinguished Lilly 

Research Scholar for Infectious Diseases 

Eli Lilly and Company 

Indianapolis, Indiana 

Rosemary B. Catanzaro, M.S., R.D. 

Department of Obstetrics, Gynecology, 

and Women’s Health 

St. Louis University 

St. Louis, Missouri 

Stephanie Chalifour 

Research Assistant 

St. Louis, Missouri 

Kaveri Chaturvedi 

Graduate Student 

Biochemistry 

St. Louis, Missouri 

Mark Chavez, Ph.D. 

Associate Director for Research Training 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

Swaine Chen, M.D., Ph.D. 

Instructor 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Weijen Chua 

Graduate Student (Ph.D.) 

Washington University in St. Louis 

St. Louis, Missouri 

Sherry Claxton 

Clinical Researcher 

Washington University in St. Louis 

St. Louis, Missouri 

Janine Austin Clayton, M.D. 

Deputy Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Graham A. Colditz, M.D., Dr.P.H. 

Niess-Gain Professor of Surgery 

Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Carol Conway-Long, M.S.N., CIP 

Biomedical Expedited Review Manager 

Human Research Protection Office 

Washington University School of Medicine 

St. Louis, Missouri 

314
Amber R. Cooper, M.D. 

Fellow, and K30 Postdoctoral Scholar 

Division of Reproductive Endocrinology 

and Infertility 

Washington University 

St. Louis, Missouri 

Leslie J. Crofford, M.D. 

Professor of Internal Medicine 

Chief, Division of Rheumatology 

University of Kentucky 

Lexington, Kentucky 

Lillian Cruz-Orengo 

Postdoctoral Research Associate 

Infectious Diseases 

Washington University School of Medicine 

St. Louis, Missouri 

Jaqueline Cunkelman, M.D., M.P.H. 

Washington University in St. Louis 

St. Louis, Missouri 

Corinne Cusumano 

Graduate Student 

Washington University 

St. Louis, Missouri 

Margot S. Damaser, Ph.D. 

Associate Professor 

Department of Biomedical Engineering 

Cleveland Clinic Lerner College of Medicine 

Cleveland, Ohio 

Tina Darling 

Associate Director 

Indiana University School of Medicine 

IU National Center of Excellence in 

Women’ s Health 

Indianapolis, Indiana 

Nupur Dasgupta 

Staff Scientist 

Washington University Medical School 

St. Louis, Missouri 

Catherine C. Davis, Ph.D. 

Principal Scientist 

The Procter & Gamble Company 

Cincinnati, Ohio 

Geert J. de Vries, Ph.D. 

Professor 

University of Massachusetts 

Amherst, Massachusetts 

Carolyn Deal, Ph.D. 

Branch Chief 

Sexually Transmitted Disease Branch 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Rochelle Dean, M.S.W., M.E.D. 

FIMR Manager 

Maternal, Child & Family Health Coalition 

St. Louis, Missouri 

Kimberly A. Delli-Zotti 

Washington University School of Medicine 

St. Louis, Missouri 

K. Deschryver, M.D. 

Washington University in St. Louis 

St. Louis, Missouri 

Nancy L. Desmond, Ph.D. 

Associate Division Director 

Division of Neuroscience and Basic 

Behavioral Science 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

Elizabeth Dodson, Ph.D., M.P.H. 

Research Assistant Professor 

Washington University in St. Louis 

George Warren Brown School of Social Work 

St. Louis, Missouri 

Karen W. Dodson, Ph.D. 

Instructor 

Washington University 

St. Louis, Missouri 

Tamara Doering 

Associate Professor 

Washington University Medical School 

St. Louis, Missouri 

315
Kaaren J. Downey 

Assistant Director, Research Office 

Washington University 

St. Louis, Missouri 

Mariah Dreisinger, M.P.H. 

Program Manager 

Prevention Research Center 

Washington University in St. Louis 

St. Louis, Missouri 

Katie Duggan, M.P.H., M.S. 

Manager 

Prevention Research Center 

Washington University 

St. Louis, Missouri 

Wm. Michael Dunne, Ph.D. 

Professor of Pathology and Immunology, 

Molecular Microbiology, and Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Marie G. Dyak 

Entertainment Industries Council, Inc. 

Reston, Virginia 

Anna Eccher 

Dosimetry QA Specialist 1 

Washington University 

St. Louis, Missouri 

Jennifer Stine Elam, Ph.D. 

Managing Director 

Center for Women’s Infectious Disease 

Research 

Washington University 

St. Louis, Missouri 

Evelyn A. Ellis 

EMG-Tech 

Washington University Medical School 

St. Louis, Missouri 

C. Neill Epperson, M.D. 

Associate Professor of Psychiatry & OB/GYN 

Yale University School of Medicine 

New Haven, Connecticut 

Amy Eyler, Ph.D. 

Associate Research Professor 

Institute of Public Health 

Washington University in St. Louis 

St. Louis, Missouri 

Tekeda Freeman Ferguson, Ph.D. 

Professor 

St. Louis University 

St. Louis, Missouri 

Brian Finck, Ph.D. 

Center for Human Nutrition 

Washington University School of Medicine 

St. Louis, Missouri 

Anne F. Fish, Ph.D., R.N. 

Associate Professor of Nursing 

College of Nursing 

University of Missouri-St. Louis 

St. Louis, Missouri 

Susan M. Fitzpatrick, Ph.D. 

Vice President 

James S. McDonnell Foundation 

St. Louis, Missouri 

Patty M. Flynn, B.S.N., R.N. 

Research Coordinator Psychology 

Department of Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

Patricia J. Fogertey, R.N., M.S.N. 

Clinical Research Nurse Coordinator 

Department of OB/GYN 

Washington University School of Medicine 

St. Louis, Missouri 

Bradley Ford, M.D., Ph.D. 

Medical Resident 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Morgan A. Ford, M.S. 

Program Officer 

Institute of Medicine 

The National Academies 

Washington, District of Columbia 

316
Larry Forney, Ph.D. 

Professor 

Initiative for Bioinformatics and 

Evolutionary Studies 

University of Idaho 

Moscow, Idaho 

Deborah J. Frank, Ph.D. 

Research Scientist 

Washington University 

St. Louis, Missouri 

Victoria J. Fraser, M.D. 

J. William Campbell Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

David Fredricks, M.D. 

Associate Professor 

University of Washington 

Fred Hutchinson Cancer Research Center 

Seattle, Washington 

Alberto Friedmann 

Exercise Physiologist 

Washington University School of Medicine 

St. Louis, Missouri 

Keith S. Garcia, M.D., Ph.D. 

Assistant Professor in Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

Jeffrey A. Gavard, Ph.D. 

Research Assistant Professor 

St. Louis University School of Medicine 

St. Louis, Missouri 

Anne M. Gaynor 

Graduate Student 

Department of Microbiology 

Washington University 

St. Louis, Missouri 

Alison F. Gee 

V.P. Public Policy 

Planned Parenthood of the St. Louis Region 

St. Louis, Missouri 

Rebekah E. Gee, M.D., M.P.H., FACOG 

Robert Wood Johnson Clinical Scholar 

University of Pennsylvania 

Washington, District of Columbia 

Robert W. Gereau, Ph.D. 

Professor 

Department of Anesthesiology 

Washington University School of Medicine 

St. Louis, Missouri 

Nupur Ghoshal, M.D., Ph.D. 

ADRC Fellow 

Department of Neurology 

Washington University 

St. Louis, Missouri 

Paula M. Gianino 

CEO 

Planned Parenthood of the St. Louis Region 

and Southwest Missouri 

St. Louis, Missouri 

Maria Y. Giovanni, Ph.D. 

Assistant Director for Microbial Genomics 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Linda C. Giudice, M.D., Ph.D., M.Sc. 

Professor and Chair 

Department of OB/GYN & Reproductive 

Sciences 

University of California, San Francisco 

San Francisco, California 

Rae Marie Gleason 

Executive Director 

National Fibromyalgia Association 

Anaheim, California 

Anne L. Glowinski, M.D., M.P.E. 

Director of Education and Training 

Child and Adolescent Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

317
Jill M. Goldstein, Ph.D. 

Professor of Psychiatry, Director of Research 

for Women’s Health 

Harvard Medical School 

Brigham & Women’s Hospital 

Boston, Massachusetts 

Joi Goodbread 

Scleroderma Foundation, Missouri Chapter 

Board Member, Advocacy committee 

Advocacy Chairman for Missouri Chapter 

Missouri Chapter Board Member 

St. Louis, Missouri 

Barbara Gordon, M.B.A., R.D. 

Executive Director 

Interstitial Cystitis Association 

Rockville, Maryland 

Jeffrey Gordon, M.D. 

Professor and Director 

Center for Genome Sciences 

Washington University School of Medicine 

St. Louis, Missouri 

Scoie S. Green, M.P.H. 

Health Policy Analyst 

School of Social Work 

Washington University in St. Louis 

St. Louis, Missouri 

Sharon L. Green, M.H.A. 

Executive Director 

Northwestern University 

Institute for Women’s Health Research 

Chicago, Illinois 

Phyllis Greenberger, M.S.W. 

President and CEO 

Society for Women’s Health Research 

Washington, District of Columbia 

Shelly F. Greenfield, M.D., M.P.H. 

Associate Professor in Psychiatry,
�

Chief Academic Officer, Director Clinical and 

Health Services Research and Education 

Division on Alcohol and Drug Abuse 

McLean Hospital 

Harvard Medical School 

Belmont, Massachusetts 

Ann M. Gronowski, Ph.D. 

Associate Professor 

Washington University 

St. Louis, Missouri 

Christina A. Gurnett, M.D., Ph.D. 

Assistant Professor 

Division of Pediatric Neurology 

Washington University in St Louis 

St. Louis, Missouri 

Maria Hadjifrangiskou, Ph.D. 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Debra Haire-Joshu 

Professor 

George Warren Brown School of Social Work 

Associate Dean for Research 

Washington University School of Medicine 

St. Louis, Missouri 

Paula D. Hampton 

Secretary III 

Department of Obstetrics and Gynecology 

Washington University School of Medicine 

St. Louis, Missouri 

Diana M. Hankey Underwood, M.S., 

W.H.N.P.-BC 

Executive Director 

Grace Anatomy, Inc. 

Huntsville, Alabama 

Melanie A. Hansmann 

The Procter & Gamble Company 

Cincinnati, Ohio 

Ann Harbert 

Temp. Health Policy Analyst 

Washington University in St. Louis 

St. Louis, Missouri 

Diane M. Harper, M.D., M.P.H., M.S. 

Professor 

Truman Medical Center Lakewood 

University of Missouri-Kansas City 

Kansas City, Missouri 

318
Ericka V. Hayes, M.D. 

Co-Medical Director, Washington University 

Pediatric HIV Program 

St. Louis Children’s Hospital 

Washington University School of Medicine 

St. Louis, Missouri 

Ellen Heislen 

Kekwood, Missouri 

Jeffrey P. Henderson, M.D., Ph.D. 

Instructor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Joyce Herman, B.S.N., M.Ed. 

Research Advocate Susan G. Komen 

Millstadt, Illinois 

Tamara Hershey, Ph.D. 

Associate Professor 

Psychiatry Department 

Washington University School of Medicine 

St. Louis, Missouri 

Jody K. Hirsh, Ph.D. 

Clinical Research Associate 

Division of Endocrinology 

Northwestern University 

Chicago, Illinois 

Christine Hoehner 

Assistant Professor 

Washington University School of Medicine 

St. Louis, Missouri 

Kristi Holmes, Ph.D. 

Bioinformaticist 

Washington University School of Medicine 

St. Louis, Missouri 

Thomas M. Hooton, M.D. 

Associate Dean and Professor 

Institute for Women’s Health 

University of Miami Miller School of Medicine 

Miami, Florida 

Dixie D. Horning 

Executive Director 

University of California 

UCSF National Center of Excellence in 

Women’s Health 

San Francisco, California 

Dennis Hourcade, Ph.D. 

Research Associate Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Scott Hultgren, Ph.D. 

Helen L. Stoever Professor of Molecular 

Microbiology 

Department of Molecular Microbiology 

Washington University 

St. Louis, Missouri 

Chia Hung, Ph.D. 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

David A. Hunstad, M.D. 

Assistant Professor 

Washington University 

St. Louis, Missouri 

Devyani Hunt, M.D. 

Assistant Professor of Physical Medicine 

and Rehabilitation 

Department of Orthopaedic Surgery 

Washington University School of Medicine 

St. Louis, Missouri 

Pamela Jackson, R.N., B.S.N, M.A. 

Research Instructor 

Washington University- Neurology 

St. Louis, Missouri 

Julie A. Jacobs 

Graduate Research Assistant 

Prevention Research Center in St. Louis 

St. Louis, Missouri 

Raksha Jain, M.D. 

Washington University 

St. Louis, Missouri 

319
Donna B. Jeffe, Ph.D. 

Research Associate Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Carlotta Jethroe 

EM6 Tech 

Neurology 

Washington University in St. Louis 

St. Louis, Missouri 

Carol Jin 

Statistic Data Analyst 

Washington University Medical School 

St. Louis, Missouri 

Sharon Johnson 

Associate Professor 

School of Social Work 

University of Missouri-St. Louis 

St. Louis, Missouri 

Michelle M. Jung 

Medical Student 

Washington University School of Medicine 

St. Louis, Missouri 

Emily S. Jungheim, M.D. 

Instructor 

Washington University in St. Louis 

St. Louis, Missouri 

Leslie E. Kahl, M.D. 

Professor of Medicine 

Washington University 

St. Louis, Missouri 

Linda M. Kaste, D.D.S., M.S., Ph.D. 

Associate Professor 

College of Dentistry and School of Public 

Health 

University of Illinois at Chicago 

Chicago, Illinois 

Rosetta Keeton 

Patient Advocate 

St. Louis ConnectCare 

St. Louis, Missouri 

Kimberly S. Kenton, M.D., M.S., 

FACS, FACOG 

Associate Professor 

Associate Residency Program Director 

Pelvic Medicine & Reconstructive Surgery 

Loyola University Medical Center 

Maywood, Illinois 

Fareesa G. Khan, M.D. 

Assistant Professor 

Department of Obstetrics and Gynecology 

Washington University School of Medicine 

St. Louis, Missouri 

Karen Kharasch 

Business Director, Radiology 

Washington University in St. Louis 

St. Louis, Missouri 

Juhee Kim, Ph.D. 

Assistant Professor 

Department of Kinesiology and 

Community Health 

University of Illinois at Urbana-Champaign 

Champaign, Illinois 

Allison King, M.D., M.P.H. 

Assistant Professor 

Washington University School of Medicine 

St. Louis, Missouri 

Michael K. Klebert, Ph.D., R.N. 

Study Coordinator/ Research Instructor 

Washington University School of Medicine 

St. Louis, Missouri 

Samuel Klein, M.D. 

Director, Center for Human Nutrition 

Chief, Division of Geriatrics and 

Nutritional Science 

Washington University School of Medicine 

St. Louis, Missouri 

Kristen Kling, Ph.D. 

Research Scientist 

Washington University 

St. Louis, Missouri 

320
Kathy Kniepmann, O.T.D, M.P.H., 

Ed.M., O.T.R./L 

Instructor of Occupational Therapy and 

Neurology 

Washington University in St. Louis 

St. Louis, Missouri 

Mary Koenig, R.N. 

Research Nurse Coordinator 

Washington University in St. Louis 

St. Louis, Missouri 

Robert H. Koff, Ph.D. 

Professor, Assistant Vice Chancellor 

Director, Center for Advanced Learning 

Washington University 

St. Louis, Missouri 

Mary M. Kogut, M.B.A. 

Vice President of Patient Services 

Planned Parenthood of the St. Louis Region 

St. Louis, Missouri 

Susan G. Kornstein, M.D. 

Professor of Psychiatry and Obstetrics/ 

Gynecology 

Executive Director, Institute 

Virginia Commonwealth University 

Richmond, Virginia 

Jukka Korpela, M.D., Ph.D. 

Program Medical Officer 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Maria Kostakioti, Ph.D. 

Department of Molecular Biology 

Washington University School of Medicine 

St. Louis, Missouri 

Elizabeth A. Kostas-Polston, Ph.D., 

W.H.N.P.-BC 

Assistant Professor of Nursing 

Women’s Health Nurse Practitioner 

St. Louis University School of Nursing 

St. Louis, Missouri 

Joslyn Y. Kravitz, Ph.D. 

AAAS Science & Technology Policy Fellow 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Pamela K. Kreeger, Ph.D. 

Assistant Professor 

Department of Biomedical Engineering 

University of Wisconsin-Madison 

Madison, Wisconsin 

Linda L. Kusner, Ph.D. 

Assistant Professor of Ophthalmology 

St. Louis University 

St. Louis, Missouri 

Erin Laciny 

Clinical Research Coordinator 

Washington University School of Medicine 

St. Louis, Missouri 

Eve M. Lackritz, M.D. 

Division of Reproductive Health 

Centers for Disease Control and Prevention 

Atlanta, Georgia 

Virginia Ladd 

President 

Autoimmune Diseases Association 

Clinton Township, Michigan 

Linda A. Landon, Ph.D. 

President 

Research Communiqué 

Jefferson City, Missouri 

Christy Lapka, M.S., R.D. 

Research Coordinator 

Center for Obesity Prevention and Policy 

Research Work 

Washington University in St. Louis 

St. Louis, Missouri 

Missy D. Lavender, M.B.A. 

Executive Director 

Women’s Health Foundation 

Chicago, Illinois 

321
Phoebe S. Leboy, Ph.D. 

President, Association for Women in Science 

University of Pennsylvania 

Narberth, Pennsylvania 

William J. Ledger, M.D. 

Professor Ob-Gyn 

Weill Medical College of Cornell University. 

New York, New York 

Chang Lee 

Vice President, Clinical and Medical Affairs 

KV Pharmaceutical 

St. Louis, Missouri 

Julio Leey, M.D. 

Endocrinology Fellow 

Washington University in St. Louis 

St. Louis, Missouri 

Barbara Leighton, M.D. 

Chief, Section of Obstetric Anesthesiology 

Washington University in St. Louis 

St. Louis, Missouri 

Deborah J. Lenschow, M.D., Ph.D. 

Assistant Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Christina Lessov-Schlaggar, Ph.D. 

Research Instructor 

Psychiatry 

Washington University in St. Louis 

St. Louis, Missouri 

Tamara E. Lewis Johnson, M.B.A., M.P.H. 

Women’s Health Program Manager 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Kim L. Lipsey 

Reference Librarian 

Washington University-Becker Medical 

Library 

St. Louis, Missouri 

Jennifer K. Lodge, Ph.D. 

Associate Dean for Research 

Washington University School of Medicine 

St. Louis, Missouri 

Erica D. Louden, Ph.D. 

Post-Doctor 

OB/GYN 

Washington University School of Medicine 

St. Louis, Missouri 

Jennifer Loughman, Ph.D. 

Postdoctoral Research Associate 

Department of Pediatrics 

Washington University School of Medicine 

St. Louis, Missouri 

Melissa Lowe 

St. Louis, Missouri 

Jillian Lucas 

Coordinator, Post Graduate Affairs 

Washington University School of Medicine 

St. Louis, Missouri 

Barbara S. Lynch, Ph.D. 

Lead Science Writer 

BSL Writing Services 

Durango, Colorado 

Nancy Ryan Macklin, Ph.D., R.N. 

Professor Emeritus of Nursing 

Maryville University St. Louis 

Belleville, Illinois 

Mary B. Mahowald, Ph.D. 

Professor 

University of Chicago 

Chicago, Illinois 

Kara Mandell 

Research Analyst 

National Association of State Alcohol and 

Drug Abuse Directors, Inc 

Washington, District of Columbia 

Linda W. Manning, Pharm.D. 

Section Head 

Procter & Gamble 

Cincinnati, Ohio 

322
Donna M. Marin, R.N. 

Bariatric Coordinator 

Department of Surgery 

Washington University School of Medicine 

St. Louis, Missouri 

Saralyn Mark, M.D. 

President SolaMed Solutions, LLC 

Sr. Medical Advisor NASA 

National Aeronautics and Space 

Administration 

Washington, District of Columbia 

Lynne Matallana, M.A. 

President 

National Fibromyalgia Association 

Anaheim, California 

Emeran A. Mayer, M.D. 

Director 

UCLA Center for Neurobiology of Stress 

Los Angeles, California 

John D. Mayfield, Ph.D. 

Postdoctoral Research Scholar 

Washington University School of Medicine 

St. Louis, Missouri 

Timothy D. McBride, Ph.D. 

Associate Dean for Public Health 

George Warren Brown School of Social Work 

Washington University 

St. Louis, Missouri 

Denise A. McCartney 

Associate Vice Chancellor for Research 

Administration 

Washington University 

St. Louis, Missouri 

Colleen McKee, M.F.A. 

Lecturer 

University of Missouri St. Louis 

St. Louis, Missouri 

Suzanne S. Medgyesi-Mitschang, Ph.D. 

Strategic Planner 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Susan Meikle, M.D. M.S.P.H. 

Program director, Pelvic Floor Disorders 

Eunice Kennedy Shriver National Institute 

of Child Health and Development 

National Institutes of Health 

Bethesda, Maryland 

Alexander Y. Mitrophanov, Ph.D. 

Postdoctoral Associate 

Howard Hughes Medical Institute 

Washington University School of Medicine 

St. Louis, Missouri 

Bettina Mittendorfer, Ph.D. 

Center for Human Nutrition 

Washington University School of Medicine 

St. Louis, Missouri 

Stephen M. Moerlein, Pharm.D., Ph.D. 

Associate Professor 

Mallinckrodt Institute of Radiology 

Washington University 

St. Louis, Missouri 

Robert M. Moldwin, M.D. 

Associate Professor of Clinical Urology 

The Arthur Smith Institute for Urology 

Hofstra University School of Medicine 

New Hyde Park, New York 

Kelle Moley, M.D. 

Department of Obstetrics and Gynecology 

Washington University School of Medicine 

St. Louis, Missouri 

Judy Monroe, M.D. 

State Health Commissioner 

Indiana State Department of Health 

Indianapolis, Indiana 

Valerie C. Montgomery Rice, M.D. 

Sr. V.P. for Health Affairs, Dean, School 

of Medicine 

Meharry Medical College 

Nashville, Tennessee 

Elizabeth R. Mueller, M.D., FACS 

Assistant Professor 

Loyola University Medical Center 

Maywood, Illinois 

323
Chris Mullins, Ph.D. 

Director of Basic Cell Biology 

National Institute of Diabetes and 

Digestive and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

Nathaniel H. Murdock, M.D. 

Obstetrician-Gynecologist 

Washington University 

St. Louis, Missouri 

Sandra Murdock, M.A. 

Health Science Educator 

Missouri State Medical Alliance 

St. Louis Metropolitan Medical Society 

Alliance 

St. Louis, Missouri 

Carol A. Murray 

Senior Librarian 

Becker Medical Library 

Washington University Medical School 

St. Louis, Missouri 

Indira U. Mysorekar, Ph.D. 

Assistant Professor 

Department of Obstetrics and Gynecology 

Washington University School of Medicine 

St. Louis, Missouri 

Fatiha Nassir, Ph.D. 

Research Assistant Professor in Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

D. Michael Nelson, M.D., Ph.D. 

Virginia S. Lang Professor of Obstetrics and 

Gynecology 

Washington University School of Medicine 

St. Louis, Missouri 

Ashley A. Nenninger, Ph.D. 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Stacey G. Newman 

Executive Director 

Missouri Women’s Coalition 

St. Louis, Missouri 

Tracy Nicholson 

Ph.D. Student 

Washington University 

St. Louis, Missouri 

Ginger E. Nicol, M.D. 

Instructor of Clinical Psychiatry (Child) 

Department of Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

Nancy Nielsen, M.D., Ph.D. 

President 

American Medical Association 

Chicago, Illinois 

Donna Nonnenkamp 

Technology Coordinator 

Washington University 

St. Louis, Missouri 

Mary O’Brien Uhlmansiek, M.A. 

IRB Review Analyst 

School of Medicine 

Washington University 

St. Louis, Missouri 

Mary Beth O’Connell, Pharm.D. 

Associate Professor, Wayne State University 

Eugene Applebaum College of Pharmacy 

& Health Sciences 

Detroit, Michigan 

Anthony Odibo, M.D. 

Washington University in St. Louis 

St. Louis, Missouri 

Catina O’Leary, Ph.D., M.S.W. 

Research Instructor 

Epidemiology and Prevention Research 

Group 

Washington University School of Medicine 

St. Louis, Missouri 

Kathleen M. O’Leary, M.S.W. 

Acting Chief, Women’s Program 

National Institute of Mental Health 

National Institutes of Health 

Bethesda, Maryland 

324
Margaret A. Olsen, Ph.D., M.P.H. 

Research Asst Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Andrew Onderdonk, Ph.D. 

Professor of Pathology 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Thomas W. Osborn, Ph.D. 

Research Fellow, Victor Mills Society 

The Procter & Gamble 

Cincinnati, Ohio 

Joe Palermo, M.D., Ph.D. 

Instructor 

Gastroenterology - Pediatrics 

Washington University 

St. Louis Childrens Hospital 

St. Louis, Missouri 

Ameeta Parekh, Ph.D. 

Director, R & D Program 

Office of Women’s Health 

Food and Drug Administration 

Rockville, Maryland 

Estella Parrott, M.D., M.P.H. 

Medical Officer 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Michael Pasque, M.D. 

Professor of Surgery 

Washington University School of Medicine 

St. Louis, Missouri 

Jeffrey F. Peipert, M.D., Ph.D. 

Vice Chair of Clinical Research 

Washington University School of Medicine 

St. Louis, Missouri 

Ligia Peralta, M.D. 

Chief Division Adolescent and Young Adult 

Medicine 

University of Maryland School of Medicine 

Baltimore, Maryland 

Linda R. Peterson, M.D. 

Associate Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Susan G. Pfefferle, Ph.D. 

Research Associate 

Washington University in St. Louis 

George Warren Brown School of Social Work 

St. Louis, Missouri 

Mary Pfenning, R.N., M.S.N. 

Spirit of Women Coordinator 

St. Luke’s Hospital 

Chesterfield, Missouri 

Maureen Phipps, M.D., M.P.H. 

Associate Professor of Obstetrics & 

Gynecology and Community Health 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Katherine J. Pierce, Ph.D. 

Research Statistician 

Department of Psychiatry 

Washington University 

St. Louis, Missouri 

Jerry S. Pinkner, M.S. 

Research Lab Manager 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Sarah J. Pinkner 

Research Lab Technician 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Vivian W. Pinn, M.D. 

Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Amelia Pinto 

Postdoctoral Fellow 

Washington University School of Medicine 

St. Louis, Missouri 

325
Linda L. Porter, Ph.D. 

Program Director 

National Institute of Neurological Disorders 

and Stroke 

National Institutes of Health 

Rockville, Maryland 

Jessica Portillo, M.D. 

St. Louis, Missouri 

Heidi Prather, D.O. 

Associate Professor of Physical Medicine and 

Rehabilitation 

Department of Orthopaedic Surgery 

Washington University School of Medicine 

St. Louis, Missouri 

Charlotte A. Pratt, Ph.D., R.D. 

Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Patrice L. Pye, Ph.D. 

Clinical Psychologist 

Women Veterans Health Clinic 

Veterans Administration Medical Center 

St. Louis, Missouri 

Susan B. Racette, Ph.D. 

Assistant Professor 

Washington University School of Medicine 

St. Louis, Missouri 

Janet S. Rader, M.D. 

Professor 

Washington University 

St. Louis, Missouri 

Jacques Ravel, Ph.D. 

Associate Professor 

University of Maryland School of Medicine 

Institute for Genome Sciences 

Baltimore, Maryland 

Uma M. Reddy, M.D., M.P.H. 

Medical Officer 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

David Relman, M.D. 

Professor of Medicine, and of Microbiology & 

Immunology 

Stanford University 

Palo Alto, California 

Leslie M. Rickey, M.D., M.P.H. 

Assistant Professor of Surgery 

University of Maryland Medical Center 

Baltimore, Maryland 

Joan Riley, Ph.D. 

Instructor 

Washington University School of Medicine 

Department of Obstetrics and Gynecology 

St. Louis, Missouri 

Catherine M. Roe, Ph.D. 

Research Instructor 

Washington University School of Medicine 

Alzheimer’s Disease Research Center & 

Department of Neurology 

St. Louis, Missouri 

Lynne H. Roney 

Past President 

American Association of University Women 

of Missouri 

Clayton, Missouri 

David Aaron Rosen, M.D. 

Ph.D. Student 

Washington University 

St. Louis, Missouri 

Diane Rubaii 

Caregiver 

St. Louis, Missouri 

Craig Rubens, M.D., Ph.D. 

Executive Director, Global Alliance to Prevent 

Prematurity & Stillbirth 

Seattle Childrens/University of Washington 

Seattle, Washington 

Joyce Rudick 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

326
Melissa Runtch 

Chief, Health Promotion Services 

Washington University in St. Louis 

St. Louis, Missouri 

Vetta L. Sanders Thompson, M.A., Ph.D. 

Associate Professor 

GWB, Institute of Public Health 

Washington University in St. Louis 

St. Louis, Missouri 

Anna E. Santiago, R.N. 

Clinical Studies Research Coordinator 

Washington University 

St. Louis, Missouri 

Carolyn Sargent, Ph.D. 

Professor 

Women, Gender & Sexuality Studies Program 

Washington University 

St. Louis, Missouri 

Gloria E. Sarto, M.D., Ph.D. 

Co-Director 

School of Medicine and Public Health 

Center for Women’s Health Research 

University of Wisconsin 

Madison, Wisconsin 

Samantha Savarese 

Washington University in St. Louis 

St. Louis, Missouri 

Susan Scalise 

Fenton, Missouri 

Susan P. Scanlan 

President, Women’s Research & Education 

Institute 

National Council of Women’s Organizations 

Washington, District of Columbia 

Walter Schaffer, Ph.D. 

Senior Scientific Advisor for Extramural 

Research 

Office of Extramural Research 

National Institutes of Health 

Bethesda, Maryland 

Samantha K. Schlesinger 

Manager, Research Education and 

Information 

Washington University in St. Louis 

St. Louis, Missouri 

David Schneider, M.D., M.S.P.H. 

Professor and Chairman of Family and 

Community Medicine 

St. Louis University School of Medicine 

St. Louis, Missouri 

Todd J. Schwedt, M.D. 

Assistant Professor 

Washington University School of Medicine 

St. Louis, Missouri 

Terry Seaton, Pharm.D. 

Assistant Dean for Research 

St. Louis College of Pharmacy 

St. Louis, Missouri 

Clay F. Semenkovich, M.D. 

Professor 

Washington University 

St. Louis, Missouri 

Enbal Shacham, Ph.D. 

Research Instructor 

Department of Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

Audrey Sheppard 

Women’s Health Consultant 

Chevy Chase, Maryland 

Melanie Shouse 

President 

Healthy Eating and Living 

St. Louis, Missouri 

Luciana M. Silva, Ph.D. 

Department of Molecular Microbiology 

Washington University School of Medicine 

St. Louis, Missouri 

Cheryl A. Singsank 

Health Educator 

Belleville, Illinois 

327
Rajita Sinha, Ph.D. 

Professor of Psychiatry 

Director, Yale Stress Center 

Yale University 

New Haven, Connecticut 

Meghan M. Sinton, Ph.D. 

Post Doctoral Research Scholar 

Department of Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

Eve E. Slater, M.D., FACC 

Senior Vice President-Worldwide Policy 

Pfizer, Inc 

New York, New York 

Jennifer Anne Sledge, M.S.W. 

Research Scientist 

Center for Research 

Barnes Jewish Hospital 

St. Louis, Missouri 

Pablo F. Soto, M.D. 

Assistant Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Theresa M. Spitznagle, D.P.T., M.H.S., P.T. 

Assistant Professor 

Program in Physical Therapy 

Washington University 

St. Louis, Missouri 

Mary N. St. Clair, L.C.S.W. 

Psychotherapist 

Creative Paths to Wholeness 

St. Louis, Missouri 

David M. Stamilio, M.D., M.S.C.E. 

Chief, Division of Maternal Fetal Medicine 

Washington University in St. Louis 

St. Louis, Missouri 

Samuel L. Stanley, Jr., M.D. 

Vice Chancellor for Research 

Washington University in St. Louis 

St. Louis, Missouri 

Susan Stark, Ph.D., O.T.R. 

Assistant Professor 

Washington University 

St. Louis, Missouri 

Julie A. Statzel, R.N., B.S.N. 

Lead Clinical Research Nurse Coordinator 

Washington University School of Medicine 

St. Louis, Missouri 

Rick Stein, Ph.D. 

Research Assistant Professor of Medicine 

Washington University School of Medicine 

St. Louis, Missouri 

Deborah Stine, M.P.P. 

WAVE, Inc. 

Wildwood, Missouri 

Gregory A. Storch, M.D. 

Professor of Pediatrics, Medicine, Molecular 

Microbiology 

Department of Pediatrics 

Washington University School of Medicine 

St. Louis, Missouri 

Gina M. Story, Ph.D. 

Assistant Professor 

Department of Anesthesiology 

Washington University Pain Center 

St. Louis, Missouri 

Ann M. Stowe, Ph.D. 

Fellow, Hope Center for Neurological 

Disorders 

Department of Neurosurgery 

Washington University School of Medicine 

St. Louis, Missouri 

Megan Straiko, Ph.D. 

Post Doctoral Research Fellow 

Washington University in St. Louis 

St. Louis, Missouri 

Priya Sudarsanam 

Senior Staff Scientist 

Center for Genome Sciences 

Washington University School of Medicine 

St. Louis, Missouri 

328
Vivian W. Sung, M.D., M.P.H. 

Assistant Professor 

Women and Infants Hospital of Rhode Island 

Warren Alpert Medical School at Brown 

University 

Providence, Rhode Island 

Dace Svikis, Ph.D. 

Deputy Director 

Virginia Commonwealth University 

Institute for Women’s Health 

Richmond, Virginia 

Elsa Taricone, M.P.H. 

Project Coordinator 

Washington University in St. Louis 

St. Louis, Missouri 

Phillip I. Tarr, M.D. 

Professor, Division Director 

Washington University School of Medicine 

Division of Pediatric Gastroenterology 

St. Louis, Missouri 

Kelly R. Theim, M.A. 

Student 

Department of Psychiatry 

Washington University in St. Louis 

St. Louis, Missouri 

Jill Thompson 

Education Manager 

Maternal, Child & Family Health Coalition 

St. Louis, Missouri 

Stuart A. Tobet, Ph.D. 

Professor 

Department of Biomedical Sciences 

Colorado State University 

Fort Collins, Colorado 

Ronald A. Tompkins, M.A., M.S., R.N. 

Chief Nursing Officer 

Nurses for Newborns Foundation 

St. Louis, Missouri 

Maria E. Trent, M.D., M.P.H. 

Assistant Professor 

Johns Hopkins Schools of Medicine & 

Public Health 

Baltimore, Maryland 

Bulganzaya Tumurbaatar 

Visiting Scholar 

Social Work 

St. Louis, Missouri 

Tommie Turner, Ph.D. 

Scientist 

The St. Louis Center for Inquiry in 

Science Teaching and Learning 

St. Louis, Missouri 

Nneka Ufere 

Medical Student 

Washington University School of Medicine 

St. Louis, Missouri 

Dorothy J. Van Buren, Ph.D. 

Research Assistant Professor 

Department of Psychiatry 

Washington University School of Medicine 

St. Louis, Missouri 

Anna L. Vannucci 

Washington University School of Medicine 

St. Louis, Missouri 

Sarah J. VanVickle-Chavez, Ph.D. 

Postdoctoral Research Associate/Instructor 

Department of Surgery 

Washington University School of Medicine 

St. Louis, Missouri 

Caroline Vemulapalli, M.S. 

Clinical Research Coordinator 

Washington University in St. Louis 

St. Louis, Missouri 

Joseph Vogel, Ph.D. 

Associate Professor 

Department of Molecular Microbiology 

Washington University 

St. Louis, Missouri 

Kelly Vogel 

Wildwood, Missouri 

Ender Volkan 

Graduate Student 

Hultgren Lab 

Washington University in St. Louis 

St. Louis, Missouri 

329
B. Timothy Walsh, M.D. 

Professor of Psychiatry 

Columbia University 

College of Physicians & Surgeons 

New York, New York 

Mary Ge Wang, L.Ac. 

Acupuncture Clinic 

Rockville, Maryland 

Sarah Ward, M.S. 

Researcher 

Washington University School of Medicine 

St. Louis, Missouri 

Barbara B. Warner, M.D. 

Associate Professor of Pediatrics 

Washington University in St Louis 

St. Louis, Missouri 

Val Weaver, Ph.D 

Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Lauren Weiss 

Washington University in St. Louis 

St. Louis, Missouri 

Anjanette A. Wells, Ph.D., M.S.W., L.C.S.W. 

Assistant Research Professor 

Washington University in St. Louis 

University City, Missouri 

Joni L. Westerhouse 

Executive Director for Medical 

Communications 

Washington University School of Medicine 

in St. Louis 

St. Louis, Missouri 

Cora Lee Wetherington, Ph.D. 

Women & Sex/Gender Differences Research 

Coordinator 

Behavioral & Cognitive Science Research 

Branch 

National Institute on Drug Abuse 

National Institutes of Health 

Rockville, Maryland 

Emily White, Ph.D. 

Study Coordinator 

Washington University 

St. Louis, Missouri 

Robert A. Wild, M.D., Ph.D., M.P.H. 

Professor Reproductive Endocrinology/ 

Epidemiology 

Oklahoma University Health Sciences Center 

Oklahoma City, Oklahoma 

Denise E. Wilfley, Ph.D. 

Professor
�

Departments of Psychiatry, Medicine, 

Pediatrics, & Psychology 

Washington University School of Medicine 

St. Louis, Missouri 

Consuelo Hopkins Wilkins, M.D. 

Director, CARE in Our Community 

Division of Geriatrics and Nutritional Science 

Washington University School of Medicine 

St. Louis, Missouri 

Monique M. Williams, M.D. 

Assistant Professor 

Washington University 

St. Louis, Missouri 

Saydra R. Wilson 

Writer 

St. Louis University 

Florissant, Missouri 

Kathleen Winters 

Washington, Missouri 

Kathleen Y. Wolin, Sc.D. 

Assistant Professor 

Department of Surgery & Siteman Cancer 

Center 

Washington University School of Medicine 

St. Louis, Missouri 

Nanette C. Wollfarth 

Chapter Coordinator 

Florida Director NAMA 

National Alliance of Methadone Advocates 

Bell, Florida 

330
Susan F. Wood, Ph.D. 

Research Professor 

The George Washington University School of 

Public Health 

Jacobs Institute of Women’s Health 

Washington, District of Columbia 

Nancy F. Woods, Ph.D., R.N., FAAN 

Professor 

University of Washington 

Seattle, Washington 

Mary Woolley 

President 

Research!America 

Alexandria, Virginia 

Fei Yang, Ph.D. 

Washington University in St. Louis 

St. Louis, Missouri 

Lian-Fai Yee, Ph.D. 

Postdoctoral Associate 

Washington University 

St. Louis, Missouri 

Esther B. Yoon, M.D., M.P.H. 

Occupational Therapy Student 

Washington University School of Medicine 

St. Louis, Missouri 

Gerald S. Zavorsky, Ph.D. 

Associate Professor 

Department OB/GYN 

St. Louis University 

St. Louis, Missouri 

Dequan Zhou, Ph.D. 

Washington University Nutritional Sciences 

St. Louis, Missouri 

Helen Zhu 

Assistant Professor 

St. Louis University School of Public Health 

St. Louis, Missouri 

SAN FRANCISCO, CALIFORNIA 

MAY 27–29, 2009 

PARTICIPANTS 

Nancy Adler, Ph.D. 

Professor 

University of California, San Francisco 

San Francisco, California 

Jennifer Aenast 

Graduate Student 

University of California, Davis 

Berkeley, California 

Amina Ahmed 

University of California, San Francisco 

San Francisco, California 

Brian K. Alldredge, Pharm.D. 

Professor & Associate Dean 

School of Pharmacy 

University of California, San Francisco 

San Francisco, California 

Kimberly Alvarenga 

District Director 

Assembly Member Tom Ammiano 

San Francisco, California 

Bradley E. Aouizerat, Ph.D., M.A.S. 

Associate Professor 

University of California, San Francisco 

San Francisco, California 

331
Elizabeth Arndorfer 

Consultant 

Reproductive Health Technologies Project 

Palo Alto, California 

Brian Auerbach 

Communications Coordinator 

National Center of Excellence in Women’s 

Health 

University of California, San Francisco 

San Francisco, California 

Francesca Aweeka, Pharm.D. 

Professor 

University of California, San Francisco 

San Francisco, California 

Jim Batterson 

Executive Director, Women’s Health 

Stanford University 

Palo Alto, California 

Amy E. Beddoe, Ph.D., R.N. 

Faculty 

Walden University 

Aptos, California 

Lisa Begg, Dr.P.H., R.N. 

Director of Research Programs 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Michelle Berlin, M.D., M.P.H. 

Vice Chair, OB/GYN & Associate Director 

Oregon Health & Science University 

Center for Women’s Health 

Portland, Oregon 

Kathleen Besinque, Pharm.D., M.S.Ed. 

Associate Professor of Clinical Pharmacy 

School of Pharmacy 

University of Southern California 

Los Angeles, California 

Yewoubdar Beyene, Ph.D. 

Associate Professor 

University of California, San Francisco 

San Francisco, California 

Kirsten Bibbins-Domingo, Ph.D., M.D., 

M.A.S. 

Assistant Professor 

Medicine and Epidemiology and Biostatistics 

University of California, San Francisco 

San Francisco, California 

Joyce Bichler, M.S.W., A.C.S.W. 

Deputy Director 

Breast Cancer Action 

San Francisco, California 

Elise Blaese, M.S., M.B.A. 

Business Development Executive 

IBM Research 

Rockville, Maryland 

Mary C. Blehar, Ph.D. 

Science Writer Consultant 

Office of Research on Women’s Health 

National Institutes of Health 

Potomac, Maryland 

Manfred Boehm, M.D. 

Investigator 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, Maryland 

Katharine A. Brady, M.D. 

University of California, San Francisco 

San Francisco, California 

Rebecca Braun, M.P.H. 

Program Manager 

California Family Health Council 

Berkeley, California 

Kama Brockmann, Ph.D. 

Policy and Program Coordinator 

Office of AIDS 

California Department of Public Health 

Sacramento, California 

Karen Butter 

University Librarian 

University of California, San Francisco 

San Francisco, California 

332
Carol L. Cannon, M.A. 

Associate Research Scientist 

Pacific Institute for Research and Evaluation 

Alcohol, Policy, and Safety Research Center 

Felton, California 

Annemarie Charlesworth, M.A. 

Program Evaluator 

National Center of Excellence in Women’s 

Health 

University of California, San Francisco 

San Francisco, California 

Amber Christiansen, M.P.H. 

Research Analyst 

California Department of Public Health 

Sacramento, California 

Amander Clark, Ph.D. 

Assistant Professor 

University of California, Los Angeles 

Los Angeles, California 

Janine Austin Clayton, M.D. 

Deputy Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Jennifer M. Cocohoba, Pharm.D. 

Health Sciences Assistant Clinical Professor 

School of Pharmacy 

University of California, San Francisco 

San Francisco, California 

Patricia Cody 

Editor 

DES Action 

Berkeley, California 

Deborah L. Cohan, M.D., M.P.H. 

Associate Professor 

Department of OB/GYN 

University of California, San Francisco 

San Francisco, California 

Elly J. Cohen, Ph.D. 

Program Director Breast Cancer Trials 

University of California, San Francisco 

San Francisco, California 

Craig R. Cohen, M.D., M.P.H. 

Associate Professor 

University of California, San Francisco 

San Francisco, California 

Natalie Collins 

Manager 

Center for Vulnerable Populations at San 

Francisco General Hospital 

University of California, San Francisco 

San Francisco, California 

Carol Conell, Ph.D. 

Senior Data Consultant 

Division of Research 

Kaiser Permanente Northern California 

Oakland, California 

Nadia Conrad 

Intern 

San Francisco National Women’s Health 

Center 

San Francisco, California 

Deborah A. Craig 

M.P.H. Candidate 

Graduate Student Assistant 

San Francisco State University 

Berkeley, California 

Yvette Cuca, M.P.H., M.I.A. 

School of Nursing 

University of California, San Francisco 

San Francisco, California 

Judith S. Currier, M.D., M.Sc. 

Professor of Medicine 

David Geffen School of Medicine 

University of California, Los Angeles 

Los Angeles, California 

Katherine Davenny, M.P.H. 

Associate Director 

National Institute on Drug Abuse/AIDS 

Research Program 

National Institutes of Health 

Bethesda, Maryland 

Sheila J. Davis, M.D., M.S. 

Associate Director 

W. Montague Cobb Institute 

Washington, District of Columbia 

333
Amy Day, N.D. 

Endometriosis Association 

Milwaukee, Wisconsin 

Carolyn Deal, Ph.D. 

Branch Chief 

National Institute of Allergy and 

Infectious Diseases 

National Institutes of Health 

Bethesda, Maryland 

Baylee DeCastro 

Harvard Kennedy School and University 

of California, San Francisco 

San Francisco, California 

Marguerite Desko, Ph.D. 

Teaching Fellow, Asian University for Women 

Postdoctoral Scholar 

University of California, San Francisco 

San Francisco, California 

Matthew L. Donne 

SRAII 

University of California, San Francisco 

San Francisco, California 

Dena Dubal, M.D., Ph.D. 

Postdoctoral Fellow 

Neurology and Gladstone Institutes 

University of California, San Francisco 

San Francisco, California 

Irene Sue Dubman, M.A. 

Senior Director, Standards & Architecture 

Genzyme 

Cambridge, Massachusetts 

Ann Duerr, M.D., Ph.D. 

Associate Director 

HIV Vaccines Trial Network 

Seattle, Washington 

Chris Dufield, Ph.D. 

Assistant Professor 

Stanford University 

Palo Alto, California 

Andrea Dunaif, M.D., Ph.D. 

Charles F. Kettering Professor of Medicine 

and Chief 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Jennifer Stine Elam, Ph.D. 

Managing Director 

Center for Women’s Infectious Disease 

Research 

Washington University School of Medicine 

St. Louis, Missouri 

Laura J. Esserman, M.D., M.B.A. 

Director, Carol Franc Buck Breast Care 

Center 

University of California, San Francisco 

San Francisco, California 

Alicia Fernandez, M.D. 

Associate Professor of Clinical Medicine 

University of California, San Francisco 

San Francisco, California 

Lauren Fiel 

Health Educator 

University of California, San Francisco 

San Francisco, California 

Susan J. Fisher, Ph.D. 

Professor 

University of California, San Francisco 

San Francisco, California 

Valerie Flaherman, M.D., M.P.H. 

Assistant Professor of Pediatrics 

University of California, San Francisco 

San Francisco, California 

Jessica Fogler, M.D. 

Assistant Clinical Professor of Family and 

Community Medicine 

University of California, San Francisco 

San Francisco, California 

Martina Frank, M.P.H. 

Consultant 

Global Health 

San Francisco, California 

334
Marcy A. Fraser, M.B.A., R.N. 

Director of Operations 

Investigational Therapeutics 

University of California, San Francisco 

San Francisco, California 

Elena Fuentes-Afflick, M.D., M.P.H. 

Professor of Pediatrics, Epidemiology, and 

Biostatistics 

San Francisco General Hospital 

University of California, San Francisco 

San Francisco, California 

Yoshimi Fukuoka, Ph.D., R.N. 

Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Sarah S. Gainey, M.S.W., L.I.S.W.-CP 

Women’s Research Center Coordinator 

Clinical Neurosciences Division 

Medical University of South Carolina 

Charleston, South Carolina 

Monica Gandhi, M.D., M.P.H. 

Assistant Professor, Divisions of HIV/AIDS 

and Infectious Diseases 

University of California, San Francisco 

San Francisco, California 

Elizabeth Garner, M.D., M.P.H. 

Associate Director 

Merck & Co. 

North Wales, Pennsylvania 

Holly A. Garriock, Ph.D. 

University of California, San Francisco 

San Francisco, California 

Elena A. Gates, M.D. 

Professor and Chief, Division of Gynecology 

University of California, San Francisco 

San Francisco, California 

Debabrata Ghosh, Ph.D. 

Professor of Physiology 

Department of Physiology 

All India Institute of Medical Sciences 

Ansari Nagar, New Delhi 

Harlan R. Giles, M.D. 

Maternal Fetal Medicine 

Pittsburgh, Pennsylvania 

Katie Gillespie, M.A. 

Graduate Student 

Mel and Enid Zuckerman College of Public 

Health 

University of Arizona 

Tucson, Arizona 

Linda C. Giudice, M.D., Ph.D., M.Sc. 

Professor and Chair 

Dept. of OB/GYN & Reproductive Sciences 

University of California, San Francisco 

San Francisco, California 

Ellen B. Gold, Ph.D. 

Professor and Chair 

Department of Public Health Sciences 

University of California, Davis 

Davis, California 

Sue W. Goldstein 

Program Coordinator 

San Diego Sexual Medicine 

San Diego, California 

Ellen Goldstein, M.A. 

Program Manager 

University of California, San Francisco 

San Francisco, California 

Cynthia A. Gomez, Ph.D. 

Director 

Health Equity Institute 

San Francisco State University 

San Francisco, California 

Suzan Goodman, M.D., M.P.H. 

TEACH Program Director, ARHP Member 

Association of Reproductive Health 

Professionals 

University of California, San Francisco 

Oakland, California 

Deborah Gordon, Ph.D. 

Assistant Professor 

University of California, San Francisco 

Berkeley, California 

335
Illeya Gordon 

University of California, San Francisco 

San Francisco, California 

Rivka Gordon, M.H.S., P.A.-C 

Director, Strategic Initiatives 

Association Reproductive Health 

Professionals 

Oakland, California 

Shannon M. Gorman 

National Multiple Sclerosis Society 

San Francisco, California 

Ruth Greenblatt, M.D. 

Professor of Clinical Pharmacy 

University of California, San Francisco 

San Francisco, California 

Warner C. Greene, M.D., Ph.D. 

Director and Professor 

Gladstone Institute of Virology and 

Immunology 

University of California, San Francisco 

San Francisco, California 

Jessica Grossman, M.D. 

JG Limited, LLC 

San Francisco, California 

Jupie Gueperio 

Nursing Department Research 

San Francisco, California 

Kathy Hajopoulos, M.P.H. 

Executive Director, Breast COE 

University of California, San Francisco 

San Francisco, California 

Margaret Handleg, Ph.D., M.P.H. 

Assistant Professor 

Preventive Medicine/ Public Health 

University of California, San Francisco 

San Francisco, California 

Gray Handley, M.S.P.H. 

Associate Director for International Research 

Affairs 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Eve Harris 

San Francisco, California 

Kelly M. Haston 

Ph.D. Candidate 

Biomedical Sciences Program UCSF 

Stanford University, Stem Cell Department 

Palo Alto, California 

Meldy Stehmeier Hernandez, M.P.H., P.H.N. 

Case Manager/Nurse Childhood Lead 

Prevention Program 

San Francisco Department of Public Health 

San Francisco, California 

Kasha H. Ho 

Program Associate 

Breast Cancer Action 

CA Healthy Nail Salon Collaborative 

San Francisco, California 

Brooke A. Hollister, Ph.D. 

Assistant Professor 

Social & Behavioral Sciences 

University of California, San Francisco 

San Francisco, California 

Jane Honikman, M.S. 

Founder 

Postpartum Support International 

Santa Barbara, California 

Dixie Horning 

Executive Director 

National Center of Excellence in Women’s 

Health 

University of California, San Francisco 

San Francisco, California 

Kathryn Horsley, Dr.P.H. 

Director of Monitoring and Evaluation 

California Family Health Council 

Berkeley, California 

Becky Howsmon, Ph.D. 

Women in Science Careers 

Berkeley, California 

Hongmei Huang, Ph.D. 

Associate Director 

Exelixis, Inc. 

South San Francisco, California 

336
Megan J. Huchko, M.D., M.P.H. 

Research Fellow 

Department of Obstetrics, Gynecology and 

Reproductive Science 

University of California, San Francisco 

San Francisco, California 

Janice C. Humphreys, Ph.D., R.N., N.P., 

FAAN 

Associate Professor & Vice-Chair for 

Faculty Practice 

Department of Family Health Care Nursing 

University of California, San Francisco 

San Francisco, California 

Loris Hwang, M.D. 

Assistant Professor 

Division of Adolescent Medicine 

University of California, San Francisco 

San Francisco, California 

Erika Ilagan 

Staff Research Associate II 

University of California, San Francisco 

San Francisco, California 

Vanessa Jacoby, M.D. 

Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Sarah J. Janssen, M.D., Ph.D., M.P.H. 

Staff Scientist 

Natural Resources Defense Council 

San Francisco, California 

Thomas M. Jones, M.D. 

Chief Medical Officer 

Tolven 

Sonoma, California 

Loren R. Jones 

Policy Associate 

Positive Women’s Network 

WORLD 

Oakland/Berkeley, California 

Tristan W. Juhan 

SRA II 

University of California, San Francisco 

San Francisco, California 

Lori D. Karran, M.D. 

Associate Clinical Professor 

University of California, San Francisco 

San Francisco, California 

Wendy B. Katzman, D.P.T.Sc., P.T. 

Assistant Clinical Professor, BIRCWH Scholar 

Department of PT and Rehabilitation Science 

University of California, San Francisco 

San Francisco, California 

Miriam Kelty, Ph.D. 

Consultant 

Bioethics and Research Management 

Bethesda, Maryland 

Theo Kemos 

Social Scientist 

Patalumon, California 

Surina Khan 

Vice President of Programs 

Womans Foundation of California 

San Francisco, California 

Naina Khanna 

Director of Policy and Community 

Organizing 

Women Organized to Respond to Life 

Threatening Diseases 

Oakland, California 

Karen Kimura 

Director, IT & Informatics 

Theravance, Inc. 

South San Francisco, California 

Dorothy Kleffner, Ph.D. 

Co-chair 

CA State Women’s Task Force on HIV 

San Rafael, California 

Jane E. Koehler, M.D. 

Division of Infectious Diseases 

University of California, San Francisco 

San Francisco, California 

Margaret J. Kristof, M.S., R.N. 

Academic Coordinator 

Women’s Health Clinical Research Center 

University of California, San Francisco 

San Francisco, California 

337
Katherine Krolikowski, Ph.D. 

Professor of Biology and Biotechnology 

Contra Costa College 

San Pablo, California 

Fredi Kronenberg, Ph.D. 

Stanford University 

Clayman Institute for Gender Research 

Stanford, California 

Rebecca Krow-Boniske 

Albany, California 

Miriam Kuppermann, Ph.D., M.P.H. 

Professor 

Dept. of OB/GYN & RS 

University of California, San Francisco 

San Francisco, California 

Rebecca D. Kush, Ph.D. 

President and CEO 

Clinical Data Interchange Standards 

Consortium 

Austin, Texas 

Lawrence H. Kushi, Sc.D. 

Associate Director 

Kaiser Permanente 

Division of Research 

Oakland, California 

Anna Lai 

University of California, Berkeley 

Berkeley, California 

Diana Laird, Ph.D. 

Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Nicholas Larocque 

Lab Director 

University of California, San Francisco 

San Francisco, California 

Kaajal Laungani 

Research Associate 

VA Palo Alto Health Care System 

Menlo Park, California 

Mary Lawrence, M.S. 

Program Analyst 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Joe Letourneau 

University of California, San Francisco 

San Francisco, California 

Amy J. Levi, Ph.D., C.N.M. 

Associate Clinical Professor 

University of California, San Francisco 

San Francisco, California 

Amy Levine, Ed.D. 

Executive Director 

Center for Gender Equity 

University of California, San Francisco 

San Francisco, California 

Deborah K. Levine, M.A. 

Executive Director 

Internet Sexuality Information Services, Inc. 

Oakland, California 

Juan Lewin, M.D., Ph.D. 

Associate Director 

University of California, San Francisco 

San Francisco, California 

Teri Liegler, Ph.D. 

Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Lorena Liu-Lee 

San Francisco, California 

Margarita Lopez 

Health Educator 

San Francisco State University 

San Francisco, California 

Louise Lourent, M.D., Ph.D. 

Assistant Professor 

University of California, San Francisco 

San Diego, California 

338
Lindsey Lubbock, M.P.H. 

Project Manager (Analyst) 

Global Heath Sciences 

University of California, San Francisco 

San Francisco, California 

Bertram H. Lubin, M.D. 

President, Director of Medical Research 

Children’s Hospital & Research Center 

Oakland 

Children’s Hospital Oakland Research 

Institute 

Oakland, California 

Nadya L. Lumelsky, Ph.D. 

Program Director 

National Institute of Dental and Craniofacial 

Research 

National Institutes of Health 

Bethesda, Maryland 

Nicole Maderas, M.P.H. 

Program Administrator 

Pharmacy Access Partnership 

Pacific Institute for Women’s Health 

Oakland, California 

Purnima Madhivanan, M.D., Ph.D., M.P.H. 

Adjunct Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Kiko Malin, M.P.H., M.S.W. 

Preconception Health Coordinator 

Maternal Child and Adolescent Health 

Division 

California Department of Public Health 

Sacramento, California 

Emily R. Mangone 

Grants Manager 

Bixby Center for Global Reproductive Health 

University of California, San Francisco 

San Francisco, California 

Seyoum Michael 

Medical Interpreter 

City College 

San Francisco, California 

Nancy Milliken, M.D. 

Vice Dean, Director 

National Center of Excellence in Women’s 

Health 

University of California, San Francisco School 

of Medicine 

San Francisco, California 

Jennifer A. Millis 

Analyst III 

OB/GYN & RS Dept., Chair’s Office 

University of California, San Francisco 

San Francisco, California 

Dixie I. Mills, M.D. 

Medical Director 

Dr. Susan Love Research Foundation 

Love/Avon Army of Women 

Santa Monica, California 

Maro Minasi 

RSDP Program Administration 

Reproductive Scientist Development 

Program 

University of California, San Francisco 

San Francisco, California 

Deborah Mindry, Ph.D. 

Global AIDS Research Fellow 

University of California, Los Angeles 

Program in Global Health 

Los Angeles, California 

Sally Marshall, Ph.D. 

Vice Provost 

University of California, San Francisco 

San Francisco, California 

Brigid McCaw, M.D., M.P.H., M.S., FACP 

Medical Director, Family Violence Prevention 

Kaiser Permanente 

Oakland, California 

Ramsey H. McIntire, Ph.D. 

Postdoctoral Fellow 

Dept. of OB/GYN and Reproductive Sciences 

University of California, San Francisco 

San Francisco, California 

339
Suzanne S. Medgyesi-Mitschang, Ph.D. 

Strategic Planner 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Synthia H. Mellon, Ph.D. 

Professor
�

Department of Obstetrics, Gynecology, & 

Reproductive Science 

University of California, San Francisco 

San Francisco, California 

Meridithe A. Mendelsohn, M.P.A. 

Manager 

Helen Diller Family Comprehensive Cancer 

University of California, San Francisco 

San Francisco, California 

Mary I. Menz, P.H.N., B.S.N. 

Administrative Nurse Consultant 

Bixby Center for Global Reproductive Health 

University of California, San Francisco 

Sacramento, California 

Carinne D. Meyer, M.P.H. 

Project Analyst 

Safe Motherhood Programs 

University of California, San Francisco 

Alexandra Minnis, Ph.D. 

Epidemiologist 

Women’s Global Health Imperative 

RTI International 

San Francisco, California 

Ketty Mobed, Ph.D., M.S.P.H. 

Research Analyst 

Academic Research Systems 

University of California, San Francisco 

San Francisco, California 

Lynne M. Mofenson, M.D. 

Chief, Pediatric, Adolescent and Maternal 

AIDS Branch 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Rockville, Maryland 

Christine H. Morton, Ph.D. 

Research Sociologist 

California Maternal Quality Care 

Collaborative 

Stanford University 

Palo Alto, California 

Barbara Moscicki, M.D. 

Professor 

University of California, San Francisco 

Kathleen Mulligan, Ph.D. 

Associate Professor of Medicine 

San Francisco General Hospital 

University of California, San Francisco 

San Francisco, California 

C. Myser, Ph.D. 

Global Heath 

San Francisco, California 

Renee Navarro, M.D., Pharm.D. 

Associate Dean Academic Affairs 

Director of Academic Diversity 

Professor of Anesthesia 

University of California, San Francisco 

San Francisco, California 

Cheryl Nazario, M.S., C.A.S.A.C. 

Assistant Vice President Treatment Services 

Daytop Village, Inc. 

New York, New York 

Janine Nesset Tominaga, M.P.H, R.D. 

Patient Advocate 

Berkeley, California 

Raushanah Newman 

Program Analyst 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Jessie Norris, M.P.H. 

Health Educator 

Lupus Foundation of America 

La Mirada, California 

340
Rhoda Nussbaum, M.D. 

Board Member 

Prevention International: No Cervical Cancer 

San Francisco, California 

Mary Beth E. O’Connell, Pharm.D. 

Associate Professor 

College of Pharmacy and Health Sciences 

Wayne State University 

Detroit, Michigan 

Nancy Oliva, Ph.D., M.H.A., M.P.A., R.N. 

AHRQ Fellow 

P.R. Lee Institute for Health Policy Studies 

University of California, San Francisco 

San Francisco, California 

Deborah Venise Ortiz, J.D. 

VP of Public Affairs California 

Planned Parenthood Mar Monte 

Sacramento, California 

Charlotte D. Owens, M.D. 

Associate 

Booz Allen Hamilton 

Atlanta, Georgia 

Elizabeth Ozer, Ph.D. 

Associate Professor of Pediatrics 

University of California, San Francisco 

San Francisco, California 

Bobbo Pallas 

University of California, San Francisco 

San Francisco, California 

Maria Pallavicini, Ph.D. 

Professor 

University of California, Merced 

Merced, California 

Eileen Palmer, Ph.D. 

Managing Partner 

Partners in Change 

Oakland, California 

Karen Parker, M.S.W. 

Women’s Health Officer 

National Cancer Institute 

National Institutes of Health 

Rockville, Maryland 

Estella Parrott, M.D., M.P.H. 

Program Director 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Andrea Pawlonek 

Academic Assistant, Gynecology 

University of California, San Francisco 

San Francisco, California 

Maureen Pearlman, M.S., R.N. 

Director, Education and Community 

Outreach 

Women & Infants Hospital 

Providence, Rhode Island 

Linnette Peralta-Haynes 

Legislative Aide of Supervisor Campos 

Representative of District 9 

San Francisco, California 

Marion G. Peters, M.D. 

Professor of Medicine 

University of California, San Francisco 

San Francisco, California 

Karen G. Pierce, J.D. 

Coordinator 

San Francisco Department of Public Health 

Community Health Promotion and 

Prevention 

San Francisco, California 

Vivian W. Pinn, M.D. 

Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Susan Plaeger, Ph.D. 

Director, Basic Sciences Program 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

341
Gisel Prado 

Executive Secretary 

Dept. of OB/GYN & RS 

University of California, San Francisco 

San Francisco, California 

Sunita Puri, M.S., M.A. 

Medical Student 

University of California, San Francisco 

San Francisco, California 

Tina Raine-Bennett, M.D., M.P.H. 

Associate Professor 

OB-GYN-RS, San Francisco General Hospital 

University of California, San Francisco 

Oakland, California 

Alissa Ralston, M.S. 

Project Director 

Bay Area Community Resources 

San Rafael, California 

Sally Rankin, Ph.D., R.N. 

Professor and Chair, Department of Family 

Health Care Nursing 

University of California, San Francisco 

San Francisco, California 

Barbara A. Rapp, Ph.D. 

Chief, Office of Planning and Analysis 

National Library of Medicine 

National Institutes of Health 

Bethesda, Maryland 

Joan Y. Reede, M.D., M.P.H., M.B.A. 

Dean for Diversity and Community 

Partnership 

Harvard Medical School 

Boston, Massachusetts 

Renee A. Reijo Pera, Ph.D. 

Director and Professor 

Stanford Center For HESC Research, 

OB-GYN 

Palo Alto, California 

Elise Riley, Ph.D. 

Associate Professor 

University of California, San Francisco 

San Francisco, California 

Paolo Rinaoso 

Assistant Professor 

University of California, San Francisco 

San Francisco, California 

Elena Rios, M.D., M.S.P.H. 

President & Chief Executive Officer 

National Hispanic Medical Association 

Washington, District of Columbia 

Nancy R. Robbins, M.S.W. 

Project Director, Foster Youth Health Project 

Family Health Care Nursing 

School of Nursing 

University of California, San Francisco 

San Francisco, California 

Kathryn R. Robertson 

University of California, San Francisco 

San Francisco, California 

Patricia A. Robertson, M.D. 

Professor 

Department of Obstetrics, Gynecology and 

Reproductive Sciences 

University of California, San Francisco 

San Francisco, California 

Angela Rojas 

Graduate Student 

University of California, San Francisco 

San Francisco, California 

Ann Marie Rojas-Cheatham, Ph.D., M.P.H. 

Asian Communities for Reproductive Health 

Berkeley, California 

Joyce Rudick 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Caitlin C. Ryan, Ph.D., A.C.S.W. 

Director, Family Acceptance Project 

San Francisco State University 

San Francisco, California 

342
Simran K. Sabherwal, M.H.S. 

Research Assistant 

Philip R. Lee Institute for Health Policy 

Studies 

University of California, San Francisco 

San Francisco, California 

Sona R. Saha, M.P.H., Ph.D. 

Director 

East Bay AIDS Research Institute 

Oakland, California 

Mijiza M. Sanchez, M.P.A. 

University of California, San Francisco 

San Francisco, California 

Heather Sarantis, M.S. 

Women’s Health Program Manager 

Commonwealth 

Berkeley, California 

George Sawaya, M.D. 

Professor 

University of California, San Francisco 

San Francisco, California 

Aenor Sawyer, M.D. 

Assistant Professor 

University of California, San Francisco 

Oakland, California 

Patricia R. Sax, Ph.D, L.C.S.W. 

Development Director 

Prevention International: No Cervical Cancer 

Oakland, California 

Karen Schlein, M.P.H., M.B.A. 

Project Manager 

Institute for OneWorld Health 

San Francisco, California 

Rachel L. Schwartz 

Ph.D. Candidate 

University of California, San Francisco 

San Francisco, California 

Jackie M. Schwartz, M.P.H. 

Research Scientist 

Program on Reproductive Health and the 

Environment 

University of California, San Francisco 

Oakland, California 

Joan P. Schwartz, Ph.D. 

Assistant Director 

Office of Intramural Research 

National Institutes of Health 

Bethesda, Maryland 

Janet P. Searles 

Administrative Coordinator 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Hilary K. Seligman, M.D., M.A.S. 

Assistant Professor of Medicine 

University of California, San Francisco 

San Francisco, California 

Jayasree Sengupta, Ph.D. 

Professor and Head 

Department of Physiology 

All India Institute of Medical Sciences 

New Delhi, India 

Ruby T. Senie, Ph.D. 

Professor Clinical Public Health 

Mailman School of Public Health 

Columbia University 

New York, New York 

Barbara L. Shacklett, Ph.D. 

Associate Professor 

Medical Microbiology and Immunology 

University of California, Davis 

Davis, California 

W. Sue Shafer, Ph.D. 

Consultant 

Women’s Careers in Science 

San Francisco, California 

Alissa Shaw 

Assistant Vice President of Campaigns 

Planned Parenthood 

San Jose, California 

343
Eveline Shen, M.P.H. 

Executive Director 

Asian Communities for Reproductive Justice 

Oakland, California 

Songtao Shi, D.D.S., Ph.D. 

Associate Professor 

University of Southern California 

Los Angeles, California 

Pat Shiono, Ph.D. 

Supervising Epidemiologist 

San Francisco Department of Public Health 

San Francisco, California 

Maren Shipe 

San Francisco Department Public Health 

San Francisco, California 

Sally A. Shumaker, Ph.D. 

Senior Associate Dean for Research 

Wake Forest University School of Medicine 

Winston-Salem, North Carolina 

Pratheepa Sivaswarupan 

University of California, San Francisco 

Medical School 

Concord, California 

Trina Slabiak, RAC 

Science Writer 

BioReport 

San Francisco, California 

Dawn K. Smith, M.D., M.S., M.P.H. 

Associate Chief for Science 

Epidemiology Branch 

Division of HIV/AIDS Prevention 

Centers for Disease Control and Prevention 

Atlanta, Georgia 

Sonia Sonik 

M.P.H. Student 

California Department of Public Health 

University of California, Davis 

Sacramento, California 

Marcia Stefanick, Ph.D. 

Professor of Medicine 

Stanford University 

Los Angeles, California 

Amy L. Stenson, M.D., M.P.H. 

BIRCWH Scholar 

University of California, Los Angeles 

Venice, California 

Evelin D. Szakal, Ph.D., M.Sc. 

Research Scholar 

University of California, San Francisco 

San Francisco, California 

Richard J. Tasca, Ph.D. 

Acting Deputy Director 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Rockville, Maryland 

Paula Tavrow, Ph.D. 

Director and Assistant Professor 

Bixby Program in Population and 

Reproductive Health 

UCLA School of Public Health 

Los Angeles, California 

Kristina Thayer, Ph.D. 

Staff Scientist 

National Institute of Environmental Health 

Sciences 

National Institutes of Health 

Durham, North Carolina 

Mary Thomas, Ph.D. 

St. Jude Children’s Hospital 

Memphis, Tennessee 

Darlene Thomas-Woods 

Director Information Systems 

Amgen 

Thousand Oaks, California 

Lisa Thompson, Ph.D., F.N.P. 

Assistant Professor 

School of Nursing 

University of California, San Francisco 

San Francisco, California 

344
Jonathan L. Tilly, Ph.D. 

Professor of OB/GYN and Reproductive 

Biology 

Vincent Center for Reproductive Biology 

Massachusetts General Hospital/Harvard 

Medical School 

Boston, Massachusetts 

Debra A. Toney, Ph.D., R.N. 

President 

National Black Nurses Association 

Silver Spring, Maryland 

Florita Toveg, M.A. 

Manager 

Breast Health Access for Women with 

Disabilities (BHAWD) 

Alta Bates Summit Medical Center 

Berkeley, California 

Alexander C. Tsai, M.D., Ph.D. 

PGY-3 

Langley Porter Psychiatric Institute 

University of California at San Francisco 

San Francisco, California 

Janet M. Turan, Ph.D., M.P.H. 

Department of Obstetrics, Gynecology, and 

Reproductive Sciences 

University of California, San Francisco 

San Francisco, California 

Virginia V. Valian, Ph.D. 

Distinguished Professor 

Hunter College & CUNY Graduate Center 

New York, New York 

Chris Van Dyke, M.D. 

Professor of Psychiatry 

University of California, San Francisco 

San Francisco, California 

Julia R. Varshavsky 

Fertility/Reproductive Health Coordinator 

Collaborative on Health and the Environment 

Oakland, California 

Michael C. Velarde, Ph.D. 

Postdoctoral Fellow 

University of California, San Francisco 

San Francisco, California 

Lynohila Ward 

National Center of Excellence Women’s 

Health 

University of California, San Francisco 

San Francisco, California 

Shannon Weber, M.S.W. 

Perinatal Hotline Coordinator 

San Francisco General Hospital 

University of California, San Francisco 

San Francisco, California 

Edith L. Weinrub, Ed.D. 

Assistant Professor 

Holy Names University 

Oakland, California 

Allen Weinrub, Ph.D. 

Grant Writer 

Holy Names University 

Oakland, California 

Jane A. Weintraub, D.D.S., M.P.H. 

Lee Hysan Professor 

Center to Address Disparities in Children’s 

Oral Health 

University of California, San Francisco School 

of Dentistry 

San Francisco, California 

Tracy A. Weitz, Ph.D., M.P.A. 

Assistant Professor
�

ANSIRH Program, Bixby Center, Dept. 

Ob/Gyn 

University of California, San Francisco 

Oakland, California 

Kim Welty, J.D., M.A. 

Managing Partner 

Partners in Change 

Oakland, California 

Zena Werb, Ph.D. 

Professor 

University of California, San Francisco 

San Francisco, California 

Phyllis Whiteley, Ph.D. 

Venture Capital 

Mohr Davidow Ventures 

Menlo Park, California 

345
Loreen G. Willenberg 

CEO/Founder
�

Zephyr L.T.N.P. Foundation, Inc.
�

Women’s Research Initiative (WRI)
�

Sacramento, California
�

Deborah M. Winn, Ph.D. 

Deputy Director 

Division of Cancer Control and Population 

Sciences 

National Cancer Institute 

National Institutes of Health 

Bethesda, Maryland 

Janice L. Wong 

Analyst 

Reproductive Scientist Development 

Program 

University of California, San Francisco, Dept. 

of OB/GYN and Reproductive Science 

San Francisco, California 

Stephanie Wong 

Piedmont, California 

Katherine Woo, Ph.D. 

Senior Director, Corporate Partnering and 

Portfolio Development 

Institute For OneWorld Health 

Oakland, California 

Susan F. Wood, Ph.D. 

Research Professor 

George Washington University 

School of Public Health and Health Services 

Washington, District of Columbia 

Tracey Woodruff, Ph.D., M.P.H. 

Associate Professor and Director 

Program on Reproductive Health and the 

Environment 

University of California, San Francisco 

Oakland, California 

Linda L. Wright, M.D. 

Deputy Director 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Rockville, Maryland 

Barbara W.K. Yee, Ph.D. 

Professor 

FCS, University of Hawaii at Manoa 

Honolulu, Hawaii 

Susan L. Young 

Molecular and Cell Biology 

University of California, Berkeley 

El Cerrito, California 

Judy Young, M.P.H. 

Assistant Director 

National Center of Excellence in Women’s 

Health 

University of California, San Francisco 

San Francisco, California 

Rohan Zamanian, M.D., FCCP 

Assistant Professor of Medicine 

Stanford University School of Medicine 

Purtule Valley, California 

346
PROVIDENCE, RHODE ISLAND 

SEPTEMBER 21-23, 2009 

PARTICIPANTS 

Gil Abramovici 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Carolina Abuelo, M.D., M.Sc. 

Clinical Fellow 

Miriam Hospital 

Providence, Rhode Island 

Rebecca H. Allen, M.D., M.P.H. 

Assistant Professor of OB/GYN 

Brown University 

Women and Infants Hospital of Rhode Island 

Providence, Rhode Island 

Ann Alouisa 

Consultant 

Yorktown Heights, New York 

Raymond Anchan, M.D., Ph.D. 

Instructor of OB/GYN 

Harvard Medical School 

Boston, Massachusetts 

Brenna Anderson, M.D. 

Assistant Professor 

Warren Alpert Medical School of Brown 

University 

Women & Infant’s Hospital of Rhode Island 

Providence, Rhode Island 

Alicia Y. Armstrong, M.D., M.H.S.C.R. 

Associate Fellowship Director Reproductive 

Endocrinology Fellowship 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Jane C. Atkinson, D.D.S. 

Director, Center for Clinical Research 

National Institute of Dental and Craniofacial 

Research 

National Institutes of Health 

Bethesda, Maryland 

Christine A. Bachrach, Ph.D. 

Acting Director 

Office of Behavioral and Social Sciences 

Research 

National Institutes of Health 

Bethesda, Maryland 

Robert Barbieri, M.D. 

Chairperson, Obstetrics and Gynecology 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Katie Barker, M.D. 

OB/GYN Resident 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Ashley Barrett 

Philanthropy Officer 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Cynthia Battle, Ph.D. 

Woman & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Lisa Begg, Dr.P.H., R.N. 

Director of Research Programs 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Michelle Berlin, M.D., M.P.H. 

Vice Chair, OB/GYN & Director, OHSU Center 

of Excellence in Women’s Health 

Oregon Health & Science University 

Portland, Oregon 

Monica L. Bertoia, M.P.H. 

Epidemiology Ph.D. Candidate 

Brown University 

Memorial Hospital of Rhode Island 

Providence, Rhode Island 

347
Amy Bianchi, M.P.H. 

Public Health Analyst 

Office of Population Affairs 

Department of Health and Human Services 

Rockville, Maryland 

Courtney C. Bilodeau, M.D. 

Attending 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Mary C. Blehar, Ph.D. 

Science Writer Consultant 

Office of Research on Women’s Health 

National Institutes of Health 

Potomac, Maryland 

Onolee Bock, M.P.H. 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Alyssa Boss 

AVP/General Counsel 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Ghada Bourjeily 

Assistant Professor of Medicine 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown 

Providence, Rhode Island 

Wendy R. Brewster, M.D., Ph.D. 

Director, Center for Women’s Health 

Research 

University of North Carolina at Chapel Hill 

Chapel Hill, North Carolina 

Carrie Bridges, M.P.H. 

Team Lead, Health Disparities & Access to 

Care 

Rhode Island Department of Health 

Providence, Rhode Island 

Claire D. Brindis, Dr. P.H. 

Director, Philip R. Lee Institute for Health 

Policy Studies 

University of California, San Francisco 

San Francisco, California 

Julia Brody, Ph.D. 

Executive Director 

Silent Spring Institute 

Newton, Massachusetts 

Joanna Brown, M.D., M.P.H. 

Assistant Professor of Family Medicine 

Brown University 

Providence, Rhode Island 

Joanna M. Cain, M.D. 

Chace/Joukowsky Professor and Chair 

Assistant Dean for Women’s Health 

Warren Alpert School of Medicine, Brown 

University 

Providence, Rhode Island 

Donna Caldwell, Ph.D. 

Vice President 

National Perinatal Information Center 

Providence, Rhode Island 

Susan M. Campbell, M.P.H. 

Director of Public Policy 

WomenHeart: The National Coalition for 

Women with Heart Disease 

Washington, District of Columbia 

Dawn Campbell, R.D. 

Research Assistant 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Cassandra Carberry, M.D. 

Associate Urogynecologist/Clinical Assistant 

Professor 

Woman & Infants Hospital of Rhode Island 

Brown Medical School 

Providence, Rhode Island 

Alana Casciello 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Stacey D. Chambers, M.S. 

Program Analyst 

National Institute of Neurological Disorders 

and Stroke 

National Institutes of Health 

Bethesda, Maryland 

348
Kenneth Chen, M.D. 

Obstetric Medicine Fellow 

Women & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Edward Chien, M.D. 

Assistant Professor 

Brown University 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Janine Austin Clayton, M.D. 

Deputy Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Kathleen A. Connell, M.D. 

Assistant Professor, Research Director 

Section of Urogynecology 

Yale University Department of OB/GYN 

New Haven, Connecticut 

Mary Reich Cooper, M.D., J.D. 

Chief Quality Officer 

Lifespan Corporation 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Ann Cooper, R.N.P., M.S. 

Nurse Practitioner 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Paulette Corey, B.S.N., M.S.N. 

Nurse Practitioner 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Donald R. Coustan, M.D. 

Maternal Fetal Medicine Specialist 

Women & Infants Hospital of Rhode Island 

Maternal Fetal Medicine Division 

Providence, Rhode Island 

Cindy Crowninshield 

Dietetic Intern 

Southcoast Hospitals Group 

Belmont, Massachusetts 

Loredana C. Cuccia, M.D. 

Medical Scientist 

Boehringer Ingelheim 

Norwalk, Connecticut 

Michele Cyr, M.D. 

Associate Dean for Academic Affairs 

Brown University 

Providence, Rhode Island 

Tanya L. Dailey, M.D. 

Maternal Fetal Medicine - Assistant Professor 

Women & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Kristin B. Dalbec, L.M.T. 

Assistant Program Coordinator 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Suzanne M. de la Monte, M.D., M.P.H. 

Professor 

Rhode Island Hospital 

Warren Alpert Medical School-Brown 

University 

Providence, Rhode Island 

Alan DeCherney, M.D. 

Program Head 

Eunice Kennedy Shriver National Institute 

of Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Kristen Lynn DeLayo 

Research Assistant 

Women & Infants Hospital of Rhode Island 

Warwick, Rhode Island 

Sheridan Denert 

Dietetic Intern 

Southcoast Hospitals Group 

New Bedford, Massachusetts 

Dee Devlin, R.D.H., M.P.H. 

Clinical Research Dental Hygienist 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

349
Susan DiBattista 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Christy L. Dibble, D.O. 

Gastroenterologist 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Christine Duffy, M.D., M.P.H. 

Assistant Professor of Medicine 

Brown University 

Providence, Rhode Island 

Eileen M. Dykeman, L.C.M.H.C. 

Clinical Program Manager 

Project Link 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Charles B. Eaton, M.D., M.S. 

Director, Center for Primary Care and 

Prevention 

Memorial Hospital of Rhode Island 

Pawtucket, Rhode Island 

Julie M. Eckles 

Patient Education/ Community Outreach 

Women & Infants Hospital of Rhode Island 

East Greenwich, Rhode Island 

Jennifer Stine Elam, Ph.D. 

Managing Director 

Center for Women’s Infectious Disease 

Research 

Washington University School of Medicine 

St. Louis, Missouri 

Erika Elvander, M.A. 

Chief, Advocacy and Analysis Program 

Clearinghouse, Outreach, and Advocacy 

Defense Centers of Excellence on 

Psychological Health and Trauma 

Arlington, Virginia 

Silvia Degli Esposti, M.D. 

Director 

Center for Women’s Gastrointestinal Services 

Brown University 

Providence, Rhode Island 

Mary T. Falvey, R.N. 

Program Manager, The Family Van 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Raina Fichorova, M.D., Ph.D. 

Associate Professor of Obstetrics, 

Gynecology and Reproductive Biology 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Kelly Findlay 

Student 

Providence College 

Providence, Rhode Island 

Loretta P. Finnegan, M.D. 

President 

Finnegan Consulting, LLC 

Avalon, New Jersey 

Timothy Flanigan, M.D. 

Professor of Medicine 

Brown Medical School 

Providence, Rhode Island 

Michele Follen, M.D., Ph.D. 

Professor of Gynecologic Oncology 

M.D. Anderson Cancer Center 

Houston, Texas 

Michelle Forcier, M.D. 

Assistant Professor 

Brown University 

Hasbro Children’s Hospital 

Providence, Rhode Island 

Stephanie Forschner 

Ph.D. Student 

University of Rhode Island 

Biomedical and Pharmaceutical Sciences 

Kingston, Rhode Island 

Mary A. Foulkes, Ph.D. 

Research Professor, Epidemiology, 

Biostatistics, Health Policy 

George Washington University 

School of Public Health 

Rockville, Maryland 

350
Sarah D. Fox, M.D. 

Assistant Professor 

Women & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Karen Freund, M.D., M.P.H. 

Professor of Medicine 

Boston University School of Medicine 

Boston, Massachusetts 

Paula K. Friedman, D.D.S., M.S.D., M.P.H. 

Associate Dean for Strategic Initiatives 

Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Conchetta W. Fulton, Pharm.D. 

College of Pharmacy 

Xavier University of Louisiana 

New Orleans, Louisiana 

Melissa Gallagher 

Dietetic Intern 

Southcoast Hospital Group 

Storghton, Massachusetts 

Kim M. Gans, Ph.D. 

Professor 

Brown University 

Institute for Community Health Promotion 

Providence, Rhode Island 

Raul Garcia, D.M.D., M.M.Sc. 

Professor and Chair 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Margery Gass, M.D. 

Executive Director Designate 

The North American Menopause Society 

Mayfield Heights, Ohio 

Susan A. Gerbi, Ph.D. 

George Eggleston Professor of Biochemistry 

Brown University BioMed Division 

Providence, Rhode Island 

Nicole Girard, M.B.A., C.C.R.P. 

Research Manager 

Women & Infants Hospital of Rhode Island 

Rhode Island Hearing Assessment Program 

Providence, Rhode Island 

Jill M. Goldstein, Ph.D. 

Professor. Psychiatry & Medicine 

Director of Research for Women’s Health 

Brigham & Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Amy S. Gottlieb, M.D. 

Assistant Professor of Medicine & OB/GYN 

Warren Alpert Medical School of Brown 

University 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Vinita Goyal, M.D., M.P.H. 

Assistant Professor in OB/GYN 

Brown University 

Women and Infants Hospital of Rhode Island 

Providence, Rhode Island 

Gilman Grave, M.D. 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Dorcas Greene, M.S.D. 

Coach for Caregivers, Owner 

Collaborative Coaching USA 

Cranston, Rhode Island 

Marsha K. Guess, M.D. 

Assistant Professor 

Section of Urogynecology/ Department 

OB/GYN 

Yale University 

New Haven, Connecticut 

Fusun Gundogan, M.D. 

Staff Pathologist 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

351
Janet R. Hardy, Ph.D. 

Assistant Professor 

Departments of Medicine, OB/GYN, and 

Pediatrics 

University of Massachusetts Medical School 

Worcester, Massachusetts 

Bernard L. Harlow, Ph.D. 

Professor 

University of Minnesota 

Minneapolis, Minnesota 

Abigail Harrison, Ph.D. 

Assistant Professor 

Brown University 

Providence, Rhode Island 

Meghan Hayes, M.D. 

Obstetric Internist 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Mai He, M.D., Ph.D. 

Pathologist, Assistant Professor 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Brenda Heaton, M.P.H. 

Investigator 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Denise A. Henry, R.N., B.S.N., M.S., R.L.N.C., 

C.P.H.Q. 

Director of Quality Management 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Michelle M. Henshaw, D.D.S. 

Assistant Dean 

Henry M. Goldman School of Dental Medicine 

Boston University 

Boston, Massachusetts 

Michelle A. Hladunewich, M.D. 

Assistant Professor 

University of Toronto 

Toronto, ON, Canada 

Mark Hollmer 

Media Relations 

Brown University 

Providence, Rhode Island 

Maya E. Holt-Brockenbrough, M.H.S. 

Deputy Director, Women’s Health Institute 

Howard University Hospital 

Washington, District of Columbia 

Meaghen M. Hoops 

Research Assistant, BAM BAM/BAMBI 

Studies 

Centers for Behavioral & Preventative 

Medicine 

The Miriam Hospital 

Women & Infants Hospital 

Providence, Rhode Island 

Margaret Howard, Ph.D. 

Director, Day Hospital 

Woman & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Anthony Hunes, M.S., Ph.D. 

Brown University 

East Providence, Rhode Island 

Annie Jack 

Research Assistant 

Lifespan 

Centers for Behavioral and Preventive 

Medicine 

Providence, Rhode Island 

Amanda Jackson, M.D. 

OB/GYN Resident 

Woman & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Ernestine G. Jennings, Ph.D. 

Assistant Professor (Research) 

The Miriam Hospital 

Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Indira P. Jevaji, M.D., M.S.L. 

Senior Medical Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

352
Crystal Jocelyn 

Research Assistant 

Division of Research 

Women & Infants Hospital of Rhode Island 

Bristol, Rhode Island 

Linda Johnson 

Senior Grant Administrator 

Brigham and Women’s Hospital 

Boston, Massachusetts 

Tamera Lewis Johnson, M.B.A., M.P.H. 

Women’s Health Program Manager 

National Institute of Allergy and Infectious 

Diseases 

National Institute of Health 

Bethesda, Maryland 

Joann Johnson, M.B.A. 

Senior Business Manager 

Woman & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Julie Johnson 

Maternal Fetal Medicine Fellow 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Renée Joskow, D.D.S., M.P.H., FAGD 

Dental Officer (Research) 

National Center for Research Resources 

National Institutes of Health 

Bethesda, Maryland 

Ana Karina Mascarenhas, B.D.S. 

Director, Division of Dental Public Health 

Boston University 

Boston, Massachusetts 

Linda M. Kaste, D.D.S., Ph.D., M.S. 

Associate Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Colleen Renee Kelly, M.D. 

Gastroenterologist 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Holly Powell Kennedy, Ph.D., C.N.M. 

Professor 

Yale University 

American College of Nurse-Midwives 

Branford, Connecticut 

Anita Kestin, M.D., M.P.H. 

Safety Fellow 

Lifespan 

Providence, Rhode Island 

Amy King, M.S. 

Dietetic Intern 

Southcoast Hospitals Group 

Barrington, Rhode Island 

Lisa R. King, M.A. 

Women’s Health Specialist 

Health Resources and Services 

Administration 

Maternal and Child Health Bureau 

Rockville, Maryland 

Brenda Korte, Ph.D. 

Program Director 

National Institute of Biomedical Imaging and 

Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Melissa Jo Kottke, M.D., M.P.H. 

Assistant Professor 

Obstetrics & Gynecology 

Emory University School of Medicine 

Atlanta, Georgia 

Joslyn Yudenfreund Kravitz, Ph.D. 

Policy Analyst 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Catherine K. Kuo, Ph.D. 

Assistant Professor 

Biomedical Engineering 

Tufts University 

Medford, Massachusetts 

353
Virginia T. Ladd 

President 

Autoimmune Diseases Association 

Eastpointe, Michigan 

Christie Lancaster, M.D. 

Robert Wood Johnson Clinical Scholar; 

Clinical Lecturer, Department of Obstetric 

University of Michigan 

Robert Wood Johnson Clinical Scholars 

Program 

Ann Arbor, Michigan 

Lucia Larson, M.D. 

Director, Division of Obstetric and 

Consultative Medicine 

Women and Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Susan LaSalle, R.N. 

Manager, Quality Management 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Helen Leffers 

Project Director 

Miriam Hospital 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Tim Leghan, M.P.A. 

Director of Government Relations 

Brown University 

Providence, Rhode Island 

Rose H. Lemay, C.L.C. 

Lactation Counselor 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Lovie F. Lewis, Pharm.D. 

Clinical Assistant Professor 

Xavier University of Louisiana College of 

Pharmacy 

New Orleans, Louisiana 

Stacy Tessler Lindau, M.D., M.A.P.P. 

Assistant Professor 

University of Chicago 

Chicago, Illinois 

Bets Loucks, M.P.H. 

Manager, Rhode Island Research Alliance 

Science and Technology Council 

Providence, Rhode Island 

Francois I. Luks, M.D., Ph.D. 

Professor of Surgery, Pediatrics, Obstetrics & 

Gynecology 

Hasbro Children’s Hospital 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Barbara S. Lynch, Ph.D. 

Writer 

BSL Writing Services 

Durango, Colorado 

Shirley M. Malcom, Ph.D. 

Head, Directorate of Education and Human 

Resources 

American Association for the Advancement 

of Science 

Washington, District of Columbia 

Neil Maniar, Ph.D., M.P.H. 

Director, Health Equity 

Brigham & Women’s Hospital of Rhode 

Island 

Boston, Massachusetts 

Bess H. Marcus, Ph.D. 

Professor, Department of Community Health 

Department of Psychiatry &Human 

Behavior 

Brown University 

The Miriam Hospital/Centers for Behavioral &

 Preventive Medicine 

Providence, Rhode Island 

Erin N. Marcus, M.D., M.P.H. 

Associate Professor of Clinical Medicine 

University of Miami Miller School of Medicine 

Miami, Florida 

354
Felisha Marques 

Urogynecology Research Assistant 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Sandra Kazahn Masur, Ph.D. 

Professor 

Mount Sinai School of Medicine 

Department of Ophthalmology 

New York, New York 

Kristen A. Matteson, M.D., M.P.H. 

Assistant Professor of Obstetrics and 

Gynecology 

Women & Infants Hospital of Rhode Island 

Alpert Medical School 

Providence, Rhode Island 

Donald R. Mattison, M.D. 

Senior Advisor 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Meaghan E. McCallum, B.A. 

Research Assistant 

The Miriam Hospital 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Marlene McCarthy, H.L.D. 

National Breast Cancer Coalition 

Coventry, Rhode Island 

Alyson J. McGregor, M.D. 

Assistant Professor in Emergency Medicine 

Rhode Island Hospital 

Warwick, Rhode Island 

Julia McQuillan, Ph.D. 

Associate Professor 

University of Nebraska - Lincoln 

Lincoln, Nebraska 

Suzanne S. Medgyesi-Mitschang, Ph.D. 

Strategic Planning Consultant 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Ann S. Meers, R.N. 

Urogynecology Research Coordinator 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Niharika Mehta, M.D. 

Assistant Professor (clinical) 

Brown University 

Women and Infants Hospital of Rhode Island 

Providence, Rhode Island 

Judith Merca, Ph.D., C.N.M. 

Professor 

University of Rhode Island 

Cranston, Rhode Island 

Sara Metro 

Dietetic Intern 

Sodexho at Southcoast Hospital Group 

New Bedford, Massachusetts 

Karin B. Michels, Ph.D., Sc.D. 

Associate Professor 

Department of Obstetrics, Gynecology and 

Reproductive Biology 

Brigham and Women’s Hospital 

Boston, Massachusetts 

Joe Michels, M.A., M.S. 

Administrator for Pathology & Laboratory 

Medicine 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Margaret A. Miller, M.D. 

Assistant Professor 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown 

Providence, Rhode Island 

Jeannine Miranne, M.D. 

Woman & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Stacey Ann Missmer, Sc.D. 

Assistant Professor 

Department of Obstetrics, Gynecology, and 

Reproductive Biology 

Brigham and Women’s Hospital and Harvard 

Medical School 

Boston, Massachusetts 

355
Srilakshimi Mitta, M.D. 

Doctor 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Andrew A. Monjan, Ph.D., M.P.H. 

Scientist Consultant 

National Institute on Aging 

National Institutes of Health 

Columbia, Maryland 

Valerie C. Montgomery Rice, M.D. 

Executive Director CWHR 

Meharry Medical College 

Nashville, Tennessee 

Cynthia Casson Morton, Ph.D. 

Professor 

Brigham and Women’s Hospital 

Harvard Medical School 

Boston, Massachusetts 

Linda Moulton, M.S.N., F.N.P. 

Certified Registered Nurse Practitioner 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Joan Davis Nagel, M.D., M.P.H. 

Medical Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Kacie Nakamura, M.S. 

Dietetic Intern 

Southcoast Hospitals Group 

Chestnut Hill, Massachusetts 

Elizabeth Neubouek, B.S.N. 

Nurse 

Cranston, Rhode Island 

Errol R. Norwitz, M.D., Ph.D. 

Professor 

Yale University School of Medicine 

New Haven, Connecticut 

Barbara M. O’Brien, M.D. 

Assistant Professor 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Patricia O’Connell, M.S. 

Nurse Practitioner 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Nnenna Okpara, M.D. 

Physician 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Jorge Pablo Orezzoh, M.D. 

Resident 

Women & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Charlotte Owens, M.D. 

Booz Allen Hamilton 

Atlanta, Georgia 

Kelly Pagidas, M.D. 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Michael Paglia, M.D., Ph.D. 

Women & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Patricia Ann Paluzzi, Dr.P.H., C.N.M. 

President and CEO 

Healthy Teen Network 

Baltimore, Maryland 

Ameeta Parekh, Ph.D. 

Director 

Office on Women’s Health, Food and Drug 

Administration 

National Institutes of Health 

Rockville, Maryland 

Donna R. Parker, Sc.D. 

Director of Research and Community Health 

Center for Primary Care and Prevention 

Department of Community Health 

Pawtucket, Rhode Island 

356
Karen L. Parker, M.S.W. 

Women’s Health Officer 

National Cancer Institute 

National Institutes of Health 

Rockville, Maryland 

Deborah N. Pearlman, Ph.D. 

Research Faculty 

Brown University Program in Public Health 

Providence, Rhode Island 

Maureen Pearlman, M.S., R.N. 

Director, Education and Community 

Outreach 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Teri B. Pearlstein, M.D. 

Director, Center for Women’s Behavioral 

Health 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Rebecca Perkins, M.D., M.Sc. 

Assistant Professor 

Boston University Medical Center 

Boston, Massachusetts 

Vivian W. Pinn, M.D. 

Director, Office of Research on Women’s 

Health 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Beth J. Plante, M.D. 

Clinical Assistant Professor 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Mimi Pomerleau, D.N.P., R.N.C.-OB, 

W.H.N.P.-BC 

Board of Directors 

Association of Women’s Health, Obstetric 

and Neonatal Nurses 

Reading, Massachusetts 

Raymond O. Powrie, M.D. 

Professor of Ob/Gyn, and Medicine, SVP for 

Quality & Clinical Effectiveness 

Women & Infants Hospital of Rhode Island 

Brown University 

Providence, Rhode Island 

Mercy PrabhuDas, Ph.D. 

Program Officer 

National Institutes of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Gail K. Prachniak, R.N., I.B.C.L.C. 

Lactation Consultant 

Women & Infants Hospital of Rhode Island 

Lincoln, Rhode Island 

Cathleen Sheila Prata, B.A. 

Research Assistant 

Centers for Behavioral and Preventive 

Medicine 

Providence, Rhode Island 

Amanda Pressmon, M.D. 

Fellow in Gastroenterology 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Christina A. Raker, Sc.D. 

Research Statistician 

Division of Research 

Women and Infants Hospital of Rhode Island 

Providence, Rhode Island 

Tanya M. Ratcliff, Ph.D. 

Research Fellow 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Robert W. Rebar, M.D. 

Executive Director 

American Society for Reproductive Medicine 

Birmingham, Alabama 

Karen S. Reesman, Ph.D., R.N., N.E.A., B.C. 

Associate Professor 

Appalachian State University 

Boone, North Carolina 

Patricia Relli-Moniz 

Intervention Coordinator 

The Miriam Hospital 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

357
Alessandra H. Rellini, Ph.D. 

Assistant Professor 

University of Vermont 

Psychology 

Burlington, Vermont 

Susan M. Resnick, Ph.D. 

Senior Investigator 

National Institute on Aging 

National Institutes of Health 

Baltimore, Maryland 

Lisa Reynolds 

Executive Director 

CT Oral Health Initiative 

Hartford, Connecticut 

Janet Rich-Edwards, Sc.D. 

Director of Developmental Epidemiology 

Connor’s Center for Women’s Health, 

Brigham & Women’s Hospital 

Boston, Massachusetts 

Martha E. Richmond, Ph.D., M.P.H. 

Professor and Chair 

Department of Chemistry and Biochemistry 

Suffolk University 

Boston, Massachusetts 

Barbara Riter 

Research Administration, Manager 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Scott A. Rivkees, M.D. 

Professor, Associate Chair 

Yale University 

Yale Child Health Research Center 

New Haven, Connecticut 

Audra Robertson, M.D., M.P.H. 

Brigham & Womens Hospital 

Boston, Massachusetts 

Matthew Robillard 

Dietetic Intern 

Southcoast 

South Dartmouth, Massachusetts 

Pablo Rodriguez, M.D. 

Associate Chair for Community Relationships 

Women & Infants Hospital of Rhode Island 

Women’s Care 

Pawtucket, Rhode Island 

Karen Rosene-Montella, M.D. 

Chief of Medicine 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Cynthia Rosengard, Ph.D., M.P.H. 

Associate Professor (Research) 

Women & Infants Hospital of Rhode Island 

Alpert Medical School of Brown University 

Providence, Rhode Island 

Jacques E. Rossouw, M.D. 

Branch Chief 

Women’s Health Initiative 

National Heart, Lung, and Blood Institute 

Bethesda, Maryland 

Julie Roth, M.D. 

Neurologist, Assistant Professor 

Women Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Mona J. Rowe, M.C.P. 

Associate Director for Science Policy, 

Analysis and Communication 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Joyce Rudick 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Stefanie Luise Russell, D.D.S., Ph.D., M.P.H. 

Assistant Professor 

Department of Epidemiology and Health 

Promotion 

New York University College of Dentistry 

New York, New York 

358
Rachael Schwartz, M.P.H. 

Vice President 

Lifespan 

Providence, Rhode Island 

Janet P. Searles 

Administrative Associate 

Women & Infants Hospital of Rhode Island 

East Greenwich, Rhode Island 

James Segars, M.D. 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, Maryland 

Ruby T. Senie, Ph.D. 

Professor of Clinical Public Health 

Mailman School of Public Health 

Columbia University 

New York, New York 

Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging and 

Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Katherine Sharkey, M.D., Ph.D. 

Assistant Professor 

Women & Infants Hospital of Rhode Island 

Rhode Island Hospital, Brown University 

Providence, Rhode Island 

Jan L. Shifren, M.D. 

Director, Vincent Menopause Program 

Massachusetts General Hospital 

Harvard Medical School 

Boston, Massachusetts 

Julie Shocksnider, R.N.C.-HROB, A.P.N., 

C.M.S. 

Associate Vice President 

National Perinatal Information Center 

Quality Analytic Services 

Providence, Rhode Island 

Susan Short, Ph.D. 

Associate Professor Sociology 

Brown University 

Providence, Rhode Island 

Katherine R. Silberman, J.D. 

Associate Director 

Science & Environmental Health Network 

Providence, Rhode Island 

Emma Simmons, M.D., M.P.H. 

Memorial Hospital of Rhode Island 

Brown Alpert Medical School 

Pawtucket, Rhode Island 

Gretchen D. Sloane, B.S.N. 

Project Manager Women’s Health Initiative 

Memorial Hospital of Rhode Island 

Center for Primary Care and 

Prevention - Brown University 

Pawtucket, Rhode Island 

Eileen M. Small, M.S.W. 

Project Director 

Butler Hospital 

Providence, Rhode Island 

Christine Smith 

Executive Director 

Science and Technology Council 

Providence, Rhode Island 

Simonette Soler, M.D. 

Women & Infants Hospital of Rhode Island 

North Providence, Rhode Island 

Shirley Ann Spater Freedman, D.M.D., 

M.P.H. 

Director, Samuels Sinclair Dental Center 

Rhode Island Hospital 

Providence, Rhode Island 

Nicole Sprawka, M.D. 

MFM Fellow 

Brown University 

Providence, Rhode Island 

Lucille G. St. Pierre, B.S. 

Senior Research Assistant 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

359
Marcia L. Stefanick, Ph.D. 

Professor of Medicine, and Professor of 

OB/GYN 

Stanford Prevention Research Center 

Stanford University 

Stanford, California 

Elizabeth Stier, M.D. 

Associate Professor 

Boston University Medical Center 

Boston, Massachusetts 

Lauren Stone 

Dietetic Intern 

Southcoast Hospitals 

Rehoboth, Massachusetts 

Gary E. Striker, M.D. 

Professor 

University of Miami 

Mount Sinai School of Medicine 

New York, New York 

Marilyn Stringer, Ph.D. 

Associate Professor 

University of Pennsylvania 

Philadelphia, Pennsylvania 

Laura Stroud, Ph.D. 

Assistant Professor 

Brown University 

Miriam Hospital 

Providence, Rhode Island 

Anne Stulik, M.S.N. 

OB/GYN 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Maria Sullivan 

CME Director 

Warren Alpert Medical School 

Brown University 

Providence, Rhode Island 

Vivian W. Sung, M.D., M.P.H. 

Assistant Professor 

The Warren Alpert Medical School of Brown 

University 

Women and Infants Hospital of Rhode Island 

Providence, Rhode Island 

Mary Beth Sutter 

Medical Student 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Dace Svikis, Ph.D. 

Professor of Psychology, Psychiatry, and 

OB/GYN 

Virginia Commonwealth University 

Richmond, Virginia 

Patrick J. Sweeney, M.D., Ph.D. 

Director of Ambulatory Care 

Women & Infants Hospital of Rhode Island 

The Warren Alpert Medical School of Brown 

University 

Providence, Rhode Island 

Mary Tavares, D.M.D., M.P.H. 

Senior Clinical Investigator 

Forsyth Institute 

Boston, Massachusetts 

Janice Anne Taylor 

Lactation Consultant 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Kelly Taylor, R.N. 

Research Administration 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

Margaret E. Teasdale 

Graduate Student 

University of Rhode Island 

Biomedical and Pharmaceutical Sciences 

Kingston, Rhode Island 

Glenn Tung, M.D., FACR 

Associate Dean for Clinical Affairs 

The Warren Alpert Medical School of Brown 

University 

Rhode Island Hospital 

Providence, Rhode Island 

360
Bernadette Tyree, Ph.D. 

Program Director
�

National Institute of Arthritis, 

Musculoskeletal, and Skin Diseases 

National Institutes of Health 

Bethesda, Maryland 

Rosalind Vaz 

Rhode Island Hospital 

Providence, Rhode Island 

Christin Veasley 

Associate Executive Director 

National Vulvodynia Association 

North Kingstown, Rhode Island 

Kartik Kailas Venkatesh, M.D./Ph.D.’13 

Medical/Graduate Student 

Brown University 

Alpert Medical School, Department of 

Community Health 

Providence, Rhode Island 

Risa Weisberg, Ph.D. 

Assistant Professor 

Brown University 

Providence, Rhode Island 

Marsha E. Weiss, R.N., M.S. 

Director, Community Health 

Lifespan 

East Providence, Rhode Island 

Charles Wells, Ph.D. 

Program Analysis Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Katharine D. Wenstrom, M.D. 

Director 

Women & Infants Hospital of Rhode Island 

Maternal Fetal Medicine Division 

Providence, Rhode Island 

Cora Lee Wetherington, Ph.D. 

Women & Sex/Gender Differences Research 

Coordinator 

National Institute on Drug Abuse 

National Institutes of Health 

Bethesda, Maryland 

Louise E. Wilkins-Haug, M.D., Ph.D. 

Division Director, Maternal Fetal Medicine 

and Reproductive Genetics 

Brigham & Women’s Hospital 

Boston, Massachusetts 

Jennifer Witt 

Assistant to the Director Community & 

overnment Relations 

Brown University 

Providence, Rhode Island 

David Wong, D.M.D., D.M.Sc. 

Professor 

University of California, Los Angeles 

Los Angeles, California 

Thomas C. Wright, Jr., M.D. 

President 

American Society for Colposcopy & Cervical 

Pathology 

Hagerstown, Maryland 

Thanos Zavras, D.M.D., D.M.Sc. 

Associate Professor 

Harvard University 

Boston, Massachusetts 

Cynthia T. Zembo, R.N., I.B.C.L.C. 

Lactation Consultant 

United States Breastfeeding Committee 

Women & Infants Hospital of Rhode Island 

Providence, Rhode Island 

361
CHICAGO, ILLINOIS 

OCTOBER 14–16, 2009 

PARTICIPANTS 

Judith Abramson, M.D., M.S.C.I. 

Northwestern University 

Chicago, Illinois 

Christine Ackerman 

Graduate Student 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Maricedes Acosta, Ph.D. 

Postdoctoral Fellow 

Department of Neurobiology and Physiology 

Northwestern University 

Evanston, Illinois 

Fraser Aird 

Research Assistant Professor 

Northwestern University 

Chicago, Illinois 

Barbara J. Akpan, M.S., R.N. 

Executive Board/Breast Cancer Advocate 

Metropolitan Chicago Breast Cancer Task 

Force 

Chicago Chapter Black Nurses Association 

South Holland, Illinois 

Subhashini Allu 

Clinical Research Associate 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Nicole Araneta 

Medical Student 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Kat M. Arego 

Researcher 

Northwestern University 

Chicago, Illinois 

Amanda R. Armour 

Research Projects Coordinator 

Northwestern University 

Evanston, Illinois 

Christine A. Bachrach, Ph.D. 

Acting Director 

Office of Behavioral and Social Sciences 

Research 

National Institutes of Health 

Bethesda, Maryland 

Suzanne Banuvar, M.H.S.A. 

Site Manager-OB/GYN Research 

Northwestern University 

Chicago, Illinois 

Donna R. Baptiste 

Associate Professor/Associate Director 

Center for Research on Women and Gender 

Institute for Juvenile Research 

Chicago, Illinois 

Lisa L. Barnes, Ph.D. 

Associate Professor 

Rush Alzheimer’s Disease Center 

Rush University Medical Center 

Chicago, Illinois 

Kelly Glazer Baron, Ph.D. 

Instructor 

Department of Neurology 

Northwestern University 

Chicago, Illinois 

Hope A. Barrett 

Deputy Director of LBTI Women’s Services 

Howard Brown Health Center 

Chicago, Illinois 

Laura Bartlett, M.L.S. 

Technical Information Specialist 

National Library of Medicine 

National Institutes of Health 

Bethesda, Maryland 

362
Angela Bates, M.B.A. 

Program Analyst 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Lois L. Bates 

Transgender Health Manager 

Howard Brown Health Center 

Chicago, Illinois 

Lisa Begg, Dr.P.H., R.N. 

Director of Research Programs 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Miranda Bernhardt, B.S. 

Graduate Student 

Northwestern University 

Chicago, Illinois 

Diana Bitner, M.D., N.C.M.P. 

Spectrum Health 

Michigan State University 

Grand Rapids, Michigan 

Mary C. Blehar, Ph.D. 

Writer/Editor 

National Institutes of Health (retired) 

Potomac, Maryland 

Sonja Boone, M.D. 

Director 

Physician Health and Healthcare Disparities 

American Medical Association 

Chicago, Illinois 

Luisa N. Borrell, D.D.S., Ph.D. 

Associate Professor 

Lehman College 

City University of New York 

Bronx, New York 

Wendy Bostwick, Ph.D., M.P.H. 

Assistant Professor 

Northern Illinois University 

De Kalb, Illinois 

D. Bowen, Ph.D. 

Professor 

Department of Community Health Science 

Boston University 

Boston, Massachusetts 

Rebecca G. Bowles 

Research Study Coordinator 

Northwestern University 

Chicago, Illinois 

Judith Bradford, Ph.D. 

The Fenway Institute 

Fenway Health 

Institute of Women’s Health 

Virginia Commonwealth University 

Boston, Massachusetts 

Lora E. Branch, M.S. 

Director of Administration 

STI/HIV/AIDS Division 

Chicago Department of Public Health 

Chicago, Illinois 

Sarah Bristol-Gould, Ph.D. 

Director of Research Programs 

Institute for Women’s Health Research 

Northwestern University 

Chicago, Illinois 

Allison A. Brown, Ph.D. 

Postdoctoral Fellow 

U.S. Department of Veterans Affairs 

University of Illinois at Chicago 

Chicago, Illinois 

Pamela K. Brown, M.P.A. 

Associate Director 

Mary Babb Randolph Cancer Center 

Past Chair, Intercultural Cancer Council 

Morgantown, West Virginia 

Ben Brugmann 

Northwestern University 

Chicago, Illinois 

Joanna E. Burdette, Ph.D. 

Assistant Professor 

College of Pharmacy 

University of Illinois at Chicago 

Chicago, Illinois 

363
Peggy Campbell, R.N. 

Clinical Research Nurse 

Northwestern University 

Orland Park, Illinois 

Molly L. Carnes, M.D., M.S. 

Professor and Center Director 

University of Wisconsin-Madison 

Madison, Wisconsin 

Ellen Casey, M.D. 

Sports and Spine Fellow 

Rehabilitation Institute of Chicago 

Chicago, Illinois 

Jacqueline N. Cellini, M.L.I.S. 

Reference and Education Librarian 

Northwestern Memorial Hospital 

Chicago, Illinois 

Kathy Chan 

Associate Director 

Illinois Maternal and Child Health Coalition 

Chicago, Illinois 

Adrienne Chen 

Northwestern University 

Chicago, Illinois 

Teng-Leong Chew, Ph.D. 

Director for University Imaging Resources 

Northwestern University 

Chicago, Illinois 

Eunji Chung 

Ph.D. Candidate (Graduate Student) 

Northwestern University 

Chicago, Illinois 

Marla Clayman, Ph.D., M.P.H. 

Assistant Professor 

Northwestern University 

Chicago, Illinois 

Janine Austin Clayton, M.D. 

Deputy Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Noshir S. Contractor, Ph.D. 

Jane S. & William J. White Professor of 

Behavioral Sciences 

Northwestern University 

Evanston, Illinois 

Kelly A. Corroll, Ph.D. 

Research Subject Advocate 

Northwestern University Clinical and 

Translational Sciences Institute 

Chicago, Illinois 

Nida Hennessey Corry, Ph.D. 

AAAS Science & Technology Policy Fellow 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Colleen Corte, Ph.D. 

Assistant Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Emily Crow 

Northwestern University 

Chicago, Illinois 

Cindy Danielson 

Northwestern University 

Chicago, Illinois 

John O. DeLancey, M.D. 

Professor 

University of Michigan 

Ann Arbor, Michigan 

Louis V. DePaolo, Ph.D. 

Chief, Reproductive Sciences Branch 

Center for Population Research 

Eunice Kennedy Shriver National Institute for 

Child Health and Human Development 

National Institutes of Health 

Rockville, Maryland 

Michelle Desjardins 

Research Study Programs Coordinator 

Institute for Women’s Health Research 

Northwestern University 

Chicago, Illinois 

364
Gia Gabrielle DiGiacobbe 

Educational Programs Manager 

Physician’s Assistant 

Department of Family and Community 

Medicine 

Feinberg School of Medicine 

Chicago, Illinois 

Gloria Dillard, M.P.H. 

Manager-Research Development 

American Osteopathic Association 

Chicago, Illinois 

Jessica Dirkes, M.P.H. 

Student 

University of Illinois at Chicago 

Chicago, Illinois 

Maya Doe-Simkins, M.P.H. 

Curriculum Developer 

Howard Brown Health Center 

Chicago, Illinois 

Steven E. Domino, M.D., Ph.D. 

Associate Professor Obstetrics and 

Gynecology 

University of Michigan 

Ann Arbor, Michigan 

Dilyan Doyanovski 

Graduate Student 

Northwestern University 

Chicago, Illinois 

Sharon Dubois 

Graduate Student 

Northwestern University 

Evanston, Illinois 

Andrea Dunaif, M.D. 

Professor and Chief, Endocrinology 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Diane L. Dunniway, M.S., W.H.N.P. 

DNP Candidate 

Clinical Instructor, Women’s Health Nurse 

Practitioner 

Kindred OB/GYN 

College of Nursing 

University of Illinois at Chicago 

Peoria, Illinois 

Beatrice J. Edwards, M.D. 

Associate Professor of Medicine 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Esther Eisenberg, M.D., M.P.H. 

Professor of Obstetrics and Gynecology 

Vanderbilt University Medical Center 

Nashville, Tennessee 

Jennifer S. Elam, Ph.D. 

Managing Director 

Center for Women’s Infectious Disease 

Research 

Washington University School of Medicine 

St. Louis, Missouri 

Carin Emery 

Northwestern University 

Chicago, Illinois 

Elisa Evitts 

Northwestern University 

Chicago, Illinois 

Holly Falk-Krzesinski, Ph.D. 

Director, Office of Research Team Support 

Northwestern University 

Chicago, Illinois 

Megan E. Faurot, M.Ed. 

Director of Education Programs 

Institute for Women’s Health Research 

Northwestern University 

Chicago, Illinois 

Dee Fenner, M.D. 

Professor 

University of Michigan 

Ann Arbor, Michigan 

Colleen M. Fitzgerald, M.D. 

Assistant Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Sarah Foder, Ph.D. 

Director 

Northwestern University 

Evanston, Illinois 

365
Mary A. Foulkes, Ph.D. 

Research Professor 

George Washington University 

Rockville, Maryland 

Pamela T. Frazier, M.D. 

Psychiatrist in Private Practice 

Examiner, American Board of Psychiatry and 

Neurology 

Chicago, Illinois 

Robyn Gabel, M.P.H. 

Executive Director 

Illinois Maternal and Child Health Coalition 

Chicago, Illinois 

Lilin Gallot 

Medical Monitor 

Robert H. Lurie Comprehensive Cancer 

Center 

Northwestern University 

Chicago, Illinois 

Tondalaya Gamble, M.D. 

OB/GYN Urogynecology 

Cook County 

Northwestern University 

Chicago, Illinois 

Francisco Garcia, M.D., M.P.H. 

Director and Professor 

University of Arizona 

Center of Excellence in Women’s Health 

Tucson, Arizona 

Obed Aram Garcia 

Research Technician 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Craig Garfield, M.D. 

Physician-Researcher 

Feinberg School of Medicine 

NorthShore University HealthSystem 

Evanston, Illinois 

Margery L. S. Gass, M.D. 

Executive Director Designate 

The North American Menopause Society 

Mayfield Heights, Ohio 

Sandra Gaynor, Ph.D., R.N. 

Adjunct Faculty 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Sarah J. Gehlert, Ph.D. 

E. Desmond Lee Professor of 

Racial and Ethnic Diversity at the Brown 

School 

Washington University 

St. Louis, Missouri 

Stacie E. Geller, Ph.D. 

Professor 

Department of Obstetrics and Gynecology, 

Center for Research on Women and 

Gender University of Illinois at Chicago 

Chicago, Illinois 

Elizabeth E. Gerard, M.D. 

Assistant Professor 

Department of Neurology 

Northwestern University 

Chicago, Illinois 

Naomi Lynn Gerber, M.D. 

Director, Center for the Study of Chronic 

Illness and Disability 

George Mason University 

Fairfax, Virginia 

Ronald S. Gibbs, M.D. 

Professor 

Department of Obstetrics and Gynecology 

University of Colorado-Denver School of 

Medicine 

Aurora, Colorado 

Mary L. Gillaspy, M.L.S., M.S. 

Manager, Health Learning Centers 

Northwestern Memorial Hospital 

Chicago, Illinois 

Linda C. Giudice, M.D., Ph.D., M.Sc. 

Professor and Chair 

OB/GYN and Reproductive Sciences 

University of California, San Francisco 

San Francisco, California 

Emily Godfrey, M.D., M.P.H. 

Assistant Professor 

University of Illinois at Chicago 

Chicago, Illinois 

366
Jacqueline K. Gollan, Ph.D. 

Assistant Professor, Psychiatry and 

Behavioral Sciences 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Sharon L. Green, M.H.A. 

Executive Director 

Institute for Women’s Health Research 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Susan Greenberg, B.S. 

Medical Technologist 

Northwestern Memorial Hospital 

Berwyn, Illinois 

Tatyana Grushko, Ph.D. 

Staff Scientist 

University of Chicago, Department of 

Medicine, Section of Hematology/ 

Oncology 

Chicago, Illinois 

Xiaoxiao Catherine Guo 

Postbaccalaureate Intramural Research 

Trainee/Fellow 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

Bethesda, Maryland 

Dhanesh Kumar Gupta, M.D. 

Associate Professor 

Director of Neuroanesthesia Research 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Eleanor Z. Hanna, Ph.D. 

Associate Director for Special Projects and 

Centers 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Martha L. Hare, Ph.D., R.N. 

Program Director 

Center to Reduce Cancer Health Disparities 

National Cancer Institute 

National Institutes of Health 

Rockville, Maryland 

Karen J. Hartwell, M.D. 

Assistant Professor 

Department of Psychiatry and Behavioral 

Sciences 

Medical University of South Carolina 

Charleston, South Carolina 

Bryna Harwood, M.D., M.S. 

Associate Professor 

Obstetrics and Gynecology 

University of Illinois at Chicago 

Chicago, Illinois 

Geoff Hayes, Ph.D. 

Assistant Professor 

Endocrinology 

Northwestern University 

Chicago, Illinois 

Jennifer Hebert-Beirne, Ph.D. 

Director of Research/Adjunct Assistant 

Professor 

Womens Health Foundation 

University of Illinois at Chicago 

Chicago, Illinois 

Carole Ann Heilman, Ph.D. 

Director 

Division of Microbiology and Infectious 

Diseases 

National Institute of Allergy and Infectious 

Diseases 

National Institutes of Health 

Bethesda, Maryland 

Ronda S. Henry-Tillman, M.D. 

Director, Cancer Control 

Winthrop P. Rockefeller Cancer Institute 

University of Arkansas for Medical Sciences 

Little Rock, Arkansas 

367
Patricia Ensweiler Hershberger, Ph.D., 

A.P.R.N. 

Assistant Professor 

Department WCFHS 

University of Illinois at Chicago 

Chicago, Illinois 

Monique E. Hinchcliff, M.D. 

Clinical Instructor 

Northwestern University 

Chicago, Illinois 

Eleanor Hinton Hoytt, M.S., M.A. 

President & CEO 

Black Women’s Health Imperative 

Washington, District of Columbia 

Jody K. Hirsh, Ph.D. 

Clinical Research Associate 

Division of Endocrinology 

Northwestern University 

Chicago, Illinois 

Michelle D. Hoersch, M.S. 

Regional Women’s Health Coordinator 

Office on Women’s Health 

U.S. Department of Health and Human 

Services 

Chicago, Illinois 

Louisa W. Holaday 

Study Coordinator 

Northwestern University 

Chicago, Illinois 

Amber L. Hollibaugh 

Chief Officer of Elder & LBTI Women’s 

Services 

Howard Brown Health Center 

Chicago, Illinois 

Vickie Howard 

Administrative Assistant 

Northwestern University 

Chicago, Illinois 

Constance A. Howes, J.D. 

President & CEO 

Women & Infants Hospital 

Providence, Rhode Island 

Tonda L. Hughes, Ph.D. 

Research Director/Professor/Department 

Head 

National Center of Excellence in Women’s 

Health College of Nursing 

University of Illinois at Chicago 

Chicago, Illinois 

Scott Hultgren, Ph.D. 

Director 

Center for Women’s Infectious Disease 

Research 

Washington University School of Medicine 

St. Louis, Missouri 

Mildred Hunter 

Regional Minority Health Coordinator 

U.S. Department of Health and Human 

Services 

Chicago, Illinois 

Kristian Hurley, B.S., B.A. 

Assistant Director 

American Autoimmune Related Diseases 

Association 

East Detroit, Michigan 

Carol Isaac, Ph.D., P.T. 

University of Wisconsin-Madison 

Madison, Wisconsin 

Linda Marie Jagielski, L.P.N. 

Licensed Practical Nurse 

Office Staff Maternal-Fetal Medicine 

Northwestern Medical Faculty Foundation 

Chicago, Illinois 

Catherine Jefcoat 

Director, LCCP 

Howard Brown Health Center 

Chicago, Illinois 

Hyunyoung Jeong, Pharm.D., Ph.D. 

Assistant Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Paula A. Johnson, M.D., M.P.H. 

Chief, Division of Women’s Health 

Brigham and Women’s Hospital 

Boston, Massachusetts 

368
Riley D. Johnson 

Founder (QPHC); Co-Founder (TGAP) 

Queer People’s Health Collective (QPHC) 

Trans Gynecology Access Program (TGAP) 

Chicago, Illinois 

Anna Kaatz, M.A. 

University of Wisconsin-Madison 

Madison, Wisconsin 

Mayuko Kadono, M.D., Ph.D. 

Postdoctoral Fellow 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Anastasia Z. Kalea, Ph.D. 

Postdoctoral Research Fellow 

Nephrology/Hypertension 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Linda M. Kaste, D.D.S., Ph.D., M.S. 

Associate Professor 

College of Dentistry 

University of Illinois at Chicago 

Chicago, Illinois 

Theresa Keeley, R.N. 

Research Nurse 

Northwestern University 

Chicago, Illinois 

Terri Kendrix 

Administrative Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Diana R. Kerwin, M.D. 

Assistant Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Sultana Khan, M.D. 

Senior Consultant, Obstetrics-Gynecology 

Khoula Hospital, Muscat, Oman 

Northfield, Illinois 

Melina Kibbe, M.D. 

Associate Professor of Surgery 

Department of Surgery 

Northwestern University 

Chicago, Illinois 

Sarah Kilpatrick, M.D., Ph.D. 

Professor and Head, Vice Dean 

Department of OB/GYN 

University of Illinois, College of Medicine 

Chicago, Illinois 

Alison Kim 

Northwestern University 

Chicago, Illinois 

Karen Kim, M.D., M.S. 

Associate Professor of Medicine 

The University of Chicago 

Chicago, Illinois 

Jingjing Kipp, Ph.D. 

Northwestern University 

Evanston, Illinois 

Mary Kleinman, M.A. 

Research Administrator 

Loyola University Chicago 

Chicago, Illinois 

Eileen Knightly 

Director, Women’s Health and the Breast 

Care Center 

Mercy Hospital and Medical Center 

Chicago, Illinois 

Abby Koch, M.A. 

Research Specialist 

University of Illinois at Chicago 

Chicago, Illinois 

Simone Koehlinger, Psy.D. 

Director 

Office of Lesbian, Gay, Bisexual, and 

Transgender Health 

Chicago Department of Public Health 

Chicago, Illinois 

Katania Kotuik, Ph.D. 

Northwestern University 

Chicago, Illinois 

369
Elizabeth Krause, Pharm.D. 

University of Illinois at Chicago 

Chicago, Illinois 

Jelena Kravarusic, M.D., Ph.D. 

Endocrinology Fellow 

Northwestern University 

Chicago, Illinois 

Howard M. Kravitz, D.O., M.P.H. 

Professor of Psychiatry 

Rush University Medical Center 

Chicago, Illinois 

Eileen Krepkovich, M.S. 

Research Engineer 

Rehabilitation Institute of Chicago 

Northwestern University 

Chicago, Illinois 

Sheila Krishnan 

Fellow 

Northwestern University 

Chicago, Illinois 

Lisa M. Kuhns, Ph.D., M.P.H. 

Associate Director of Research 

Howard Brown Health Center 

Chicago, Illinois 

Nina Lambert, B.S.N. 

Clinical Nurse Specialist 

Northwestern University 

Chicago, Illinois 

Monica Laronda 

Northwestern University 

Chicago, Illinois 

Missy D. Lavender, M.B.A. 

Executive Director 

Women’s Health Foundation 

Chicago, Illinois 

Jen Lawrence 

Associate Director, Foundation Relations 

Northwestern University 

Evanston, Illinois 

Mary G. Lawrence 

Program Analyst 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Alanna N. Lazarowich, M.B.A. 

Senior Project Director 

Northwestern Memorial Hospital 

Chicago, Illinois 

Milos Lazic 

Graduate Student 

Northwestern University 

Chicago, Illinois 

Sharon B. Lear 

Philanthropy Director 

Northwestern Memorial Foundation 

Chicago, Illinois 

Phoebe Starfield Leboy, Ph.D. 

President 

Association for Women in Science 

University of Pennsylvania 

Narberth, Pennsylvania 

Sandra Lee, Ph.D. 

MSTP Associate Director 

Northwestern University 

Chicago, Illinois 

Kimberly K. Leslie, M.D. 

Professor and Head, Department of OB/GYN 

University of Iowa Hospitals and Clinics 

Iowa City, Iowa 

Anait S. Levenson, M.D., Ph.D. 

Research Associate Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Clara Lingle 

Daily Northwestern Reporter 

Northwestern University 

Evanston, Illinois 

370
Guoying Liu, Ph.D. 

Program Director 

National Institute of Biomedical Imaging and 

Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Jing Liu, M.D. 

Research Associate 

Northwestern University 

Chicago, Illinois 

Rebecca Liu, M.D. 

Associate Professor 

Department of Obstetrics & Gynecology 

University of Michigan 

Ann Arbor, Michigan 

Suhuan Liu 

Research Associate 

Northwestern University 

Division of Endocrinology 

Chicago, Illinois 

Yu Liu 

Postdoctor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Tanya Lopez 

Senior Research Associate 

Division of Physician Health & Health Care 

Disparities 

American Medical Association 

Chicago, Illinois 

Brian Lowe, Ph.D. 

Research Scientist 

QIAGEN, Inc. 

Gaithersburg, Maryland 

Chi-Hao Luan, Ph.D. 

Director, Northwestern High Throughput 

Analysis Laboratory 

Northwestern University 

Evanston, Illinois 

Xia Luo, Ph.D. 

Researcher 

Northwestern University 

Chicago, Illinois 

Susan Magasi, Ph.D. 

Research Assistant Professor 

Department of Medical Social Sciences 

Northwestern University 

Chicago, Illinois 

Pauline M. Maki, Ph.D. 

Associate Professor 

Departments of Psychiatry and Psychology 

University of Illinois at Chicago 

Chicago, Illinois 

Trudy Mallinson, Ph.D. 

Clinical Research Scientist 

Rehabilitation Institute of Chicago 

Chicago, Illinois 

Buvana Manickam, M.D. 

Instructor in Medicine 

Northwestern University 

Chicago, Illinois 

Spyridoula Maraka, M.D. 

Postdoctoral Fellow 

Northwestern University 

Chicago, Illinois 

Kelly R. Martin, M.Ed., M.P.H. 

Project Director 

University of Illinois at Chicago 

Chicago, Illinois 

Rebecca Martin 

Northwestern University 

Chicago, Illinois 

Lisa A. Martinez, J.D., R.N. 

Executive Director 

The Women’s Sexual Health Foundation 

Cincinnati, Ohio 

Ellen D. Mason, M.D. 

Internal Medicine Consultant 

Division of Maternal-Fetal Medicine 

John H. Stroger Jr. Hospital of Cook County 

Chicago, Illinois 

Sandra Kazahn Masur, Ph.D. 

Director, Office for Women’s Careers 

Department of Ophthalmology 

Mount Sinai School of Medicine 

New York, New York 

371
Agnella Izzo Matic, Ph.D. 

Postdoctoral Fellow 

Department of Otolaryngology 

Northwestern University 

Chicago, Illinois 

Alicia Matthews, Ph.D. 

Associate Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Celia J. Maxwell, M.D. 

Assistant Vice President for Health Sciences 

Howard University Hospital 

Washington, District of Columbia 

Kelly E. Mayo, Ph.D. 

Professor and Chair 

Center for Reproductive Science 

Northwestern University 

Evanston, Illinois 

Vickie M. Mays, Ph.D., M.S.P.H. 

Department of Health Services 

UCLA School of Public Health 

Los Angeles, California 

Pamela McCann, M.S. 

Public Health Administrator 

Office of Lesbian, Gay, Bisexual, and 

Transgender Health 

Chicago Department of Public Health 

Chicago, Illinois 

Beverly J. McElmurry, Ed.D. 

Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Richard McGee, Ph.D. 

Associate Dean, Faculty Recruitment and 

Professional Development 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Donna V. McGregor, M.S.N., R.N., A.N.P. 

Nurse Practitioner, Infectious Diseases 

Northwestern University 

Chicago, Illinois 

Suzanne S. Medgyesi-Mitschang, Ph.D. 

Strategic Planning Consultant 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Marissa A. Michaels, M.S. 

Senior Research Technologist 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Susan Fisher Miller, Ph.D. 

Associate Director, Foundation Relations 

Northwestern University 

Evanston, Illinois 

Peggy Mitchell, M.S. 

Administrative Director 

Clinical and Translational Sciences Institute 

Northwestern University 

Chicago, Illinois 

Arlen Moller, Ph.D. 

Research Assistant Professor 

Department of Preventive Medicine 

Northwestern University 

Chicago, Illinois 

Joanne M. Monreal-Amrein 

Data Coordinator/Manager 

HSCT Transplantation Northwestern 

Memorial 

Northwestern University 

Chicago, Illinois 

Priscilla Mutharasan, M.D. 

Fellow 

Division of Endocrinology 

Northwestern University 

Chicago, Illinois 

Joan Davis Nagel, M.D., M.P.H. 

Medical Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Amy Neustadt, M.P.H. 

University of Chicago Medical Center 

Chicago, Illinois 

372
Wanda Nicholson 

Associate Professor 

Johns Hopkins Medical Institution 

Baltimore, Maryland 

Nonso Njokanma, M.S., M.P.H. 

Center for Women’s Health Research 

University of Wisconsin-Madison 

Madison, Wisconsin 

Annmaree Nobelius, Ph.D., M.Sc., B.Sc. 

Monash University 

Kallista, VIC 

Mona Norieaga 

Ph.D. Student Public Administration 

University of Illinois at Chicago 

Chicago, Illinois 

Nancy J. Norton 

President 

International Foundation for Functional 

Gastrointestinal Disorders 

Milwaukee, Wisconsin 

Samia Dawud Noursi, Ph.D. 

Health Scientist Administrator 

Women and Sex/Gender Differences 

Research Program 

National Institute on Drug Abuse 

National Institutes of Health 

Bethesda, Maryland 

Mary Beth O’Connell, Pharm.D. 

Associate Professor 

College of Pharmacy and Health Sciences 

Wayne State University 

Detroit, Michigan 

Diane O’Connor, R.N., M.P.A. 

Administrative Director 

University of Minnesota 

Minneapolis, Minnesota 

Mary I. O’Connor, M.D. 

Associate Professor 

Mayo Clinic 

Jacksonville, Florida 

Christine A. O’Conor 

Medical Student 

Northwestern University 

Chicago, Illinois 

Elizabeth O. Ofili, M.D. 

Professor of Medicine, Chief of Cardiology, 

and Associate Dean of Clinical Research 

Clinical Research Center 

Morehouse School of Medicine 

Atlanta, Georgia 

Tochi Okwuosa, D.O. 

Postdoctoral Research Fellow 

Preventive Medicine 

Northwestern University Department of 

Chicago, Illinois 

Ellen O’Ned, C.N.M., M.S. 

Nurse 

Northwestern University 

Chicago, Illinois 

Anthony Opipari, M.D. 

Associate Professor 

Department of Obstetrics & Gynecology 

University of Michigan 

Ann Arbor, Michigan 

Eugene P. Orringer, M.D. 

Executive Associate Dean for Faculty Affairs 

and Faculty Development 

University of North Carolina School of 

Medicine 

Chapel Hill, North Carolina 

Kwame Osei, M.D. 

Professor of Medicine 

The Ohio State University 

Columbus, Ohio 

Charlotte Owens, M.D. 

Booz Allen Hamilton 

Atlanta, Georgia 

Hannah Park 

Study Coordinator 

Buehler Center on Aging, Health & Society 

Northwestern University 

Chicago, Illinois 

373
Karen L. Parker, M.S.W. 

Women’s Health Officer 

National Cancer Institute 

National Institutes of Health 

Rockville, Maryland 

Beth Pellettieri 

Student/Research Assistant 

University of Illinois at Chicago 

Chicago, Illinois 

Nicole Perez, M.A. 

Research Coordinator 

Amigas Catinas 

Chicago, Illinois 

Janice Phillips, Ph.D. 

Nurse Researcher 

University of Chicago Medical Center 

Chicago, Illinois 

Vivian W. Pinn, M.D. 

Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Kristen Pozolo, B.S. 

Clinical Research Coordinator 

North Shore University 

Chicago, Illinois 

Kathleen Ann Prendergast 

Clinical Research Coordinator 

Northwestern University 

Chicago, Illinois 

Jodi Ram 

Intern 

University of California, San Francisco 

Lesbian Health & Research Center 

San Francisco, California 

Rosalind Ramsey-Goldman, M.D., Dr.P.H. 

Solovy Arthritis Research Society Research 

Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Judith G. Regensteiner, Ph.D. 

Professor 

University of Colorado-Denver School of 

Medicine 

Aurora, Colorado 

Jessica Reimer, Ph.D. 

Northwestern University 

Chicago, Illinois 

Robin Remich, M.A. 

Research Associate 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Leticia Reyes 

Division Chief, Division of Health Policy 

Illinois Department of Public Health 

Chicago, Illinois 

Lourdes S. Richardson, M.S.N., Ed.D., R.N. 

Manager, PCOS Research 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Valerie Rochester 

Director of Program Development & Training 

Black Women’s Health Imperative 

Washington, District of Columbia 

Brian Rood, M.A. 

Student 

DePaul University 

Chicago, Illinois 

Sally E. Rosen, M.D., M.F.S. 

Founding Director, Center for Women’s 

Health Research, Leadership, and 

Advocacy 

Temple University 

Wynnewood, Pennsylvania 

Archana Roy, M.D. 

Chicago, Illinois 

374
Joyce Rudick 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, Maryland 

Donita Russell 

Information Technology 

Northwestern University 

Chicago, Illinois 

Yamini Sabherwal, Ph.D. 

Postdoctoral Trainee 

Northwestern University 

Chicago, Illinois 

Diane Abbe Sabin, D.C. 

Executive Director 

Lesbian Health & Research Center 

University of California, San Francisco 

San Francisco, California 

Kathryn Sandberg, Ph.D. 

Professor of Medicine 

Director, Center for the Study of Sex 

Differences 

Georgetown University 

Washington, District of Columbia 

Gloria Sarto, M.D., Ph.D. 

Co-Director 

Center for Women’s Health Research 

University of Wisconsin 

Madison, Wisconsin 

Carolina Gonzalez Schlenker, M.D., M.P.H. 

Health Disparities Scholar 

Center for Women’s Health Research 

University of Wisconsin-Madison 

Madison, Wisconsin 

Bethanee J. Schlosser, M.D., Ph.D. 

Assistant Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Barbara L. Schuster, M.D., M.S. 

Adjunct Professor, University of Georgia 

Campus Dean, Medical College of Georgia 

Athens, Georgia 

Neena B. Schwartz, Ph.D. 

Deering Professor Emerita 

Department of Neurobiology and Physiology 

Northwestern University 

Evanston, Illinois 

Dorie Schwertz, Ph.D. 

Associate Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Esther Sciannarella, M.S. 

Director 

Chicago Hispanic Health Coalition 

Chicago, Illinois 

Scout, Ph.D. 

Director 

National LGBT Tobacco Control Network 

The Fenway Institute 

Boston, Massachusetts 

Nance A. Seiple, M.Ed., R.N., C.R.N.A. 

Science Writer 

Medical Communications 

Park Ridge, Illinois 

Maria Serratto, M.D. 

Professor 

University of Illinois College of Medicine at 

Chicago 

Chicago, Illinois 

Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging and 

Bioengineering 

National Institutes of Health 

Bethesda, Maryland 

Shailja P. Sharma, M.S. 

Clinical Research Associate 

Northwestern University 

Chicago, Illinois 

Jessica E. Shore, B.S.N. 

Research Nurse 

University of Illinois at Chicago 

Northwestern University 

Chicago, Illinois 

375
Farida Siddiqui, B.S., C.C.R.P. 

Clinical Research Coordinator 

Northwestern University 

Chicago, Illinois 

Melissa A. Simon, M.D., M.P.H. 

Assistant Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Yaa Simpson, M.P.H. 

The Association of Clinical Trial Services 

Chicago, Illinois 

Jeanne C. Sinkford, D.D.S., Ph.D. 

Associate Executive Director and Director, 

ADEA Center for Equity and Diversity 

American Dental Education Association 

Washington, District of Columbia 

Cheryl L. Sisk, Ph.D. 

Director, Neuroscience Program 

Michigan State University 

East Lansing, Michigan 

Susan P. Sloan, M.D. 

Clinical Associate Professor of Medicine 

Director, IM Residency Program 

Drexel University 

Easton Hospital 

Easton, Pennsylvania 

Carrol Smith, Ph.D. 

Clinical Assistant Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Farida Sohrabji, Ph.D. 

Professor 

Neuroscience and Experimental Therapeutics 

Texas A&M Health Science Center, 

College Station, Texas 

Linda Greer Spooner, M.D., J.D. 

Medical Director 

Cape Fear Valley Medical System 

Fayetteville, North Carolina 

Bonnie Spring, Ph.D. 

Professor 

Department of Preventive Medicine 

Northwestern University 

Chicago, Illinois 

Carolyn R. Stern, M.D. 

Physician & Partner 

DeafDOC.org 

Unity Health System 

Rochester, New York 

Paula H. Stern, Ph.D. 

Professor 

Northwestern University 

Chicago, Illinois 

Noreen Stewart, B.S. 

NorthShore University HealthSystem 

Evanston, Illinois 

Ljuba Stojiljkovic, M.D., Ph.D. 

Associate Professor of Anesthesiology 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Nada L. Stotland, M.D., M.P.H. 

Professor of Psychiatry 

Immediate Past President, American 

Psychiatric Association 

Rush Medical College 

Chicago, Illinois 

Gary E. Striker, M.D. 

Professor 

Mount Sinai School of Medicine 

New York, New York 

Preeti Sukerkar 

Northwestern University 

Evanston, Illinois 

Anne E. Sumner, M.D. 

Investigator 

National Institute of Diabetes and Digestive 

and Kidney Diseases 

National Institutes of Health 

Bethesda, Maryland 

376
Sarah Sutton, M.D. 

Assistant Professor 

Northwestern University 

Chicago, Illinois 

Mallory R. Swift 

Research Study Programs Coordinator 

Northwestern Memorial Faculty Foundation 

Northwestern University 

Chicago, Illinois 

Derrick C. Tabor, Ph.D. 

Centers of Excellence Program 

Office of Scientific Programs 

National Institute on Minority Health and 

Health Disparities 

National Institutes of Health 

Bethesda, Maryland 

Susan Taymans, Ph.D. 

Program Director 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Rockville, Maryland 

Rita Terterian 

Philanthropy Director 

Northwestern Memorial Foundation 

Chicago, Illinois 

Sandra D. Thomas, M.D., M.S. 

Assistant Commissioner for Epidemiology 

Chicago Department of Public Health 

Chicago, Illinois 

Candace Tingen 

Northwestern University 

Chicago, Illinois 

Paloma Toledo, M.D. 

Instructor in Anesthesiology 

Northwestern University 

Chicago, Illinois 

Debra A. Toney, Ph.D., R.N. 

President 

National Black Nurses Association 

Las Vegas, Nevada 

Kim Tran 

Intern 

National Council of Asian and Pacific 

Islander Physicians 

Chicago, Illinois 

Joy Tsai, M.D. 

Resident 

Northwestern University 

Chicago, Illinois 

Frank F. Tu, M.D., M.P.H. 

Assistant Professor 

NorthShore University HealthSystem 

University of Chicago 

Evanston, Illinois 

Rodney Ulane, Ph.D. 

Director, Division of Scientific Programs 

National Institutes of Health 

Bethesda, Maryland 

Margrit Urbanek, Ph.D. 

Assistant Professor 

Feinberg School of Medicine 

Center for Genetic Medicine 

Northwestern University 

Chicago, Illinois 

Sandra Uribe, A.P.N., C.N.M. 

CNM 

Labor/Delivery 

Northwestern Memorial Hospital 

Chicago, Illinois 

Thasarat S. Vajaranant, M.D. 

Assistant Professor 

University of Illinois at Chicago 

Chicago, Illinois 

Linda Van Horn, Ph.D., R.D. 

Professor 

Associate Dean for Faculty Development 

Department of Preventive Medicine 

Northwestern University 

Chicago, Illinois 

Annabelle Volgman, M.D. 

Medical Director 

Rush Heart Center for Women 

Rush University Medical Center 

Chicago, Illinois 

377
Amisha Wallia, M.D. 

Endocrinology Fellow 

Northwestern Memorial Hospital 

Chicago, Illinois 

Joseph (Jay) T. Walsh, Ph.D. 

Vice President for Research 

Northwestern University 

Evanston, Illinois 

Nanette K. Wenger, M.D. 

Chief of Cardiology, Grady Memorial Hospital 

Professor of Medicine (Cardiology) 

Emory University School of Medicine 

Atlanta, Georgia 

Cora Lee Wetherington, Ph.D. 

Women & Sex/Gender Differences Research 

Coordinator 

National Institute on Drug Abuse 

National Institutes of Health 

Bethesda, Maryland 

JoEllen Wilbur, Ph.D. 

Professor 

Rush University 

Chicago, Illinois 

Karen Williams, C.C.R.P. 

Clinical Research Coordinator 

Northwestern University 

Chicago, Illinois 

Vanessa Willis, R.N. 

Instructor/Supervisor 

Chicago Chapter Black Nurses Association 

American Heart Association 

Calumet City, Illinois 

Bianca D.M. Wilson, Ph.D. 

Assistant Professor 

California State University, Long Beach 

Long Beach, California 

Katie Wilson, L.C.S.W. 

Clinical Patient Navigator 

American Cancer Society 

Northwestern Memorial Hospital 

Chicago, Illinois 

Karen Winkfield, M.D., Ph.D. 

Harvard Radiation Oncology Program 

Boston, Massachusetts 

Winifred Wong, Ph.D. 

Postdoctoral Research Fellow 

Northwestern University 

Chicago, Illinois 

Susan F. Wood, Ph.D. 

Associate Professor 

Department of Health Policy 

George Washington University School of 

Public Health and Health Services 

Washington, District of Columbia 

Teresa K. Woodruff, Ph.D. 

Professor 

Northwestern University 

Chicago, Illinois 

Nancy Fugate Woods, Ph.D., R.N. 

Professor 

School of Nursing 

University of Washington 

Seattle, Washington 

Jane Wu, M.D. 

Professor of Neurology 

Northwestern University 

Chicago, Illinois 

Pei-Hsuen Wu, B.A. 

Northwestern University 

Chicago, Illinois 

Sudha Yalamanchi, M.D. 

Postdoctoral Fellow 

Northwestern University 

Chicago, Illinois 

Barbara Yee, Ph.D. 

Professor and Chair 

University of Hawaii at Manoa 

Honolulu, Hawaii 

Fruma Yehiely, Ph.D. 

Northwestern University 

Chicago, Illinois 

378
Eva Yerende 

Student 

University of Illinois at Chicago 

Oak Park, Illinois 

Elizabeth J. Yoder, Ph.D. 

University of California, San Diego 

La Jolla, California 

Phyllis C. Zee, M.D., Ph.D. 

Professor 

Northwestern University 

Chicago, Illinois 

John X. Zhang, Ph.D. 

Professor 

Feinberg School of Medicine 

Northwestern University 

Chicago, Illinois 

Kristine J. Zimmermann, M.P.H. 

Assistant Director 

Center for Research on Women and Gender 

University of Illinois at Chicago 

Chicago, Illinois 

Laurie Zoloth, Ph.D. 

Director, Center for Bioethics 

Science, and Society 

Northwestern University 

Chicago, Illinois 

ATLANTA, GEORGIA 

FEBRUARY 16–17, 2010 

PARTICIPANTS 

Larissa Avilés-Santa, M.D., Ph.D. 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Elizabeth Barrett-Connor, M.D. 

Professor 

Family and Preventive Medicine 

University of California San Diego 

La Jolla, CA 

Debbie S. Barrington, Ph.D., M.P.H. 

Assistant Professor 

Department of Epidemiology 

Columbia University 

New York, NY 

Lisa Begg, Dr.P.H., R.N. 

Director, Research Programs 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Raquel Bennett-Gittens, M.D. 

Science Writer 

Emory University School of Medicine 

Marietta, GA 

Sarah L. Berga, M.D. 

James Robert McCord Professor/Chair 

Emory University School of Medicine 

Atlanta, GA 

Diana L. Bitner, M.D. 

Director, Women’s Health Network 

Spectrum Health, Michigan State University 

Grand Rapids, MI 

Mary Blehar, Ph.D. 

Science Writer, Consultant 

Office of Research on Women’s Health 

National Institutes of Health 

Potomac, MD 

379
Barbara D. Boyan, Ph.D. 

Professor 

Biomedical Engineering 

Georgia Institute of Technology 

Atlanta, GA 

Ian Campbell 

Graduate Student 

Georgia Institute of Technology 

Atlanta, GA 

Sundeep Chaudhry, M.D. 

Chief Medical Officer 

Research & Development 

Met-test, Inc. 

Atlanta, GA 

Janine Austin Clayton, M.D. 

Deputy Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Nakela Cook, M.D., M.P.H. 

Medical Officer 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Matthew A. Corriere, M.D., M.S. 

Assistant Professor
�

Vascular Surgery and Endovascular Therapy/
�

Surgery 

Emory University School of Medicine 

Atlanta VA Medical Center 

Atlanta, GA 

Nida Hennessey Corry, Ph.D. 

AAAS Science & Technology Policy Fellow 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Dorothy L. Coverson, Ph.D. 

Research Assistant Professor 

Cardiovascular Research Institute & 

Community Health and Preventative 

Medicine 

Morehouse School of Medicine 

Atlanta, GA 

Anne B. Curtis, M.D. 

Professor & Director 

Cardiovascular Disease 

University of South Florida 

Tampa, FL 

Elvan Catherine Daniels, M.D., M.P.H. 

Associate Director for Community Oriented 

Primary Care 

National Center for Primary Care/Community

 Health and Preventive Medicine 

Morehouse School of Medicine 

Atlanta, GA 

Patrice Marie Desvigne-Nickens, M.D. 

Medical Officer 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Neal W. Dickert, M.D., Ph.D. 

Fellow 

Cardiology/Medicine 

Emory University School of Medicine 

Atlanta, GA 

Clara-Ann Earls, Ph.D., M.Div., M.A.C.E., 

Pastor 

Bread of Life Church of the Living Christ 

Decatur, GA 

Reza Fazel, M.D., M.Sc. 

Assistant Professor of Medicine 

Cardiology 

Emory University 

Atlanta, GA 

Victoria Fort 

Guest Researcher 

Office of Minority and Women’s Health 

Emory University 

Atlanta, GA 

Cheryl Franklin, M.D., M.P.H. 

Morehouse School of Medicine 

Atlanta, GA 

Erin M. Galbraith, M.D. 

Fellow 

Cardiology 

Emory University 

Atlanta, GA 

380
Gary Gibbons, M.D. 

Director, Cardiovascular Research Institute 

Professor School of Medicine 

Cardiovascular Research Institute 

Morehouse School of Medicine 

Atlanta, GA 

Amy M. Goetzinger, Ph.D. 

Post-doctoral Fellow 

Medical Psychology, Department of 

Psychiatry & Behavioral Science 

Duke University Medical Center 

Durham, NC 

Maria Carolina Gongora, M.D. 

Cardiology Fellow 

Medicine Department, Cardiology Division 

Emory University 

Atlanta, GA 

Yvonne Green 

Director, Office of Women’s Health 

Centers for Disease Control and Prevention 

Atlanta, GA 

Kathy K. Griendling, Ph.D. 

Professor of Medicine 

Vice Chair for Faculty Development 

Emory University School of Medicine 

Atlanta, GA 

Sarah Griffiths, Eng.D. 

Post Doctoral Fellow 

Georgia Institute of Technology 

Atlanta, GA 

Divya Gupta, M.D. 

Science Writer 

Emory University Hospital 

Atlanta, GA 

Jane L. Harman, D.V.M., Ph.D., M.S. 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Sharonne N. Hayes, M.D. 

Director, Women’s Heart Clinic 

Cardiovascular Diseases 

Mayo Clinic 

Rochester, MN 

Frances C. Henderson, Ed.D., R.N. 

Deputy Director 

Jackson Heart Study 

Jackson, MS 

Yolanda Y. Hendley, M.D. 

Cardiology Fellow 

Emory University 

Atlanta, GA 

Roberto Hodara, M.D. 

Cardiology Fellow 

Emory University 

Atlanta, GA 

Charles F. Jackson, M.D. 

Cardiology Fellow 

Emory University 

Decatur, GA 

Indira P. Jevaji, M.D., M.S.L. 

Senior Medical Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Jennifer Johnson 

Associate Director 

Health Sciences Communications 

Emory University 

Atlanta, GA 

Ryan Jordan, M.D. 

Cardiology Fellow 

Emory University 

Atlanta, GA 

Claire Z. Kalpakjian, Ph.D., M.S. 

Assistant Professor 

Physical Medicine and Rehabilitation 

University of Michigan 

Ann Arbor, MI 

Jay Ross Kaplan, Ph.D. 

Professor, Section Head, and Director 

Pathology/Comparative Medicine 

Wake Forest University Health Sciences 

Winston-Salem, NC 

381
Suma H. Konety, M.D. 

Assistant Professor 

Cardiology 

University of Minnesota 

Minneapolis, MN 

Thomas J. Lawley, M.D. 

Dean 

School of Medicine 

Emory University 

Atlanta, GA 

E. Clinton Lawrence, M.D. 

Augustus J. McKelvey Professor of Medicine 

McKelvey Lung Transplantation Center 

Emory University School of Medicine 

Atlanta, GA 

Rebecca D. Levit, M.D. 

Cardiology Fellow 

Cardiovascular Disease 

Emory University 

Atlanta, GA 

Catherine (Cay) Loria, Ph.D., M.S. 

Nutritional Epidemiologist 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Martha Shauck Lundberg, Ph.D. 

Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Benjamin Mackie, M.D. 

Science Writer 

Emory University 

Atlanta, GA 

Dennis F. Mangan, Ph.D. 

Health Scientist 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Deborah A. McClendon, N.P.-C., M.P.H 

Ph.D. candidate 

Unit Director, Nursing 

Emory Healthcare 

Atlanta, GA 

Marian McDonald, Dr.P.H., M.P.H., M.A. 

Associate Director for Minority and Women’s 

Health 

Division of Emerging Infections and 

Surveillance Services 

Centers for Disease Control and Prevention 

Atlanta, GA 

Theresa McIlraith, C.C.D.S., M.S.E.E. 

Manager 

Arrhythmia Center 

Emory University Hospital Midtown 

Atlanta, GA 

Suzanne S. Medgyesi-Mitschang, Ph.D. 

Strategic Planning Consultant 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Chiara Melloni, M.D. 

Assistant Professor 

Department of Cardiology 

Duke University Medical Center 

Durham, NC 

Nadya Merchant, M.P.H., Ph.D. 

Vice President, Clinical Operations 

Atlantic Clinical Research Center 

Tucker, GA 

Virginia M. Miller, Ph.D. 

Professor of Surgery and Physiology 

Departments of Surgery, Physiology and 

Biophysics 

Mayo Clinic 

Rochester, MN 

Nancy Murrah, R.N., B.S.N. 

Sr. Supervisor Research Nurse 

Emory University 

Atlanta, GA 

Joan Davis Nagel, M.D., M.P.H. 

Medical Officer 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Robert Nerem, Ph.D. 

Georgia Institute of Technology 

Atlanta, GA 

382
Elizabeth O. Ofili, M.D. 

Professor of Medicine, Chief of Cardiology 

Associate Dean of Clinical Research 

Clinical Research Center 

Morehouse School of Medicine 

Atlanta, GA 

Modele O. Ogunniyi, M.D., M.P.H. 

Assistant Professor of Medicine (Cardiology) 

Division of Cardiology, Department of 

Medicine 

Emory University 

Atlanta, GA 

Christen Ohaire, Ph.D. 

Program Coordinator 

Department of Obstetrics and Gynecology 

Oregon Health & Science University 

Portland, OR 

Patricia A. Pellikka, M.D. 

Professor of Medicine, Co-Director, 

Echocardiography Laboratory 

Division of Cardiovascular Diseases 

Mayo Clinic College of Medicine 

Rochester, MN 

Susanne Pickering, M.S., M.P.H. 

Health Educator/Occupational Therapist 

Emory University 

Decatur, GA 

Ileana L. Pina, M.D., M.P.H. 

Professor of Medicine, Professor of 

Epidemiology/Biostatistics 

Case Western Reserve University 

Cleveland Heights, OH 

Vivian W. Pinn, M.D. 

Director 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Ximei Qian, Ph.D. 

Doctor 

Emory University 

Atlanta, GA 

Arshed A. Quyyumi, M.D., FRCP 

Emory University School of Medicine 

Atlanta, GA 

Kanni Ramasamy, M.S.N., N.P. 

Nurse-Practitioner 

Cardiology 

Emory University 

Cumming, GA 

Judith G. Regensteiner, Ph.D. 

Professor of Medicine 

Denver School of Medicine 

University of Colorado 

Aurora, CO 

Nicole Lynn Retland 

Program Manager 

Women’s Health Institute 

Howard University 

Washington, DC 

Janet W. Rich-Edwards, M.P.H., Sc.D. 

Director of Developmental Epidemiology 

Division of Women’s Health/Department of 

Medicine 

Brigham and Women’s Hospital 

Boston, MA 

Cherie Rooks, Ph.D. 

Post-Doctoral Fellow 

Emory University 

Atlanta, GA 

Jacques E. Rossouw, M.D. 

Chief, WHI Branch 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Don Rowe, M.D. 

Emory University School of Medicine 

Decatur, GA 

Joyce Rudick 

Director, Programs and Management 

Office of Research on Women’s Health 

National Institutes of Health 

Bethesda, MD 

Stacey C. Schutte, Ph.D. 

Postdoctoral Scientist 

IBB 

Georgia Institute of Technology 

Atlanta, GA 

383
Belinda Seto, Ph.D. 

Deputy Director 

National Institute of Biomedical Imaging and 

Bioengineering 

National Institutes of Health 

Bethesda, MD 

Amit Shah, M.D. 

Cardiology Fellow 

Emory University 

Atlanta, GA 

Andrea J. Sharma, Ph.D. 

Epidemiologist 

Reproductive Health 

Centers for Disease Control and Prevention 

Atlanta, GA 

Leslee Shaw, Ph.D. 

Professor 

Department of Cardiology 

Emory University School of Medicine 

Atlanta, GA 

Neil Shulman, M.D. 

Associate Professor 

Emory University School of Medicine 

Decatur, GA 

David Siscovick, M.D., M.P.H. 

Professor of Medicine and Epidemiology 

Cardiovascular Health Research Unit 

University of Washington 

Seattle, WA 

Susan P. Sloan, M.D. 

Director, Internal Medicine Residency 

Program 

Clinical Associate Professor of Medicine, 

Drexel University College of Medicine 

Easton, PA 

George Sopko, M.D., M.P.H. 

Medical Officer, Program Director 

National Heart, Lung, and Blood Institute 

National Institutes of Health 

Bethesda, MD 

Catherine Y. Spong, M.D. 

Chief, Pregnancy and Perinatology Branch 

Eunice Kennedy Shriver National Institute of 

Child Health and Human Development 

National Institutes of Health 

Bethesda, MD 

Amy R. Steinkellner, Pharm.D. 

V.P. Women’s Health TRC 

Medco Health Solutions, Inc. 

Waukesha, WI 

Lisa Tate 

CEO 

WomenHeart: The National Coalition for 

Women with Heart Disease 

Washington, DC 

Gwen Joyce Taylor 

Community Health Advocate 

Association of Black Cardiologists 

Jackson, MS 

Robert N. Taylor, M.D., Ph.D. 

Professor and Vice Chair for Research 

Gynecology and Obstetrics 

Emory University School of Medicine 

Atlanta, GA 

W. Robert Taylor, M.D., Ph.D. 

Director, Division of Cardiology 

Professor of Medicine 

Emory University School of Medicine 

Atlanta, GA 

Malcolm P. Taylor, M.D. 

Director CHF Clinic, Mississippi Heart 

Institute 

Past President, Association of Black 

Cardiologists 

Jackson, MS 

Viola Vaccarino, M.D., Ph.D. 

Professor 

Medicine (Cardiology) 

Emory University School of Medicine 

Atlanta, GA 

384
Juan C. Velasquez, M.D. 

Fellow 

Emory University 

Scottdale, GA 

Emir Veledar, Ph.D. 

Assistant Professor 

Emory University 

Atlanta, GA 

David A. Vorp, Ph.D. 

Professor 

Surgery and Bioengineering 

University of Pittsburgh 

Pittsburgh, PA 

Nanette K. Wenger, M.D. 

Chief of Cardiology, Grady Memorial 

Hospital, Professor of Medicine 

(Cardiology) 

Emory University School of Medicine 

Atlanta, GA 

Heather B. Westmoreland, M.D. 

Cardiovascular Disease Fellow 

Cardiology 

Emory University 

Decatur, GA 

Peter W.F. Wilson, M.D. 

Professor of Medicine 

Medicine/Cardiology 

Emory University School of Medicine 

Atlanta, GA 

Paul Root Wolpe, Ph.D. 

Asa Griggs Candler Professor of Bioethics 

Center for Ethics 

Emory University 

Atlanta, GA 

Jackson T. Wright, Jr., M.D., Ph.D. 

Professor of Medicine 

Nephrology & Hypertension/Medicine 

Case Western Reserve University 

Cleveland, OH 

Michael A. Young, M.H.A., FACHE 

President and Chief Executive Officer 

Grady Health System 

Atlanta, GA 

385
INDEX 

acculturation, 201 

acupuncture, 330 

addiction, 126, 136, 142, 149 

adolescence, 37-39, 56, 106, 136, 142, 147-

150, 220 

adolescent(s), 37, 38, 41, 47, 66, 74, 79, 80, 

84, 86, 104, 119, 121, 125, 128, 140, 146-151, 

156-158, 222, 291 

African-American, 50, 53, 73, 100, 168, 292 

aging, 23, 27, 30, 65, 70, 72, 82, 96, 102, 105, 

106, 113, 115, 119, 125, 130, 131, 167-173, 175-

179, 208, 212, 227, 229, 241, 266 

alcohol use, 102, 148, 216 

allergies, 148, 157 

Alzheimer’s disease, 27, 234, 235 

American Indian, 147, 201 

angina, 270, 286 

angiogenesis, 272, 276, 279, 280 

anorexia nervosa, 37, 40, 41 

antidepressant(s), 31, 35, 135 

antiretroviral therapy, 49, 100, 185 

anxiety disorder(s), 27 

apoptosis, 269, 270, 273, 274, 276 

arrhythmia, 382 

arthritis, 131, 173, 186, 202, 278, 280 

Asian, 68, 147, 201, 202, 207 

assisted reproductive technologies, 50 

asthma, 148, 157, 203 

atherosclerosis, 254, 269, 273, 281-283, 286, 

291, 293 

behavior(s), 16, 30-32, 34, 37-39, 43, 47, 53, 

54, 72, 74-76, 96, 101-103, 105, 109, 110, 

126, 136, 140, 147-150, 152, 154, 171, 182, 

183, 185, 191, 201, 202, 208, 215, 218, 219, 

237-240, 254, 255, 291 

binge eating, 37, 38, 41 

bioengineering, 51, 125, 132, 171, 187, 194, 198, 

225, 254 

biofilm(s), 49, 51 

biomarker(s), 20, 30, 31, 33, 36, 50, 72, 94, 

103, 105, 106, 108, 121, 139-143, 145, 146, 

154, 156, 158, 161, 169, 183, 184, 209, 269, 

270, 272, 275, 284, 290 

biomedical 

careers, 1, 6, 12, 20, 57, 58, 62, 188, 190, 

248, 256, 297 

imaging, 132, 187, 198, 225 

biospecimen(s), 145, 209 

bisexual, 74, 148, 150, 194, 197, 215, 216, 221 

Black, 16, 29, 54, 135, 147, 152, 153, 169, 192, 

201, 202, 287, 293 

body mass index, 150, 216, 260 

bone 

disease, 15, 234, 235 

resorption, 183 

brain, 6, 9, 13, 27-31, 35, 37, 39, 85, 138, 139, 

142, 203, 237-241 

breast cancer, 14, 22, 74-75, 135, 142, 155, 

168-169, 183-184 

breastfeeding, 44, 85, 106, 139, 148, 149 

Building Interdisciplinary Research Careers 

in Women’s Health (BIRCWH), 18, 82, 

295 

bulimia nervosa, 37, 41 

calcium, 175, 286, 290, 292, 293 

cancer(s), 14, 16, 22, 32, 54-56, 69, 74, 75, 

88-91, 105, 113, 114, 135, 142, 149, 150, 152, 

153, 155, 156, 168, 169, 172, 173, 180, 183-

187, 196, 198, 201, 202, 211, 216, 220, 234, 

235 

cardiovascular disease, 15, 32, 75, 105, 136, 

139, 141, 163, 171, 181, 226, 234, 235, 247-

251, 253, 258, 259, 263, 264, 269, 274, 

275, 280, 281, 286, 288-291 

386
caregiver(s), 73, 81, 173, 174, 176, 177, 206, 

212, 299 

caregiving, 99, 176, 179, 212, 298 

cervical cancer, 14, 149, 150, 183, 201, 211 

chemotherapy, 43, 152, 184 

chest pain, 282, 283, 287 

childbirth, 44, 78, 79 

childhood, 35, 53, 54, 56, 86, 93, 125, 128, 

136, 138-141, 143, 145, 146, 150, 178, 180, 

182, 277 

chlamydia, 50, 152 

cholesterol, 286, 289, 290 

chronic 

fatigue syndrome, 32, 157, 182 

illness, 37, 100, 196, 366 

obstructive pulmonary disease, 81, 143 

pain syndromes, 6, 10, 32-34, 157, 185 

clinical trial(s), 18, 25, 34-36, 39, 47, 51, 76, 

90, 91, 102, 106, 108, 110, 111, 113, 114, 118, 

135, 144, 186, 206, 207, 211, 212, 222, 223, 

226, 228, 231, 236, 253, 255, 261, 262, 

265-268, 276, 290 

colorectal cancer, 172 

contraception, 15, 49, 80, 106, 148 

coronary 

artery disease, 138, 273, 275, 281, 285, 

287 

heart disease, 16, 168, 269, 277, 286, 293 

cultural influences, 220 

culture(s), 19, 20, 33, 59, 61, 80, 89, 94, 103, 

111, 112, 116, 119, 120, 148, 171, 201, 210, 211, 

227, 229, 238, 280 

cytokine(s), 26, 138, 141, 142, 156 

cytomegalovirus, 144 

dehydroepiandrosterone, 168, 172 

dementia, 73, 105 

dental and oral health, 125, 131, 162, 180-186 

dentist, 148, 181 

dentition, 182 

depression, 25, 27, 28, 32, 37, 78, 81, 82, 85, 

113, 135, 139, 142, 143, 147, 148, 157, 163, 

166, 168, 184, 202, 237 

DHEAS, 168 

diabetes, 6, 9, 10, 15, 16, 18, 19, 22, 25, 26, 32, 

55, 57, 73, 75, 81, 134, 136, 138-142, 146, 

148, 162, 164, 165, 167, 171, 181, 184, 197, 

202, 203, 206, 212, 215, 234, 235, 254, 

255, 258, 259, 261, 263, 275, 290 

diet, 16, 33, 43, 47, 56, 57, 82, 95, 164, 222, 

260, 261 

dieting, 39 

dietitians, 289 

dimorphism(s), 139, 143 

dioxins, 155 

disability 

disadvantaged, 118, 148, 164, 245 

disasters, 207 

discipline, 13, 30, 75 

discomfort, 160, 168 

discontinuation, 135 

discrepancy, 53 

disenfranchised, 102 

disparity, 14, 53, 135, 164, 165, 183, 238 

distress, 210 

diversity, 1, 19, 20, 31, 34, 70, 71, 75, 106, 110, 

116, 118, 119, 126, 132, 137, 188, 191, 206, 

207, 210, 295, 297, 298 

Dobutamine, 287 

drinking, 147 

drug 

abuse, 27, 164, 237 

resistance, 49 

dysmenorrhea, 155, 157 

dyspareunia, 155 

dysregulation, 136 

early detection, 50, 153, 209 

early-onset, 135 

387
early-stage, 75 

eating disorders, 6, 10, 27, 32, 36, 37, 39-41, 

148, 184, 237 

eclampsia, 263 

education 

and training, 114, 213 

program, 286 

elderly, 125, 131, 135, 173-179, 185, 208, 209, 

213, 214, 248, 250, 253, 264-268, 281, 286 

embryos, 153 

emotion(s), 39, 103, 136 

empathy, 256 

employment, 190 

endocrine-disrupting, 99, 141 

endocrine-mediated, 143 

endocrinology, 104, 128, 129, 146, 172, 178, 

192, 199, 247, 254, 279 

endocrinopathy, 153 

endometriosis, 75, 90, 92, 151, 155-159 

endometrium, 156 

endophenotype(s), 33,35 

environment, 2, 35, 43-45, 47, 54, 59, 65, 68, 

69, 82, 84, 91-94, 96-99, 120, 126, 133, 

136, 138, 150, 152, 155, 156, 164, 166, 171, 

188-190, 201, 205, 222, 240, 244, 245, 

266, 277 

environmental factors, 29, 37, 39, 47, 72, 82, 

92-96, 98, 99, 152, 154, 165, 171, 208, 222 

epidemiology, 6, 9, 19, 27, 50, 67, 69, 70, 79, 

87, 97, 109, 169, 173, 198, 247, 249, 250, 

255, 264, 266 

epigenetics, 141, 145, 152, 169, 194, 199, 229-

233, 266, 267 

epigenomic, 241 

epilepsy, 233, 237 

equality, 15 

estradiol, 134, 168, 276, 280 

estrogen replacement therapy, 275 

ethnicities, 104, 116 

etiology, 18, 23, 25, 33, 36-38, 49, 50, 75, 79, 

92-94, 182, 183, 267, 281 

eugenics, 207 

evidence-based, 35, 37, 40, 54, 56, 84, 86, 

109, 111, 118, 144, 149, 153, 154, 224, 237, 

265 

extramural, 10, 12, 58, 68, 121, 196 

family history, 153, 258, 282 

family-based, 37 

fatty, 161, 209 

feasibility, 42, 152, 278 

fecal, 22 

fecundity, 92, 152 

fellowships, 36 

fertility, 79, 90, 99, 152, 154, 159, 171, 258, 

260 

fetus, 140-142, 161-163, 165, 166, 254 

fibrillation, 264, 266 

fibroblast, 280 

fibroids, 92, 151-155, 158 

fibromyalgia, 32, 34, 157, 182 

fibrosis, 144 

fillings, 182 

fistula, 79, 86 

gender 

differences, 1, 6, 14, 16, 18, 27-29, 33, 34, 

105, 134, 136, 138, 176, 179, 221, 223, 

235, 238, 273, 279-281, 285 

equity, 62, 72, 244 

genderomics, 228 

gene therapy, 146 

gene-environment interaction, 29, 263 

genistein, 155 

genitourinary, 48, 50, 52 

genomics, 7, 11, 18-20, 30, 47, 48, 75, 83, 95, 

109, 186, 272 

genotype, 154, 236 

388
genotyping, 49 

gerontology, 131, 178, 179 

gestation, 50, 144, 162 

gestational diabetes, 134, 146, 162, 165, 167, 

254, 255, 258, 261, 263 

glaucoma, 202 

global health, 50, 71, 183, 225 

gynecology, 5, 6, 9, 15, 19, 27, 41, 64, 75, 125, 

129, 159, 179, 186, 192, 196, 198, 199, 201, 

250, 263 

hard-of-hearing, 74, 201, 202 

Hawaiians, 207 

hazard(s), 98, 259 

HDL, 289 

headache, 32, 168 

health 

behavior(s), 54, 182, 183, 201, 202, 254 

care, 1-3, 6, 13, 14, 16, 17, 19, 22, 27, 31, 33, 

34, 44, 45, 47, 50, 53, 72, 73, 76, 79, 

81-83, 96, 99, 104, 107, 109-115, 119, 131, 

134, 138, 140, 148-150, 154, 155, 159, 

160, 163, 165, 169, 171, 173, 174, 176, 177, 

179, 181, 201, 202, 206, 209-212, 215, 

217, 225, 229, 232 

careers, 65, 70, 115 

disparities, 14, 30, 31, 71, 72, 76, 99, 121, 

135, 137, 150, 183, 197, 201-203, 206, 

217, 219, 227 

literacy, 155, 202, 214, 215 

promotion, 133, 219 

statistics, 14, 17, 172, 268 

hearings, 2, 13 

heart 

attack(s), 254 

disease, 16, 26, 143, 168, 172, 253, 254, 

258, 264, 268, 269, 277, 281, 285, 286, 

293 

helper-nurturer, 72 

hematopoietic, 89, 91, 279 

hemorrhage, 285 

hepatitis, 202 

herbals, 143, 146 

hernia, 144 

herpes simplex virus, 144 

highly active antiretroviral therapy 

(HAART), 100 

HIPAA, 95 

Hispanic, 66, 73, 147, 247, 254 

histocompatibility, 91 

HIV/AIDS, 65, 69, 71, 83, 86, 100-104, 107, 

256 

Hmong, 74 

holistic, 75, 218, 222 

homelessness, 102, 207, 210 

homicide, 147 

homosexuality, 105 

hormone replacement therapy, 106, 235, 275 

hormone(s), 29, 37, 88, 90, 95, 104, 168, 172, 

182, 183, 185, 194, 199, 203, 233-241, 254, 

270, 271, 278 

hospitalization(s), 203, 208, 209, 260, 290 

host-environment interaction, 44 

hot flashes, 95, 168 

hurricane, 163 

hygienist, 349 

hypercholesterolemia, 136 

hyperglycemia, 19, 26, 139, 145 

hyperlipidemia, 135, 258, 260 

hyperplasia, 143 

hypertension, 134, 136, 138, 163-165, 171, 202, 

252, 258-260, 275, 278 

hypertrophy, 290 

hypoxia, 134 

hysterectomy, 24, 153, 156 

imaging, 17, 25, 29, 30, 33, 36, 109, 113, 132, 

144, 149, 154, 156, 157, 171, 187, 194, 198, 

204, 209, 225, 226, 229, 241, 256, 269, 

270, 272, 273, 283-285, 287 

389
immigration, 82, 210 

immune 

disorder(s), 75 

response, 156 

immunization, 202 

immunobiologics, 49, 51 

implant, 15, 106, 183 

impoverished, 164 

Indian(s), 147, 201, 207 

induction, 274, 280 

inequality, 99, 238 

inequity, 243 

infancy, 51, 53, 55, 96, 125, 128, 136, 138, 277 

infectious disease, 4-6, 15, 18, 83, 84, 87 

infertility, 50, 128, 151-153, 155, 156, 158, 247, 

254 

influenza, 163, 193, 203 

information technology, 16, 17, 65, 70, 71, 76, 

85, 107, 108, 114, 165, 171, 228 

informed-consent, 106 

infrastructures, 46, 82 

insemination, 105 

insomnia, 168 

institutionalization, 207 

insulin resistance, 135, 139, 141, 142, 145 

interstitial cystitis, 32 

intolerance, 55, 289 

ischemia, 269, 273, 275, 279, 281, 283-285, 

287 

Jewish, 247 

kidney disease, 9, 10 

kinetics, 280 

Koreans, 74 

labor and delivery, 7, 50, 165, 262 

lactation, 44, 156, 243 

laparoscopy, 156 

Latino(s), 14, 247, 254 

legislation, 14, 253 

lesbian, 72, 74, 118, 148, 150, 194, 197, 215-217, 

220, 221 

leuprolide, 156 

life span, 1, 27, 31, 37, 43-47, 71, 79, 84, 85, 

94, 96, 99, 101-104, 119, 123-126, 131, 133-

138, 169, 174-176, 180, 181, 184-186, 191, 

207-210, 212, 214, 219, 222, 231, 233-236, 

240, 248, 252, 253, 262, 271, 277, 288 

lifestyle factors, 85 

linguistics, 65, 72 

longevity, 72, 73, 79, 81, 134, 177, 281, 291 

low 

birth weight, 259 

literacy, 213 

vision, 213 

lung cancer, 169 

luteal phase, 275 

macrophage(s), 156, 273, 279 

macrovasculature, 272 

magnetic resonance 

imaging (MRI), 154 

Mammaprint, 75 

mammogram(s), 14 

mapping, 29, 30, 44 

marijuana, 147 

maturation, 39, 50 

meconium, 140 

Medicaid, 169 

Medicare, 169, 267 

memory, 176 

menarche, 54, 56, 171, 236, 291, 292 

menopause, 27, 28, 31, 39, 54, 56, 95, 119, 

156, 168-172, 176, 182, 185, 222, 231, 236, 

239, 275, 277, 291-293 

menorrhagia, 155 

menstrual cycle, 85, 105, 168, 271, 275 

menstruation, 90 

390
mental health, 9, 10, 27-29, 31, 32, 36, 41, 74, 

81, 104, 105, 143, 149, 163, 165, 166, 206, 

208, 210, 213, 214, 218
�

mentoring, 15, 59-62, 116, 118, 119, 121, 187-

190, 205, 242-244, 256, 294-296, 298
�

metabolic syndrome, 57, 135, 275, 289, 292, 

293 

metabolism, 55, 106, 160, 164, 172, 178, 192, 

199, 236, 264
�

metabolites, 75
�

metabolizers, 106, 235
�

metagenomes, 19
�

metagenomics, 6, 11, 13, 20, 41, 42
�

metalloproteinases, 270, 280
�

metals, 93
�

metastases, 183
�

metastasis, 75
�

Metformin, 215
�

Mexican(s), 201
�

microbicides, 106
�

microbiome, 6, 7, 11, 20, 41-47
�

microchimerism, 156, 169
�

microcirculation, 284
�

microparticles, 260, 270
�

middle age, 38
�

migraine, 34
�

migration, 272, 276
�

military, 72, 188, 221
�

mind-body, 157
�

minority, 45, 49, 118, 121, 138, 182, 197, 202, 

206, 216-219, 290, 292
�

minority-serving, 245
�

minority-specific, 290
�

misdiagnosis, 229
�

misperception, 227
�

mobility, 177, 208
�

mood disorder(s), 139
�

mosaicism, 233 

mucositis, 184
�

multidisciplinary, 18, 34, 49, 51, 73, 90, 97, 

145, 149, 158, 176, 201, 204, 205, 207
�

multigenerational, 54, 55
�

multiple sclerosis, 237, 336
�

mutualism, 43
�

myoblasts, 276, 279
�

myocardial infarction, 134, 138, 139, 168, 172, 

235, 254, 262, 265, 275, 279, 280, 285, 

286, 291, 293
�

nanotechnology, 30
�

nephropathy, 25
�

nerves, 26, 203
�

neuroanesthesia, 367
�

neurobehavioral, 238
�

neurobiobehavioral, 143
�

neurobiological, 33, 142, 237
�

neurodevelopment, 126, 141
�

neurogenesis, 31
�

neuroimaging, 36, 39
�

neuropathogenesis, 105
�

neuropathy, 25
�

neuropeptides, 29
�

neurophysiology, 239, 240
�

neuroscience, 23, 29, 194, 200, 237-241
�

neurotoxins, 29
�

newborn, 44, 140
�

nicotine, 27, 126
�

nocioception, 237
�

norethindrone, 156
�

nuclear, 155, 284, 288
�

nutrient-deficient, 141
�

nutrition, 12, 42, 53, 54, 57, 79, 81, 92, 95, 

106, 128, 148, 152, 164, 166, 167, 183, 185, 

293
�

391
obesity, 6, 12, 16, 19, 25, 26, 32, 38, 39, 52-57, 

73, 96, 105, 139-143, 145, 146, 149, 151, 152, 

156, 163, 164, 166, 167, 171, 201-203, 220, 

234, 235, 258, 289 

obstetrics, 5, 6, 9, 15, 19, 27, 41, 64, 75, 86, 

125, 129, 159, 179, 186, 192, 196, 198, 199, 

201, 250, 263 

octogenarians, 265 

oncofertility, 204, 205 

oophorectomized, 170 

oral 

contraceptives, 156, 171 

health, 125, 131, 162, 180-186 

oropharyngeal, 183 

orphans, 80 

orthodontics, 183 

osteoarthritis, 280 

osteopetrosis, 183, 185 

osteoporosis, 15, 172, 175, 178, 183, 185 

osteoradionecrosis, 185 

ovarian 

cancer, 88, 156, 184 

failure, 170 

function, 90, 292 

overweight, 39, 56, 57, 139, 148, 164, 167, 258 

ovulation, 151 

ovulatory, 152 

Pacific Islander, 147, 201 

pain-processing, 33 

pain-relevant, 36 

palpitations, 168 

pandemic, 141, 163 

papilloma, 149, 183, 211 

papillomavirus, 49 

paresthesias, 168 

partner-notification, 152 

passion, 297 

paternity, 119 

pathobiology, 283 

pathogenesis, 23, 49, 102, 105, 106, 134, 139, 

143, 144, 153, 157, 182, 226, 235, 281, 283 

pathophysiology, 25, 26, 29, 30, 37-39, 49, 

140, 153, 155, 156, 183, 184, 234, 264, 265, 

269, 273, 290-292 

patient-centered, 17 

patient-generated, 109, 114 

patient-oriented, 119 

patient-physician, 25 

patient-reported, 25, 35 

patient-specific, 88 

pelvic 

floor disorders, 6, 9, 22, 23, 24, 25, 26, 

323 

inflammatory disease, 49, 158 

perimenopause, 27, 28 

periodontal disease, 181, 184, 186 

periodontitis, 181 

personalized medicine, 47, 75, 111, 176, 255, 

271 

pharmacists, 294, 296 

pharmacodynamics, 106 

pharmacogenetics, 233 

pharmacogenomics, 106 

pharmacology, 102, 104, 106, 164, 166, 167 

pharmacotherapy, 46, 187 

pharynx, 183, 184 

phenotyping, 30, 34 

phone-based, 109 

phthalates, 141 

physical activity, 39, 54, 56, 148, 150, 152, 

222, 289 

placenta, 138, 140-142, 145, 254, 260 

pollution, 81, 113 

posttraumatic Stress Disorder (PTSD), 27, 32 

postmarketing, 81 

postmenopausal women, 28, 169, 269, 275-

277 

postpartum depression, 148 

392
prediabetes, 25, 26 

preeclampsia, 134, 142, 161-163, 166, 254, 

255, 260, 263-264 

pregnancy, 15, 23, 28, 39, 43, 44, 49-52, 54-

57, 78, 79, 83, 84, 90, 105, 106, 113, 124, 

125, 129, 133-135, 138, 140, 142, 143, 145, 

148-150, 159-166, 175, 181, 184, 203, 207, 

231, 233, 234, 247, 248, 250, 253-255, 

258-264, 277, 291 

premature ovarian failure, 170 

prenatal, 93, 125, 128, 136, 138-142, 144-146, 

160-162, 165, 166, 178, 262 

prescription drugs, 146, 147, 155 

preterm birth, 11, 19, 48, 50, 52, 134, 139, 162, 

163, 165, 166, 186, 259 

progesterone, 106, 155, 156, 277 

progestin, 18, 168 

prosthetic, 203 

prostitution, 86 

proteome, 171 

proteomics, 18, 20, 30, 75, 89, 95, 109, 141, 

186, 204, 230, 231, 233, 234, 266, 267, 

272 

psychiatric disorders, 6, 9, 13, 27-32, 241 

psychoses, 32 

psychotherapies, 40 

puberty, 27-29, 92, 93, 99, 140, 142, 145, 148, 

231, 236, 240, 277 

public 

health, 4, 13, 14, 16, 19, 39, 49, 51, 52, 56, 

66, 67, 75, 77, 82, 93, 96, 97, 124, 133, 

134, 139, 143, 144, 155, 161, 162, 166, 171, 

174, 175, 192, 196, 201, 208, 220, 253, 

258 

policy, 2, 13, 14, 124, 219, 282 

pulmonary disease, 81, 143, 254 

quality of 

care, 74, 102, 108, 174, 281 

life, 19, 22, 54, 113, 153, 155, 169, 170, 173, 

178, 179, 182, 185, 203, 264-266, 268, 

281 

racial and ethnic groups, 47, 92 

radiation, 93, 185, 209, 284 

radioisotopes, 284 

radiology, 287, 320, 323 

reendothelialization, 276, 280 

reentry, 59, 189, 244 

regenerative medicine, 75, 88-91, 204, 248, 

251, 253, 274, 277 

rehabilitation, 194, 203, 221, 291, 292 

religion, 210, 218 

reproduction, 69, 94, 101, 104, 128, 151, 157, 

158 

reproductive 

age, 44, 45, 102, 163, 164 

function, 171 

health, 11, 52, 67, 69, 79, 80, 82-84, 86, 

97-99, 102, 104, 148, 149, 158, 264, 291 

resiliency, 43, 218 

resilient, 150 

resource-constrained, 80, 85 

resource-intensive, 102 

resource-restricted, 50 

retinopathy, 25 

retirement, 175, 178 

revascularization, 275, 283, 288 

rheumatism, 186 

rheumatoid arthritis, 278 

rheumatology, 10, 280, 315 

rhythm, 136 

salaries, 62, 119, 121, 296 

sarcopenia, 208-209 

schizophrenia, 27, 28, 142 

segregation, 91, 99 

self-care, 110, 208 

self-management, 107 

self-renewal, 88, 89, 91 

sepsis, 49 

393
sex 

and gender differences, 1, 2, 6, 14, 16-18, 

27-31, 33, 34, 88, 89, 104-106, 119, 134, 

136, 138, 144, 168, 169, 176, 179, 199, 

203, 204, 221, 223, 226, 229, 230, 233, 

235, 237-241, 254, 255, 266, 269-273, 

275, 278-281, 285, 293 

hormones, 90, 182, 194, 199, 233-236, 

271, 278 

sexomics, 269, 272 

sexual 

abuse, 72, 79 

assault, 216 

orientation, 116, 210, 214, 216, 219, 220 

sexually transmitted 

diseases (STDs), 15, 16, 49, 79, 143, 152, 

202 

infections (STIs), 49, 85, 113, 147 

shortness of breath, 282 

siblings, 212 

signaling pathways, 20, 236, 254 

single 

Sjögren’s syndrome, 180, 182-184 

Skype, 209 

slave, 207 

sleep 

apnea, 163 

disorders, 234, 235, 237 

disturbances, 237 

slums, 83 

smoking, 16, 106, 136, 142, 143, 147, 150, 164, 

216, 260 

somatic, 277 

standards-based data, 113 

statin(s), 261, 263 

stem cells, 26, 30, 31, 65, 68, 71, 87-91, 95, 

169, 248, 251, 274-277, 279, 280 

stereotypes, 188 

stress, 9, 10, 24, 26, 27, 30, 35, 37, 73, 92, 93, 

96, 99, 135, 136, 139, 141-143, 146, 155, 

161-163, 165, 207, 209, 214, 216, 219, 228, 

237, 254, 259, 271, 287 

stroke, 10, 32, 81, 134, 138, 202, 213, 253, 256, 

268, 285 

subclinical atherosclerosis, 286 

substance abuse, 37, 136, 143, 146, 148 

suicide, 37, 143, 147 

supplement, 24, 97, 134 

surgeon(s), 10, 32, 186, 296 

survey, 34, 40, 53, 62, 73, 172, 175, 185, 216, 

293 

survivorship, 184 

sustainability, 21, 214 

syndrome-focused, 33 

synthase-dependent, 280 

synthase-mediated, 280 

teaching-focused, 245 

team-based, 15, 204 

technology-based, 178 

telecommunications, 209 

telelinks, 209 

telemedicine, 108, 291 

telomeres, 65, 72, 266, 267 

temporomandibular 

disorders, 180, 182, 184, 185 

testosterone, 88, 143, 276 

thalassemia, 144 

thrombi, 269 

thrombin, 269 

thromboembolism, 135 

thrombogenesis, 273 

thrombogenicity, 274 

thrombotic, 274 

thrombus, 269 

thyroid disease, 165 

tissue engineering, 20 

tomography, 209 

394
toxin(s), 72, 138-143, 145, 146
�

toxoplasmosis, 144
�

trafficking, 79, 84, 207
�

transcriptomics, 75, 89
�

transgender, 74, 101, 102, 148, 150, 194, 197, 

215, 216, 219, 221
�

transgenerational, 55, 94
�

translational research, 18, 21, 22, 26, 49, 51, 

56, 66, 75, 81, 84, 109, 124, 133, 134, 145, 

146, 149, 154, 174, 194, 198, 220, 221, 234, 

239
�

transplant, 89, 90
�

transplant-related, 89
�

trial-specific, 284
�

Tribes, 201
�

triglyceride, 289
�

tropical diseases, 83
�

tuberculosis, 80, 83
�

tumorigenicity, 89
�

twins, 144
�

Twitter, 150
�

underinsured, 134, 289
�

underrepresentation, 14, 120, 205, 206, 266
�

unions, 73
�

unpaid, 243
�

unplanned, 15, 80
�

unpublished, 230
�

upregulation, 135
�

urbanization, 201
�

urethral, 25
�

urinary
�

incontinence, 19, 22, 24, 27, 175
�

tract infection(s), 18, 24, 48, 49
�

urine, 49, 154, 157
�

urogenital tract, 6, 18
�

usability, 98
�

uterine fibroids, 92, 153, 154, 159
�

vaccine(s), 18, 49, 51, 104, 105, 149, 152, 183, 

185
�

vaginitis, 46
�

vascular endothelial growth factor, 275
�

vasculogenesis, 280
�

vasoconstrictors, 254
�

vasomotor, 171
�

vectors, 276
�

ventricular hypertrophy, 290
�

vertigo, 168
�

victimization, 157
�

victims, 213, 216
�

violence, 16, 72, 78, 79, 84, 93, 96, 99, 102, 

141, 143, 147, 148, 152, 165, 166, 202, 207
�

viremia, 105
�

virology, 67, 104
�

vitamin D, 290, 292
�

vocabulary, 34
�

vomiting, 37
�

vulvodynia, 32
�

waist, 169
�

walking, 201
�

wealth, 133, 210
�

weight
�

control, 19
�

gain, 37, 54, 56, 57, 136, 139, 145, 168
�

loss, 38, 53-57
�

WISEWOMAN, 253
�

women-centered, 291, 292
�

women-controlled, 103
�

Women’s Health Initiative (WHI), 18
�

X-inactivation, 233
�

xenoestrogens, 155
�

xerostomia, 185
�

XX chromosome, 90
�

XXcellence, 117, 122
�

395
NIH Publication No. 10-7606-B 
NIH Publication No. 10-7606-C
Moving Into the Future With New Dimensions and Strategies: 

A Vision for 2020 for Women's Health Research 

Office of Research on Women’s Health 

National Institutes of Health 

VOLUME III 

PUBLIC TESTIMONY 

i
The views expressed in this volume are solely those of individuals testifying at the public 

hearings and do not necessarily reflect the positions or judgments of the National Institutes 

of Health, the U.S. Department of Health and Human Services, or the Administration. 

U.S. Department of Health and Human Services, Public Health Service, National Institutes 

of Health, Office of Research on Women’s Health. (2010). Moving Into the Future With New 

Dimensions and Strategies: A Vision for 2020 for Women's Health Research. Bethesda, MD: 

National Institutes of Health. 

NIH Publication No. 10-7606-C 

Copies of this report and other publications of the Office of Research on Women’s Health 

are available at no charge from: 

Office of Research on Women’s Health 

National Institutes of Health 

6707 Democracy Blvd., Suite 400, MSC 5484 

Bethesda, Maryland 20892-5484 

Fax: 301-402-1798 

Voice: 301-496-8176 

http://orwhpubrequest.od.nih.gov 

ii
Table of Contents 

INTRODUCTION 1 

PUBLIC TESTIMONY 

St. Louis Regional Meeting 5 

San Francisco Regional Meeting 107

Providence Regional Meeting 252

Chicago Regional Meeting 355

Atlanta Regional Meeting 412

INDEXES 

Testimony Providers by name 440 

Testimony Providers by organization 442 

Subject Index 445

iii
iv
 
INTRODUCTION 

The Office of Research on Women’s Health (ORWH) was established in September 1990 in 

response to congressional, scientific, and advocacy concerns that a lack of systemic and consistent inclusion of women in NIH-supported clinical research could result in clinical decisions 

being made about health care for women based on findings from studies of men—without evidence that they were applicable to women. The Office was further established in statute in the 

NIH Revitalization Act of 1993 (Public Law 103–43). Congress codified the Office’s mission and 

included directives that expanded its leadership role in identifying and promoting research on 

women’s health. 

Since that time, the Office has been the focal point for guiding the national research effort on 

women’s health issues and is responsible for ensuring that women’s health research priorities 

are integrated into the wider NIH research agenda. The mission of ORWH is to: 

1. advise the NIH Director on matters relating to research on women’s health; 

2. strengthen and enhance research related to diseases, disorders, and conditions that 

affect women; 

3. ensure that research conducted and supported by NIH adequately addresses issues 

regarding women’s health; 

4. ensure that women are appropriately represented in biomedical and biobehavioral 

research studies supported by NIH; 

5. develop opportunities for and support recruitment, retention, reentry, and advancement of women in biomedical careers; and 

6. support research on women’s health issues. 

To advance a robust research agenda to guide women’s health research at the NIH, ORWH 

previously initiated two intensive planning initiatives, one beginning in 1991 and a second one 

in 1997. ORWH called upon experts in the fields of basic and clinical sciences, practitioners 

interested in women’s health, and representatives of professional and women’s organizations 

to develop specific and workable recommendations to advance research activities on behalf 

of the diversity of women and define the research priorities for women’s health research at 

the NIH. The first research agenda from 1991, The Report of the National Institutes of Health: 

Opportunities for Research on Women’s Health redefined the parameters of women’s health 

to encompass the life span going beyond the reproductive system and to better understand 

sex and gender differences between women and men in development, health, and disease. It 

also brought attention to the need to focus on populations of women that had been underrepresented in clinical research. The 1997 report, Agenda for Research on Women’s Health for 

the 21st Century, expanded upon the initial scientific agenda for women’s health research and 

emphasized the relevance of the full spectrum of research from basic to clinical research, epidemiological and population studies, translation into clinical applications and health outcomes, 

with continued emphasis on sex and gender comparisons and the introduction of an emphasis 

on interdisciplinary research on women’s health. 

1
Science is dynamic and evolving at a remarkable pace with emerging knowledge from results 

of investigations and from new concepts of health and disease based on new technologies and 

approaches to research endeavors. Each decade has brought new discoveries, new understanding of the intricacies of molecular contributions to health and the workings of the totality 

of the human body, and new opportunities to leverage the knowledge from science to improve 

human health and, specifically, women’s health. The first two reports ensured that women’s 

health rose to prominence within the national psyche, as well as within the research environment. The next 10 years can bring new research advances with improved therapeutics based 

on sex differences with an expansion of the evidence based clinical application to women’s 

health care. Achieving new dimensions and innovative strategies for research is an important 

element of the NIH women’s health research agenda for the future. 

Moving Into the Future With New Dimensions and Strategies: 

A Vision for 2020 for Women’s Health Research 

Ten years after the last women’s health research agenda was updated, the ORWH launched 

a series of five regional scientific workshops and public hearings to ensure that research 

on women’s health continues to be on the cutting edge of science, based upon the most 

advanced techniques and methodologies. Four of the five regional scientific workshops were 

held during 2009, and the final was in 2010. The meetings were hosted by five universities: 

1. Washington University, St. Louis, Missouri, March 4–6, 2009 

2. University of California, San Francisco, May 27–29, 2009 

3. Women and Infants Hospital/Brown University, Providence, Rhode Island, 

September 21–23, 2009 

4. Northwestern University, Chicago, Illinois, October 21–23, 2009 

5. Emory University, Atlanta, Georgia, February 16–17, 2010 

The format of each of the regional scientific workshops was designed to promote an interactive discussion involving leading scientists from across the nation, women’s health advocates, 

public policy experts, health care providers, and the general public. Individuals representing 

the full spectrum of academic institutions, professional associations, advocacy organizations, health care facilities interested in biomedical and behavioral research on women’s health 

and sex/gender issues, or those wishing to present their personal opinions on these issues 

were encouraged to provide both written and public testimony at each of the regional meetings. In each of the meetings, the ORWH Director challenged conference attendees to think 

beyond traditional women’s health issues in defining the women’s health research agenda of 

the future. Participants were asked to give attention to new areas of scientific application, 

innovative technologies, and sex differences research in basic and laboratory investigations. 

Clinical questions for which documented answers are still not evident were to be considered 

in determining research priorities, recognizing the importance of new health care and research 

paradigms that will be facing the Nation in the years ahead. 

2
A total of 37 scientific and career development working groups were co-chaired by research 

scientists representing 44 academic institutions and 19 NIH institutes, centers and the Office 

of the Director. Participants came from thirty-three states, and scientists from Great Britain 

and Australia also contributed to the discussions. Scientific panels and concurrent workshops 

addressed a wide range of topics, from the interplay of research and health care to specific 

areas of research, resulting in nearly 400 recommendations. The working group reports and 

recommendations are found in the companion Volume II to the ORWH Strategic Plan. 

A key element of each of the regional meetings was the time devoted to receiving public testimony. From its earliest establishment, ORWH has actively welcomed input from advocacy 

organizations, health and disease interest groups, health care providers, and the general public. Over the years, public testimony has served as an important reality gauge to inform the 

research agenda-setting process. During the course of the five meetings, 141 organizations and 

individuals presented written and public testimony, always on the first day of the meeting. The 

testimonies from the meetings are found in Volume III of the ORWH Strategic Plan. 

At the conclusion of the five regional workshops, the working group reports and recommendations were synthesized by ORWH staff and the resulting document (Vol. 1) was reviewed 

by three separate groups: (1) the Advisory Committee on Research for Women’s Health (the 

non-Federal advisory committee to the Director of ORWH); (2) an outside group of experts 

in women’s health research convened April 14, 2010 at the NIH; and (3) the Coordinating 

Committee on Research on Women’s Health Research/NIH (composed of NIH institute and 

center directors or their designees). The final document, entitled Moving Into the Future With 

New Dimensions and Strategies: A Vision for 2020 for Women’s Health Research, represents 

the conclusion of an intensive 2-year national planning discussion. This new Strategic Plan 

for research and career development opportunities to guide efforts towards the year 2020 

is being unveiled on September 27, 2010 as part of the 20th anniversary celebration of the 

establishment of the ORWH at the NIH. 

Vivian W. Pinn, M.D. 

Associate Director for Research on Women’s Health and 

Director, Office of Research on Women’s Health 

National Institutes of Health 

3
Public Testimony 

Washington University in St. Louis 

St. Louis, Missouri 

March 4, 2009 

Lynne Roney 

AAUW of Missouri 

Kristian Hurley 

American Autoimmune Related Diseases Association 

Cheryl Healton, Dr.P.H. 

American Legacy Foundation 

Donna Vallone, Ph.D. 

American Legacy Foundation 

Claire Saxton 

Bladder Cancer Advocacy Network 

Megan Whinery 

Endometriosis Association 

Susan Wood, Ph.D. 

The George Washington University School of Public Health and Health Services 

Diana Hankey Underwood, M.S.,WHNP-BC 

Grace Anatomy, Inc. 

Nancy Norton 

International Foundation for Functional Gastrointestinal Disorders 

Madeline Nolan 

LAM Foundation 

Lynne Matallana 

National Fibromyalgia Association 

Christin Veasley 

National Vulvodynia Association 

Paula Gianino 

Planned Parenthood of the St. Louis Region and Southwest Missouri 

Rino Aldrighetti 

Pulmonary Hypertension Association 

5
Mary Blades 

Scleroderma Foundation 

Phyllis Greenberger, M.S.W. 

Society for Women’s Health Research 

Sue Baebler 

St. Louis Breast Cancer Coalition 

Raul Artal, M.D. 

St. Louis University 

Rosemary B. Catanzaro M.S., RD, CDE 

Saint Louis University 

Lyse Norian, Ph.D. 

University of Iowa College of Medicine 

Susan Pfefferle, Ph.D. 

Washington University, George Warren Brown School of Social Work Research 

Ericka Hayes, M.D. 

Washington University Pediatric HIV Program 

Keith S. Garcia, M.D., Ph.D. 

Washington University School of Medicine 

Jeffrey Henderson, M.D., Ph.D. 

Washington University School of Medicine 

Raksha Jain, M.D. 

Washington University School of Medicine 

Catina O’Leary, Ph.D., M.S.W. 

Washington University School of Medicine 

Linda Peterson, M.D. 

Washington University School of Medicine 

Joan Riley, Ph.D. 

Washington University School of Medicine 

Gina Secura, Ph.D., M.P.H. 

Washington University School of Medicine 

Clay Semenkovich, M.D. 

Washington University School of Medicine 

6
William J. Ledger, M.D. 

Weill Medical College of Cornell University 

Jane Murray 

Women in Balance 

Missy Lavender, M.B.A. 

Women’s Health Foundation 

Maura Riordan 

Women Organized to Respond to Life-Threatening Diseases (WORLD) 

Claire Chosid 

Self 

Ellen Heislen, PA-C 

Self 

Robert Kokenyesi 

Self 

Patricia Marsh 

Self 

Colleen McKee 

Self 

Diane Rubaii 

Self 

Aretha Webb 

Self 

7
LYNNE RONEY 

AAUW of Missouri 

Improve Girls’ and Women’s Opportunities in Science, Technology, Engineering, and Math 

My presentation is taken in part from an AAUW (formerly known as the American Association 

of University Women) document entitled, “Improve Girls’ and Women’s Opportunities in Science, Technology, Engineering, and Math.” AAUW, founded in 1881, has approximately 100,000 

members (in Missouri, approximately 1,000 members and 25 branches across the State). 

AAUW advances equity for women and girls through advocacy, education, and research. 

The American Association of University Women (AAUW) supports promoting and strengthening science, technology, engineering, and mathematics (STEM) education, especially for girls 

and other underrepresented populations. The lack of women and girls in STEM fields has significant implications for women’s economic security as well as the overall economy and America’s 

global competitiveness. Fortunately, the United States has an untapped pool of potential workers. If women and members of other traditionally underrepresented groups joined the STEM 

workforce in proportion to their representation in the overall labor force, the shortage of STEM 

professionals would disappear.1 AAUW supports the following efforts to improve girls’ achievement in math and science and increase the number of women who choose STEM careers. 

1. Enact recommendations from Beyond Bias and Barriers. The National Academies’ 

report, Beyond Bias and Barriers, found that women face a lifetime of subtle biases that 

discourage them from STEM careers. To overcome these challenges, AAUW supports 

enactment of the report’s recommendations, which would require agencies that fund 

scientific research to conduct antigender-bias workshops, enforce existing Federal antidiscrimination laws (including Title IX), publish demographic and funding data for grant 

applications, and extend grant support for researchers on caregiving leave. AAUW 

strongly supports the report’s recommendation that colleges form an interinstitutional 

monitoring organization like the National Collegiate Athletic Association, which shares 

data, evaluates progress, and works to eliminate gender bias in faculty recruitment, 

retention, and promotion in the STEM fields. 

2. Ask for a report responding to Rising Above the Gathering Storm. The report, commissioned by Congress from The National Academies of Science and Engineering, and the 

Institute of Medicine and published in 2007, states that the United States’ advantages 

in science and technology are eroding and discusses the need to improve math and 

science education. Unfortunately, the report largely ignores the issue of women and 

underrepresented minorities in STEM fields. AAUW recommends a followup report on 

methods to increase the number of women in STEM fields and what effect this would 

have on enabling the United States to remain a leader in the global marketplace. 

3. Use Title IX to improve the climate for women in STEM fields: AAUW recommends 

requiring agencies to proactively conduct Title IX compliance reviews at grantee institutions. All agencies are required to ensure they are not violating Title IX; however, very 

few Title IX reviews are conducted outside of the Department of Education. Agencies 

should ensure that universities that receive agency funding are complying with Title IX. 

8
4. Measure student achievement in science. AAUW supports measuring student achievement in science. This will provide schools with necessary information on how well 

students are progressing and the improvements that still need to be made. The data 

gathered from such testing programs should always be disaggregated by sex, race, and 

socioeconomic status; and cross-tabulated. While testing is an important measure of 

success, high-stakes testing should not be the sole indicator of student competency or 

a school’s progress. Additional flexibility in Adequate Yearly Progress (AYP) measures 

required by the No Child Left Behind Act should be explored. 

5. Teacher training. AAUW supports efforts that create more STEM teachers and train 

teachers to encourage girls and other underrepresented groups to pursue math and 

science careers in the face of gender-based differences, peer pressure, and parental 

expectations. This is particularly important because while studies show that all students 

start to lose interest in science and math by junior high, the loss is particularly steep for 

girls at puberty and results from gender-based social expectations and peer pressure.1 

6. Encourage the inclusion of STEM subjects and activities in cocurricular programs. 

Incorporating STEM subjects and activities in after-school and summer programs 

enables students to explore the field in a supportive atmosphere. Research suggests 

that information about the usefulness of engineering to everyday life and hands-on 

experiences with science, math, and technology help girls develop a sustained interest 

in these fields. 

Missouri challenges. Our challenges in Missouri include educating parents and peers about the 

value of STEM education. In some places in Missouri, the term “STEM” is so negatively associated with stem cell research that we’ve had to use a new acronym, METS, to define math, 

engineering, technology, and science. Partly because of negative parental pressure, State education offices struggle to enroll girls in technical education programs that potentially would 

pay them more than traditionally female occupations. 

But in Missouri, we do have a number of programs that are listed in the National Girls Collaborative Project, including programs in Springfield, at Missouri S&T in Rolla, at Washington 

University, and at the St. Louis Science Center. Community organizations such as AAUW work 

with educational institutions to find ways to show girls these opportunities. I urge increasing 

support for these projects. 

Women make up half of the population and are a largely untapped resource that could prove 

essential in maintaining the technological competitiveness of the United States. With better enforcement of Title IX and increased investment, the United States can begin to close the 

gender divide in STEM fields. 

Reference 

1.	� Congressional Commission on the Advancement of Women and Minorities in Science, 

Engineering and Technology Development. (2000). Land of plenty: Diversity as America’s competitive edge in science, engineering and technology [Report]. Retrieved from 

http://www.nsf.gov/pubs/2000/cawmset0409/cawmset_0409.pdf 

9
KRISTIAN HURLEY 

American Autoimmune Related Diseases Association 

Autoimmune Diseases: A Women’s Health Issue—Recommendations for Research Priorities 

from the American Autoimmune Related Diseases Association in Collaboration with the National 

Coalition of Autoimmune Patient Groups 

Autoimmune Diseases: A Women’s Health Issue 

Named a major women’s health issue by the Office of Research on Women’s Health (ORWH) 

at the National Institutes of Health (NIH), autoimmunity is the underlying cause of more than 

100 serious, chronic illnesses. Women are the primary targets of these autoimmune diseases— 

they represent about 75 percent of the patients. It has been estimated that autoimmune 

disease treatment costs more than $100 billion per year. 

The term “autoimmune disease” refers to a family of genetically and clinically interrelated 

illnesses. They involve almost every human organ and system, including diseases of the nervous, gastrointestinal, and endocrine systems; skin and other connective tissues; eyes; blood 

and blood vessels. In all of these diseases, the underlying problem is the same—the body’s 

immune system becomes misdirected and attacks the very organs it was designed to protect. 

Autoimmunity and Women 

Taken together, autoimmune diseases strike women three times as often as men. Some 

diseases have an even higher incidence in women (Table I). For example, 9 out of 10 people 

who have lupus are women. Of the estimated 50 million Americans living with autoimmunity, 

30 million are women. 

Autoimmune disease is 1 of the top 10 leading causes of deaths among U.S. women age 65 

and younger. Moreover, these diseases represent the fourth largest cause of disability among 

women in the United States. 

Different ethnic groups are more susceptible to certain autoimmune diseases. In lupus, for 

example, African-American, Hispanic, Asian, and Native American women are two to three 

times more likely to develop the disease than Caucasian women. 

Autoimmunity: A New Disease Category 

Just as cancer is an umbrella category for a range of diseases (leukemia, breast cancer, prostate cancer, non-Hodgkin’s lymphoma, etc.), autoimmune disease also represents a group of 

genetically and clinically interrelated illnesses. Autoimmune diseases cross the different medical specialties, such as rheumatology, endocrinology, hematology, neurology, cardiology, 

gastroenterology, and dermatology. Specialists tend to focus on singular diseases within their 

particular category. But this must change since autoimmune diseases tend to cluster in individuals and families, making it very difficult for patients with multiple autoimmune illnesses 

(a common occurrence) to get comprehensive, coordinated treatment. 

10
Diagnosis and Women 

Table I: Female to Male Ratios in Autoimmune Diseases 

Systemic lupus erythematosus 9:1 

Hashimoto’s thyroiditis 10:1 

Sjögren’s syndrome 9:1 

Antiphospholipid syndrome-secondary 9:1 

Primary biliary cirrhosis 9:1 

Autoimmune hepatitis 8:1 

Graves’ disease 7:1 

Scleroderma 3:1 

Rheumatoid arthritis 2.5:1 

Antiphospholipid syndrome-primary 2:1 

Autoimmune thrombocytopenic purpura (ITP) 2:1 

Multiple sclerosis 2:1 

Myasthenia gravis 2:1 

Rheumatoid arthritis 2.5:1 

Getting a proper diagnosis is sometimes as difficult as living with an autoimmune disease 

itself. Victims face problems because physicians often don’t think of autoimmunity as a possible diagnosis. Women, especially those in the childbearing years, have an especially hard time. 

Often, women who suffer from autoimmune diseases are not taken seriously when they first 

begin consulting their doctors. Their symptoms are likely to be vague in the beginning, with a 

tendency to come and go, and hard to describe accurately to a physician. In a typical scenario, 

she is often shunted from specialist to specialist and forced to undergo a battery of tests and 

procedures before a correct diagnosis is made, which can sometimes take years. 

According to a 2001 survey by the American Autoimmune Related Diseases Association 

(AARDA), more than 45 percent of patients with autoimmune diseases have been labeled 

chronic complainers in the earliest stages of their illness. This can be devastating to a young 

woman who may then begin to question her sanity as she tries desperately to find out what 

is wrong. Tragically, many of these patients suffer significant damage to their organs and 

end up carrying this health burden with them for the rest of their lives because of the delay 

in diagnosis. 

If the public, particularly women, and medical practitioners were more aware of the genetic 

predisposition to develop autoimmune disease, clearly there would be more emphasis on 

including familial autoimmune disease when taking a medical history on a patient who presents with confusing symptoms. Earlier consideration of and testing for these diseases could 

only prevent significant and lifelong health problems. 

11
An example is antiphospholipid antibody syndrome (APS). In this disease, the patient produces antibodies against phospholipids—fat found in every cell wall. The major consequence 

of APS is blood clotting, which can cause stroke, miscarriages, migraine headaches, and 

clotting disorders. APS occurs by itself or may accompany many of the other autoimmune 

diseases. It is a significant cause of strokes in women under the age of 35 as well as recurrent miscarriage. Yet it would be unusual for a patient with an autoimmune disease other than 

lupus to be checked for it. APS has also been indicated as a causative factor in cardiovascular 

disease in women. APS can be treated simply with a baby aspirin or other blood thinner given 

to prevent strokes, miscarriage, and blood clots. The sad fact, however, is that many patients 

who could be treated in such a manner are never identified until after they have had a heart 

attack, stroke, or miscarriage. 

Highest Priority Research Recommendations for the National Institutes of 

Health/Office of Research on Women’s Health 

AARDA, in collaboration with the National Coalition of Autoimmune Patient Groups (NCAPG), 

recommended that NIH/ORWH provide maximum available resources into the following high 

priority research areas: 

Sex Bias in Autoimmunity 

Autoimmune diseases affect women disproportionately more often than men, some as high 

as 9:1. Although there has been some research into sex bias differences in autoimmune disorders, there is no substantial research into this area. It is commonly thought that hormones may 

play a significant role in the unbalanced nature of the diseases in women in comparison to 

men. For example, many autoimmune diseases seem to occur more often in women who have 

completed menopause, while other disorders may significantly improve during pregnancy with 

no outward provocation. Although these findings seem to point to an obvious link, the role of 

hormones in autoimmune disorders has not been conclusively proven. Recent findings indicate 

a need for more research concerning pregnancy influences on the incidence and natural history of autoimmune diseases. 

Autoimmune Disease Biomarkers 

NIH should focus considerable efforts into research on biomarkers for the more than 100 autoimmune diseases. There is a critical need for the creation of a database of autoimmune disease 

biomarkers. This database would assist in tracking the relation of biomarkers to disease severity. In addition, there is a need to develop a differential diagnosis technique to use groups 

of biomarkers to determine the presence of specific autoimmune diseases. The last item is 

based on the concept that autoimmune diseases can be determined by looking for groups 

of biomarkers as though they were chords played on a piano. There is also a need to expand 

autoimmune disease research to include the relationship between these diseases and other 

serious health conditions. 

12
Genetic Predisposition and External Triggers 

There are more than 80 known and 40 suspected autoimmune diseases afflicting as many as 

24.5 million Americans. These diseases are genetically interrelated, tending to cluster in individuals and families. An individual’s susceptibility to autoimmune diseases is determined by 

that individual’s set of genes. However, studies on identical twins show only a 30–50 percent 

concordance in autoimmune disease expression. Therefore, genetic makeup alone does not 

determine whether someone will “get” an autoimmune disease. There are other risk factors, 

external to the body, involved in initiating and exacerbating the disease process. 

It is common knowledge that autoimmune disorders are on the rise. While one-third of the risk 

of developing an autoimmune disorder lies in one’s genetic makeup, the remaining causes are 

thought to be noninherited and may contain several environmental factors. For example, exposure to certain metals, such as mercury, gold, and silver are thought to induce lymphocyte 

proliferation and subsequent autoimmunity. 

While our current understanding of the role environmental factors play in the autoimmune 

attack remains rudimentary, a wide range of triggers have been implicated in autoimmune 

disease expression, including the following: 

• Viral and infectious agents 

• Broad groups of chemicals 

• Heavy metals 

• Iodine 

• Organic compounds (including PCBs and estrogenic compounds) 

• Phthalates 

• Pharmaceuticals 

• Pesticides 

• Some foods such as gluten and cow’s milk 

• Ultraviolet radiation 

More research in this area is required to fully understand the relationship between environmental factors and autoimmune diseases that affect millions of Americans at an increasingly 

higher rate each year. It is imperative that we understand the full range of environmental triggers and the role they play in the autoimmune process. Understanding how environmental 

factors fit into the autoimmune attack puzzle may provide approaches to preventing these 

diseases or reducing their severity. This is certainly more desirable than trying to control an 

ongoing autoimmune attack with immunosuppressive drugs that expose patients to many 

well-known serious side effects. 

13
AARDA, therefore, strongly recommends to the NIH ORWH that a coordinated research program be initiated to better understand the role of environmental triggers across the family of 

autoimmune diseases. The ultimate goal of this program is the development of approaches to 

prevent autoimmune diseases or decrease their severity, thereby minimizing the very serious 

financial and societal burdens they place on our healthcare system and on afflicted individuals 

and their families. 

Awareness Through Education 

Lastly, we recommend that the NIH Office of Research on Women’s Health sponsor a crossinstitute scientific meeting to examine the latest in research on the issues discussed above in 

order to identify additional areas of opportunity in autoimmune disorders research. 

About the American Autoimmune Related Diseases Association 

The American Autoimmune Related Diseases Association is dedicated to the eradication of 

autoimmune diseases and the alleviation of suffering and the socioeconomic impact of autoimmunity through fostering and facilitating collaboration in the areas of education, public 

awareness, research, and patient services in an effective, ethical, and efficient manner. 

AARDA is the only national nonprofit health agency dedicated to bringing a national focus to 

autoimmunity, the major cause of serious chronic diseases. Approximately 50 million Americans, 20 percent of the population, or one in five people, suffer from autoimmune diseases. 

Women are more likely than men to be affected; some estimates say that 75 percent of those 

affected—some 30 million people—are women. Still, with these statistics, autoimmunity is 

rarely discussed as a women’s health issue. 

Autoimmunity is a result of a misdirected immune system that causes one’s own immune system to attack the self. There are more than 80 known autoimmune diseases; and unlike the 

many forms of cancer that are recognized as being part of the general term, “cancer,” autoimmune diseases are recognized singularly rather than in the overall category of autoimmunity. 

The public in general is unaware of the autoimmune nature of these diseases. When most people hear one of these diseases referred to as an autoimmune disease, they incorrectly confuse 

the term autoimmune with acquired immune deficiency syndrome (AIDS); or they think it is a 

form of cancer. 

This lack of knowledge and collaborative effort results in untold suffering for persons with 

autoimmune diseases due to misdiagnosis and delayed diagnosis, which may result in damage 

to vital organs. The need to bring a national focus to autoimmunity as the common factor in all 

autoimmune diseases is vital in order to bring a collaborative effort to research, funding, early 

detection, and eventually, prevention and cure for all autoimmune diseases. 

Some of the more than 80 autoimmune diseases are lupus, type I diabetes, scleroderma, 

celiac, multiple sclerosis, Crohn’s disease, autoimmune hepatitis, rheumatoid arthritis, Graves’ 

disease, myasthenia gravis, myositis, antiphospholipid syndrome (APS), Sjögren’s syndrome, 

uveitis, polymyositis, Raynaud’s phenomenon, and demyelinating neuropathies. 

14
About the National Coalition of Autoimmune Patient Groups 

Mission: To consolidate the voice of autoimmune disease patients and to promote increased 

education, awareness, and research into all aspects of autoimmune diseases through a collaborative approach. 

• American Autoimmune Related Diseases Association 

• American Behçet’s Disease Association 

• American Vitiligo Research Foundation 

• APS Foundation of America 

• Arthritis Foundation 

• Celiac Disease Foundation 

• Coalition for Pulmonary Fibrosis 

• Crohn’s and Colitis Foundation of America 

• Endometriosis Association 

• Gluten Intolerance Group 

• International Pemphigus & Pemphigoid Foundation 

• Lupus Alliance of America 

• Lupus Foundation of America 

• Lupus Foundation of Mid and Northern New York, Inc. 

• The Myositis Association 

• Myasthenia Gravis Foundation of America 

• National Adrenal Diseases Foundation 

• National Alopecia Areata Foundation 

• National Kidney Foundation 

• National Multiple Sclerosis Society 

• National Psoriasis Foundation 

• National Sleep Foundation 

• Platelet Disorder Support Association 

• Scleroderma Foundation 

• Sjögren’s Syndrome Foundation 

• Takayasu’s Arteritis Research Association 

• Vasculitis Foundation (formerly Wegener’s) 

• Vitiligo Support International 

15
DONNA VALLONE, PH.D., AND CHERYL HEALTON, DR.P.H. 

American Legacy Foundation 

Including Tobacco in the ORWH Research Agenda: An Essential Step Toward Improving the 

Health of American Women 

The board of directors and the staff of the American Legacy Foundation® (Legacy) urge the 

Office of Research on Women’s Health (ORWH) to give the prevention of tobacco use, smoking cessation, and tobacco-related disease a prominent position within the research agenda 

being developed for the National Institutes of Health (NIH) ORWH. Including tobacco in the 

ORWH research agenda is a critical first step toward improving the health of women in the 

United States. 

Smoking Is a Social Justice Issue 

National Health Interview Survey data show that, in 2007, 17 percent of all women over age 

18 in the United States were smokers, with substantially higher smoking rates among women 

with lower levels of education and income.1

 For example, 39 percent of women with a GEDlevel education smoked in 2007, as did 26 percent of women living below the Federal poverty 

level.1

 In fact, as a result of decades-long trends in which those with greater educational and 

financial resources smoke at lower rates,1,2 quit at higher rates, 2,3,4 are more likely to be covered by health insurance,5

 and are more likely to promptly seek medical care,5 tobacco use has 

become not only a public health issue, but also a social justice issue.6 

While the relationship between socioeconomic status and tobacco has been well documented, 

there are certain populations within which smoking rates are believed to be high, and yet a 

scarcity of data often relegates these groups to the sidelines of tobacco control interventions. 

Among these populations are gay, lesbian, bisexual, and transgender individuals and racial/ 

ethnic minorities, such as American Indians and Alaska Natives.7

 Disparities are compounded 

by the fact that smoking translates into mortality at different rates within different population groups. For example, African-American women smoke at lower rates than White women, 

but have higher death rates resulting from cancer.8

 A great deal more research will be needed 

before we can unravel the many factors influencing smoking and smoking-attributable disease 

and death in these populations. 

Smoking-Attributable Morbidity, Mortality, and Costs to Society 

Between 2000 and 2004 (the most recent data available), the Centers for Disease Control and 

Prevention (CDC) estimated that 173,940 U.S. women died annually as a result of tobaccorelated disease.9

 The leading causes of smoking-attributable death among U.S. women were 

heart disease, cerebrovascular disease, and lung cancer.9

 It is further estimated that approximately 18,000 U.S. women died annually during the years of the study period as a result of 

exposure to secondhand smoke.9 Collectively, these deaths represent more than 2 million years 

of potential life lost to U.S. women each year.9

 Furthermore, in each year from 2000 to 2004, 

the CDC estimated that 776 infant deaths were caused by smoking during pregnancy.9

 In 

addition to the devastating impact of these deaths on families who have lost mothers, wives, 

daughters, and children to tobacco-related disease, the average annual productivity costs of 

these deaths are estimated by the CDC to be $33 billion.9 

16
Smokers Underestimate Risk and the Addictiveness of Nicotine 

While the vast majority of women today know that smoking is harmful to their health, many 

fail to fully understand the risks smoking poses to themselves, their families, and their children. 

For example, although lung cancer has been the leading cause of cancer death among women 

since 1987, a Legacy study shows that 80 percent of women in the United States mistakenly 

believe that breast cancer is the primary cause of cancer death among women.10 Furthermore, 

girls and young women overestimate their ability to quit smoking; survey data show that more 

than half of teens who currently smoke do not expect to be smoking in 1 year.7

 Unfortunately, 

tobacco is highly addictive, so while most smokers—including teenage girls—report wanting to quit, very few are successful in a given year.7,11 One study showed that, among girls who 

smoked, 60 percent of those in middle school and 58 percent of those in high school had tried 

and failed to quit smoking during the previous year.7

 Survey data show us that of the approximately 43 million smokers in the United States, the majority of whom report wanting to quit, 

fewer than 5 percent will successfully quit within a 1-year period.1,11 

The State of Cessation Interventions 

In recent years, the science related to smoking cessation has advanced markedly; a combination of pharmacotherapy, counseling, and social support can vastly improve a smoker’s 

chances of successfully quitting.12 Based on evaluations of mass media cessation efforts in 

California, Massachusetts, and Oregon—in which high-intensity, research-based, paid media 

campaigns were combined with excise tax increases and community and school-based programs—the Task Force on Community Preventive Services “strongly recommends” mass media 

campaigns to increase tobacco cessation when the media campaign is combined with other 

interventions.13 However, recent research suggests that many mass media interventions, which 

have been successful overall, have in fact done a poor job of reaching those most in need— 

disadvantaged and low socioeconomic status smokers.14,15,16 Greater attention must be paid to 

1) developing interventions that will influence smoking cessation within these high-risk populations, including women; and 2) evaluating interventions in such a way that overall program 

success does not mask failure to influence important subgroups. 

The Tobacco Industry Encourages Smoking Among Women 

It is worth bearing in mind that the cessation interventions of the tobacco control and public 

health communities are continually undermined by billions of dollars worth of tobacco industry marketing and promotion. Just this week, the American Cancer Society Cancer Action 

Network, American Heart Association, American Lung Association, Robert Wood Johnson 

Foundation, and Campaign for Tobacco-Free Kids released a report called, Deadly in Pink: Big 

Tobacco Steps Up Its Targeting of Women and Girls.17 The report describes how two tobacco 

companies—Philip Morris and R. J. Reynolds—have recently “stepped up” tobacco marketing directed toward women and girls, threatening to undermine the advances made in recent 

years by the tobacco control and public health communities. The report describes two new 

products: Philip Morris’ Virginia Slims “purse packs,” released in October 2008; and R. J. Reynolds’s “Camel No. 9” released in January 2007. The report concludes that, given the aggressive 

marketing of these new products, these tobacco company efforts could be “devastating” to 

smoking-initiation rates among girls and, ultimately, to women’s health. 

17
A separate study conducted by American Legacy Foundation indicated that after the first 6 

months of the Camel No. 9 marketing campaign, more than 40 percent of youth (12–17) and 

young adult (18–24) smokers had tried the product and that many more planned to try it. Furthermore, interest in trying Camel No. 9 was high even among young adults who were not 

current smokers, suggesting that the product may serve to lure new smokers (Legacy data available upon request).18 Given these emerging female-oriented tobacco products and marketing 

efforts, combined with the enormous promotional budget of the tobacco industry—$13 billion 

in 2005, the most recent data available19—it is of paramount importance to track the impact of 

these products on initiation, smoking rates, and quit rates among girls and young women. 

Setting a Research Agenda for Women and Tobacco Use 

The authors of the 2001 Surgeon General’s report on women and smoking set a research 

agenda to “build the science-base on gender-specific outcomes and on how to reduce disparities among women.”7

 Moreover, the American Legacy Foundation has noted gaps in the 

research that has emerged since the time of the 2001 report. The following are presented as 

specific areas of research that Legacy believes should be pursued by the ORWH in an effort to 

improve the health of women in the United States: 

1. Conduct research to better understand why so many mass media cessation campaigns 

have been less effective or ineffective among disadvantaged or lower socioeconomic 

status populations 

2. Conduct research to learn how new media and Internet cessation services can be used 

to increase smoking cessation among women, and whether they can be effectively used 

across the socioeconomic spectrum 

3. Conduct research regarding smoking rates, smoking patterns, cessation rates, and factors associated with initiation and quit success among high-risk populations such as 

gay, lesbian, bisexual, and transgender individuals; minority racial/ethnic populations; 

population groups targeted by the tobacco industry; and lower education/lower income 

population groups 

4. Conduct research regarding tobacco products designed for and marketed to women 

specifically, whether they vary significantly in terms of the levels of known carcinogens 

and how this relates to lung cancer histology 

5. Conduct research to further explore the link between smoking and health outcomes 

among women, such as breast cancer and reproductive outcomes 

6. Conduct research to better understand how secondhand tobacco smoke impacts 

women who do not smoke 

7. Encourage scientists to report gender-specific results whenever possible when reporting on research about factors that influence smoking initiation or cessation, the health 

effects of tobacco, and new tobacco products 

Considering the toll of tobacco use on the health of American women, research into tobacco 

and tobacco-related diseases is underfunded. There is still much we need to learn so that we 

18
can prevent youth initiation, help adult smokers quit, and deliver care to women who suffer 

from tobacco-related disease. 

The American Legacy Foundation 

Legacy is a national, independent public health foundation created in 1998 out of the landmark 

Master Settlement Agreement (“MSA”) between the tobacco industry, 46 State governments, 

and 5 U.S. territories. Our mission is to build a world where young people reject tobacco and 

anyone can quit. Legacy does not lobby or take positions on specific legislation. Our programs 

include the following: 

• EX®—A groundbreaking and innovative smoking cessation public education campaign 

designed to help smokers “re-learn” life without cigarettes. 

• truth®—A national youth smoking prevention media campaign cited as contributing to 

significant declines in youth smoking. 

• Research Initiatives—Examining how public health public education can reduce smoking 

initiation and prompt smoking cessation. 

• Outreach to Priority Populations—Targeted outreach to underserved and minority communities using methods that are culturally competent and tailored to improve the reach 

and retention of programmatic efforts. 

References 

1. Centers for Disease Control and Prevention. (2008). Cigarette smoking among adults— 

United States, 2007. Morbidity and Mortality Weekly Report, 57, 1221–1226. 

2. U.S. Department of Health and Human Services. (1989). Reducing the health consequences of smoking: 25 years of progress. A report of the Surgeon General. (DHHS 

Publication No. [CDC] 89-8411). Washington, DC: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease Control, Center for Chronic Disease 

Prevention and Health Promotion, Office on Smoking and Health. 

3. Pleis, J. R., & Lethbridge-Cejku, M. (2007). Summary health statistics for U.S. adults: 

National Health Interview Survey, 2006. National Center for Health Statistics. Vital 

Health Statistics, 10(235). 

4. Fagan, P., Shavers, V. L., Lawrence, D., Gibson, J. T., & O’Connell, M. E. (2007). Employment characteristics and socioeconomic factors associated with disparities in smoking 

abstinence and former smoking among U.S. workers. Journal of Health Care for the Poor 

and Underserved, 18(4 Suppl), 52–72. 

5. Adams, P. F., Lucas, J. W., & Barnes, P. M. (2008). Summary health statistics for the U.S. 

population: National Health Interview Survey, 2006. National Center for Health Statistics. Vital Health Statistics, 10(236). 

6. Healton, C., & Nelson, K. (2004). Reversal of misfortune: Viewing tobacco as a social 

justice issue. American Journal of Public Health, 94(2), 186–191. 

19
7. U.S. Department of Health and Human Services. Women and smoking. A report of the 

Surgeon General. (2001). Rockville, MD: U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. 

8. Albano, J. D., Ward, E., Jemal, A., Anderson, R., Cokkinides, V. E., Murray, T., . . . Thun, M. 

J. (2007). Cancer mortality in the United States by education level and race. Journal of 

the National Cancer Institute, 99, 1384–1394. 

9. Centers for Disease Control and Prevention. (2008). Smoking-attributable mortality, 

years of potential life lost, and productivity losses—United States, 2000–2004. Morbidity and Mortality Weekly Report, 57, 1226–1228. 

10. American Legacy Foundation. (2001). Women and lung cancer survey. Washington, DC: 

Author. 

11. Centers for Disease Control and Prevention. (2002). Cigarette smoking among adults— 

United States, 2000. Morbidity and Mortality Weekly Report, 51, 642–645. 

12. Fiore, M. C., Bailey, W. C., Cohen, S. J., Dorfman, S. F., Fox, B. J., Goldstein, M. G., . . . Baker, T. B. (2000). A clinical practice guideline for treating tobacco use and dependence. 

Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. 

13. Task Force on Community Preventive Services. (2001). Recommendations regarding 

interventions to reduce tobacco use and exposure to environmental tobacco smoke. 

American Journal of Preventive Medicine, 20(2s), 10–15. 

14. Niederdeppe, J., Fiore, M. C., Baker, T. B., & Smith, S. S. (2008). Smoking-cessation 

media campaigns and their effectiveness among socioeconomically advantaged and 

disadvantaged populations. American Journal of Public Health, 98, 916–924. 

15. Niederdeppe, J., Kuang, X., Crock, B., & Skelton, A. (2008). Media campaigns to promote smoking cessation among socioeconomically disadvantaged populations: What 

do we know, what do we need to learn, and what should we do now? Social Science & 

Medicine, 67, 1343–1355. 

16. Fagan, P. (2008). Examining the evidence base of mass media campaigns for socially 

disadvantaged populations: What do we know, what do we need to learn, and what 

should we do now? A commentary on Niederdeppe’s article. Social Science & Medicine, 

67, 1356–1358. 

17. American Cancer Society, Cancer Action Network, American Heart Association, 

American Lung Association, Robert Wood Johnson Foundation, & Campaign for 

Tobacco-Free Kids. Deadly in pink: Big tobacco steps up its targeting of women and 

girls. Retrieved from http://www.lungusa.org/assets/documents/publications/ 

other-reports/deadly-in-pink.pdf 

18. American Legacy Foundation. (n.d.) Camel No. 9 study. Washington, DC: Author. 

19. Federal Trade Commission. (2007). Federal Trade Commission cigarette report for 2004 

and 2005. Washington, DC: Author. 

20
CLAIRE SAXTON 

Bladder Cancer Advocacy Network 

Women and Bladder Cancer Research 

The Bladder Cancer Advocacy Network (BCAN, pronounced “beacon”) is the first national 

advocacy organization dedicated to improving public awareness of bladder cancer and 

increasing research directed toward the diagnosis, treatment, and cure of the disease. BCAN 

works to raise awareness of bladder cancer among the general public and medical community; 

to advocate for allocation of additional governmental and private funds to research programs 

directed to the diagnosis, treatment, and cure of bladder cancer; to provide services to bladder cancer patients, their caregivers, and their loved ones; and to directly fund and increase 

bladder cancer research. Founded in May 2005, BCAN is a cooperative effort among bladder 

cancer survivors, their families and caregivers, and the medical community. 

Women and Bladder Cancer Research 

Bladder cancer has long been considered a disease of older men. Though it is more prevalent in men, studies have shown that women are more likely to present more advanced tumors 

and have a worse prognosis than men at almost every stage of the disease. According to a 

report published by the National Cancer Institute, the survival rate for women with bladder 

cancer lags behind that of men at all stages of the disease. African-American women in particular have poor outcomes when diagnosed with bladder cancer. They present with the highest 

proportion of advanced and aggressive tumors when compared to African-American men and 

Caucasian men and women. In addition, the number of women diagnosed with bladder cancer 

has been increasing. 

In many cases, there are significant delays in diagnosing bladder cancer in women. Many 

women ignore the most basic symptom—blood in the urine—which they may associate with 

menstruation or menopause and delay reporting this symptom to their doctors. Even after 

reporting the problem to their doctors, blood in the urine may be initially misdiagnosed as 

a symptom as postmenopausal bleeding, simple cystitis, or as a urinary tract infection. As a 

result, a bladder cancer diagnosis in women can be overlooked for a year or more. 

However, according to a research study published in the January 1 issue of the journal, Cancer,

1

 the increased lethality of bladder cancer in women (and African Americans) cannot be 

explained away simply by age, tumor type, and stage of the disease upon diagnosis. In fact, 

less than one-third of the difference in lethality between White men and women can be 

explained away by these factors. 

So what other important factors help explain the increased lethality of bladder cancer in 

women (and African Americans)? Other than being diagnosed at a later stage, why else is 

bladder cancer almost twice as lethal in women, who are a third less likely to get the disease? 

Do hormonal differences help account for bladder cancer’s increased mortality in women? The 

sad reality is that there has not been enough research done on women and bladder cancer to 

answer this question. 

21
The Impact of Bladder Cancer on Women 

In 2008, approximately 17,500 women were diagnosed with bladder cancer and approximately 

4,150 women died from this disease in the United States. To put a face to the devastating 

impact that bladder cancer and what the lack of research and physicians’ awareness of bladder cancer in women has on those affected by bladder cancer, we are sharing the story of one 

of BCAN’s volunteers. 

Karen, who was diagnosed in the fall of 2003, experienced a delay of more than 3 years between 

the first symptom of blood in her urine and being diagnosed with bladder cancer. “In retrospect, 

the symptoms of bladder cancer had been there since 1999, when my general practitioner had 

first found microscopic blood in my urine sample, but dismissed it as ‘normal’ for me.” By the 

time it was diagnosed, Karen’s bladder cancer had progressed to stage 2 and had invaded the 

muscle wall of her bladder. Her treatment required a long, complex surgery that included complete removal of her bladder and having a “neobladder” fashioned out of her intestines. Today, 

her life has gone back to a new normal, but it took months of healing and learning how to 

work with a new part of her body created by the surgery in order to void her urine. 

Had Karen’s bladder cancer been caught in its earliest stage, it is possible she could have 

been treated without resorting to the complete removal of her bladder and urinary diversion. Karen says she encourages other women to “be their own health advocate. Research for 

yourself, know your options. Encourage your medical team to work with you as an individual, 

not as an illness.” 

New Research and Strategies Are Needed 

When it comes to bladder cancer research, new strategies, ideas, and approaches are clearly 

needed to help understand and manage the disease in women on par with how well physicians and researchers in the United States understand and manage the disease in men. 

Reference 

1. Scosyrev, E., Noyes, K., Feng, C., & Messing, E. (2009). Sex and racial differences in 

bladder cancer presentation and mortality in the U.S. Cancer, 115, 68–74. 

MEGAN WHINERY 

Endometriosis Association 

Endometriosis 

Thank you for taking the time to read this submittal and seriously consider endometriosis 

as an area for research and improvement in the coming years. I am writing and speaking on 

behalf of both the Endometriosis Association and myself, as I have been living with this disease for an estimated 18 years. I have been fortunate enough to find a wonderful doctor, 

receive support through a dedicated organization and an understanding husband, and experience the miracle of motherhood in spite of my disease. But not every woman is this lucky, and 

I’m hoping that, one day, through events like these, we ALL can have these chances in life. 

22
The Endometriosis Association was the first organization in the world created for those with 

endometriosis. As an independent self-help organization of women with endometriosis, doctors, and others interested in the disease, it is a recognized authority in its field whose goal 

is to work toward finding a cure for the disease as well as providing education, support, and 

research. I was fortunate enough to find them shortly after I was diagnosed, and was given the 

privilege to help others by organizing a local support group here in St. Louis. 

The definition as posted on the Web site, http://www.pelvicpain.com, reads as follows: Endometriosis occurs when endometrial tissue, the tissue that lines the uterus and is shed during 

menstruation, grows outside of the uterus—on the ovaries, fallopian tubes, ligaments supporting the uterus, and other areas in the pelvic cavity. Endometriosis can also appear in a woman’s 

bladder, bowel, vagina, or other places in her body. Like the lining of the uterus, these areas of 

endometrial tissue respond to the hormones of the menstrual cycle—they build up tissue each 

month, then break down and bleed during menstruation. But unlike the uterus lining, when 

these endometrial implants (also called growths or lesions) outside the uterus bleed, they can 

irritate a woman’s body. It is estimated that 71–87 percent of women studied with chronic pelvic pain were found to have endometriosis. And, among infertile women, about 30–45 percent 

have this disease, making it one of the top three causes of infertility. Other symptoms include, 

but are certainly not limited to dysmenorrhea, pain before and during menstruation; dyspareunia, pain during and after sexual intercourse; and irregular vaginal bleeding. 

To further complicate matters, the only way to diagnose endometriosis for sure is during a laparoscopy, which is a surgical procedure. This, in combination with a lack of information to the 

public, leads to long periods of misdiagnosis. According to a survey of 4,000 women with 

endometriosis posted on http://www.OBGYN.net, the average length of time to diagnosis is 

9.28 years, allowing for a delay in the patient seeking help from a physician for an average 

of 4.67 years (this resulted mostly from women being under the age of 25 when symptoms 

began). Due to the lack of a “test,” endometriosis accounts for approximately 25 percent of 

laparotomies performed by gynecologists. Among gynecologic disorders, endometriosis is 

surpassed in frequency only by leiomyomas (fibroids). There is also no cure for endometriosis, 

making the need for more than one surgery common in moderate to extreme cases. 

This disease is not only physically but also mentally and emotionally exhausting due to the 

effects it has on all aspects of life. Unfortunately, women are not always taken seriously when 

trying to explain “pain” they feel during their menstrual cycle, and are often dismissed with 

a phrase similar to “welcome to womanhood.” There was an article recently published about 

a woman named Claire Reynolds and her struggle with this disease. After talking to many 

women over the past several years in our support group, I found that this article expressed 

many of the same quotes uttered by most sufferers that I’ve encountered. I personally don’t 

believe that any woman should have to say, “I just wish doctors had listened to me and spotted the severity of my case sooner. It would have saved (18) years of agony.” And, as medical 

professionals, I don’t think you ever want to hear anyone say, “I gave up going to doctors 

after a while as I felt stupid because they didn’t believe me. But I knew there was something wrong.” I can attest to the sentiment that, “When I woke up after the operation I said, 

‘I haven’t felt this good since I was 13’.” And, in conclusion, while I am honored that the 

23
Endometriosis Association asked me to speak on their behalf, it really comes down to the fact 

that I just want other young girls to know about this so they don’t have to go through the pain 

and suffering I did. Thank you to Claire for sharing her story to the world. 

SUSAN WOOD, PH.D. 

George Washington University School of Public Health and Health Services 

Women’s Health Research: Current and Future Implementation and Policy Implications 

The research agenda and strategies for the next decade to be identified by the Office of 

Research on Women’s Health at the National Institutes of Health (NIH) will be built through a 

series of national conferences starting first with this conference at Washington University in 

St. Louis, MO. The range of topics to be discussed at this conference reflects a sampling of the 

large number of health issues confronting women and the basic biomedical, behavioral, and 

clinical research needed to address them. 

Women’s health, as we know, requires a comprehensive, interdisciplinary, and lifespan 

approach to increase our understanding of girls’ health, reproductive health, and the health 

of aging women of all races and ethnicities. Prevention, early detection, and appropriate and 

effective interventions and care all require an underlying base of evidence and knowledge that 

NIH is uniquely qualified to provide, through its own research or the research that it funds. 

The NIH also faces challenges, when considering priorities and funding strategies, to work to 

ensure that the knowledge and information that is generated is available and useful to the 

public, to health professionals, to the larger scientific and medical communities, and to policymakers. It is these policy implications and challenges that I would like to discuss. I will identify 

some of the key questions that need to be explored and addressed as the research strategy 

is developed. 

Translation of research is one of these key challenges. Often called bringing research from 

bench to bedside, it is the ability to identify and move basic biological research findings to 

clinical utility. A second layer of translation involves moving clinically relevant findings into the 

appropriate level of widespread use. Both of these require successful interactions with other 

Federal health agencies, such as the Food and Drug Administration and Agency for Healthcare 

Research and Quality, and also with health professional and educational organizations. Evaluation of current successful mechanisms and application to women’s health research can add to 

ongoing efforts. 

Policy mechanisms for promoting interdisciplinary research are also critical. What do we know 

about what works in cross-disciplinary research? The NIH Roadmap for Medical Research has 

created mechanisms such as the Research Teams for the Future to promote interdisciplinary 

research. It is important to evaluate whether these mechanisms have been used for women’s 

health research, and if, along with programs, such as the Building Interdisciplinary Research 

Careers in Women’s Health scholars, they have led to increased interdisciplinary research 

24
and findings. Lessons can be learned from these approaches for interdisciplinary research in 

women’s health over the next decade. 

A research agenda and strategy also has significant impacts on the workforce. Training programs 

and grants provide the foundation for the next generation of researchers and clinicians. Since 

part of the ORWH mission is to advance women in biomedical research careers, this fits well with 

the goals of the office. From another perspective, the knowledge and findings from NIH-sponsored research profoundly affect the direction of medical care and the medical workforce needs 

of the future. Understanding and evaluating the impact of the research agenda and priorities on 

the training needs and the next generation of providers will be important to attain success. 

Effective communication of NIH research activities and findings on women’s health both to 

the public and to policymakers is critical. The public understanding of both the promise and 

limitations of NIH-funded research requires proactive outreach and partnerships for success. 

Information provided by the NIH traditionally has targeted the scientific and medical professionals, with less information targeted at the general public or that reaches across cultural 

differences. Successful initiatives, such as through the National Cancer Institute and other 

institutes, and through ClinicalTrials.gov, has expanded dir ormafo ins tesct acec wtion. Ho -

ever, reaching women facing health concerns in their daily lives and who don’t actively seek 

NIH information requires expanding existing programs and developing new and innovative 

approaches and partnerships. Community organizations, health centers, and social networks, 

for example, can serve as the basis for information exchange and for health promotion. Communication of risks and benefits, as well as what is known and what yet remains to be learned 

through research, is key to empowering women to take what steps they can to improve their 

health and the health of their families. 

Policymakers as well, at all levels, benefit from a fuller understanding of research needs, scientific and medical methodologies and findings, and strategies for bringing research to fruition 

to the benefit of the public. National, State, and local efforts to engage the policymaking community, including the many advocates for women’s health research, provide opportunities to 

bring NIH expertise to the community and for NIH experts to learn of policymaker’s priorities 

and community needs. The policy stakeholders include researchers, advocates, policymakers at all levels, relevant health agencies, scientific and health professional organizations, and 

community representatives. 

As policymakers at the State and national levels potentially begin to address healthcare 

reform, issues of quality and comparative effectiveness research have moved to the fore. 

Research and the evidence base are central to these questions, and it is equally important 

that new data on sex and gender differences be available and analyzed appropriately. Ensuring women’s health is addressed in healthcare reform is linked to continuing the research 

focus on women’s health. Providing policymakers with relevant data and information on the 

NIH priorities in women’s health research gives them the tools they can use for decisions in 

health policy. 

25
The Institute of Medicine and the Government Accountability Office have issued a number of 

reports over the past two decades on women’s health research and services, and on the broad 

issues of workforce, training, and translation and communication of research agendas and 

scientific findings. As the NIH Office of Research on Women’s Health moves forward in developing the agenda and strategies for women’s health research over the next decade, it should 

include a strong focus on these and other related policy implications throughout its development. I look forward to the series of national conferences as an opportunity to highlight the 

potential policy issues, approaches, and strategies that can promote the health of all women 

across the lifespan. 

DIANA HANKEY UNDERWOOD, M.S., WHNP-BC 

Grace Anatomy, Inc. 

Childbirth Classes Changed Women’s Health Care in the Delivery Room All Over America—Now 

We Need Incontinence Classes To Improve Care in the Outpatient Setting 

Good afternoon. My name is Diana Hankey Underwood. I am a Nurse Practitioner in Women’s 

Health and am currently the Director of Grace Anatomy, Inc., a nonprofit organization involved 

in local, national, and international work in healthcare issues involving incontinence. Other 

incontinence problems, related birth defects, and their associated psychological distresses are 

other areas that Grace Anatomy, Inc., is resolutely dedicated to improving. We are involved 

in teaching; researching; and sharing resources, experiences, and ideas among people who 

have and/or who treat these conditions. This work led to two national awards in 2007. I was 

awarded the Nurse Practitioners in Women’s Heath (NPWH) and Bayer HealthCare Inspirations 

in Women’s Health Award. I received another award titled, “Continence Care Champion 2007” 

from the National Association for Continence (NAFC), which was sponsored by the American 

Urogynecologic Society (AUGS) Foundation. 

I had the privilege of training under Dr. Carolenn Sampselle, a great researcher on the relationship of childbearing to incontinence, and an organized woman of immense compassion. 

Another mentor of mine was one of the first women in the United States to teach childbirth 

classes. The stories I heard from her of the really inhumane treatment of women, even by reputable doctors, helped me when I later suffered from similar treatment in a gynecology clinic. 

At one time, it was common for women to have their hands slapped and tied down, and for 

them to be gassed unconscious, with or without their consent. Midline episiotomies were 

the standard. Any given woman who complained was labeled and treated quite badly. Many 

doctors resisted those first childbirth classes, stating that teaching patients would only confuse them. Of course, today, treating a woman in a labor room in such a manner is completely 

unacceptable. These practices began to change only when public education became available. 

Unfortunately, the current “standard of care” for patients in the gynecology and urology clinics is, in my opinion, often just as inappropriate. Today, women are not provided with accurate 

information and I often hear that teaching them about their urinary system and pelvic floor 

would just confuse them. 

26
My own experience is an example of how punishing our medical system can be to women 

who “complain.” My experience with bladder problems began with surgery to stop hemorrhaging from my trigone when I was 17. By the time I started my graduate studies in my early 30s, I 

was an expert at concealing and controlling leaking blood and urine. I would not have listed this 

as a great stressor in my life; any more than having to dye the gray out of my hair is now—a bit 

of an expense, a bit of a hassle, but nothing that shakes the ground under your feet. 

That changed when I started infertility treatments at a leading institution and had a pregnancy 

confirmed by ultrasound at 5 weeks. Everything was fine while I took the name-brand progesterone, but when the pharmacist switched me to a generic, I knew something wasn’t the 

same and I asked the nurse to let me see the doctor. I was told that I was being ridiculous; we 

all know generics are as good as name brands and I was not “allowed” to see the doctor. (This 

drug lot was later recalled due to faulty manufacturing, and the company generously offered 

to reimburse my five dollar copay.) I was finally seen by a friend and an ultrasound was done. 

My husband and the technician and I watched my baby die on the screen right in front of our 

eyes. After a horrible D & C in which I hemorrhaged profusely, the doctors were forced to leave 

a catheter in my uterus as a tampon aid. Unfortunately, this left me with a non-functioning 

bladder and the need to self-catheterize, mild fecal incontinence, a mass in my labia that grew 

quite large before passing any solid stool, and an endometrial mass in my cervix that started 

to create the sensation of being in labor. This pain grew more and more intense over the following months, interfering with my daily activities and my sleeping. 

We brought a baby home from overseas. I couldn’t wear paper products because they 

scratched this tender tissue, so I wore his cloth diapers and cried. Keeping my brain constantly 

on maximum concentration and overload was the only way I could shut out the pain, so when 

our baby began to walk, I began to manage a clinic for the uninsured. While waiting to see a 

top pelvic floor specialist, I was forced to become very creative, wearing a tampon in my rear 

and several layers of cloth diapering and girdling. At my first appointment, I was given a questionnaire that began with a picture of man’s body (no genitals) with a request to show where 

I hurt. I was asked, “How often do you use your digits to evacuate your rectum.” I thought 

“about as often as you pick your nose, i.e., ‘use your digits to evacuate your nostrils’.” I had no 

idea why they would ask me such an off-the-wall and vulgar question out of the blue. They 

could not have made the appointment more humiliating or frustrating if they had tried. 

Later, when I told them that I was sure I had parasites, I was laughed at. When I insisted they 

test me, I was given a lot of grief. (They had ordered and my insurance paid for three MRIs, 

but a parasite test would be a “waste of money”). My first stool sample was lost. The second 

one was ‘”mishandled.” I was getting worse in every way. My spirits and my cholesterol continued to drop. I took my husband to an appointment and when I told the top surgeon that I was 

pretty sure that besides parasites, there was something wrong with my levator muscle and 

that I had a mass “right there.” He pushed his finger into my vulva, into this excruciating area 

that would swell out. He raised his voice and stated, “That is NOT your levator muscle! That is 

your vulva!” He asked no other questions about fecal incontinence. 

27
My husband was as incensed as I was. He suggested I take a picture of it when it bulged out and 

then show someone in Risk Management so that they would tell the doctor to change his manners. After quite a bit of battle, I was told to sue and go away. “No one else wants to see you and 

get their name added to a law suit.” I told them I didn’t believe in suing and that I wanted them 

to live up to the advertisements they do about providing excellence in care for women. 

I had a hysterectomy, which finally helped stop the constant horrible, labor-like pain that had 

lasted day and night for almost 2 years. When I was told the pathology was normal, I called a 

head pathologist, whom I knew from a cancer research project I had previously worked on. I 

asked to see my slides, because I KNEW I had a mass in my cervix. The nurse called me from 

the gynecology clinic and told me, “you cannot come back for your two-week post-op appointment. The doctors were all talking and they said they never wanted to see you again as long as 

they lived.” I guess their theory was that if you are going to get sued anyhow, you might as well 

enjoy the licks that you can get in first. (Later, the pathologist apologized as he showed me the 

slides, stating that they were “completely misread and clearly are full of endometriosis.”) 

I still had the incontinence, but after the hysterectomy, I began to smell worse and worse. It 

was so humiliating and distressing, and only the pelvic floor physical therapist gave me any 

tools to make it bearable. So much time and suffering had gone by. Then one day, my sweet 

little boy woke up, suddenly unable to walk, and could only flop around. He was hospitalized 

and we were both finally treated for Giardia, a very contagious parasite and a B12 deficiency. 

We were treated with five dollars worth of metronidazole and twenty dollars worth of B12. 

Within 3 weeks of getting appropriate care, I was dramatically better. (My son was not so fortunate and has spent years in occupational and physical therapy.) 

One of my really faithful friends continued to encourage me with stories of women she had 

known and where they had gotten the fire to fight for childbirth classes. Their stories echoed 

the same ingredients that provided fuel and stoked the fire for change that ultimately brought 

conferences such as this very one into existence. These common features exist today: welleducated, yet ignorant, women like me; indecent treatment; arrogance on the part of many 

leaders; their often cruel beliefs that women with a lot of physical problems deserve them; an 

arrogant belief that women could not understand; and that any woman who doesn’t go with 

the flow and obey and revere the doctors deserves to be put in her place. 

Just after my son was released from the hospital, I received a call that changed my life. A friend 

in another country had called to ask if I could help some really dedicated surgeons work in the 

United States with one “Dr. Alberto Pena.” She said she couldn’t explain why, but that it was 

imperative that I find him—could I please just find him! So I did. When you complain you have 

no shoes, God shows you those who have no feet. Dr. Pena is a doctor who specialized in fecal 

incontinence in children. I later found out that five orphans had tried to commit suicide after 

unsuccessful attempts to repair birth defects that left them with fecal incontinence and emotional scars. The doctors were hoping to learn how to do a better job of understanding the pelvic 

floor and doing repairs in the most effective manner. I met with the surgeons from overseas and 

with the staff at Cincinnati Children’s Hospital and I was so surprised by how many things we 

could be doing for women that we aren’t, and how many things we do for women that we could 

28
do for children that we aren’t. Already from this work, one paper has been published on a completely new repair protocol that combines Russian/United States protocols and has resulted in 

success in five out of seven cases, where previously no one in either country had ever had success.1 I am hopeful that we can work with them on tissue histopathology, because understanding 

these birth defects may lead us to a better understanding of why two women can both go 

through horrendous deliveries, but one ends up with fistulas and the other doesn’t. 

With a move to New York and the encouragement from my mentor and also from Cheryle Gartley and Jasmine Schmitt from the Simon Foundation for Continence, I spent 1 year 

researching and adapting their course on incontinence. Working as adjunct faculty at the 

State University of New York in Buffalo, I began to teach about how to cope, about the most 

common causes of incontinence, and about what we can do to treat it. I created an elimination diary that adds a lot of dignity and understanding to this vital part of the care. I taught 

patients how to use it to communicate clearly with their providers, something that I was 

very bad at, but that I learned a lot about, albeit, sadly too late. I hope others will look at it 

here today. This program was extremely well received; it helped many people and eventually 

became the first incontinence program in the United States to receive insurance reimbursement. I am in the process right now of getting the entire lecture series posted to an Internet 

site. I am also working on a research project, reviewing how women do after pelvic floor mesh 

insertion. I could write several more paragraphs about the almost obscene things I have seen 

and heard in the last few years, but most of this could have been eliminated by educated 

patients and a provider willing to give them the right to be involved in their own care. 

To change the outcomes and costs of bladder and pelvic floor disorders affecting women’s care right now, we have to invest in independent patient education courses. I hope you 

will consider grants that would allow the Wound, Ostomy, and Continence Nurses Society; 

National Association for Continence; Simon Foundation; International Foundation for Functional Gastrointestinal Disorders; and Women’s Health Foundation and Grace Anatomy, Inc. to 

test classes and other public awareness and education programs. Let us teach the public and 

the nurses and compare which courses are best for which specific populations. Each of our 

programs has a little different angle, but in the end, I believe these differences are like childbirth methods proposed by Dick-Reed, Lamaze, and Bradley. It took more than one kind of 

class, and many leaders, but the fact that women began to understand the process changed 

the face of women’s health care in America. 

Each of our organizations, individually, and collectively, need to have funding to do public 

education, paid for initially from Federal funds, not from grants provided by drug companies. Grace Anatomy has the ability to provide classes that appeal to groups who want to hear 

straight talk that they can identify with. Please give us the opportunity to demonstrate what 

a life-changing difference it can make and to see how much money can be saved by teaching 

men and women what they need to know. Thank you for your consideration. 

Reference 

1. Akhparov, N. N., Aipov, R. R., & Ormantayev, K. S. (2008). The surgical treatment of 

H-fistula with normal anus in girls. Pediatric Surgery International, 24, 1207–1210. 

29
NANCY NORTON 

International Foundation for Functional Gastrointestinal Disorders 

Impact of Fecal and Urinary Incontinence on Health Consumers 

About the International Foundation for Functional 

Gastrointestinal Disorders 

The International Foundation for Functional Gastrointestinal Disorders (IFFGD) is a nonprofit 

education and research organization dedicated to informing, assisting, and supporting people 

affected by gastrointestinal or motility disorders and fecal incontinence. The largest organization of its kind in the United States, IFFGD has been working with patients, families, physicians, 

practitioners, researchers, employers, regulators, and others to broaden understanding about 

gastrointestinal (GI) disorders. We work closely with healthcare professionals and the medical 

and pharmaceutical industries. This cooperative effort places IFFGD at the forefront of functional GI and motility disorders care and research, helping us to aid and benefit those affected. 

We work with an international group of experts from multiple disciplines who serve on our 

medical advisory board. We provide a link between clinical research and patient care. Working 

together, we help ensure that clinical advancements concerning GI disorders result in improvements in the quality of life of those affected. 

Introduction 

The impact of living life as a person with incontinence carries a burden, whether it is urinary 

incontinence, fecal incontinence, or both. The nature of the condition, one that few feel comfortable even mentioning, presents unusual challenges. There is a tendency to believe that 

bowel incontinence affects only the frail and elderly. But while it is the primary cause of nursing home admissions, incontinence affects all ages, children and adults alike. For example, 

women may develop bowel incontinence as a result of a vaginal delivery. Incontinence is also 

associated with spinal cord injuries, multiple sclerosis, diabetes, colon cancer, prostate cancer, 

uterine cancer, and a host of other digestive diseases. 

The prevalence of fecal incontinence in women living in the community increases with age, 

from 6 percent in those younger than 40 years to 15 percent in older women. In nursing 

homes, the overall prevalence of fecal incontinence is about 45 percent, with a rate as low as 

10–15 percent in more independent residents and up to 70 percent in the most dependent. 

Prevalence of urinary incontinence in women living in the community also increases with age, 

from 19 percent at age younger than 45 years, to 29 percent in age 80 years or older. In nursing homes, the prevalence of urinary incontinence is much higher than that in the community: 

rates are 60–78 percent in women. 

Challenges Patients Face 

Incontinence is a chronic condition with often unpredictable symptom episodes. Uncertainty, 

it has been said, is the worst illness.1

 The effects of persistent uncertainty surrounding onset of 

an episode of incontinence can be disabling. There is no socially acceptable way to talk about 

toilet habits or bodily waste. Thus, a social stigma is attached to the symptoms of incontinence, and by attribution, to the sufferer. 

30
For the patient who seeks treatment, effective therapies are often elusive. Moreover, symptoms of chronic illness place demands on families as well as patients. They impair functioning 

while placing continual demands on the individual patient.2 

The impact of having a chronic illness may be subjective and it may change within each individual over time. A variety of external and internal factors intersect, influencing whether or not 

a person will seek medical help, and their ability to adapt to their illness demands and benefit 

from treatment. This personal impact is influenced by cultural, social, and psychological factors 

along with concepts of self-image, self-worth, and health expectations.3 

It has only been in the past 20 years that we have gained a better understanding of the 

impact of urinary incontinence on the psychosocial well-being of affected individuals. The 

emergence of new tools for assessment of quality of life with urinary incontinence has 

changed the way this condition is viewed and managed.3 The same assessment needs to be 

made for fecal incontinence. 

Neither urinary incontinence nor fecal incontinence is a single disease. Rather, they are 

symptoms of many different conditions. Patients come to it from many perspectives with 

different expectations. 

Until recently, the focus for establishing a diagnosis and assessing a therapeutic outcome of 

urinary incontinence has been on the objective measurement of urinary loss. Fecal incontinence has been measured in similar ways looking at frequency, amount, composition, and the 

circumstances surrounding fecal leakage.4 However, objective measurements, such as weight 

of urinary incontinence pads or frequency of fecal incontinence episodes, are not always practical, nor do they describe the true impact of incontinence on the patient.3

 As better tools 

emerge, we will capture a more comprehensive and truer picture of the impact of incontinence 

and the burden it represents to the individual. 

Taboos and Stigmatization 

The person with incontinence is faced with a persistent challenge of overcoming social and 

cultural taboos. Socially, it is expected that we acquire bladder and bowel control skills during childhood. We are taught cultural norms about when and where to eliminate and dispose 

of bodily wastes. We react generally with disgust to the presence of bodily waste, particularly 

feces. Possibly this is a basic human emotion to protect us from disease. In any event, the loss 

of urine or feces, particularly as an adult, carries significant societal taboos.5 

When bladder or bowel control is lost, especially in public, overwhelming feelings of shame 

and embarrassment often result. This loss of control over elimination and public humiliation 

represents major threats to self-esteem.5 

Individuals who suffer incontinence will go to great lengths to keep their condition a secret if 

they are able. Revelation of this secret can have a profound affect on their well-being. They 

may be subjected to gossip, hostility, and other forms of social exclusion. The elderly are frequently relocated to other living arrangements and are at risk for institutionalization.6

 Anal 

31
incontinence may be one of the most common reasons for social isolation and institutionalization of the elderly. Incontinent patients have been reported to be less likely to marry and hold 

a normal job. In the workplace, in addition to lost productivity, individuals face stigmatization 

and reduced self-esteem.7 

With incontinence, the illness experience is not limited to the symptoms. It is accompanied by 

what is called a “second illness”—the reactions of the social environment and the stigma associated with the disorder. Stigmatization is a dimension of suffering added to the illness experience, 

and has been found to lead to social isolation, limited life chances, and delayed help-seeking.8 

Barriers to Seeking Help 

Almost every article published on incontinence makes some kind of reference to the strong, 

if not devastating, impact of having the disorder. Yet 50 percent to 70 percent of incontinent 

persons do not seek help for their condition.3,4,5,9,10 

Physicians Don’t Ask/Patients Don’t Tell. A study of primary care physicians found that the 

majority of these physicians asked only 25 percent or fewer of their patients about incontinence.3

 But significantly, while up to 70 percent of incontinent patients did not voluntarily 

report the problem, more than 75 percent did report the condition when asked about it by 

their physician.3 

Because patients are often reluctant to introduce the topic, physicians need to take the lead. 

They need to ask their patients about bowel and bladder function, about the patient’s ability 

to control it, and whether it’s resulting in changes in daily routine. 

Severity of symptoms may be a driving factor that brings people to the physician because they 

are no longer able to cope with the symptoms. But incontinent people have a need to perceive 

the benefits of treatment in order to overcome the emotional costs they will expend in revealing their incontinence to a physician.9 For some patients, there is a fear that they won’t be able 

to even get to the doctor’s office for an appointment without being incontinent. Others have 

sought help in the past, but were met with a lack of interest, or they may have tried various 

treatments with no success and are therefore reluctant to pursue another course of treatment. 

Breaking Down Barriers 

How can we break down these barriers in order to reach patients and improve the standards 

of prevention and care? We can begin by speaking up, by educating, by affirming, and by 

reaching out openly to those who are at risk or who are affected. The magnitude of the prevalence and burden of incontinence has been masked in this country by silence for far too long. 

The 2007 National Institutes of Health State of the Science Conference made recommendations for prevention of incontinence. However, fecal and urinary incontinence are associated 

with a range of risk factors. In most instances, the pathways are complex, involve multiple factors, and are not well understood. Overall, the evidence is insufficient to recommend 

preventative interventions, except for a few specific risk areas. Organized approaches to 

improving clinical detection of fecal and urinary incontinence are needed and require rigorous 

32
evaluation. There is good evidence that some risks for developing fecal and urinary incontinence can be modified and reduced. Routine episiotomy is the most easily preventable risk 

factor for fecal incontinence. Pelvic floor muscle training and biofeedback are effective in preventing and reversing fecal and urinary incontinence in some women during the first year after 

giving birth. 

Efforts to raise public awareness about incontinence and the benefits of prevention and management should also aim to eliminate stigma, promote self-disclosure and care-seeking, and 

reduce suffering. 

To reduce the suffering and burden of fecal and urinary incontinence, research is needed to— 

• Establish underlying mechanisms 

• Describe a classification system 

• Determine natural history 

• Classify persons according to their future risk for incontinence 

• Design interventions targeted to specific population groups 

• Determine the effects of these interventions 

• Guide policy 

Conclusion 

We believe there is more that can be done on all fronts to not only aid in preventing incontinence, but to also improve the awareness around it; to make it easier for people to seek help; 

and find solutions to managing the condition, if not resolving it. 

References 

1. Moyers, B. (1993). Healing and the mind. New York: Doubleday Books. 

2. Royer, A. (1998). Life with chronic illness: Social and psychological dimensions. Westport, CT: Praeger Publishers. 

3. Hajjar, R. R. (2004). Psychosocial impact of urinary incontinence in the elderly population. Clinics in Geriatric Medicine, 20(3), 553–564, viii. 

4. Bharucha, A. E., Zinsmeister, A. R., Locke, G. R., Seide, B. M., McKeon, K., Schleck, C. D., 

et al. (2005). Prevalence and burden of fecal incontinence: A population-based study in 

women. Gastroenterology, 129, 42–49. 

5. Garcia, J. A., Crocker, J., Wyman, J. F., & Krissovich, M. (2005). Breaking the cycle of 

stigmatization: Managing the stigma of incontinence in social interactions. Journal of 

Wound, Ostomy, and Continence Nursing, 32(1), 38–52. 

6. Mittness, L. S. (1987). The management of urinary incontinence by community-living 

elderly. The Gerontologist, 27(2), 185–193. 

33
7. Crowell, M. D., Schettler, V. A., Lacy, B. E., Lunsford, T. N., Harris, L. A., DiBaise, J. K., & 

Jones, M. P. (2007, January 9). Impact of anal incontinence on psychosocial function 

and health-related quality of life. [Electronic version]. Digestive Diseases and Sciences, 

52(7), 1627–1631. 

8. Schulze, B., Angermeyer, M. C. (2003). Subjective experiences of stigma. A focus group 

study of schizophrenic patients, their relatives and mental health professionals. Social 

Science & Medicine, 56, 299–312. 

9. Shaw, C., Tansey, R., Jackson, C., Hyde, C., & Allan, R. (2001). Barriers to help seeking in 

people with urinary symptoms. Family Practice, 18(1), 48–52. 

10. Melville, J. L., Fan, M.-Y., Newton, K., & Fenner, D. (2005). Fecal incontinence in U.S. 

women: A population-based study. American Journal of Obstetrics and Gynecology, 193, 

2071–2076. 

MADELINE NOLAN

 LAM Foundation 

LAM—A Very Gender-Specific Disease That Strikes Young Women 

As a patient with lymphangioleiomyomatosis, LAM for short, I have had the privilege to participate in a research protocol under the direction of Dr. Joel Moss at the National Institutes of 

Health (NIH). 

LAM is a rare lung disease that affects women. LAM is the only disease that is very genderspecific that is not related to reproductive systems of males or females. Both genders have 

lungs, kidneys, and lymph systems that are the targets for LAM. Yet it is women who manifest 

this devastating disease. Therefore, this makes LAM quite scientifically interesting. 

Progress in understanding LAM has come a long way in just the short time since Sue Byrnes 

established The LAM Foundation in 1995 and the NIH protocol began. There was no research 

being done before this time. While researchers have made exciting discoveries, there is yet 

to be a treatment or cure. One of the greatest challenges is identifying patients. LAM is often 

misdiagnosed as asthma or emphysema for years. There needs to be more awareness among 

healthcare providers about this disease that affects women before women are in the severe 

stages of LAM and their lungs are destroyed; they need to be diagnosed. 

In the past several years, funding at the NIH was reduced for LAM research. As scientists are 

getting closer to finding possible treatments, the momentum cannot be allowed to slow down. 

Women with LAM and those yet to be diagnosed need this continued support for research. 

Please visit http://www.thelamfoundation.org to learn more about LAM. There are many published research articles, as well. Hopefully, with continued scientific research, there will be 

many more in the near future. Thank you for your consideration. 

34
LYNNE MATALLANA 

National Fibromyalgia Association 

Fibromyalgia: A “Real” Chronic Pain Condition 

In 1997, while in my pink bathrobe and from my bed, I cofounded the National Fibromyalgia Association (NFA), a nonprofit organization headquartered in Orange County, CA, which 

develops and executes programs dedicated to improving the quality of life for people affected 

by fibromyalgia. The organization advocates for more than 10 million Americans afflicted with 

fibromyalgia who individually have not had a voice loud enough to be heard by the National 

Institutes of Health or the medical community. The NFA focuses on patient support and education, awareness outreach, healthcare provider education, patient advocacy, and the facilitation 

of scientific research. By providing an array of services, the NFA has helped advance the 

understanding of this chronic pain disorder and has assisted people affected by fibromyalgia 

in developing skills to regain control of their lives, reduce isolation, and restore hope. 

To carry out its mission, the NFA collaborates with and relies on a number of individuals and 

organizations. In addition to staff members, the NFA is assisted by volunteers; support group 

leaders; partnering nonprofit organizations; sponsors; its board of directors; and more than 65 

fibromyalgia research experts who serve on the NFA’s advisory boards, committees, and “Circle of Care” collaboration. 

Although this chronic widespread pain condition was christened with the name fibromyalgia syndrome in the mid-1980s, it has been around for centuries. Our grandmothers were 

probably told they had rheumatism and Elizabeth Barrett Browning was thought to suffer 

from the “vapors,” but their symptoms all point to fibromyalgia. In 1981, a pivotal paper, Primary Fibromyalgia, by Dr. Muhammad Yunus, was published and a new era of scientific study 

began. There was no research money available at that time, so researchers often funneled leftover funds from other projects into small, often single-blinded investigations and the science 

of fibromyalgia was finally instigated. In the beginning, because of small participant numbers and limited study designs, the researchers and their work were chastised by their peers 

for being beneath most scientific standards. However, researchers continued to push forward. 

In 1993, there were approximately 200 published fibromyalgia studies. Today, there are more 

than 4,500. Despite these strides, the scientific journey for fibromyalgia has been bumpy and 

arduous. Research is still lacking, funding is almost nonexistent, and scientific interest in fibromyalgia is low. 

However, more than 10 million Americans, approximately 80 to 90 percent of them women, 

have fibromyalgia. More than one-third of patients seen in rheumatology offices have fibromyalgia and patients’ annual visits to healthcare professionals are frequent. The amount of 

National Institutes of Health (NIH) money allocated to fibromyalgia is deplorable. In 2005, 

inflammatory bowel disease was granted $61 million by NIH for research. That same year, the 

NIH awarded $21 million for interstitial cystitis research, an illness that affects just over 1 million 

Americans. Lupus, with an estimated American patient population of between 1.5 and 2 million 

people, was granted $99 million. All of these illnesses are comorbid conditions of fibromyal35
gia and yet the National Institutes of Health granted only $10 million that year to fibromyalgia 

research. This is a travesty. 

In 2002, NIH sponsored the Fibromyalgia Program Assessment meeting in Virginia. NIH provided funding for fibromyalgia researchers and patient advocates to meet and discuss the state 

of fibromyalgia science and what the next steps should be in expanding scientific investigations. 

Many institutes were represented and varying research areas were scrutinized, including pain 

and pain processing; HPA axis and autonomic nervous system function; epidemiology; risks; 

psychosocial issues; and overlap syndromes and intervention research. To date, fibromyalgia 

has not received an increase in annual NIH funding and most of the research ideas and future 

directions generated from that meeting have never come to fruition or have been shelved. 

The procrastination and neglect by the National Institutes of Health in addressing the need for 

more and better fibromyalgia science is helping to propagate a negative view of not only the 

illness, but also the patients. The quality of life for patients with fibromyalgia is more negatively affected than those with lung disease, insulin-dependent diabetes, rheumatoid arthritis, 

and osteoarthritis, and yet FM patients are relegated to being viewed as whiny, lazy, complaining, women undeserving of their doctors’ time and scientific research. 

Because of the dedication of university researchers who relied on funding from nonprofit 

bingo games, individual donations, and small fibromyalgia nonprofits to do FM research, science is proving the existence of this disorder as indicated by frequent new discoveries. Several 

different imaging techniques, including functional MRIs and SPECT scans, are revealing subtle, 

but important, changes in the brains of FM patients in response to a pain stimulus compared 

to healthy subjects. Neurochemical abnormalities, including lower than normal levels of dopamine and serotonin and higher levels of substance P have become evident. Three medications 

approved by the U.S. Food and Drug Administration—pregabalin, duloxetine, and milnaciprin— 

are making a positive impact on FM symptoms in some patients. And yet the public and the 

medical community are still questioning fibromyalgia’s validity. 

Even now with more than 4,500 published scientific studies, the question of fibromyalgia as a 

viable medical disorder is in doubt. The headline of a January 14, 2008, New York Times article 

read, “Drug Approved. Is Disease Real?” On February 8, 2009, an Associated Press (AP) article 

created to debunk pharmaceutical companies’ marketing tactics took aim at patients suffering with a chronic pain condition that has been in existence for centuries and once again made 

the statement, “whether it’s a real disease at all.” Even Fred Wolf, the lead researcher from the 

1990 American College of Rheumatology Fibromyalgia Diagnostic Criteria study, is quoted in 

the New York Times article as having doubts: “Some of us in those days thought that we had 

actually identified a disease, which it clearly is not. To make people ill, to give them an illness, 

was the wrong thing.” 

Through the media’s questioning of pharmaceutical company motives, it is the patient who 

suffers. They continue to be stigmatized when journalists quote people such as Dr. Norton Hadler in the AP article who said “that telling people they have fibromyalgia can actually 

doom them to a life of suffering by reinforcing the idea that they have an incurable disease.” 

36
The idea perpetuated in both of these articles is that the pharmaceutical companies made up 

a disease to sell drugs. So now even when help is available for some patients, rights granted to 

most ill people regarding access to FDA-approved medications are being denied. At the conclusion of the AP article, Dr. Dan Clauw stated, “At the end of the day, I don’t care how you 

categorize this—it’s a legitimate condition and these people are suffering.” Shouldn’t that be 

the real message both to scientists and to the medical community? 

Scientific studies are needed to raise the credibility barrier that exists in the medical community. Because studies haven’t proven the exact cause of fibromyalgia or generated clinical 

diagnosis techniques, the disorder is still not taught in medical schools and many doctors still 

do not recognize or diagnose the condition. In a recent survey, 90 percent of physicians agree 

there is a need for more physician-oriented information and 82 percent of physicians agree 

that FM is difficult to treat with currently available tools. 

Without earlier diagnosis, better treatment options, and more recognition, the financial burden 

generated by FM will continue to escalate: 

• Fibromyalgia costs the United States $12–$14 billion each year. 

• A survey of the work and disability status of 1,668 FM patients reported that 25 percent 

had received disability payments. 

• Total healthcare costs over 12 months are about three times higher among fibromyalgia 

patients compared to patients without any healthcare encounter with FM. 

• Failure to diagnose a true case of fibromyalgia has its own costs, largely in excess 

general-practitioner visits, investigations, and prescription costs. 

• Use of complementary and alternative medicine is 11⁄2 times higher in FM patients. 

The National Fibromyalgia Association holds the National Institutes of Health at least partially 

responsible for the negative attitudes that exist concerning fibromyalgia and the patients it 

afflicts. Bench science and clinical science must be instigated to help unlock the mysteries of 

this chronic pain condition that affects so many lives. To that end, the National Fibromyalgia 

Association, working with a lobbyist, was able to submit and get the following 2009 Congressional Language approved: 

National Institute of Arthritis and Musculoskeletal and Skin Disorders 

The committee is deeply concerned regarding the lack of a sustained commitment to fibromyalgia-specific research at the National Institute of Arthritis and Musculoskeletal and Skin 

Diseases (NIAMS) and encourages a much greater emphasis on fibromyalgia at the Institute. 

Therefore, the committee urges NIAMS to convene an international symposium to elucidate 

the “state of the science” with regard to fibromyalgia and to publish a consensus document 

within 1 year establishing a roadmap for future fibromyalgia research. The Committee urges 

NIAMS to establish a funded Center with dedicated staffing to serve as a nexus for research on 

fibromyalgia and related disorders that will explore the broad spectrum of neurotransmitter 

abnormalities and other potential problems, including sleep disturbances, abnormal cervical 

anatomy, and genetic factors, which might contribute to symptom development and expression. 

37
In addition, the Committee encourages NIAMS to support basic research into animal models of 

the disease. The Committee also encourages NIAMS to collaborate with the NIDDK in support 

of its Multi-disciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) initiative. 

National Institute of Neurological Disorders and Stroke 

Whereas fibromyalgia has traditionally been considered a musculoskeletal disorder, the 

committee acknowledges that substantial evidence implicates pathology within the central nervous system in the development and expression of fibromyalgia symptoms, including 

abnormal brain activity, abnormal concentrations of a variety of neurochemicals in cerebrospinal fluid, dysautonomia, and neuroendocrine dysfunction. The Committee, therefore, urges the 

National Institute of Neurological Disorders and Stroke (NINDS) to collaborate with the NIAMS 

in convening an international symposium to elucidate the “state of the science” with regard 

to fibromyalgia, and publish a consensus document within 1 year establishing a roadmap for 

future fibromyalgia research. The Committee urges NINDS to foster and conduct fibromyalgia-specific intramural research related to the cause, prevention, and treatment of the disorder 

through funding and by making available resources related to this pursuit. The Committee 

encourages NINDS to support basic research into animal models of the disorder. 

An NIH-funded fibromyalgia research center would go a long way to raise not only the credibility of fibromyalgia to the public, but also to new scientists interested in researching a “real,” 

viable, and complicated illness. Young researchers with original and innovative ideas are 

needed to help unravel the scientific mysteries of fibromyalgia. An international researchers’ 

conference is timely, especially with all of the innovative fibromyalgia research that is being 

published by scientists from all over the world. The NIH can make both of these requests come 

to fruition and help open doors to better fibromyalgia science and understanding. 

The National Fibromyalgia Association is grateful to be represented at this meeting. It is both 

timely and expedient that fibromyalgia is included in discussions about chronic pain and discrepancies in women’s scientific research. Dialogue is appreciated, but action is needed by the 

National Institutes of Health to elevate fibromyalgia on the medical and scientific ladder to the 

level it deserves. It is time that fibromyalgia is recognized as a devastating illness that impacts 

not only the quality of life of its victims but also their families, employers, and friends. 

CHRISTIN VEASLEY 

National Vulvodynia Association 

The Need for an Expanded Research Effort on Vulvodynia—A Prevalent and Neglected 

Gynecological Pain Disorder 

Vulvodynia, a chronic pain condition affecting up to 16 percent of American women, is 

plagued by misunderstanding, misdiagnosis, ineffective and inappropriate treatment, as well 

as a lack of scientific research. Since FY 1998, the United States Congress has repeatedly 

called upon the National Institutes of Health (NIH) to expand Federal research efforts on vulvodynia. To date, the NIH has supported a mere total of 12 applications totaling $11,015,227, or 

38
approximately $1 million per fiscal year. The FY 2009 NIH Appropriations Report contained 

the following language on vulvodynia: 

Vulvodynia 

For the 12th consecutive year, the Committee has called on the Eunice Kennedy Shriver National 

Institute of Child Health and Human Development (NICHD) to expand research efforts on vulvodynia, yet only 11 total awards have been made to date and only 3 in the past 3 fiscal years. This 

is especially discouraging, given that in 2006, results from a ground-breaking NICHD-funded 

study were published showing that up to 16 percent of American women suffer from Vulvodynia, 60 percent consult at least three providers in search of a diagnosis, and 40 percent of 

them remain undiagnosed. The Committee strongly urges the NICHD to substantially increase 

the number of awards for vulvodynia studies in fiscal year 2009, with a particular emphasis on 

etiology and multicenter therapeutic trials. In addition, to ensure that experts in vulvodynia, 

related chronic pain, and female reproductive system conditions are adequately represented 

on peer review panels, the Committee recommends that the current program announcement, 

PA-07-182, Vulvodynia—Systematic, Epidemiologic, Etiologic or Therapeutic Studies, be reissued with “special review.” Finally, the Committee calls on NICHD to employ the full range of 

award mechanisms available to expand research and research capacity in this area. 

The following testimony summarizes vulvodynia’s impact on the physical and emotional wellbeing of millions of American women and provides research recommendations for the Office 

of Research on Women’s Health’s (ORWH’s) consideration in planning the next decade of 

women’s health research at the NIH. 

Vulvodynia Defined 

Vulvodynia, as defined by the International Society for the Study of Vulvovaginal Disease, is 

“vulvar discomfort, most often described as burning pain, occurring in the absence of relevant 

visible findings or a specific, clinically identifiable, neurologic disorder.”1

 Although burning is 

the most commonly reported symptom, many women also describe the pain as scalding, searing, lacerating, raw, and stabbing.2

 The condition varies in persistence and location. The pain 

may be constant or intermittent, localized or diffuse. The two main subtypes of vulvodynia, 

which may coexist, are provoked vestibulodynia (i.e., vulvar vestibulitis syndrome) and generalized vulvodynia. Provoked vestibulodynia (PVD) refers to pain experienced primarily when 

pressure is applied to the vulvar vestibule; this pain typically occurs with sexual intercourse, 

tampon insertion, a gynecological exam, or simply sitting. Pain patterns in women with generalized vulvodynia are highly individualized since they can experience pain anywhere within 

the distribution of the pudendal nerve. The pain is typically unprovoked, but also worsens with 

pressure on the vulva. 

Prevalence and Risk Factors 

According to an NIH-funded study conducted at Harvard Medical School, approximately 16 

percent of American women between 18 and 64 years of age report suffering from chronic 

vulvar pain at some point in their lives, with more than 90 percent reporting ongoing pain for 

many years. Approximately 6 million women currently suffer with chronic vulvar pain.3

 Two 

studies, including the above Harvard study, have demonstrated that the incidence of symptom 

39
onset is highest between the ages of 18 and 25.3,4 Once considered to be a condition affecting 

primarily Caucasian women, recent studies have shown that African-American and Hispanic 

women are just as likely to develop vulvodynia.3,5,6 

To date, there has been very little research on risk factors associated with the development of 

vulvodynia. Preliminary results suggest that there may be multiple risk factors involved, including vulvovaginal infection and oral contraceptive use, particularly at an early age.7,8,9,10,11 Other 

studies have implicated the following risk factors: early age of first intercourse, early age of 

menarche, history of childhood nocturnal enuresis, and difficulty or severe pain with first tampon use.3,12,13,14,15 

Misdiagnosis 

Although vulvodynia was first documented in medical texts in 1880, the medical community did not start seriously addressing the condition until the 1970s. Because vulvodynia is 

rarely covered in medical school curricula and residency programs in the United States, and 

its symptoms mimic those of common vulvovaginal infections, women are routinely misdiagnosed. The above NIH-funded Harvard prevalence study found that nearly 60 percent of 

patients reported visiting three or more healthcare providers to obtain a diagnosis and 40 percent remained undiagnosed, even after this many consultations.3 

Burden of Illness 

Living with vulvodynia imposes serious limitations on a woman’s ability to engage in normal 

daily activities. In many cases, the pain is so severe and unremitting that it forces women to 

resign from career positions; abstain completely from sexual relations; and limit many physical activities, often destroying a woman’s self-image. In addition, because genital disorders 

are not openly discussed, women with vulvodynia experience shame, isolation, and hopelessness. According to an NIH-funded study conducted at Robert Wood Johnson Medical School, 

75 percent of women with vulvodynia feel “out of control” of their bodies, 60 percent report 

that it compromises their ability to enjoy life, and 60 percent cannot have sexual intercourse 

because of the pain.16 

Comorbid Conditions 

Some women with vulvodynia report suffering from multiple conditions, including endometriosis, interstitial cystitis, temporomandibular joint and muscle disorders, migraine headache, 

fibromyalgia, irritable bowel syndrome, low back pain, multiple chemical sensitivities, allergies, 

and chronic fatigue syndrome; however, there has been little scientific research on the overlap of these conditions. Interstitial cystitis (IC) has been the focus of the majority of published 

studies. The reported percentage of women who have both IC and vulvodynia varies widely, 

from 12 to 68 percent, depending on the study.17,18 Similar findings have been reported for 

women with vulvodynia and irritable bowel syndrome or fibromyalgia. A recent NIH-funded 

study conducted at Robert Wood Johnson Medical School found that women with vulvodynia were 3.1 and 3.8 times more likely to have either a comorbid diagnosis of irritable bowel 

syndrome or fibromyalgia, respectively.8

 Another recent NIH-funded study, conducted at the 

University of North Carolina, found that 78 percent of 137 women with provoked vestibulodynia had either clinical or subclinical orofacial pain. Upon formal evaluation by an orofacial 

40
pain specialist, the majority of patients exhibited signs and symptoms highly suggestive of 

temporomandibular joint and muscle disorders.19 Although preliminary, these findings warrant 

additional substantive research into this area. 

Etiology 

With modest financial support from the National Vulvodynia Association, a number of pilot 

studies investigating the etiological mechanisms of PVD have been conducted. Although the 

pathophysiology of PVD remains inconclusive, multiple factors have been associated with the 

initiation and/or perpetuation of symptoms. Recent tissue studies have found that women 

with PVD, as compared to controls, exhibit 1) vestibular nerve fiber proliferation; 2) elevated 

levels of inflammatory cytokines IL-1beta and TNF-alpha in vestibular tissue; 3) increased levels of IL-1-beta, IL-6, and IL-8 in vestibular fibroblasts, both at baseline and following in vitro 

stimulation with Candida albicans; 4) increased vanilloid receptor (VR1) expression in vestibular tissue; 5) decreased estrogen receptor alpha expression in vestibular tissue; 6) increased 

blood flow and erythema in the posterior vestibule; and 7) an increase in inflammatory infiltrate, number of mast cells, and degranulated mast cells in vestibular tissue.20,21,22,23,24,25,26 

Studies have also shown that subsets of women with PVD have polymorphisms in the following genes: IL-1ra, IL-1beta, mannose-binding lectin, and melanocortin-1 receptor.27,28,29,30 

Studies of central sensitization in PVD patients have demonstrated increased pressure sensitivity in both the vulva and peripheral body regions; increased pain intensity and unpleasantness 

in response to tender-point examination at nine nongenital sites; higher levels of brain activity in primary and secondary somatosensory cortices and insular cortex during application of 

pressure to the posterior vestibule; enhancement of post-capsaicin pain response extending 

far beyond the anatomic location of the primary complaint; and lower pain pressure thresholds 

to noxious cold stimulation, suggesting a systemic hypersensitivity. Pelvic floor muscle pathology has also been implicated in some women.31,32,33,34,35 

There is a scarcity of research on the pathophysiology of generalized vulvodynia. The prevailing theory is that it exhibits the characteristics of a neuropathic pain syndrome with elements 

of central sensitization.31 

Treatment 

Because of a lack of research on treatment efficacy, evidence-based treatment guidelines for 

vulvodynia do not exist. Consequently, once a woman is diagnosed, it typically takes months 

to years of trial and error to find a treatment or combination of treatments to alleviate the 

symptoms. Experts favor a multidisciplinary, individualized treatment approach that includes 

one or more of the following: oral “pain-blocking” medications (e.g., tricyclic antidepressants, 

anticonvulsants, selective serotonin reuptake inhibitors, narcotics); topical preparations (e.g., 

estrogen, anesthetics, individualized compounded topical formulations); vulvar, pudendal, 

and/caudal nerve blocks; neurostimulation; pelvic floor muscle therapy (e.g., physical therapy, 

biofeedback); psychotherapy; and surgery for a select population with PVD.36 

41
Future Research Recommendations 

Since 1997, the NIH has supported three vulvodynia conferences. The purpose of the most 

recent consensus conference, held in 2004, was to analyze available data on vulvodynia and 

related syndromes and develop a consensus paper that would include recommendations for 

basic and clinical research.37 The 2004 conference recommendations remain pertinent and The 

National Vulvodynia Association respectfully requests that ORWH consider these recommendations in planning the next decade of NIH women’s health research. 

Definition, Comorbid Conditions, and Disease Progression 

• Standardize the definition 

• Characterize the pain precisely 

• Identify comorbid conditions and risk factors for vulvodynia 

• Investigate the biologic mechanisms involved 

• Clarify antecedent and subsequent sexual dysfunction 

• Establish the natural progression of vulvodynia 

Diagnosis and Workup 

• Include specific education on the diagnosis and treatment of vulvodynia during medical 

school and residency training programs in women’s health 

• Develop evidence-based guidelines for assessment 

Clinical Management of Vulvodynia 

• Commence well-designed, prospective, multicenter trials 

• Standardize dosing requirements for pharmacologic interventions 

• Address sexual issues 

Expand Vulvodynia Research 

• Investigate the biologic and genetic basis of vulvodynia 

• Increase the number of clinical trials 

• Establish a vulvodynia registry 

• Establish a national vulvodynia referral network 

About the National Vulvodynia Association 

The National Vulvodynia Association (NVA) is the only international organization serving both 

women who suffer from vulvodynia and healthcare providers who treat the disorder. Created 

in 1994 by five vulvodynia patients, the NVA strives to improve the quality of life of women 

with vulvodynia through education, support, advocacy and research. To fulfill its mission, 

the NVA distributes educational resources to patients and the public; develops educational 

42
materials for the medical community, including an online continuing medical education/continuing education accredited teaching program (http://learn.nva.org); advocates for increased 

Federal funding of vulvodynia research; funds pilot medical research studies; administers a 

career development award for clinicians who want to pursue a clinical or research interest in 

vulvodynia; works with the media to promote public awareness of vulvodynia; coordinates an 

international patient support network; and works cooperatively with other patient advocacy 

organizations serving women who suffer from conditions that overlap with vulvodynia. 

References 

1. Haefner, H. K. (2007). Report of the International Society for the Study of Vulvovaginal 

Disease terminology and classification of vulvodynia. Journal of Lower Genital Tract 

Disease, 11, 48–49. 

2. Bergeron, S., Binik, Y. M., Khalifé, S., Pagidas, K., & Glazer, H. I. (2001). Vulvar vestibulitis 

syndrome: reliability of diagnosis and evaluation of current diagnostic criteria. Obstetrics and Gynecology, 98, 45–51. 

3. Harlow, B. L., & Stewart, E. G. (2003). A population-based assessment of chronic unexplained vulvar pain: Have we underestimated the prevalence of vulvodynia? Journal of 

the American Medical Women’s Association, 58(2), 82–88. 

4. Jantos, M., Burns, N. R. (2007). Vulvodynia: Development of a psychosexual profile. 

Journal of Reproductive Medicine, 52, 63–71. 

5. Reed, B. D., Crawford, S., Couper, M., Cave, C., & Haefner, H. K. (2004). Pain at the vulvar 

vestibule: A Web-based survey. Journal of Lower Genital Tract Disease, 8, 48–57. 

6. Lavy, R. J., Hynan, L. S., & Haley, R. W. (2007). Prevalence of vulvar pain in an urban, 

minority population. Journal of Reproductive Medicine, 1, 59–62. 

7. Edgardh, K., & Abdelnoor, M. (2007). Vulvar vestibulitis and risk factors: A populationbased case-control study in Oslo. Acta Dermato-Venereologica, 87, 350–354. 

8.  Arnold, L. D., Bachmann, G. A., Rosen, R., Kelly, S. W., & Rhoads, G. G. (2006). Vulvodynia: Characteristics and associations with comorbidities and quality of life.  Obstetrics 

& Gynecology, 10, 617–624. 

9. Smith, E. M., Ritchie, J. M., Galask, R., Pugh, E. E., Jia, J., & Ricks-McGillan, J. (2002). 

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Medicine, 49, 888–892. 

11.  Bouchard, C., Brisson, J., Fortier, M., Morin, C., & Blanchette, C. (2002). Use of oral 

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12. Bazin, S., Bouchard, C., Brisson, J., Mown, C., Meisels, A., & Fortier, M. (1994). Vulvar 

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13. Berglund, A. L., Nigaard, L., & Rylander, E. (2002). Vulvar pain, sexual behavior and 

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14. Harlow, B. L.,Wise, L. A., & Stewart, E. G. (2001). Prevalence and predictors of chronic 

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545–550. 

15. Greenstein, A., Sarig, J., Chen, J., Matzkin, H., Lessing, J. B., & Abramov, L. (2005). Childhood nocturnal enuresis in vulvar vestibulitis syndrome. The Journal of Reproductive 

Medicine, 50, 49–52. 

16. Arnold, L. D., Bachmann, G. A., Rosen, R., & Rhoads, G. G. (2007). Assessment of vulvodynia symptoms in a sample of U.S. women: A prevalence survey with a nested case 

control study. American Journal of Obstetrics and Gynecology, 196, 128.e1–6. 

17. Wu, E. Q., Birnbaum, H., Mareva, M., Parece, A., Huang, Z., Mallett, D., Taitel, H. (2006). 

Interstitial cystitis: Cost, treatment and co-morbidities in an employed population. PharmacoEconomics, 24, 55–65. 

18. Kennedy, C. M., Nygaard, I. E., Saftlas, A., Burns, T. L., Torner, J. C., & Galask, R. P. (2005). 

Vulvar disease: A pelvic floor pain disorder? American Journal of Obstetrics and Gynecology, 192, 1829–1834; discussion 1834–1835. 

19. Zolnoun, D. A., Rohl, J., Moore, C. G., Perinetti-Liebert, C., Lamvu, G. M., & Maixner, W. 

(2008). Overlap between orofacial pain and vulvar vestibulitis syndrome. The Clinical 

Journal of Pain, 24, 187–191. 

20.Tympanidis, P., Terenghi, G., & Dowd P. (2003). Increased innervation of the vulval vestibule in patients with vulvodynia. British Journal of Dermatology, 148, 1021–1027. 

21. Foster, D. C., & Hasday, J. D. (1997). Elevated tissue levels of interleukin-1 beta and tumor necrosis factor-alpha in vulvar vestibulitis. Obstetrics and Gynecology, 89, 291–296. 

22.Foster, D. C., Piekarz, K. H., Murant, T. I., LaPoint, R., Haidaris, C. G., & Phipps, R. P. 

(2007). Enhanced synthesis of proinflammatory cytokines by vulvar vestibular fibroblasts: Implications for vulvar vestibulitis. x e1–e8. 

23.Tympanidis, P., Casula, M. A., Yiangou, Y., Terenghi, G., & Dowd, P. (2004). Increased 

vanilloid receptor VR1 (TRPV1) innervation in vulvodynia. European Journal of Pain, 8, 

129–133. 

24.Eva, L. J., MacLean, A. B., Reid, W. M. N., Rolfe, K. J., & Perrett, C. W. (2003). 

Estrogen receptor expression in vulvar vestibulitis syndrome. American Journal of 

Obstetrics and Gynecology, 189, 458–461. 

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25.Bohm-Starke, N., Hilliges, M., Blomgren, B., Falconer, C., & Rylander, E. (2001). Increased 

blood flow and erythema in the posterior vestibular mucosa in vulvar vestibulitis. 

Obstetrics and Gynecology, 98, 1067–1074. 

26.Bornstein, J., Goldschmid, N., & Sabo, E. (2004). Hyperinnervation and mast cell activation may be used as histopathologic diagnostic criteria for vulvar vestibulitis. Gynecologic and Obstetric Investigation, 58, 171–178. 

27. Jeremias, J., Ledger, W. J., & Witkin, S. S. (2000). Interleukin 1 receptor antagonist gene 

polymorphism in women with vulvar vestibulitis. American Journal of Obstetrics and 

Gynecology, 182, 283–285. 

28.Gerber, S., Bongiovanni, A. M., Ledger, W. J., & Witkin, S. S. (2003). Interleukin-1beta 

gene polymorphism in women with vulvar vestibulitis syndrome. European Journal of 

Obstetrics, Gynecology, and Reproductive Biology, 107, 74–77. 

29.Babula, O., Linhares, I. M., Bongiovanni, A. M., Ledger, W. J., & Witkin, S. S. (2008). Association between primary vulvar vestibulitis syndrome, defective induction of tumor 

necrosis factor-a, and carriage of the mannose-binding lectin codon 54 gene polymorphism. American Journal of Obstetrics and Gynecology, 198, 101.e1–101.e4. 

30.Foster, D. C., Sazenski, T. M., & Stodgell, C. J. (2004). Impact of genetic variation in interleukin-1 receptor antagonist and melanocortin-1 receptor genes on vulvar vestibulitis 

syndrome. The Journal of Reproductive Medicine, 49, 503–509. 

31. Giesecke, J., Reed, B. D., Haefner, H. K., Giesecke, T., Clauw, D. J., & Gracely, R. H. (2004). 

Quantitative sensory testing in vulvodynia patients and increased peripheral pressure 

pain sensitivity. Obstetrics and Gynecology, 104, 126–133. 

32. Pukall, C. F., Baron, M., Amsel, R., Khalifé, S., & Binik, Y. M. (2006). Tender point examination 

in women with vulvar vestibulitis syndrome. The Clinical Journal of Pain, 22, 601–609. 

33.Pukall, C. F., Strigo, I. A., Binik, Y. M., Amsel, R., Khalifé, S., & Bushnell, M. C. (2005). 

Neural correlates of painful genital touch in women with vulvar vestibulitis syndrome. 

Pain, 115, 118–127. 

34.Foster, D. C., Dworkin, R. H., & Wood, R. W. (2005). Effects of intradermal foot and forearm capsaicin injections in normal and vulvodynia-afflicted women. Pain, 117, 128–136. 

35.Reissing, E. D., Brown, C., Lord, M. J., Binik, Y. M., & Khalifé, S. (2005). Pelvic floor 

muscle functioning in women with vulvar vestibulitis syndrome. Journal of Psychosomatic Obstetrics and Gynaecology, 26, 107–113. 

36.Haefner, H. K., Collins, M. E., Davis, G. D., Edwards, L., Foster, D. C., Hartmann, E. D. H., 

. . . Wilkinson, E. J. (2005). The vulvodynia guideline. Journal of Lower Genital Tract 

Disease, 9, 40–51. 

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�

45
PAULA GIANINO 

Planned Parenthood of the St. Louis Region and Southwest Missouri 

Women’s Reproductive Health as Top Priority 

Good afternoon. My name is Paula Gianino and I am President and CEO of Planned Parenthood of the St. Louis Region and Southwest Missouri (PPSLR), an affiliate of Planned 

Parenthood® Federation of America, Inc., (PPFA®). 

PPFA is the Nation’s leading sexual and reproductive healthcare provider and advocate serving women, men, teens, and families. We do more than any other organization in the United 

States to prevent unintended pregnancies and protect women’s health and safety. Planned 

Parenthood provides the highest quality sexual and reproductive health care, education, and 

information to women, men, and teens through our 97 affiliates operating nearly 880 local 

health centers across the United States. In 2006–2007, our affiliate health centers served 3.1 

million women, men, and teens. These services include contraception (38 percent of our total 

services), testing and treatment for sexually transmitted diseases and infections (29 percent), 

cancer screening and prevention (19 percent), and abortion services (3 percent). We also provided in 2006 comprehensive, medically accurate sex education to an additional 1.2 million 

women, men, and teens. 

It is our real-world experience as a provider of reproductive healthcare services to a predominantly low-income, racially and culturally diverse patient population that informs our policies 

and advocacy and that necessitates our presence at this important conference. 

In January alone, 598,000 jobs were cut in the United States—the largest loss since 1974. Tragically, when Americans lose their jobs, they often lose their health insurance coverage, too. In 

fact, for every 1 percentage point rise in unemployment, 1 million people become uninsured. 

Women, in particular, are affected by this economic downturn. Because of their reproductive 

capacity, women pay more for their health care than men and because they earn less, these 

health care expenses make up an even greater share of their income. When women lose their 

jobs, they are less likely to qualify for unemployment benefits, putting health care even further 

out of reach. In addition, women and children are more likely to be insured through public programs like Medicaid and the State Children’s Health Insurance Program, which are being cut in 

many States due to the economy. 

As the economic crisis worsens, women and their families are increasingly turning to healthcare safety net providers, such as Planned Parenthood and other family planning health 

centers, for a reliable source of care. At the same time, the State revenue support and private 

funding that safety net providers depend on is dwindling fast. 

This year, Missouri faces a $300 million budget deficit, there are more than 750,000 uninsured 

Missourians including 146,150 uninsured children (Kaiser Family Foundation), and 350,000 

women and teens in need of publicly funded contraceptive services (Guttmacher Institute). 

46
Missouri’s teen birth rate went up 6 percent in 2006 compared to a national average increase 

of 4 percent (Guttmacher Institute). 

Despite the clear cost-effectiveness—in addition to health protection—of preventive health 

care (every $1 spent on publicly funded family planning services saves $4 in Medicaid costs 

alone), the past administrations in Washington, DC, and in Jefferson City, Missouri, worked 

hard to place barriers in the way of women’s access to advances in contraceptive and other 

reproductive health technologies. It is time to move from an era of ideology to an era of scientific-based, evidence-based research and health reform. And women’s reproductive health 

care must be a critical cornerstone in any healthcare reform debate and future plans. 

For Planned Parenthood health centers across the country, the costs of providing contraceptive care have increased, while access to effective and affordable methods of contraception 

has decreased. We would urge NIH to assert its leadership to perform the following: 

• Encourage the development of more low-cost, safer, and more effective contraceptive 

methods 

• Explore ways to make long-term, reversible contraceptive options affordable and available to more women 

• Encourage research and development of dual-modality contraception that also prevents 

sexually transmitted infections 

• Push for more funding to research the efficacy of family planning services, teen pregnancy prevention programs, and more widespread access to emergency contraception 

• Assist providers like Planned Parenthood to better understand which particular contraceptive methods are most suited for which women 

• Partner with Planned Parenthood and other nonprofit family planning agencies on this 

clinical research and on advocacy at the State and national levels 

In addition, this country has unacceptable rates of highly preventable sexually transmitted 

infections (STIs). This past August, the Centers for Disease Control and Prevention (CDC) 

announced the devastating news that human immunodeficiency virus (HIV)/acquired immune 

deficiency syndrome (AIDS) prevalence is 40 percent higher in the United States than we ever 

thought. And last month, they announced that chlamydia rates are at an all-time high. This 

news is compounded by another CDC report released this past year showing that one in four 

teenage girls in the United States has an STI. These concerns are particularly relevant to Missouri. Missouri ranks among the top 15 States for sexually transmitted diseases, with St. Louis 

rating first in the Nation for gonorrhea and chlamydia (CDC). 

Untreated infections of gonorrhea and chlamydia can lead to infertility, chronic pain, and 

potentially fatal ectopic pregnancy. In fact, chlamydia is the number one cause of preventable 

infertility. These infections also exact a tremendous economic toll. In the United States, direct 

medical costs associated with STIs are estimated at up to $15.3 billion annually (CDC). This 

total cost does not include lost wages and productivity, out-of-pocket expenses, or the costs 

associated with transmission of diseases to infants. 

47
New treatments, like the human papillomavirus (HPV) vaccine, can improve our ability to 

reduce the prevalence of STIs in this country. PPSLR is supporting legislative efforts to 

increase information about and access to the HPV vaccine—and I am proud to say that last 

year, our affiliate administered more than 3,400 doses of the HPV vaccine to area teens and 

young women. We are also supporting public policy that would allow for expedited partner therapy when a woman tests positive for gonorrhea and chlamydia. But we need better, 

quicker, cheaper, and more effective tools to detect and treat STIs earlier. We urge the NIH to 

make this a priority in women’s health research. 

Finally, we must address the huge healthcare disparities that exist in the United States based on 

race and ethnicity. The CDC’s 2007 sexually transmitted disease (STD) Surveillance Report shows 

persistent racial and ethnic disparities in the prevalence of STIs. While representing just 12 percent of the population in 2007, African Americans represented 70 percent of reported cases of 

gonorrhea and half of reported chlamydia and syphilis cases in the United States [CDC]. 

Unfortunately, disparities are not unique to STIs; they exist across the spectrum of health care 

for women. Latinas have the highest rates of new cases of cervical cancer [American Cancer Society]. And despite having a lower incidence of breast cancer, African-American women 

have a higher mortality rate—32.3 per 100,000, compared to 23.8 for White women in 2004 

[National Cancer Institute]. As the National Institutes of Health (NIH) develops priorities for 

research in women’s health, reducing health disparities must be on the agenda. The development of new contraceptives and STI prevention and treatment methods is critically important 

for women’s health, but this research must include a diverse study population as well as comparative effectiveness research to ensure that women of all racial and ethnic backgrounds can 

receive the most effective health care. 

In conclusion, I’d like to thank the NIH for making women’s health research a priority. Women 

have unique healthcare needs, and nobody understands this better than Planned Parenthood. 

One in four women has chosen Planned Parenthood for health care at least once in her lifetime, and we deliver vital healthcare services to millions of women every year. 

As you move forward in developing your priorities for women’s health research, we urge you 

to do the following: 

• Encourage research and development of low-cost, safer, and more effective contraceptive and STI prevention and treatment methods 

• Explore ways to make long-term contraceptive options available to more women 

• Expand efficacy research in areas, including family planning services, teen pregnancy 

prevention programs, and more widespread access to emergency contraception 

• Ensure that women of all racial and ethnic backgrounds are represented in your research 

• Make comparative effectiveness a priority to assist providers in determining the treatments and methods best suited for different women 

48
RINO ALDRIGHETTI 

Pulmonary Hypertension Association 

A Perfect Storm: The Need for and Value of Pulmonary Hypertension Research as a Priority of 

the Office of Research on Women’s Health 

Thank you for the opportunity to provide today the perspective of the Pulmonary Hypertension 

Association on one important area of investment for the Office of Research on Women’s Health. 

I am honored today to represent the hundreds of thousands of Americans who are fighting 

a courageous battle against a devastating disease. Pulmonary hypertension (PH) is a serious 

and often fatal condition where the blood pressure in the lungs rises to dangerously high levels. In PH patients, the walls of the arteries that take blood from the right side of the heart to 

the lungs thicken and constrict. As a result, the right side of the heart has to pump harder to 

move blood into the lungs, causing it to enlarge and ultimately fail. 

PH can occur without a known cause or be secondary to other conditions such as collagen vascular diseases (i.e., scleroderma and lupus), blood clots, human immunodeficiency virus, sickle 

cell, or liver disease. Patients develop symptoms that include shortness of breath, fatigue, chest 

pain, dizziness, and fainting. Unfortunately, these symptoms are frequently misdiagnosed, leaving patients with the false impression that they have a minor pulmonary or cardiovascular 

condition. By the time many patients receive an accurate diagnosis, the disease has progressed 

to a late stage, making it impossible to receive a necessary heart or lung transplant. 

PH occurs in individuals of all ages, races, and genders. However, women are more than twice 

as likely as men to develop PH. Women most often develop PH during their childbearing years. 

Pregnancy can be a painful subject for PH patients because it is associated with life-threatening risks for both the mother and baby. 

PH is chronic and incurable with a poor survival rate. Fortunately, new treatments are providing 

a significantly improved quality of life for patients. Recent data indicate that the length of survival is continuing to improve, with some patients managing the disorder for 20 years or longer. 

Eighteen years ago, when three patients who were searching to end their own isolation 

founded the Pulmonary Hypertension Association, there were fewer than 200 diagnosed cases 

of this disease. It was virtually unknown among the general population and not well known in 

the medical community. They soon realized that this was unacceptable, and formally established PHA, which is headquartered in Silver Spring, Maryland. 

Today, PHA includes the following: 

• More than 9,000 patients, family members, and medical professionals as members and 

an additional 36,000 supporters and friends 

• A network of more than 200 patient support groups 

• An active and growing patient-to-patient telephone helpline 

49
• Three research programs that, through partnerships with the National Heart, Lung, and 

Blood Institute (NHLBI) and the American Thoracic Society, have directed more than $6 

million toward PH research 

• Numerous electronic and print publications, including the first medical journal devoted 

to pulmonary hypertension—published quarterly and distributed to all cardiologists, pulmonologists, and rheumatologists in the United States 

• A Web site dedicated to providing educational and support resources to patients, medical professionals, and the public that, over the past 9 years, has grown from receiving 

600 visits a month to 390,000 visits a month 

The Pulmonary Hypertension Community 

I am privileged to serve as the President of the Pulmonary Hypertension Association and to 

interact daily with the patients and family members who are seeking to live their lives to the 

fullest in the face of this deadly, incurable disease. I would like to share with you the stories 

of two remarkable PH patients, Emily Stibbs and Charity Tillemann-Dick. Emily’s and Charity’s 

stories illustrate the impact of pulmonary hypertension not only on PH patients, but also on 

everyone who cares about them. 

When their daughter, Emily, was 5, Jack and Marcia Stibbs noticed that she could not keep up 

with the other children in the neighborhood. She seemed to lack the energy and strength to 

run and play. This condition worsened to the point where she would have to stop and rest after 

coming down the steps in the morning. Jack and Marcia noticed that when she was sitting on 

the bottom step in the morning, Emily’s lips appeared to have a bluish color. 

After pressing for an answer to these problems for several months, Emily was finally diagnosed with pulmonary hypertension and the doctors told the Stibbs family that her probable 

remaining lifespan was 3 years. 

Charity Tillemann-Dick’s diagnosis with pulmonary hypertension took not months, but years. 

When Charity was in her late teens, she had the opportunity to travel abroad and share her 

considerable talents as a budding opera singer at her grandfather’s 75th birthday party in 

Budapest. Just before the performance, Charity collapsed, but the episode was explained 

away as a case of nerves. 

Over the next few years, Charity continued to have occasional fainting spells as well as a progressive loss in energy. She was diagnosed as being everything from out of shape to anemic. 

When Charity finally received an accurate diagnosis, her PH had progressed further, and was 

therefore more difficult to treat than it would have been if she had been diagnosed while the 

disease was in its early stages. 

I am happy to report that, with treatment, Charity has continued to live a full and accomplished life, including performing at several world capitals. Emily, too, has outlived her 3-year 

50
prognosis by 7 years and continues to thrive. There is, however, no cure for pulmonary hypertension. Each day, courageous patients of every age lose their battle with PH. 

Thanks to congressional action and to advances in medical research largely supported by the 

NHLBI and other Government agencies, Emily and Charity have an increased chance of living with their pulmonary hypertension for many more years. However, additional support is 

needed for research and related activities to continue to develop treatments that will extend 

the life expectancy of PH patients beyond the NIH estimate of 2.8 years after diagnosis and to 

raise awareness of this rare, deadly condition. 

Recommendations 

In December 2006, the NHLBI and the National Institutes of Health Office of Rare Diseases 

co-sponsored a 2-day scientific conference on pulmonary hypertension. This important event 

provided an opportunity for leading PH researchers from the United States and abroad to discuss the state of the science in pulmonary hypertension and future research directions. 

According to these leading researchers, we are on the verge of significant breakthroughs in 

our understanding of PH and the development of new and advanced treatments. Twelve years 

ago, a diagnosis of PH was essentially a death sentence, with only one approved treatment for 

the disease. Thanks to advancements made through the public and private sectors, patients 

today are living longer and better lives with a choice of six FDA-approved therapies. 

At a congressional hearing on pulmonary hypertension in December 2005, Dr. Mark Gladwin 

said, “I study what is happening in pulmonary hypertension as an example of what you can do 

with an orphan disease. With the combination of advocacy, industry involvement, and stateof-the-art basic science, they came together, in a perfect storm of opportunity.” 

Recognizing that we have made tremendous progress, we are also mindful that we are a long 

way from where we want to be in 1) the management of PH as a treatable chronic disease, 

and 2) a cure. Our needs are in both clinical research and public and medical professional 

education. PH patients typically visit three physicians before a fourth makes an accurate diagnosis—often losing a year or more and making their prognosis significantly less promising. 

With this in mind, the Pulmonary Hypertension Association respectfully requests that the 

Office of Research on Women’s Health make pulmonary hypertension a research priority 

now and in the future. 

MARY BLADES 

Scleroderma Foundation 

Mary Blades Testimony for NIH 

Hello, my name is Mary Blades and I am the Scleroderma Foundation Missouri 

Chapter President. 

51
Scleroderma, although a big word to pronounce, is not unlike the ravaging effects it can have 

on a person’s body. Sclero, meaning hard, and derma, meaning skin, is a simple explanation of 

what it means, but to those of us who have it, it is much, much more. It means that it cannot 

only affect the skin, which in itself is frightening, but it can also affect internal organs, which 

can be life threatening. I have seen people with very tight skin and then wonder what in the 

world their organs must be like. I have witnessed how hard it is to breathe for someone with 

hard lungs. Their breathing is labored, talking is challenging, and living becomes too much for 

them. When it affects the gastrointestinal tract, again I have witnessed persons not being able 

to swallow, limiting their intake, and losing their desire to want to eat—now we all know where 

that leads. I have also witnessed persons suffering from scleroderma’s side effects, one being 

watermelon stomach; another was suffering from the effects of having contracted another disease. I have witnessed a gal die of breast cancer; a higher incidence is found in women with 

scleroderma. Scleroderma is chronic pain that can lead to severe depression, withdrawal from 

society, and the want to give up the fight. Right now, today, I have a friend who is in so much 

pain that she is continually asking me if there is anymore that can be done for her because 

she does not want the pain anymore. I can only tell her to continue doctors’ orders and go get 

a second or third opinion. I have given her this advice because sometimes a second or third 

opinion means a doctor may say or do something that another doctor did not think of, to at 

least make her somewhat comfortable. You see what is really happening is that the collagen, 

a protein that heals a wound, for whatever reason, in scleroderma patients, goes wild and will 

not stop reproducing, thus causing the skin, or perhaps the organs, to get hard. 

The Scleroderma Foundation is a nonprofit national organization founded in 1998 whose 

mission is to provide support, education, and research. It exists for people with scleroderma and their friends and families. The support of patients and families with scleroderma 

is accomplished through mutual support programs, peer counseling, physician referrals, and 

educational information. The education aspect promotes public awareness and education 

through patient and health professional seminars, literature, and publicity campaigns. 

The research aspect promotes stimulation and support to improve treatment and ultimately 

find the cause of and cure for scleroderma and related diseases. The Foundation has been an 

eye opener for me because it has allowed me to see and meet so many different scleroderma 

patients and their friends and families and I have seen first hand how varied this disease is. 

The camaraderie from the Foundation and the people I have met has been therapy for myself, 

the support has been healing, and the caring has been a treatment. Plus the added bonus that 

they seek research dollars—research dollars to improve treatment and to find a cure. Because 

scleroderma is so varied in symptoms, many doctors misdiagnose and a patient can go for 

years without knowing what is wrong with them. They literally keep getting worse because 

no one can tell them what is wrong. With some, when a diagnosis is given, the restraint on 

medication can be severe because doctors are reluctant to give medication for fear of habitforming drugs. Thus, the patient is left with, again, chronic pain or thoughts of no hope. 

I cannot tell you how lucky I have been; I have had the right doctors, I have had determination, I have had the knowledge of what makes my body happy and what does not. Twelve 

years ago, I was waking up every night with my arms falling asleep. At the time, I was not very 

52
in tune to my body—with the exception of giving birth to four children, the only other sickness I had had was ulcers at the age of 18. After a 2-year bout with that, I was well. I carried 

and delivered my children without incident. I remember marveling once when I would see sick 

people how lucky I was to have such a healthy body, not even a headache. Oh, okay, the occasional cold and flu. It was a good thing that I was very healthy because the ulcers left me with 

this weak stomach that would not tolerate aspirin and only so much Tylenol. So when, after 2 

weeks of waking up in the middle of the night with my arms in pain, that last night was more 

pain than I could bear, I called the doctor the next morning and went in to see her. She did an 

antinuclear antibody test and found it to show that something was wrong with my body; she 

just knew that it had to be an autoimmune problem. When she told me that she was referring 

me to a rheumatologist, I thought she was crazy. This was just my arms falling asleep and they 

would quit just as soon as you can give me something for it, I thought. Well, I ended up at the 

rheumatologist, who was not sure what I had but it could be lupus or it could be scleroderma. 

I wanted a second opinion. I was off to the Mayo Clinic in Rochester, again back in the rheumatology department and with an autoimmune disease diagnosis, probably scleroderma, the 

doctor said. She wanted to start me on medicine and I refused because my arms were no longer falling asleep and I felt that maybe they were all wrong, although I did not feel really back 

to normal. Well, 2 weeks after getting back home, I called the doctor at the Mayo and told her 

about some new symptoms. 

My body was literally changing; I could feel it changing by the second. I would look in the mirror and my wrinkles were diminishing; my face was looking like a doll’s face, the skin on my 

hands, arms, and legs were younger looking and was getting very, very hard. The doctor said 

now we know you have scleroderma and started me on Methotrexate. My skin was no longer 

changing by the second, but it was also not getting softer. Then a phone call from my sister-inlaw, who had seen a news program where a doctor at Harvard was trying, with some success, 

minocycline. I went to my doctor and she was willing to try it if I wanted to, but she would also 

keep me on methotrexate. After some time on the medications, my skin started to soften. With 

the exception of my fingers, I have maintained my softened skin, but after 10 years of being 

on those two medicines, I had to go off of them because my body started to reject them. I am 

now on cellcept, in hopes that lowering my immune system will keep my collagen from reproducing rapidly. I can tell that scleroderma is active because I can feel my skin get hard, only 

not as rapidly as it was in the beginning. 

When I first became involved to see what I could do to help others who were not as fortunate 

as myself and to be sure that research continues toward a cure, I was amazed as to how little was known about this disease. Now things have changed somewhat and more and more 

is known about it. Because this is mostly a women’s disease—if I am recalling correctly, 85 

percent of those diagnosed are women—the need to prioritize research on diseases that disproportionately affect women that have no approved therapies, like scleroderma, is imperative 

for those of us who suffer day in and day out. 

53
PHYLLIS GREENBERGER, M.S.W. 

Society for Women’s Health Research 

The Future of Women’s Health Research 

The Society for Women’s Health Research is the only national advocacy organization dedicated to improving the health of women through research, education, and advocacy. Founded 

in 1990, the Society brought to national attention the need for the appropriate inclusion of 

women in major medical research studies and the need for more information about conditions affecting women exclusively, disproportionately, or differently than men. The Society 

advocates increased funding for research on women’s health; encourages the study of sex differences that may affect the prevention, diagnosis, and treatment of disease; promotes the 

inclusion of women in medical research studies; and informs women, providers, policymakers, 

and the media about contemporary women’s health issues. 

Over the past two decades, the Society has had a pivotal role in establishing women’s health 

research in our Federal agencies and in the research community at large. The Society changed 

the way current biomedical clinical research is conducted by successfully obtaining a congressional mandate that the National Institutes of Health (NIH) include women in clinical trials; 

that the NIH permanently establish the Office of Research on Women’s Health; and perhaps its 

most influential contribution to science, the 2001 Institute of Medicine (IOM) report, Exploring 

the Biological Contributions to Human Health: Does Sex Matter? The IOM determined that sex 

does matter in health and disease, from “womb to tomb.” The report emphasized the need to 

carefully evaluate sex-based differences in medical research and incorporate these differences 

into clinical practice. 

Biological differences between men and women result from a combination of genetic, hormonal, physiological, and environmental factors. These differences begin at the time of 

fertilization, depending on whether an egg is fertilized with a sperm carrying an X or a Y chromosome. Gonadal hormones have organizational and activational effects during development, 

and to a large extent, these effects influence physiology and behavior throughout the lifespan. 

Many sex differences are already present at birth, whereas others develop later in life. 

Fortunately, scientists have begun exploring potential biological mechanisms for clinically 

observed sex differences in susceptibility, prevalence, time of onset, severity, and response to 

treatment for various diseases and conditions. But much more needs to be done. 

Heart Disease 

Heart disease kills 500,000 American women each year; more than 50,000 more women than 

men; and strikes women, on average, 10 years later than men. Also, women are more likely than 

men to have a second heart attack within a year of the first one. Anatomically, women’s vessels 

tend to be smaller than men’s. Physiologically, women and men have different blood flow characteristics and differences in electrical activity; evidence also exists for differences in vessel cell 

behavior and extent of vascular injury, as well as differences in gene expression. Women have 

54
different patterns of plaque formation, higher stroke incidence, older/more comorbidities, less 

coronary vessel disease, and more valve disease and congestive heart failure. 

Despite knowing these differences, women at risk are, to this day, often not referred for diagnostic testing that would be standard for men. Studies have shown in hospital settings that women 

frequently receive clot-busting therapy much later than men. Women have a higher mortality 

rate and a higher risk of complications, and yet the healthcare treatment disparities persist. 

Neurological Disorders 

Men’s and women’s brains are different structurally and functionally. This may result from a 

combined effect of sexual differentiation of the brain during development and differences in 

the localized actions of steroid hormones in various regions of the brain. Additionally, sex differences in neurological disorders have shown the following: 

Females > Males Males > Females 

Depression Autism 

Anxiety Disorder Attention Deficit Hyperactivity Disorder 

Anorexia Nervosa Tourette’s Syndrome 

Alzheimer’s Disease Parkinson’s Disease 

Drug Abuse 

Women and men differ in their characteristics of drug abuse, and this pattern of sex differences is the same for all drugs of abuse. Compared to males, females begin regularly 

self-administering licit and illicit drugs at lower doses, proceed to addiction more rapidly, and 

they are at greater risk for relapse following abstinence. 

Autoimmune Disease 

Three out of four people suffering from autoimmune diseases, such as multiple sclerosis, rheumatoid arthritis, and lupus, are women. 

Obesity 

While there is no significant difference in the prevalence of obesity between women and men, 

the prevalence of extreme obesity is higher in women (7 percent vs. 3 percent). Obese women 

are particularly susceptible to diabetes and cardiovascular disease and have an increased risk 

of several major cancers, especially postmenopausal breast cancer and endometrial cancer. 

Women and men deposit fat differently. In general, men deposit fat viscerally in the abdomen 

and surrounding the internal organs. Visceral fat is associated with increased risk for diabetes and cardiovascular disease (CVD). Women tend to deposit fat subcutaneously in the hips 

and thighs, but the pattern changes to mimic that of men after menopause. The change in fat 

deposition at this critical hormonal transition coincides with increased risk of diabetes and 

CVD in the postmenopausal period. Currently, we know very little about the differences in adipose depots and how fat deposition is regulated differently between men and women. 

55
Lung Cancer 

Lung cancer is the leading cause of cancer death in the United States and kills more women 

per year than breast, ovarian, and cervical cancer combined. Women smokers and nonsmokers appear to be at a higher risk for the development of lung cancer compared to men. In fact, 

women comprise 80 percent of the lung cancer cases not caused by smoking. 

Research has uncovered biological mechanisms for why women smokers are more susceptible 

to lung cancer. Compared to male smokers, female smokers have reduced DNA repair capacity 

to fix damaged DNA caused by tobacco carcinogens. 

All of these examples clearly demonstrate evident sex differences and where studying sex 

differences is essential, though barriers to scientific progress persist. 

Awareness Among the Scientific and Clinical Research Community 

The Society and many scientists devoted to sex differences are spreading the word, and many 

in the scientific community are beginning to understand the importance of using both sexes 

in basic and clinical research studies. However, many scientists are still unaware of the importance of including male and female rats, for example, in their studies, as well as analyzing the 

results of the studies by sex. Another important point of progress relates to the appropriate 

development of databases, which must consistently use sex and hormonal status as variables 

to ensure comparisons across studies. 

Visibility in the Scientific and Clinical Literature 

A major limitation to scientific progress in women’s health is that scientific journals do not 

require authors to report their data broken down by sex. If this were a requirement, scientists 

would have to design their studies appropriately to ensure inclusion of both sexes in the study 

design, analysis of results by sex, and dissemination of the results by sex to the scientific community. One important point to remember is that the absence of sex differences in a study is 

equally as important as the presence of sex differences. Authors should always report when no 

sex differences are found. 

Funding 

We would like to see every Institute and Center of NIH funding sex differences research, 

especially those Institutes whose areas of health and disease have already shown evidence 

of sex differences. However, several NIH Institutes that receive the most Government funding 

for research and have extraordinary potential to uncover important sex differences fund the 

fewest number of sex differences grants. There is room here for change. 

Selection of Study Subjects and Study Design 

Changes need to take place at the level of the individual experiment and in the study design. 

For example, even though women are being included in NIH-funded clinical research studies 

at numbers proportional to the general population, for the most part, disparities in recruitment to all other trials remain. More and more trials are conducted outside government 

institutions (in 1999, 80 percent of all drug trials were funded by industry), and thus the 

56
mandates of Federal requirements on inclusion have limited impact on non-federally funded 

clinical research. Further, institutional review boards generally do not evaluate protocols with 

a view toward determining or measuring retention. 

One striking example is CVD, where although it is the number one killer of women, women are 

still not included in CVD trials at appropriate numbers. On average, many cardiovascular trials 

show a breakdown of about 20–25 percent female participants to male. Further, a 2007 review 

of published data from CVD trials showed that of the 628 reviewed studies, sex differences 

analysis was not performed in three-fourths of trials; 41 trials did not provide the sex of the 

participants; and 17 trials did not include women at all, even though the CVD condition studied 

affected both sexes. 

The Society believes that to change the face of sex differences research and to improve health 

care for all women, six fundamental issues must be addressed: 

1. First and foremost, physicians must be appropriately trained and educated in medical 

school, residencies, and in continuing medical education about sex differences in order 

to communicate the information effectively to their patients. Currently, sex differences 

research is not included in nursing and medical curricula. This needs to change to 

become a requirement of academic coursework at medical school. It is an investment in 

future generations of healthcare providers and investment in the future of medicine. 

2. Even if a physician is aware of sex differences in an area of health, they may be more 

likely to diagnose and treat a patient in a certain way based on the patient’s sex. This 

“Physician Bias” has been noted in two separate peer-reviewed studies, one in the 

diagnosis of CVD risk factors and the other for treatment of knee osteoarthritis. In both 

cases, the male and female patients had the exact same conditions and symptoms, but 

the physicians’ diagnosis was more aggressive for the men. 

3. Patients, especially women patients, must be informed and thus empowered to ask for 

sex-specific information wherever possible. This will help enormously to advance the 

translation of research into practice, as well as advancing the science. However, we do 

recognize that while patients need to be their own advocates, the system is extremely 

complicated and not easily navigated to ensure receipt of the best care. How well a 

patient can make educated decisions about their own, and most often, their family’s 

health, is dependent on many issues. 

Women are still unaware of the dangers of heart disease (2003 American Heart Association [AHA] study of more than 1,000 women conducted by Harris Interactive, Inc). 

The AHA study showed that a mere 13 percent of women in America believe that heart 

disease and stroke are the greatest health threat to women. While it was shown in 2006 

that more than 50 percent of women understood that heart disease is the number one 

killer of women, the 13 percent had only risen to 21 percent of those recognizing that 

heart disease and stroke are the greatest health threat they will personally face. 

57
Women often receive conflicting information when endeavoring to obtain medical 

information from multiple medical sources such as physicians, family/friends, the 

media, the Internet, magazines, and direct-to-consumer ads, where each carries with it 

emotional or social influences. A patient may feel overwhelmed with information and 

not know how much weight to place on it to make a quality healthcare decision. The 

media have only added to this challenge by misrepresenting trial results in headlines, 

causing confusion and panic demonstrated best by the Women’s Health Initiative. This 

can contribute to a patient’s confusion and lack of confidence in science. 

4.	�The Society sees a future where sex is a variable in all basic and clinical research 

design and analysis, and reporting of results by sex, age, race, and ethnicity is a 

fundamental requirement. Further, scientists should determine and disclose the sex 

of origin of cells and tissues in their studies. Scientists/researchers must identify the 

reproductive cycle status of female research subjects. The scientific and medical community should collaborate on programs that will result in the faster translation of basic 

research results into the clinic and the faster incorporation of new treatments and 

technologies at physician’s offices and hospitals. Finally, scientists should study the 

influence of sex differences on health and illness across the lifespan. 

5. The Society has long advocated that a strong patient-centered comparative clinical 

effectiveness research program will add value to understanding biological and physiological sex differences that affect disease prevention, diagnosis, and treatment. As we 

have demonstrated, a complex combination of genetic, hormonal, physiological, and 

environmental factors influence health and disease in extraordinarily different ways in 

women and men. Biological sex differences in disease and the response to therapeutics, some of which are present at birth and others that develop later, are pervasive 

and compelling. 

Comparative research must freely evaluate and compare the clinical effectiveness, risks, 

and benefits of two or more medical treatments, services, drugs, devices, biologics, 

care processes, and care management while also taking into account differences based 

on a patient’s sex, age, race, and ethnicity. 

6. Research and innovation into new diagnostics and imaging tools is critical to our 

healthcare system’s ability to address new and emerging diseases and illnesses. The 

Society urges continued development of new innovative medical imaging technologies 

and diagnostics to further enhance patient outcomes and reduce costs. For example, 

access to modern cardiac diagnostic and imaging tools is an issue of critical importance 

to women’s health care that goes beyond general prevention efforts. Timely access to 

imaging results in fewer surgeries and shorter recovery times and hospital stays, saving 

patients and the healthcare system money. 

The Society for Women’s Health Research believes that the study of sex differences is the 

strongest approach to improve women’s health. The study of sex differences will benefit both 

sexes equally and will lead to better health and better health care for women and men. 

58
SUE BAEBLER 

St. Louis Breast Cancer Coalition 

The Value of Consumer Advocates, Transparency, and Accountability in Women’s Health Research 

My name is Sue Baebler, President Emeritus of the St Louis Breast Cancer Coalition (SLBCC). 

SLBCC was founded in 1992 by a group of concerned breast cancer survivors and activists, 

and is a registered Missouri nonprofit grassroots advocacy organization. Our motto “Educate, 

Advocate, Eradicate” means we work to educate the local community with programs concerning all aspects of breast cancer, we advocate adequate Federal funding for well-designed 

breast cancer research and access to quality care for all, and our ultimate goal is to see breast 

cancer eradicated through action and advocacy. 

SLBCC as an organization has been a member of the National Breast Cancer Coalition (NBCC) 

for well over a decade. I also serve as the volunteer Missouri Field Coordinator for NBCC, 

sponsored as such by SLBCC. I welcome the opportunity to present testimony on behalf of 

the National Breast Cancer Coalition and the St. Louis Breast Cancer Coalition (in agreement 

on all statements herein) at this hearing on women’s health research. NBCC is a nationwide 

grassroots organization dedicated to ending breast cancer through action and advocacy. The 

Coalition’s main goals are to increase Federal funding for breast cancer research and to collaborate with the scientific community to implement new models of research, improve access 

to high-quality health care and breast cancer clinical trials for all women, and expand the 

influence of breast cancer advocates wherever breast cancer decisions are made. The NBCC 

Fund has developed core values for breast cancer research that reflect its vision and are fundamental to all of its research-related work. NBCCF’s Position Statement on Core Values for 

Breast Cancer Research articulates and describes these values: integrity, impact, accountability, respect, beneficence, justice, shared decisionmaking, and flexibility. These values can and 

should be applied to all forms of women’s health research. 

I commend the Office of Research on Women’s Health at the National Institutes of Health 

(NIH) for embarking on this endeavor to collect information and solicit input from scientific 

and public policy experts, healthcare providers, and advocacy organizations as it looks toward 

the next decade of women’s health research. NBCC strongly believes that the enterprise of 

clinical and scientific research at NIH could be vastly improved with greater participation from 

educated healthcare consumers and trained advocates who can help to inform all aspects of 

decisionmaking at the Office of Women’s Health Research and across the Institutes. NBCC 

also has deep concerns about the lack of transparency, external oversight, and accountability in research priority-setting, decisionmaking, and evaluation. What is important now is to 

determine the right process for and atmosphere within which women’s health research will be 

prioritized and conducted. We must make certain that the process maximizes our getting the 

right research done in the right way. 

Need for Greater Transparency, Oversight, and Accountability 

During this era of change, all Federal agencies, but particularly at the NIH, must embrace and 

incorporate greater transparency and public accountability at every level and in everything 

they do. As our nation’s foremost biomedical research institution, NIH’s lack of diversity in 

59
stakeholder representation and dissenting viewpoints in evaluating programs and projects is 

alarming. For instance, when the National Cancer Institute decided to evaluate the cancer centers, the committee chosen had a significant number of cancer center directors as members. 

The NIH Reform Act created the Scientific Management Review Board to conduct periodic 

reviews and issue reports on organizational issues at NIH. The NIH Director submitted the list 

of members of this Board to Congress and its membership includes nine institute directors, 

several major institutions that receive significant funding from NIH, and one industry representative. There were no consumer advocates as part of this Review Board. The Review Board 

clearly lacks independence and the ability to conduct meaningful oversight. 

While there is a great deal of discussion about reform and innovation, there does not appear 

to be an overarching framework or objectives and a strategy to analyze past funding and to 

govern funding going forward, at least not one that includes meaningful benchmarks and critical evaluations and is accessible by the public and policymakers. Taxpayers deserve to know 

that the agency tasked with charting scientific and medical breakthroughs is being prudent 

stewards of the billions being appropriated to its mission each year. 

Consumer Advocate Participation in Research Decisionmaking 

Consumers—lay advocates who are trained and educated—can play an integral role in ensuring 

that the research that is funded is responsive to the needs of both the scientific and patient 

communities. Their perspective is necessary to ensure that the grants funded are meaningful 

and will have impact. Consumer advocates bring a vitally important perspective to scientific 

research. And they keep the scientists on task. Together, they can look at the current state of 

knowledge, and then design appropriate and necessary mechanisms to allow scientists, in collaboration with advocates, to develop proposals to research the most important questions 

as well as advise on priorities for funding research. The Department of Defense Peer Review 

Breast Cancer Research Program (DOD BCRP) has proven that this is an effective and valuable 

model of scientist–advocate collaboration. SLBCC sponsors one of our members among the 

many trained consumer advocates involved in the DOD BCRP process. 

The peer review process is the accepted method for identifying meritorious scientific trials and 

studies. However, the peer review process has traditionally excluded those most affected by 

research—the patients themselves. The peer review process is only enhanced by the involvement of advocate “peers”—activists outside the scientific and medical communities who bring 

a unique and important perspective to the scientific discussion. Ideally, educated advocates 

must be included on all research peer review panels, in both the public and private sectors. 

Another critical area for advocate involvement is in clinical trials. Advocates can provide 

important insights into the design of clinical trials and invaluable assistance in increasing 

awareness and knowledge of clinical trials. They must be substantive collaborators in the 

research process. Moreover, it is important to have meaningful advocate involvement in scientific meetings in which the Office on Women’s Health is involved. Advocates must be part 

of program planning committees and participate as session chairs or cochairs. There must be 

opportunities for interaction between scientists and advocates at discussion sessions and in 

60
mentoring programs. Finally, advocates must be provided opportunities to present their work 

and their perspectives at poster and platform sessions. 

Educated advocates can have a meaningful impact on how best to communicate information 

and research findings to providers, patients, and the public. The NBCC framework for national 

healthcare reform calls for a national panel to be established to work with the public to review 

evidence and help design effective methods for communicating healthcare information to consumers, providers, and plans. 

An example of where educated advocates played a critical part in the development and evolution of a research project is the Women’s Health Initiative (WHI). As you are well aware, it is 

a large clinical trial, one part of which looked at a particular hormone replacement therapy— 

progestin plus estrogen vs. placebo—to determine the benefits and risks of that approach. 

The trial was supposed to end in 2005, but it was stopped in 2002, because the overall health 

risks of hormone replacement therapy (HRT) exceeded the benefits. In fact, the trial showed 

an increased risk of breast cancer as well as heart disease, blood clots, and stroke. Women had 

taken HRT for years before the trial was conducted to look at these issues. While the intervention aspect of the trial was stopped, that is, women were no longer given the drugs, HRT or 

placebo, as in any well-designed trial, the investigators continued to follow the women. 

Several years of following these women after the trial stopped, it was determined that the cardiovascular risks were no longer greater in the group of women who had taken HRT than in 

the women who received placebo. However, it appears that the breast cancer risk may continue. While the higher risk remained throughout the intervention and the followup period, 

looking at the followup period alone, the results were not statistically significant. What does 

that mean? Since we are not certain what drugs the women took after the trial was stopped— 

or what else changed in their lives—and because the followup was only 3 years, we cannot yet 

say with certainty that the breast cancer risk continues. We can say it is likely. It is important 

to keep in mind that the Women’s Health Initiative would not have happened without advocacy from the women’s community. It is very important to remember that women took these 

drugs when there was no high-level evidence they would benefit and not harm them. And it is 

extremely relevant to note that advocacy groups such as the National Breast Cancer Coalition 

questioned the lack of evidence behind these drugs for many years. 

Conclusion 

In summary, the agenda for women’s health research must be set and implemented in an 

atmosphere of transparency and through a process that is accountable and includes trained, 

educated advocates. We must make certain that the public can access and understand allocation of resources and the vast array of research projects being undertaken. NIH must 

enhance its ability to conduct meaningful science through these changes. Again, I thank you 

for the opportunity to present these views and look forward to working with the Office of 

Research on Women’s Health and others at NIH to transform the Institutes, conduct meaningful research, and give the American public greater insight and involvement in women’s health 

research and biomedical research in general. 

61
RAUL ARTAL, M.D., AND 

ROSEMARY B. CATANZARO, M.S., RD, CDE 

St. Louis University 

Pregnancy, Obesity, and Weight Gain Restriction 

The rate of obesity in Missouri and the United States is reaching epidemic proportions at 

30–40 percent.1 The growing prevalence of obesity and related comorbidities has brought into 

question the current recommendations for weight gain in pregnancy and its effect on postpartum weight retention. The Institute of Medicine in 1990 provided the recommendations as 

prescribed by obstetricians and healthcare providers.2

 These guidelines are based largely on 

observational studies that focused primarily on the prevention of low-birthweight infants due 

to nutritional deficiencies and/or insufficient maternal weight gain without addressing other 

causes of growth restriction. These recommendations have not considered the consequences 

of excessive weight gain on the fetus such as macrosomia and the impact of postpartum weight retention on maternal morbidity. Raul Artal, M.D., professor and chairman of the 

Department of Obstetrics, Gynecology, and Women’s Health at St. Louis University advocates 

the revision of the gestational weight gain recommendations in light of the obesity epidemic.3 

The current guidelines do not distinguish between the different obesity classes in recommending weight gain of at least 15 pounds without an upper limit. In a population-based cohort 

study from 120,251 Missouri birth certificates (1990–2001), we found that 60–82 percent of 

obese pregnant women exceeded the 15-pound weight gain recommendation and 35–56 percent exceeded 25 pounds in weight gain.4 The women gaining less than 15 pounds, however, 

had a significantly lower incidence of cesarean section, preeclampsia, and large-for-gestational-age infants and the risk of small-for-gestational-age infants was minimal.4 Gestational 

diabetes mellitus (GDM) is another comorbidity with a strong link to obesity. GDM affects on 

average 7 percent of all pregnancies.5 Furthermore, those who are morbidly obese have almost 

an 8.5-fold increased risk of developing GDM compared with only a 2-fold increased risk in 

overweight women.6 

We have studied a lifestyle intervention of weight-gain restriction in obese women with GDM.7 

The study consisted of 96 total subjects: 39 who agreed to participate in an exercise-and-diet 

group and 57 who agreed to participate in a diet-alone group. The subjects were prescribed 

exercise on a semirecumbent bike or walk on a treadmill for 6 days per week at a level not to 

exceed 60 percent of their aerobic capacity and a eucaloric diet to limit weight gain. After 8 

weeks of exercise training, the exercise-and-diet group had significantly more subjects who 

either lost weight or had no weight change from the time of intervention to the time of delivery than the diet-only group (46 percent vs. 21 percent). Pregnancy outcomes were compared 

between the two groups. Infant birth weight, vaginal deliveries, and cesarean deliveries were 

found to be similar in both groups. Of note, there were a total of 27 subjects who lost weight 

over the course of study, and another 3 subjects who experienced no average weight change 

throughout the intervention. Table 1 summarizes the pregnancy outcomes associated with 

maternal weight change during the course of the study. 

62
Table 1. Pregnancy Outcomes by Weight Change Status 

Subjects Who Lost Weight 

or had No Weight Change 

(n = 30) 

Subjects Who Gained Weight 

(n = 66) 

Characteristic Mean + SD n percent Mean + SD n percent P-value 

Infant Birth Weight (gm) 3286.3 + 399.0 3339.5 + 612.0 0.70 

Infant Weight Category 

Normal 23 95.8 43 76.8 

Large for Gestational Age (>4000 gm) 1 4.2 10 17.9 0.12 

Small for Gestational Age (<2500 gm) 0 0.0 3 5.4 

Gestational Age at Delivery (wk) 38.6 + 1.4 38.1 + 1.5 0.17 

Delivery Method 

C-section 10 41.7 28 49.1 0.71 

Vaginal 14 58.3 29 50.9 

Infant birth weight category was unknown for 6 subjects who lost weight or had no average 

weight change and for 10 subjects who gained weight. Delivery method was unknown for 6 subjects who lost weight or had no average weight change and for 9 subjects who gained weight. 

We concluded from this study that caloric restriction and exercise resulted in limited weight 

gain in obese subjects with GDM, with a trend for fewer macrosomic neonates, and no adverse 

pregnancy outcomes. This study is ongoing and the previously published results continue to 

be validated. Continuation and implementation of this pilot program into our new Obstetrics 

and Bariatric Center offers a proactive and preventative healthcare approach of lifestyle intervention to prevent GDM and decrease the rate of excessive weight gain during pregnancy, thus 

lowering maternal obesity rates. 

Pregnancy, over the years, has become a time of overindulgence and confinement. In the 

absence of complications, all pregnant women should continue to maintain a healthy lifestyle of a sensible well-balanced diet and an active lifestyle to promote health benefits to 

avoid obesity-related comorbidities. Pregnancy is a time when women are motivated to make 

changes to improve lifestyle and therefore is an opportune time to impact their lives and the 

lives of future generations. It is our opinion, given the magnitude of the obesity problem and 

the positive results observed, that this topic should be taken up in large prospective studies. 

References 

1. Ogden, C. L., Carroll, M. D., Curtin, L. R., McDowell, M. A., Tabak, C. J., & Flegal, K. M. 

(2006). Prevalence of overweight and obesity in the United States, 1999–2004. Journal 

of the American Medical Association, 295, 1549–1555. 

2. Committee on Nutritional Status During Pregnancy and Lactation, Institute of Medicine. 

(1990). Nutrition during pregnancy: Part I, weight gain: Part II, nutrient supplements. 

Subcommittee on nutritional status and weight gain during pregnancy (1st ed.). Washington, D.C.: National Academy Press. 

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3. Artal, R. (2008). Weight gain in recommendations in pregnancy. Expert Review of Obstetrics & Gynecology, 3, 143–145. 

4. Kiel, D. W., Dodson, E. A., Artal, R., Boehmer, T. K. & Leet, T. L. (2007). Gestational 

weight gain and pregnancy outcomes in obese women: How much is enough? Obstetrics and Gynecology, 110, 752–758. 

5. Kim, C., Newton, K. M., & Knopp, R. H. (2002). Gestational diabetes and the incidence of 

type 2 diabetes: A systematic review. Diabetes Care, 25, 1862–1868. 

6. Chu, S. Y., Callaghan, W. M., Kim, S. Y., Schmid, C. H., Lau, J., et al. (2007). Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care, 30, 2070–2076. 

7. Artal, R., Catanzaro, R. B., Gavard, J. A., Mostello, D. J., & Friganza, J. C. (2007). A 

lifestyle intervention of weight-gain restriction: Diet and exercise in obese women 

with gestational diabetes mellitus. Applied Physiology, Nutrition, and Metabolism, 32, 

596–601. 

LYSE NORIAN, PH.D. 

University of Iowa College of Medicine 

The Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program as a 

Unique Career Development Opportunity for Junior Investigators 

I am a former Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) 

Scholar and would like to provide testimony as to the essential nature of this program. Not 

only did the BIRCWH program provide funding for my salary support at a critical time in my 

career, but it also provided me with experiences and skills that have proven invaluable to me 

as a researcher. 

The financial support provided to me as a BIRCWH Scholar quite literally saved my research 

career. I had recently been appointed into a Research Instructor position at Washington University, as my 5-year time limit as a postdoctoral researcher had expired. However, because I 

was working on a research project that represented a completely new avenue of research for 

my Principal Investigator and me, my progress had been slow. While my initial results were 

exciting, I did not have the data and publication record required to compete successfully for 

funding as an independent investigator on a large grant. Receipt of BIRCWH funding enabled 

me to continue to pursue this line of investigation, and provided me with the time to obtain 

necessary data and publications. 

In the current economic climate, it is difficult to acquire funding to support one’s salary and 

research, even when one has a lengthy publication record. For new investigators, it is even 

more challenging. The BIRCWH program is unique because it not only provides critical support to new investigators, but it does so over a period of years, which allows for continuity and 

freedom from the constant pressures of re-applying for 1- or 2-year grants. Thus, the continuity of support over a 3- to 5-year period, and the fact that the support is targeted specifically 

to junior faculty, are what make this program so unique and so irreplaceable. 

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As important as research and salary support are, what makes the BIRCWH program truly 

outstanding are the intangibles it provides to scholars. First, by promoting interdisciplinary research, the BIRCWH program supports research projects that may not fit neatly into a 

defined research category. For a junior investigator with a brilliant idea, but no prior publication record in a given field, it is often difficult to transition successfully into a new avenue of 

research. However, I believe that the future of biomedical research will reside in the formation 

of multidisciplinary research teams that can efficiently translate basic research findings into 

the clinic. Thus, it is essential for junior investigators to acquire the skills and mindset necessary to accomplish becoming part of an interdisciplinary research team. The BIRCWH program 

provides precisely these experiences. By requiring scholars to assemble a team of mentors, 

the BIRCWH program supports a component of career development that is often overlooked, 

but which is vitally important to continued and future success as a biomedical researcher. In 

addition, written and oral progress reports to institutional BIRCWH directors and committee 

members allow for feedback from distinguished investigators from outside one’s own field. 

These interactions with faculty from diverse research backgrounds greatly enhance the educational experiences of BIRCWH Scholars. 

Another intangible that is provided to BIRCWH scholars is the opportunity to network and 

interact with researchers at other institutions and personnel from the National Institutes of 

Health (NIH). The yearly BIRCWH meetings foster relationship building among the scholars, 

and provide a forum for learning about issues relating to women’s health that may be vastly 

different from one’s own research area, thus broadening the scholars’ scientific perspectives. 

In addition, having the ability to meet in small groups with NIH employees, to discuss grant 

application and review processes, among other topics, are opportunities that are not available 

to most junior investigators, but which are invaluable. The written materials I received from 

such sessions have become important resources for me. Books on such topics as career development for life scientists were provided at no cost to scholars. The entire program is geared 

toward providing enhanced research and educational experiences during the first years of 

being a faculty member. As such, being selected as a BIRCWH Scholar is an event that can 

profoundly impact the course and success of one’s future career in biomedical research. 

At a time when the topic of women’s success in science is being actively discussed, and many 

institutions are seeking to identify specific actions that can be taken to promote and retain 

women scientists, the BIRCWH program stands as a striking example of how research institutions can support the career development of junior faculty—both men and women. Salary 

support over a period of years, mentorship from a team of successful faculty members, opportunities for and experience in networking, and the promotion of interdisciplinary research 

projects, all combine to provide an environment where junior investigators can flourish. I feel 

fortunate to have been associated with the BIRCWH program. 

65
SUSAN PFEFFERLE, PH.D. 

Washington University George Warren Brown School of Social Work Research 

Getting Health Services to Women: Needs for Blended Funding and Implementation Science 

My name is Susan G. Pfefferle. I have a master’s degree in counseling psychology and a Ph.D. 

in social policy with a concentration in health services research. My research involves access to 

depression treatment for low-income mothers. 

I have two concerns related to research on women’s health. The first concern related to the 

Institutes’ focus on bench science as opposed to services research. While I truly value the contributions of bench science to women’s health and am excited about work on biomarkers as 

they relate to personalized care, I am very concerned that effective treatments often do not 

reach vulnerable women. The lack of focus on moving effective treatments from “bench to 

trench” means that mothers, and ultimately children, families, and society, suffer. Good health 

is necessary to fully participate in work, family activities, and in society. 

For example, we now have very strong evidence that untreated maternal depression can 

severely impact child social, emotional, educational, and physical development. Long-term 

studies have shown that children of depressed parents are more likely to suffer from mental 

disorders. Good bench science and epidemiology studies have also shown us the link between 

depression, heart disease, diabetes, and obesity. Researchers from Project Viva recently found 

that when women are depressed during pregnancy, their child’s birthweight is impacted, with 

children being shorter and heavier than children of nondepressed mothers. Another recent 

study from Project Viva found that months with postpartum depression had significantly 

increased odds of weight retention 1 year after childbirth. These are very important findings. 

They show us the link between physical conditions and depression and the need to study 

these conditions together and not simply as silos of interest. 

My own research shows that the most vulnerable women never reach treatment for many reasons. They have no insurance, they are a low priority for community mental health care, and 

primary physicians and pediatricians most often do not recognize depressive symptoms, especially if the symptoms are mild. Yet even mild depression significantly impacts child outcomes 

and mother–infant bonding. 

So I ask three things. First, that we fund services research that explores the connections 

between disorders and ways to facilitate access to effective depression treatment across 

socioeconomic status, race, and ethnicity. I also ask that in genetic research and other bench 

science, we explore the mechanisms through which depression interacts, causes, and is associated with physical health outcomes. Siloed funding leads to siloed research. Whole patients 

live in the real world. If we want to improve women’s health, we have to undertake studies 

that look at relationships between disorders. This means we need blended funding with incentives for researchers to work across disciplines. Finally, we need to fund more implementation 

research on health services for women across disorders. Increased funding for implementation 

research on women’s treatments will lead to effective treatments actually reaching women. 

66
ERICKA HAYES, M.D. 

Washington University Pediatric HIV Program 

Rising Sexually Transmitted Infections in St. Louis Adolescent Females and its Impact on the 

Evolving Epidemic of HIV Infection in Area Youth 

The city of St. Louis, Missouri, and its surrounding areas have, for more than 10 years, led the 

Nation in sexually transmitted infections (STIs). We are the number one city in chlamydia and 

gonorrhea infections and in the top five for syphilis infections in the United States. Sexually 

transmitted infections in the United States tend to affect adolescents and young adults disproportionately and females more so than males. For chlamydia, the most common STI in St. 

Louis and nationwide, the leading age group is 15- to 19-year-olds, closely followed by 20- to 

24-year-olds. The number of cases diagnosed in females is almost triple the number of cases 

reported in males, and when broken down by race, African Americans have almost four times 

the number of infections as their White peers. Nationally, individuals aged 13 to 24 years of 

age account for 10 million sexually transmitted infections annually, 50 percent of all STIs. This 

age group also accounts for 50 percent of new human immunodeficiency virus (HIV) diagnoses, 28,000 annually, and it is the only age group in which rates are continuing to rise. 

Why are the high rates of gonorrhea, syphilis, and chlamydia important for teenage girls and 

influencing our youth HIV epidemic? Adolescent females are at higher risk of contracting cervicitis from STIs due to the immature cervix than more mature women. We also know that all 

STIs are more efficiently transmitted from males to females; often males may have asymptomatic infections as well, leading to further unwitting spread. Significant literature exists to 

support that genitourinary tract inflammation (cervicitis, vaginitis) from other STIs such as 

herpes simplex virus, syphilis, gonorrhea, and chlamydia increases the chances of HIV transmission, especially in women. Therefore, adolescent females are doubly at risk for acquiring 

HIV infection. 

In my role as the co-Medical Director of the pediatric HIV clinic at Washington University, we 

have seen an evolution in the pediatric HIV epidemic locally that mirrors national trends. In 

2001, when I joined our group, infants being born with HIV infection were becoming rare. If the 

mother is diagnosed with HIV in pregnancy and adherent with available therapies, we are very 

successful in preventing the infant from being infected, bringing the number of infants born 

annually with HIV in the United States to less than 100, almost all of whom were born to mothers who were not tested for HIV during pregnancy. As far as behaviorally infected teenagers, 

they were few and far between in 2001, perhaps two to three joining our clinic population 

annually. However, in 2006, we noticed a significant uptick in the number of newly diagnosed 

behaviorally infected youth we were seeing in clinics, to greater than 10 annually. In an analysis 

of newly diagnosed, behaviorally infected youth in St. Louis for the period from 1997 to 2007, 

we saw a doubling of the number of new diagnoses in the region for that 10-year period. Like 

national trends, African Americans are disproportionately represented, accounting for 75 percent of diagnoses in this age group compared with the national rate in African Americans of 

50 percent. However in St. Louis, we saw disturbing trends regarding young women, in that for 

this age group in the St. Louis area, 35 percent of new diagnoses were women, for whom their 

only risk factor was unprotected heterosexual intercourse. This is much increased over the 

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national percentage of females making up 25 percent of new HIV diagnoses. Both these trends 

in HIV infection mirror the incidences of other STIs in the St. Louis region. 

So we know that there has been a significant increase in HIV diagnoses in adolescents and 

young adults in the St. Louis region over the past 10 years, and that our regional epidemic in 

this age group is affecting both African Americans and females more heavily than national 

trends. What is the next step? 

In September 2006, the Centers for Disease Control and Prevention (CDC) announced new 

recommendations regarding HIV testing in the United States. The main thrust of these new 

guidelines was to recommend universal HIV screening for all individuals 13 to 64 years of 

age, disregarding any risk factors. The reasons for this dramatic shift in recommendations 

were multifold: 

1.	� To make HIV testing a routine part of medical care, attempting to remove the stigma 

associated with HIV testing that it has carried since its inception 

2. To focus resources on identifying HIV-positive individuals, whom data show modify 

their behaviors after testing positive to decrease transmission 

3. To help identify individuals earlier in their infections before decline of their immune 

system; it is known that individuals have better outcomes with HIV therapies when it is 

started before the immune system has been compromised. Of note, young adults represent the largest percentage of so called “late testers,” individuals who are diagnosed 

with HIV within a year of meeting criteria for AIDS 

4. To stress that risk-based testing is no longer appropriate, given that fully a third of 

individuals being diagnosed annually in the United States with HIV infection have none 

of the classical risk factors associated with those who were infected early in the U.S. 

epidemic of intravenous drug use, blood transfusion/product exposure, or males who 

have sex with other men. This especially is true for women, the majority of whom have 

none of these risk factors 

In response to our rising numbers locally and further support by new CDC recommendations, 

we at Washington University and St. Louis Children’s Hospital (SLCH), with a collaboration 

between the departments of pediatric infectious disease and pediatric emergency medicine, began work to improve access of adolescents and young adults to HIV testing. After 20 

months of building support, planning, gathering resources, implementing, and gaining the 

support of a CDC grant to support such initiatives, we launched on July 28, 2008, free, confidential rapid HIV testing to be offered to all adolescents 15 years and older presenting for 

care to the SLCH emergency department (ED). We were the first children’s hospital in the 

Nation to launch such a program. In September of 2008, free, confidential rapid HIV testing 

was also launched at the new high-risk youth center, the Supporting Positive Outcomes with 

Teens (SPOT), as well. There have now been approximately 2,000 youth tested in our ED, and 

approximately 280 youth at the high-risk youth center. We have diagnosed seven young people with HIV, four of whom were less than 18 years of age since our start, all of whom were 

identified at the SPOT, for an overall percentage of positive HIV diagnoses at that site of 2.5 

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percent, which is an astoundingly high number that was much higher than our initial estimates. 

This is certainly suggestive that the burden of other STIs in the St. Louis area in youth may be 

allowing for an amplification of transmission of HIV in that same population. 

Obviously, there is still much left to be done. Despite the recommendations, the majority of 

hospitals have not implemented the new CDC HIV screening recommendations. Also, the CDC 

stressed the recommendation should be applied across practice settings, although the ED, 

being a point of access to the healthcare system for many patients who may not see a healthcare practitioner regularly, is a logical place to start. We must continue the drive to remove 

the stigma from HIV, which is now a treatable chronic disease, and identify positive individuals, both to help them maintain their health as well as break the cycle of ongoing transmission. 

Furthermore, in order to control HIV, control of other sexually transmitted infections that promote the more efficient transmission of HIV is also key, especially for young women. One 

major stride in this direction is the SPOT, our high-risk youth center that was passionately 

championed and launched by Dr. Katie Plax of the adolescent center at Washington University 

in collaboration with the Pediatric HIV program and Project ARK. This center provides barrier-free access for teenagers to free STI testing, including chlamydia, gonorrhea, syphilis, and 

HIV, as well as free treatment of STIs. They have a close relationship with our HIV program so 

that identified positives can be immediately plugged into the care and support that they need. 

Support for programs like this one and at SLCH and the emergence of more programs focused 

on getting youth tested and treated for all STIs will be key in starting to control and eliminate 

the STI and HIV epidemics in both young women and young men in the St. Louis region. 

KEITH GARCIA, M.D., PH.D. 

Washington University School of Medicine 

Women’s Mental Health During the Perinatal Period—A Pandora’s Box 

There is growing evidence to challenge the notion that pregnancy protects patients from mental illness. Major depressive disorder during the perinatal period is a common, undertreated 

psychiatric condition. Although currently pregnant women have a lower risk of having a mood 

disorder than nonpregnant women, there is a higher prevalence of major depressive disorder during this period (e.g., 20 percent).1,2 It has been estimated that an episode of major 

depression occurs in 10–15 percent of all delivering women,3-6 making it the most common 

complication of childbirth and a significant public health problem.7,8 

Maternal depression is a significant burden on the mother and it may adversely impact 

the child in both the short and long term.9-11 One of the most significant negative outcomes 

documented is maternal suicide. For instance, Oates12 noted that suicide was the leading 

indirect cause of maternal death (i.e., accounting for 28 percent of all deaths in a sample 

of 242 maternal deaths from 1997 to 1999 in the United Kingdom). Other investigators have 

documented that maternal death from suicide increases 70-fold in the first postpartum year.13 

Equally disturbing are the negative impacts on mothering skills, perhaps imposing a risk 

of physical, as well as mental, harm to the infant.9,14,15 Research indicates that a significant 

69
proportion of women (i.e., 41 percent) experience thoughts of harming their infants, including 

aggressive, obsessional thoughts, such as throwing their infant out the window and strangling 

the infant.9,16,17 While not pathognomonic of depression, postpartum depression is correlated 

with impairment in mother–infant bonding. For instance, 10–25 percent of mothers referred 

for psychiatric care following delivery of their child exhibit disorders of the mother–infant 

relationship.18 The existence of depressive symptoms in the early postnatal period has been 

shown to correlate with mother–infant bonding difficulties up to a year later.19 Additionally, 

infants of depressed mothers show a significantly reduced possibility of having a secure 

attachment with their mother and a raised likelihood of having an avoidant or disorganized 

style of attachment.20 Presumably because of this perturbation in normal attachment during 

early rearing, children of mothers with postpartum depression (PPD) are at significant risk of 

impaired cognitive and emotional development. Thus, the treatment of depressive symptoms 

can be potentially lifesaving for both the mother and infant. 

Depression that occurs during pregnancy poses some unique challenges for both the patient 

and the healthcare provider. Many standard screening tools (i.e., Beck Depression Inventory) 

focus on somatic symptoms and, therefore, make detection of depression during pregnancy 

difficult. Very little work has been completed on developing specific tools that can take into 

account the overlap of pregnancy-related symptoms and symptoms of depression. The use 

of medication during pregnancy remains a controversial and complicated issue,21 yet maternal anxiety and stress during the pregnancy appear to predict adverse pregnancy outcomes.22 

Treatment of postpartum depression should take into consideration that many antidepressants 

readily cross into breast milk, and so the risks and benefits of taking antidepressants while 

breastfeeding should be evaluated in each patient to determine what is best for that patient 

and her child.15,23-29 Research addressing these three “orphaned” areas of interest regarding 

depression in the perinatal period needs to be expanded. 

Both interpersonal and cognitive-behavioral therapies have been studied for treating/preventing depression in women during and following pregnancy.30-35 Some women, however, 

are unable to take advantage of these therapies or do not respond to them.36 Despite the 

frequency of depression in pregnant women, information to guide patients and physicians 

through the process of considering treatment during pregnancy is limited.2

 As a consequence, many physicians and patients react to this lack of information with a “wait and watch” 

approach, often with disastrous consequences. 

The development of safe and effective alternative therapies for treating perinatal depression 

would have broad impact and is a socially desirable endeavor, as would a more complete evaluation of our currently available treatment approaches. Because of the liability involved with 

performing research on pregnant and nursing women with psychiatric illness, this population remains largely ignored by the private sector and treatment outcome studies are few and 

far between. Thus, Federal avenues of research funding remain the only viable mechanism for 

assuring that these patients get the attention they deserve. 

70
References 

1. Gotlib, I. H., Whiffen, V. E., Mount, J. H., Milne, K., & Cordy, N. I. (1989). Prevalence rates 

and demographic characteristics associated with depression in pregnancy and the postpartum. Journal of Consulting and Clinical Psychology, 57, 269–274. 

2. Wisner, K. L., Gelenberg, A. J., Leonard, H., Zarin, D., & Frank, E. (1999). Pharmacologic 

treatment of depression during pregnancy. Journal of the American Medical Association, 

282, 1264–1269. 

3. Beck, C. T., & Gable, R. K. (2001). Comparative analysis of the performance of the Postpartum Depression Screening Scale with two other depression instruments. Nursing 

Research, 50, 242–250. 

4. Beck, C. T., & Gable, R. K. (2001). Further validation of the Postpartum Depression 

Screening Scale. Nursing Research, 50, 155–164. 

5. Gavin, N. I., Gaynes, B. N., Lohr, K. N., Meltzer-Brody, S., Gartlehner, G., & Swinson, T. 

(2005). Perinatal depression: A systematic review of prevalence and incidence. Obstetrics and Gynecology, 106, 1071–1083. 

6. Gaynes, B. N., Gavin, N., Meltzer-Brody, S., Lohr, K. N., Swinson, T., Gartlehner, G., . . . 

Miller, W. C. (2005). Perinatal depression: Prevalence, screening accuracy, and screening 

outcomes. Evidence Report/Technology Assessment, 119, 1–8. 

7. Grace, S. L., Evindar, A., & Stewart, D. E. (2003). The effect of postpartum depression on 

child cognitive development and behavior: A review and critical analysis of the literature. Archives of Women’s Mental Health, 6, 263–274. 

8. Wisner, K. L., Chambers, C., & Sit, D. K. (2006). Postpartum depression: A major public 

health problem. Journal of the American Medical Association, 296, 2616–2618. 

9. Burke. L. (2003). The impact of maternal depression on familial relationships. International Review of Psychiatry, 15, 243–255. 

10. Herrera, E., Reissland, N., & Shepherd, J. (2004). Maternal touch and maternal childdirected speech: Effects of depressed mood in the postnatal period. Journal of Affective 

Disorders, 81, 29–39. 

11. Stein, A., Gath, D. H., Bucher, J., Bond, A., Day, A., & Cooper, P. J. (1991). The relationship 

between post-natal depression and mother-child interaction. British Journal of Psychiatry, 158, 46–52. 

12. Oates, M. (2003). Perinatal psychiatric disorders: A leading cause of maternal morbidity 

and mortality. British Medical Bulletin, 67, 219–229. 

13. Appleby, L., Mortensen, P. B., & Faragher, E. B. (1998). Suicide and other causes of mortality after post-partum psychiatric admission. British Journal of Psychiatry, 173, 209–211. 

14. Boyd, R. C., Zayas, L. H., & McKee, M. D. (2006). Mother-infant interaction, life events 

and prenatal and postpartum depressive symptoms among urban minority women in 

primary care. Maternal and Child Health Journal, 10(2), 139–148. 

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15. Newport, D. J., Hostetter, A., Arnold, A. & Stowe, Z. N. (2002). The treatment of postpartum depression: Minimizing infant exposures. Journal of Clinical Psychiatry, 63 Suppl 

7, 31–44. 

16. Jennings, K. D., Ross, S., Popper, S., & Elmore, M. (1995). Thoughts of harming infants in 

depressed and nondepressed mothers. Journal of Affective Disorders, 54, 21–28. 

17. Wisner, K. L., Gracious, B. L., Piontek, C. M., Peindl, K., & Perel, S. (2003). Postpartum 

disorders: Phenomenology, treatment approaches, and relationship to infanticide. In M. 

G. Spinelli (Ed.) Infanticide: Psychosocial and legal perspectives on mothers who kill (pp. 

35–60). Washington DC: American Psychiatric Publication. 

18. Brockington, I. (1996). Motherhood and mental health. Oxford: Oxford University Press. 

19. Moehler, E., Brunner, R., Wiebel, A., Reck, C., & Resch, F. (2006). Maternal depressive 

symptoms in the postnatal period are associated with long-term impairment of motherchild bonding. Archives of Women’s Mental Health, 9, 273–278. 

20.Martins, C., & Gaffan, E. A. (2000). Effects of early maternal depression on patterns of 

infant-mother attachment: A meta-analytic investigation. Journal of Child Psychology 

and Psychiatry, and Allied Disciplines, 41, 737–746. 

21. Chambers, C. D., Polifka, J. E., & Friedman, J. M. (2008). Drug safety in pregnant women 

and their babies: Ignorance not bliss. Clinical Pharmacology and Therapeutics, 83, 

181–183. 

22.Hendrick, V., Altshuler, L., Strouse, T., & Grosser, S. (2000). Postpartum and nonpostpartum depression: Differences in presentation and response to pharmacologic treatment. 

Depression and Anxiety, 11, 66–72. 

23.Battle, C. L., Zlotnick, C., Pearlstein, T., Miller, I. W., Howard, M., Salisbury, A., et al. 

(2008). Depression and breastfeeding: Which postpartum patients take antidepressant 

medications? Depression and Anxiety, 25, 888–891. 

24.Burt, V. K., Suri, R., Altshuler, L., Stowe, Z., Hendrick, V. C., & Muntean, E. (2001). The use 

of psychotropic medications during breast-feeding. American Journal of Psychiatry, 158, 

1001–1009. 

25.Chabrol, H., Teissedre, F., Armitage, J., Danel, M., & Walburg, V. (2004). Acceptability of 

psychotherapy and antidepressants for postnatal depression among newly delivered 

mothers. Journal of Reproductive and Infant Psychology, 22, 5–12. 

26.Jain, A. E., & Lacy, T. Psychotropic drugs in pregnancy and lactation. Journal of Psychiatric Practice, 11, 177–191. 

27. Miller, L. J. (2002). Postpartum depression. Journal of the American Medical Association, 

287, 762–765. 

28.Stowe, Z. N., Owens, M. J., Landry, J. C., Kilts, C. D., Ely, T., Llewellyn, T., et al. (1997). 

Sertraline and desmethylsertraline in human breast milk and nursing infants. American 

Journal of Psychiatry, 154, 1255–1260. 

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29.Wisner, K. L., Hanusa, B. H., Perel, J. M., Peindl, K. S., Piontek, C. M., Sit, D. K., et al. 

(2006). Postpartum depression: A randomized trial of sertraline versus nortriptyline. 

Journal of Clinical Psychopharmacology, 26, 353–360. 

30.Cooper, P. J., Murray, L., Wilson, A., & Romaniuk, H. (2003). Controlled trial of the shortand long-term effect of psychological treatment of post-partum depression: I. Impact 

on maternal mood. British Journal of Psychiatry, 182, 412–419. 

31. Dennis, C. L. (2003). The effect of peer support on postpartum depression: A pilot randomized controlled trial. Canadian Journal of Psychiatry, 48, 115–124. 

32.Milgrom, J., Negri, L. M., Gemmill, A. W., McNeil, M., & Martin, P. R. (2005). A randomized 

controlled trial of psychological interventions for postnatal depression. British Journal 

of Clinical Psychology, 44, 529–542. 

33.O’Hara, M. W., Stuart, S., Gorman, L. L., & Wenzel, A. (2000). Efficacy of interpersonal 

psychotherapy for postpartum depression. Archives of General Psychiatry, 57, 1039–1045. 

34.Ugarriza, D. N. (2004). Group therapy and its barriers for women suffering from postpartum depression. Archives of Psychiatric Nursing, 18, 39–48. 

35.Ugarriza, D. N., & Schmidt, L. (2006). Telecare for women with postpartum depression. 

Journal of Psychosocial Nursing and Mental Health Services, 44, 37–45. 

36.Grigoriadis, S., & Ravitz, P. (2007). An approach to interpersonal psychotherapy for 

postpartum depression: focusing on interpersonal changes. Canadian Family Physician, 

53, 1469–1475. 

JEFFREY HENDERSON, M.D., PH.D. 

Washington University School of Medicine 

ORWH Successes as Seen from the Perspective of a BIRCWH Scholar 

First, I would like to express my appreciation for the support given to me through the Building 

Interdisciplinary Research Careers in Women’s Health (BIRCWH) program. This program has 

helped me tremendously as I began the transition from mentored research toward an independent research career. Through this, I have obtained protected time to establish a research 

track record and have established a helpful mentoring relationship with several successful and 

established researchers. It has also helped me to better understand women’s health and the 

outstanding questions in this area. 

As we look to the future, I would like to review what it was that drew me toward research topics 

in women’s health as I began postgraduate medical research as an infectious diseases fellow. 

Quality of Research 

I decided to work with Scott Hultgren at Washington University. He has an established track 

record of excellent basic research on bacteria causing urinary tract infection. Although I had 

73
completed clinical training in infectious diseases, I felt his laboratory would be an excellent 

place to gain more experience with research microbiology. 

It is clear that attracting skilled researchers increases the visibility and desirability of research 

in women’s health and I hope this fact is considered as we move forward. 

Accommodation of Interdisciplinary Research 

As a new fellow, Scott Hultgren introduced me to the Specialized Centers of Research (SCOR) 

in urinary tract infection that he leads and I knew immediately that I wanted to be involved 

with this. The SCOR brings together researchers from disparate scientific disciplines to weave 

together new approaches to issues in women’s health. As somebody trained in basic biochemistry and completing clinical training, this was exactly the kind of approach I hoped to find as 

I contemplated the next steps of my career. I strongly believe in this approach and have come 

to appreciate the groundbreaking nature of this SCOR program that was initiated by ORWH. 

At meetings and in numerous informal discussions, I have seen and participated in lively conversations in which accommodation of disparate points of view and approaches helped 

investigators focus upon critical questions. The SCOR organization appears to me to strike 

the right balance between coordinated and individual efforts among investigators. Investigators work as a group of peers that WANTS to cooperate, not as a hierarchical group that HAS 

to cooperate! 

I hope that ORWH can reflect upon what the SCOR program has done well and either continue 

it or build similar programs in the future. 

Training Focused on Junior Faculty 

My continuation in the area of women’s health was facilitated by the availability of a Building 

Interdisciplinary Research Careers in Women’s Health (BIRCWH) program at Washington University. With this support, I could explicitly lay out a research plan in the area of women’s health and 

pursue it. As a BIRCWH scholar, I took advantage of the patient samples made available by the 

existing SCOR program to move quickly on a new research question in urinary tract infections. 

Despite being at a different institution, Drs. Hooton and Stamm at the University of Washington 

helped me to utilize clinical samples from their resource fully from project conception to completion. The BIRCWH periodically brings together a mentorship group in which both research and 

organization issues have been resolved. This group, led by Dr. Tom Baransky, was able to bring 

parties to the table to resolve problems and to take full advantage of new opportunities. Lastly, 

the BIRCWH national meeting made evident many of the big questions in women’s health. 

Although women’s health encompasses a broad array of topics, the BIRCWH was effective at 

highlighting commonalities and giving this area a distinct intellectual grounding. 

I hope ORWH and NIH can see some of the distinct advantages of the BIRCWH, how it enhances 

research in women’s health and how, in my case, it has effectively synergized with a SCOR. 

I would like to close with thanks to ORWH, Dr. Vivian Pinn, and ORWH investigators for their 

well-considered approaches to improving women’s health and I wish them continued success 

as we look to the future. 

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RAKSHA JAIN, M.D. 

Washington University School of Medicine 

Gender Differences in Airway Diseases 

Women have a higher incidence of many chronic lung diseases than men. The etiology of this 

disparity is unclear and this represents a significant disease burden in women that requires 

research attention. 

Women have long been recognized as being more vulnerable to inflammatory diseases, 

including rheumatoid arthritis and inflammatory bowel disease. This gender disparity holds 

true for certain lung diseases, as well. The medical literature provides clear evidence that 

women have more severe airway diseases than men. Airway diseases are the most common 

form of chronic lung disease, including asthma, bronchogenic carcinoma, chronic bronchitis, chronic obstructive pulmonary disease (COPD), and bronchiectasis. It is well established 

in multiple epidemiologic studies that women have more severe asthma, are more commonly 

affected by bronchogenic carcinomas, and have a worse outcome from smoking. 

The disparity in women suffering from asthma is significant. Women with asthma have a lower 

asthma-specific quality of life and have more frequent and severe exacerbations than men. 

Postmenopausal women using estrogen replacement therapy have increased asthma symptoms and more frequent use of bronchodilators. Reasons for these differences and the impact 

of estrogen therapy represent important questions for healthcare research. 

Bronchogenic carcinoma, the most common form of lung cancer, has been progressively 

increasing in women over the past few decades. The proportion of lung cancer cases is higher 

in women than in men at any given level of smoking. Bronchogenic carcinoma tissue has an 

increased presence of estrogen and progesterone receptors relative to normal lungs, and studies have also reported that women are more sensitive to the carcinogenic effects of smoke. 

In addition, gender is now recognized as being a risk factor for COPD where approximately 70 

percent of early-onset COPD occurs in women. The burden on the healthcare system is significant for these patients and lifespans are shortened by this disease. 

Women have also been shown to be more susceptible to chronic airway infections with organisms such as nontuberculous mycobacterial and Pseudomonas aeruginosa, commonly present 

in bronchiectasis patients. Though these descriptions exist, little is known as to why this gender difference is present. 

In conclusion, dedicated research efforts need to be sought to determine if behavioral, environmental, hormonal, genetic, or immune-mediated reasons put women at this disadvantage 

in airway diseases. 

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CATINA O’LEARY, PH.D., M.S.W. 

Washington University School of Medicine 

Medically Underserved Women: A Population in Need 

Epidemiology and Prevention Research Group Description 

The Epidemiology and Prevention Research Group (EPRG) is a group of research investigators 

from the Department of Psychiatry at the Washington University School of Medicine. The team 

conducts randomized behavioral interventions among out-of-treatment, medically underserved women. Women are located through a street-outreach team, drug courts, shelters, and 

respondent-driven sampling methods. The team has been funded by the National Institute 

on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, and National Institute 

of Nursing Research to conduct a series of these studies since 1987. Over these many years, 

we have produced culturally relevant, gender-specific human immunodeficiency virus (HIV) 

prevention interventions that include peer-delivered interventions with HIV, Hepatitis C, chlamydia, gonorrhea, and syphilis pre- and posttest counseling; field-based well-woman exams; 

and case management strategies to reduce high-risk behavior and improve life outcomes. The 

team has also developed diagnostic tools to assess psychiatric disorders, substance abuse and 

dependence, sexual risk behaviors, life events, and exposure to violence, specifically among 

women. In the years we have been conducting this work, we have found that these women are 

highly traumatized and that they suffer from numerous comorbid conditions. The women are 

medically underserved, but are highly motivated to find appropriate care. They are also deeply 

interested in research and are compliant and cooperative. 

Community-based Findings 

Over the past 10 years, the EPRG has had the opportunity to intervene with approximately 

1,100 women through our NIH-funded HIV-prevention studies. Among those recruited from 

the community, women have been, on average, 38 years old, mostly African American (87 percent), married (63 percent), with at least one child (85 percent), and employed (57 percent). A 

third considered themselves homeless and more than two-thirds had a history of arrest. These 

women were undereducated, with an average of 11 years of education. In terms of health status, women reported major medical issues, including high blood pressure, anemia, weight 

problems, kidney problems, arthritis, and diabetes. Forty percent reported being diagnosed 

by a health provider with one or more health problems. Emergency department and health 

clinics were the most reported venues where care was received. Approximately one-third of 

the women met Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for 

depression. Childhood sexual victimization was common, with approximately one-quarter 

reporting that as a child they were forced to kiss or touch someone else, one-third reporting they were forced to allow someone else to kiss or touch them, and one-quarter reporting 

being forced to have sex with another person. Victimization and trauma frequently extended 

into adulthood with one-quarter reporting recent physical abuse and one-fifth reporting 

recent sexual abuse. Our data show that history of physical and sexual victimization in childhood, depression, and antisocial behavior predict adult victimization. 

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Among these groups of women targeted for their HIV risk, substance use was prevalent. More 

than 90 percent reported lifetime cocaine use, and of those, 81 percent met DSM-IV criteria for 

cocaine abuse or dependence. Alcohol use was also high, with 92 percent reporting use and 

65 percent meeting DSM-IV criteria for abuse or dependence. Rates of other drug use (or misuse) were reported, as follows: 71 percent marijuana, 23 percent opioids, 14 percent stimulants, 

13 percent PCP, 12 percent sedatives, 9 percent hallucinogens, 2 percent club drugs, and 2 percent inhalants. Approximately 18 percent reported a history of injection drug use. Almost half 

of the women reported participating in residential substance abuse treatment, one-quarter 

reported having participated in a methadone maintenance program, and 13 percent reported 

receiving substance abuse treatment through a jail or prison program. 

In terms of sexually transmitted illnesses, 4 percent tested positive for syphilis, 2 percent for 

gonorrhea, 5 percent for chlamydia, and 25 percent for hepatitis C. Myths about how to protect themselves against HIV and sexually transmitted diseases (STDs) were common: 40 

percent thought that washing their genitals before sex with soap would prevent HIV and STDs, 

40 percent said that “having sex with only healthy-looking people” would protect them from 

HIV and STDs, and 50 percent asked their partner if they were HIV-positive as a means of preventing infection. Sixty-four percent of the women said that they were victimized in the past 

12 months and half of them suffered from depression. 

Additionally, our team identified a general level of “chaos” present, which may serve as a barrier to behavior change. As such, we created a Chaos Scale, which categorized more than half 

the women in our study as having a high level of chaos as determined by the following: using 

drugs before age 15, having a baby before age 19, being physically or sexually abused before 

age 15, having one or both parents absent for 6 or more years before age 15, reported sexual 

promiscuity, or perpetrating violence against someone else. 

It is also important to note our team’s success in maintaining contact with these women over 

extended followup periods. Our team has been able to recruit, enroll, and randomize approximately a large number of community women for intervention. Followup rates have been high, 

with approximately 94 percent of substance-using women returning for their 4-month followup and 96 percent returning for their 12-month postintervention interview. In addition, we 

have evaluated the impact of chaos, depression, and other psychiatric comorbidities on study 

participation and have found that these factors do not impact the effort needed to recruit, 

enroll, and retain women in research, suggesting that community efforts to target hidden populations of women into research are feasible, and that women are responsive. 

We have also had the opportunity to work with female offenders recruited through area 

drug courts and reentry programs. The sociodemographic profile, substance use, and sexual risk behaviors of these female offenders was similar to that of the community-recruited 

women we’ve worked with. In comparison to community-recruited women, female offenders were more likely to report lifetime sex trading and rape as an adult. They were also more 

likely to meet DSM-IV criteria for cocaine dependence. Because sex-trading behaviors are 

inextricably linked with criminal justice involvement and drug use, for the past 5 years, our 

team has focused intervention efforts exclusively on female offenders. We’ve elicited specific 

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information about sex-trading partners and methods of protection from violence as well as 

pregnancy or sexually transmitted infection. We conducted focus groups with female offenders to understand more about their sex-trading behaviors and learned that while some women 

reported trading sex for drugs, most needed to trade sex for money to put toward necessities including food, clothes, and shelter for themselves and their children. In fact, many women 

indicated that they only traded sex for drugs when they were in really bad shape from not 

having any drugs, because they realized that they were “paid” less for their service when they 

exchanged sex for drugs compared to when they exchanged sex for money. Further, when 

sex was exchanged for drugs, women were unable to convert the drugs into money to meet 

their basic needs. 

Among female offenders enrolled from drug courts, we noticed a subset of women who were 

the most vulnerable—women who traded sex with police officers to avoid arrest. Approximately 25 percent of the women we interviewed reported trading sex with a police officer and 

many were coerced into this. In terms of protection, compared to those who did not report 

trading sex with a police officer, these women were less likely to use a condom to protect 

themselves for HIV and other sexually transmitted infection. 

Recently, our team had the opportunity to recontact women who had participated in prior 

interviews and “deconstruct” the process. It is rare that investigators have the opportunity to 

debrief women about study participation. In terms of how women felt about the intervention 

provided through our HIV-prevention research studies, women said testing, counseling, and 

intervention gave them a sense of belonging. They also said they learned skills to take care of 

their health. Free testing was also important. Women reported that study staff were persistent, 

patient, and treated them “like a human being,” which was cited as a reason that they continued to come back for followup interviews. Barriers to study participation were lifted with the 

transportation that was provided. Other women said the following: 

•	�“I felt proud that I completed something from start to finish for the first time in my life.” 

•	�“The educational component taught me things I didn’t know and it gave me someone 

to trust.” 

During this debriefing process, we also asked women to tell us three things they would do, if 

in charge of the world, to make life easier for other women. These data, straight from women 

in the community, provide the basis for our team’s recommendations, bulleted below. But first, 

we feel it necessary to note that often women were surprised at being asked this type of question—they indicated that no one had ever asked them what they thought could be helpful. 

They seemed pleased to be asked this question, which was the last question in the interview 

process; it seemed to provide a wonderful close to the session. However, the fact that women 

are not accustomed to being asked what changes would make their lives better seems like a 

significant oversight in terms of policy and service provision, especially in light of the thoughtful, detailed responses they most often provided. 

In terms of responses, the women we interviewed primarily focused on resources and were 

able to quickly volunteer resources that would be helpful to them and, as such, to other 

women. They frequently noted that they would provide help with education and job training 

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to help other women start to take care of themselves, as well as shelter, clothing, food, and 

health insurance so that women could get on their feet. Among this sample of women, physical, sexual, and emotional abuse were regularly reported, and in addition to emergency shelter 

for women and children, many women indicated that they felt it important to have counseling or someone to talk to about their abusive situations. Women suggested that it would be 

important to provide protection for other women from drug dealers and “johns” and they 

pleaded for someone to stop the physical, sexual, and emotional abuse of women. Finally, in a 

more global sense, women noted that they would want other women to be independent and 

mentioned the importance of women in positions of political power, and even as the “bosses” 

in companies where women are hired. 

Policy Recommendations 

Necessary strategies to improve the health of these most vulnerable women and to encourage 

the participation of women in research must address the following concerns: 

1. Federal grants should address basic needs of women and children and remove barriers 

to study participation, completion, and service access. Efforts should include the provision of a) transportation for women and their children to research and clinical sites, b) 

healthy snacks for women and children at research sites so that they can focus on the 

questions being asked, c) babysitting services for those women who cannot identify 

a safe place for their child while they participate in research or receive services. Large 

practices could make this available. 

2. Federal grants should include funds for persistent, professional efforts to sustain women in research or treatment protocols. Our data show that even the most vulnerable 

women are willing to enroll and fully participate throughout short- and long-term study 

protocols. However, persistent efforts to engage women, remind them of appointments, 

and reinforce the importance of the information they provide are critical. The same 

respectful efforts will help women continue to access and receive care for chronic and 

treatment-intensive conditions. 

3. Interventions can impact behavior. Specifically, we can reduce binge drinking, cocaine 

use, and high-risk sexual behaviors. Women do want to improve their lives. Care needs 

to be holistic and specifically target the interrelated barriers women face. The basic 

needs of women and their families should be considered. Remuneration should be 

increased to allow women to meet the needs of their families while they are participating in research. 

4. More community-based research efforts focused on female offenders, medically 

underserved women, out-of-treatment female drug abusers, heavy-drinking women, 

and college-age women are needed to ensure we meet their varied and complicated 

needs. Interventions should routinely be deconstructed and research funding should 

mandate this. 

Longitudinal studies of women’s health must include the most vulnerable women who have 

more barriers to participation in research and care. These barriers can be overcome. The health 

of all women is too important to our society as a whole. 

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LINDA PETERSON, M.D. 

Washington University School of Medicine 

The Building Interdisciplinary Research Careers in Women’s Health Legacy: 

A Scholar’s Perspective 

Before my research year of my cardiology fellowship, I had intended to follow in my dad’s 

footsteps and become a clinical cardiologist. But during my research year of fellowship, I realized I really enjoyed research. I enjoyed thinking about mechanisms of disease, seeing how my 

data turned out, and trying to push the bounds of what we know about heart disease, so as to 

better prevent and treat it. I was particularly drawn to translational research; I wanted to study 

humans using novel imaging techniques. But although I had enjoyed some success in obtaining grants (to study the effects of estrogen on the postmenopausal heart), when I joined the 

faculty, I had no additional protected time and no startup package to assure that I would have 

the time and the resources to do research. 

I knew it wasn’t feasible to pursue a very productive research career without support. I applied 

for the Building Interdisciplinary Research Careers in Women’s Health (BIRCWH). I remember saying to myself, “if I don’t get this, I’m not going to do research.” I got it. I was one of the 

first BIRCWH scholars at Washington University. The BIRCWH program allowed for me to have 

a significant amount of protected time and the resources to successfully begin my research 

career. One of the other major benefits of the BIRCWH program was that it had monies for 

inviting visiting professors in my field to be my guest, i.e., the professors had to spend time 

with me discussing my chosen field of research—obesity-related heart disease. This networking 

and interacting with other researchers in my field was invaluable to my career. These interactions have led to me being invited to lecture at other universities and international meetings, 

grade abstracts, and write reviews. These professors, leaders in my chosen field of study, knew 

me and my work because of the BIRCWH and the papers that it generated. Another major benefit of the BIRCWH is that it made me better known to other investigators at my own institution 

since it required a mentoring committee and presentations of my progress. 

Another important aspect of the BIRCWH award and other visionary programs from the Office 

of Research on Women’s Health (ORWH) of the NIH, was that it focused on women’s health, 

rather than lumping men’s and women’s health issues together. This was insightful. For example, in my BIRCWH study, it was important to study obesity’s effects only in women because in 

a followup study, we found that that women’s and men’s hearts do not respond to obesity in 

exactly the same way. Thus, if men and women were combined in my BIRCWH study of obesity, we would have had much less statistical power to detect obesity-related differences in the 

heart. Further research on sex-related differences in health and disease will help us understand 

disease processes better and should translate into an improved ability to individualize therapy 

and prognoses for our patients. 

In sum, because of the BIRCWH, I, and others whose careers have been fostered by the 

BIRCWH program, have been able to pursue research to help us understand not only specific 

diseases better, but also to understand the important influence of sex on health and disease. 

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I would like to take this opportunity to thank Scott Hultgren, Ph.D., for the opportunity to 

submit this testimony; Vivian W. Pinn, M.D., the director of the ORWH; the ORWH; and the 

NIH for making my research career possible. My recommendations for future research in 

women’s health issues are as follows: 

• Given the success and unique vision of the BIRCWH program and others from the ORWH, 

I very strongly recommend that these essential programs be continued and expanded. 

• Given that obesity in the United States is in epidemic proportions (approximately twothirds of adults are considered obese or overweight), the fact that it affects more women 

than men, and that we know there are sex-related differences in response to obesity, it is 

reasonable that obesity should continue to be a focus of research support by the ORWH 

and NIH. 

• Given that heart disease is the number one cause of death in women, and the fact that 

there are major sex-related differences in prevalence of different cardiac diseases, responses to cardiac drugs and interventions, and outcomes in various cardiac diseases, 

it is reasonable to assert that heart disease research deserves continued and expanded 

support from the ORWH and NIH. 

JOAN RILEY, PH.D. 

Washington University School of Medicine 

The Importance of Reproductive Immunology in Women’s Health Research 

I am currently a Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) 

scholar at Washington University in St. Louis in the Department of Obstetrics and Gynecology. 

First and foremost, I would like to thank the creators of the BIRCWH program, for I owe them 

an enormous debt of gratitude. My career took a turn after graduate school as I decided that 

I wanted to leave academics and explore the possibilities offered by industry. I spent a little 

more than 2 years in industry before realizing that, although many opportunities are afforded 

by the industrial setting, I truly missed academics and wanted to return. I needed to start over 

and complete a postdoctoral fellowship in academics. I was very fortunate in that I found an 

outstanding mentor, Dr. Kelle Moley, in the OB/GYN department at Washington University. Her 

support and advice have been fundamental in my career development. I now appreciate why 

the BIRCWH program places such an emphasis on mentorship. Simply stated, it is essential. 

In addition, Dr. Clay Semenkovich (Principal Investigator) and Dr. Thomas Baranski (Program 

Director) have done an excellent job running the BIRCWH program at Washington University. 

Their support and guidance have enabled me to take full advantage of all that the BIRCWH 

program has to offer. I hope that one day I can help shape the career of young scientists the 

way that Dr. Moley and the members of my BIRCWH advisory committee have shaped mine. 

After completing my postdoctoral fellowship with Dr. Moley, I was hired as junior faculty 

within the department. I began to try to obtain a transition award. Quickly, I realized that due 

to the time I spent in industry, I was no longer eligible for many awards because too much 

time had passed since I completed my Ph.D. The BIRCWH program was the only program I 

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found that did not disqualify me based on this criterion. Again, I was very fortunate to obtain 

the BIRCWH; it has made all the difference in my career. The BIRCWH has provided me with 

the key to open many doors. I will always be grateful to the BIRCWH program for providing 

me with the opportunity to have a career in women’s health research at an excellent academic institution. 

My research interests lie in the field of reproductive immunology. I received my Ph.D. in the 

Department of Immunology and Pathology at Washington University and I received training 

in the field of reproduction through my postdoctoral fellowship with Dr. Moley. I believe that 

Washington University provides an incredibly fertile environment for interdisciplinary research, 

the exact type of environment envisioned by the BIRCWH program. We are currently involved 

in several collaborative projects with investigators in the Department of Immunology and we 

hope that this interdisciplinary approach indeed provides a synergy that will expedite progress 

in the field of reproductive immunology. 

A growing body of data suggests that the maternal immune system plays a fundamental 

role in establishing a successful pregnancy. However, during pregnancy, interactions between 

maternal immune cells and fetal trophoblast cells of the placenta would seemingly lead to 

disaster, as the trophoblast cells are semi-allogeneic and should trigger rejection by the maternal immune response. A fundamental immunologic question of pregnancy as posed by Sir 

Peter Medawar centers on how immunologic disaster is averted. It is becoming clear that many 

different mechanisms act during gestation to render the maternal immune system tolerant of 

the fetus. Importantly and rather surprisingly, a specific immune population, namely uterine 

natural killer (uNK) cells, has been shown to promote placentation and thus the establishment 

of a successful pregnancy through the production of cytokines, chemokines, and angiogenic 

factors. In addition, immune cells are likely important in host defense against pathogens that 

may invade the uterus during gestation. However, these cells’ functions must be tightly regulated at the maternal–fetal interface. Dysregulated elements of maternal immunity have been 

associated with pregnancy complications such as preeclampsia, intrauterine growth restriction, and recurrent pregnancy loss. 

Pregnancy leads to alterations in both peripheral NK cell numbers and their functional activity. 

These observations suggest that NK cells are hormonally regulated. In vivo studies performed 

in mice have demonstrated that continuous exposure to estrogen suppresses NK cell activity, which also correlated with enhanced tumor growth or metastasis. The decrease in NK cell 

activity is thought to be due to decreased production of NK cells by the bone marrow as well 

as the suppression of NK cell cytotoxicity. Conversely, other data suggest that estrogen may 

indirectly stimulate NK cells through direct effects on T cells. These opposing results may be 

due to differences in the duration of hormone exposure or the concentration of estrogen used. 

Thus, the molecular pathways by which estrogen and progesterone mediate their effects on 

NK cells and other immune cell populations are multifactorial. Further studies are warranted 

to clearly define the mechanisms by which estrogen and progesterone mediate their immunomodulatory effects. 

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Steroid hormone regulation of immune cell function may have important ramifications with 

respect to several reproductive disorders. Since the birth of the first in vitro child in 1978, it is 

thought that more than 1 million babies have been born through assisted reproductive technologies (ART). During the course of in vitro fertilization, gonadotropins, which stimulate 

the production of estradiol and progesterone are administered to infertile women during the 

course of treatment. As previously mentioned, the duration of hormone exposure and/or the 

concentration of hormones administered are important with respect to the immune response 

elicited. Pregnancies conceived by in vitro fertilization are associated with an increased risk 

for preeclampsia and intrauterine growth restriction. Whether this is an effect of the treatment 

or is related to maternal factors or both remains to be determined. However, given this correlation, the effect of steroid hormones on immune cell function, and the importance of the 

maternal immune system in helping to establish a successful pregnancy, further studies examining the relationship between steroid hormones and the immune system are warranted. 

Similarly, there are a number of reproductive disorders in which steroid hormone levels are 

altered. These disorders may also benefit from this line of research. Obesity has become a serious public health issue. It not only has implications with respect to the health of a pregnancy, 

but also to an individual’s overall health. Obese women demonstrate elevated circulating levels 

of estrogen and are at increased risk of miscarriage, gestational diabetes, and preeclampsia. 

Moreover, obesity is associated with increased prevalence of inflammation. Again, increased 

knowledge of the role the immune system plays in pregnancy outcome may help design novel 

therapeutics that will improve the reproductive health of women. 

In summary, understanding the role that the immune system plays in successful implantation 

and pregnancy outcome and how immune cell function is regulated by estrogen and progesterone is necessary to develop strategies to improve reproductive health and fertility among 

women. In addition, gaining insight into the mechanism by which steroid hormones regulate 

the immune system will not only impact fertility, but will also help to understand gender 

differences in many immunologically mediated diseases such as diabetes or autoimmune diseases and thus, this is an area of research that has far-reaching implications with respect to 

women’s health. 

GINA SECURA, PH.D., M.P.H. 

Washington University School of Medicine 

Proven, Effective Solutions for Reducing STD Infection in Young Women: 

What We Still Need To Know 

Unmet Need 

According to the Centers for Disease Control and Prevention, St. Louis City has the highest rates of both chlamydia and gonorrhea infections in the Nation (1,330.3 and 821.2 per 

100,000 population, respectively). Our rates of these infections outpace the national average 

by roughly four- to sixfold, highlighting the dramatic burden of disease experienced in the City 

of St. Louis. 

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Currently, there are two clinics in the area that provide walk-in sexually transmitted disease 

(STD) testing services. The remaining area providers require scheduled appointments for integration into the provider system. 

Although the causes for these high infection rates are many, the factors relating to testing and 

treatment warrant special attention. Testing and treatment costs, for example, are handled differently depending on the site of care, ranging from free screening to fee schedules based on 

a sliding scale (sometimes requiring proof of income). Other barriers include lack of knowledge regarding availability of testing locations and services; the ease at which testing and 

treatment can be obtained, level of comfort with testing location; and coordination of testing, 

results notification, and treatment. 

Access to and use of effective methods for identification and treatment in the St. Louis area 

are somewhat fragmented and inadequately coordinated. The continued inability to effectively 

diagnose and treat these infections in young women will result in infertility among women of 

childbearing age. 

Necessary Research 

Although the disease burden and population at risk is well-documented in St. Louis, an evidence-based approach to sustained STD testing and treatment in young women and their 

sexual partners remains unclear. Ideally, a coordinated effort between both public and private 

health providers that builds on the strengths inherent within each provider type would result 

in an effective network that would reduce the burden of disease in St. Louis or any other area 

with significant disease burden among young women. Elements of a successful network may 

include, but are not limited to, the following: 

• Community engagement and prioritization regarding STD infection in young women 

• Effective communication to increase awareness regarding testing and treatment locations 

• Expansion of testing and treatment locations that target geographical areas with high 

rates of infection 

• Identification and sharing of best practices among participating testing and/or 

treatment locations
�

• Availability of walk-in testing and treatment options 

• Consideration of public and private business model constraints to maximize costeffective services 

• Collaboration among participating locations to maximize price reduction 

• Coordinated data collection and analysis to develop evidence-based practice protocols 

• Coordinated testing and treatment protocols to ensure— 

− Quality services 

− Stable infrastructure 

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− Standardization 

− Efficiency 

− Sustainability 

St. Louis is not the only area in the country that struggles with high rates of STD infection 

among young women without a practical approach to reducing disease burden. Given the 

limited funds available for implementing and sustaining public health programs, an evidencebased approach to reducing STD infection at the community level is warranted. Research to 

identify practical and effective methods that will result in the establishment of a collaborative, 

sustainable, and cost-effective STD testing and treatment network will significantly reduce 

STD disease in young women within a community. 

Innovation: The Potential of Behavioral Economics To Improve the 

Health of Women 

Almost without exception, healthy behaviors involve both costs (e.g., practicing safer sex) and 

benefits (e.g., avoidance of sexually transmitted infection). In addition, these costs and benefits are typically decoupled over time, with costs often incurred in the present and benefits 

accrued in the future. 

In opposition to most rational models of choice, humans tend to steeply discount future events 

relative to present events, and do so with surprisingly little regard to how far in the future 

those events occur. As a result, healthy behaviors are much easier to plan for (because in planning, both the benefits and costs are steeply but evenly discounted), but much more difficult 

to execute (because present costs loom large relative to future benefits). This effect, known to 

behavioral economists as hyperbolic discounting, helps explain why people earnestly plan to 

engage in healthy behaviors, but often fail in executing those plans. 

These psychological forces can be surprisingly powerful and contraceptive choices provide a 

useful template for understanding how these principles work. In practice, failure rates for contraceptive methods vary from less than 1 percent for long-acting reversible methods (such as 

intrauterine contraception and subdermal implants) to approximately 9 percent for refillable 

methods (such as oral contraceptives). Rationally, women seeking to prevent unintended pregnancy should select the more effective methods. Yet the national market share for long-acting 

reversible methods is about 2–3 percent. Annualized costs do not appear to be the decision 

criteria for women either, because the annual cost of the most effective methods is lower than 

refillable methods. 

Hyperbolic discounting, however, suggests that we carefully account for when the costs occur; 

annualized costs can be misleading when trying to explain behavior. The most effective methods incur all of their costs (financial and nonfinancial) upfront, and thus these costs loom large 

both in comparison to the benefits (future pregnancy prevented) and in comparison to refillable methods (in which costs are spread into the future). 

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We have undertaken a large study of contraceptive choice when 1) all financial costs are eliminated, and 2) women are provided balanced, nondirective counseling on all contraceptive 

options. Our results, although preliminary, support the principle of hyperbolic discounting. 

Removing the upfront costs (for all methods) has resulted in a striking proportion of women 

choosing long-acting reversible methods—approximately 65 percent. 

As noted above, nearly all healthy behaviors involve incurring upfront costs for downstream 

gains. The upfront cost can be substantial or minimal, financial or nonfinancial; the tradeoff 

is the same. We believe this is also the case for both testing for and preventing STD infection. Within our contraceptive research project, we offer chlamydia and gonorrhea testing 

at no cost to the participant and provide treatment to the participant and her partner(s) at 

no cost. Preliminary research findings suggest that women will test for STDs and return with 

their partners for treatment when access and cost are not an obstacle. In addition to identifying practical strategies for increasing STD testing and treatment, we strongly encourage the 

exploration, evaluation, and implementation of the relevant findings emerging from behavioral 

economics into health care for women. 

CLAY SEMENKOVICH, M.D. 

Washington University School of Medicine 

Building Interdisciplinary Research Careers in Women’s Health at Washington University 

Introduction 

The Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) Program at 

Washington University School of Medicine supports the career development of junior faculty members who show exceptional promise for an independent research career that will 

benefit the health of women. These junior faculty members, known as Interdisciplinary Women’s Health Research (IWHR) Scholars, are nurtured as they make the critical transition from 

junior faculty member to independent investigator. The program targets individuals who have 

recently completed clinical training or postdoctoral fellowships, bridging the gap between this 

advanced training and research independence. It also crosses different scientific disciplines 

and areas of interest in women’s health through a mentor pool of independent scientists representing various departments. 

The goal of the Program at the Washington University (WU) School of Medicine is to produce 

independent investigators conducting interdisciplinary research in women’s health. To achieve 

this goal, our program has identified outstanding young scientists committed to women’s 

health who have completed fellowship training, matched them with mentors working in an 

environment that promotes interdisciplinary research, and provided them with career development experiences leading to their independence. 

Initiated in August of 2000, the Washington University BIRCWH Program has supported 

the careers of 15 Scholars. The Program provides a combination of a mentored research 

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experience (utilizing additional mentoring from a Scholar Career Development Committee, 

analogous to a thesis committee), didactic training, interaction with other Scholars and prominent visiting scientists, and the establishment of formal interdisciplinary research links with 

clinical programs related to women’s health. In addition, the Program provides salary support 

for the Scholars, which enables Scholars to devote a majority of their efforts to developing 

their own independent research program. This support comes at a pivotal time in the development of the Scholar and is essential for fostering their careers as biomedical researchers in the 

area of women’s health. 

Need for Research in Women’s Health 

Through the support of the Office of Research on Women’s Health, our Program has helped 

to address an unmet need in the area of biomedical research in women’s health. For years, 

studies of women’s health and gender issues were neglected either because of the flawed 

assumption that biological responses in women would be the same as in men or because of 

the concern that pregnancy might complicate recruitment and interventions. As described in 

Agenda for Research on Women’s Health for the 21st Century, Vol. 7. New Frontiers in Women’s Health,1

 major depression, osteoporosis, autoimmune diseases such as lupus, urinary 

tract infections, and type 2 diabetes, to name a few, are all more common in women than 

men. Heart attacks and certain cancers are more deadly in women than men. The outcomes 

of attempting to become pregnant are not always perfect and include birth defects, preterm labor, and infertility. Women respond to therapeutic drugs in ways different from men. 

Our BIRCWH program establishes a broad research base addressing each of these issues. 

As described in Exploring the Biological Contributions of Human Health—Does Sex Matter?,2 

gender differences and their effects on disease could be better understood by addressing 

problems with the expertise of multiple disciplines, an approach seldom pursued, perhaps 

due to historical impediments to communication and cooperation. This report called for more 

synergy among scientists with different talents, enhanced collaboration between medical specialties, and better bench-to-bedside research and integration of data. The organization of our 

program and the substantial new resources committed by our institution are aimed specifically 

at these systematic barriers to research progress. 

The Washington University BIRCWH program shares the view of Dr. Vivian Pinn (Director of 

the Office of Research on Women’s Health at the National Institutes of Health [NIH]) that “The 

women’s health movement...can and will bring benefits to all members of our society.” It is our 

goal to continue the successful training of outstanding interdisciplinary researchers in women’s health. 

The Biomedical Research Environment at Washington University 

Washington University School of Medicine is one of the world’s leading medical research institutions. In fiscal year 2008, the school received $367 million in grants from the National Institutes 

of Health, making it the fifth-largest recipient of NIH dollars among U.S. medical schools. The 

School of Medicine possesses a rich tradition of interdisciplinary collaboration, fostering an exciting environment in which basic science and clinical medicine are very closely connected. 

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The School’s faculty is extremely accomplished; 17 Nobel Laureates have been associated with 

the School. World-class facilities support faculty research, including core facilities for DNA 

sequencing and genetic analysis, biostatistics, clinical research, transgenic support, higher 

brain function studies, cell and tissue culture, morphology, protein and lipid analysis, molecular design, information management, monoclonal antibody production, mass spectrometry, 

nuclear magnetic resonance spectroscopy, oligonucleotide synthesis, and X-ray crystallography. A state-of-the-art imaging research center provides positron emission tomography, 3-D 

image processing, magnetic resonance imaging, computer graphics, spiral-computed tomography, and radiopharmaceutical production. 

Clinical fellows in every subspecialty of medicine are trained at Barnes-Jewish Hospital and St. 

Louis Children’s Hospital, the teaching hospitals for the Washington University School of Medicine. Both are part of the BJC Health System, one of the largest integrated healthcare delivery 

systems in the United States. BJC was the first health system in the country to combine urban, 

suburban, and rural healthcare facilities with an academic medical center, Washington University Medical Center. Barnes-Jewish Hospital has an outstanding reputation in patient care, 

medical education, research, and community service. Clinical fellowship training at Washington 

University emphasizes a strong research component, ensuring the availability of clinical scientists with the potential for research careers in women’s health. 

Training in the basic sciences at Washington University School of Medicine is organized and 

supported by the 11 graduate programs of the Division of Biology and Biomedical Sciences, a 

graduate educational consortium that includes faculty affiliated with 20 basic science departments in the School of Medicine and College of Arts and Sciences. More than 600 students 

are pursuing Ph.D. degrees and more than 400 individuals are pursuing postdoctoral research 

through the Division. The Division also operates, with the School of Medicine, the largest Medical Scientist Training Program (MSTP) in the country, with 178 trainees pursuing the combined 

M.D.-Ph.D. degree. The Division of Biology and Biomedical Sciences represents a local model 

of interdisciplinary research. Most of the BIRCWH mentors are members of the Division. 

Program Organization 

Career development of scholars is achieved by the following: 

• Providing formal didactic training for appropriate IWHR Scholars 

• Providing protected time (75 percent or greater) for a focused, mentored research 

experience for all scholars 

• Providing formal training in the responsible conduct of research for all scholars 

• Establishing a seminar series for BIRCWH mentors and scholars consisting of journal 

clubs devoted to issues specifically relevant to women’s health, and research presentations in which both mentors and scholars discuss the results of ongoing projects 

• Providing a formal research link to existing and future clinical programs related to women’s health at Washington University 

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• Tailoring a career development plan for scholars to the needs of the prospective 

candidates. In general, the program contributes to the career development of two 

types of scholars: 

− Individuals with considerable prior research experience (such as M.D.-Ph.D.s and 

Ph.D.s) and a particular interest in research that will benefit women’s health 

− M.D.s who have completed a subspecialty fellowship involving research training and 

wish to pursue research that will benefit women’s health 

For both types, these are individuals who have not served as the Principal Investigator or 

equivalent on an NIH R01, K01, K08, P01, or P50 grant. 

The Mentoring Experience 

An essential component of the success of training our future biomedical researchers is the 

availability of mentors to guide Scholars in the early phases of their career. A strength of the 

Washington University BIRCWH program is its pool of mentors. These accomplished scientists 

are interactive, committed to developing the careers of those interested in a research career in 

women’s health, and are known for conducting interdisciplinary research that, in many cases, 

has already made important contributions to improving the health of women. Scholars obtain 

a focused research experience by spending at least 2 years with an individual mentor, but the 

interactive nature of the program and the considerable collaborations within this mentor pool 

ensures that scholars have extensive exposure to many different disciplines in the course of 

addressing biological problems related to gender and women’s heath. 

The mentor pool has evolved over the past several years to reflect our commitment to provide the best training possible to those selected for the program. Scholars can now select from 

mentors representing 10 focus areas: autoimmune disease, cancer, cardiovascular disease, 

complications of pregnancy, depression, diabetes/obesity/metabolism, epidemiology/health 

services research, genetics/pharmacogenomics, infectious diseases, and osteoporosis. 

Success of Scholars 

The Washington University BIRCWH program has had a significant impact. The most tangible 

evidence of this impact is our success in preparing Scholars for careers as independent investigators specifically performing interdisciplinary research that will benefit the health of women. 

Some of our former Scholars have achieved international recognition for their work based on 

invitations to speak at forums, service on editorial boards, and the provision of scientific input 

to other major research centers. One, Bettina Mittendorfer, has clearly become a major figure in her field. Bettina has an impressive record of publications and grant support. She has 

developed novel techniques for assessing lipid metabolism in humans using stable isotopes 

and used these techniques to provide unexpected insights into the effects of gender on fuel 

metabolism. Her findings have the potential to uncover completely new approaches to obesity. She received RO1 support for her research, is a frequent speaker at scientific conferences 

throughout the world, and has won the Peter J. Reeds Nutrition Research Award from the 

American Society for Nutritional Sciences. 

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Linda Peterson is another former Scholar who has made important contributions to women’s health. Using sophisticated imaging techniques such as positron emission tomography 

in humans, Linda has identified specific physiologic signatures in young obese women that 

appear to be powerful predictors of abnormal myocardial function. Her work was featured 

by the NIH at previous BIRCWH symposia in Bethesda. She has been elected to the editorial 

boards of the journals, Clinical Therapeutics and the Journal of Women’s Health. 

Fanxin Long is an excellent example of how the program has directed the research career of 

an outstanding young scientist toward research relevant to women’s health. An elite molecular biologist, Fanxin could have joined the faculty in an environment focused exclusively on 

basic signaling mechanisms. Instead, Dr. Long was recruited from Harvard to Washington University as an Assistant Professor in the Bone and Mineral Division (a recruitment enhanced 

by the possibility of funding through the BIRCWH program), where his talents in intracellular signaling could be applied to an area directly relevant to women’s health, osteoporosis. He 

has published important papers in top tier journals such as Cell and Nature Medicine, linking 

key signaling molecules to the formation of bone. He is now a major figure in bone metabolism, has obtained RO1 support for his research program, and is well on his way to generating 

a body of work with great potential to improve women’s health. 

Another former scholar is Consuelo Wilkins, now an accomplished clinical investigator, who 

has established herself as a research authority in the area of health problems in aging women. 

She has been honored by the National Medical Association as one of the best physicians in 

the country. 

Current Scholars 

We currently have three outstanding Scholars. The first Scholar, Jeffrey Henderson, M.D., Ph.D., 

represents an example of the potential for the Washington University BIRCWH to interact and 

complement the Center for Women’s Infectious Disease Research (cWIDR). Jeff did his postdoctoral training in the lab of Scott Hultgren, where he developed a novel project that utilizes 

the tools of mass spectroscopy for phenotyping and discovery analyses to study the impact 

of siderophore-mediated iron acquisition by E. coli on urinary tract infection in young women. 

A second Scholar, Joan Riley, Ph.D., trained in the lab of Dr. Kelle Moley in the Department of 

Obstetrics and Gynecology here at Washington University. She has initiated studies to examine the role of the immune system and the effect of hyperglycemia in placental development. 

Our third Scholar, Christina Gurnett, M.D., Ph.D., did her fellowship research in the lab of Dr. 

Anne Bowcock, an expert in human genetic disorders. Christina has developed a project for 

gene discovery in adolescent idiopathic scoliosis. We are excited about the potential of each of 

these Scholars and will continue to assist them in their development as biomedical researchers 

focused on diseases directly affecting women’s health. 

Institutional Commitment to Women’s Health and the Role of the 

BIRCWH Program 

Major initiatives in the next decade at Washington University will be focused on disease-based 

multidisciplinary research areas in women and children’s health, cancer, infectious diseases, 

cardiovascular and metabolic disorders, and neurosciences. The centerpiece moving forward is 

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BioMed 21, which is designed to expedite the translation of basic science discovery and human 

genetic data into the clinic. BioMed 21 includes a new 240,000 square foot building to house 

five interdisciplinary research centers. The Center for Women’s Infectious Disease Research 

(cWIDR) represents one component of BioMed 21 and demonstrates the institution’s commitment to women’s health. The mission of the cWIDR is to prevent and cure women’s infectious 

diseases by fostering collaborations between basic and clinical researchers in multiple disciplines around shared interests and causes. The BIRCWH program has worked closely with the 

cWIDR program and the Director, Dr. Scott Hultgren, who is on the BIRCWH Advisory Board. 

Dr. Hultgren and his colleagues have made seminal contributions to the field of recurrent urinary tract infections and role of bacterial biofilms. The BIRCWH program will continue to 

coordinate efforts with the cWIDR to train biomedical researchers in interdisciplinary studies 

on important topics in women’s health. 

The BIRCWH program has been successful by providing a focal point for research in women’s health at Washington University. The administrative office and Program Director serve as 

a resource for promoting women’s health and encouraging young investigators interested in 

women’s health through the coordination of visiting speakers, providing information about 

potential mentors, conducting regular seminars featuring the research of the mentors and 

scholars in the program, and by providing an informational portal to the broad availability of 

women’s health resources at Washington University. We look forward to continuing this effort 

and furthering our mission to train the next generation of biomedical researchers focused on 

issues in women’s health. 

References 

1. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health. (1999). Agenda for research on women’s health for the 21st Century, 

Volume 7: New frontiers in women’s health (NIH Publication No. 01-4391). Retrieved 

from http://orwh.od.nih.gov/research/agenda_book_7.pdf 

2. Committee on Understanding the Biology of Sex and Gender Differences. (2001). The 

future of research on biological sex differences: Challenges and opportunities. In T. M. 

Wizemann and M. L. Pardue (Eds.), Exploring the biological contributions to human 

health: Does sex matter? (pp. 182–183). Washington, DC: National Academy Press. 

WILLIAM J. LEDGER, M.D. 

Weill Medical College of Cornell University 

New Dimensions and Strategies for Women’s Health Research 

Currently employed techniques to implement studies of women’s health are flawed. Investigations to determine the factors causing pelvic infection in nonpregnant women and to find the 

source of premature labor and delivery have followed a similar pattern. Epidemiologic studies comparing women with bacterial vaginosis (BV) and those free of this problem have related 

BV to pelvic inflammatory disease (PID) and premature labor. Subsequent trials to prove 

these associations are cause-and-effect-related have fallen short. A prospective clinical study 

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comparing those women with BV at the onset of the study, and those free of BV, showed no 

increase in the subsequent incidence of PID in the BV group. Similarly, a large study of asymptomatic pregnant women with BV showed no decrease in the prematurity rate in those women 

given oral metronidazole, an antibiotic known to be effective against BV. In each study, the 

association with BV was proven not to be causation. Using the Gram stain technique of Nugent 

to make the diagnosis of BV lumps together a diverse clinical population. This population 

includes symptomatic women, asymptomatic women, those who clear BV spontaneously, and 

those who have frequent recurrences despite appropriate antibiotic treatment. Another mark 

of the diversity of the BV population is that the Amsel diagnostic criteria, three of four observations of a homogenous vaginal discharge, an alkaline pH, a positive whiff test, and 20 percent 

or more of the vaginal squamous cells being “clue” cells yields a much smaller BV population 

than the one confirmed by the Gram stain technique. Lumping together a diverse population of 

women eases the job of the assembly of a large population of women for prospective trials, but 

diminishes the chances of determining the exact--risk population that should be studied. 

The current population of women now categorized as having BV needs to be teased out into 

a number of diverse separate groups, who can then be subjected to prospective trials. One 

measure to accomplish this would be to use nonculture techniques to identify the subgroups 

in this diverse population, now lumped under the category of BV. Nonculture data are available from normal Caucasian, African-American, and Japanese women, which would serve as a 

documented standard for comparison. In addition, there are a number of gene polymorphisms 

associated with either a propensity for tissue inflammation or infection, potential factors for 

both a risk of PID and premature labor and delivery in pregnancy. The subsequent subgroups 

would be ideal study populations in whom to determine causation and treatment. 

JANE MURRAY 

Women in Balance 

Urgent Need for High-Quality Research on Bioidentical Hormones 

“Bioidentical” is a term used to describe those specific hormones that are identical in their 

molecular structure to ones made in the human body. According to this definition, “bioidentical” hormones include many that are manufactured by pharmaceutical companies as well 

as individualized formulations made by compounding pharmacists, both types prescribed 

by authorized medical practitioners. Some bioidentical hormone products such as dehydroepiandrosterone (DHEA) and low-dose progesterone are also available without prescription 

over-the-counter. 

The NIH held a consensus conference on menopause in 2005 about managing menopauserelated symptoms,1

 but gave only brief attention to any discussion of bioidentical hormone 

options, and prepared comments by one presenter included erroneous notions of the definition of “bioidentical” as being only compounded preparations with doses determined by saliva 

testing. David Sturdee, President of the International Menopause Society, wrote a textbook on 

hormone therapy in menopause, and devoted an entire chapter to a discussion of bioidentical 

hormone options.2 

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So widespread is the confusion regarding hormone nomenclature that the North American 

Menopause Society (NAMS), in its 2007 position statement on hormone use in peri- and postmenopausal women, discusses bioidentical hormones only in the context of compounded 

preparations and does not mention the use of bioidentical hormones manufactured by the 

pharmaceutical industry.3

 This confusion may partly stem from a 2004 review of bioidentical hormones by Boothby et al., which narrowly defines bioidentical hormones as “hormone 

treatment with individually compounded recipes of certain steroids in various dosage forms, 

including DHEA, pregnenolone, testosterone, progesterone, estrone, estradiol, and estriol.”4 

Bioidentical hormones are simply those steroids with a chemical structure identical to the ones 

found in humans, and not necessarily individually compounded medications. 

The medical literature and subsequent lay media reports are very often unclear in differentiating between conjugated equine estrogens, estradiol, and other estrogens, and simply 

discuss the risks and benefits of “estrogen” without clarifying which estrogen was studied 

or in what delivery format. Similarly, the term “progesterone” is widely used when discussing the effects of all hormones in the progestogen category, without being clear as to whether 

medroxyprogesterone acetate, norethindrone, other synthetic analogs of the progesterone 

molecule or actual progesterone is being reviewed. While some general class effects of steroid 

hormones do exist, this paper hopes to clarify that there can also be some distinct differences 

in biological effects that vary with the chemical structure of the molecule being used for hormone therapy. 

Patients are similarly bewildered about whether to take hormone therapy (HT) at all, and if so, 

what their options may be. Breslau et al. reported on a survey of women’s knowledge of and 

attitudes about HT and reported that more than 60 percent of women aged 40 to 54 and 54.4 

percent of those aged 55 to 64 were “worried about the effects of HT” and “felt uninformed 

about the Women’s Health Initiative (WHI) findings.”5

 Schonberg et al.’s 2005 publication of 

the results of an attitudinal survey about medical care and HT reported that 26 percent of 

women reported “losing trust in medical recommendations generally” and 34 percent were 

less willing to take drugs to prevent heart disease.6

 Another survey documented responses 

with emotional overtones such as worry, confusion, anger, and grief as common reactions 

by women following the WHI report.7

 A small qualitative study of hormone therapy preferences and experiences of symptomatic perimenopausal and postmenopausal women revealed 

that subjects preferred “bioidentical hormones” over conventional hormone therapy. Subjects 

characterized physician attitudes as antagonistic in response to their requests for bioidentical hormone therapy, whereas nurse practitioners and pharmacists were perceived to be more 

knowledgeable, informed, and compassionate regarding hormone-related symptoms and hormone therapy options, including bioidentical hormones.8 

An increase in interest about and use of “bioidentical” hormone therapy has emerged in recent 

years as women seek options other than the hormones (conjugated equine estrogens and 

medroxyprogesterone acetate) used in the WHI study, and read books written by both medical 

and nonmedical authors about hormone options. National and international organizations such 

as the North American Menopause Society in 2007, the Endocrine Society in 2006, and the 

International Menopause Society in 2007 have seen a need to specifically mention and discuss 

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bioidentical hormones in their position papers about menopause and HT.3,9,10 In addition, NAMS 

sponsored a special conference in October 2005 on bioidentical hormones that was so popular, 

there was standing room only during the day-long session, suggesting high healthcare provider 

interest. What remains troubling to some about the policy statements of these groups is their 

misunderstanding of “bioidentical hormones,” implying that only compounded preparations are 

“bioidentical” and excluding discussion of all the commercially available isomolecular hormone 

preparations.3 At least two commercial pharmaceutical manufacturers of hormone products 

for relief of menopausal symptoms and other women’s health concerns refer to their FDAapproved products as “bioidentical”: Solvay’s Prometrium® and BioSante’s Elestrin®.11,12,13 

Clarity in terminology and reference to specific molecular structures are becoming more 

important if clinicians and researchers are to make any consistent sense of the research 

about women’s hormones and translate that research into clinical utility. Assumptions that all 

hormones within a class act in the same manner and carry the same risks are sometimes incorrect, and not borne out in published science about certain specific hormone molecules. 

Compelling Questions Requiring Further Research 

Numerous questions remain unanswered about bioidentical hormones, and therefore ongoing 

research is very much needed. Some important continuing concerns of women and their practitioners include the following: 

1. What are the optimal hormonal components useful for abating significant menopausal 

symptoms if present and interfering with daily function? Head-to-head trials are 

needed, such as direct comparisons of the following: 

a.	� Estradiol versus conjugated equine estrogens (CEE) 

b. Compounded estriol/estradiol mixtures commonly in use versus CEE and versus 

estradiol alone 

c.	� Other non-bioidentical estrogens in use or in development versus bioidentical 

estrogen(s) 

d. Progesterone versus various specific progestins (as very little data exist directly 

comparing progesterone to any progestins other than medroxyprogesterone 

acetate) 

2. What is the optimal dosage range of various estrogens and progestogens? This “optimal” range is based on what information—symptom relief, side effects, monitoring 

of levels? 

3. Is hormone monitoring necessary? If so, what should be measured: saliva, urine, serum, 

whole blood, red cells? Does the assay methodology vary depending upon the specific 

hormone and/or delivery system? And what target levels are appropriate—luteal, follicular, or some other level? 

4. What is the safest and most effective delivery system—oral, transdermal, vaginal, transmucosal? Does this vary by which hormone is being delivered? 

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5. What are the long-term risks and benefits of various hormone regimens? 

6. How much progesterone in what delivery format is needed to protect the uterus from 

the proliferative effects of various estrogen types, doses, and delivery formats? 

7. Is cycling progesterone necessary or preferable? If so, what doses are appropriate and 

at what interval? 

8. How long should a woman use HT? 

9. Is use of progesterone alone safe? 

10. What do women know and want to know about HT options? A national survey of 

women’s use of HT of various forms, knowledge about options, sources of information, 

concerns, and questions about HT is long overdue. 

It is clear that despite a great deal of research in the field of women’s hormone therapy for 

menopause, many important questions remain unanswered. Women want and need options 

that are effective and safe, and physicians and other women’s health providers need guidelines that are based on accurate information. A wealth of research already exists about the 

efficacy and safety of some bioidentical hormone preparations. The evidence for safety, especially for progesterone over some progestins, is mounting every year. 

Precision in terminology is also critically important as clinicians review the literature and discuss hormone options with patients. National organizations, opinion leaders, and the media 

must be particularly accurate in their use of nomenclature when discussing “hormone therapy” 

or the effects of a specific hormone molecule. 

We need a clear research agenda for women’s health and hormones. The definitive study about 

hormone therapy in menopausal women has not been accomplished with the WHI—only more 

questions have arisen as a result. Now is the time to actively promote further studies through 

the National Institutes of Health and private foundations. In the meantime, clinicians must practice the best medicine possible, given the current state of the science on bioidentical hormones, 

and growing evidence that all hormones and delivery systems are not created equal. 

References 

1. National Institutes of Health. (2005). National Institutes of Health State-of-the-Science 

Conference statement: Management of menopause-related symptoms. Annals of Internal Medicine, 142(12, Pt 1), 1003–1013. 

2. Sturdee, D. W. (2004). The facts of hormone therapy for menopausal women. New York: 

The Parthenon Publishing Group. Retrieved from http://www.imsociety.org/downloads/ 

facts_of_ht_book.pdf 

3. North American Menopause Society. (2007). Estrogen and progestin use in peri- and 

postmenopausal women: March 2007 position statement of the North American Menopause Society. Menopause, 14(2), 1–17. 

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4. Boothby, L. A., Doering, P. L., & Kipersztok, S. (2004). Bioidentical hormone therapy: A 

review. Menopause, 11(3), 356–367. 

5. Breslau, E. S., Davis, W. W., Doner, L., Eisner, E. J., Goodman, N. R., Meissner, H. I., et al. 

(2003). The hormone therapy dilemma: Women respond. Journal of the American Medical Women’s Association, 58(1), 32–43. 

6. Schonberg, M. A., Davis, R. B., & Wee, C. C. (2005). After the Women’s Health Initiative: 

Decision making and trust of women taking hormone therapy. Women’s Health Issues, 

15(4), 187–195. 

7. French, L. M., Smith, M. A., Holtrop, J. S., & Holmes-Rovner, M. (2006). Hormone therapy 

after the Women’s Health Initiative: A qualitative study. BMC Family Practice, 7, 61. 

8. Holt-Waldo, N., & Stephenson, K. (2007). The lived experience of perimenopausal and 

menopausal women undergoing treatment with bioidentical human hormones. International Journal of Pharmaceutical Compounding, 11(4), 292–296. 

9. The Endocrine Society. (2006, October). Bioidentical hormones: Position statement. 

Retrieved from the North American Menopause Society Web site: http://www.endosociety.org./custom_apps/search.cfm?q=bioidentical+hormones 

10. Pines, A., Sturdee, D. W., Birkhäuser, M. H., Schneider, H. P., Gambacciani, M., & Panay, 

N.; Board of the International Menopause Society. (2007). IMS updated recommendations on postmenopausal hormone therapy. Climacteric, 10, 181–194. 

11. Solvay Pharmaceuticals, Inc. (2008, May 21). Take comfort in your protection with Prometrium®. Retrieved from Solvay Pharmaceuticals, Inc., Web site: http://www.prometrium.com 

12. Azur Pharma, Inc. (2007). Elestrin®: Estradiol gel. Retrieved from Azur Pharma, Inc. Web 

site: http://www.elestrin.com 

13. Cicinelli, E. (2008). Intravaginal oestrogen and progestin administration: Advantages 

and disadvantages. Best Practice & Research: Clinical Obstetrics & Gynaecology, 22(2), 

391–405. 

MISSY LAVENDER 

Women’s Health Foundation 

Women’s Pelvic Wellness—Shifting the Paradigm in Women’s Health 

In America, if we consider the critical health issues of women young and old; women of childbearing or post-reproductive ages; active, healthy women; and women at risk of severe health 

conditions such as diabetes or heart disease, pelvic health does not necessarily come first to 

mind. Yet issues of pelvic health and wellness will affect the majority of women at some point 

in their lives and while they may not lead to death, they may lead to inertia or inactivity or 

worse—depression, obesity, anxiety, hypertension, or diabetes. 

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Take Tina (name changed) for example. As a young girl, she was a competitive gymnast, practicing high-impact moves such as floor routines and dismounts from the beam for hours on 

end. She experienced a little leaking of urine upon dismounting from the beam, especially after 

long practice sessions or in competition, but chose not to focus on it, hoping her sweat would 

hide the accident. When Tina later married and had a baby, she found she was constantly wearing a pad to avoid leaking, especially when she laughed, coughed, or picked up her new son. 

Tina finally went to her see her obstetrician after her last baby was a year old and the leaking 

had gotten so bad she was afraid to do any of the fitness activities she had loved as a young 

woman. Her condition, stress urinary incontinence (SUI), or accidentally leaking urine, affects 

one in three new mothers and approximately 30 million women in the United States. Most 

often caused by pregnancy and vaginal deliveries, it has been shown in research that high-performance college athletes like Tina—especially those engaged in high-impact sports—have 

a higher risk of SUI than do their nonathletic peers. With her history of leaking during physical activity as a young girl, might it have been prudent for Tina to have had a regimen of pelvic 

floor exercises before, during, and after pregnancy? Should her pregnancy and delivery have 

been managed with this predisposition in mind and, if so, what might have been different? 

Pelvic health and wellness does not just involve urinary problems like incontinence (stress 

or urge). The reason it is such a compelling topic is because it includes numerous conditions 

that all have the common thread of being pelvic centered. Sexual dysfunction (1 in 4 women), 

fibroids (80 percent of African-American women), uterine prolapse (1 in 2 mothers), pelvic floor dysfunction (somewhere north of 50 million), constipation (4 million people, most 

of them women), and pelvic pain (estimated at 20 million women) are just a few. When we 

look at the statistics of women affected by all the above, it is hard to imagine that all of us 

don’t have something going on “down there.” Yet, when you look at the total dollars spent on 

research for pelvic health, it is difficult to even tabulate the total. In 2007, the NIH’s reported 

outlays for research detail that $526 million was spent on urinary disorders, and an additional 

$3.5 billion on women’s health. It is unclear how much might have gone directly into research 

about women’s pelvic health and wellness. 

Stepping back slightly from just dollars and cents, when we project forward the numbers of 

women suffering from some issue around their pelvic health, we have to ask why then aren’t 

women clamoring for solutions? Why isn’t there a prescribed algorithm of care for a new 

mother that includes pelvic floor rehab? Why don’t all pelvic surgery patients get sent to a 

pelvic floor physical therapy (PT) to learn both the strengthening exercises they may need, 

and to also unlearn any bad habits they may have that might lead them to cause their surgery 

to fail in the future? For that matter, why don’t more women know what pelvic floor PT is, or 

about urogynecology as a medical subspecialty to turn to when symptoms start to occur? 

Our position is that we first have to understand and address our American, Puritanical attitudes 

about anything that goes on in or around a women’s pelvis. For most women, the only word 

they might identify if you are discussing pelvic health topics is a “pelvic,” which they know 

as that embarrassing or painful exam they get (hopefully) once a year by their gynecologist. 

Women in the United States are unaware that all these conditions are “common, but not normal.” When they experience symptoms of pelvic floor dysfunction or other conditions, they feel 

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like they are the only one with this or that problem and often fail to seek care from their healthcare provider, fearing the surgery or drug prescription that they think is imminent. Concerning 

as well, is a statistic from the National Institute for Continence that says it takes a women four 

times bringing up symptoms of incontinence with their healthcare providers before they get 

treatment—whatever “treatment” means. These facts lead us to believe strongly that we need 

to both fund more and better research into all the pelvic health conditions, but also fund campaigns of public awareness that speak to our need as women to understand our bodies from 

the inside out, so we can be prepared if something starts to go sideways. 

We advocate for women standing up and learning and moving toward a healthier pelvis. We 

know that if women are “fit, sexy, and in control,” they will have a higher self-image and be 

more physically active. We know that women (and girls) of all ages can be taught basic facts 

about their pelvic health and wellness that can change their lives. And we know that physical 

activity needs to start to happen “down there,” as well. Women well into their later years can 

learn to recruit their pelvic floors properly, thereby even potentially slowing down the inevitable decline in continence or prolapse. At the Women’s Health Foundation, we ask, “What 

would it be like for women in their 30s and 40s to be engaged in their pelvic health and wellness all during their younger years? Would they be able to refute some of what we now think 

of as “a normal part of aging”? Could they indeed be dry, free of pain, and able to manifest 

optimal sexual health? We believe all this and more are possible when you engage women in 

conversation about this central place in their bodies—their pelvic core. 

MAURA RIORDAN 

Women Organized To Respond to Life-Threatening Diseases 

Women and HIV/AIDS: Filling the Research Gaps 

Organizational Background 

Women Organized To Respond to Life-Threatening Disease (WORLD) was founded in 1991 by 

and for women living with human immunodeficiency virus (HIV)/acquired immunodeficiency 

syndrome (AIDS). A small group of women came together to create peer support when they 

could not find services specific to the needs of HIV-positive women. They wrote a newsletter 

with an inspiring cover story featuring a woman living with HIV that went out to 200 readers. 

Today, that same newsletter goes to 12,000 readers in 87 nations. WORLD provides support, 

advocacy, and education to women living with HIV/AIDS locally in the San Francisco Bay Area, 

and nationally through a variety of projects. 

WORLD’s HIV University, a 12-week intensive training on advocacy, treatment options, and 

physical and emotional self-care, has graduated nearly 300 inspired and enthusiastic women, 

committed to advocating for their own medical needs and sharing their heightened level of 

HIV knowledge with other women and supporters in their lives. WORLD holds semiannual 

educational retreats that strengthen social networks, reduce isolation, and provide education 

and up-to-date treatment information and tips on accessing high-quality medical care for HIVpositive women worldwide, including the United States, Canada, Israel, and Africa. WORLD’s 

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Peer Advocate Program is staffed by women living with HIV, including specialized Latina and 

perinatal advocates, who have experienced a positive test result and the subsequent overwhelming process involved in accessing good medical care. Peer advocates help HIV-positive 

women advocate for improved care and resources when the woman herself is unable to, and 

provide emotional and practical support. Prevention Outreach with Women Empowering Risk 

Reduction, WORLD’s innovative peer-led HIV prevention project that works specifically with 

African-American girls between the ages of 16 and 19, focuses on gender issues, sex, and HIV 

prevention through promoting risk reduction and decisionmaking strategies. Additionally, the 

Speakers Bureau offers intensive training for HIV-positive women and their allies in telling their 

personal stories in an effort to combat stigma and provide important prevention messaging. 

WORLD recently launched the National U.S. Positive Women’s Network (PWN) in June of 

2008. The PWN is designed to strengthen the strategic power of women living with HIV in the 

United States by identifying, supporting, and cultivating meaningful leadership and relationships among HIV-positive women; building capacity for collective action between individuals 

and organizations working in the field of women and HIV; and engaging in policy analysis and 

strategic campaigns to change and improve public policy. The PWN has a national membership of more than 700. WORLD also offers the Lotus Project, a national skill-building training 

for HIV-positive women who are interested in becoming peer advocates. 

All of WORLD’s programming is based on a peer empowerment model. More than 75 percent of our staff are HIV-positive women, and the same percentage are women of color. This 

strengthens our ability to develop and implement projects that are relevant and culturally 

competent to our target population. 

Suggested Areas of Research 

There are large gaps in research in relation to women at risk for and those living with HIV/ 

AIDS. We believe that much of the HIV prevention in the United States has failed women and 

this is because it is not informed by what is happening on the ground for women. There must 

be a stronger understanding of the structural issues that put women at risk for HIV in this 

country. These issues include poverty, gender-based violence and inequities, high incarceration 

rates in particular communities, and HIV stigma. The relationship that these issues have to HIV 

infection among women must be studied, understood, and integrated into prevention strategies. Women who are becoming infected are not necessarily exhibiting “dangerous” behaviors. 

Many of them are sexually active women who are married or in relationships that appear to be 

monogamous, but are unaware of their male partner’s risk factors or history. 

We would also like to see more research on the impact of peer-led interventions focused on 

women living with HIV/AIDS, including the impact of peer support and peer advocacy on 

treatment adherence, overall health outcomes, and risk reduction. Although we can see the 

immense benefit of these interventions among the women we serve, there is a lack of research 

in this area. 

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An additional area where we would like to see further research is the impact of HIV stigma 

on women. We see the impact on the ground: hesitation in getting tested, fear of medication being discovered by others, lack of disclosure, shame related to pregnancy or desire to 

become pregnant, etc. 

There also needs to be more advocacy and support for research to find tools that put the 

power of negotiating safer sex in the hands of women (microbicides and vaccines). 

WORLD believes that it is important to emphasize research that addresses the structural, biomedical, behavioral, and sociocultural issues pertaining to women’s vulnerability and risks for 

HIV/AIDS, as well as understanding the care-seeking and support needs that are specific to 

women living with HIV/AIDS. Moreover, research must examine the dynamics of women’s relations and social networks to understand the intricacies of both risk and care seeking. Studying 

women within a vacuum without acknowledging the relationships they are engaged in and the 

roles that they play within families, neighborhoods, communities, and economies fails to study 

women holistically. 

An area of research that merits further study is the impact of male circumcision on the risk 

of HIV acquisition to women. Most studies only highlight preliminary information and do not 

examine long-term impacts on how such an intervention actually produces changes in behaviors and attitudes about sex that men have and the consequences for women. 

Our concern includes whether men will continue to have safe sex after circumcision, whether 

condom use will happen, whether men will heal fully from the procedure before becoming 

sexually active, and the overall long-term impact on female sex partners. We believe the call 

to scale-up circumcision globally has not been sufficiently thought out and additional data are 

needed in this area. 

CLAIRE CHOSID 

Self 

Chemotherapy’s Effect on Breast Cancer Patients After 10 Years 

Please excuse the informal nature of this response. I just found out about this and I’d like to be 

involved in some way. My concern is personal. I had chemotherapy 11 years ago for a late stage 

2 breast cancer. In the following years, I have been inundated with autoimmune diseases and 

heart issues. I have been struggling with memory/focusing issues, as well. I am wondering if 

the medical profession is addressing the fate of women who have survived cancer (with chemotherapy), but have gone onto other serious medical issues. Three years after chemotherapy, 

I was diagnosed with lupus. Eight years after chemotherapy, I was diagnosed with congestive 

heart failure and viral cardiomyopathy. Last year, I was diagnosed with celiac disease and thyroiditis. I am currently taking classes that lead me to believe that I am having some memory/ 

retention issues. I don’t know if this is what you’re looking for; I would like to be involved in 

some way if it were possible. 

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ELLEN HEISLEN, PA-C 

Self 

Chronic Fatigue Syndrome 

Thanks to the faculty and staff at Washington University for sponsoring this very important 

panel discussion today. I appreciate the opportunity to speak about a silent, crippling, disabling disease known as chronic fatigue syndrome (CFS). As a former healthcare provider, I 

would like to put a face and a voice to chronic fatigue syndrome. 

Everyone has fatigue. However, the fatigue experienced in CFS is severe, unrelenting fatigue 

resulting in a marked reduction in activity levels. Other symptoms include the following:1 

• Brain fog—Difficulty with short-term memory and concentration 

• Poor sleep—Nonrestorative sleep 

• Headaches/Migraines 

• Muscle and joint pain/Fibromyalgia—Diffuse achiness 

• Bowel dysfunctions—Irritable bowel syndrome 

• Flu-like symptoms 

• Anxiety/Depression 

• Recurrent and persistent infections 

I feel there are three main causes to CFS: 

I. Infections 

• Viral infection: Epstein-Barr virus (EBV), human herpes virus type 6, cytomegalovirus 

(CMV) 

• Bacterial infection: Methicillin-resistant Staphylococcus aureus (MRSA) 

• Fungal infection 

II. Hypothalamus Suppression in Brain 

• Sleep disorder 

• Hormonal dysfunctions, including adrenal, ovarian, and thyroid 

• Autonomic nervous system—Neurally mediated hypotension 

• Low body temperature 

III. Immune Dysfunction 

• “Fight or flight” response—Immune system is in overdrive 

• Infections—The four most common are EBV, human herpes virus type 6, CMV, and postpolio syndrome 

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CFS affects 6 to 10 million women in America, ranging in ages from adolescents to seniors. The 

other day, I spoke with a women age 70 who had just been diagnosed with CFS. 

CFS takes women out of the workforce and away from their families. As of 2003 research outlines in 800 pages of text, there is still no treatment for CFS.2 

In closing, I am here today to impress upon you all of the importance of research and funding toward the diagnosis and treatment of CFS. This complex, multisystem disease syndrome 

impacts areas in neurology, immunology, and infectious disease. Any crossover research in 

these areas will also provide insight into other disease processes, as well. 

References 

1. Teitelbaum, Jacob. (2001). From Fatigued to Fantastic. New York: Avery. 

2. Jason, L. A., Fennell, P. A., & Taylor, R. R. (Eds.). (2003). Handbook of Chronic Fatigue 

Syndrome. Hoboken, New Jersey: Wiley. 

ROBERT KOKENYESI 

Self 

The Role of Start-Up Biotechnology and Medical Device Entrepreneurs in Translating Academic 

Research Discoveries Into Cutting-Edge Diagnostic and Treatment Applications 

The betterment of women’s quality of life is closely linked to improvements in the diagnostic and treatment options women’s health care can offer. The academic research community 

has greatly advanced the understanding of the molecular and physiological bases of many diseases of ageing, reproduction, and cognition affecting women. 

However, the tremendous academic discoveries are rarely followed up by movement of those 

discoveries to the bedside of afflicted women. In other words, the advancements from academic research laboratories are not commercialized rapidly into clinically useful diagnostic and 

treatment solutions. Therefore, our great investment in women’s health research is not paying 

a comparably great dividend when it comes to healthcare solutions. 

One root of this difference between academic research success and lagging commercial application is that academic research laboratories have little incentive to wade into the process 

of commercialization, because these laboratories are valued for their ability to bring in grant 

money, but not for starting new business enterprises. Although the technology transfer offices 

of universities keep track of academic discoveries, they are not enabled to stimulate or assist 

the formation of new enterprises around academic discoveries. 

Another root of the problem is that there are very few scientists/physicians who could turn 

entrepreneurs, because the current training of Ph.D.s and M.D.s do not typically include preparation for entrepreneurial activities. Those few entrepreneurial-minded scientists/physicians 

who would like to start a new business to exploit academic discoveries are discouraged by 

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the enormous financial risk and the potential loss of their academic tenure once they become 

full-time entrepreneurs. 

A third root of the problem is that starting a new company focusing on diagnostic or therapeutic products is expensive. Because of the very early stage of the product development in 

start-up, the venture capitalist or angel investors may not provide early funding. Therefore, 

entrepreneurial-minded scientists/physicians are discouraged from taking research discoveries 

to the bedside, and, as a consequence, the healthcare improvements for women’s needs are 

slow to appear. 

One possible way to increase the translation of academic discoveries into new diagnostic and 

therapeutic advances would be if government granting agencies (National Institutes of Health, 

National Science Foundation, and others) could increase funding allocation to small business 

enterprises headed by scientists/physicians. Another possible way to increase the translation 

of academic discoveries into new diagnostic and therapeutic advances would be if not-forprofit disease-specific organizations would invest in small business enterprises focusing on 

new diagnostics and therapeutic approaches. 

PATRICIA MARSH 

Self 

Women’s Health Priorities 

• Cancer research 

• More affordable public clinics 

• More birth control information and availability 

COLLEEN MCKEE 

Self 

The Challenges Faced by Lower Income Women With Depression and Bipolar Disorder 

With Amanda Crowell Stiebel, I recently edited Are We Feeling Better Yet? Women Speak 

About Health Care in America, published by PenUltimate Press, an independent press that 

specializes in women and minority healthcare issues. The anthology, a collection of personal 

narratives, mostly from the perspective of women patients, has empowered me to be a more 

understanding advocate of women who are ill and underrepresented in our nation’s current 

healthcare debates. Particularly, I am interested in the challenges women with mental illness 

face, especially lower income women with clinical depression and bipolar disorder. These are 

illnesses that are typically invisible and therefore, often overlooked, even by medical professionals, even when they are asked for help. Also, it is an ugly truth that many women, even 

working women with some degree of insurance, cannot afford adequate treatment for serious 

mental healthcare problems. 

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There are many financial obstacles for lower income women with depression and bipolar disorder. According to the Kaiser Family Foundation, nearly 17 million women are completely 

lacking health insurance. For women of color, these numbers are disproportionately high. 

Women who do have health insurance are much more likely than men to be covered through 

a spouse’s work-based insurance plan. In an economic climate such as today’s, with rising 

unemployment, this is rather precarious, as, in this situation, if a married man loses his health 

care coverage, so does his wife or partner, as well as, potentially, the children. Also, it is notable that economic stresses have always been a contributor to divorce, as well as stress and 

depression. If a woman is dependent on her man for her healthcare coverage, she could really 

be in a crisis if they divorce. Women who are not dependent on men are more likely to simply 

be uninsured in the first place. For example, lesbians are twice as likely as heterosexual women 

to be uninsured. Additionally, many Americans who are insured have subpar mental healthcare 

benefits to begin with. 

For example, one of the essayists in our anthology, Sara Ohlin, visits a doctor specializing in 

women’s health care hoping to be treated for her persistent insomnia and what she thinks may 

be depression. As a woman with two jobs, baker and writer, one would think she could afford 

adequate health care, but she quickly realizes this is not the case when the doctor tells her she 

can have her well woman visit, or talk about the insomnia, but not both, as the insurance companies don’t give doctors much time. The doctor compromises, giving Ohlin her rather divided 

attention as she attempts to give her a pap smear and ask her a few questions about insomnia 

at the same time. When she realizes Ohlin’s insurance will not cover a therapist, she hurriedly 

writes a few prescriptions for an antidepressant and a sleep aid, announcing, “You don’t seem 

clinically depressed. I mean, you’re not suicidal.” In fact, she had asked her few questions that 

would lead her to a reasonable conclusion that her depression was not clinical—for example, 

she had not found time to ask about family history, recurrence of symptoms throughout the 

patient’s lifetime, or even whether or not she was feeling suicidal or inclined to hurt herself or 

others. Unfortunately, with the kinds of restrictions insurance companies frequently impose 

both on patients and doctors, this is not uncommon. 

Often, even patients who do invest in premium health insurance find the cost of health care 

prohibitive. When essayist Anita Darcel Taylor finally finds a drug cocktail that stabilizes her 

bipolar disorder without exacerbating her obesity, she is shocked when the doctor’s samples run out and she finds that she will have to pay $450 in copays per month for the top-tier 

drugs. As a woman, her salary is already lower than the average man’s; as an African-American woman, she is more likely to go without the healthcare coverage she needs; as a single 

woman, she lives without a safety net. In this case, the safety net may make the difference 

between life or death, as she is, during her depressive episodes, frequently suicidal. 

We hope that our anthology can help women patients’ stories find the ears of caring and honorable physicians, researchers, and policymakers. So many hardworking women who have so 

much to offer society, despite the challenges of mental illness, should not be restricted from 

doing so because of inadequate health care. I am honored to have this opportunity to join the 

national discussion on this crucial issue. 

104
DIANE RUBAII 

Self 

The Need for Research on Methicillin Resistant Staphylococcus Aureus (MRSA) 

Everyone knows about breast cancer; there are little pink bows, marathons, and corporate 

giants that give a percentage—AIDS red ribbons, Elizabeth Taylor, Design Industries Foundation Fighting AIDS, Bono, Diabetes, The Fire and Ice Ball, and a plethora of other organizations 

and sponsors. But when it comes to Methicillin Resistant Staphylococcus Aureus (MRSA), 

there are no pretty ribbons, no corporate giants dipping into their big corporate pockets, no 

celebrities willing to put a face on a rather ugly and insidious infection that wreaks havoc with 

one’s immune system much in the same way a hurricane destroys everything in its path. That’s 

precisely what this infection does. 

I have first-hand personal experience as the primary caregiver of my mother, who developed 

an MRSA infection in 1997 and is now still dealing with the aftermath of this disease on her 

body. The only drug in the United States in 1997 to combat this so-called super bug was Vancomycin. Other drugs were being tested in France, which were only available in trials here in 

St. Louis. The problem with these other drugs is they cause liver and kidney damage. MRSA 

attacks every organ in the human body. Hospitals don’t want to talk about it because it’s their 

dirty little secret that must be kept under wraps. Medicare will not even pay for a person who 

survives MRSA. The cost of care is astronomical. Please make this a priority. Please give the 

institutions such as Washington University the funding and the means to put an end to this 

bacterial nightmare. 

ARETHA WEBB 

Self 

Implementation of Ethics and Morals Back Into Our Community 

My name is Aretha Webb. I am a caregiver and patient advocate and am glad that you and the 

National Institutes of Health (NIH) are interested in the public’s comments on women’s health 

care. The need for ethics and morals should be considered at each facility before funding 

research with Government funds, implementing applied ethics as part of the thread and fabric 

of being in America, and should guarantee its citizens with the best of health care, especially 

when they are insured like my Mom was. My main priority is to initiate such a need for ethics 

and moral values in my community and globally because of my Mom. 

Mom was a stay-at-home Mom for years, raising the children while Dad worked three jobs. He 

had to, as they had eight children. Mom was diagnosed with breast cancer the first time in her 

early 40s, then again in her late 50s in February 2003. She came through those bouts with flying colors. Her treatment in the hospital was okay and she experienced good treatment from 

nursing. In 2004, when Mother was diagnosed with multiple myeloma (cancer of bone and 

blood plasma), her hospital treatment that would follow was challenging, lacking care and 

substance that was not expected of a hospital. 

105
There were incidents of physical abuse and neglect from every job-level position in the healthcare profession in that particular hospital. Some of the abuse I witnessed first hand, with one 

of the incidents including me begging for nursing to help my Mom with her pain. Nursing 

interpreted my concerns as a power struggle, but Mother moaned and groaned in agonizing 

pain, and was in a state of mind where she was unable to verbally ask for help for her pain. 

This was the only time I took the initiative to contact her doctor and inform her of the situation. Later that night, my Mom’s doctor contacted me back after speaking to nursing and 

apologized that the nurse misread the written orders for a higher dosage of pain medicine to 

be given to my Mom. The best thing the hospital did for my Mom was to allow me to care for 

my Mom all night in the hospital each time she was admitted. 

In the middle of May 2006, my Mom suffered a bad reaction from a new medicine that was 

given to treat a bad infection (MRSA) and was neglected and treated very badly, and even 

worse than that, I had no knowledge of the reaction. I had left to go home earlier that day to 

rest, clean up, and cook dinner for the rest of my family. When I called the hospital to check 

on Mother, they told me she had a little swelling, but she was fine. When I got to the hospital, 

Mother was drowning in her own fluid and in her room alone, reaching for me for my help. She 

was disconnected from her IV. A suction pump was off to the side, as if someone had worked 

on her and just given up and left her for dead. No one told me of the suction usage on her and 

the true health condition she was experiencing. I protested and yelled and asked nursing what 

happened. They finally told me of the reaction to the medicine she received, and that that was 

what caused the swelling and buildup of fluid in her chest. I demanded they treat the reaction, 

so they treated her with steroids to fight the reaction. They connected the suction back up, 

and though mother could not speak because of her extremely swollen tongue protruding out 

of her mouth, she—for the first time—took her fist and fought the nurse who was treating her. 

She was letting me know in her own way that something terrible happened. The point I want 

to make is that my mother was dying and she knew it and I knew it, but she was willing to go 

onto the eternal world, minus the unnecessary trauma bestowed on her. 

I am requesting time to speak to anyone who will listen about the importance of having good 

ethics and morals while and when caring for patients who are terminally ill. I am currently 

hopeful that the NIH would only fund those programs that only have a high regard for applied 

ethics in my community, the African-American community. Our community—regarding my 

Mom—did not offer optional treatment that could have prolonged her life, even if she had not 

suffered complications from abuse and neglectful behavior from her healthcare providers. 

The need for such integrity and accountability (concerning ethics and morals) is so vital for 

the terminally ill, it could have most likely prevented the development of my Mom’s shingles; 

shattered hopes; and staph (MRSA); along with abuse, which eventually caused her death. I 

would love to share my Mom’s story to anyone who will listen—in churches, schools, and public forums. 

106
Public Testimony 

University of California, San Francisco 

San Francisco, California 

May 27, 2009 

Debabrata Ghosh, Ph.D. 

All India Institute of Medical Sciences 

Cheryl Healton, Dr.P.H., M.P.A. 

American Legacy Foundation 

Lori Karan, M.D., PACP, FASAM 

American Society of Addiction Medicine 

Kathleen Besinque, Pharm.D., M.S. Ed. 

Association of Reproductive Health Professionals and USC School of Pharmacy 

Rivka Gordon, M.H.S., PA-C 

Association of Reproductive Health Professionals 

Suzan Goodman, M.D., M.P.H. 

Association of Reproductive Health Professionals 

Joyce Bichler, M.S.W. 

Breast Cancer Action 

Kasha Ho 

California Healthy Nail Salon Collaborative/Breast Cancer Action 

Debra Bingham, Dr.P.H., RN 

California Maternal Quality Care Collaborative 

Heather Sarantis, M.S. 

Commonweal 

Kari Christianson 

DES Action USA 

Betsy Rassmussen 

Endometriosis Association 

Aspen Baker 

Exhale 

Danielle Thomas 

Exhale 

Janice Humphreys, Ph.D., RN, NP, FAAN 

Group of Concerned Nurse-Researchers 

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Hugh Brown III 

HIV/AIDS Services for African Americans in Alaska 

Laura Mosier, B.S. 

Indiana State Department of Health 

Jennifer Pierce-Weeks, RN, SANE-A, SANE-P 

International Association of Forensic Nurses 

Sue Goldstein 

International Society for the Study of Women’s Sexual Health 

Deb Levine, M.A. 

ISIS, Inc. (Internet Sexuality Information Services) 

Maria Cora, M.A. 

Lesbian Health & Research Center at the University of California, San Francisco 

Sarah Janssen, M.D., Ph.D., M.P.H. 

Natural Resources Defense Council 

Yali Bair, Ph.D. 

Planned Parenthood Affiliates of California 

Deborah Ortiz, J.D. 

Planned Parenthood Mar Monte 

Jane Honikman, M.S. 

Postpartum Support International 

Rhoda Nussbaum, M.D. 

Prevention International: No Cervical Cancer 

Roham Zamanian, M.D. 

Pulmonary Hypertension Association 

Elizabeth Arndorfer 

Reproductive Health Technologies Project 

Cathy Eddy 

Scleroderma Foundation Northern California Chapter 

Hassan Sallam, M.D., Ph.D., FRCOG 

The Suzanne Mubarak Regional Center for Women’s Health and Development 

Katie Gillespie, M.A. 

University of Arizona 

Vanessa Jacoby, M.D., MAS 

University of California, San Francisco 

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Purnima Madhivanan, M.D., Ph.D., M.P.H. 

University of California, San Francisco 

Patricia A. McDaniel, Ph.D. 

University of California, San Francisco 

Ruth Malone, Ph.D., RN, FAAN 

University of California, San Francisco 

Elise Riley, Ph.D., M.P.H. 

University of California, San Francisco 

Paolo Rinaudo, M.D., Ph.D. 

University of California, San Francisco 

Patricia A. Robertson, M.D 

University of California, San Francisco 

Tracey Woodruff, Ph.D., M.P.H. 

University of California, San Francisco 

Amy Levine, Ed.D 

University of California, San Francisco 

Margaret Kristof , M.A. 

UCSF-Kaiser BIRCWH Program 

Valerie Flaherman, M.D., M.P.H. 

UCSF-Kaiser BIRCWH Program 

Yoshimi Fukuoka, Ph.D. 

UCSF-Kaiser BIRCWH Program 

Wendy B. Katzman, D.P.T.Sc., PT, OCS 

UCSF-Kaiser BIRCWH Program 

Alexandra Scranton, M.S. 

Women’s Voices for the Earth 

Loreen Willenberg 

Zephyr L.T.N.P. Foundation, Inc. 

Ken Chisholm 

Self 

Beverly Santos 

Self 

Lynn Shepler, M.D., J.D. 

Self 

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DEBABRATA GHOSH, PH.D. 

All India Institute of Medical Sciences 

Build Heuristics To Assure Sufficient Information and Efficient Negentropy and Integrate 

Them Locally and Globally To Ensure Meaningful Genesis of a Map for Future Strategies of 

Women’s Health 

I have come from a developing country, India. And I know how vivid is the reality there when 

your leaflet states, “more than one-half million women die of preventable causes related to 

pregnancy and childbirth every year, 99 percent of whom are in developing countries; for every 

woman who dies, another 30 are estimated to suffer long-term disabilities related to reproductive maternal causes.” We are also aware that a large number of the above-mentioned 

casualties can be avoided by simple means that are neither expensive nor complex. Nevertheless, as a scientist, I am involved in so-called cutting-edge-technology-based research to 

understand molecular endocrinology of blastocyst implantation and to elucidate novel molecular classification of endometriosis; both are directly related to women’s heath. Yet, there is no 

true contradiction between these two realities. On the contrary, I believe that there is a clue in it 

to inform the future road map for improvising strategies in women’s health, at least for India. 

What does it mean? It means that we need to adopt multipronged approaches while moving 

into the future of women’s health with women at the center and women at the periphery. 

I shall mention three major areas of research interest. 

Firstly, at the grass roots level, women need to possess sufficient education and empowerment so that they can execute their reproductive choices and inculcate health at the individual 

level, family level, and community level. Sufficient and integrative research at different levels with historical and geographical contexts is needed to appropriately understand the nature 

of several inhibitory motifs existing in sociology, sociobiology, social psychology, economics, and politics that impose a counterfeit effect on women’s education, empowerment, and 

health. In India, we may safely state that the agenda of women’s empowerment and health has 

never taken even a taxi run for such multifactorial convergence onto the deception process 

to women, as mentioned above, despite Jawaharlal Nehru’s draft for the 1937 Congress manifesto. And there is only meager understanding about it. 

Secondly, high-end research related to women’s health and the disease needs to be encouraged both locally and through global collaboration. The expansion of knowledge base shall, 

in turn, dispel some of the above-mentioned inhibitory motifs in specific as well as unspecific 

manners. Also, it shall promote better knowledge about the biological basis of women’s health 

and disease. The metaphysical currency and futuristic heuristics of the second wing of the proposed strategy give to it the true strength. 

Thirdly, there is a requirement of research to evolve serious approaches to attend the unmet 

need of meeting the above-mentioned two wings together, both through local as well as global 

endeavors. It is an unfortunate fact that these two wings, albeit perceived and flapped to some 

extent at individual capacities, did not fly high synchronously for lack of suitable research and 

exploration into the third domain, namely integration with and interfacing onto public contexts. 

110
Finally, I believe the policymakers need to undertake the triple helix process (as Professor 

Richard Lewontin mentioned, however in a different context) involving philosophies, strategies, and tactics while creating a road map for a newer future for women’s health. Strategies 

generated on the substratum of philosophical nothingness shall sink into (as has mostly happened in developing countries by and large) in the jungle of tactics’ tentacles. 

CHERYL HEALTON, DR.P.H., M.P.A. 

American Legacy Foundation 

Including Tobacco in the ORWH Research Agenda: An Essential Step Toward Improving the 

Health of American Women 

The Board of Directors and the staff of the American Legacy Foundation® (Legacy) urge the 

Office of Research on Women’s Health (ORWH) to give the prevention of tobacco use, smoking cessation, and tobacco-related disease a prominent position within the research agenda 

being developed for the National Institutes of Health (NIH) ORWH. Including tobacco in the 

ORWH research agenda is a critical first step toward improving the health of women in the 

United States. 

Smoking is a Social Justice Issue 

National Health Interview Survey data show that, in 2007, 17 percent of all women over age 

18 in the United States were smokers, with substantially higher smoking rates among women 

with lower levels of education and income.1

 For example, 39 percent of women with a General 

Educational Development-level education smoked in 2007, as did 26 percent of women living 

below the Federal poverty level.1

 In fact, as a result of decades-long trends in which those with 

greater educational and financial resources smoke at lower rates,1,2 quit at higher rates, 2,3,4 are 

more likely to be covered by health insurance,5

 and are more likely to promptly seek medical 

care,5

 tobacco use has become not only a public health issue, but also a social justice issue.6 

While the relationship between socioeconomic status and tobacco has been well documented, 

there are certain populations within which smoking rates are believed to be high, and yet a 

scarcity of data often relegates these groups to the sidelines of tobacco control interventions. 

Among these populations are gay, lesbian, bisexual, and transgender individuals and racial/ 

ethnic minorities, such as American Indians and Alaska natives.7 Disparities are compounded 

by the fact that smoking translates into mortality at different rates within different population groups. For example, African-American women smoke at lower rates than White women, 

but have higher death rates resulting from cancer.8

 A great deal more research will be needed 

before we can unravel the many factors influencing smoking and smoking-attributable disease 

and death in these populations. 

Smoking-Attributable Morbidity, Mortality, and Costs to Society 

Between 2000 and 2004 (the most recent data available), the Centers for Disease Control 

and Prevention (CDC) estimates that 173,940 U.S. women died annually as a result of tobaccorelated disease.9

 The leading causes of smoking-attributable death among U.S. women were 

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heart disease, cerebrovascular disease, and lung cancer.9

 It is further estimated that approximately 18,000 U.S. women died annually during the years of the study period as a result of 

exposure to secondhand smoke.9 Collectively, these deaths represent more than 2 million years 

of potential life lost to U.S. women each year.9

 Furthermore, in each year from 2000 to 2004, 

the CDC estimated that 776 infant deaths were caused by smoking during pregnancy.9

 In 

addition to the devastating impact of these deaths on families who have lost mothers, wives, 

daughters, and children to tobacco-related disease, the average annual productivity costs of 

these deaths are estimated by the CDC to be $33 billion.9 

Smokers Underestimate Risk and the Addictiveness of Nicotine 

While the vast majority of women today know that smoking is harmful to their health, many 

fail to fully understand the risks smoking poses to themselves, their families, and their children. 

For example, although lung cancer has been the leading cause of cancer death among women 

since 1987,7

 a Legacy study shows that 80 percent of women in the United States mistakenly 

believe that breast cancer is the primary cause of cancer death among women.10 Furthermore, 

girls and young women overestimate their ability to quit smoking; survey data show that more 

than half of teens who currently smoke do not expect to be smoking in 1 year.7

 Unfortunately, 

tobacco is highly addictive, so while most smokers—including teenage girls—report wanting to quit, very few are successful in a given year.7,11 One study showed that, among girls who 

smoked, 60 percent of those in middle school and 58 percent of those in high school had tried 

and failed to quit smoking during the previous year.7 Survey data show us that of the approximately 43 million smokers in the United States, the majority of whom report wanting to quit, 

fewer than 5 percent will successfully quit within a 1-year period.1,11 

The State of Cessation Interventions 

In recent years, the science related to smoking cessation has advanced markedly; a combination of pharmacotherapy, counseling, and social support can vastly improve a smoker’s 

chances of successfully quitting.12 Based on evaluations of mass media cessation efforts in 

California, Massachusetts, and Oregon—in which high-intensity, research-based, paid media 

campaigns were combined with excise tax increases and community and school-based programs—the Task Force on Community Preventive Services “strongly recommends” mass media 

campaigns to increase tobacco cessation when the media campaign is combined with other 

interventions.13 However, recent research suggests that many mass media interventions, which 

have been successful overall, have in fact done a poor job of reaching those most in need— 

disadvantaged and low socioeconomic status smokers.14,15,16 Greater attention must be paid to 

1) developing interventions that will influence smoking cessation within these high-risk populations, including women; and 2) evaluating interventions in such a way that overall program 

success does not mask failure to influence important subgroups. 

The Tobacco Industry Encourages Smoking Among Women 

It is worth bearing in mind that the cessation interventions of the tobacco control and public 

health communities are continually undermined by billions of dollars worth of tobacco industry marketing and promotion. Just this week, the American Cancer Society Cancer Action 

Network, American Heart Association (AHA), American Lung Association (ALA), Robert 

112
Wood Johnson Foundation (RWJF), and Campaign for Tobacco-Free Kids released a report 

called, “Deadly in Pink: Big Tobacco Steps Up Its Targeting of Women and Girls.”17 The report 

describes how two tobacco companies—Philip Morris and R. J. Reynolds—have recently 

“stepped up” tobacco marketing directed toward women and girls, threatening to undermine 

the advances made in recent years by the tobacco control and public health communities. 

The report describes two new products: Philip Morris’ Virginia Slims “purse packs,” released 

in October 2008; and R. J. Reynolds’ “Camel No. 9” released in January 2007. The report concludes that, given the aggressive marketing of these new products, these tobacco company 

efforts could be “devastating” to smoking initiation rates among girls and ultimately to 

women’s health. 

A separate study conducted by American Legacy Foundation indicated that after the first 6 

months of the Camel No. 9 marketing campaign, more than 40 percent of youth (12–17) and 

young adult (18–24) smokers had tried the product and that many more planned to try it. 

Furthermore, interest in trying Camel No. 9 was high even among young adults who were not 

current smokers, suggesting that the product may serve to lure new smokers (Legacy data 

available upon request).18 Given these emerging female-oriented tobacco products and marketing efforts, combined with the enormous promotional budget of the tobacco industry—$13 

billion in 2005, the most recent data available19—it is of paramount importance to track the 

impact of these products on initiation, smoking, and quit rates among girls and young women. 

Setting a Research Agenda for Women and Tobacco Use 

The authors of the 2001 Surgeon General’s Report on Women and Smoking set a research 

agenda to “build the science-base on gender-specific outcomes and on how to reduce disparities among women.”7

 Moreover, the American Legacy Foundation has noted gaps in the 

research that have emerged since the time of the 2001 report. The following are presented 

as specific areas of research that Legacy believes should be pursued by the NIH ORWH in an 

effort to improve the health of women in the United States: 

1. Conduct research to better understand why so many mass media cessation campaigns 

have been less effective or ineffective among disadvantaged or lower socioeconomic 

status populations 

2. Conduct research to learn how new media and Internet cessation services can be used 

to increase smoking cessation among women, and whether they can be effectively used 

across the socioeconomic spectrum 

3. Conduct research regarding smoking rates, smoking patterns, cessation rates, and 

factors associated with initiation and quit success among high-risk populations such as 

gay, lesbian, bisexual, and transgender individuals; minority racial/ethnic populations; 

population groups targeted by the tobacco industry; and lower education/lower income 

population groups 

4. Conduct research regarding tobacco products designed for and marketed to women, 

specifically, whether they vary significantly in terms of the levels of known carcinogens 

and how this relates to lung cancer histology 

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5. Conduct research to further explore the link between smoking and health outcomes 

among women, such as breast cancer and reproductive outcomes 

6. Conduct research to better understand how secondhand tobacco smoke impacts 

women who do not smoke 

7.	� Encourage scientists to report gender-specific results whenever possible, when reporting on research about factors that influence smoking initiation or cessation, the health 

effects of tobacco, and new tobacco products 

Considering the toll of tobacco use on the health of American women, research into tobacco 

and tobacco-related diseases is underfunded. There is still much we need to learn so that we 

can prevent youth initiation, help adult smokers quit, and deliver care to women who suffer 

from tobacco-related disease. 

The American Legacy Foundation is a national, independent public health foundation created in 1998 out of the landmark Master Settlement Agreement (“MSA”) between the tobacco 

industry, 46 State governments, and 5 U.S. territories. Our mission is to build a world where 

young people reject tobacco and anyone can quit. Legacy does not lobby or take positions on 

specific legislation. Our programs include the following: 

• EX®—A groundbreaking and innovative smoking-cessation public education campaign 

designed to help smokers “relearn” life without cigarettes 

• truth®—A national youth smoking prevention media campaign cited as contributing to 

significant declines in youth smoking. 

• Research Initiatives—Examining how public health public education can reduce smoking 

initiation and prompt smoking cessation 

• Outreach to Priority Populations—Targeted outreach to underserved and minority communities using methods that are culturally competent and tailored to improve the reach 

and retention of programmatic efforts 

References 

1. Centers for Disease Control and Prevention. (2008). Cigarette smoking among adults— 

United States, 2007. Morbidity and Mortality Weekly Report, 57, 1221–1226. 

2. U.S. Department of Health and Human Services. (1989). Reducing the health consequences of smoking: 25 years of progress. A report of the Surgeon General. (DHHS 

Publication No. [CDC] 89-8411). Washington, DC: U.S. Department of Health and Human 

Services, Public Health Service, Centers for Disease Control, Center for Chronic Disease 

Prevention and Health Promotion, Office on Smoking and Health. 

3. Pleis, J. R., & Lethbridge-Cejku, M. (2007). Summary health statistics for U.S. adults: National Health Interview Survey, 2006. National Center for Health Statistics. Vital Health 

Statistics, 10(235). 

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4. Fagan, P., Shavers, V. L., Lawrence, D., Gibson, J. T., & O’Connell, M. E. (2007). Employment characteristics and socioeconomic factors associated with disparities in smoking 

abstinence and former smoking among U.S. workers. Journal of Health Care for the Poor 

and Underserved, 18(4 Suppl), 52–72. 

5. Adams, P. F., Lucas, J. W., & Barnes, P. M. (2008). Summary health statistics for the U.S. 

population: National Health Interview Survey, 2006. National Center for Health Statistics. Vital Health Statistics, 10(236). 

6. Healton, C., & Nelson, K. (2004). Reversal of misfortune: Viewing tobacco as a social 

justice issue. American Journal of Public Health, 94(2), 186–191. 

7.	� U.S. Department of Health and Human Services. Women and smoking. A report of the 

Surgeon General. (2001). Rockville, MD: U.S. Department of Health and Human Services, 

Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. 

8. Albano, J. D., Ward, E., Jemal, A., Anderson, R., Cokkinides, V. E., Murray, T., . . . Thun, M. 

J. (2007). Cancer mortality in the United States by education level and race. Journal of 

the National Cancer Institute, 99, 1384–1394. 

9.	�Centers for Disease Control and Prevention. (2008). Smoking-attributable mortality, 

years of potential life lost, and productivity losses—United States, 2000–2004. Morbidity and Mortality Weekly Report, 57, 1226–1228. 

10. American Legacy Foundation. (2001). Women and lung cancer survey. Washington, DC: 

Author. 

11.	�Centers for Disease Control and Prevention. (2002). Cigarette smoking among adults— 

United States, 2000. Morbidity and Mortality Weekly Report, 51, 642–645. 

12. Fiore, M. C., Bailey, W. C., Cohen, S. J., Dorfman, S. F., Fox, B. J., Goldstein, M. G., . . . Baker, T. B. (2000). A clinical practice guideline for treating tobacco use and dependence. 

Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. 

13. Task Force on Community Preventive Services. (2001). Recommendations regarding 

interventions to reduce tobacco use and exposure to environmental tobacco smoke. 

American Journal of Preventive Medicine, 20(2s), 10–15. 

14. Niederdeppe, J., Fiore, M. C., Baker, T. B., & Smith, S. S. (2008). Smoking-cessation 

media campaigns and their effectiveness among socioeconomically advantaged and 

disadvantaged populations. American Journal of Public Health, 98, 916–924. 

15. Niederdeppe, J., Kuang, X., Crock, B., & Skelton, A. (2008). Media campaigns to promote smoking cessation among socioeconomically disadvantaged populations: What 

do we know, what do we need to learn, and what should we do now? Social Science & 

Medicine, 67, 1343–1355. 

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16. Fagan, P. (2008). Examining the evidence base of mass media campaigns for socially 

disadvantaged populations: What do we know, what do we need to learn, and what 

should we do now? A commentary on Niederdeppe’s article. Social Science & Medicine, 

67, 1356–1358. 

17. American Cancer Society, Cancer Action Network, American Heart Association, 

American Lung Association, Robert Wood Johnson Foundation, & Campaign for 

Tobacco-Free Kids. Deadly in pink: Big tobacco steps up its targeting of women 

and girls. Retrieved from http://www.lungusa.org/assets/documents/publications/ 

other-reports/deadly-in-pink.pdf 

18. American Legacy Foundation. (n.d.) Camel No. 9 study. Washington, DC: Author. 

19. Federal Trade Commission. (2007). Federal Trade Commission cigarette report for 2004 

and 2005. Washington, DC: Author. 

LORI KARAN, M.D., PACP, FASAM 

American Society of Addiction Medicine 

Women and Addiction: Research Needs 

Introduction 

The American Society of Addiction Medicine (ASAM) is composed of approximately 3,000 

physician members from all medical specialties and subspecialties. We are primarily clinicians 

caring for patients, but we also represent the interests of public health. We are often advocates for those who suffer from addiction because these persons are not often able to speak 

out for themselves. Our goals include improving access to and the quality of addiction treatment; educating physicians, healthcare providers, and the public about addiction medicine; 

and supporting research and prevention in this field. 

The American Society of Addiction Medicine is pleased to contribute research priorities on 

“Women and Addiction” to the Office of Research on Women’s Health. Organized under the 

categories of neurobiology, prevention, treatment access, services to improve treatment outcomes, and special topics (psychiatric comorbidity, eating disorders, pain, prescription drug 

use, and the criminal justice system), the concepts in this compendium have been selected for 

their impact and timeliness. Following a brief background, examples of research questions are 

given for each of the issues. 

The Neuroscientific Basis of Addiction in Women 

There are permanent sex differences in the structure and responsiveness of the human brain, 

including those that influence perception, cognition, and responsivity to stress. Sex differences 

occur due to the actions of gonadal hormones during early development, puberty, and preand postmenopausal adult life. 

Sex hormones may have genomic and nongenomic effects. For example, androgens and estrogens not only regulate the expression of specific neuropeptides and neuropeptide receptors, 

116
but they may also more directly influence neurotransmission such as by directly facilitating 

the opening of the GABA-benzodiazepine receptor chloride channel. Understanding gender’s 

influence on neurobiologic mechanisms can help us better understand women’s vulnerability to alcohol, nicotine, and other chemical addictions, as well as the factors that predispose to 

relapse. Improved knowledge of these mechanisms can lead to more specific interventions for 

gender-specific prevention and treatment of chemical dependency. 

Examples of research questions on this topic include the following: 

• What are gender-specific genetic and epigenetic influences, risk factors, and protective 

effects for addiction in women? 

• What are the hormonal and neurologic influences on the developing and adolescent 

brain that predispose to drug experimentation? How do these influence risk taking, 

novelty seeking, and judgment in adolescent women, as well as in women at other 

stages of life? 

• How might gender-related differences in the hypothalamus-pituitary-adrenal axis and/ 

or in the regulation of beta-endorphins (or other neuropeptides) influence stress reactivity and relapse to drug use? Can we better tailor treatment interventions based 

upon this understanding? 

• Are there certain opportunities based upon timing in the menstrual cycle when a woman is more vulnerable to drug use or when she is more likely to invoke therapeutic action 

and behavioral change? In particular, what are the effects of disordered cycling on drug 

experimentation and continued use? 

• How do hormonal effects upon the GABA benzodiazepine receptor influence individual 

sensitivity to the psychoactive effects of specific drugs? 

Preventing Substance Abuse and Dependence in Women Across 

the Lifespan 

Prevention activities may be universal (designed for the general population), selective 

(designed for groups at higher risk of subsequent addiction, such as children of alcoholics), or 

indicated (designed for persons who are displaying behaviors etiologically linked to problematic substance use)1

 and may take place on an individual basis, within the family, at a school, 

in the community, or at the workplace. Prevention activities exist for many health conditions 

even when the etiology of the illness is not fully understood.1

 By targeting risk factors known 

to be associated with an illness, the public health system can promote prevention via a risk 

reduction model. However, in contrast to illnesses such as heart disease, this model has not 

been applied to addiction prevention despite scientific evidence of risk factors associated 

with addiction.2 

Drug Use Trajectories Across a Woman’s Lifespan 

A woman’s susceptibility to abuse and addiction of alcohol, nicotine, and other mood-altering 

drugs varies according to her developmental stage. A life-course perspective can guide new 

research and approaches to the prevention and treatment of drug dependence. 

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Examples of research outlining some, but far from all, of the questions focused per life stage 

include the following: 

Perinatal Effects of Drug Use 

• What are the effects of nicotine, alcohol, and specific other psychoactive drugs in utero 

on the developing brain? How might these changes influence future vulnerability of the 

neonate to the use of these drugs? 

• Vaccines for nicotine, cocaine, and other drugs are being developed. The mechanism is 

to alter the substance before it crosses the blood–brain barrier so that it is neither psychoactive nor reinforcing. Might passive vaccination be indicated in pregnant women to 

prevent drugs from crossing the placenta? 

• How might prevention programs be tailored for newborns and infants who have a parent 

with alcohol, nicotine, or drug addiction? 

Childhood 

• What interventions are most effective in preventing erratic parenting, child abuse, and 

neglect? In addition to improving psychological functioning of these children, do these 

interventions prevent addiction or alter the course of drug use in at-risk individuals? 

• What qualities of parenting and healthy family function best protect against vulnerability to drug experimentation? What environmental and internal factors are associated with 

resiliency in female children at risk of substance misuse? How can these factors be amplified via prevention efforts? 

Adolescence 

• What type of interventions and systems can be put into place to effectively prevent 

alcohol, nicotine, and drug use by female teens who are at high risk for addiction? 

• Why is the gender gap (male > female) in initiating alcohol and drug use diminishing? 

Do public health interventions to diminish alcohol and drug experimentation in the 

general population (such as increasing cost or altering social acceptability) affect 

teens differently by gender? 

• What is the relationship between reproductive behaviors (sexual debut, contraceptive 

use, unplanned pregnancy, and abortion) and addiction? Given that prevention of alcohol 

and drug addiction results in fewer sexually transmitted diseases and unplanned pregnancies, how might this best be accomplished and evaluated? 

Pregnant and Parenting Women 

• The majority of women decrease or stop drug and alcohol use during pregnancy 

(unfortunately only to resume at prior levels after delivery). What are the factors 

associated with successful behavioral change during pregnancy? How might these 

be marshaled for general preventative efforts? 

• How can the child–parent relationship be strengthened through prevention efforts? 

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• Many public health interventions aimed at adult women focus on reproduction. 

What are specific prevention interventions for lesbian women and those who choose 

to forgo childbearing? 

Postmenopausal Women and Geriatric Women 

• How do changes in estrogen levels and lack of estrogen affect mood and drug use? 

Treatment Access 

Improving Access to Drug and Alcohol Treatment for Women 

Women face unique barriers in both accessing care and remaining in treatment. These barriers 

exist at the level of the individual (fear of separation from children and/or loss of child custody, stigma, lack of financial resources, greater problem severity and complexity, medical and 

psychiatric comorbidities, lack of safe drug-free housing, lack of transportation); at the level 

of the treatment facility (long waiting lists, lack of child care); and at the level of the provider 

(lack of knowledge about women and addiction).3,4 

Examples of research questions include the following: 

• What is the current treatment capacity for women in the United States? Is it sufficient to 

meet treatment need/demand? 

• What are cost-effective means of reducing barriers to treatment for women in general, 

and specifically for minority women? 

• What strategies can be initiated during the time waiting to enter treatment and how do 

these strategies improve engagement in treatment and treatment outcome? 

• How can linkages to specialized addiction treatment and longer term recovery support 

be facilitated given that women are more likely to seek help for alcohol and drug problems in mainstream health care and counseling agencies? 

Improving Access to Treatment for Family Members: A Systems Approach 

Our current system for addictions treatment and reimbursement focuses upon acute intervention for a specified patient. However, professional intervention, education, and support 

for family members (including nontraditional family structures) of those suffering from 

addiction can result in an even greater benefit. A functional family system can alleviate the 

stress of its members, and reduce the continuation of intergenerational trauma. Healthy 

partners, families, and social networks can enhance an individual’s motivation for treatment 

and continued recovery.5 

• What are the long-term costs and benefits for a systems approach to addiction? 

• Might there be increased incentives for family intervention in a system of universal 

health care? 

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Improving Drug and Alcohol Treatment for Women 

Gender-Responsive Services To Improve Outcomes 

Interest in providing treatment services specific to women began in the 1970s, but there 

remain many unanswered questions about what is essential. Research is challenging because 

it is difficult to disentangle the elements that work. Models for gender-responsive treatment 

often do not lend themselves to rigorous research designs because of their complex composition. However, there are many identifiable issues: 

• What is the importance of providing practical assistance (transportation, child care, 

homework help) in fostering treatment engagement and retention? 

• What features of clinical programming are important? Are women-only programs the 

most effective, or do women do as well when women-specific components are added to 

a mixed program? 

• Having female role models is often cited as important, but what is the contribution 

of positive male role models (on staff) to good outcomes for mothers as well as 

their children? 

• What modifications are needed to address variations in cultural background and 

sexual orientation? 

• What interventions/forms of assistance encourage programs to serve pregnant women? 

• How can programs best serve the children of the primary patient, to make best use of 

the prevention and early intervention opportunities that arise? 

• What gender-specific long-term outcome measures (emotional and relational health; 

life meaning and purpose; social contribution) can best measure recovery, and how can 

these be utilized to further continuing support and care? 

Special Topics 

Psychiatric Comorbidity 

It is well documented that substance-abusing women have high levels of psychiatric comorbidity,6

 particularly mood disorders, anxiety disorders (especially posttraumatic stress 

disorder), eating disorders, and borderline personality disorders. Clinicians widely agree that 

it is best to integrate treatment for co-occurring disorders, if possible, at a single site, utilizing 

physicians familiar with addiction medicine. Key questions include the following: 

• How accessible is screening, assessment, and treatment for both substance abuse and 

psychiatric disorders, regardless of where women enter the healthcare system? 

• How can assessment and treatment be made more accessible, given that many substance users do not have insurance and hence will not benefit from parity? 

• What are the important gender differences in response to psychotropic medications, 

especially those originally studied in predominantly male samples? 

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• What modifications of currently accepted evidence-based practices (e.g., cognitive 

behavioral therapy, motivational enhancement therapy) augment their effectiveness 

in women with co-occurring disorders? For example, is it preferable to start cognitive 

behavioral therapy after a woman has been stabilized on antidepressants, as her brain 

reward system will be more responsive? 

• What are the most important combinations of medications and psychosocial interventions? For which disorders? 

• What are the most cost-effective treatment interventions? 

• What are the most potent interventions for women who are the recipients of physical 

and sexual violence, in childhood and adulthood? 

Eating Disorders 

Anorexia, Bulimia, and Binge-Eating 

• Are there effective ways to prevent anorexia and/or bulimia? Do such interventions alter 

drug experimentation or the course of drug use in at-risk individuals? 

• Despite the high prevalence of co-occurring substance use and eating disorders, most 

addiction treatment programs do not address eating disorders either through assessment or treatment.7 Using standardized assessment tools, what is the prevalence of 

eating disorders in women with substance use disorders? What treatments for eating 

disorders are most effective in this population? 

Obesity: An Emerging Women’s Issue 

There is a growing epidemic of overweight and obese women. Obesity is a chronic condition, 

reflecting “nonhomeostatic eating” or eating without caloric need. Many overweight women 

are emotional eaters who report increased intake after stress. Even when they are not hungry, they report an inability to overcome cravings for highly palatable food when this food is 

omnipresent and easily available. It is important to understand how similar compulsive eating 

is to drug addiction, which may offer clues to treatment and prevention of obesity, as well as 

insights into drug addiction psychobiology. 

Examples of research questions on this topic include the following: 

• What are the sociologic, environmental, behavioral, and neurobiological similarities 

between overeating and drug addiction? 

• Under what conditions do foods rich in carbohydrates and/or fats stimulate the 

reward center? 

• How do dopaminergic, opioid, cannabinoid, and other neuropeptide pathways trigger 

overeating, especially after stress? 

• Does volitional restraint from palatable foods (common to dieters), and life stress sensitize a woman’s biology, leading to the higher reward value of palatable food? 

121
• What is the preferred treatment goal for nonhomeostatic eating since complete abstinence from food is untenable? 

• What treatment modalities lead to an optimal outcome? 

• What dose and frequency of continuing intervention is needed to prevent rebound 

weight gain after weight loss? 

Pain in Women 

Women experience pain differently then men. In particular, they have lower pain thresholds, 

higher pain ratings, and less tolerance for pain. Additionally, both visceral pain syndromes 

(such as irritable bowel and interstitial cystitis) and chronic pain syndromes (such as fibromyalgia and chronic pelvic pain) are more common in women. The prevalence of chronic pelvic 

pain is comparable with that of asthma and is the single most common indication for referral 

to a gynecologist. Although addiction and chronic pelvic pain are comorbid conditions, little 

research to date has explored this relationship. 

Examples of research questions on this topic include the following: 

• Why is opiate therapy more likely to fail in the treatment of chronic pelvic pain compared 

with other pain syndromes? 

• What role does sexual abuse play in modulating the association of addiction with 

chronic pain? 

• What is the relationship between self-medication for pain syndromes and gender? 

• How does the hormonal milieu contribute to the immunologic basis for specific rheumatologic illnesses and chronic pain syndromes in women? What are the implications of this 

pathophysiology for the effective medical management of pain? 

Women’s Nonmedical Use of Prescription Medication 

There is an epidemic of prescription drug abuse in the United States. Women seek medical 

care more often than men and are more likely to be prescribed medications for a variety of 

symptoms, including pain, mood disorders, and insomnia. The nonmedical use of prescription 

drugs in women has been associated with a lifetime history of post-traumatic stress disorder, 

use and abuse of other substances including alcohol, as well as a history of drug- or alcoholfacilitated rape.8

 Some women use stimulants to suppress weight and/or to give focus and 

energy to completing a task. 

• How is the nonmedical use of prescription medication different in rural and urban areas? How might prevention efforts and therapeutic interventions be tailored based upon 

these differences? 

• How can prescribing practices for pain, anxiety, depression, and attention deficit disorder 

optimize functional outcome while minimizing the potential for abuse? 

• Can effective drugs for weight loss and pain be developed that are less prone to abuse? 

122
Women and the Criminal Justice System 

Criminal justice system clients are an increasing proportion of admissions to substance abuse 

treatment, and women are the fastest growing population in the criminal justice system. Most 

are parents of multiple children. Although specific services continue to be developed to meet 

their needs, there is much to be learned about how to use resources effectively.9

 Although successful models for collaboration exist, the corrections emphasis on safety and control often 

conflicts with the principles of effective treatment for substance abuse problems. The following applies to incarcerated populations and those in the community on probation, parole, or 

with some other criminal justice system involvement.6

 Questions include the following: 

• What are the key access barriers to obtaining physical and mental health services for 

women in these settings? 

• What are the most common medical problems for incarcerated women? 

• What are the most common psychiatric problems for incarcerated women? 

• What is the quality of the health care they receive for these problems? 

• What are the successful interventions/programs for reducing the negative consequences 

for the children of incarcerated mothers? 

• What are the key elements of gender-responsive treatment for female offenders that reduce recidivism as well as alcohol and other drug use? 

• What are the distinctive impediments to implementing effective treatment within the 

criminal justice system? How does the “corrections culture” conflict with substance abuse 

treatment principles? 

• What are the successful models for treatment and criminal justice collaboration? 

• How can employment barriers be reduced for women with a criminal justice history? 

Conclusion 

Preventing and treating addiction in women in all life stages has important biological, 

psychological, financial, social, and cultural consequences. Research advances are necessary 

but insufficient to improve public health. The links among basic science, epidemiology, systems of prevention and care, and support for wellness and recovery need to be streamlined 

and strengthened. 

The focus of this paper has been to emphasize those research topics that have the potential for 

the greatest impact. Given scarce resources, it is most important to know what works, and what 

components of assessment, prevention, and treatment are most efficient and cost effective. 

The American Society of Addiction Medicine is grateful for the opportunity to contribute its 

research priorities on addiction and women to improve the future of women’s health. 

123
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9.	�Little Hoover Commission. (2004). Breaking the barriers for women on parole (Report 

No. 177). Sacramento, California: Author. 

Joan Zweben, Ph.D.; and Mishka Terplan, M.D., M.P.H., also contributed to this testimony. 

KATHLEEN BESINQUE, PHARM.D., M.S.ED. 

Association of Reproductive Health Professionals 

Recommendations From the Pharmacy Profession on Priorities for NIH Related to 

Reproductive Health 

My name is Kathleen Besinque. I am an Associate Professor of Clinical Pharmacy at the University of Southern California School of Pharmacy, a practicing pharmacist in women’s health 

care, and a member of the Board of Directors for the Association of Reproductive Health 

Professionals (ARHP). Thank you for the opportunity to speak to the Office of Research on 

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Women’s Health as you explore women’s health research priorities for the NIH for the coming years. As a leader in providing evidence-based interdisciplinary educational programming 

in broad areas of reproductive and sexual health, ARHP is trusted by healthcare professionals. 

Pharmacists are the fastest growing membership category for ARHP. 

I am speaking today to encourage the NIH to prioritize investment in the following areas: 

1. Research: Research is needed to evaluate the effects of the environment on reproductive health—Research into safety, toxicology, and most appropriate methods for 

discarding unused chemicals, including medications by consumers. 

2. Education: There is not enough curricular time in pharmacy education to cover all the 

topics that could/should be included in the Doctor of Pharmacy programs. There are 

significant gaps in the coverage of women’s health in general across the curricula within 

pharmacy education and there is little to no coverage on the topic of the environment 

and its impact on women’s health or reproductive health. 

3. The role of the pharmacist in providing health education is often under appreciated. 

Pharmacists are the “most accessible” healthcare professionals in the community—no 

appointment is needed to see a pharmacist and there is no charge to ask the pharmacist for advice. The pharmacist may, for many, be the first point of contact in the 

healthcare system, especially for those with limited access to the healthcare system 

who may visit a pharmacy seeking self-care remedies or advice. There is a pharmacy in 

almost every town, including rural environments where the effects of toxins, including 

pesticides, pose significant health risks to their communities. There is also a need for 

educational programs, including programs for students and practicing professionals, 

to support all of the members of the healthcare team in their efforts to educate their 

communities. 

4. Policy reform in the area of chemical safety: A pharmaceutical company is not able 

to promote a product for use in pregnant women without controlled studies demonstrating both efficacy and safety. All FDA-approved medications must contain in their 

product labeling a clear statement indicating if the drug has been studied in pregnant 

women and the outcome of those studies. This statement reminds everyone of the 

importance of determining the reproductive effects of a medication. Lessons from DES, 

Thalidomide, and Accutane have taught us about the effects of chemicals when taken 

by pregnant or soon-to-be pregnant women. 

In summary, I join in support of ARHP as a representative of the team including nurses, 

pharmacists, physicians, PAs, educators, and scientists in urging that the NIH prioritize 

the following: 

1. Development, evaluation, and dissemination of evidence-based, accredited reproductive environmental health educational resources that meet the current training and 

practice gaps in reproductive environmental health education and clinical care 

2. Support for chemical policy reform that restricts chemicals known to cause harm and 

invests in green chemistry that will provide safer alternatives that will protect the public’s health and the health of future generations 

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SUZAN GOODMAN, M.D., M.P.H. 

Association of Reproductive Health Professionals 

Testimony To Be Presented to the NIH Office of Research on Women’s Health 

by Suzan Goodman, M.D., M.P.H. 

My name is Dr. Suzan Goodman. I am a family and emergency physician; a UCSF faculty member; and Director of the TEACH Program, which integrates reproductive health curriculum into 

a number of Bay Area primary care residency programs. Today I am speaking to you as an 

active member of the Association of Reproductive Health Professionals (ARHP). I work with 

ARHP because it is a leading source of trusted education and information on reproductive 

health issues, and it supports first-rate science informing clinical decisionmaking across the 

entire healthcare team. 

After seeing multiple patients in the emergency department for respiratory problems following a particularly heavy pesticide spray in a nearby agricultural community, I was spurred 

to look more deeply into what is known about such exposures. Two of those patients were 

pregnant women, also concerned about risks for developmental and birth outcomes. What 

I learned is that even for pesticides with known deleterious effects such as atrazine, lindane, 

and endosulfan, there are limited mechanisms in place to track, study, or control related exposures. I also learned that as healthcare professionals, we do not have nearly as much data on 

pesticide health effects as we need to make the best recommendations to our patients. 

I started educating myself and my colleagues about endocrine-disrupting chemicals in common use, including pesticides, brominated flame retardants, heavy metals such as lead and 

mercury, and plastic components such as phthalates and bisphenol A. As a physician deeply 

committed to the scientific process, I know that we do not have the kind of time that it took 

for the DES exposure story to unfold, waiting for definitive proof of significant harm before 

taking action. As you know, our lessons from DES included that the placenta is a limited barrier, and that maternal exposures can have unexpected, delayed effects in offspring. I quickly 

learned why the absence of definitive evidence of cause-and-effect does not necessarily indicate absence of harm. 

Ethical concerns prevent us from ever being able to conduct randomized double-blind control trials on pregnant women to learn about health effects of suspected endocrine disruptors. 

Yet further research is needed. While the Centers for Disease Control and Prevention collects 

biomonitoring data on some 200 chemicals and their persistence in the body, these studies 

have not, to date, gathered data on amniotic fluid, cord blood, and breast milk. Additional data 

are needed on low-dose effects, combined effects of multiple chemicals and their cumulative 

impacts, and critical windows of exposure among vulnerable subpopulations. 

Under our current Toxic Substances Control Act (TSCA), tens of thousands of chemicals have 

been deemed “innocent until proven guilty,” with the burden of proof of harm primarily falling 

on the Environmental Protection Agency (EPA). The standard of evidence is set high enough 

that this burden of proof has been all but impossible to meet, as is illustrated by the EPA’s 

inability to prohibit the use of known hazards such as asbestos. The fact that TSCA does not 

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require the development of chemical hazard data ensures that scientific uncertainty will persist. In the face of such uncertainty and credible threats of harm, I join the ARHP in strongly 

supporting both a call for further research and, meanwhile, action based on the Precautionary Principle, which suggests that “when activity raises threats of harm to human health or the 

environment, precautionary measures should be taken, even if some cause-and-effect relationships are not fully established scientifically.” 

In summary, my recommendations to the NIH Office of Research on Women’s Health are 

as follows: 

1. Increase research on low-dose effects, cumulative impacts of multiple chemicals exposures, and critical windows of exposure among vulnerable subpopulations 

2. Expand biomonitoring of pregnant and breastfeeding women, newborns, and children 

under 6 years of age 

3. Develop educational resources for training clinicians to understand the science required 

to help reduce patients’ exposures to chemical hazards 

4. Require that chemical safety evaluations take into account the entire body of research 

(including studies by nonindustry-based researchers) 

5. Develop and support policies based on the Precautionary Principle in the absence of 

scientific certainty when taking any action that will affect public health, particularly 

with regards to exposures to women, infants, and children 

RIVKA GORDON, M.H.S., PA-C 

Association of Reproductive Health Professionals 

Incorporating Reproductive Environmental Health Into Reproductive Health Education and Advocacy 

My name is Rivka Gordon. I am a primary care physician assistant (PA), a women’s healthcare 

specialist, and the director of strategic initiatives with the Association of Reproductive Health 

Professionals (ARHP). Thank you for the opportunity to speak to the Office of Research on 

Women’s Health as you explore women’s health research priorities for the National Institutes 

of Health for the coming years. For nearly 50 years, ARHP has established itself as the leading 

source for trusted medical education on reproductive and sexual health. On behalf of its 11,000 

members, ARHP applauds the renewed commitment to develop priorities based on sound science and the fundamental value of scientific integrity. 

ARHP members represent the full healthcare team, physicians, nurses, nurse practitioners 

and midwives, PAs, pharmacists, scientists, and educators who provide reproductive health 

services, educate clinicians, conduct research, and influence policy. ARHP provides evidence-based programs on all that is current and urgent in reproductive health. ARHP defines 

reproductive health broadly and incorporates emerging science into its educational and policy 

activities. We have taken a leadership role in introducing reproductive environmental health 

science to the reproductive health field. 

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The emerging science that links reproductive health outcomes to environmental exposures is 

compelling and must be incorporated into reproductive health education and clinical practice. 

However, healthcare training programs, whether they be in medicine, nursing, pharmacy, or 

health education, are woefully deficient in any content that relates to the link between reproductive health and environmental exposures. 

Patients ask their clinicians about the safety of plastic baby bottles, whether to eat fish while 

they’re pregnant, and if their breast milk is toxic. Clinicians are challenged to understand the 

causes of reduced fecundity, early pregnancy loss, and pubertal development in very young 

girls. They are unsure of the best course of action in the absence of clinical guidelines that can 

take years to develop. All this is complicated by the assumption that animal data do not translate to human health outcomes and have limited application to patient care. 

To enable the reproductive health field to address these challenges, ARHP urges the NIH to 

prioritize investment in the following: 

1. Research that identifies gaps in clinicians’ critical assessment skills that limit their ability 

to integrate reproductive environmental health science into clinical practice. Ethical 

concerns prevent scientists from conducting randomized, double-blinded, placebocontrolled studies on women and children, exposing them to chemicals that show clear 

toxicity in animals. But the absence of evidence based on human randomized clinical 

trials does not mean absence of evidence of harm. Clinicians need the ability to assess 

the strength of the scientific literature, but a gap has been documented over the past 

decade showing that providers are not receiving critical appraisal skills training in undergraduate and graduate education.1,2 Because reproductive environmental health data 

are derived differently, this deficit in appraisal skills is particularly relevant. We need 

research that will identify the multitiered training and knowledge gaps that must be 

addressed to accomplish the full integration of environmental health into reproductive 

health care. 

2. Based on this research, ARHP urges an investment in effective, innovative, accredited 

educational programs that train the full range of healthcare professionals in critical 

appraisal skills so that they can guide their patients and help them to navigate the constant barrage of inaccurate, confusing, and often sensationalized information on health 

risks from the food they eat, the water they drink, the pharmaceuticals they take, the 

products they use, or the air they breathe. 

3. Success of these educational programs depends on evaluation of various training and 

educational modalities for their effectiveness in implementing change in clinical practice. Building on adult-learning theories, ARHP recommends developing and disseminating interactive, Web-based educational programs on reproductive environmental 

health and comparing the practice change outcomes with more traditional methods 

of learning. As a pioneer in Web-based educational programs, ARHP believes that 

reproductive environmental health topics are particularly suited to Web-based state-ofthe-art modalities. The Web provides the potential for reaching a greater number and 

more diverse cross-section of the healthcare field. It permits educational sessions to be 

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targeted to providers caring for patient populations that are impacted by particular environmental exposures. The Web has potential for creating networks of providers that 

can share knowledge and experience and, thereby, enhance patient care. 

4. And finally, as advocates in support of a healthy environment that provides women and 

men with the best opportunity to have a healthy child when and if they decide to do so, 

ARHP urges the NIH to support chemical policy reform and shift the “burden of proof” 

to the chemical manufacturers to demonstrate the safety of their products. Neither 

patients nor their healthcare providers can or should be expected to simply avoid exposures that might affect their health or the health of their families but are everywhere in 

their homes, schools, communities, and work places. ARHP joins with our environmental health colleagues to urge the NIH to support basic and applied research into green 

chemistry and to underscore the necessity of requiring industry to thoroughly test all 

chemicals, provide information on health hazards, and phase out persistent bioaccumulative toxicants. These “upstream” measures will provide support for a reproductive 

healthcare team that is educated about the effects of endocrine-disrupting chemicals 

and is motivated to improve the health and well-being of the families they care for. 

In sum, ARHP represents the reproductive health team including nurses, pharmacists, physicians, PAs, educators, and scientists in urging that the NIH prioritize the following: 

1. Development, evaluation, and dissemination of evidence-based, accredited reproductive environmental health educational resources that meet the current training and 

practice gaps in reproductive environmental health education and clinical care 

2. Support for chemical policy reform that restricts chemicals known to cause harm and 

invests in green chemistry that will provide safer alternatives that will protect the 

public’s health and the health of future generations 

References 

1. Caspi, O., Mcknight, P., Kruse, L., Cunningham, V., Figueredo, A.J., & Sechrest, L. (2006) 

Evidence-based medicine: Discrepancy between perceived competence and actual 

performance among graduating medical students. Medical Teacher, 28, 318–325. 

2. Grimes, D. A., Bachicha, J. A., & Learman, L. A. (1998). Teaching critical appraisal to 

medical students in obstetrics and gynecology. Obstetrics and Gynecology, 92(5), 

877–882. 

JOYCE BICHLER M.S.W. 

Breast Cancer Action 

Differences in Incidence and Mortality: Reducing Inequalities in Cancer 

Disparities—differences—in breast cancer incidence and mortality between and among different racial and ethnic groups are well documented. Social, political, and economic inequities 

play an important role in these differences, yet they are mostly ignored in discussions and 

research about breast cancer in different communities. 

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Social Determinants of Health 

While considerations of the social determinants of health are beginning to emerge in a number 

of health fields, the cancer world still focuses on genes and differences in screening patterns. 

Thus, while many people in public health understand that we can reduce the burden of asthma 

by focusing on the physical environments in which people live, the conversation in cancer 

focuses on the biological differences between people, or differences in personal behavior. 

For example, a recent study that focused on teenage girls showed that regular physical activity may reduce their risk for breast cancer later in life. A resulting news article admonished 

readers to “get your daughters off the couch.” Similarly, studies have shown an increased risk 

for breast cancer in postmenopausal women who are overweight. 

While these types of studies point to what might be done to reduce breast cancer risk, they 

miss the larger context of the social, economic, and historical reality in which many people 

lead their lives. The choices people make are shaped by the choices that are available to them. 

A healthy diet and regular exercise are important for all of us, but they are about far more than 

self-discipline. Some neighborhoods have easy access to healthy and organic foods; others 

have only fast food restaurants and liquor stores nearby. Some communities have safe streets 

and green environments in which to run and play, while others are unsafe to walk even during 

the daytime. Some have safe housing with minimal exposure to environmental contaminants, 

while others are near toxic release sites or live in communities built with cancer-causing materials. Like the hazardous waste facilities, these neighborhood differences follow a pattern. They 

reflect communities with differences in race and income. 

Breast Cancer Action (BCA) knows that differences in breast incidence and outcomes are 

about far more than lifestyle choices and biology. BCA has changed many conversations in 

breast cancer, and we must change this one, as well, so that people understand the social justice lens through which breast cancer needs to be seen and studied so that we eliminate the 

differences in breast cancer outcomes that affect different groups of people. 

Therefore, BCA aims to change the focus of discussions and research on inequities in a way 

that does not lead to racial or genetic stereotyping or marginalizing of affected groups. 

JOYCE BICHLER M.S.W. 

Breast Cancer Action 

Environmental Health Issues: Reducing Individual Risk and Preventing Breast Cancer in 

Populations of People 

The primary prevention of breast cancer means taking steps to keep breast cancer from ever 

developing. Breast Cancer Action (BCA) believes that the primary prevention of breast cancer in populations of people, and the reduction of the risk of breast cancer in individuals, 

must focus on identifying and eradicating the involuntary environmental exposures that are 

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contributing to the increased incidence of the disease. Since no one can honestly promise to 

be able to prevent a single case of breast cancer by eliminating environmental triggers, we 

refer to breast cancer risk reduction in individuals, and prevention of breast cancer in groups 

of people by making the policy changes that will reduce exposures to environmental triggers of cancer. The “Stopping Cancer Where It Starts” initiative refers to these larger policy 

changes of reducing everyone’s exposure to toxics and other cancer triggers, rather than personal changes made in hopes of keeping individuals from getting breast cancer. 

Issues of lifestyle that can be controlled by individuals are important, but are not BCA’s focus. 

We are concerned that this emphasis leads some women to blame themselves for getting sick. 

While it is laudable that others focus attention on healthy lifestyles, this information must be 

balanced with information on exposures that are outside a woman’s individual control and can 

contribute to her risk. 

A Precautionary Approach 

There is already sufficient scientific information to warrant policy changes to reduce exposures of toxins linked to breast cancer. Where sufficient evidence exists that something used 

in the environment is contributing to the risk of cancer, the manufacturers or proponents 

must be required to either show that the danger does not exist or to use less toxic alternatives if they are available. The decisions about whether the exposure should be reduced or 

eliminated, and what alternatives to use, must be made with the input of the community 

affected by the exposure. 

Balancing the Research Portfolio 

While policy changes move forward, society needs to balance current research expenditures 

for treatment for those living with cancer now, and reduction of the risk of breast cancer in 

future generations. Current research funding is heavily focused on developing new treatments 

for cancer, leaving underfunded the research necessary to keep people from developing the 

disease. We don’t necessarily need more funding for breast cancer research, but we do need 

to refocus how the available funds are spent. 

Developing New Scientific Tools 

Calling for more environmental research is not enough. Instead, we need research directed 

to developing tools that will allow us to link health outcome data to environmental exposure 

information. Health outcome data, as well as information on environmental exposures and 

their potential for contributing to breast cancer and other cancers, are becoming increasingly 

available. But we do not yet have the scientific tools necessary to link the exposure information to the health outcome data. This is where environmental research should focus now and 

into the future. 

Addressing Underlying Causes, Not Substituting Diseases 

BCA’s approach to risk reduction is based on the premise that we must address underlying 

causes to truly reduce the risk of the disease, and that any pill powerful enough to reduce a 

person’s risk of breast cancer is very likely to cause a different disease. Moreover, focusing on 

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the development of pills to “prevent” breast cancer diverts resources from the environmental 

research that is needed. We therefore oppose devoting resources to the development of pills 

to “prevent” breast cancer. 

Many communities bear a disproportionate burden of environmental exposures, which has 

implications for their health and well-being. These affected communities are entitled to participate in decisionmaking on how to address these exposures. And the inequities that lead to this 

disproportionate exposure need to be addressed by the cancer community. 

KASHA HO 

California Healthy Nail Salon Collaborative/Breast Cancer Action 

Ensuring the Health and Safety of Nail Salon and Cosmetology Workers: The Need for 

Workplace Toxic Exposure Research 

My name is Kasha Ho’okili Ho. I am a Program Associate at Breast Cancer Action, and I’m here 

representing the California Healthy Nail Salon Collaborative. Breast Cancer Action (BCA) is an 

education and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the breast cancer epidemic. Nearly 

20 years ago, BCA initiated the conversation to address toxic exposures and environmental 

links to breast cancer. Because of those early conversations, researchers and some mainstream 

breast cancer groups are now dedicating time and money to understanding those links. 

Breast Cancer Action believes that it is not just genes, but social injustices—political, economic, and racial inequities—that lead to disparities in breast cancer outcomes. Discussions of 

the social determinants of health are beginning to emerge in a number of health fields, but the 

cancer world still focuses on genes and differences in screening patterns. So, while many people in public health understand that we can reduce the burden of asthma by focusing on the 

physical environments in which people live, the conversation in cancer focuses on the biological differences between people, or differences in access to breast cancer screening. We know 

there is more to it than this. BCA has changed many conversations in breast cancer, and we 

will work to change this one as well, so that people understand the social justice lens in which 

breast cancer needs to be seen and studied if we are ever to be able to change the differences 

in breast cancer outcomes that affect different groups of people. 

BCA is a member of the California Healthy Nail Salon Collaborative (the Collaborative). We 

first collaborated in raising the concerns of toxic exposure among nail salon workers during the passing of the California Safe Cosmetics Act of 2005 (SB 484), of which BCA was a 

cosponsor. The California Healthy Nail Salon Collaborative was created in 2005 out of growing concern for the health and safety of nail salon and other cosmetology workers, owners, 

and consumers. The Collaborative uses policy advocacy, research, industry advocacy outreach, 

and education strategies to address health and safety concerns facing these communities. Our 

mission is to advance a preventative environmental health agenda for the nail salon and cosmetology sector in California. 

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The Collaborative’s members include nail salon workers and owners, cosmetologists, nonprofit 

and community organizations focused on environmental and reproductive health/justice, labor 

and Asian-American community health, educational institutions, and government agency allies. 

In California and throughout the United States, the beauty industry is booming. Over the past 

20 years, nail salon services have tripled and cosmetology is now the fastest growing profession in California. Currently, there are approximately 115,000 nail salon technicians in California, 

and most are women of color. Of these women, 59–80 percent are estimated to be Vietnamese immigrants, and more than 50 percent are of childbearing age. Many nail salon workers 

can earn less than $18,200 a year and work in conditions that can be hazardous to their health. 

On a daily basis, nail salon workers handle numerous solvents, glues, and other nail care products. These contain many chemicals known to and are suspected of causing acute and chronic 

illnesses, including cancer, respiratory problems, skin problems, and reproductive harm. There 

is very little State and Federal Government regulation of the chemicals used in these products. 

Also, little research has been done on the health issues that nail salon workers experience from 

long-term exposure to these chemicals. In fact, there are more than 10,000 chemicals used in 

personal care and nail products and yet 89 percent have not been tested independently for 

their impact on human health. Nail salon workers and other cosmetologists are at greater risk 

for health issues related to their work because of various challenges, such as language and 

cultural barriers and lack of access to health care. In addition, there is not enough culturally 

and linguistically appropriate education and outreach to this diverse population. 

Through the California Healthy Nail Salon Collaborative, advocates are working together at 

the intersection of workers rights, women’s rights, environmental and reproductive health/ 

justice, and Asian-American community health to advance greater worker health and safety 

for this sector. 

The California Healthy Nail Salon Collaborative has just produced a Report and Policy Agenda 

entitled, “Overexposed and Underinformed: Dismantling Barriers to Health and Safety in 

California Nail Salons.” This report articulates policy goals and recommendations aimed at 

improving the lives of nail technicians and salon owners, as well as benefitting consumers of 

nail care services. These include the following: 

• Improving access to occupational health and safety information 

• Reducing or eliminating toxic exposures and other health hazards in nail salons 

• Ensuring greater access to health care and occupational medicine 

The full Report and Policy Agenda is available for download at http://www.cahealthynailsalons.org. 

On April 27–28 of this year, the California Healthy Nail Salons Collaborative held a Research 

Convening in Oakland, CA, to set an agenda for “Protecting Worker Health and Safety in 

the Nation’s Nail Salons.” This groundbreaking event brought together, for the first time, 

more than 100 nail salon and cosmetology workers and owners, scientists, reproductive and 

environmental justice advocates, government representatives, policymakers, and community 

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and academic researchers from around the Nation to discuss the issue of occupational exposure to toxins in salons and identify priority areas of research needed to advance worker 

health and safety. 

Funding for this Research Convening was provided in part by the Breast Cancer Research 

Project, as concerns exist regarding the possibility of increased rates of breast cancer 

and other reproductive health impacts associated with working in the nail salon and 

cosmetology industry. 

Some of the research priorities identified at the Convening included the need for the following: 

• Study of cumulative chemical exposure on nail salon and cosmetology workers in 

nail salons (Currently, thresholds for “safe exposure” to chemicals are not set at levels 

appropriate for women of reproductive age, which most salon workers are, or for 

women who are pregnant, and do not take into consideration the cumulative effects 

of constant exposure throughout the work day as well as the synergistic effects of 

exposure to multiple chemicals). 

• Human health studies, descriptive data, and other research that examines chronic 

health effects related to nail salon and cosmetology workers’ exposure to toxins in 

their workplace 

• Studies of safer alternative products for use in nail salons 

• Study of appropriate health and safety precautions in nail salons to protect worker and 

customer health, which includes improving air quality 

A full report summarizing these findings will be available from the California Healthy Nail 

Salon Collaborative within the next few months. 

Despite tremendous growth in the nail salon and cosmetology industry, I would like to emphasize that, to date, there are no published studies examining chronic health outcomes, such as 

birth defects, infertility, or cancers, specifically in nail salon workers. Advocates and scientists 

are increasingly calling for additional research. Biomonitoring projects, cumulative chemical exposure, indoor air, and longevity studies by specific health outcomes are all needed to 

address data gaps and advance an overall understanding of the health impacts associated 

with this sector’s workplace exposures. Given the high level of concerns expressed by advocates, scientists, community members, and consumers alike nationwide, we, as the California 

Healthy Nail Salon Collaborative members, feel it is of utmost importance to ensure that the 

health and safety of nail salon and cosmetology workers, the majority whom are of reproductive age and female, has a place on NIH’s women’s health research agenda. 

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DEBRA BINGHAM, DR.P.H., RN 

California Maternal Quality Care Collaborative 

Improving the Quality of Maternity Care 

Mainstream obstetrics and public health officials now acknowledge a growing and serious problem: The U.S. maternal mortality rate is steadily increasing after several decades 

of decline. No one is sure of the reasons why and case ascertainment does not adequately 

account for these worsening trends. In 2006, the Health Resources and Services Administration reported that the national maternal mortality rate was 15.1 per 100,000, or 84 percent 

higher than the rate reported in 1990 (8.2 per 100,000). Although actual numbers are small— 

4 million births per year translates into 623 women dying—maternal death is considered a 

sentinel event. For every death, 50–100 women suffer a severe morbidity, with an average of 

5.1 hospitalizations.1

 Moreover, maternal complications were the fourth leading cause of infant 

death in 2005. The World Health Organization reported that the U.S. ranked 41st among 

developed countries for maternal deaths in 2005, despite spending $2 trillion on health care 

that year, 16 percent of the Nation’s Gross Domestic Product.2 

Efforts to address this alarming situation are underway. Maternity care advocates are turning their attention to quality improvement, essentially the implementation of evidence-based 

care.3

 This represents a new focus for obstetrics, compared to other medical specialties, such 

as neonatal intensive care, cardiology, or internal medicine, which have long had institutionalized systems for designing, measuring, and tracking specific data points to signal quality in 

medical care. One immediate challenge is to identify quality indicators of maternal health care 

that can be used for comparative and assessment purposes, such as the 17 perinatal measures 

the National Quality Forum recently adopted. 

When population-level data are utilized to provide comparative assessments of healthcare 

quality, the findings illustrate large variations in medical practice. The Dartmouth Atlas Project is one such example, but their source of data, Medicare, does not allow for examination of 

birth trends. However, in our early analyses of obstetrical outcomes in California, we see large 

variation, at the hospital level, in rates of primary cesareans among low-risk women. These 

data highlight the possibility for changing medical practice to better reflect best evidence and 

yield more optimal outcomes for patients. As these data become available, many questions 

remain as to how they can be best utilized to inform change at the institutional level. 

In California, our group is identifying compelling questions arising out of population-level data: 

Why are first-time, young, healthy Latina women who present in labor with a head down singleton more likely to experience labor induction, augmentation, and cesarean surgeries than 

other groups in one county? How is it that African-American women are more than three times 

more likely to die from obstetric hemorrhage, although they are not at greater risk prenatally 

than other racial/ethnic groups? 

Clinicians are realizing that analyzing quantitative data is only the first step toward changing 

behaviors, and are acknowledging that healthcare culture drives much of this practice variation. Yet most clinician researchers are untrained in the methods best suited to discovering 

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how to maximize quality improvement efforts—ethnography and qualitative research. 

Clinicians whose careers have been dedicated to quality improvement in health care are 

increasingly aware of the value of such approaches. Donald M. Berwick (Institute for Healthcare Improvement) has argued for a wider embrace of methodologies beyond the “gold 

standard” randomized control trial, to assist quality improvement efforts in health care. 

In particular, he informs his clinical colleagues that approaches such as “ethnography, 

anthropology, and other qualitative methods ... are not compromises in learning how to 

improve; they are superior.”4 

Clinicians (and maternity care advocates) have long relied on population data to make the 

case that evidence-based care can improve maternal and infant health outcomes. To do this, 

however, Berwick claims that clinician advocates, and the administrators and policymakers to 

whom they must answer, “need information on both mechanisms (i.e., the ways in which specific social programs actually produce social changes) and contexts (i.e., local conditions that 

could have influenced the outcomes of interest).” 

Women’s Health Research Opportunities 

There is, therefore, an exciting and urgent opportunity for research on women’s experiences of 

birth and especially among the women who experience adverse obstetric events to contribute 

to quality improvement in obstetrics. Outcome research using population variables is limited in 

its ability to shed light into clinicians’ everyday obstetric practices or on the processes of care 

that women receive once admitted to the hospital. There has been little ethnographic study 

of hospital birth in the United States since Brigitte Jordan and Nancy Stoller Shaw’s groundbreaking work in the early 1970s. In contrast, much social science research on U.S. childbirth 

has largely focused on the 1 percent of women choosing homebirth and their midwives, a 

number that has remained constant for more than 30 years. Focusing on edge cases leaves 

mainstream obstetrics and everyday practices in hospital birth unexamined. There have been 

very few ethnographic studies of more prevalent maternity care roles, such as doulas, childbirth educators, labor and delivery nurses, and obstetricians. 

Improving childbirth outcomes in the United States will require thick description and earnest 

efforts to understand the cultures that have created current obstetric practices and the variation that exists within and between them. More than 99 percent of U.S. women are giving 

birth in hospital settings; without systematic ethnographic research findings, these women will 

not be fully informed on how obstetric care is delivered, in all its variation. Additional funding 

for systematic ethnographic research into local cultures of obstetric practice can help inform 

birthing women and clinicians, and work to improve the quality of care in childbirth. 

Ethnographers are uniquely positioned with the tools to assess the gap between formal 

quality assessment measures and how work actually takes place by observing social interactions; indeed, we have long been doing this in other work settings. Reproductive researchers 

urgently need to turn their attention to the task of gathering systematic empirical data on 

everyday practices in labor and delivery units, in a number of hospital settings. We must begin 

talking to obstetricians, labor and delivery nurses, other hospital workers, and birthing women 

about their views of, and experiences with, hospital birth. 

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Summary of Recommendations 

1. Ensure thorough examination at the national and local levels of both maternal mortality 

and morbidity trends 

2. Develop a maternity-specific Atlas project to track variation in both processes and 

outcomes of care 

3. Increase adoption of quality improvement indicators and enhance quality improvement 

leadership capacity at the frontlines 

4. Increase research in culture and processes by funding ethnographic and other qualitative research on quality improvement work in maternity care 

References 

1. Callaghan, W. M., Mackay, A. P., Berg, C. J. (2008). Identification of severe maternal 

morbidity during delivery hospitalizations, United States, 1991–2003. American Journal 

of Obstetrics and Gynecology, 199, 133.e1–e8. 

2. Hill, K., Thomas, K., AbouZahr, C., Walker, N., Say, L., Inoue, M., & Suzuki, E.; Maternal 

Mortality Working Group. (2007). Estimates of maternal mortality worldwide between 

1990 and 2005: An assessment of available data. The Lancet, 370, 1311–1319. 

3. Sakala, C. & Corry, M.P. (2008). Evidence-based maternity care: What it is and what it 

can achieve. Milbank Memorial Fund, Childbirth Connection, and the Reforming States 

Group. Retrieved from http://www.milbank.org/reports/0809MaternityCare/0809Mater 

nityCare.html 

4. Berwick, D. M. (2008). The science of improvement. Journal of the American Medical 

Association, 299, 1182–1184. 

HEATHER SARANTIS, M.S. 

Commonweal 

Women’s Health and Environment Initiative 

Thank you for the opportunity to speak today. My name is Heather Sarantis and I am the 

Women’s Health Program Manager at Commonweal, a nonprofit organization based in 

Bolinas, CA. One of my roles at Commonweal is to coordinate the Women’s Health and 

Environment Initiative, a national network of leaders in environmental health, environmental 

justice, reproductive health, and reproductive justice. We have been working to build bridges 

between our organizations in order to overcome the social, political, and scientific barriers 

to a healthier world. 

Health problems and disabilities such as asthma, birth defects, cancer, diabetes, and infertility affect more than 100 million men, women, and children, or about one-third of the U.S. 

population. Scientific research shows that exposure to chemicals may increase a person’s risk 

for these and other health concerns. Pregnancy and early childhood are especially vulnerable 

times, but exposure throughout our lives can be harmful. 

137
We can be exposed to chemicals from household products, food, air pollution from vehicles or 

factories, hazardous waste sites, and other sources. Chemicals can be found in many homes, 

communities, schools, and workplaces. 

With thousands of chemicals in use, more research is needed to understand how they affect 

human health. I am especially interested in research on links between exposure to chemicals 

and the impacts on pregnancy, fertility, reproductive health, and women’s health. 

We need better understanding of the cumulative effects of exposure to multiple chemicals. 

This includes low-level exposures from multiple sources, such as from everyday use of cosmetics, cleaners, and other consumer products. 

We need research that supports better understanding of the disproportionate impacts of 

chemical exposure in the workplace. 

We need a greater emphasis on community-based research, which is essential for improving our understanding of disproportionate impacts on highly exposed communities, especially 

communities of color, and vulnerable populations. 

We need to expand and modernize our health and environmental tracking infrastructure so we 

can better understand and prevent environmental contributors to disease. 

Finally, we also need to expand and modernize biomonitoring efforts that provide important 

information on what chemicals we are being exposed to across the population. 

KARI CHRISTIANSON 

DES Action USA 

Prenatal DES Exposure: Research Needed for the Generations 

Thank you to the National Institutes of Health, the Office of Research on Women’s Health and 

the University of California, San Francisco for this opportunity to provide written testimony 

about the research concerns of almost 10 million diethylstilbestrol (DES)-exposed people in 

the United States. 

For more than 30 years, DES Action USA has been advocating for individuals who were 

prenatally exposed to DES. DES Action is the national, nonprofit consumer organization 

dedicated to helping DES-exposed individuals with important health information, to informing 

the public and healthcare professionals about the health and fertility concerns related to DES, 

and to advocating for research about the health effects to all generations affected by exposure to DES. 

138
Many terms that could be used to describe the DES-exposed population: the canaries in the 

endocrine-disruptor coalmine, the silent generation of infertility and reproductive tract cancer, 

the forgotten medical tragedy. But these limited descriptions carry the stories of real people 

who have suffered a range of health concerns, many of which have been ignored or dismissed 

by healthcare providers. Without the research efforts of the National Institutes of Health, this 

population would never have been studied at all. 

It is with acknowledgement of what already has been learned from studying DES exposure 

that we advocate for renewed emphasis on DES research. There is still much that can be and 

needs to be learned about DES exposure, particularly as the research community continues to 

find increased risks for adverse health effects among DES Daughters and needs to assess real 

and potential health concerns of DES Granddaughters. 

In the past few years, the National Cancer Institute DES Followup Study found an almost twofold increase in breast cancer risk among DES Daughters over the age of 40, an increased 

incidence in uterine fibroids and paraovarian cysts, and a slightly earlier onset of menopause. 

These findings have been added to the small but lifelong risk for clear cell adenocarcinoma 

of the vagina or cervix; a higher incidence of neoplasia; and structure changes of the reproductive tract, including the vagina, cervix, uterus, fallopian tubes, and ovaries, which can 

adversely affect fertility, causing a higher risk for ectopic pregnancy, miscarriage, preterm 

labor, and infertility. 

Research on the health effects of DES Granddaughters, another generation affected by the 

DES given to their grandmothers, is of great need now. Recent studies have indicated there 

may be some concern about overall fertility based on the delayed onset of menstrual regularity. Also, there was the troubling finding of several cases of ovarian cancer within the cohort 

of DES Granddaughters. These preliminary findings require more research, not only for this 

generation of the DES population, but also for researchers and the public concerned about all 

epigenetic exposures to hormonally active substances. 

The DES-exposed cohorts of the National Cancer Institute are the best available populations 

for continued research into the effects of DES, the first known endocrine disruptor, and for 

understanding the health effects of generational exposures. The DES-exposed population of 

daughters and granddaughters provides the opportunity to understand developmental biology, emerging diseases and conditions that may affect women’s health differently, and to 

address how research information can be and is translated to healthcare delivery. 

Most certainly, for the DES-exposed population, “Moving Into the Future” means 

continuing to learn from this human tragedy, which has been and still is a vital and timely 

research opportunity. 

139
BETSY RASMUSSEN 

Endometriosis Association 

Endometriosis, Toxins, and Reproductive Health 

Organization Background 

The Endometriosis Association is a nonprofit organization that exists to provide education and 

support to women and girls suffering from endometriosis and to conduct research to identify 

a cause and cure for the disease. 

Endometriosis, Toxins, and Reproductive Health 

Endometriosis is a disease of the endocrine and immune systems in which tissue similar to the 

endometrial tissue of the uterus occurs abnormally in other areas of the abdomen, causing 

pain, fatigue, intestinal upset, heavy or irregular periods, painful sexual intercourse, dizziness, 

headaches, low resistance to infections, and/or infertility. Infertility afflicts 30 to 40 percent of 

women with endometriosis and is a common result with progression of the disease. 

Incidence of endometriosis, which was considered relatively rare even in the early 1980s, has 

been skyrocketing. Affecting at least 7.5 million women and girls in the United States and Canada, it afflicts millions more worldwide. Advances in diagnosis and reporting do not explain 

the current epidemic rates of endometriosis. Greater awareness fails to explain documented 

increased rates of hysterectomies due to endometriosis, most notably in teenage girls. It has 

been established, however, that endometriosis is a disease related to environmental toxins. In 

fact, it is one of the first diseases to be linked to persistent organic pollutants in humans. Since 

1992, Endometriosis Association research findings have been showing that dioxins (chemicals 

that mimic hormones or cause other dysfunctions in the endocrine and immune systems) can 

cause the development of endometriosis. 

There is also a growing concern that these same hormonally active chemicals are accelerating 

the onset of puberty. According to a recent study in the Journal of Pediatrics, girls in the United 

States are reaching puberty earlier than ever. Nearly half of African-American girls and 15 percent of Caucasian girls are beginning to develop sexually at the age of eight. The authors of the 

study called for more investigation into whether hormonally active chemicals are responsible for 

these findings. Results of a 1998 study by the Endometriosis Association revealed that the earlier 

the onset of endometriosis symptoms, the greater the length of time before diagnosis, the more 

severe the symptoms, and the wider the variety of symptoms young women experienced. 

Endocrine disruptors can have other negative effects on the female reproductive system, 

as well, including increased risk of breast cancer, altered menstruation, decreased fertility, 

increased miscarriages, and early menopause. 

Since 1999, the Endometriosis Association has partnered with the Vanderbilt University School 

of Medicine to fund and coordinate a team of scientists to research endometriosis. This scientific team has led the way in understanding the impact of embryonic exposure to dioxins. They 

found that exposure to dioxins in the womb during the early part of pregnancy is toxic, and 

140
that toxicity extends into many generations in the future. The Vanderbilt team described some 

of their recent work in epigenetics this way: “We have recently demonstrated adult endometrial dysfunction in mice following developmental exposure to TCDD [dioxin]. Endometrial 

changes were markedly similar to alterations observed in the endometrium of women with 

endometriosis, and it resulted in reduced progesterone responsiveness and infertility.” 

Following are more key findings of the Endometriosis Association Research Program at Vanderbilt University School of Medicine regarding endometriosis, environmental pollutants, and 

reproductive health: 

• Identified that in utero and developmental dioxin exposure in mice creates the same 

endometrial phenotype observed in women with endometriosis 

• Discovered an epigenetic link between dioxin action and the loss of progesterone 

response observed in women with endometriosis 

• Presented evidence that dioxin exposure leads to an altered pathway of cell–cell 

communication in the endometrium that mimics an inflammatory-like event 

• Discovered developmental exposure of mice to dioxin leads to disruption of endometrial 

function for multiple generations, suggesting this toxicant can impact endometrial biology through the germline 

• Demonstrated that nutritional anti-inflammatory agents such as fish oil can provide 

some protection against the disruptive impact of dioxin on endometrial function 

Endometriosis is, without question, one of the most puzzling diseases affecting women and 

girls. While the lives of some girls and women are relatively unaffected by endometriosis, too 

many others have suffered severe pain and emotional stress, have at times been unable to 

work or carry on normal activities, and have experienced financial and relationship problems 

because of the disease. We need to know more about the effect environmental toxins play in 

the lifelong health of girls and women with endometriosis. Please choose to help the millions 

suffering with this life-altering disease. 

ASPEN BAKER 

Exhale 

The Science of Support: Why We Need Research That Promotes Well-Being After an Abortion 

In a recent New York Times interview about health care, President Obama said, “Consumers 

have gotten more active in their own treatments in a way that’s very useful. And I think that 

should continue to be encouraged. To the extent that we can provide consumers with more 

information about their own well-being—that, I think, can be helpful.” 

My name is Aspen Baker and I am here to testify and advocate for research to better understand what women and their loved ones need after an abortion in order to support their own 

emotional well-being. 

141
I am the founder and executive director of Exhale (www.4exhale.org), an Oakland, California-based national nonprofit organization that provides direct emotional support services to 

women and their loved ones after an abortion. 

Our service is nonjudgmental and without political affiliation. Our mission is to create a social 

climate in which each person’s unique experience with abortion is respected, supported, and 

free from stigma. We call that mission “pro-voice.” 

Exhale is a nationally renowned, award-winning, multilingual organization. We have been featured in Glamour magazine, the New York Times magazine, and on National Public Radio and 

CNN, among many other media outlets. We are currently partnering with the Advancing New 

Standards in Reproductive Health program at the University of California, San Francisco to 

study women’s emotions after an abortion, a research project that is the first of its kind. 

In my testimony today, I will 1) share my own personal experience with abortion, which led 

me to found Exhale; 2) describe the work of Exhale and what we have learned from women 

regarding their own well-being after an abortion; 3) describe the social and political landscape in which abortions take place today, and how Americans’ view of emotional health 

has changed; 4) explain how past research on abortion and mental health falls short; and 

5) explain what new research is necessary for women’s health and well-being today. 

Personal Experience Led to the Founding of Exhale and a 

Nonjudgmental Talkline 

Ten years ago in August, I had an abortion. I was 23 years old. I had just graduated from college, and I made what was for me the very difficult decision to end my pregnancy. After the 

abortion, I remember feeling relieved that the angst-ridden decisionmaking process had finally 

come to an end, as well as the unfamiliar medical procedure, which I had been dreading, to say 

the least. 

I also remember feeling totally surprised that nowhere in the chain of medical services did 

anyone talk to me about what I might expect to feel afterward, or what I could do to take care 

of myself emotionally. No one offered me any resources to contact afterward for counseling, 

should I need to. My abortion, while a simple medical procedure, was personally, a very emotional one, and I wanted support in acknowledging and processing those feelings. 

When I looked for resources myself, I found instead politically and emotionally charged services 

that claimed to support me if I felt traumatized, or if I felt liberated. Nowhere did I find sound, 

helpful information grounded in credible research into women’s real experiences after abortion. 

Today’s Social and Political Landscape, and New Beliefs About 

Emotional Health 

What I didn’t know then, but what I know now, is that I was not alone, either in my abortion 

experience, or in my search for information about my own emotional well-being. 

142
According to the Guttmacher Institute, abortion remains one of the most commonly performed medical procedures in the United States, and approximately one in three women will 

have one in her lifetime. In 2005, 1.21 million abortions were performed, down from 1.31 million abortions in 2000. In 2005, 208,430 women obtained abortions in California, a rate of 

27.1 abortions per 1,000 women of reproductive age. The rate declined 13 percent since 2000, 

when it was 31.2 abortions per 1,000 women ages 15–44. Abortions in California represent 17.3 

of all abortions in the United States. In short, abortion is incredibly common. 

And yet, as we all know, abortion is so much more than a simple medical procedure. It is at 

the center of a major political and moral debate that has been raging for decades. The debate 

raises important questions about our ideals and our values around human rights, women’s 

health, and fetal life. Human dignity is also at stake in this debate, as opposing sides attack 

each other on emotional, political, and social grounds. In fact, as we all know, the conflict over 

abortion can be so intense that it is commonly referred to as a war. 

But while this “war” around abortion has raged, American life has changed dramatically. 

Research shows we’ve increased our emotional intelligence, our emotional IQ. We have gained 

a respect, understanding, and a vocabulary for feelings about a whole range of life events, 

and we see the importance of being able to identify, share, and process those feelings. We 

want to know how to be physically and emotionally well, through good times and bad, and we 

expect our healthcare providers to be able to give us the information, resources, and support 

that help us experience well-being. We also take a much more active role in our own health, as 

President Obama said in his interview. 

But when it comes to abortion, no research exists to help us do that. We need new scientific 

research to better understand what women and their loved ones need after an abortion in 

order to support their own emotional well-being, and help them take a leadership role in their 

own care. 

What Women and Healthcare Providers Are Telling Exhale 

I founded Exhale in 2000, and in 2002, we launched the Nation’s first post-abortion talkline in 

the Bay Area, that is neither religion-based nor politically affiliated. My cofounders and I envisioned Exhale as a safe space for every woman who has had an abortion, and her loved ones, 

across the range of experiences, beliefs, and political persuasions. At Exhale, we believe that 

after an abortion, whether you are pro-life or pro-choice, you deserve to have your own unique 

experience seen and heard, and to get what you need for your long-term emotional wellbeing. This is the “pro-voice” message. 

Exhale’s national, multilingual talkline is operated by trained peer counselors who have undergone extensive training in our empowerment-based model. The number one way people learn 

about our service is through direct referral from abortion providers throughout the Nation. The 

second—and the fastest growing—way people learn about our service is through the Internet. They find Exhale after searching for “abortion counseling,” “after-abortion support,” and 

“women after abortion,” among many other terms. 

143
We know that after an abortion, many women go online to search for ways to share, connect, 

and communicate about their personal experience with others who can relate to them and 

support them in a nonjudgmental and respectful way. We believe this is a positive trend that 

can produce even more support for women if they also find, in addition to nonjudgmental services like Exhale, sound and helpful information that is the result of good research. 

Since its launch in 2002, Exhale’s post-abortion talkline has received more than 18,000 calls. 

We reach more than 35,000 women every year through our outreach and education efforts. 

We have trained more than 100 Bay Area women to be volunteer counselors on our talkline, 

and we recently received an award for “Excellence in Nonprofit Volunteer Management” from 

the Volunteer Center of the Bay Area. 

Because of Exhale, women now have more access to nonjudgmental emotional support after 

an abortion than ever before. At a clinic, they are now more likely to speak to a staff person 

who is trained to discuss emotions around abortion, and they are more likely to receive a referral to the Exhale talkline or other nonjudgmental resources. Previously unheard-of resources 

are now available to them: They can read other women’s stories online in our zine and in 

several mainstream media publications, thanks to our outreach; they can send or receive a 

postabortion e-card that recognizes their unique experience; and they can engage in pro-voice 

advocacy by sharing their personal abortion stories in a public forum, like a blog or Web video 

channel hosted by a nonjudgmental resource. 

Exhale’s efforts over the past 7 years have made a significant difference in the lives and emotional well-being of women who have had abortions, and their loved ones. They are able to 

take a leadership role in their own well-being. But there’s more to be done. 

We need you, the National Institutes of Health, to join us in our mission to understand, 

acknowledge, and support the emotional needs of women postabortion. We need research 

that helps us better understand women’s emotional experiences, and that research provides 

women with the helpful information they need to support their own well-being and their own 

mental and reproductive health. 

Why Past Research Is Not Enough 

Since the 1970s, research regarding women’s emotions around abortion has focused on 

whether abortion, on its own, has negative consequences for women’s mental health, and the 

research was meant to serve one side of the political debate or the other. 

Famously, the Surgeon General under President Reagan determined that despite the popular claim that abortion has negative consequences on women’s psychological health, the data 

behind that claim were insufficient. Most recently, in 2008, the American Psychological Association completed another review of existing literature and concluded there is no evidence 

of negative mental health effects from abortion. They found that the research that did show 

negative emotional impact had severe methodological flaws that made the data unreliable. 

Further scientific inquiry into women’s mental health after an abortion has found other predictors for poor mental health outcomes, including pre-existing mental health conditions; a lack 

144
of social support; a lack of self-esteem; and the heated public controversy around abortion, 

just to name a few. It is safe to say that there is scientific agreement that abortion, on its own, 

rarely causes severe negative outcomes for a woman’s mental health. 

But what else about women’s emotional well-being after an abortion has been determined by 

science, beyond the fact that abortion, on its own, does not damage women’s mental health? 

At a time when the emotional experience of any life event is publicly accepted as important 

and relevant to our overall health and wellness, there remains a great deal to be studied and 

researched about abortion. 

Today, more than ever, there is a great need for sound, thorough research into women’s emotional well-being after an abortion. The abortion procedure is so common; the families and 

communities impacted are so diverse; the debate around abortion is so loud; and the overwhelming stigma—which, according to NIH’s own definition, “threatens psychological and 

physical well-being, and helps to perpetuate health inequalities within societies”—is so harmful 

that it is time for the National Institutes of Health to proactively address the emotional needs 

of women who have abortions by using its support and resources to undertake and share 

sound, thorough research into women’s real experiences. 

This research would accomplish the following: 

• Assess the psychological and emotional needs of women after an abortion 

• Evaluate the effects of different postabortion emotional support models on a woman’s 

well-being 

• Examine men’s emotional experience with abortion 

• Understand the characteristics of healthy coping after an abortion in diverse communities 

• Explore the connection between the social experience and the emotional experience 

of abortion 

Why This Research Matters 

It is critical that the National Institutes of Health address emotional and mental health as part 

of its strategies to promote women’s health and wellness. And when an issue is as common 

and as contentious as abortion, it is even more critical. Not only can research promote longterm emotional well-being, it can also dispel politically and emotionally charged claims that 

distract from emotional well-being. 

Benefits of this research include the following: 

• Provide medical and emotional care providers with the information we need to support 

patients’ emotional resiliency and well-being in the long term 

• Provide intimate partners, family members, and communities with information about 

how to be a source of comfort and support for their loved ones and each other 

145
• Provide women with the tools and information to make well-informed decisions about 

their health, including pregnancy and abortion, and strategies to promote their own 

emotional well-being 

• Provide information to women and healthcare providers about appropriate interventions and responses when a woman does have negative emotional consequences after 

an abortion 

As a woman who has had an abortion, as the cofounder of an organization that now serves 

thousands of women and men each year, and as a peer counselor who has listened to many 

women share their stories and their feelings after an abortion, I know that Exhale has already 

met a need, just by providing safe, nonjudgmental emotional support for women and men 

after an abortion. 

But I also know that we need to do more. We need to provide women and men with the 

kind of helpful, well-researched information that supports their well-being after an abortion. 

We need sound, detailed research that addresses the broad range of experiences and feelings people have around abortion, immediately afterward, and far into the future. We need 

research that reflects the real experiences of people like the women and men who call Exhale 

to share their stories, receive emotional support, and achieve emotional well-being. 

Today, I call on the National Institutes of Health to join us in this work. I ask the NIH to take a 

leadership role, as only it can, in providing the research and information that will help today’s 

healthcare providers and patients achieve emotional well-being after an abortion. 

DANIELLE THOMAS 

Exhale 

The Science of Support: Why We Need Research That Promotes Well-Being After an Abortion 

Introduction 

In a recent New York Times interview about health care, President Obama said: “Consumers 

have gotten more active in their own treatments in a way that’s very useful. And I think that 

should continue to be encouraged. To the extent that we can provide consumers with more 

information about their own well-being—that, I think, can be helpful. 

My name is Danielle Thomas and I am here to testify and advocate for research to better 

understand what women and their loved ones need after an abortion in order to support their 

own emotional well-being. 

I am an After-Abortion Peer Counselor at Exhale (www.4exhale.org), an Oakland, Californiabased national nonprofit organization that provides direct emotional support services to 

women and their loved ones after an abortion. 

146
Our service is nonjudgmental and without political affiliation. Our mission is to create a social 

climate in which each person’s unique experience with abortion is respected, supported, and 

free from stigma. We call that mission “pro-voice.” 

Exhale is a nationally renowned, award-winning, multilingual organization. We have been featured in Glamour magazine, the New York Times magazine, and on National Public Radio and 

CNN, among many others. We are currently partnering with the Advancing New Standards in 

Reproductive Health program at University of California–San Francisco to study women’s emotions after an abortion, a research project that is the first of its kind. 

In my testimony today, I will do the following: 

• Share my volunteer experience as an After-Abortion Peer Counselor 

• Describe the work of Exhale and what we have learned from women regarding their own 

well-being after an abortion 

• Describe the social and political landscape in which abortions take place today, and how 

Americans’ view of emotional health has changed 

• Explain how past research on abortion and mental health falls short 

• Explain what new research is necessary for women’s health and well-being today 

Volunteer Experience as an After-Abortion Counselor 

“I’m so glad this service exists” is a statement I hear frequently as a counselor on the Exhale 

talkline. Many times, women have no support or safe space to speak about their abortion 

experience. Exhale provides that support and space, and I continually bare witness to the positive impact the counseling model has on the emotional health of our callers. 

A prevalent emotion in my calls is one of surprise. Women are surprised that the feelings 

they’re having are experienced by others, that abortion happens a lot, and that people still 

aren’t talking about it. These simple facts are surprises because as a society, we still haven’t 

made it okay to talk about abortion in a safe and understanding way. These women and the 

people in their lives desperately want to connect with others who’ve had similar experiences. 

Women with abortion experiences long for a place where they can be understood and accepted. 

The Exhale talkline allows callers to share their story free from judgment and stigma and the 

more shifts I have, the more I realize this environment isn’t available anywhere else. The lack 

of availability of this thinking and space coupled with the impact I see drives me to dedicate 

myself to Exhale and its mission more and more. This environment and the “pro-voice” spirit 

are true catalysts for change. 

147
Today’s Social and Political Landscape, and New Beliefs About 

Emotional Health 

According to the Guttmacher Institute, abortion remains one of the most commonly performed medical procedures in the United States, and approximately one in three women will 

have one in her lifetime. 

In 2005, 1.21 million abortions were performed, down from 1.31 million abortions in 2000. In 

2005, 208,430 women obtained abortions in California, a rate of 27.1 abortions per 1,000 

women of reproductive age. The rate declined 13 percent since 2000, when it was 31.2 abortions per 1,000 women ages 15–44. Abortions in California represent 17.3 of all abortions in the 

United States. In short, abortion is incredibly common. 

And yet, as we all know, abortion is so much more than a simple medical procedure. It is at 

the center of a major political and moral debate that has been raging for decades. The debate 

raises important questions about our ideals and our values around human rights, women’s 

health, and fetal life. Human dignity is also at stake in this debate, as opposing sides attack 

each other on emotional, political, and social grounds. In fact, as we all know, the conflict over 

abortion can be so intense that it is commonly referred to as a war. 

But while this “war” around abortion has raged, American life has changed dramatically. 

Research shows we’ve increased our emotional intelligence, our emotional IQ. We have gained 

a respect, understanding, and a vocabulary for feelings about a whole range of life events, and 

we see the importance of being able to identify, share, and process those feelings. We want to 

know how to be physically and emotionally well, through good times and bad, and we expect 

our healthcare providers to be able to give us the information, resources, and support that 

helps us experience well-being. We also take a much more active role in our own health, as 

President Obama said in his interview. 

But when it comes to abortion, no research exists to help us do that. We need new scientific 

research to better understand what women and their loved ones need after an abortion in 

order to support their own emotional well-being, and help them take a leadership role in their 

own care. 

What Women and Healthcare Providers Are Telling Exhale 

In 2002, Exhale launched the Nation’s first postabortion talkline in the Bay Area that is neither religion based nor politically affiliated. The cofounders envisioned Exhale as a safe 

space for every woman who has had an abortion, and her loved ones, across the range of 

experiences, beliefs, and political persuasions. At Exhale, we believe that after an abortion, 

whether you are pro-life or pro-choice, you deserve to have your own unique experience 

seen and heard, and to get what you need for your long-term emotional well-being. This is 

the “pro-voice” message. 

Exhale’s national, multilingual talkline is operated by trained peer counselors who have undergone extensive training in our empowerment-based model. The number one way people learn 

about our service is through direct referral from abortion providers throughout the Nation. The 

148
second—and the fastest growing—way people learn about our service is through the Internet. They find Exhale after searching for “abortion counseling,” “after-abortion support,” and 

“women after abortion,” among many other terms. 

We know that after an abortion, many women go online to search for ways to share, connect, 

and communicate about their personal experience with others who can relate to them and 

support them in a nonjudgmental and respectful way. We believe this is a positive trend that 

can produce even more support for women if they also find, in addition to nonjudgmental services like Exhale, sound and helpful information that is the result of good research. 

Since its launch in 2002, Exhale’s postabortion talkline has received more than 18,000 calls. 

We reach more than 35,000 women every year through our outreach and education efforts. 

We have trained more than 100 Bay Area women to be volunteer counselors on our talkline, 

and we recently received an award for “Excellence in Nonprofit Volunteer Management” from 

the Volunteer Center of the Bay Area. 

Because of Exhale, women now have more access to nonjudgmental emotional support after 

an abortion than ever before. At a clinic, they are now more likely to speak to a staff person who is trained to discuss emotions around abortion, and they are more likely to receive 

a referral to the Exhale talkline or other nonjudgmental resources. Previously unheard-of 

resources are now available to them: They can read other women’s stories online in our zine 

and in several mainstream media publications thanks to our outreach; they can send or receive 

a post-abortion e-card that recognizes their unique experience; and they can engage in provoice advocacy by sharing their personal abortion stories in a public forum, like a blog or Web 

video channel hosted by a nonjudgmental resource. 

Exhale’s efforts over the past 7 years have made a significant difference in the lives and emotional well-being of women who have had abortions and their loved ones. They are able to 

take a leadership role in their own well-being. But there’s more to be done. 

We need you, the National Institutes of Health, to join us in our mission to understand, 

acknowledge, and support the emotional needs of women post-abortion. We need research 

that helps us better understand women’s emotional experiences, and that provides women 

with the helpful information they need to support their own well-being, and their own mental 

and reproductive health. 

Why Past Research Is Not Enough 

Since the 1970s, research regarding women’s emotions around abortion has focused on 

whether abortion, on its own, has negative consequences for women’s mental health, and it 

was meant to serve one side of the political debate or the other. 

Famously, the Surgeon General under President Reagan determined that despite the popular claim that abortion has negative consequences on women’s psychological health, the data 

behind that claim was insufficient. Most recently, in 2008, the American Psychological Association completed another review of existing literature, and concluded there is no evidence 

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of negative mental health effects from abortion.6

 They found that the research that did show 

negative emotional impact had severe methodological flaws that made the data unreliable. 

Further scientific inquiry into women’s mental health after an abortion has found other predictors for poor mental health outcomes, including pre-existing mental health conditions; a lack 

of social support; a lack of self-esteem; and the heated public controversy around abortion, 

just to name a few. 

It is safe to say that there is scientific agreement that abortion, on its own, rarely causes severe 

negative outcomes for a woman’s mental health. 

But what else about women’s emotional well-being after an abortion has been determined by 

science, beyond the fact that abortion, on its own, does not damage women’s mental health? 

At a time when the emotional experience of any life event is publicly accepted as important 

and relevant to our overall health and wellness, there remains a great deal to be studied and 

researched about abortion. 

Today, more than ever, there is a great need for sound, thorough research into women’s emotional well-being after an abortion: The abortion procedure is so common, the families and 

communities impacted are so diverse, the debate around abortion is so loud, and the overwhelming stigma – which, according to NIH’s own definition, “threatens psychological and 

physical well-being, and helps to perpetuate health inequalities within societies” – is so harmful that it is time for the National Institutes of Health to proactively address the emotional 

needs of women who have abortions, by using its support and resources to undertake and 

share sound, thorough research into women’s real experiences. 

This research would accomplish the following: 

• Assess the psychological and emotional needs of women after an abortion 

• Evaluate the effects of different postabortion emotional support models on a woman’s 

well-being 

• Examine men’s emotional experience with abortion 

• Understand the characteristics of healthy coping after an abortion in diverse communities 

• Explore the connection between the social experience and the emotional experience 

of abortion 

Why This Research Matters 

It is critical that the National Institutes of Health address emotional and mental health as part 

of its strategies to promote women’s health and wellness. And when an issue is as common 

and as contentious as abortion, it is even more critical. Not only can research promote longterm emotional well-being, it can also dispel politically and emotionally charged claims that 

distract from emotional well-being. 

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Benefits of this research include the following: 

• Provide medical and emotional care providers with the information we need to support 

patients’ emotional resiliency and well-being in the long term 

• Provide intimate partners, family members, and communities with information about 

how to be a source of comfort and support for their loved ones and each other 

• Provide women with the tools and information to make well-informed decisions about 

their health, including pregnancy and abortion, and strategies to promote their own 

emotional well-being 

• Provide information to women and healthcare providers about appropriate interventions and responses when a woman does have negative emotional consequences after 

an abortion 

As a woman who has had an abortion, and as a peer counselor who has listened to many 

women share their stories and their feelings after an abortion, I know that Exhale has already 

met a need, just by providing safe, nonjudgmental emotional support for women and men 

after an abortion. 

But I also know that we need to do more. We need to provide women and men with the 

kind of helpful, well-researched information that supports their well-being after an abortion. 

We need sound, detailed research that addresses the broad range of experiences and feelings people have around abortion, immediately afterward, and far into the future. We need 

research that reflects the real experiences of people like the women and men who call Exhale 

to share their stories, receive emotional support, and achieve emotional well-being. 

Today, I call on the National Institutes of Health to join us in this work. I ask the NIH to take a 

leadership role, as only it can, in providing the research and information that will help today’s 

healthcare providers and patients achieve emotional well-being after an abortion. 

JANICE HUMPHREYS, PH.D., RN, CS, NP 

Group of Concerned Nurse–Researchers 

Violence and Abuse Are Global Health Problems for Women 

While the documents describing women’s health globally make compelling reading, they fail 

to address a major factor that disproportionally affects women and underpins both many of 

women’s unique health problems and the factors that underpin their failure to receive adequate 

treatment, namely violence and abuse. Because of the comprehensive nature of violence and 

abuse, my colleagues and I have chosen to follow the general framework developed by the 

World Health Organization (WHO) in their 2002 report, World Report on Violence and Health.1 

In addition, the most recent update, Third Milestones of a Global Campaign for Violence Prevention Report 2007,2

 reviews the global progress to date. More importantly, it sets out what 

we can do over the next 5 years to expand global violence prevention programming and to 

demonstrate, in terms of lives saved and suffering averted, the impact of violence prevention. 

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Violence is defined as “the intentional use of physical force or power, threatened or actual, 

against oneself, another person, or against a group or community, that either results in or has 

a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation,” according to the 2002 report. This definition encompasses interpersonal violence, 

suicidal behavior, and armed conflict. “It also covers a wide range of acts, going beyond physical acts to include threats and intimidation. Besides death and injury, the definition also 

includes the myriad and often less obvious consequences of violent behavior such as psychological harm, deprivation, and maldevelopment that compromise the well-being of individuals, 

families, and communities.” 

The WHO and others generally take an ecological approach in conceptualizing the causes of 

violence. Individual (e.g., biology, personal history, socioeconomic status, education, substance 

abuse, etc.), relationship (e.g., exposure to harsh childrearing, family dysfunction, forced marriages of children, childhood exposure to intimate partner violence between parents, etc.), 

community (e.g., poverty, racism, high population density, low social status, etc.), and societal 

(e.g., societal tolerance for violence, easy availability of weapons, gender/race/ethnicity-based 

inequalities, “culturally-based” sexual enslavement of children, etc.) factors are intertwined in a 

complex interaction that must be considered when attempting to understand and prevent violence. The initial WHO report posed that violence was preventable and that interventions were 

possible at each of these levels. The 2007 report updates the status of these efforts. 

Based upon the growing body of increasingly rigorous research, we believe that there is strong 

evidence that violence, in and of itself, is a global health concern, especially for women. Violence-related suffering and death occur across the lifespan and in recent years, it has become 

increasingly clear that there are links among the different types of violence, whether they 

are self-inflicted, interpersonal, or collective. For example, the presence of one type of violence tends to directly increase the risk of an individual, family, or community for another type. 

In addition, risk factors, such as substance abuse, mental illness, and economic inequalities 

increase the risk for most types of violence. Therefore, efforts to prevent one type of violence 

have the potential to reduce the risk of another. Interventions that reduce risk factors can have 

across-the-board benefits in reducing violence. 

Violence itself is now understood to be a major risk factor for other women’s health consequences. “Evidence now suggests that in addition to the immediate physical consequences, 

violence has a variety of other less obvious health, social, and economic consequences.”2 Intimate partner violence, which disproportionately affects women, has been shown to result in 

physical injury and death. However, it is also associated with risk of chronic physical syndromes, 

and psychological and behavioral consequences. Violence has also been associated with various chronic diseases, including cancer, ischemic heart disease, and chronic lung disease, in part 

due to unhealthy behaviors. Violence can be a risk factor for a range of sexual and reproductive 

health problems, including infertility, pregnancy-related complications, unsafe abortion, pelvic 

inflammatory disorders, sexually transmitted infections, and unwanted pregnancy. 

The intersections of human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) and intimate partner violence for both men and women are increasingly being 

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recognized and definitively documented with persuasive and rigorous research. The important 

interfaces of HIV and violence for women can be summarized as follows: 1) epidemiological 

studies showing significant overlap in prevalence; 2) studies showing intimate partner violence 

as a risk factor for HIV; 3) studies showing violent victimization increasing HIV risk behaviors, 

including intravenous drug use; 4) emerging research showing immune system alteration from 

violence victimization in women; 5) studies showing violence or stigma and/or fear of violence impeding or as a consequence of HIV testing; 6) studies showing partner violence as a 

risk factor for sexually transmitted diseases, which increases the rate of transmission of HIV; 

7) data indicating that abusive men are more likely to have other sexual partners unknown 

to their wives; and 8) studies showing the difficulties of negotiating safe sex behavior for 

abused partners. In addition, there are hypothesized but as yet untested relationships between 

increased HIV transmission and intimate partner violence through intimate partner forced sex, 

known as a frequent form of intimate partner violence. Forced vaginal sex may cause trauma 

that increases the chance of transmission. In addition, abused women report forced anal sex 

as a frequent form of forced sex in violent intimate relationships, and anal sex is known to 

increase HIV transmission. 

The last decade has seen the use of rape as a “weapon” of war in many parts of Africa. Rape 

is all too common with many of the victims subjected not only to forcible sexual intercourse, 

but also to an array of torture and mutilation over extended periods of time. The vast majority of rape victims are female and age offers no protection.3

 If the victim survives the trauma 

of the actual assault, her trauma is further increased by the risk of HIV infection, disease, and 

social isolation. The psychological effects of stigmatization, loss of family, and trauma related 

to violence causes severe harm and can lead to post-traumatic stress syndrome and depression. Further, survivors of rape are often stigmatized by the community, especially if they are 

infected with HIV and/or pregnant from the rape; they may be forced to abandon the child as 

“cursed.” All of these human rights violations cause rapid and unnecessary deaths. 

We must also consider other direct and indirect forms of violence, especially against women. 

In the home, within families, many nations presume there is safety for women. This often 

proves to be a falsehood. The trading of girl children for dowries, placing them in arranged 

marriages at 10, 12, 15 years of age, while they are still developing physiologically, intellectually, 

and emotionally, increases their risk for violent victimization. The educational process for these 

child brides is often ended, to say nothing of the fact that in some countries, girls are not sent 

to school at all. Economic, educational, and health disparities are subtle forms of violence that 

are too often morally invisible. Women rejected by their husbands, or who have been culturally deemed “unmarriageable,” may be beaten, stoned, or forced to commit suicide. Religious 

excuses are given for these misogynist “rules,” while in truth, the major religions do not condone these violent practices. They stem from cultural and patriarchal assumptions that simply 

favor males over females, deeming women the property of fathers, brothers, and husbands. 

Infanticide of girl children has not ceased with the march of modern advancements. Children, 

especially poor girls whose parents reject them, or who run away from untenable marriage, fall 

prey to pimps and purveyors of the flesh trade. Girls and women are sold and traded into slaveries where they face confinement and/or forced sweatshop labor. 

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Violence has been shown to damage the social fabric of communities and is disruptive to 

community and family relationships. Intimate partner violence can result in isolation and 

problems with social integration. Increasingly, intimate partner violence is being shown to 

jeopardize abused women’s ability to sustain employment and to be productive members of 

society. In addition, it is necessary to recognize that when compared to men in the workforce, 

women are underemployed, undercompensated, and underpromoted. Crucially, in all cultures, 

they spend many hours doing delegitimized, unpaid labor that sustains children and families. As immigrants and refugees, they often are limited to low-wage work as maids, cooks, 

and nannies. This economic disparity is one source of violence against women and carries 

with it health risks that result in limited or no access to health insurance and/or health care 

and indeed threatens the survival of women. Additional research is now associating women’s 

exposure to intimate partner violence even with infants’ development. Childhood aggression has been shown to be a predictor of violence in adolescence and adulthood. Both child 

maltreatment and intimate partner violence are associated with relationship, academic, and 

employment problems. 

The economic costs of violence are staggering and place an enormous burden on national 

economies through increased healthcare and legal costs, absenteeism from work, and lost 

productivity. The Centers for Disease Control and Prevention concluded that the total costs 

associated with nonfatal injuries and deaths due to violence in 2000 were more than $70 billion in the United States alone! The majority of this cost was due to lost productivity, but an 

estimated $5.6 billion was spent on health care for more than 2.5 million injuries that were 

due to interpersonal and self-directed violence. However, the WHO also concludes that the 

economic consequences of violence are limited due to the scarcity of studies in this area from 

low- and middle-income countries that are known to be disproportionately affected by violence. 

We believe that any effort to improve the health of women must also address violence. Furthermore, violence prevention efforts must be expanded and an ecological perspective that 

considers individual, family, community, and societal factors is essential. Toward that end, we 

support the recommendations of the WHO, which are summarized below. 

Recommendations of the World Report on Violence and Health: 

1. Create, implement, and monitor a national action plan for violence prevention 

2. Enhance capacity for collecting data on violence 

3. Define priorities for, and support research on, the causes, consequences, costs, and 

prevention of violence 

4. Promote primary prevention responses 

5. Strengthen responses for victims of violence 

6. Integrate violence prevention into social and educational policies, and thereby promote 

gender and social equality 

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7.	� Increase collaboration and exchange of information on violence prevention 

8. Promote and monitor adherence to international treaties, laws, and other mechanisms 

to protect human rights 

9.	�Seek practical, internationally agreed-upon responses to the global drug trade and the 

global arms trade 

References 

1.	� Krug, E. G., Dahlberg, L. L., Mercy, J. A., Zwi, A. B. & Lozano, R. (Eds.). (2002). World 

report on violence and health. Geneva: World Health Organization. 

2. Brown, D., Butchart, A., Harvey, A., Bartolomeos, K., Meddings, D., & Sminkey, L. (2007). 

Third milestones of a global campaign for violence prevention report 2007. Geneva: 

World Health Organization. 

3. Barbour, V., Clark, J., Peiperl, L., Veitch, E., Wong, M., & Yamey, G. (Eds.). (2009). Rape in 

war is common, devastating, and too often ignored. Public Library of Science Medicine, 

6(1), e1000021. doi:10.1371/journal.pmed.1000021 

HUGH BROWN III 

HIV/AIDS Services for African-Americans in Alaska 

More Research Is Needed for Women of Color 

Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) Services 

for African-Americans fully support more research for women, especially women of color in 

regard to HIV/AIDS. 

HUGH BROWN III 

HIV/AIDS Services for African-Americans in Alaska 

Support Contractual and Grant Funding for African-American Organizations in Alaska for Health 

Research for Women and Men 

It is important to build the capacity of smaller organizations that serve women locally. These 

organizations can advance the wellness of our nation if we make the investments now. 

Research priorities should include HIV prevention risk factors. Racism, poverty, domestic 

violence, and mental illness must be addressed. Reproductive rights are important. Lack of 

healthcare access can be somewhat reduced in communities by increasing research activities. 

Work in collaboration with community stakeholders. 

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LAURA MOSIER 

Indiana State Department of Health 

The Indiana Women’s Diabetes Initiative Client Navigation System 

Vision 

Improve outcomes and quality of life for women living with diabetes in Indiana through 

enhanced self-management. 

Mission 

Connect women living with diabetes to education, resources, and services through the 

development of meaningful State and local partnerships, identification and removal 

of barriers, and collection and analyses of data. Take Control of Your Diabetes. 

Share. Learn. Live. 

Program Description 

The Indiana Women’s Diabetes Initiative focuses on implementing Healthy People 2010 

objectives on diabetes and the cross-cutting focus areas of nutrition and overweight, physical activity and fitness, as well as smoking cessation. The Indiana Diabetes Advisory Council 

serves as the public health system/collaborative that is the foundation for this project, and 

the Women’s Health Committee under the Indiana Diabetes Advisory Council serves as the 

steering committee for this project. The Office on Women’s Health (OWH) employs a fulltime project director serving as the committee chair and oversees all aspects of the project. 

A part-time epidemiologist is under contract to assist with surveillance tracking, data collection, and reporting. Three community partners (Northern: Elkhart County Health Department; 

Central: Howard County Medical Society; and Southern: Hoosier Uplands [Lawrence County]) 

implement the pilot client navigation system for female clients with diabetes. Each navigation 

system utilizes evidence-based strategies to focus on specified Healthy People 2010 objectives 

(see below) to improve outcomes for Hoosier women with diabetes. In addition, sustainability 

plans are being developed to continue project activities after the initial grant funding through 

the U.S. Department of Health and Human Services ends, and to expand to additional counties 

in the future. 

A description of the eligible population: 

• Women 

• Over 18 years of age 

• Diagnosed by a physician with type 1 or type 2 diabetes 

The Five Steps of Client Navigation 

Community Outreach. Program coordinators share with women the benefits of participating 

in the Diabetes Initiative. 

Eligibility. Any woman over age 18 who has been diagnosed with diabetes is invited to participate and learn how to better control her diabetes. 

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Client Data Assessment Screening. Women meet with the program coordinator in their 

county to confidentially share problems they are having with diabetes, including barriers to 

getting care. 

Individual Client Plan. Women learn from program coordinators about how to set achievable 

goals and get connected to resources that will help them better control their diabetes. 

Followups. Program coordinators continue to work with women to assess their diabetes care 

and set new goals. The end result is for each woman to better self-manage her diabetes and 

live a longer, healthier life. 

Targeted Healthy People 2010 Objectives 

Diabetes 

5-1	� Increase the proportion of persons with diabetes who receive formal diabetes 

education 

5-12	� Increase the proportion of adults with diabetes who have a glycosylated hemoglobin 

measurement at least once a year 

5-13	� Increase the proportion of adults with diabetes who have an annual dilated eye 

examination 

5-14	� Increase the proportion of adults with diabetes who have at least an annual foot 

examination 

5-15	� Increase the proportion of adults with diabetes who have at least an annual dental 

examination 

5-17	� Increase the proportion of adults with diabetes who perform self-blood-glucosemonitoring at least once daily 

Nutrition and Overweight 

19-1 Increase the proportion of adults who are at a healthy weight 

19-2 Reduce the proportion of adults who are obese 

Physical Activity and Fitness 

22-1	� Reduce the proportion of adults who engage in no leisure-time physical activity 

Smoking Cessation 

27-1	� Reduce tobacco use by adults 

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I. Goal/Purpose of the ASIST 2010 Program 

The overarching goal of the Indiana Advancing System Improvements to Support Targets 

for Healthy People 2010 (ASIST 2010) project is to use a public health systems approach to 

improve women’s access to diabetes care and related outcomes for clinical management, 

nutrition and weight, and physical activity and fitness. This goal will be accomplished by 

expanding the Indiana Diabetes Advisory Council to include a Women’s Health Committee that 

will provide guidance for the development of three pilot patient navigation systems focused 

on assisting females with diabetes to navigate barriers related to specified Healthy People 

2010 objectives. The target audience for the pilot patient navigation system is females who are 

18 years of age and older with a self-reported physician diagnosis of diabetes in Elkhart, 

Howard, and Lawrence counties. 

II. ASIST 2010 Focus Area and Objectives 

The following Healthy People 2010 Objectives are being addressed by the Indiana ASIST 

2010 Program: 

Diabetes 

5-1	� Increase the proportion of persons with diabetes who receive formal diabetes 

education 

5-12	� Increase the proportion of adults with diabetes who have a glycosylated hemoglobin 

measurement at least once a year 

5-13	� Increase the proportion of adults with diabetes who have an annual dilated eye 

examination 

5-14	� Increase the proportion of adults with diabetes who have at least an annual foot 

examination 

5-15	� Increase the proportion of adults with diabetes who have at least an annual dental 

examination 

5-17	� Increase the proportion of adults with diabetes who perform self-blood-glucose-monitoring at least once daily 

Nutrition and Overweight 

19-1	� Increase the proportion of adults who are at a healthy weight 

19-2	� Reduce the proportion of adults who are obese 

Physical Activity and Fitness 

22-1	� Reduce the proportion of adults who engage in no leisure-time physical activity 

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A. Progress-to-Date With Focus Area/Objective Activities 

The Indiana Women’s Diabetes Initiative (IWDI) is making tremendous strides in connecting diabetic women to resources related to the diabetes Healthy People 2010 objectives in 

each of the three pilot counties. The Project Director and the Program Coordinators are building and sustaining partnerships on the State and county levels. In addition to building and 

sustaining partnerships, the IWDI efforts from January 2009 until April 2009 have revolved 

around developing a marketing plan and building, maintaining the infrastructure for our diabetes program, presenting at a State and a national conference, continuing client enrollment, and 

collecting annual followup data. 

IWDI Partnerships. IWDI is continuing to build new partnerships, but in addition, we are sustaining workable partnerships. The program director has been working on streamlining the 

partnerships on State and county levels. 

IWDI Marketing Plan. The IWDI Marketing Plan is completed and we have submitted it to the 

Indiana State Department of Health/Office of Women’s Health Division for final approval. The 

marketing plan will be effective for Year 2 and Year 3 of the grant for all levels (county and 

State). To assist in marketing the IWDI program, we have designed, developed, approved, and 

printed postcards and bookmarks to be distributed on the State and county levels. 

IWDI Presentations. The program director and epidemiologist each submitted abstracts for 

presentations to conferences and each of the abstracts was accepted to present in April 2009. 

The program director abstract was accepted for a poster presentation at the Indiana Public Health Association Conference in Indianapolis, IN, and the epidemiologist abstract was 

accepted for an oral presentation at the Centers for Disease Control and Prevention Diabetes 

Translation Conference in Long Beach, CA. 

IWDI Infrastructure. We are continuing to strengthen the communication within IWDI through 

monthly conference calls, quarterly trainings, and semiannual county site visits. All the counties are working extremely hard to promote the IWDI program. This is truly evident when the 

majority of the clients in most of the counties indicated that they learned about the IWDI program through “word of mouth.” 

IWDI Data and Surveillance. Enrollment is steadily increasing for IWDI. We have enrolled 249 

women in the 3 pilot counties in April 2009. We are continuing to track our enrollment numbers, the needs of our clients, and the amount of time and resources it takes to provide quality 

services so that we can develop updated enrollment goals that are realistic based on what we 

have learned. We are also exploring possible ways to integrate our data into existing statewide surveillance systems so that we can be part of and benefit from established surveillance 

efforts. The project director, director of OWH, and our epidemiologist are currently working 

with the ISDH Surveillance director to discuss possible data linkages and crossover, specifically related to the HP 2010 diabetes objectives we are monitoring and the related program 

components. Effort on each focus area/objective relates directly to the development and 

maintenance of the Indiana ASIST 2010 Client Navigation System. 

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Diabetes 

5-1 Increase the proportion of persons with diabetes who receive formal diabetes education 

(83.3 percent [n=125] of current IWDI clients have NOT ever taken a formal diabetes 

education class) 

5-12 Increase the proportion of adults with diabetes who have a glycosylated hemoglobin 

measurement (A1C) at least once a year 

(36.9 percent [n=55] of current IWDI clients have NOT had an A1C measurement in the 

past 12 months) 

5-13 Increase the proportion of adults with diabetes who have an annual dilated eye examination 

(64.4 percent [n=96] of current IWDI clients have NOT had or don’t know if they have 

had an eye exam in the past 12 months) 

5-14 Increase the proportion of adults with diabetes who have at least an annual foot examination 

(56.1 percent [n=83] of current IWDI clients have NOT had or don’t know if they have 

had a foot exam in the past 12 months) 

5-15 Increase the proportion of adults with diabetes who have at least an annual 

dental examination 

(69.8 percent [n=104] of current IWDI clients have NOT had or don’t know if they have 

had a dental exam in the past 12 months) 

5-17 Increase the proportion of adults with diabetes who perform self-blood-glucose-monitoring at least once daily 

(54.0 percent [n=81] of current IWDI clients do not check their blood for glucose at 

least one time per day) 

Nutrition and Overweight 

19-1 Increase the proportion of adults who are at a healthy weight 

(19.8 percent [n=26] of current IWDI clients are overweight and 74.1 percent [n=103] are 

obese [combined 93.9 percent are overweight or obese]) 

19-2 Reduce the proportion of adults who are obese 

• The Indiana State Department of Health (ISDH) received CDC Obesity and Nutrition 

funds for the first time to develop nutrition and physical activity programs in Indiana. 

• The director of this grant spoke at our last Women’s Health Steering Committee to 

begin discussing ways to integrate our efforts. 

• The mean body mass index for current IWDI clients is 36.6. 

Physical Activity and Fitness 

22-1 Reduce the proportion of adults who engage in no leisure-time physical activity. 

(56.1 percent [n=82] of current IWDI clients do not participate in leisure-time 

physical activity.) 

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B. Describe Problems Encountered With Program Implementation and 

Their Resolution 

Problem 1. Given that this is a pilot project and we are gaining valuable insight as we go, we 

are still determining exactly how we envision the program operating and how the day-to-day 

operations affect that overall vision. At times, it has been clear that not all staff working on the 

project had the same vision in mind or the best way to achieve that vision. This has led to miscommunication and misinterpretations along the way and opened our eyes to the need for 

clearer expectations for all staff as well as the clients we serve and our partners. 

Solution. The development of a vision and mission statement, a community outreach event 

and activity authorization form, implementation of the IWDI share point site, and conduct of 

monthly conference calls and quarterly trainings are helping to improve communication and 

get everyone on the same page to see the big picture and ensure we are all working toward 

the same overall goal, while taking into consideration the valuable insights we have gained thus 

far. In addition, we have started to meet every other month and have an all-day “face to face” 

working meeting to discuss problems, lessons learned, and program development sustainment. 

Problem 2. Indiana ASIST 2010 was not able to enroll 500 women into the patient navigation 

system in year one. Reasons include the following: 

• The project team was not fully hired until late February 2008 due to the ISDH hiring process, which delayed planning and implementation of the client navigation system (CNS). 

• The number of clients to be enrolled annually was overestimated at the time of the proposal. Our clients tend to have numerous unmet objectives, so contact with participants 

is time-consuming to ensure the quality and depth of service needed. 

Solution. The Director of the OWH and Indiana ASIST 2010 Project Director have begun work 

to reevaluate program objectives and set more realistic projections based on what we learned 

during the first grant year. Additionally, the ASIST 2010 staff has been hired and the program 

is fully staffed, so this is no longer a barrier. We currently have 249 women enrolled (as of 

April 2009). The program coordinators have been working 30 hours per week doing baseline 

assessments and—starting in April 2009—annual assessments. By the end of the grant cycle in 

August 2010, the program coordinators should have 500 baseline assessments and 250 annual 

assessments. The numbers are not where we originally predicted, but the client navigation system works and the program coordinators have connected the clients to resources; eliminated 

barriers; and navigated each woman to becoming her own advocate, taking control of her diabetes, and living a better quality of life. 

Problem 3. Dental care partnerships have been difficult to establish in each pilot county due 

to the high cost of dental equipment and lack of low income dental clinics. 

Solution. They are working with three dental clinics and have reached an agreement to provide an annual dental examination based on a sliding scale. The project director is negotiating 

a sliding-fee scale for annual dental exams because the majority of our IWDI clients do not 

have dental insurance. IWDI has formed a partnership with the Mobile Smiles program from 

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Michigan. The program director has negotiated for the Michigan portable dental units to go to 

each county every summer to provide dental care examination, dental education, and oral cancer screening for $25.00 per client. In addition, the client can receive two bitewing X-rays for 

an additional $35.00. The mobile dental unit has the summer free because they normally do 

children’s dental examinations during the school year. This meets our objective for an annual 

dental examination for our client navigation program. If the clients have more extensive dental 

needs, we can refer the clients to the Indiana Health Care Center/Dental Clinics in their county. 

C. Lessons Learned and Recommendations To Improve the ASIST 2010 Program 

There have been many lessons learned in the past year and a half. The first lesson learned is 

that since this is a pilot project, there is nothing set in stone and there is more than one way to 

do something. What works in one county may not work in another county. Flexibility and communication are key to the success of our project. 

The second lesson learned is that each member of our IWDI team has strengths and talents; 

this has really come in handy in the development of the infrastructure of our team. For example, one of our county coordinators has graphic design experience. Now that we have an 

approved logo, slogan, tagline, and mission and vision statement, she is able to design flyers 

and each county can get them printed as needed. Another county coordinator is bilingual and 

she is able to translate our printed materials into Spanish. The third county coordinator has 20 

years’ experience in health education and worksite wellness and she has developed training 

manuals. She will also develop a training manual for the county coordinators (navigators) and 

assist in our sustainability efforts. By having the IWDI team members strengthen and use their 

talents, it brings our team together and gives each of the county coordinators a sense of ownership to the IWDI program. 

The last lesson learned is to speak to be understood and to listen to understand. This is hard 

because everyone has something to say, but interruptions and misinterpretation can be 

halting factors. 

III. Status Updates 

A. Surveillance System Implementation 

IWDI staff met with the director of the State Health Data Center and the Behavioral Risk 

Factor Surveillance System Coordinator in January 2009 to discuss surveillance resources 

available at the Indiana State Department of Health that might support and help sustain the 

IWDI. The goal of this initial meeting was to share information and examine opportunities for 

collaboration on data sharing and tracking. During this meeting, we learned that although 

the Indiana State Department of Health (ISDH) surveillance system is primarily designed for 

preparedness, some behavioral and clinical data are available via the system’s partners, specifically Indiana Health Information Exchange (IHIE). It was suggested that we expand our 

conversations to include the State Health Data Center partners, including members of the 

IHIE and the Technical Assistance Program at Purdue University. Immediate next steps include 

meeting with these partners to discuss collaboration and providing the director of the State 

Health Data Center with copies of our assessment forms and other documents that will provide additional information about our data needs and capabilities. 

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B. Sustainability Efforts/Activities 

The development of the IWDI marketing plan has been a big endeavor this quarter. The purpose of this plan is to establish policies on the State and county levels, maintain sustainable 

partnerships relative to the IWDI program, and to establish conformity among the three pilot 

counties on how outreach opportunities are analyzed and selected. IWDI has also made great 

strides in having sustainable HP 2010 objectives. The HP 2010 objectives listed below have 

been met and sustained into the IWDI program. 

5-1 Increase the proportion of persons with diabetes who receive formal diabetes education. The program director has established and sustained a free diabetes education 

program in all three pilot counties. Each county has a certified diabetes educator, certified registered dietician, or a retired registered nurse to teach the classes in conjunction 

with Roche Diagnostics “Healthy Habits” classes. The partnership with the diabetes 

educators and Roche Diagnostic has proven to be a valuable part of sustaining the diabetes education classes. The classes are taught every 6 months for 3 consecutive weeks 

and each class is 11⁄2 to 2 hours. The program coordinators have opened the classes to 

the entire community, but incentives are given to only the IWDI clients. 

5-13 Increase the proportion of adults with diabetes who have an annual dilated eye examination. The program director has partnered with Prevent Blindness Indiana (PBI) “Gift 

of Vision” Program. This program provides a free annual eye examination and a free 

pair of eyeglasses (if needed) to eligible clients (based upon dire financial need). PBI 

tracks the IWDI referrals to the “Gift of Vision” program; to date, we have referred 77 

IWDI clients and had 60 IWDI confirmed appointments. PBI has a network of ophthalmologists in each pilot county for the IWDI clients to choose from and the program 

coordinator connects the IWDI clients to this resource. 

5-14 Increase the proportion of adults with diabetes who have at least an annual dental 

examination. The program director has partnered with a Michigan Mobile Dental Unit 

that will be providing annual dental examinations, dental health education, oral cancer screening, and bitewing X-rays for a minimum fee. The portable dental unit will be 

providing services in the summer months (during the rest of the year, they provide services to schools all over the country). The program coordinators schedule their visits. 

The dental units do not charge time for travel; they only charge for services. The annual 

dental examinations, dental health education, and oral cancer screening is $25.00/client. The two bitewing X-rays is an additional $35.00/client. The dental unit will provide 

services to the communities each summer. This is sustainable for each community and 

the IWDI program. 

The other sustainability efforts that the program director is developing is to integrate 

the other ISDH chronic disease divisions to incorporate the client navigation system. 

The IWDI Team is compiling an IWDI Resource toolkit, including a program coordinator’s 

training manual, to enhance a client navigation system for chronic disease in Indiana. 

C. Public Health System/Collaborative Partnership 

The IWDI meets with the Indiana Diabetes Advisory Council (IDAC) on a quarterly basis. The 

meetings are a collaboration of diabetes efforts and initiatives in Indiana as they relate to 

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diabetes care. IWDI staff runs the Woman’s Health Steering Committee meetings, and we 

have guest speakers to assist in tackling the barriers in our pilot counties. At the upcoming 

IDAC in January, the project director and epidemiologist will be giving a presentation of the 

IWDI program. 

D. Incorporation of Gender Focus 

Women over 18 who have a self-reported physician diagnosis of diabetes continue to be the 

target audience for the Indiana ASIST 2010 project. Women were chosen as the focus group 

for this project because they are the main caretakers in families of all types and vital to the 

household infrastructure and management. Our goal is to provide women with the tools 

needed to self-manage their diabetes through a coordinated client navigation system, and we 

feel that their families will also benefit. The focus on women is proving valuable because the 

county program coordinators are finding that by helping the women, their families are also 

becoming more active and the women are cooking healthier meals for everyone. 

E. Staffing 

Laura Mosier, B.S., Project Director of ASIST 2010 

Tanya Parrish, M.P.H., CHES, Director of OWH 

Carolyn Muegge, M.S., M.P.H., Epidemiologist 

Jennifer Kerner, Research Assistant 

Monica Brooks, MT, CNHP, Program Coordinator (Elkhart County) 

Katie Hillman, M.Ed., Program Coordinator (Howard County) 

Violet Reynolds, AS, Program Coordinator (Lawrence County) 

JENNIFER PIERCE-WEEKS, RN, SANE-A, SANE-P 

International Association of Forensic Nurses 

Funding Priorities for Research Dollars 

The International Association of Forensic Nurses (IAFN) is an international professional nursing 

association whose mission is to provide leadership in forensic nursing practice by developing, 

promoting, and disseminating information internationally about forensic nursing science. 

Violence and Health of Women 

Violence against women is a public health and healthcare issue rooted in poverty, social 

injustice, and systems unresponsive to the health needs of women.1

 Violence is a major factor that disproportionally affects women and underpins many of the unique health problems 

experienced by women.1,2 Violence against women is comprehensive in its impact on women’s health, affecting physical, emotional, psychological, and spiritual health.2

 Violence against 

women contributes to the failure of women to receive adequate health care and treatment1 

targeted by the National Institutes of Health (NIH) women’s health research agenda initiatives. 

However, the comprehensive response necessary for the development of prevention and treatment of violence against women is not identified as a priority in this NIH initiative. The IAFN 

encourages the NIH Women’s Health Research Agenda initiatives to look at the overwhelming 

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evidence and include a research focus on the prevention, intervention, and treatment of the 

environments leading to and the health effect of violence against women. 

Violence is defined as “the intentional use of physical force or power, threatened or actual, 

against oneself, another person, or against a group or community, that either results in or has 

a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation.”1

 This definition encompasses interpersonal violence, suicidal behavior, and armed 

conflict. “It also covers a wide range of acts, going beyond physical acts to include threats and 

intimidation. Besides death and injury, the definition also includes the myriad and often less 

obvious consequences of violent behavior, such as psychological harm, deprivation, and maldevelopment that compromise the well-being of individuals, families, and communities.”1 

The World Health Organization (WHO) and others generally take an ecological approach 

in conceptualizing the causes of violence. Individual (e.g., biology, personal history, socioeconomic status, education, substance abuse, etc.), relationship (e.g., exposure to harsh 

childrearing, family dysfunction, forced marriages of children, childhood exposure to intimate 

partner violence between parents, etc.), community (e.g., poverty, racism, high population density, low social status, etc.), and societal (e.g., societal tolerance for violence, easy 

availability of weapons, gender/race/ethnicity-based inequalities, “culturally-based” sexual enslavement of children, etc.) factors are intertwined in a complex interaction that must 

be considered when attempting to understand and prevent violence.1

 The initial WHO report 

posed that violence was preventable and that interventions were possible at each of these levels.1

 The 2007 report updates the status of these efforts. 

Based upon the growing body of increasingly rigorous research, we believe that there is strong 

evidence that violence, in and of itself, is a global health concern, especially for women.3 

This notion has been supported by evidence-based research and organizations globally have 

adopted initiatives to define and end violence against women.3

 Violence-related suffering and 

death occur across the lifespan, and in recent years, it has become increasingly clear that there 

are links among the different types of violence, whether they are intended, unintended, interpersonal, or collective. For example, the presence of one type of violence tends to directly 

increase the risk of an individual, family, or community for another type. In addition, risk factors, such as substance abuse, mental illness, and economic inequalities, increase the risk for 

most types of violence. 

Therefore, efforts to prevent one type of violence have the potential to reduce the risk of another. 

Interventions that reduce risk factors can have across-the-board benefits in reducing violence. 

Violence itself is now understood to be a major risk factor for other women’s health consequences. “Evidence now suggests that in addition to the immediate physical consequences, 

violence has a variety of other less obvious health, social, and economic consequences” 

(WHO, 2007). Intimate partner violence, which disproportionately affects women, has been 

shown to result in physical injury and death. However, it is also associated with risk of chronic 

physical syndromes, and psychological and behavioral consequences. Violence has also been 

associated with various chronic diseases, including cancer, ischemic heart disease, and chronic 

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lung disease, in part due to unhealthy behaviors. Violence can be a risk factor for a range of 

sexual and reproductive health problems, including infertility, pregnancy-related complications, unsafe abortion, pelvic inflammatory disorders, sexually transmitted infections, and 

unwanted pregnancy. 

The intersections of human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) and intimate partner violence for both men and women are increasingly being 

recognized and definitively documented with persuasive and rigorous research. The important 

interfaces of HIV and violence against women can be summarized as follows: 1) epidemiological studies showing significant overlap in prevalence; 2) studies showing intimate partner 

violence as a risk factor for HIV; 3) studies showing violent victimization increasing HIV risk 

behaviors, including intravenous drug use; 4) emerging research showing immune system 

alteration from violence victimization in women; 5) studies showing violence or stigma and/ 

or fear of violence impeding or as a consequence of HIV testing; 6) studies showing partner violence as a risk factor for STDs, which increase the rate of transmission of HIV; 7) data 

indicating that abusive men are more likely to have other sexual partners unknown to their 

wives; and 8) studies showing the difficulties of negotiating safe sex behavior for abused partners. In addition, there are hypothesized but as yet untested relationships between increased 

HIV transmission and intimate partner violence through intimate partner forced sex, known 

as a frequent form of intimate partner violence. Forced vaginal sex may cause trauma that 

increases the chance of transmission. In addition, abused women report forced anal sex as a 

frequent form of forced sex in violent intimate relationships, and anal sex is known to increase 

HIV transmission. 

We must also consider other direct and indirect forms of violence, especially against women. 

In the home, within families, many nations presume there is safety for women, but the belief 

often proves to be false. The trading of girl children for dowries, placing them in arranged 

marriages at 10, 12, 15 years of age, while they are still developing physiologically, intellectually, and emotionally, increases their risk for violent victimization. The educational process for 

these child brides is often ended, to say nothing of the fact that in some countries, girls are 

not sent to school at all. Economic, educational, and health disparities are subtle forms of violence that are too often morally invisible. Women rejected by their husbands or who have 

been culturally deemed “unmarriageable,” may be beaten, stoned, or forced to commit suicide. Religious excuses are given for these misogynist “rules” while in truth, the major religions 

do not condone these violent practices. They stem from cultural and patriarchal assumptions 

and privilege that simply favor males over females, deeming women the property of fathers, 

brothers, and husbands. Infanticide of girl children has not ceased with the march of modern advancements. Children, especially poor girls whose parents reject them or who run away 

from untenable marriages fall prey to pimps and purveyors of the flesh trade. Girls and women 

are sold and traded as slaves, where they face confinement and/or forced sweatshop labor. 

Violence has been shown to damage the social fabric of communities and is disruptive to community and family relationships. Intimate partner violence can result in isolation and problems 

with social integration. Increasingly, intimate partner violence is being shown to jeopardize 

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abused women’s ability to sustain employment and to be a productive member of society. In 

addition, it is necessary to recognize that when compared to men in the workforce, women are 

underemployed, undercompensated, and underpromoted. Crucially, in all cultures, they spend 

many hours doing delegitimized, unpaid labor that sustains children and families. As immigrants and refugees, they often are limited to low-wage work as maids, cooks, and nannies. 

This economic disparity is one source of violence against women and carries with it health 

risks that result in limited or no access to health insurance and/or health care. Lack of equity 

indeed threatens the survival of women and their children. Additional research is now associating women’s exposure to intimate partner violence with infants’ development. Childhood 

aggression has been shown to be a predictor of violence in adolescence and adulthood. Both 

child maltreatment and intimate partner violence are associated with relationship, academic, 

and employment problems. 

The economic costs of violence are staggering and place an enormous burden on national 

economies and international relationships through increased healthcare and legal costs, 

absenteeism from work, and lost productivity.4 The Centers for Disease Control and Prevention 

(CDC) concluded that the total costs associated with nonfatal injuries and deaths due to violence in 2000 were more than $70 billion in the United States alone.5

 The majority of this cost 

was due to lost productivity, but an estimated $5.6 billion was spent on health care for more 

than 2.5 million injuries that were due to interpersonal and self-directed violence.5 The WHO 

also concludes that the knowledge about economic consequences of violence is limited due to 

the scarcity of studies in these areas from low- and middle-income countries that are known 

to be disproportionately affected by violence.1

 In 2008, the United Nations Secretary-General 

launched a global campaign, “Unite to End Violence Against Women,” and this initiative has 

set internationally agreed-upon objectives, which include eradicating poverty, achieving universal gender equality in education, and reversing the rate of HIV/AIDS incidence.3 

IAFN believes that any effort to improve the health of women must also address the violence 

that affects as many as one in three women globally.6

 Furthermore, violence prevention and 

intervention efforts must be expanded using an ecological perspective that considers individual, family, community, systems, and societal factors.1,6,7 

In summary, the National Institutes of Health Women’s Health Research Agenda has the 

opportunity to plug a gaping hole in the NIH research agenda proposed to date and to 

address a major cause of morbidity and mortality in women—violence against women. The 

evidence is clear and the momentum is growing, not only in the United States, but internationally through organizations such as WHO and the United Nations. We want to add our voices 

to the chorus and recommend that the NIH research agenda add the focus area of violence 

against women. The sections under this focus area should include ecological 1) study of prevention efforts; 2) study of evidence–based interventions; 3) study of processes and programs; 

and 4) study of the medical sequelae of violence against women in order to facilitate the prevention, intervention, treatment, and mitigation of violence against women and their children. 

Thank you for consideration of IAFN’s proposals and we remain available to this important 

initiative as internationally recognized experts on the health of women following violence. 

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References 

1. Krug, E. G., Dahlberg, L. L., Mercy, J. A., Zwi, A. B. & Lozano, R. (Eds.). (2002). World 

report on violence and health. Geneva: World Health Organization. 

2. Felitti, V. J., Anda, R. F., Nordenberg, D., Williamson, D. F., Spitz, A. M., Edwards, V., . . . 

Marks, J. S. (1998). Relationship of childhood abuse and household dysfunction to many 

of the leading causes of death in adults: The adverse childhood experiences (ACE) 

study. Journal of Preventative Medicine, 14, 245–258. 

3. United Nations. (2009). Unite to end violence against women. Retrieved from http:// 

www.un.org/en/women/endviolence/factsheets.shtml 

4. United Nations. (2008, March 8). Cost of violence against women “beyond calculation,” 

warns UN chief. UN News Centre. Retrieved from http://www.un.org/apps/news/ 

story.asp?NewsID=30118&Cr=women&Cr1=secretary-general 

5. Centers for Disease Control and Prevention. (2009). The cost of violence in the United 

States. U.S. Rockville, MD: U.S. Department of Health and Human Services. Retrieved 

from http://www.cdc.gov/ncipc/factsheets/CostOfViolence.htm 

6. United Nations. (2009). Ending widespread violence against women. United Nations 

Population Fund. Retrieved from http://www.unfpa.org/gender/violence.htm 

7. National Institutes of Justice. (1986). Public health and private ethics. In Profiles: C. 

Everett Koop, M.D., Surgeon General. Washington, DC: U.S. Department of Justice, 

National Institutes of Justice. 

SUE GOLDSTEIN 

International Society for the Study of Women’s Sexual Health 

Need for Research and Education in Women’s Sexual Health 

My name is Sue Goldstein. I am here today representing the International Society for the Study 

of Women’s Sexual Health (ISSWSH), an international, multidisciplinary, academic clinical 

and scientific organization, whose purposes are to provide opportunities for communication 

among scholars, researchers, and practitioners about women’s sexual health; to support the 

highest standards of ethics and professionalism in research, education, and clinical practice 

of women’s sexual health; and to provide the public with accurate information about women’s sexual health. In addition, I have had the privilege of interviewing countless women with 

sexual dysfunction for a book I coauthored 2 years ago and in my capacity as clinical trials 

coordinator of a sexual medicine practice. 

The World Health Organization claims all people are entitled to health; this includes sexual 

health. For many years, this meant reproductive freedom for women. While we applaud the 

necessity for safe and effective contraception, freedom from abuse, and availability of care 

for basic medical needs, a growing number of women are complaining of sexual health problems. This is not merely a lifestyle issue, but a quality-of-life problem that extends far beyond 

the bedroom. There is no longer any debate about the negative effects erectile dysfunction 

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can have on a man with regard to his self-esteem, his relationships with loved ones, and in the 

workplace. Yet for generations, when women have the courage to share their sexual health 

problems with providers, they are told “it’s all in your head” or “relax, go away for the weekend.” Everyday women are being denied the benefit of health care. 

Why is this happening? The simple answer is knowledge, but that is not so simple. Our organization was founded because so many researchers and providers knew little pieces about 

women’s sexual function, but no one could see the whole picture. By sharing information 

both formally at our annual meetings and informally on our listserve, we are starting to piece 

together parts of the puzzle. We offer educational programs annually in the United States for 

clinicians in addition to those held concomitantly with our annual meetings, but we cannot 

hope to educate all the primary care physicians, family practitioners, internists, and gynecologists who are the primary caregivers of women. Residency programs need to recognize the 

importance of sexual health to women and need to incorporate what evidence-based information is currently available into their training programs. 

The biggest problem we have, however, is a universal paucity of support for the research in this 

field. This includes moral and financial support. Every time someone calls the treatment of sexual dysfunction in women medicalization, we in this area feel the pinch. A total of 43 percent of 

women have sexual health concerns. Approximately 16 percent of women meet the criteria for a 

diagnosable sexual dysfunction. Members of ISSWSH see these women in their offices and clinics 

every day. Women don’t seek treatment for an ailment concocted by the pharmaceutical companies. They want help because they are in pain, both mentally and physically. 

Sexual dysfunction involves problems with sexual desire, arousal, orgasm, and/or pain. To 

understand these, one has to step back a little and examine the physiology. The genital tissues are supported by both androgen and estrogen; therefore, blood hormone levels of each 

should be in the normal range to maintain healthy genitalia. Our first problem here is assessing normal values. Since few people attended to women’s sexual health, normal ranges were 

determined based on healthy women who were not necessarily sexually healthy. The Princeton 

Consensus Conference developed a solution to that problem by eliminating the lowest quartile 

of any given lab range for estrogens and androgens. Once this hurdle of normal lab ranges is 

overcome, we must address specific dysfunctions. 

Desire may be centrally controlled—that is, in your brain—but a biochemical imbalance is not 

necessarily a psychological problem. When this was discovered about depression, the taboo of 

that mental illness was lifted and research funds poured into understanding it better. Currently, 

research dollars to better understand desire are limited. Evidence points to alleviation of desire 

problems through administration of centrally acting drugs such as wellbutrin and flibanserin, 

which is currently being studied. Testosterone also influences desire and that is being studied in women with libigel. Evidence will be shown through clinical trials of the effectiveness of 

these medications, but there is still controversy about their use. Women with sexual dysfunction today currently use agents such as wellbutrin and testosterone, but these are off-label 

FDA-approved drugs, not indicated for low desire. 

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While having desire may seem like an irrelevant issue, the lack of it can and does destroy relationships every day. Who is to say if a woman were more interested in a sexual relationship 

with her spouse that a divorce might not be averted? Divorce is an epidemic in this country. 

Desire issues are also prevalent among women who experience pain. Please think about it— 

who wants to have sexual intercourse when it hurts every time you have sex? 

As scientists and educators, we ask about arousal next. For a woman who wants to have intimate relations, but who has no physiologic response, frustration is a mild word. We have some 

initial research into women’s arousal response, but still know very little. And we have only 

recently come to the conclusion that women may have arousal in the genitals with or without concomitant feelings of arousal in the brain, and conversely, may sense arousal without 

her genitalia actually undergoing physiologic engorgement. This is a huge hole in our understanding of women’s sexual physiology. This lack of knowledge is particularly poignant for 

those women with persistent genital arousal disorder (PGAD), where a woman has unresolving, unrelenting sensations of genital arousal not associated with sexual thoughts or feelings. 

This disorder all but paralyzes women as they lose their ability to focus, have difficulty traveling, 

making work all but impossible, and when help is sought, are either told there is nothing that 

can be done, or that “I wish I had that kind of problem.” Trust me, you wouldn’t wish PGAD on 

your worst enemy. 

For a woman who cannot reach orgasm, she may suffer from frustration, embarrassment, 

and discomfort, to name a few. There is a biochemical release that occurs either with or after 

orgasm that provides relaxation and helps with mood and self-assurance. While all this may 

seem frivolous to the physician battling AIDS, let me reassure you that women with any or all 

of these problems often become antisocial with an inability to maintain relationships, become 

depressed, and have significant body-image issues. 

The most heart-wrenching problem in the sexual health realm is that of sexual pain. Have 

you ever seen a woman married for several years, but unable to consummate her marriage 

because intercourse is too painful? Then forced to get a divorce because her religious beliefs 

do not allow the husband and wife to remain together in an unconsummated marriage? Or a 

couple desperately wanting children who cannot have intercourse because it is too painful... 

we see this far too often in our practices. Sometimes merely restoring the hormonal milieu to a 

normal level is all that is required, but the Women’s Health Initiative (WHI) make many fearful 

of endogenous estrogen and the Endocrine Committee Guidelines make practitioners hesitant 

to prescribe testosterone. 

There are two issues at play here. First, we need to educate both practitioners and the public that the estrogen used in the WHI study was not bioidentical, and one cannot extrapolate 

results from studies using estrogen derived from horse urine. Second, the negative findings 

that forced the study to be stopped were in the cohort of women who were approximately 10 

years post-menopause when hormone therapy was initiated, and among those women closer 

to menopause at the start of therapy, there was no significant difference in occurrence of 

breast cancer or stroke. The disservice done by both the report and the press is that women 

who had been on hormone therapy or who could potentially benefit from it became fearful 

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of estrogens. It behooves your office and organizations like ISSWSH to explain the need for 

estrogen and appropriate treatment paradigms. 

As for the endocrine guidelines for testosterone use, the clinicians and researchers who 

developed these had little or no involvement in the care or study of sexual health or sexual 

physiology. Their fear that testosterone would cause breast cancer has never been shown— 

as a matter of fact, the initial treatment for metastatic breast cancer was testosterone. Their 

belief that women would become hirsute, have lower voices, and all that comes with masculinization is unfounded because testosterone blood levels are only being returned to within a 

normal range. Due to the lack of understanding on the part of the endocrinologists, they chose 

to simply ignore sexual health needs. 

I stand before you today asking you to no longer ignore those needs. If I had cancer, you 

would not turn your back on me. If I had heart disease, you would not turn your back on me. 

If I had depression, you would not turn your back on me. So what gives our healthcare system 

and the United States Government the right to turn their back on me when I tell you I have 

sexual dysfunction? And I will openly admit to more than 6 years of being treated for my 

sexual dysfunction. 

One irony is that many of the sexual problems experienced by women are, in fact, iatrogenic. 

We see women who have lost part of their womanhood to breast cancer or uterine cancer. The 

treatments they receive to keep them alive devastate their bodies in other ways. For many of 

these women, quality of life becomes extremely important, and sexual health is a big part of 

that picture. Working closely with their oncologists, sexual medicine providers can help restore 

function—labias can regrow and vaginas can regain rugae and elasticity—allowing these cancer survivors the dignity of feeling like women again with a modicum of sexual function. 

Physicians have innocently caused a generation of women to have sexual health problems 

through lack of knowledge. When prescribing medications containing ethinyl estradiol, the 

artificial estrogen found in hormonal contraception, do physicians ever stop to think about the 

consequences of the rise in sex hormone–binding globulin (SHBG)? The SHBG has a strong 

bond with testosterone, thereby depleting the testosterone circulating in the blood available 

for genital health, bone density, and muscle strength, not to mention energy and mood. The 

ethinyl estradiol also stops the ovaries from producing hormones for the time being, including natural estradiol. This combination of no estrogen and no androgen is turning our young 

women into postmenopausal beings with all the commensurate problems, including depression, low energy, loss of libido, resorption of the labia, and sexual pain. We don’t even give 

women the right to complain about these issues. They are told they look normal, so it must 

be in their head. I cannot tell you how many times we hear the same story from women of all 

ages. And when their complaints are heard, they are often put on a selective serotonin reuptake inhibitor that only intensifies their problems. 

What we know about physiology of sexual function is minimum compared to what we know 

about men’s sexual function. But we women are no longer second-rate citizens in every other 

aspect of health care. We cannot hope to understand pathophysiology without having an 

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understanding of “normal,” for lack of a better term. With a better understanding, we cannot 

only help women suffering, but provide prophylaxis to those who seek it. Sexual dysfunction is a biopsychosocial problem that needs biopsychosocial treatments. We cannot make a 

tacit statement that it is purely psychological until proven otherwise, which is the statement 

from so many professionals and nonprofessionals, and implied when the Office of Research on 

Women’s Health ignores sexual health. 

I started by saying that women’s health often means reproductive freedom. Do not get me 

wrong—we are not advocating women being barefoot and pregnant. We are asking for support to address the issues of sexual health instead of ignoring them. We need to better 

understand mechanisms of action of sexual desire, arousal, orgasm, and pain problems in 

order to find better solutions and begin prevention. We need to better educate those men and 

women currently caring for women with these problems. And we need to provide a world in 

which it is acceptable to request help for sexual health issues without being told there is nothing that can be done. What we do know is that sexual health complaints may be indicative 

of a larger problem, be it low androgens or estrogens, a thyroid imbalance, pelvic floor dysfunction, or a myriad of other issues that might otherwise go unaddressed. We also know that 

women suffering from sexual dysfunction find those negative affects reaching into all aspects 

of their lives as human beings, affecting their relationships and their productiveness, coloring 

them beige, as one woman once told me. 

On behalf of the International Society for the Study of Women’s Sexual Health, I would like to 

request that the Office of Research on Women’s Health include sexual health as part of their 

platform, and put forth Requests for Proposals in the various aspects of sexual health so that 

our daughters and our granddaughters do not have to suffer the way our mothers and grandmothers did. I am not asking for the world, only a little corner of it. The members of ISSWSH 

are committed to understanding all aspects of women’s sexual function and dysfunction. We 

are asking you to consider including this as part of women’s health as your office moves forward supporting health care, and to provide financial support for those of us who are best 

equipped to research this aspect of women’s health. 

DEB LEVINE, M.A. 

Internet Sexuality Information Services (ISIS Inc.) 

Women’s Health and Information Technology 

As Executive Director of ISIS, Inc., based in Oakland, CA, I know well the power of people and 

technology to develop and deliver innovative services for sexual and reproductive health, 

locally, nationally, and internationally. 

The years 2009 to 2013 present a critical time of opportunity for the intersection of health 

information technology and women, children, and family planning issues. While many people think the most at-risk or vulnerable population are disconnected, it’s time to rethink those 

assumptions. As of December 2008, 75 percent of adult women in the United States use the 

Internet regularly, and 41 percent of all people aged 65 and over go online. Seventy-seven 

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percent of Caucasians, 64 percent of African Americans, and 58 percent of English and Spanish-speaking Latino/as are online. In addition, 57 percent of people earning $35,000 a year or 

less are online. And these numbers are steadily increasing. 

Knowing that women, girls, and families increasingly rely on online, mobile, and new media 

technology to support healthy lives and relationships, I’d like to offer five “technology wellness” elements for women’s health: 

1. Engage Our Communities in Our Work 

Parents and daughters bring more and require less than we think for tackling tough problems. 

By incorporating their experiences, ideas, and energy—not simply substituting expert opinion, 

judgment, and frustrations—we can tackle seemingly impossible challenges in women’s health 

in culturally appropriate ways. 

2. Reintroduce Relevancy 

Just as we engage those whom we serve, we must also ensure the priority status of women’s 

health in all disciplines of health and technology. Sexual and reproductive health, whether in 

community-based research or international medical discussions, matter in the context of health 

IT, health 2.0, health leadership, and health insurance. Every discussion about health and health 

IT needs to include women’s nutrition, fitness, mental health, hygiene, and sexual health. 

3. Develop Accessible and Affordable Options 

Technology provides a starting point for easy, cost-effective prevention, education, and disease 

management solutions. From here, we can increase access for women to free and low-cost 

testing and diagnostic services, mobile and text-messaging reminders, location-based tools 

to bridge work and childcare with health needs, and critical information to ensure informed 

health consumers. 

4. Evaluate Innovatively 

It is our duty to understand what women and girls are doing online, and adapt our methods to 

use new media and technology to reach them on their turf and their own terms. We need our 

peer reviewers to become risk takers, to understand that there are research models out there 

based on proven methods that can be adapted for modern Internet and mobile interventions. 

We need to have a plan for new media and technology strategies, and design bold new ways 

to measure their effectiveness and disseminate results. 

5. Effectively Advocate 

Coordination and collaboration, instead of battles over funding, naming rights, turf, and credibility, strengthen the fight for those women we claim to serve. Online or offline, sexually 

transmitted infections, human immunodeficiency virus, unplanned pregnancy, and healthy sexuality all affect women’s health—and affect our fertility, economic status, educational level, and 

family lifestyles. There will be enough room for all the actors to fight the many battles ahead. 

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Technology improves traditional women’s health services through increased capacity and 

enhanced access—informing, educating, and empowering women as consumers and advocates. Technology, however, won’t reveal answers without input. Used effectively, it can 

increase access to healthcare, offer options that meet the pace of women’s lives, and sharpen 

the questions a woman might ask when they do get to talk to a health professional. Whether 

the next few years produce opportunity or uncertainty depends on how well we—researchers, 

clinicians, decisionmakers, and innovators—work together to meet women’s health and wellness needs and learn about and evaluate all the available tools to create positive change. 

MARIA CORA, M.A. 

Lesbian Health & Research Center at UCSF 

Lesbian Health Is Women’s Health 

This testimony is presented on behalf of the Lesbian Health & Research Center (LHRC) at the 

University of California, San Francisco (UCSF). LHRC is dedicated to improving the health and 

well-being of lesbians, bisexual women, transgender people, and all families. To accomplish 

this mission, LHRC develops collaborative, precedent-setting programs, community initiatives, 

education and training, leadership development, and research. LHRC is the only organization 

housed within a world-renowned health science institution with this mission. It is a joint project of the UCSF Schools of Nursing and Medicine. 

The health obstacles faced by lesbian/gay/bisexual/transgender/queer/questioning (LGBTQQ) 

people, as well as our strengths and resiliency in the face of multiple oppressions, remain 

largely unstudied. As a result, we lack data about our community, and little evidence-based 

information exists to guide the design of effective public health policy and the provision of 

culturally appropriate healthcare services. Despite increasing recognition of unique LGBT 

health issues, there is a lack of representative, population-based data that describes the full 

extent of LGBT people’s health experiences. This “invisibility in research” reinforces societal 

stigma and marginalization for this population. LGBT people face a number of health disparities compared to the majority, including experiencing reduced access to health care, obtaining 

fewer cancer screenings, greater tobacco use, substance abuse, obesity, violence, depression, and suicide. The magnitude of these health disparities warrants scientific attention. LGBT 

people may also differ from the majority in other, positive ways. Recent research shows that 

same-sex couples report greater relationship quality, compatibility, and intimacy, and lower 

levels of conflict compared to their straight peers. 

There are an estimated 8.8 million LGB adults in the United States, which is comparable to 

the population of North Carolina. This number is likely an underestimate of sexual and gender 

minorities since it does not include youth or transgender people. The estimated LGBT proportion of the general population varies by location but is comparable to other minority groups, 

likely greater than Native Americans and Asians (<1 percent and 4 percent of the U.S. population, respectively) but less than African Americans (12 percent) and Hispanics (15 percent). 

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Sexual minority health is an emerging field and the health issues specific to LGBT people 

are gaining increasing recognition. Sexual orientation has been included in 10 of the 28 

focus areas for Healthy People 2010. A companion document produced by the Gay and 

Lesbian Medical Association in collaboration with community health experts further explores 

the HP2010 issues relevant to LGBT people. However, significant gaps in knowledge exist 

that warrant immediate study and consideration. LHRC recognizes that these gaps can be 

addressed by ensuring LGBT inclusion in demographic data gathered by researchers. Therefore, LHRC recommends all researchers routinely collect sexual orientation and gender identity 

data as part of their research protocols. The American Medical Association, American Public Health Association, and National Coalition for LGBT Health also recommend that research 

include sexual orientation and gender identity as key demographic variables, as research that 

assumes a heterosexual norm may not be generalizable to sexual and gender minorities. 

Several large national surveys now collect sexual identity data, including the National Health 

and Nutrition Examination Survey (NHANES), the Nurses Health Study II, and the National 

Alcohol Survey. Although the Behavioral Risk Factor Surveillance System (BRFSS) does not 

assess sexual orientation in its core questions, six States and three localities have collected 

sexual orientation data through their optional modules (CA, CT, MA, ND, OR, VT; San Francisco; New York; and Fulton County, GA). The California Health Interview Survey (CHIS), the 

largest State health survey in the United States, now collects sexual-orientation data. 

LHRC has already advanced the concept of a more rigorous scientific standard in the demographic section of all general research studies and governmental surveys to be inclusive of the 

LGBT population, thereby moving closer to achieving the goal of expanding the conventional 

research paradigm to routinely identify and be inclusive of the LGBT population. We initiated 

a pilot project with the UCSF Institute for Health & Aging in which they agreed to incorporate 

a tested question regarding sexual orientation and gender identity in the demographic section 

of their research endeavors. LHRC produced a briefing sheet to serve as a guide for the IHA 

faculty. As a successful result of this advocacy, the Alzheimer’s Disease Research Centers of 

California (ARCC), a program funded by the California Department of Public Health Services, 

included a sexual-orientation item in their data collection instrument starting in June 2008. 

There are 10 ARCCs located throughout the State, which collectively serve approximately 

1,000 individuals per year. It is our hope that this model of inclusive research will be broadly 

replicated and incorporated into all curricula used to educate student researchers. LHRC is 

advocating that all health science institutions adopt this strategy, beginning with the examination of health disparities and expanding to encompass all research protocols. 

In summary, LHRC strongly recommends not only the routine inclusion of demographic questions on sexual orientation and gender identity in research protocols going forward, but we 

also recommend routine inclusion of teaching on LGBT health to all individuals training to 

become healthcare workers. Model curriculum on LGBT health and LGBT mental health exist 

and need to be routinely taught to medical, dental, pharmacy, and nursing students, plus those 

pursuing postgraduate training (such as residencies). Part of the work of LHRC going forward 

will be the creation of a National Lesbian Health Agenda (NLHA). This agenda will be used 

at the Federal and State levels and will dovetail with efforts to generate a national women’s 

health agenda and a national LGBT health agenda. Input for the NLHA will be sought through 

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community surveys, focus groups and interviews with researchers, community leaders, academics, and healthcare providers. We are here today because LHRC’s overall mission, aimed at 

the population of lesbian, bisexual, and transgender women, makes us especially interested in 

inclusion of these populations within the broad focus on women’s health. 

SARAH JANSSEN, M.D., PH.D., M.P.H. 

Natural Resources Defense Council 

Hormone Disruptors and Women’s Reproductive Health: Recommendations from the Women’s 

Reproductive Health and the Environment Workshop 

I am submitting these comments on behalf of the Natural Resources Defense Council (NRDC). 

NRDC is a nonprofit, nongovernmental advocacy organization with more than 1.2 million 

members and online activists. We have offices in New York; Washington, DC; Chicago; San 

Francisco; Santa Monica; and Beijing. Our staff of nearly 400 employees consists of attorneys, 

scientists, physicians, and policy experts who apply our expertise to ensure a safe and healthy 

environment for all living things. I am a physician and scientist in the Health Program of NRDC, 

which focuses on a number of different threats to women’s reproductive health, including pesticides, endocrine-disrupting chemicals, heavy metals, and other pollutants found in the air 

we breathe, water we drink, food we eat, and consumer products we bring into our homes. A 

major part of our work involves staying abreast of the latest scientific advances so that scientific findings are appropriately considered and incorporated into public health policy decisions. 

In addition to my affiliation with NRDC, I am an Assistant Clinical Professor in the Department 

of Medicine at the University of California–San Francisco (UCSF), and was a participant and 

discussant in the 2007 UCSF–Collaborative on Health and the Environment (CHE) Summit. 

The 2007 UCSF–CHE Summit highlighted the evident need for increased research on environmental influences on female reproductive disorders and disease. After the Summit, a 

collaboration was formed, which led to the Women’s Reproductive Health and the Environment Workshop in January 2008 at Commonweal in Bolinas, California. 

This invitational workshop had three goals: 

• Assess the key science linking environmental contaminant exposures to reproductive 

health outcomes currently being reported at ever greater rates in women and girls. In 

particular, assess xenobiotics and phytoestrogens and the deleterious effects of these 

compounds on normal ovarian, uterine, breast, and hypothalamic/pituitary function. 

• Identify research directions that will fill current gaps in the scientific understanding in 

this field. 

• Translate this information for a lay audience of journalists, policymakers, NGOs, community groups, and others who can develop a strategy for prevention and intervention. 

The workshop brought together 18 leading researchers specializing in issues related to endocrine-disruption and women’s health to conduct a literature review on endocrine-disrupting 

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compounds (EDCs) and female reproductive health outcomes. The results of the workshop 

were published in the October 2008 issue of Fertility and Sterility and was titled Female reproductive disorders: The roles of endocrine-disrupting compounds and developmental timing. 

The workshop proceedings have been translated into a lay form in the report, Girl, Disrupted: 

Hormone Disruptors and Women’s Reproductive Health. These reports are available free of 

charge on the CHE Web site. 

The key finding of the workshop was that exposure to endocrine-disrupting compounds— 

particularly during fetal development and early life—may lead to female reproductive health 

problems, such as uterine fibroids, endometriosis, polycystic ovarian syndrome, early puberty, 

and others. Perhaps most importantly, the workshop scientists outlined a comprehensive 

research agenda to fill critical information gaps in women’s environmental reproductive health 

science, which can be found in both the scientific report and the lay document publication. 

• The need to prioritize research funding to study the effects of hormone disruptors on 

women’s health. Most of the research to date has been limited and focused on health 

outcomes in males, leaving large gaps in our understanding of how females may 

be impacted. 

• Improve health tracking systems. Currently, the systems that track rates of various health 

problems are inadequate. In order to understand the full impact of hormone disruptors on human health, particularly women’s health, we need to track female reproductive 

health trends. 

• Assess chemicals for their hormonal and reproductive health effects. Knowledge about 

the hormone-disrupting potential of most of the more than 80,000 industrial chemicals 

in production is very limited. These chemicals also have not been systematically assessed 

for their effects on reproductive health. Since industrial chemicals occur in nearly everything we buy and also are found in food, air, and water, this is a crucial step. Increasing 

the use of in vitro and in vivo testing can help identify potentially harmful chemicals. 

Investigate the impacts of hormone-disruptor exposure during critical windows of vulnerability. The major impediment to understanding whether hormone disruptors influence 

female reproductive disorders is the lack of information linking fetal exposures to adultonset reproductive disorders in humans. We have come to realize over the past decade that 

the embryonic/fetal origin of adult disease is a likely phenomenon and requires significant 

research and a change in our approach to linking disease with exposure. We need to carefully 

examine human exposures—especially during prenatal, newborn, and pubertal development— 

and consider whether these exposures relate to particular reproductive health disorders later 

in life. Moreover, the hypothesis that secondary adult exposures may initiate or exacerbate 

conditions that were set up prenatally requires further investigation. 

•	�Support long-term studies. Because hormone disruptors can have lifelong impacts, it is 

especially important to initiate studies tracking women’s health over large spans of their 

lives and to evaluate longer periods of time in animal studies. This will help us understand long-term and multigenerational effects. 

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•	�Encourage collaboration. Currently, most reproductive disorders are studied in isolation. 

This approach yields detailed information about single disorders, but it neglects commonalities that might exist among multiple disorders. By pooling data such as tissue 

samples and study results, a broader picture might emerge. 

Following the January 2008 meeting, the workshop scientists got together in a series of meetings to brainstorm ways in which these research gaps can be filled in a multidisciplinary and 

collaborative way. The consensus idea that came out of these meetings was the concept of a 

virtual consortium, or “lab without walls.” Our proposal is to construct a Virtual Consortium 

For The Environment and Women’s Reproductive Health. It has an overall structure that is not 

centered at one institution, but rather a consortium that takes advantage of the unique contributions each institution can make to the whole, thereby creating something that cannot be 

done at any one place or through any one RO1. We think this is a way to creatively leverage 

our expertise across the country with minimal funding input, rather than spending millions of 

dollars to create new centers. 

Our teams of investigators are developing several truly collaborative, transdisciplinary, and 

translational working groups focused on a selection of female reproductive disease areas, 

including uterine disorders such as uterine fibroids and endometriosis, and ovarian disorders 

such as polycystic ovarian syndrome and premature ovarian failure. We believe the virtual 

consortium model being developed by this research team will add greatly to our understanding, and ultimately prevention, of women’s reproductive health disorders, as well as address 

the public need to raise awareness around these disorders and the grave health disparities 

that exist. 

YALI BAIR, PH.D. 

Planned Parenthood Affiliates of California 

Planned Parenthood Affiliates of California Research Recommendations 

Introduction 

Planned Parenthood Affiliates of California (PPAC) represents nine separately incorporated 

Planned Parenthood affiliates throughout California on statewide governmental issues. We 

are 1 of 21 State public affairs offices of Planned Parenthood Federation of America. 

PPAC actively follows State and Federal legislation in a number of public policy arenas and 

promotes education, counseling, research, and clinical services in the field of reproductive 

health care. We monitor administrative, legislative, and regulatory actions, including local, 

statewide, and Federal initiatives. PPAC also engages in electoral or political activity as 

allowed by law and provides technical assistance to affiliates regarding Government 

healthcare programs. 

PPAC’s mission is to create a personally and politically safe climate in which individuals have 

universal and unfettered access to sexual and reproductive health services and are free to follow their own beliefs, values, and moral code when making decisions about these services. 

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Incorporated in 1974, PPAC has been a driving force at the Capitol regarding reproductive 

health care and reproductive freedom issues. It was the first such organization of its type in 

the Planned Parenthood Federation of America family and served as a model for other States. 

It was created because the Planned Parenthood organization in California saw the need for a 

common policy on information and education, fundraising, public relations, public education, 

and public affairs. 

PPAC’s vision and leadership has spurred lawmakers to enact legislation that makes California the number one State in the funding of family planning and other reproductive healthcare 

services. PPAC played a key role in improving access to reproductive health care, reducing 

unintended pregnancy and sexually transmitted infection rates in California. 

PPAC Research Recommendations 

Disparities in Disease Outcomes and Access to Care. Planned Parenthood supports research 

that seeks to reduce socioeconomic, racial, and ethnic disparities in health outcomes and 

access to care. In particular, our health centers and providers would benefit from research that 

elucidates the link between socioeconomic status, race and ethnicity, and access to care. In 

order to best serve low-income communities and communities of color, we must understand 

the likely barriers to seeking, accessing, and engaging in health care. 

Environmental Effects on Reproduction. Planned Parenthood supports healthy sexuality and 

reproduction and seeks to reduce any impediment to self-determination of reproductive decisions. Environmental effects on reproduction, particularly those that disproportionately affect 

communities of color, are barriers to reproductive choice and justice. Planned Parenthood supports research that would yield accurate and up-to-date information about risk factors for 

reproductive harm and limiting exposure to environmental toxins. In addition, research related 

to environmental policy that specifically addresses reproductive risk would benefit women’s 

health advocates working to develop informed policy in an area with a growing base of scientific knowledge. 

Reproductive Technology. Stem cell research is one of the reproductive technologies that will 

change how we provide reproductive health care in the future. Planned Parenthood supports 

a research agenda that addresses the health benefits and risks of reproductive technologies. 

Specifically, we are interested in research that identifies the role of stem cells in genderrelated health disparities and reproductive function and outcomes. In addition, research that 

addresses the health consequences of reproductive technologies that are becoming more 

commonly available (such as oocyte donation) are critical to inform the development of women’s health policy. 

Health Technology. Planned Parenthood believes that the role of technology in women’s 

health is an important component of healthcare delivery and personal health management. 

In the reproductive health arena, privacy of medical information is paramount to our providers and our patients. At the same time, the secure and appropriate use of health information 

through technology allows us to provide care in a more efficient manner and allows women 

to play a more central role in their health care. Planned Parenthood supports a research 

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agenda that incorporates the use of technology in women’s health care. In particular, we value 

research that identifies opportunities to integrate the latest science into health education at 

the community level and the use of health information technology to provide patients and 

providers with opportunities to become involved in research studies. 

Women in Research. The participation of women in research and in clinical medicine has 

transformed women’s health care. Planned Parenthood believes it is essential to continue this 

progress by enhancing research about women in science. In particular, we would be interested 

in models of providers participating in research in clinical settings, the role of women’s health 

researchers in policy development, and opportunities to increase racial and ethnic diversity 

among women’s health scholars. 

HIV. Planned Parenthood provides human immunodeficiency virus (HIV) testing for millions 

of high- and low-risk patients each year. Our organization would benefit from research that 

addresses barriers to testing, HIV/acquired immune deficiency syndrome prevention education, and community-based models for early testing and prevention. 

Intimate Partner Violence and Reproductive Coercion. Planned Parenthood is very interested 

in research relating to the effects of intimate partner violence on reproductive health behaviors and outcomes, particularly among adolescents. The current research in this area indicates 

that reproductive coercion and violence have significant health impacts. Further research is 

needed on the role that counseling and education about healthy relationships and sexuality 

have on reproductive care and health. 

DEBORAH ORTIZ, J.D. 

Planned Parenthood Mar Monte 

Testimony of Deborah Ortiz, VP of Public Affairs, California, Planned Parenthood Mar Monte Before 

the NIH Office of Research on Women’s Health at the University of California–San Francisco 

Dear members of the Congress, Office of Research on Women’s Health Committee members, and staff. My name is Deborah Ortiz and I am the California Vice President (VP) of Public 

Affairs for Planned Parenthood Mar Monte (PPMM). Thank you for allowing me to share our 

recommendations for future women’s research initiatives. 

Prior to my role as VP of Public Affairs with Planned Parenthood Mar Monte, I served as a California State Senator and Chair of the California Senate Health Committee. I was honored in 

2006 when Governor Schwarzenegger signed my legislation that established The California 

Environmental Contaminant Biomonitoring Act. That is why I am so proud of Planned Parenthood’s unique commitment to educating and empowering communities to understand 

how environmental contaminants may affect pregnancy outcomes, fertility, and reproductive 

development of girls. I will share Planned Parenthood Mar Monte’s two innovative community 

initiatives with the panel today. 

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Planned Parenthood Mar Monte is one of nine California Planned Parenthood affiliates. We 

serve 27 counties in California and 13 counties in Northern Nevada. In California, PPMM spans 

the Central Valley from Yuba City and Marysville to Bakersfield, and includes the Silicon Valley 

and coastal counties of Santa Clara, Santa Cruz, San Benito, and Monterey; and we serve the 

Sacramento and Sierra Foothill regions. 

Our mission is to ensure that every individual has the knowledge, opportunity, and freedom to 

make every child a wanted child and every family a healthy family. 

We consider this mission consistent with the right to healthy pregnancies free from exposure to environmental contaminants that may harm fertility, birth outcomes, and reproductive 

development in young girls. We also believe that partnerships with public and environmental 

health communities are essential to achieve our mission. 

Our affiliate has had great success educating communities about family planning and sexual 

health and we decided to increase community awareness about the intersection of environmental exposure and reproductive health. We are in a unique position to know about the 

threat because our clinicians often see their troubling effects ranging from low self-esteem 

due to early puberty, to problems conceiving healthy children, to a higher risk for breast cancer in young women. 

It is time for more people to know that Planned Parenthood’s family planning mission is promoting the health and safety of pregnant women and children. We provide primary and 

prenatal care to many uninsured families throughout our affiliate. Many work in agricultural 

communities and in workplaces that expose them and their children to chemicals, pesticides, 

plastics, perfumes, and sources of endocrine-disruptor chemicals. 

We also know that troubling new research indicates that a broad range of chemicals—including many that are associated with everyday products such as household cleansers, flame 

retardants, personal care and beauty aids, and even plastic water bottles—could have a complex and far-reaching impact on men’s and women’s reproductive health and fertility and 

healthy fetal development. 

Although most people know someone who has been affected by infertility, birth defects, or 

other childhood afflictions such as autism, many are not aware of the possible connection to 

common chemicals in our environment. We believe that once people are aware of the connections, they will be motivated to take action, both personally, to improve their health and the 

health of their families, and publicly, to ensure better policies for all. 

Planned Parenthood Mar Monte’s innovative leadership resulted in two initiatives that will educate and empower women and families on how their reproductive health can be affected by 

their environment. We went into two very different communities with the intent of one outcome: to ensure that every individual has the information on how the environment may affect 

their health and health of their families. 

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Today, I would like you to share these two examples that provide a more comprehensive vision 

of reproductive health and may serve as models for your important work in women’s health 

research initiatives. 

From the Personal to the Political 

PPMM’s first initiative was a Stanford lecture series, “From the Personal to the Political— 

Reproductive Health and Environmental Toxins.” The topics during the three lectures from 

March to May of 2008 studies early puberty, impacts of chemicals on fertility, and pesticides 

in playgrounds. PPMM partnered with Acterra and Reproductive Health Technologies Project 

in this effort. 

Those who attended the Stanford educational forums were primarily parents with young 

children and couples planning to become pregnant. This concern for their children’s health 

generated a large turnout throughout the educational forums on the links between environmental and reproductive health. Our hope is that our series provided the opportunity for 

participants to translate their education into personal and public actions. 

Our goal was to educate these parents and future parents about the growing evidence linking 

environmental contaminants to reproductive health issues such as fetal development, early 

puberty, breast cancer, asthma, and the harmful chemicals in cosmetics. We recruited specialists in this field who presented the information in a dynamic and engaging way. 

After each event, we encouraged the participants to take some kind of action and to develop 

effective collaborations between environmental and women’s health organizations. 

PPMM strongly believes that reproductive health organizations and environmental organizations are stronger and more effective when we work together and that, by working together, 

we will have more success in reaching new and diverse audiences. 

The intersection of reproductive health and the environment provides a unique and valuable 

opportunity for both the reproductive and environmental health communities to educate women 

and their families about the harmful effects of environmental contaminants and how to avoid 

them. In addition, we believe that this issue provides a critical opportunity to work across 

isolated movements for the long-term success of a progressive movement in this country. 

Pajaro Valley Health Action Team 

The second PPMM initiative is equally important, although it is underway in a vastly different community within PPMM’s service areas. The Pajaro Valley Health Action Team (PVHAT) 

is based in the Watsonville and Salinas communities of Pajaro Valley. Fewer than 60 miles 

divide the highly educated, primarily White university community of Palo Alto and poor, 

Latino, and largely shifting but still agricultural communities of Pajaro Valley that include 

Salinas and Watsonville. 

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PP Mar Monte received a 2-year grant from the Community Clinics Initiative (CCI), which is a 

joint effort of the Tides Foundation and the California Endowment to review the health outcomes of pesticides and agricultural chemical exposure to farm worker families. This unique, 

community-based collaborative assembled stakeholders to review anecdotal, local, and published data on the effects of pesticide exposure on the reproductive health of farm workers 

and their families in the Pajaro Valley. 

We knew that a true collaborative had to include farm worker, agribusiness, academia, environmental and public health groups, pesticide activists groups, and farm worker advocacy 

groups in order to successfully begin a conversation about how to measure our assumptions. 

Although still in our first year, we are well underway in designing a summit that will share 

information gathered with the public on data collected and encourage their input to develop 

a community-driven action plan. Pajaro Valley Health Action Team has focused on building a 

community-based collaborative to have an informed discussion about pesticide exposure and 

its effects on the reproductive health of farm workers in the Pajaro Valley of California. 

Activity has focused on enlisting community healthcare providers to develop a means of gathering data on reproductive health outcomes associated with pesticide exposure. The program 

staff continues to meet with local community stakeholders, leaders, and elected officials to 

advise them of the project and enlist their support and participation. We hired a facilitator, 

Spanish-language translators, and interpreters for the collaborative meetings as we consider 

participation by the largely Latino immigrant populations essential to our success. Finally, we 

are in the process of convening a collaborative planning group to flesh out community input 

for the structure and content of the meetings. 

The collaborative has had three meetings and has tentatively settled on the Center for the 

Health Assessment of Mothers and Children of Salinas (CHAMACOS) project out of the University of California-Berkeley as its source for data. CHAMACOS staff will be presenting their 

findings at a day-long working session to be held on June 17 in Watsonville and at that time, 

the collaborative will also formulate their common vision, with the intention of developing a 

strategic action plan within the next 2 months for presentation to the public. 

PPMM staff are working with an epidemiologist in Santa Cruz County and an analyst with 

the Monterey County Agriculture Commissioner’s office to retrieve data on birth outcomes 

and pesticide applications in the area. We are proud of our efforts to empower communities 

with information and opportunities to become advocates in the full spectrum of reproductive 

rights—from controlling their fertility to establishing the right of farmworker communities to 

be free from chemical exposure during their pregnancies. 

We hope that you will embrace this mission as your own and find ways to fund long-term and 

meaningful research that will result in policies to protect communities throughout the country. 

Our hope is that this is the beginning of many opportunities to share the future of women’s 

health research and thank you for your commitment to this work. 

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JANE HONIKMAN, M.S. 

Postpartum Support International 

Maternal Mental Health—Moving Forward 

Thank you for this opportunity to submit written and oral testimony at the Moving into the 

Future public hearing at the University of California, San Francisco. I am Jane Honikman, 

founder of Postpartum Support International (PSI). I have been an advocate for maternal mental health since the 1970s as a result of my own experience. My expertise is in social support 

and the formation of community-based perinatal peer support, self-help networks. PSI is the 

world’s largest nonprofit organization dedicated to helping women suffering from perinatal 

mood and anxiety disorders. 

Women are at highest risk for depression and anxiety during the childbearing years. These mood 

disorders not only exact a heavy toll on women and their families, but also yield a legacy of poor 

outcomes for their offspring. Effective treatments and interventions exist, yet mothers continue 

to suffer at an unacceptable rate. The outcomes of this psychiatric illness include infanticide, suicide, compromised mother/infant attachments, divorce, and loss of a productive life. 

I attended my first scientific conference about maternal mental illness in 1984. It was organized by a San Francisco physician named James Alexander Hamilton. I mention his name for 

the record because he deserves the credit for bringing childbearing psychiatric illness to our 

attention. Dr. Hamilton was an associate clinical professor of psychiatry at Stanford University, School of Medicine, and the chief of service, psychiatry at Saint Francis Memorial Hospital, 

San Francisco when he published his first book on postpartum psychiatric problems in 1962. 

He was a historian, as well as a clinician and researcher. To put the theme of “Moving into the 

Future” into perspective, I quote Dr. Hamilton’s opening paragraph in his chapter on history. 

“The first clinical description of postpartum mental illness was written in the fourth century, 

B.C., by Hippocrates. In the Third Book of the Epidemics, he cited the case of a woman who 

gave birth to twins, experienced severe insomnia and restlessness on the sixth day postpartum, became delirious on the eleventh day and then comatose, and died on the seventeenth 

day. Hippocrates speculated regarding the cause of postpartum mental illness, offering two 

hypotheses: 1) that lochial discharge, when suppressed, could be carried toward the head 

and result in agitation, delirium, and attacks of mania, and 2) that ‘when blood collects at the 

breasts of a woman, it indicates madness.’ These hypotheses were transformed into dogma 

and were accepted for more than two thousand years.” 

The 19th century brought a revival of interest in postpartum psychiatric problems. The International Marcé Society is named for a young French physician who put forth a connection 

between organic changes and the emergence of psychological symptoms in his book published 

in 1858. This was well before the discovery of chemical or hormonal relationships in the body. 

More than 100 years passed before medicine took up the debate during the second half of the 

20th century. Both international scientific research and public awareness began to increase. 

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We are making progress. I want to acknowledge the leadership of our Federal Government 

during this first decade of the 21st century. During 2004, the Health Resources and Services 

Administration (HRSA) held a Perinatal/Patient Safety Pilot Health Disparities Collaborative Expert Panel meeting, and a National Perinatal Depression Collaborators meeting. This 

same year, the CDC published a Pregnancy Risk Assessment Monitoring System and Postpartum Depression flyer in June, and in October, Postpartum Support International was invited to 

join the National Institute of Mental Health Outreach Partnership Program as a member of the 

National Partnership Network. In 2004 and 2006, State grants for perinatal depression and 

related mental health problems in mothers and their families were awarded by HRSA. In 2005, 

HRSA’s Maternal and Child Health Bureau Office of Women’s Health began developing a Federal booklet on perinatal depression, and in November 2006, it was published. I’m extremely 

proud to have been a part of these historic contributions for women and their families. 

And yet, there are enormous gaps in perinatal mental health services throughout our country 

and the world. In 2003, I participated in a conference at the University of Pittsburgh called 

Mothers and Depression: Beyond Talk and Into Action. For 2 days, professionals in several multidisciplinary groups addressed the research literature to translate science into practice and 

policy. It is clear that maternal mental health is a public health and welfare issue. Some models 

are now in place delivering effective interventions and treatments, however, they are not universal or uniform. They are rare and random. 

Research has shown us who is most at-risk for a childbearing psychiatric illness: those with 

a personal or family history of mental illness and those with low levels of social support. A 

pre-conception conversation about mental health and social support should be a routine 

healthcare practice. Every woman should be screened during her pregnancy and the conversation continued during the entire first postpartum year. Husbands and partners must also be 

included in this discussion. It is essential to have culturally appropriate educational and referral 

information, treatment options, and free support services available. 

I want to recommend a cost-effective, creative strategy, and innovative way to approach this 

persistent women’s health issue. On page 21 of HRSA’s booklet, Depression During and After 

Pregnancy: A Resource for Women, Their Families, and Friends, there is a very short list under 

“Where Help is Available.” Postpartum Support International (PSI) and Postpartum Education 

for Parents (PEP) are both based in Santa Barbara, CA. PEP has been serving its community for 

more than 30 years, offering free self-help emotional support to expectant and new parents by 

experienced parents. Trained volunteers actively listen to concerns and questions through its 

Warmline and/or parent discussion groups, and refer callers and/or participants to appropriate 

resources. I believe that a PEP-type model needs to be in every community, worldwide. 

Childbearing women and their families need and deserve easy access to emotional support 

and accurate information on perinatal healthcare issues. Healthcare professionals need a community-based organization where they can refer their patients and clients for peer support. 

Grassroots self-help, consumer organizations have proven to be a successful way to achieve 

this. We need to move back to the common sense approach of bringing people together to 

talk, gain confidence, learn their options, and find professional care when needed. Indeed, it is 

about moving into the future by using strategies from the past. 

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RHODA NUSSBAUM, M.D. 

Prevention International: No Cervical Cancer 

Prevention International: No Cervical Cancer 

So much has been learned about cervical cancer over the past two decades: identification of 

the causative agent and its epidemiology; understanding of the process of regression of low 

grade neoplasia; appreciation of the significance of persistent infection with the risk of transformation to invasive disease; the rapid development of technology, including modifications of 

standard cytology collection and preparation; development of sensitive and specific oncogenic 

human papillomaviruses infection diagnostic; and now vaccination for the strains responsible 

for 70 percent of significant precancerous and invasive disease. All of these advances in science 

have further decreased the incidence of invasive cancer and mortality in the developed world. 

The reasons for this dramatic impact go beyond technology. Access to screening and treatment of preinvasive lesions, effective public health educational campaigns, development of 

evidence-based screening, and treatment guidelines have all played a part in the decreased 

disease burden in the developed world. In the United States, significant disparities in incidence 

and outcome continue to exist between socioeconomic groups. Even these pervasive markers of healthcare injustice are decreasing and outcome data are more comparable between 

groups as the science, access, and infrastructure are advanced. 

But disparities in the burden of this disease between the developed world and areas of the 

globe now referred to as “low resource” is staggering and unacceptable. This has led to abundant research and publication. This work has been sponsored by generous private funders 

such as the Bill and Melinda Gates Foundation via the Alliance for Cervical Cancer Prevention; 

by international consortiums such as the International Agency for Research on Cancer of the 

World Health Organization; by professional associations, academic institutions, and numerous 

nongovernmental organizations both large and small, working in Africa, Asia, and Central and 

South America with a literature spanning more than a decade. 

Yet no sustained decrease in cervical cancer incidence and mortality is demonstrable in these 

“low resource” nations. 

Is the problem a lack of adequate technology? One would think so after reviewing the abundant literature comparing specificity and sensitivity of cytology versus visual inspection of the 

cervix, and most recently with HPV testing. 

Is the problem a lack of money? One would again think so after reviewing the many cost comparisons between one screening protocol and another. 

Is the problem a lack of sociopolitical will? One would think so after experiencing the low 

value placed on women, especially postreproductive-aged women, in many of the cultures and 

countries with the highest incidence of the disease. 

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Is the problem a lack of systemic analysis in the appropriate unit of society: village, regional, 

national, or multinational level? One would think so after examining the great diversity of 

medical infrastructure that exists from one area to the next. 

Is the problem a lack of perspective or too narrow a focus? One would think so after reviewing 

the studies, letters, and responses to letters in professional journals. Pathologists argue for the 

superiority of cytology-based programs. Public health professionals argue for low technology 

programs like VIA (Volunteers in Asia). Comparison of new technologies such as the human 

papillomaviruses polymerase chain-reaction testing, conducted with large numbers of women, 

but over a relatively short period of time, led to a recommendation of the further development 

of and widespread adoption of this as the best strategy. Development of a vaccination is proposed as the preferred strategy, even before long-term studies demonstrate long-term efficacy. 

Each of the strategies to attack and decrease cervical cancer incidence in the developing, low 

resource world has its unique contribution and benefit. On-the-ground research on integration 

of practice and protocols using different screening technologies and instituting vigorous quality 

control review is what is needed in the women’s health research agenda for the next decade. 

Prevention International: No Cervical Cancer, PINCC, is a 501(c)3 organization founded by Dr. 

Kay Taylor, an obstetrician/gynecologist who retired from her practice in the Bay Area several 

years ago. She was driven to address the unequal burden of cervical cancer in women in the 

developing world. After reviewing the literature and with no particular focus, bias, or affiliation 

with large funders, she developed a program of training local healthcare providers using technologies available, affordable, and appropriate for the area. The emphasis is on training and 

education. The emphasis is on outcome. The program utilizes VIA where appropriate, cytology 

when VIA is inadequate, and insists upon a cervical biopsy whenever destructive technologies (cryotherapy) are used. The program involves one-visit screening and treatment where 

possible, and trains physicians in loop electrosurgical excision procedure, which may be the 

ideal intervention based on lesion characteristics and the availability of electricity. All-volunteer teams of physicians, nurses, educators, and lay people return to each training site every 

6 months until the local healthcare personnel and infrastructure can continue to screen, treat, 

and carry out quality control independently. PINCC has worked in Central America and Africa 

and will begin trainings in South India this summer. 

Future priorities for women’s health research for the National Institutes of Health must include 

funding and support of research in prevention of cervical cancer. Continued development of 

technologies in the area of vaccination and cheaper and more rapid HPV identification are one 

small facet of this campaign that will be well funded by others. It is the integration of technologies into processes matched to the needs, culture, and resources of the region that need 

to be carried out in the coming decade. Evaluation of strategies for assessment of local and 

regional infrastructure, educational, and cultural readiness to be followed by the design of flexible programs stressing training, resources, quality control, and sustainable deployment will 

be imperative. Scalable programs that can influence populations will pay off as the disease 

burden is decreased and the numbers begin to approach what has been achieved in highresource areas of the globe. 

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This conference inviting public input recognizes the vast pool of knowledge, innovation, and 

commitment that exists in this country and is ready to be tapped and organized into a coordinated set of research priorities. This call for public input represents the humble request of one 

of the premier research organizations in the world to all organizations large and small, who 

wish to promote justice and better health throughout the world. 

We thank you for this opportunity and anticipate the results of this work. We look forward to 

celebrating the marked decreases in incidence, morbidity, and mortality of cervical cancer in 

the next decade. 

References 

(Selected bibliography for additional detail.) 

1.	� Sankaranarayanan, R., Nene, B. M., Shastri, S. S., Jayant, K., Muwonge, R., Budukh, A. M., 

. . . Dinshaw, K. A. (2009). HPV screening for cervical cancer in rural India. New England 

Journal of Medicine, 360, 1385–1394. 

2. Suba, E. J., Murphy, S. K., Donnelly, A. D., Furia, L. M., Huynh, M. L., & Raab, S. S. (2006). 

Systems analysis of real-world obstacles to successful cervical cancer prevention in 

developing countries. American Journal of Public Health, 96, 480–487. 

3. Suba, E. J., Donnelly, A. D., Furia, L. M., Huynh, M. L., Raab, S. S.; Viet/American Cervical 

Cancer Prevention Project. (2007). Cervical cancer prevention for all the world’s women: Genuine promise resides in skilled quality management rather than novel screening 

approaches. Diagnostic Cytopathology, 35, 187–191. 

4. Agosti, J. M., & Goldie, S. J. (2007). Introducing HPV vaccine in developing countries— 

Key challenges and issues. New England Journal of Medicine, 356, 1908–1910. 

ROHAM ZAMANIAN, M.D. 

Pulmonary Hypertension Association 

Pulmonary Hypertension in Women 

Thank you for the opportunity to provide today the perspective of the Pulmonary Hypertension 

Association on one important area of investment for the Office of Research on Women’s Health. 

I am honored today to represent the many thousands of Americans who are fighting a courageous battle against a devastating disease. Pulmonary hypertension (PH) is a serious and 

often fatal condition where the blood pressure in the lungs rises to dangerously high levels. 

In PH patients, the walls of the arteries that take blood from the right side of the heart to the 

lungs thicken and constrict. As a result, the right side of the heart has to pump harder to move 

blood into the lungs, causing it to enlarge and ultimately fail. 

PH can occur without a known cause or can be secondary to other conditions such as collagen vascular diseases (i.e., scleroderma and lupus), blood clots, human immunodeficiency virus, 

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sickle cell, or liver disease. Patients develop symptoms that include shortness of breath, fatigue, 

chest pain, dizziness, and fainting. Unfortunately, these symptoms are frequently misdiagnosed, 

leaving patients with the false impression that they have a minor pulmonary or cardiovascular 

condition. By the time many patients receive an accurate diagnosis, the disease has progressed 

to a late stage, making it impossible to receive a necessary heart or lung transplant. 

PH occurs in individuals of all ages, races, and genders. However, women are more than twice 

as likely as men to develop PH. Women most often develop PH during their childbearing years. 

Pregnancy can be a painful subject for PH patients because it is associated with life-threatening 

risks for both the mother and baby. Survivability for PH patients carrying to term is 50 percent. 

PH is chronic and incurable, with a poor survival rate. Fortunately, new treatments are providing 

a significantly improved quality of life for patients. Recent data indicate that the length of survival is continuing to improve, with some patients managing the disorder for 20 years or longer. 

Nineteen years ago, when three patients who were searching to end their own isolation 

founded the Pulmonary Hypertension Association, there were fewer than 200 diagnosed cases 

of this disease in the entire United States. It was virtually unknown among the general population and not well known in the medical community. The three patients’ desire to change this 

bleak picture led to their establishment of the Pulmonary Hypertension Association (PHA), 

which is headquartered in Silver Spring, MD. 

Today, PHA includes the following: 

• More than 10,000 patients, family members, and medical professionals as members and 

an additional 36,000 supporters and friends 

• A network of more than 200 patient support groups 

• An active and growing patient-to-patient telephone helpline 

Three research programs that, with partnerships with the National Heart, Lung, and Blood 

Institute and the American Thoracic Society, have directed more than $7.5 million toward 

PH research. 

• Numerous electronic and print publications, including the first medical journal devoted to 

pulmonary hypertension, which is published quarterly and distributed to all cardiologists, 

pulmonologists, and rheumatologists in the United States 

• A Web site dedicated to providing educational and support resources to patients, medical professionals, and the public that, over the past decade, has grown from 600 visits a 

month to between 270,000 and 390,000 visits per month 

The Pulmonary Hypertension Community 

I would like to share with you the stories of two remarkable PH patients, Emily Stibbs and 

Charity Tillemann-Dick. Emily’s and Charity’s stories illustrate the impact of pulmonary hypertension not only on PH patients, but also on everyone who care about them. 

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When their daughter, Emily, was 5 years old, Jack and Marcia Stibbs noticed that she could 

not keep up with the other children in the neighborhood. She seemed to lack the energy and 

strength to run and play. This condition worsened to the point where she would have to stop 

and rest after coming down the steps in the morning. Jack and Marcia noticed that when she 

was sitting on the bottom step in the morning, Emily’s lips appeared to have a bluish color. 

After pressing for an answer to these problems for several months, Emily was finally diagnosed with pulmonary hypertension and the doctors told the Stibbs family that her probable 

remaining lifespan was 3 years. 

Charity Tillemann-Dick’s diagnosis with pulmonary hypertension took not months, but years. 

When Charity was in her late teens, she had the opportunity to travel abroad and share her 

considerable talents as a budding opera singer at her grandfather’s 75th birthday party in 

Budapest. Just before the performance, Charity collapsed, but the episode was explained 

away as a case of nerves. 

Over the next few years, Charity continued to have occasional fainting spells as well as a progressive loss in energy. She was diagnosed as being everything from out of shape to anemic. 

When Charity finally received an accurate diagnosis, her PH had progressed further, and was 

therefore more difficult to treat than it would have been if she had been diagnosed while the 

disease was in its early stages. 

I am happy to report that, with treatment, Charity has continued to live a full and accomplished life, including performing at several world capitals. Emily, too, has outlived her 3-year 

prognosis by 7 years and continues to thrive. There is still, however, no cure for pulmonary 

hypertension. Each day, courageous patients of every age lose their battle with PH. Thanks to 

congressional action, and to advances in medical research largely supported by the National 

Heart, Lung, and Blood Institute (NHLBI) and other Government agencies, Emily and Charity have an increased chance of living with their pulmonary hypertension for many more 

years. However, additional support is needed for research and related activities to continue to 

develop treatments that will extend the life expectancy of PH patients beyond the National 

Institutes of Health (NIH) estimate of 2.8 years for 50 percent after diagnosis, and to raise 

awareness of this rare, deadly condition. 

Recommendations 

In December 2006, the NHLBI and the NIH Office of Rare Diseases cosponsored a 2-day scientific conference on pulmonary hypertension. This important event provided an opportunity for 

leading PH researchers from the United States and abroad to discuss the state of the science 

in pulmonary hypertension and future research directions. 

According to these leading researchers, we are on the verge of significant breakthroughs in 

our understanding of PH and the development of new and advanced treatments. Twelve years 

ago, a diagnosis of PH was essentially a death sentence, with only one approved treatment 

for the disease. Thanks to advancements made through the public and private sector, patients 

today are living longer and better lives with a choice of six FDA-approved therapies. 

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At a congressional hearing on pulmonary hypertension in December 2005, Dr. Mark Gladwin, 

who was then chief of the Vascular Medicine Branch at NIH’s NHLBI said, “I study what is happening in pulmonary hypertension as an example of what you can do with an orphan disease. 

With the combination of advocacy, industry involvement, and state-of-the-art basic science, 

they came together, in a perfect storm of opportunity.” 

Recognizing that we have made tremendous progress, we are also mindful that we are a long 

way from where we want to be in 1) the management of PH as a treatable chronic disease, 

and 2) a cure. Our needs are in both clinical research and public and medical professional 

education. PH patients typically visit three physicians before a fourth makes an accurate diagnosis—often losing a year or more and making their prognosis significantly less promising. 

With this in mind, the Pulmonary Hypertension Association respectfully requests that the 

Office of Research on Women’s Health make pulmonary hypertension a research priority now 

and in the future. 

ELIZABETH ARNDORFER 

Reproductive Health Technologies Project 

Public Testimony of the Reproductive Health Technologies Project to the Office of Research on 

Women’s Health 

Since its inception, the mission of Reproductive Health Technologies Project (RHTP) has been 

to advance the ability of every woman to achieve full reproductive freedom with access to the 

safest, most effective, appropriate, and acceptable technologies for ensuring her own health 

and controlling her fertility including preventing, terminating, or continuing a pregnancy. 

Mounting scientific research indicates that chemical contaminants are impacting health, 

including reproductive health and fertility. 

• About 10 percent of women report difficulty conceiving and maintaining a wanted pregnancy. Women under the age of 25 report the largest increase in this problem. 

• An expert panel recently commissioned by the government concluded that breast development and menarche in girls is beginning at an earlier age and that early puberty is 

linked to breast cancer and behavioral disorders. 

• Compared to 30 years ago, more than 25 percent more women get breast cancer and 

three times as many women are being diagnosed with thyroid cancer. 

• While there are no population-wide data, estimates suggest that uterine fibroids and 

endometriosis are harming the health and fertility of between 10 to 50 percent of 

American women. Uterine fibroids are the single largest reason for hysterectomy in 

women of childbearing age. 

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• Thirty percent more babies are born premature, and on average, babies are born 1 week 

earlier now than they were 15 years ago. Prematurity puts a child at risk for a host of 

health problems, including neurodevelopmental and respiratory conditions and later-inlife diabetes and heart disease. 

• Human studies show that endocrine-disrupting chemicals are impacting the ratio of 

male-to-female births. The most recent example of this finding is a new study of women 

in the San Francisco Bay area who gave birth in the 1960s. If the mother’s polychlorinated biphenyl levels were relatively high, they were one-third less likely to give birth to 

baby boys. 

• Some of the most common birth defects today are malformations of the male reproductive system. Hypospadias (deformities of the penis in infants), cryptorchidism 

(undescended testicles), and testicular cancer appear to be increasing, while sperm 

count and testosterone levels are declining in certain populations. 

• While cancer mortality is declining, the incidence of most childhood cancers continues to 

rise. These cancers are suspected to occur from alterations while the woman is pregnant 

and carrying the fetus. 

Research links these human health problems to chemical contaminants in the environment. 

• In biomonitoring studies of more than 150 contaminants in the American people, the U.S. 

Centers for Disease Control and Prevention (CDC) reported that all 150 chemicals were 

detected in some portion of the U.S. population and that several of the chemicals, such 

as environmental tobacco smoke, lead, mercury, phthalates, and bisphenol A, are detected in nearly all or all of the population. Some of the contaminants were measured at 

levels that cause adverse effects on reproductive health in animal studies. 

• Epidemiologic studies in several countries have linked maternal exposure to air pollution 

with low birth weight and preterm delivery. 

• Animal studies show that exposures to chemical contaminants around the time of conception, during pregnancy, or during infancy can be particularly powerful because these 

are times of extreme vulnerability. 

• A May 2009 study found that exposure to bisphenol A in the womb causes infant male 

monkeys to behave more like infant females, highlighting a new and potentially important consequence of exposure to low doses of BPA. The species of monkey used in this 

study was chosen for its similarity to humans. 

• Other studies show that during this time, exposures to bisphenol A can cause permanent 

changes and increased risks of later reproductive health problems (infertility, miscarriage, 

breast cancer, prostate cancer). 

• Prenatal exposure to phthalates found in personal care and vinyl products has been 

linked to reproductive effects in male babies, like undescended testicles and deformities 

of the penis. 

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• Cadmium, a metal found in cigarette smoke and in other types of air pollution, has 

been linked to gynecological disorders in women, such as endometriosis and reduced 

sperm motility. 

• Animals exposed prenatally to perfluorinated chemicals, common in stain-proof and 

stick-free products, show increased allergic response, elevated cholesterol, abnormal thyroid hormone levels, liver inflammation, and weaker immune systems. Human babies 

born with higher levels of these chemicals in their umbilical cord blood have lower birth 

weight and smaller body mass. 

Further research and data collection are needed in the area of environmental contaminants 

and human health. The Office of Research on Women’s Health is in the position to provide 

significant leadership to these efforts. RHTP recommends the following: 

• Conduct a Comprehensive Scientific Review. As stated in this testimony, increasing 

evidence points to links between environmental toxicants and human fertility and birth 

defects. However, the Federal Government is not collecting data on this subject in a systematic and authoritative manner. The Government needs to engage in a comprehensive 

review of existing and forthcoming research and issue a report on the links between 

chemical contaminants and reproductive health. 

• Support Environmental Research and Clinician Training. Renew and expand support for 

the National Toxicology Program, National Institute of Environmental Health Studies, 

National Institute of Occupational Safety and Health to study biology of pregnancy, 

fetal development and reproductive health, the complexities of racial and social disparities, and the impact of the environment on human health. Clinician training should be 

funded to add environmental health issues to the provision of health care. 

• Support Increased Funding for the National Children’s Health Study. The Children’s 

Health Act of 2000 authorized the Eunice Kennedy Shriver National Institute of Child 

Health and Human Development (NICHD) and other agencies to follow 100,000 children 

from birth to age 21 to measure environmental influences on their health and development. The study seeks to address six chronic illnesses that cost Americans $642 billion 

each year (obesity, injury, asthma, diabetes, schizophrenia, and autism). If the study resulted in a 1 percent reduction in the cost of these diseases, it would save Americans $6.4 

billion a year, paying for itself twice over in only 1 year. The National Children’s Study will 

provide groundbreaking children’s health data crucial to establishing causal links and 

preventing disease. Increased funding will expand the capacity of researchers and the 

study to provide the evidence needed to safeguard the health of America’s children for 

generations to come. 

• Expand and Modernize Our Disease Surveillance Infrastructure. The disease surveillance 

system, specifically the National Center for Health Statistics, the National Environmental 

Public Health Tracking Program, and the biomonitoring efforts of the Centers for Disease 

Control and Prevention must be expanded and modernized. Without a strong healthmonitoring infrastructure, we cannot thoroughly track reproductive health outcomes 

such as disparities in low-birth weight births among racial groups, and trends in female 

health developments. 

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• Acknowledge and Reduce Socioeconomic and Racial Disparities. Recent studies have 

shown that people of color, immigrants, and people living in low-income neighborhoods 

are far more likely to be exposed to toxic chemicals in their workplaces and communities. Biomonitoring studies also show that these demographics have higher levels of 

these chemicals in their bodies and often have less access to institutions that protect 

their health and well-being. For instance, rates of breast cancer mortality, early puberty, low birth weight, and premature deliveries are all higher in African-American women. 

Improved access to health care and educational and economic opportunities, including 

job training, adequate housing, healthy food, transportation, child care, and other socioeconomic factors, can individually and collectively reduce the environmental impacts on 

women’s health. 

• Expand Contraceptive Research and Development. There is growing concern that pharmaceutical waste may be impacting the environment. Some concerns have been raised 

about the harmful effect of hormonal contraceptives, but the current scientific evidence 

is inconclusive. Nevertheless, expanding research for “greener contraceptives” as well as 

nonhormonal contraceptives would accomplish the twin goals of protecting the environment and ensuring that women have the best options for controlling their fertility. 

The agenda laid out above is ambitious and long term. RHTP believes that the ORWH would 

be in a stronger position to accomplish these goals if the ORWH were established by statute, 

leaving it less vulnerable to understaffing, underfunding, and future elimination. RHTP would 

strongly support such an action. 

Conclusion 

We applaud the Office Research on Women’s Health for conducting these hearings and 

for specifically looking into the connection between women’s health and environmental contaminants. There is much that the ORWH can do in the coming years to enhance our 

understanding of the significant problems in this area and to protect women from the negative 

impact of chemicals. 

CATHY EDDY 

Scleroderma Foundation Northern California Chapter 

My Scleroderma Story: A Disease That Disproportionately Affects Women 

My name is Cathy Eddy and I am the president of the Scleroderma Foundation Northern 

California Chapter. I would like to share with you my story about how scleroderma has 

affected my life. 

Scleroderma is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. There are an estimated 300,000 people in the United States who 

have scleroderma, about one-third of whom have the systemic form of scleroderma. Eighty 

percent of those with scleroderma are women, usually diagnosed between the ages of 25 and 

55. It is a chronic disease, often disabling and disfiguring, and potentially life threatening. 

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Common symptoms include hands or feet being overly sensitive to the cold, with pain and 

color changes; thickening of the skin, usually starting in the hands; shortness of breath; trouble 

swallowing; stiffness of the hands; joint or bone pain; and fatigue. Since scleroderma presents 

with symptoms similar to other autoimmune diseases, diagnosis is difficult and there may be 

many misdiagnosed or undiagnosed cases, as well. 

The disease may take several forms. Localized scleroderma is more common in children, 

whereas systemic scleroderma is more common in adults. There is also much variability among 

patients. The effects of scleroderma can range from very mild to life threatening. The seriousness will depend on what parts of the body are affected and the extent to which they are 

affected. A mild case can become more serious if not properly treated. Prompt and proper 

diagnosis and treatment by qualified physicians may minimize the symptoms of scleroderma 

and lessen the chance for irreversible damage. The exact cause or causes of scleroderma are 

still unknown, but scientists and medical investigators in a wide variety of fields are working 

hard to make those determinations. 

I was diagnosed with diffuse cutaneous systemic scleroderma in 1996 when I was 39 years 

old. I was a wife and mother of three young sons. I had a career that I loved in bedside nursing. Even though I was a registered nurse for 18 years, I really had no idea what a diagnosis 

of scleroderma would mean. My doctors were familiar with the disease, but had very limited 

experience with it. 

As I began to research scleroderma, the news was not very encouraging. At best, it is a lifelong chronic, painful, disfiguring, and disabling disease. At worst, it is potentially fatal within a 

few years. As you can imagine, it is very frightening. I worried that my children would grow up 

without their mother. 

As my disease progressed, I became more and more affected by scleroderma. My hands 

became bent and stuck in a claw-like position. Due to the circulatory changes caused by 

scleroderma, I began to develop open ulcers on my knuckles and fingertips. I had to leave my 

nursing job and apply for disability. That was devastating for me because I’m used to being 

self-sufficient, and I lost my health benefits. I developed severe gastroesophageal reflux disease, as scleroderma can damage the entire gastrointestinal system. I have scarring in my 

lungs and heart. Scleroderma can also damage the kidneys. My skin was so tight that it felt like 

it was two sizes too small. I could not raise my arms above my shoulders or reach down to put 

on my socks. I had incredible pain and fatigue. 

I spent a lot of time going to the doctors—rheumatologist, dermatologist, cardiologist, and 

pulmonologist, in addition to my family practice physician and OB-GYN. I have participated 

in research studies, at one point going to the Mayo clinic in Rochester. It was all I could do to 

take care of myself and try to care for my family. I tried many medications. Some helped, others did not. I spent hours on the phone with insurance companies trying to get authorization 

for many tests. I also spent much time researching scleroderma on my own, as many of the 

doctors were not familiar with it or had never had a patient with it. 

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In my research, I found out about the Scleroderma Foundation. The Scleroderma Foundation 

is a nonprofit national organization founded in 1998 whose mission is to provide support, 

education, and research. It exists for people with scleroderma and their friends and families. 

I became a member and attended the conferences. It opened many doors for me. I was able to 

talk to the doctors on the cutting edge of scleroderma research and treatment. 

I remained hopeful that a cure would be found, or at least we could identify a cause and a 

treatment. I am still waiting. 

Today, I am doing better due to many new medications and the care of many fine medical professionals. I have had surgery on both hands to remove my middle knuckles and extend my 

fingers in a locked and functional position. I had to travel to the University of California–Los 

Angeles to find a doctor who would operate on my hands, and had many serious complications. I am taking 12 prescription medications. I developed skin cancer due to the side effects 

of my immunosuppressants. However, they are reversing the skin tightness and preventing 

my body from a further attack on my lungs. I have lost 50 percent of my lung function at this 

point. My out-of-pocket drug costs for last month alone were $2,500. I reached the Medicare 

Part D coverage gap in February. My husband is self-employed and we are barely making ends 

meet. I am grateful to be doing better, but the cost of these drugs is killing us. 

In my chapter president position with the Scleroderma Foundation, I talk to many patients. I 

see the depression that comes from chronic disease and hopelessness. I see the pain and the 

breathing difficulty that comes when the lungs turn to scar tissue. I have lost some of my best 

friends to the devastating effects of scleroderma. There are still no approved therapies. There 

is still not enough awareness of scleroderma in the medical community. 

One of the potential therapies that is being tested right now is stem cell transplant for scleroderma. It is showing promise, but much more research needs to be done. The need to prioritize 

research on diseases that disproportionately affect women and that have no approved therapies, like scleroderma, is imperative for those of us who suffer day in and day out. 

Thank you very much for this opportunity to share my scleroderma story. 

HASSAN SALLAM, M.D., PH.D., FRCOG 

The Suzanne Mubarak Regional Center for Women’s Health and Development 

The Suzanne Mubarak Regional Center for Women’s Health and Development 

Introduction 

The Suzanne Mubarak Regional Centre for Women’s Health and Development (SMC) is a 

nonprofit training and research organization active in all areas of women’s health and development, situated in Alexandria, Egypt. It offers its activities to women at large and to all 

professionals working in the area of women’s health and development in Egypt and friendly 

neighboring countries. The SMC is governed by a board of trustees headed by H. E. Mrs. 

Suzanne Mubarak, First Lady of Egypt. The SMC was established in March 2007 and receives a 

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yearly budget from the Egyptian government to cover its running expenses. However, its activities are covered by national and international sponsoring bodies. 

During its first 2 years of operation, the SMC has managed to attract funds from the World 

Health Organization, the United Nations Population Fund, the Ford Foundation, and the 

Swedish International Development Agency (SIDA) to support various training and research 

projects. The SMC is academically linked to the University of Alexandria and many of its staff 

members are academic staff members of the University, particularly the Faculty of Medicine and the High Institute of Public Health. The SMC is headed by Professor Hassan Sallam, 

M.D., FRCOG (England), Ph.D. (London), who is also the Professor and Chair of Obstetrics and 

Gynecology at the Alexandria University Faculty of Medicine. 

Vision 

To see women in Egypt and friendly neighboring countries enjoy the highest standards 

of health and development, health being a state of complete physical, mental, and social 

well-being, and not merely the absence of disease or infirmity, and is firmly linked to 

women’s development. 

Mission 

To work with women in Egypt and neighboring countries toward achieving the following: 

• A healthy infancy with no gender gap in morbidity or mortality 

• A healthy adolescent life free from violence or genital mutilation 

• A healthy reproductive life with a safe outcome to mothers and their babies 

• A healthy sexual life free from sexually transmitted disease, including HIV/AIDS 

• A healthy and active postreproductive life 

• Fertility by choice and not by chance 

• A productive life free from poverty or gender discrimination 

Tools 

In order to achieve its vision, the SMC conducts the following activities: 

Training (capacity building). Training courses are organized in all areas of women’s health and 

development for doctors, nurses, midwives, health administrators, pharmacists, and medical 

and laboratory technicians. The trainers come from all Egyptian as well as international academic and clinical institutions. During 2008, the SMC conducted 45 training courses in which 

a total of 1,818 trainees from Egypt and 12 African and 2 Asian countries participated. Examples include basic and advanced courses on ultrasound (in collaboration with professor Stuart 

Campbell, University of London), courses on evidence-based medicine (in collaboration with 

professor Paul Glasziou, University of Oxford), courses on gynecologic endoscopy (in collaboration with Professor Maurice Bruhat, University of Lyon), and courses on urodynamics (in 

collaboration with Professor Uwe Ikinger, University of Heidelberg). 

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Research. Various research projects are conducted, including basic research in the laboratories, clinical research with patients, epidemiological research, and operational research. 

Advocacy. The SMC organizes awareness campaigns in important topics related to women’s health and women’s rights. These campaigns are conducted in collaboration with various 

nongovernmental organizations with whom the SMC enjoys excellent working relationships. 

Examples include awareness campaigns for self-breast examination for the early detection of 

breast cancer and the new vaccine against human papillomavirus and cervical cancer. Awareness campaigns were also organized against female genital mutilation, active and passive 

smoking, as well as violence against women. 

Conferences, workshops, seminars. These are conducted for the purpose of educating the 

medical staff and the public. They are also organized to disseminate the results of research 

among interested bodies. In addition, these events serve to highlight important issues related 

to women’s health and development. 

Organization 

The SMC consists of six departments: three active departments supported by three supporting 

departments. The three active departments are as follows: 

1. Training Department 

2. Research Department 

3. Department of Women’s Development 

The supporting departments are as follows: 

1. Department of Conventions and Logistics 

2. Administrative and Financial Department 

3. Medical Department 

In addition, the following units are directly attached to the Office of the Director: 

1. The public relations unit 

2. The legal advisory unit 

3. The security unit 

4. The information technology/data bank unit 

5. The quality assurance unit (under construction) 

Premises 

The SMC occupies an impressive building overlooking the Mediterranean Sea in the centre of 

Alexandria and is owned by the Egyptian state. This 60-room building was established in 1929 

to house the “Medical Quarantine of the East.” In 1948, it was occupied by the East Mediterranean Regional Office of the World Health Organization (WHO–EMRO). When the latter moved 

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to Cairo in 2000, the building resorted to the Egyptian government. It was then decided to 

house the newly established SMC in the premises. 

Facilities 

The SMC possesses excellent training and research facilities appropriate to its activities. Besides 

the main meeting hall capable of hosting 60 to 80 seated persons (the Suzanne Mubarak Hall), 

it has 3 other meeting rooms with 30- to 50-persons capacity. All rooms have audiovisual facilities and can be connected to the videoconferencing system. In addition, the SMC possesses a 

digital library connected to the most important databases and journals related to its fields of 

interest as well as a skills laboratory with a fully computerized human mannequin. 

Research facilities include all basic laboratories for blood chemistry, histopathology and 

microbiology, as well as a cytogenetics laboratory, a molecular biology laboratory, and tissue-culturing facilities. Imaging facilities include mammography equipment, bone-scanning 

equipment, as well as 2D and 4D ultrasound facilities. Laboratory and imaging equipment are 

provided with tele-medicine capacities. In addition, the equipment includes a urodynamic unit 

with biofeedback facilities, fetal monitoring, and various aesthetic dermatology equipment. 

The SMC has 12 specialized clinics in various aspects of women’s health, offering their services to 

referred patients from Alexandria hospitals and doctors or from the two screening clinics receiving self-referred patients. Besides offering help to the needy patients, these clinics provide an 

excellent background for training and research purposes. Patients in need of hospital admission 

are transferred to the Alexandria University Hospital, where the treatment is free. An up-to-date 

computer network connects the various departments, offices, and clinics of the SMC. 

Research at SMC 

Research at the SMC encompasses all areas of women’s health and development. Currently, 

the SMC is engaged in the following areas of research: 

Genetics of Pre-Eclamptic Toxemia (PET). The SMC is currently conducting a research project in collaboration with the University of Lund in Sweden (Professor Stefan Hansson, past 

National Institutes of Health grant recipient). For many reasons, PET is still commonly seen in 

pregnant women in Egypt. As some women do not enjoy full antenatal care services, cases of 

eclampsia are often seen. The current research aims at finding a genetic marker for the prediction and/or early detection of PET. The project is sponsored by a grant of 300,000 Swedish 

krona from SIDA. A patent is pending. 

Endometriosis as a Cause of Pain and Infertility in Women. A meta-analysis of randomized 

studies was conducted in collaboration with Professor Aydin Arici (Yale University), Professor 

Juan Garcia Velasco (Juan Carlos University, Madrid, Spain) and Dr. Sonia Dias (University of 

Manchester). The work was published in the Cochrane Library.1 

Infertility in Developing Countries. The SMC is currently involved in a project of bringing 

infertility services to developing countries, in collaboration with the Task Force on Infertility in developing countries of the European Society for Human Reproduction and Embryology 

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(ESHRE), the International Federation of Fertility Society (IFFS), and the Low Cost In Vitro Fertilization Foundation. The research involves the simplification of current technology to be suitable 

for developing countries. Part of the research has been published in the monograph published 

by Human Reproduction (the official journal of the European Society for Human Reproduction 

and Embryology). A grant is sought from the African Development Bank for this project. 

Menopause in Developing Countries. As the age of women is rising in some developing countries, including Egypt (now standing at 71), the SMC is interested in studying the problems 

and management of menopause in these countries. A paper has already been published in 

Climacteric, the official journal of the International Menopause Society.2

 This study was SMC 

self-funded. 

Breast Health Awareness. Knowledge and attitudes toward breast cancer and self-breast 

examination in women living in two deprived areas of Egypt have been studied (Ezbet Sekinah 

and Abou-Sliman). A total of 620 women was studied. Of these, 72 percent have heard about 

breast cancer, but only 10 percent had performed self-breast examination during the past 6 

months. On questioning, 34 percent expressed their strong belief that self-breast examination (SBE) is beneficial, 16 percent had little belief in its value, and 18 percent thought it had an 

intermediate value. The rest, 32 percent, had never heard about SBE. Finally, 14 percent stated 

that they knew how to perform SBE, while the rest, 86 percent said that they did not know 

how to perform it. The paper is being submitted. This project was SMC self-funded.2 

Operational Research on Self-Breast Examination. Based on the above findings, a research 

project is currently being conducted in the same deprived areas of Alexandria, Egypt. A total 

of 518 women has so far been studied. One year after training on SBE, the percentage of 

women practicing SBE rose to 71.6 percent during the past 6 months (from 3.1 percent before 

training), with 7.1 percent saying that they had SBE during the past month (compared to 1.7 

percent before training). The project is still ongoing and is SMC self-funded. 

Attitudes of Women Toward Domestic Violence. This research project sponsored by the Ford 

Foundation is currently ongoing. So far, a total of 250 women was interviewed. Preliminary 

results show the following: 

• A total of 55 percent of the studied women agree that men have the right to beat 

their wives. 

• The most common cause for wife battering is asking for money (82 percent). 

• A total of 85 percent of the studied women accept violence from their husbands because 

they are afraid of divorce. Most of them leave and return several times to their homes, 

but they never asked for divorce. 

• Most women (87 percent) consider the act of battering as an intimate personal issue between husband and wife and no one has the right to know their problems or get involved 

in them. 

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• Most of the studied women (72 percent) have suffered from family abuse (psychological 

abuse) from their brothers and fathers since they were young. 

• The most common cause of psychological abuse was answering husband back or 

answering loudly (77 percent). 

• Approximately 66 percent of the studied women were financially abused and 49 percent 

mentioned that they beg their husband to give them money, either for themselves or for 

their children. 

• In 51 percent of cases, the husband takes the wife’s money, as he believes that by marriage, the husband owns his wife, giving him the rights to take her money. 

Laws Related to Violence Against Women (VAW). The SMC is currently conducting a research 

project in collaboration with the Protection Project of Johns Hopkins School of Advanced 

International Studies (SAIS), with the aim of revising the laws regarding VAW in an attempt to 

devise a model law to be presented to the Arab League of Nations. The project is jointly sponsored by the SMC and the SAIS. A workshop was conducted in March 2009, with the presence 

of Dr. Yakin Irturk, UN special rapporteur on VAW, and Professor Mohamed Mattar, executive 

director of the Protection Project. 

Prevalence of HPV and its Various Serotypes. This multicenter study will start in earnest in 

collaboration with the departments of obstetrics and gynecology of Cairo and Ain Shams Universities. The project is sponsored by Glaxo-Smith-Kline. Currently, the prevalence of HPV virus 

serotypes in Egypt is not exactly known. Before implementing the new vaccine, this study is 

warranted. A total of 1,500 women attending the outpatient clinics of the 3 centers (500 subjects per center) will be studied. 

A Study of Basic Development Needs (BDN) in a Deprived Area of Alexandria (El-Amrawy). 

This study sponsored by the WHO is now complete. The results show that 80.9 percent of the 

8,000 targeted families were reached. The illiteracy rate in this deprived area of Alexandria is 

18.1 percent and the unemployment rate is 4.6 percent. Pregnant women pay an average of 3.6 

antenatal visits per pregnancy. The family planning services reach 90 percent of the population. The under-5 infant mortality rate is 25.32/1,000 live births and the maternal mortality rate 

is 34.29/100,000 live births. The paper is currently being submitted. 

Prevalence of Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency in Egyptian Newly 

Born Babies. A study was conducted on 6,000 male newborn babies and 165 (2.8 percent) 

were found to have G6PD deficiency. This study was SMC self-funded and the paper is currently being submitted. 

Prevalence of Congenital Adrenal Hyperplasia (CAH) in Egyptian Newly Born Babies. A study 

was conducted on 7,000 male and female newborn babies and 11 (0.16 percent or 1.6/1,000) 

were found to be affected by the CAH. This study was SMC self-funded and the paper is currently being submitted. 

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A Study of Healthy Life Styles of Egyptian Women is Currently Being Conducted and Is 

Sponsored by WHO. This project is currently being conducted. 

The following are research projects in their final stage of planning: 

• Prevalence of gestational diabetes in Egyptian women, a multicenter study in the Mediterranean Area, to be sponsored by the Mediterranean Group for the Study of Diabetes 

(Head: Professor Moshe Hod, Israel) 

• A study on embryo selection in assisted reproduction using various metabolomics 

• A study of various constituents of the amniotic fluid in very early pregnancy (<7 weeks) 

Conclusion 

Despite its recent debut, the SMC is striving to achieve its goals of promoting women’s health 

and development in its part of the world, and is using basic and applied research to reach 

these goals. 

References 

1. Sallam, H. N., Garcia-Velasco, J. A., Dias, S., & Arici, A. (2006, January 25). Long-term 

pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis (Article). Cochrane Reviews [CD004635]. The Cochrane Collaboration, London, 

England. 

2. Sallam, H., Galal, A. F., & Rashed, A. (2006). Menopause in Egypt: Past and present 

perspectives. Climacteric, 9, 421–429. 

KATIE GILLESPIE, M.A. 

University of Arizona 

Research Priorities for Rural Women: Assessing Health Status, Enhancing Health Literacy 

The mission of the Arizona Rural Health Office at the University of Arizona Mel and Enid Zuckerman College of Public Health is to promote the health of rural and medically underserved 

individuals, families, and communities through service, education, and research. The Arizona 

Rural Women’s Health Initiative is a project of the Rural Health Office in collaboration with several agencies across the State. Since 2006, the Arizona Rural Women’s Health Initiative has 

developed and grown to address rural women’s health and healthcare needs. The Initiative has 

sought to use research on rural women’s health, along with the experiences and perspectives 

of members working in rural communities, to assess, coordinate, and respond to the multiple 

issues that shape rural women’s health in Arizona. 

Two items have been identified for a rural women’s health research agenda: 

• Data on rural women’s health status 

• Rural health literacy 

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The victory of dedicated support and funding for research on women’s health is a huge 

accomplishment, in part, because it was recognized years ago that women’s health status and 

health needs are different from men’s and research was needed to understand and address 

those needs. The same can be said for rural women. Rural populations face significant health 

disparities. Rural women’s health status and health needs are different from those of nonrural 

women, and research is needed to understand and address those needs. 

Background and Significance 

The obstacles to maintaining personal health in rural areas are vastly different from those in urban 

areas. Rural Americans face a unique combination of factors that create health disparities not 

found in urban areas. Economic factors, geography, cultural and social differences, lower educational attainment, lack of recognition by policymakers, and the sheer isolation of living in remote 

rural areas all conspire to impede rural Americans in their struggle to lead a normal, healthy life. 

In addition to maintaining their own health, rural women, like women everywhere, are given 

responsibility for the mental, emotional, and physical health of their families and communities. 

They knit together the fabric of family and community life, often serving as the caregivers, 

supporters, and volunteers in a community. As a result, women are disproportionately affected 

by the lack of access to a range of healthcare services close to home, not only because they 

tend to be the main users of healthcare services, but because they are traditionally responsible 

for maintaining life at home as well as providing support and transportation if a family member must travel elsewhere for care. Women are further disadvantaged because they generally 

prefer to see female healthcare providers, but few women physicians are available in rural settings, and other health-related services that specifically benefit women, including women’s 

shelters, are scarce. 

Importantly, the work of the Arizona Rural Women’s Health Initiative arrived at a critical observation related to the empowerment of rural women to have a voice in their own health care. 

Specifically, the gap to be addressed was defined as the need for leadership development 

among women in rural communities. Too often, urban-based programs “reach out” to rural 

health consumers, and the health system structure within a rural community tends to reinforce 

a woman’s feelings of disconnectedness from her health. 

Rural living poses special challenges (and opportunities) for the significant health intermediary role that women enact. It is well established that people living in rural areas have shorter life 

expectancies and higher rates of disability, and experience more accidents, poisonings, and incidents of violence than their urban counterparts. Limited local services, long distances to travel, 

and a lack of transportation alternatives constrain rural dwellers’ access to healthcare services. 

Rural areas are not uniform and research on rural women’s health needs to address the 

nuances of rural areas. Arizona provides a useful example. Rural Arizona is not a uniform 

landscape environmentally, socially, or culturally. The diversity of rural areas ranges from borderlands to Indian reservations to areas classified as frontier. Population composition varies 

greatly among regions, and includes large percentages of Hispanic and American Indian people. Consequently, rural women in Arizona face an array of healthcare issues, and multiple 

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agencies in different regions have developed specialized responses for the communities that 

they serve. Despite continual and concerted efforts, however, significant gaps in services for 

rural women persist in all areas of the State. 

Agenda Items 

1. Data on Rural Women’s Health 

Research on rural women’s health requires data. Some data collection sources and systems 

exist, but women’s health data often are generally not examined beyond a State or county level. 

Health data for rural versus urban women is woefully lacking. Additionally, better data and more 

research on rural health systems delivery and rural health/human services are needed. Data on 

rural versus urban women’s health should be a priority of a women’s health research agenda. 

Recommendations for Research 

Include Rural Populations, Areas, or Systems in More Studies. Entities that sponsor or conduct health services research—particularly through large national or regional studies and 

surveys—should more often include identifiers for rural people, areas, or systems in studies. 

Incorporate Rural Sites into Program Evaluations. Since one-fifth of the Nation’s population 

lives in rural areas, differences in the impacts and costs of programs that serve rural families could be large, both in social and in budgetary terms. Therefore, including rural sites and 

samples in evaluations, or conducting evaluations specifically designed for rural areas, could 

improve rural programs and policies. 

Oversample Rural Sites and Populations. Rural populations are small. This can make statistical 

analysis less precise or preclude the use of sophisticated analytic approaches. Oversampling 

of rural areas is an important option for improving rural health services research, conducting 

more sophisticated analyses, and better identifying significant rural findings or rural versus 

urban differences. It is particularly important when there may be differences among racial/ethnic, cultural, or other demographic or community subgroups. 

Report Rural Findings. Many national and regional studies do include rural data. But if rural 

issues are not a specific focus of the study, or if key findings do not differ between rural and 

urban sites, report authors generally do not include discussions of rural experiences and findings in published reports, or even provide information on the breakdown of sample members by 

rurality. Providing such information could help answer many important rural research questions. 

Make Better Use of Existing, Detailed Rural Classification Systems. Detailed and informative classifications of rural areas have been developed for use in demographic and economic 

studies. To date, however, they have been little used in a number of rural health research topics such as poverty and health and human services issues. As a result, a paucity of information 

is available to study variation across diverse rural areas, or to capture the complexity of rural 

versus urban differences. To the extent possible, rural data should include geographic identifiers that can support the use of detailed rural classification typologies, and researchers should 

make more use of alternative rural classification approaches. 

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Disclose Rural Definitions and Classifications Used in Studies. Study authors should disclose 

the definitions used to classify rural observations. Failure to do so makes it difficult to interpret 

rural research findings, as well as to summarize and synthesize findings across studies. 

Add Information to Make Small, Region-Specific Rural Studies More Generalizable. The rural 

health and human services research literature is largely composed of small, region-specific 

studies. Findings from such studies can be useful, in the absence of nationally representative 

studies. Their generalizability could be improved, however, if in addition to including operational definitions of rurality, authors provided detailed descriptions of rural samples, along 

with descriptive and demographic information on rural study sites. 

These recommendations will have a direct impact on the current health monitoring systems. 

For example, the Arizona Department of Health Services Bureau of Women’s and Children’s 

Health has recognized the need to examine women’s health data by rural and nonrural populations. Given the current exigencies of the economy, however, the Bureau has few resources to 

add this level of analysis at this time. 

2. Health Literacy 

Poor health literacy levels are linked to poor health outcomes, which impact the health and 

quality of life, as well as the healthcare system. Health literacy must be a priority for research 

on women’s health needs. In addition, although there have been some national studies on 

health literacy, these studies have not analyzed health literacy in rural populations versus 

urban populations. A search of the literature for rural health literacy reveals only two small 

studies that address this need. Research should also examine the sources of health information 

that rural and urban women use; women’s understanding and interpretation of health information; and women’s use of different media to access health information. 

Summary 

Research agendas translate into funding opportunities and rural areas have unique funding 

needs. Specialized priorities for funding research on rural populations have been essential for 

the work that has been done so far, and rural populations need to continue to receive priority 

opportunities. Research agendas also set up qualifications for what counts as rural. In defining 

what is rural, there should be recognition of different types of rural populations, for example, migrant farm- workers. Additionally, rural communities have raised the issue of equitable 

access to grant funding, at a basic level of receiving timely information and using the grants. 

gov system for submitting grant applications. The research agenda for women’s health needs 

to be aware of the limited capabilities of rural communities for accessing funding and provide 

extra technical assistance to develop greater capability. Finally, the research agenda should 

include the perspective of doing research “with” rural women instead of “on” rural women. A 

community-based participatory research model empowers women and empowers communities while building capacity and enhancing the potential research results. Research on rural 

women’s health and strategies to improve it is a key factor for understanding and addressing the health disparities that rural women experience and for identifying unique opportunities 

and assets that support rural women’s health. 

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VANESSA JACOBY, M.D., MAS 

University of California, San Francisco 

K12 Training Programs and Randomized Trials for Benign Gynecologic Conditions 

My name is Vanessa Jacoby. I am an Assistant Professor in the Department of Obstetrics, 

Gynecology, and Reproductive Sciences at the University of California, San Francisco (UCSF). 

I am a second-year scholar in the K12 Women’s Reproductive Health Research Career Development Program (WRHR). I am here to wholeheartedly thank the Office of Research on Women’s 

Health for initiating and supporting K12 training programs such as the WRHR. 

When I was in residency, there were several faculty members who made a particularly strong 

impression on me. They were smart, creative, insightful, dynamic leaders impacting women’s health on a national scale. I wanted to emulate their careers and improve women’s health 

through high-quality clinical research. I quickly realized the common starting point for all of 

these successful faculty—an NIH-supported training grant in women’s health. 

I was elated when I received an acceptance letter for the WRHR program. The WRHR has 

been essential support toward building my career as an independent clinical researcher. I have 

highly committed mentors who meet with me regularly, didactic training in advanced epidemiology and biostatistics, peer support and networking with other K scholars, and protected 

time for original research. I am so grateful to be a WRHR recipient.
�

My one concern is the apparent disparity in funding for K programs in women’s health compared to other specialties. Every Friday, I meet with a peer group of about 30 K12 and K23 

recipients from across UCSF. All of these junior faculty members receive $10–20,000 dollars 

more in annual research funding than the WRHR recipients. This has a significant impact on 

the scope of projects we can complete and sends a clear message regarding the value of 

women’s health research compared to other fields. I urge you to continue advocating for K12 

training in women’s health and to work toward gaining financial parity with other K programs. 

My WRHR research is focused on elective oophorectomy at the time of hysterectomy for 

benign conditions. Approximately 50 percent of the 600,000 hysterectomies performed 

every year include oophorectomy. While some observational studies have found adverse consequences for oophorectomy on cardiovascular health, bone health, and cognitive function, 

others have not. The practice of oophorectomy warrants the highest quality evidence to guide 

informed decisionmaking. To that end, we are conducting a pilot study, the first randomized 

controlled trial of oophorectomy vs. ovarian conservation among women undergoing benign 

hysterectomy. Our ultimate goal is to conduct a larger multicentered randomized trial of 

oophorectomy. Given the frequency of oophorectomy and the significant impact it may have 

on a diverse range of health outcomes, we believe that a randomized trial is paramount and 

hope that you will support this aim.
�

The lack of randomized trials for oophorectomy is indicative of a larger problem in gynecologic 

surgery research. Surgical devices are approved by the Food and Drug Administration (FDA) and 

widely disseminated without randomized trial data to support their use. This is in stark contrast 

206
to the FDA standards for approval of a new medication. Interventions such as robotic surgery 

and hysteroscopic morcellators have gained widespread popularity though there are, to date, no 

randomized trials to determine whether these methods are truly superior to current standards of 

care. Without randomized trials, the introduction of new surgeries and surgical devices will continue to expand without high-quality studies to assess their safety and efficacy. I strongly urge 

the ORWH to support randomized trials for surgical interventions to treat common gynecologic 

conditions such as uterine fibroids and abnormal bleeding. Women undergoing gynecologic surgery deserve informed counseling based on the highest quality evidence. 

PURNIMA MADHIVANAN, M.D., M.P.H. 

University of California, San Francisco 

State of Research in Women in Developing Countries 

I’m Purnima Madhivanan, Infectious Disease Epidemiologist for the San Francisco Department 

of Public Health, Assistant Clinical Professor at the University of California, San Francisco, and 

Executive Director for the Public Health Research Institute in India. 

I would like to first thank the National Institutes of Health, the Office of Research on Women’s 

Health; the Department of Obstetrics, Gynecology, and Reproductive Sciences at UCSF; and 

the National Center of Excellence in Women’s Health for sponsoring this important meeting. 

While a portion of my work focuses on prevention of sexually transmitted infections among 

young women here in San Francisco, today I want to take this opportunity to speak on another 

subject that is very close to my heart: the state of reproductive health research in India and 

other developing countries. 

Public Health Research Institute India was chartered to address the health challenges facing 

women and children in India. Having worked in research on HIV and women’s health for more 

than 10 years, I remember when ORWH launched the women’s health research agenda. I have 

to say quite bluntly that we have not moved far enough in achieving those far-reaching goals 

that were first articulated in 1996. 

• We are still largely extrapolating research on men to women without modification. As 

an Human Immunodeficiency Virus physician, I have struggled daily with antiretroviral 

dosing options that are poorly defined and often inappropriate for low-weight females 

and children. 

• Researchers continue to exclude women, particularly those who are pregnant, from clinical trials, even though they are often in greatest need of treatment options. 

• Infectious and parasitic diseases continue to claim more lives than any other disease category in settings like India, while research dollars are more than ever focused on more 

profitable treatments for chronic diseases. 

Most importantly in developing countries, we know almost nothing about the health issues 

across the lifespan of women. Current research on women has been almost entirely focused 

207
on the issue of safe pregnancy, which while important, completely ignores the importance of 

developmental issues from birth to young adulthood, and the importance of mature women to 

families, communities, and newer generations. 

Several months ago, I saw a patient in our reproductive health clinic who illustrates this conundrum. It was the first time that Ashwini, who was 21 years old, had ever seen an allopathic 

doctor. She was pregnant—the only time young women in India ever receive basic medical 

care. At just 90 pounds, a little under 5 feet tall, she was obviously suffering from chronic malnutrition. With hemoglobin below 7 grams, she was badly anemic and she was complaining 

of a white discharge. I did what I could, but knew that the prognosis for Ashwini and her baby 

was poor. Not surprisingly, she delivered an underweight girl at 33 weeks. We now have a sick 

21-year-old mother caring for a sick infant who has already been in the hospital several times 

with serious respiratory illness. 

As public health researchers, how can we ensure that bad health is not a continuing legacy— 

a continuing cost from one generation to the next? 

Perhaps it’s appropriate as we look forward to an updated research agenda on global health 

that we acknowledge that we have only just begun to tackle the important issues set out in 

the 1999 Report of the Task Force on the NIH Women’s Health Research Agenda. 

First, we need to rid ourselves of dangerous assumptions that threaten the health of women 

and children everywhere. 

• Women are not like men. While there has been considerable progress toward the inclusion of women in clinical trials, the same cannot be said about their levels of participation 

in the developing world. In East Africa for instance, Phase I and Phase II trials had 1:8 

female-to-male participation ratio. The NIH should aggressively move to ensure that 

trials are representative and yield relevant data for treatment guidelines. 

• Pregnant women must be included in clinical trials. It’s time that we acknowledged that 

while this may represent an elevated level of risk for researchers, pregnant women represent a disproportionate number of females seeking healthcare in developing countries. 

• Research on women must be holistic and oriented to the entire lifespan. We are fooling 

ourselves if we don’t acknowledge that a sick child goes onto become a sick adult. 

• The etiology of disease differs in different populations. It’s time that we acknowledge 

that a study conducted among antenatal attendees in the United States may not necessarily be relevant in a developing country like India. This is particularly true in the study 

of how infectious and parasitic disease is related to preterm birth. 

I hope that this audience will not misunderstand me. We are making progress in prioritizing 

the health needs of women in many parts of the world. Many of you in this room have been an 

important part of that changing paradigm. As we look toward that brighter future, however, 

I hope that we renew our efforts to ensure that women in developing countries benefit from 

that increased focus on improving the health of all women. 

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PATRICIA A. MCDANIEL, PH.D., AND 

RUTH MALONE, PH.D., RN, FAAN 

University of California, San Francisco 

Tobacco Is a Critical Women’s Health Issue 

Tobacco Is a Critical Women’s Health Issue 

Although tobacco use is the leading cause of preventable death among American women, killing more women each year than AIDS, suicide, murder, car accidents, and drugs combined,1 

tobacco goes largely unrecognized as a women’s health issue.2 Women’s magazines devote 

most of their attention to breast cancer, despite the fact that, in 1987, lung cancer, a cancer almost exclusively due to smoking, surpassed breast cancer as the leading cancer-related 

cause of death among women.3-6 Women underestimate the health effects of tobacco use.7,8 

Women’s groups, many of whom have received tobacco industry funding, also largely ignore 

tobacco.9-11 Reducing tobacco use among women should be one of the highest priorities for 

women’s health. 

Prevalence of Smoking Among Women And Girls 

Although the overall smoking rate among women has declined in the United States, it is unlikely 

to reach the Healthy People 2010 goal of 12 percent.12 Currently, 17.4 percent of women smoke, 

but there is significant variation by race and ethnicity, with American Indian women having the 

highest prevalence rate (36 percent), followed by White women (19.8 percent), Black women 

(15.8 percent), Hispanic women (8.3 percent), and Asian women (4.0 percent).13 Smoking prevalence rates also vary by poverty and education level. Women living below the poverty line 

report higher smoking rates than those living above it, and women with a high school or general educational development diploma or less report higher rates of smoking than those with 

an undergraduate or graduate degree.13 Of 12th grade girls, 19.1 percent smoke;14 although this 

represents a slight decline from previous years, because even occasional smoking is extremely 

addictive.15 The majority of these girls are likely to remain smokers well into adulthood, regardless of their intentions to quit.16 Similar to adult women, smoking prevalence rates among 12th 

grade girls are higher among Whites, followed by African Americans and Hispanics.14 

Tobacco’s Health Effects 

Tobacco’s toll on women includes lung cancer, a particularly deadly cancer. In the United States, 

5 years after diagnosis, nearly 90 percent of women diagnosed with breast cancer are alive, 

whereas nearly 85 percent of women diagnosed with lung cancer have died.17 Smoking also 

accounts for one of every five deaths from cardiovascular disease, the leading cause of death 

among women overall.18 Smoking is the primary cause of chronic obstructive pulmonary disease 

(COPD) among women, and increases the risk that women will suffer from cancers of the larynx, liver, bladder, kidney, stomach, colon, and pancreas.3 Although women and men who smoke 

share excess risks for many diseases, women also experience unique smoking-related disease 

risks related to reproduction. The use of oral contraceptives has been linked with increased risk 

of cardiovascular disease in women smokers.19 Smoking is also linked to cervical and uterine cancer, reduced fertility, and early menopause.3 Smoking during pregnancy increases the risks of 

spontaneous abortion, ectopic pregnancy, premature labor, and low birth weight.3 

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Smoking and Health Disparities 

Although it has long been assumed that “women who smoke like men, die like men who 

smoke,”20 recent research indicates that women smokers are at higher risk than men of developing lung cancer and colon cancer at the same level of smoking.21,22 Women smokers are also 

more susceptible to COPD than men smokers, even when they have smoked for fewer years 

and with less intensity.23 Because smoking is increasingly concentrated among the poor and 

those with lower educational attainment, the burdens of tobacco-caused disease will fall heavily on disadvantaged women. 

Secondhand Smoke Is a Women’s Health Issue 

Women and children are the majority of the world’s involuntary smokers. Children exposed 

to secondhand smoke in utero are at increased risk for adverse health outcomes, including 

low birth weight and preterm delivery.24 Infants exposed to smoke are at higher risk for respiratory illness and sudden infant death syndrome.24 During early childhood, children exposed 

to secondhand smoke are at increased risk of developing bronchitis and pneumonia.25 Nonsmoking women married to smoking men are at increased risk of developing lung cancer,25 

and, among premenopausal women, secondhand smoke has been identified as a causal factor in breast cancer.24 

Women’s employment opportunities also frequently result in secondhand smoke exposure 

and its attendant health risks. For example, food service workers, the majority of whom are 

women, have the most exposure to indoor secondhand smoke of any occupation.26 Even in 

States with comprehensive clean indoor air laws, workplaces that are out of compliance with 

the law have been found to be more likely to employ women.27 

Smoking Cessation 

Women find it more difficult to quit smoking than men.28 Nicotine replacement therapies are 

more effective in men than women.29 Women are also less confident than men of their ability to quit smoking, and, while three-quarters of women smokers report wanting to quit, only 

2.5 percent succeed for at least 1 year.30 In addition to nicotine addiction, women face barriers 

such as fear of weight gain, depression, and family stress, such as childcare, that make quitting difficult.30 

Tobacco Industry Targeting of Women and Women’s Groups 

Marketing is key to the creation and spread of the tobacco epidemic among women. Tobacco 

companies first singled out women in the United States and other high-income countries as an 

important target market, creating advertising images centered around emancipation, glamour, 

and attractiveness to appeal to women and introducing cigarette brands designed specifically 

for them.31-33 They have employed similar strategies, including using images of Western “emancipated” women in tobacco advertising, when encouraging women in low- and middle-income 

countries to take up smoking.25,34,35 Tobacco companies have also preyed on women smokers’ health concerns, marketing slimmer, “light,” and “low tar” cigarettes to women to give 

the impression that they are safer than other cigarettes.36 These efforts have been linked to 

increases in smoking initiation among women and girls.37 

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Tobacco companies have also sought to secure women as allies who could help maintain 

a policy environment favorable to the tobacco industry. Their strategies for doing so have 

included funding women’s organizations, which were then less likely to support policies, such 

as raising cigarette excise taxes, that conflicted with tobacco company business objectives.9-11 

In recent years, as the tobacco industry has lost credibility with the general public, tobacco 

companies have also tried to improve their image among politically influential women.38 

Tobacco as a Global Health Issue for Women 

Globally, approximately 250 million women smoke.39 While men’s smoking rates have peaked 

or are declining, women’s rates continue to rise.40 The World Health Organization predicts that 

25 percent of women will smoke by 2025.40 (This does not include other forms of tobacco 

used by women in various regions, including chewing tobacco, water pipes, bidis, chutta, betel 

nut, and snus or snuff).34 Women in developing nations are particularly vulnerable, as they represent the prime growth market for the tobacco industry, with only 9 percent estimated to 

be current smokers.39,41 Even if they do not take up tobacco themselves, tobacco may represent an economic burden on their households. Spending on tobacco products translates into 

less money for food, education, housing, and health care.34 Tobacco-caused disease can lead 

to increased family health care costs, or result in the loss of a family member and his/her earning power.34 

Research Priorities 

Key research priorities for addressing tobacco as a women’s health issue should include, in 

addition to studies of tobacco’s effects on women’s bodies, studies of the gendered dynamics 

of tobacco prevention, use, and cessation; whether/how tobacco control policies may have differential effects on males and females; how women perceive tobacco marketing, the tobacco 

industry, tobacco control efforts, and tobacco use; and the intersections between women’s 

rights and tobacco control policy issues. 

References 

1. Stewart, S. L., Cardinez, C. J., Richardson, L. C., Norman, L., Kaufmann, R., Pechacek, T. F., 

. . . Sabatino, S. A. (2008). Surveillance for cancers associated with tobacco use—United 

States, 1999–2004. MMWR Surveillance Summaries, 57(8), 1–33. 

2. Haviland, L. (2004). A silence that kills. American Journal of Public Health, 94(2), 176–178. 

3. U.S. Department of Health and Human Services. (2001). Women and smoking: A report 

of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, 

Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. Retrieved from http:// 

www.cdc.gov/tobacco/data_statistics/sgr/2001/complete_report/index.htm 

4. Tobler, K. J., Wilson, P. K., & Napolitano, P. G. (2009). Frequency of breast cancer, lung 

cancer, and tobacco use articles in women’s magazines from 1987 to 2003. Journal of 

Cancer Education, 24(1), 36–39. 

211
5. Hoffman-Goetz, L., Gerlach, K. K., Marino, C., & Mills, S. L. (1997). Cancer coverage and 

tobacco advertising in African-American women’s popular magazines. Journal of Community Health, 22, 261–270. 

6. Hoffman-Goetz, L., & MacDonald, M. (1999). Cancer coverage in mass-circulating Canadian women’s magazines. Canadian Journal of Public Health, 90(1), 55–59. 

7. Moran, S., Glazier, G., & Armstrong, K. (2003). Women smokers’ perceptions of smoking-related health risks. Journal of Womens Health, 12, 363–371. 

8. Oncken, C., McKee, S., Krishnan-Sarin, S., O’Malley, S., & Mazure, C. M. (2005). Knowledge and perceived risk of smoking-related conditions: A survey of cigarette smokers. 

Preventive Medicine, 40, 779–784. 

9. The Advocacy Institute. (1998). Smoke and mirrors: How the tobacco industry buys and 

lies its way to power and profits. Washington, DC: Author. 

10. Williams, M. (2001, April 11). This kills women. Do feminist groups even care? The Washington Post, pp. A27. 

11. Williams, M. (1991, November 14). Tobacco’s hold on women’s groups: Anti-smokers 

charge leaders have sold out to industry money. The Washington Post, pp. A1. 

12. U.S. Department of Health and Human Services. (2003). Healthy people 2010: Understanding and improving health. Washington, DC: Author. 

13. Centers for Disease Control and Prevention. (2008). Cigarette smoking among adults— 

United States, 2007. Morbidity and Mortality Weekly Report, 57, 1221–1226. 

14. Monitoring the Future. (2008). Trends in 30-day prevalence of use of cigarettes by 

subgroups grade 12 [Data table]. Retrieved from http://monitoringthefuture.org/ 

data/09data/pr09cig8.pdf 

15. O’Loughlin, J., DiFranza, J., Tyndale, R. F., Meshefedjian, G., McMillan-Davey, E., Clarke, P. 

B., . . . Paradis, G. (2003). Nicotine-dependence symptoms are associated with smoking 

frequency in adolescents. American Journal of Preventive Medicine, 25, 219–225. 

16. Pierce, J. P., & Gilpin, E. (1996). How long will today’s new adolescent smoker be addicted to cigarettes? American Journal of Public Health, 86, 253–256. 

17. Ries, L. A. G., Eisner, M. P., Kosary, C. L., Hankey, B. F., Miller, B. A., Clegg, L., . . . 

Edwards, B. K. (2005). SEER cancer statistics review, 1975–2002. Retrieved from 

http://seer.cancer.gov/csr/1975_2002. 

18. Campaign for Tobacco-Free Kids. (2009). Background on women and girls and tobacco. 

Retrieved from http://www.tobaccofreekids.org/research/factsheets/pdf/0137.pdf 

19. Ernster, V. L. (2001). Impact of tobacco use on women’s health. In Samet, J., & Yoon, S., 

(Eds.), Women and the tobacco epidemic: Challenges for the twenty-first century (pp. 

1–15). Baltimore, MD: The World Health Organization, Institute for Global Tobacco Control, and Johns Hopkins School of Public Health. 

212
20.U.S. Department of Health, Education, and Welfare. (1979). Smoking and health: A 

report of the Surgeon General. Washington, DC: Public Health Service, Office on 

Smoking and Health. 

21. Payne, S. (2001). Smoke like a man, die like a man?: A review of the relationship 

between gender, sex, and lung cancer. Social Science & Medicine, 53, 1067–1080. 

22.American College of Gastroenterology. (2008, October 6). Women require less tobacco 

exposure than men to increase colon cancer risk. Science Daily. Retrieved from 

http://www.sciencedaily.com/releases/2008/10/081006102533.htm 

23.British Lung Foundation. (2005). Femme fatality: The rise and rise of COPD in women. 

Middlesex, England: Allen and Hanburys. 

24.State of California Air Resources Board. (2005). Proposed identification of environmental tobacco smoke as a toxic air contaminant. Part B—Health effects. Retrieved from 

http://www.arb.ca.gov/toxics/id/summary/etspt_b.pdf 

25.Ernster, V., Kaufman, N., Nichter, M., Samet, J., & Yoon, S. Y. (2000). Women and tobacco: Moving from policy to action. Bulletin of the World Health Organization, 78, 891–901. 

26.Shopland, D. R., Anderson, C. M., Burns, D. M., & Gerlach, K. K. (2004). Disparities in 

smoke-free workplace policies among food service workers. Journal of Occupational 

and Environmental Medicine, 46, 347–356. 

27. Moore, R. S., Lee, J. P., Antin, T. M., & Martin, S. E. (2006). Tobacco-free workplace 

policies and low socioeconomic status female bartenders in San Francisco. Journal of 

Epidemiology and Community Health, 60 Suppl 2, 51–56. 

28.Osler, M., Prescott, E., Godtfredsen, N., Hein, H. O., & Schnohr, P. (1999). Gender and determinants of smoking cessation: A longitudinal study. Preventive Medicine, 29, 57–62. 

29.Perkins, K. A., & Scott, J. (2008). Sex differences in long-term smoking cessation rates 

due to nicotine patch. Nicotine & Tobacco Research, 10, 1245–1250. 

30.Hunter, S. M. (2001). Quitting. In J. M. Samet & S. Y. Yoon (Eds.), The tobacco epidemic: 

Challenges for the 21st Century (pp. 121–146). Baltimore, MD: The World Health Organization, Institute for Global Tobacco Control, and Johns Hopkins School of Public Health. 

31. Amos, A., & Haglund, M. (2000). From social taboo to “Torch of freedom”: The marketing of cigarettes to women. Tobacco Control, 9, 3–8. 

32.Ernster, V. L. (1986). Women, smoking, cigarette advertising, and cancer. Women & 

Health, 11(3–4), 217–235. 

33.American Cancer Society, Cancer Action Network, American Heart Association, 

American Lung Association, Robert Wood Johnson Foundation, & Campaign for 

Tobacco-Free Kids. Deadly in pink: Big tobacco steps up its targeting of women and 

girls. Retrieved from http://www.lungusa.org/assets/documents/publications/otherreports/deadly-in-pink.pdf 

213
34.Greaves, L., Jategaonkar, N., & Sanchez, S. (2006). Turning a new leaf: Women, tobacco, 

and the future. Vancouver: British Columbia Centre of Excellence for Women’s Health 

and International Network of Women Against Tobacco. 

35.Lee, K., Carpenter, C., Challa, C., Lee, S., Connolly, G. N., & Koh, H. K. (2009). The strategic targeting of females by transnational tobacco companies in South Korea following 

trade liberalization. Global Health, 5(1), 2. 

36.Carpenter, C. M., Wayne, G. F., & Connolly, G. N. (2005). Designing cigarettes for women: New findings from the tobacco industry documents. Addiction, 100, 837–851. 

37. Pierce, J. P., Lee, L., & Gilpin, E. A. (1994). Smoking initiation by adolescent girls, 1944 

through 1988. An association with targeted advertising. Journal of the American Medical 

Association, 271, 608–611. 

38.McDaniel, P., & Malone, R. (2009, March). “Women might be our natural enemies”: Philip 

Morris’s efforts to improve its image among women. Paper presented at the World Conference on Tobacco or Health, Mumbai, India. 

39.Shafey, O., Eriksen, M., Ross, H., & Mackay, J. (2009). The tobacco atlas. Atlanta, GA: 

American Cancer Society. 

40.Greaves, L. (2007). Sifting the evidence: Gender and tobacco control. Geneva: World 

Health Organization. 

41. Collin, J. (2005). Opening a global gold mine: Globalization, gender, and transnational 

tobacco companies. In I. Kickbusch, K. A. Hartwig, & J. M. List (Eds.), Globalization, 

women, and health in the twenty-first century (pp. 201–218). New York: Palgrave 

MacMillan. 

ELISE RILEY, PH.D., M.P.H. 

University of California, San Francisco 

Poverty, Unstable Housing, and HIV Infection Among Women Living in the United States 

Synopsis 

Women who are HIV-positive incur a higher risk of mortality than men who are HIV-positive, 

a difference that is primarily based in the social context of poverty. Economic crises that lead 

to homelessness, unmet subsistence needs, and sex exchange often reorder priorities among 

HIV-infected women, deemphasizing consistent medical care or the use of antiretroviral therapy. High rates of mental illness, drug use, and victimization further increase health and safety 

risks. HIV prevention messages highlighting education and behavior change insufficiently 

address the predicament of indigent women where constrained survival choices in the context 

of poverty may take precedence over safe behaviors. This testimony highlights the current scientific evidence regarding health and safety risks of poor and unstably housed women, and 

concludes that a better understanding of the context in which risks occur is needed. 

214
Introduction 

HIV infection disproportionately affects populations with high rates of mental illness, illicit 

drug use, poverty, and homelessness. Additionally, HIV surveillance data suggest increasing 

rates of HIV infection among women, and women of color in particular. The overlay of these 

issues complicates HIV prevention and treatment provision, contributing to excess morbidity and mortality among highly vulnerable individuals, such as poor and homeless women. 

Although effective interventions exist to reduce the impact of these exposures on HIV risk and 

progression, impoverished women continue to incur high rates of HIV infection and suffer from 

inadequate access to health care with consequently worse treatment outcomes. 

Survival differences in HIV infection by sex are embedded not in biological differences, but in 

economic and power imbalances between the sexes.1

 In recent years, researchers have become 

increasingly aware that improving our understanding of women’s risk for HIV and developing 

effective interventions to reduce HIV risk “rests on the awareness that the epidemic is deeply 

rooted in a larger context, one in which HIV/AIDS co-occurs with other public health problems 

such as violence, and with structural inequities involving poverty and homelessness.”2

 This testimony describes the intersection of competing and unmet needs of U.S. women at risk for or 

living with HIV. The work presented here indicates that a better understanding of the sociocultural context in which HIV is transmitted and HIV infection progresses will lead to better 

intervention strategies, better outreach services, and ultimately better healthcare strategies to 

serve vulnerable women. 

HIV Infection and Mortality: Why Are Women Dying Faster? 

Women account for an estimated 27 percent of the 1.1 million cases of HIV/AIDS in the United 

States.3

 Three-quarters of HIV infections among women were acquired through heterosexual 

contact,3

 and more than 80 percent occur in racial and ethnic minorities (African-American or 

Latina).4 Overall, HIV infection is the fifth leading cause of death for all U.S. women ages 25 to 

34, and the third leading cause of death in Black women in that age group.5

 During the 1990s, 

it was reported that the risk of death among women was 33 percent higher than among men.6 

Also during the 1990s, survival after receiving an AIDS diagnosis was 24 percent lower among 

women.7

 The reasons for these disparities are multifactorial and include a more advanced disease state at diagnosis and less frequent use of antiretroviral therapy (ART). 

Use of ART is the single most important predictor of survival among patients with advanced 

HIV infection,8

 and sustained use of ART is the strongest predictor of survival among the 

homeless and marginally housed.9

 In the United States, significantly fewer women than men 

who qualify for ART actually receive it.10 Even when women do receive ART, studies from both 

the pre- and post-combination ART eras have shown that women are twice as likely as men to 

discontinue therapy due to adverse effects.11,12 Combined, these factors result in comparatively 

fewer women being on ART when clinically indicated. Gender differences in mortality diminish 

significantly after adjustment for access to care, receipt of ART, and adherence to ART.13 The 

reasons behind differential access to care and ART use are multifaceted and are tightly linked 

to women’s risk factors for becoming HIV infected. 

215
Barriers to Health Care Among Poor and Marginally Housed Women: 

The Context of HIV Risk 

Homelessness Among Women in the United States. In cities throughout the United States, the 

estimated growth in homelessness within certain neighborhoods is as high as 25 percent per 

year, resulting in about 1 percent of the total U.S. population experiencing homelessness each 

year.14 Societal and structural factors contributing to increased numbers of homeless women 

include the deinstitutionalization of mental health services, the crack cocaine epidemic, low 

wage structures, and limited employment opportunities for women with limited job skills; a 

shrinking supply of affordable housing and barriers to receiving and maintaining government 

subsidies15 also play a role in women’s housing instability. 

Homelessness can manifest itself in ways other than sleeping on the street or in a homeless 

shelter.16 Women are particularly susceptible to less visible forms of homelessness, such as 

doubling up with friends or family because they have no place of their own, moving frequently 

among different friends (“couch surfing”), or exchanging sex for shelter.17,18 Women also often 

reside in marginal housing environments such as low-cost single-room occupancy (SRO) 

hotels, where two-thirds of occupants have been homeless at some point in their lives and 27 

percent have been homeless within the past 12 months.19 Just as with literal homelessness, living in SRO hotels has been linked to high rates of drug/alcohol use, health complications, and 

unsafe conditions.20,21 Because transitions in and out of homelessness occur quite frequently, 

it is important to consider housing status, and the risks inherent therein, as a dynamic process 

rather than a fixed state.22 

Social Issues and Risk Are Different for Unstably Housed Men and Women. Female gender is 

one of the strongest predictors of poor health among homeless adults,23 and there are a number of interrelated reasons for gender-associated differences in health status among those 

infected with HIV. In an environment of drug use, poverty, and mental illness, health care is 

often fragmented and numerous barriers exist to health care and social support for impoverished women.24 

Illicit drug use is an established risk factor for the acquisition of HIV25 and has also been 

strongly linked to homelessness among women.26 Unsheltered women have significantly higher 

odds of using illicit drugs; having multiple sex partners; and reporting poor physical, as well as 

mental, health compared to their sheltered counterparts.27 Among HIV-infected homeless persons, health-related quality of life is significantly lower among those who use illicit drugs.28 

Drug users with HIV infection often continue to engage in high-risk behaviors. For instance, 

HIV-positive injection drug users inject at higher rates than HIV-negative injectors, with similar rates of sharing used syringes.29 In addition, high-risk sexual behavior is common after the 

initiation of ART among HIV-infected drug users.30 While some risk-reduction programs effectively reduce drug and sexual risk behaviors among injectors,31 particularly among HIV-positive 

individuals,32 others show that injectors continue to engage in high-risk behaviors, even after 

learning their HIV serostatus through post-test counseling or intervention sessions.33 

216
Sex exchange for money, drugs, housing, food, and safety has been shown to expose individuals to violence34 as well as sexually transmitted infections, including HIV and hepatitis C 

virus.35 The most common routes of exposure to HIV for women of color are injection drug use 

and sex work related to drug use.36 In a recent study of HIV-positive marginally housed adults, 

more than one-third of both women and men had a history of trading sex for money, drugs, 

or a place to sleep, but duration of homelessness was correlated with sex trade activity only 

among women.37 Survival sex, especially among HIV-infected women, often arises out of economic crisis and increases health risks in an already risky environment. Moreover, the illegal 

stigmatized nature of sex work makes usual public health strategies to prevent HIV transmission more difficult to apply among unstably housed women.38 

Mental Illness Creates Additional Challenges Among Homeless Women. Compared to men, 

women are at increased risk for being dually diagnosed with both mental illness and HIV.39 

As many as half of sexually active HIV-positive women with severe mental illness report having multiple sex partners and never using condoms.40 Furthermore, HIV-seropositive women 

exhibit significantly higher rates of major depressive disorder and more symptoms of depression and anxiety than HIV-seronegative women with similar demographic characteristics.41 

This finding is significant since depression predicts ART nonadherence.42 

Violence and Victimization Against Women Predicts HIV Risk Behavior and Poor Health. 

Victimization (sexual assault, incest, or physical abuse) is common among HIV-infected 

women.43 Victimization predicts subsequent high-risk HIV behaviors and serves as a barrier 

to accessing health services.44 Up to two-thirds of HIV-infected women are shown to have a 

history of physical or sexual abuse, which is associated with nonadherence to ART,45 higher 

levels of distress and depression,43 and higher rates of AIDS-defining conditions.43 Among 

street-based sex workers, physical and sexual abuse is significantly more common among 

women who are homeless, rely on sex trade as their main source of income, and are HIV-positive.46 Paradoxically, women’s attempts at HIV risk-reduction behaviors, such as requesting 

condoms during sex, have been associated with increased intimate partner violence.47 

Health Services Use in an Environment of Homelessness and HIV Infection. Despite the fact 

that the homeless incur high rates of functional disabilities, are prone to infectious diseases,48 

and experience disproportionately high mortality rates,49 especially among women,50 accessing appropriate health care is not always a priority among homeless women. In addition to 

competing needs like housing and food, transportation and scheduling can present substantial 

barriers to accessing health care, even for individuals at a high risk of death.51 Services used 

by the homeless also tend to be emergency-based, inadequate, and less consistent than those 

used by sheltered persons.52 Some homeless women reportedly feel stigmatized by healthcare providers,53 which may in part explain their lower likelihood of reporting visiting a regular 

healthcare provider.52 

Women, people of color, and the uninsured are least likely among people living with HIV to 

receive appropriate care and antiretroviral therapy.54 Among HIV-positive persons, stable 

housing is associated with improved CD4 cell counts and functional status,55 while female sex 

is associated with worse overall health among HIV-infected persons who are also marginally 

217
housed.28 Mistrust in the healthcare establishment among African-American women, language 

barriers, lack of decisionmaking capability within the family structure among Latina women, 

and a lack of culturally competent healthcare providers for all minority populations contribute 

to these disparities.56 

When homeless patients receive care from programs targeted to their specific needs, they 

return for followup visits and utilize services at rates comparable to that of low-income housed 

patients.57 For example, shelter-based interventions hold promise for improving treatment 

engagement in homeless populations with psychiatric and drug use problems.58 

Structural Barriers to Changing Risk Behavior. Many of the public health strategies to prevent 

HIV during the late 1990s and early 2000s focused on education and behavior change, which 

did not take into account the social context in which risk was navigated or negotiated.59 A more 

recent approach has been to consider environmental and structural barriers to using knowledge 

and exercising autonomous agency. A sociostructural approach posits that there are structural 

factors both intrinsic (such as gender and race/ethnicity) and extrinsic (such as institutions and 

policies) that strongly influence individual choice and behavior. Furthermore, structural factors such as laws, policies, economic conditions, social inequalities, and wider cultural beliefs 

interplay with social relationships and individual behaviors. The social structural production of 

HIV risk has been described as the interplay of the physical, social, economic, legal, and policy 

environments influencing HIV risk and prevention.60 This approach contends that if HIV risk is 

socially produced, then so are public health solutions that can minimize risks.60 

Socioeconomic factors and environmental factors have been shown to condition and constrain lifestyle choices, which may result in increased risks for disease.61 For instance, limited 

economic opportunity has been associated with risky sexual practices.62 If a woman is impoverished and depends on subsistence strategies such as trading sex, self-protection against the 

seemingly improbable threat of infection may be overshadowed by the more immediate need 

to obtain money, food, or a place to sleep.63 In addition, a woman’s financial dependence on 

her partner, either in a relationship or during sex work, may result in sexual safety decisions 

that are dictated by her partner rather than arrived at by mutual agreement.63 A different but 

equally extensive line of research focusing on structural inequities has broadly supported the 

concept of a social gradient whereby higher social status is related to better physical health.64 

Research has also shown that living in an impoverished or deteriorated urban neighborhood is 

associated with poor health and risk of sexually transmitted infections such as HIV, even after 

controlling for individual risk factors.65 

Conclusion: Using Context To Reduce Health Disparities Among 

HIV-Positive Poor And Marginally Housed Women 

Unstable housing and homelessness is a growing problem among indigent women. Consequently, associated health and safety concerns, along with their influence on acquiring and/ 

or managing HIV infection, are unlikely to subside in the near future. The dynamic and interconnected processes of homelessness, illicit drug use, sexual risk, and violence have been well 

established in the medical and public health literature. Continually improving HIV education 

218
and services targeted toward HIV-infected persons is important; however, the best planned 

programs are ineffectual if their potential clients are unable to use them. 

A recent focus on social structural barriers to risk reduction indicates that the existing public healthcare infrastructure has yet to effectively address the health needs of HIV-infected, 

unstably housed women. Reforming laws and policies to address these inequities and structural barriers to care is crucial.2 In the meantime, healthcare and service providers cannot rely 

on impoverished women to do what is “best” for their health because poor women do not often 

have the agency or means to do so. Strategies to improve health and social services for impoverished women who are infected with, or at risk for becoming infected with, HIV require the 

consideration of the social context in which women’s risks occur. Considering women’s psychosocial needs as a priority, which on occasion will take precedence over physical health needs, 

may be the first step toward successfully engaging them in consistent use of health services. 

A new research emphasis on the sociocultural context in which HIV is transmitted and HIV 

infection progresses will lead to better intervention strategies, better outreach services, and 

ultimately, better healthcare strategies to serve vulnerable women. 

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467–471. 

PAOLO RINAUDO, M.D., PH.D. 

University of California, San Francisco 

Importance of the Women’s Reproductive Health Research (WRHR) Program for the Physician– 

Scientist: A Personal Perspective 

The National Institutes of Health (NIH), together with the National Cancer Institute and the 

Eunice Kennedy Shriver National Institute of Child Health and Human Development, created 

the WRHR Program to fund obstetricians and gynecologists interested in pursuing a research 

career. The WRHR program allows clinicians to start an independent career in research 

addressing women’s health issues. One of the main advantages of the program is that scholars 

receive funding, and more importantly, have 75 percent of their time protected and devoted to 

research. I have been a scholar for 4 years and I would like to share my experience. 

Thanks to the program, I have been able to thrive and start a research program. The focus of 

my research is to understand how in vitro fertilization and in vitro culture during the preimplantation period (the first 4–5 days of life, before the embryos attach to the uterus) affect 

fetal and adult development. This has particular relevance in light of the widespread use of 

artificial reproductive techniques (like in vitro fertilization). In fact, approximately 3 million 

children worldwide and up to 1 percent of children in the Western World have been conceived 

with these technologies. 

Indeed, it is well known that a fetus that has a suboptimal growth in utero (secondary, for 

example, to maternal disease or to a poor nutrition), will be predisposed to diabetes, high 

blood pressure, and coronary heart disease during adult life. We believe that this phenomenon, termed the “developmental origin of adult health and disease,” can be extrapolated back 

to the preimplantation development. 

My laboratory is therefore performing in vitro fertilization in mice, using the mouse as a model 

to study the consequences of in vitro fertilization. The mice generated in vitro are followed 

until they reach adult age and are compared to mice conceived normally. 

The results of this research are important because they have implications not only for women’s health, but for the health of the whole population in general. This is an important common 

trend: results of women’s health research benefit not only women, but the wider population. 

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I think it is of paramount importance that the NIH continue funding women’s health research 

because this will allow for better doctors and, in general, for better care to be devoted to women. 

This is particularly important in light of the following facts. First, Federal support to academic 

departments of obstetrics and gynecology through the National Institutes of Health is the 

lowest among other major specialties. For example, in 2006, only 1.1 percent of the total NIH 

budget was awarded to obstetric and gynecologic departments. 

Second, there is a lack of competitive physician–scientists in the OB/GYN department who can 

successfully obtain NIH funding. As an example, in 2006, only 14 percent of individual applicants in a department of OB/GYN were successful in obtaining funding, the lowest percentage 

of any specialty surveyed. 

In summary, the WRHR program has represented and still represents a fantastic opportunity 

for me to grow and become a better physician and I strongly advocate continuous funding in 

women’s health research. 

PATRICIA A. ROBERTSON, M.D. 

University of California, San Francisco 

Lesbian Health Research Priorities 

Introduction 

In 1999, the National Institute of Medicine designated lesbians as underserved by the healthcare system in the United States. However, in 2000, with the change in administration to the 

Bush presidency, there was no effort to address the health inequities documented in this population. In fact, for the next 8 years, no research grant could be submitted with any hope of 

Federal funding with the words lesbian in the title or abstract. Despite that, small increments 

of research were accomplished toward lesbian health issues, usually by volunteer efforts. The 

Lesbian Health Fund was started at the Women in Medicine Conference, an annual scientific 

meeting of lesbian physicians. That fund supported a few pilot research projects in lesbian 

health. There remains much to be done. Today from Dr. Dibble’s and my combined experiences 

as clinicians and researchers in the lesbian health field for the past three decades, we propose 

a lesbian health research agenda for the next 10 years that will not only bring much-needed 

information on specific lesbian health issues, but also critically needed intervention studies to 

establish effective prevention and treatment of illness among lesbians. 

National Survey to Ph.D.s and M.D.s for Lesbian Health 

Research Priorities 

In preparation for this testimony, we prepared a survey via the Internet that was sent across 

the United States to lesbian physicians who provide health care for a substantial portion of the 

lesbians in our country, as well as to lesbian health researchers. This survey was distributed 

to some listserves such as the Gay and Lesbian Medical Association; the Women in Medicine 

retreat; the Society for Adolescent Medicine’s lesbian, gay, bisexual, and transgender (LGBT) 

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members; and the Association of Gay and Lesbian Psychiatrists. We had 345 respondents 

over the 10 days designated for input, and have created a subset of 200 physicians and Ph.D. 

researchers to articulate their priorities for lesbian health research. The mean age of this group 

was 48 years, reflecting a considerable length of career, with 89 percent of respondents identified as female, and 91 percent of the group identified as lesbian/gay. Ethnicity was 74 percent 

Caucasian, demonstrating significant input from ethnic minority respondents. Of the total 

sample, 45 percent had a faculty appointment, and for 22 percent of them, research was part 

of their job descriptions. However, many in this group did volunteer research, especially when 

they were involved with lesbian health issues. For the physicians, 33 percent did volunteer 

research that was not part of their job description, and 10 percent did volunteer research work 

on top of their job description that included research. For the Ph.D.s, 13 percent did volunteer 

research that was not part of their job description, and 53 percent did volunteer research in 

addition to other research that was part of their job. 

Participants were asked to rank 44 topics on a Likert scale from most important (1) to least 

important (5). This list of 44 topics included childhood abuse (either sexual or physical), elder 

abuse, advanced directives, aging, alcohol abuse, anxiety, arthritis, cancer prevalence, cancer treatment, coming out, depression, diabetes, prescription drug abuse, illegal substance use 

(cocaine, club drugs, etc.), ethnic differences, exercise, families-of-choice, families-of-origin, 

fertility, fibroids, generational differences, hate crimes, heart disease, homophobia, internalized 

homophobia, hypertension, incontinence, menopause, obstetric issues, parenting, polycystic ovarian syndrome, pregnancy, quality of life, resilience, sexual function, sexual harassment, 

smoking cessation, spirituality and health, sexually transmitted infections, social support, transition issues (e.g., female to male), intimate partner violence, weight management, and youth. 

There was also a space where participants could register their comments. 

The top 16 priorities for lesbian health research from Ph.D.s and M.D.s that were identified on 

the 1–5 Likert scale were depression (1.70), quality of life (1.75), internalized homophobia (1.80), 

hate crimes (1.82), homophobia (1.87), resilience (1.89), aging (1.91), alcohol abuse (1.91), weight 

management (1.93), coming out (2.01), intimate partner violence (2.03), smoking cessation 

(2.03), parenting (2.03), prevalence of cancer (2.03), youth (2.04), and social support (2.04). 

Brief Background for Identified Lesbian Health Research Priorities 

• Depression is well-documented to be increased in lesbians. It is thought that the increased incidence of depression is associated with the stress of daily homophobia. 

Lesbians more frequently choose psychotherapy rather than antidepressants for the 

treatment, compared to heterosexual women. The most effective treatment for depression in lesbians has not been established, whether cognitive behavioral approach, 

medication (and which are most accepted/effective specifically in lesbians), personal 

psychotherapy, group therapy, or complementary medicine therapies. 

• Quality of life is a concept that we know very little about among lesbians. What are the 

components and predictors of quality of life in lesbians of different generations, ethnicities, abilities, or educational attainment? To date, there have been no studies exploring or 

intervening to improve the quality of life for lesbians. 

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• Internalized homophobia or self-loathing/sensitivity about one’s sexual orientation has a 

strong association with depression and perhaps alcohol, food, and other substance abuse. 

Most lesbians are raised by heterosexual parents, and received constant messages as children about the unacceptable lifestyle of lesbians. Understanding the experience of what 

contributes to internalized homophobia may provide some interventions for parents, which 

will then contribute to healthier outcomes for all children who later identify as LGBT. That is 

only one issue in this very complex subject that needs the attention of researchers. 

• Hate crimes are experienced by lesbians both from their families of origin (25 percent of 

lesbians) as well as from external sources, from levels of name-calling, physical violence, 

to murder. Very few resources are provided for lesbians who are victims of these crimes, 

and very little is done to decrease their incidence, such as education in the schools about 

sexual-orientation differences. The use of the word “gay,” “lezzy,” and “fag” are in common use on school playgrounds, and often precede a physical assault. 

• Homophobia is a common experience in the United States and can affect the physical 

and mental health of lesbians in various ways, from accessing healthcare due to fear of 

judgment from homophobic office staff and medical practitioners, to being “outed” at 

work, which can leave lesbians open to discrimination in the workplace as well as hate 

crimes. How best to change homophobia into acceptance is a major issue for which we 

have few answers. 

• Resilience is a little-studied concept, but some lesbians are able to overcome barriers, 

be successful career-wise, financially, and health-wise. What factors are associated 

with resilience, and how can resilience be encouraged for all lesbians to improve their 

lives and health? 

• Aging among lesbians as a physical, psychological, and cultural process has not been 

studied in depth. Most lesbians have not borne children who may assist them in their aging years. In one city, “ondines” have been created in which lesbians come together as a 

small group and pledge to care for one another, with money saved for the last survivor to 

be able to go to an assisted-care facility. There are also anecdotal reports of increased elder abuse of LGBT clients in nursing homes. This must be studied. 

• Alcohol abuse is increased in the lesbian community for women ages 20–40. Often, barriers exist to treatment, such as inpatient staff of alcohol treatment centers who have not 

been trained in LGBT culture. Are Alcoholics Anonymous groups even effective for most 

lesbians with an alcohol problem? Are there better methods to help lesbians have an improved relationship with alcohol? 

• Weight management in lesbians is crucial to their health and quality of life. Lesbians have 

increased body mass index and thus are probably also at increased risk for diabetes and 

hypertension. There has been no research about the effectiveness of weight-management protocols for lesbians. There is currently one researcher who is working on a pilot 

study for a weight management program for lesbians; however, she has no research 

funding for it. 

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• Coming out is usually a painful process for lesbians, who risk loss of employment, friends, 

children, church, and family. Understanding the process better and studying the most 

effective and least painful methods may be of assistance to lesbians. We know that better mental health is correlated with lesbians being open with their sexual orientation but 

many, especially lesbians of color, remain in the closet. 

• Intimate partner violence is probably at the same prevalence in lesbian couples as in heterosexual couples (11 percent), but there is very limited research in this area for lesbians 

and almost no shelters have a staff who have been trained in culturally appropriate care 

for LGBT victims of violence. Lesbians often do not turn to anyone for help in this situation because of fear of judgment from friends, police, and others when they disclose they 

are in an unhealthy relationship. 

• Smoking prevention/cessation is of vital importance to the lesbian community, as in some 

studies, the rate of cigarette smoking is four times higher in lesbians than in heterosexual women. We are now seeing lung cancer and chronic obstructive pulmonary disease in 

older lesbians who have a smoking history. Intervention trials need to be established for 

lesbians to determine effective methods for smoking cessation in this population. 

• Parenting for lesbians has many challenges within the context of homophobia. 

Although almost all of the studies show that the children of lesbian parents cannot be 

distinguished from those raised by heterosexual parents, there are increased and specific stresses these families undergo that need to be studied. How to determine the most 

appropriate school placement so that the child encounters minimal homophobia, since 

homophobia may contribute to behavior issues for the child, is an issue that needs study. 

Another issue that needs exploring is how the child successfully negotiates the inevitable 

name-calling of their parents. These issues and more require appropriate study in order 

to help families with lesbian parents. 

• The prevalence of cancer is unknown among lesbians. We do not have the denominator to determine this basic epidemiological fact for this population. From our studies, we 

know that lesbians are at increased risk for breast cancer and it is assumed that lesbians 

are at increased risk for endometrial cancer and for ovarian cancer due to their low childbearing rate. It is also assumed that lesbians are at increased risk for colon cancer due to 

their increased body mass index and for lung cancer due to their increased prevalence of 

smoking. We need to study the prevalence of cancer in lesbians to target the preventable 

cancers such as colon cancer. Appropriate cancer education and interventions for lesbians need to be developed and tested. 

• Adolescent female youth who are lesbian/queer/questioning are at increased risk for unintended pregnancy, sexually transmitted infections, suicide, and substance use. We need 

to study intervention/education strategies to decrease morbidity and mortality in this 

vulnerable group. 

• Social support needs to be studied in the lesbian community to determine which types 

of social support are most needed to contribute to a healthier and more encouraging 

lesbian community. Elderly lesbians are sometimes isolated with little social support as 

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their friends die. Lesbian youth also may feel isolated and hopeless during the comingout process. The link to health with social support in the lesbian community needs to 

be studied. 

Lesbian Health Researchers 

Prior to the change of administrations in 2000, a national conference was convened by the 

Office on Women’s Health on lesbian health research, just after the publication of the proceedings by the National Institute of Medicine, which mandated further research on lesbian health 

issues. I, Patricia Richardson, was a member of the working group for career development. Our 

report reflected the risk that young researchers took when they focused their work on lesbian 

health. Comments such as “you are throwing your career away” were not uncommon. An additional concern was that there was no funding for lesbian health research so a young researcher 

would fail to rise up the academic ladder. There was also the issue of homophobia within the 

academic setting and the potential lack of promotion. Today, if there were significant funding 

for lesbian health research, we are confident that some young researchers would embrace lesbian health research as a priority, but we also think that there is a capacity in the midcareer 

Ph.D.s and physicians to contribute. Based on the responses from our survey, we determined 

that there was a significant volunteer involvement in lesbian health research. In the responses 

to our research questions about number of grants and their sources, we discovered that very 

little money has been able to be accessed for lesbian health research even when the same 

researcher has been successful in obtaining NIH funds for other research and has published 

scholarly articles. 

Proposed Mechanisms for Funding Lesbian Health Research 

1. Add a supplement for support for a lesbian health researcher to existing grants, 

similar to the current minority supplements. Not only could the sexual-orientation 

question be added to the project and a subset of lesbians recruited as research subjects and analyzed as such, but this individual would help to educate the team about 

lesbian health issues. 

2. Establish a competitive small grant application cycle for a designated topic area in 

lesbian health each year. For instance, generate a Request For Application (RFA) on interventions for lesbians with depression and fund six different pilot intervention studies 

of $200,000 each at six different sites. Selection of the grants would be done by a specialized group with lesbian health research background. At the end of these 18-month 

grants, bring these researchers, along with others in the field, together to determine 

which study should move forward for a multisite trial of the intervention. Each of the 

six investigators would be a site Principal Investigator and additional funds would be 

provided for this larger intervention trial. 

3. After the multisite 3-year grant was completed, bring the researchers together again to 

create a final report of “best practices” recommendations and/or guidelines so that the 

research findings can be translated quickly into clinical practice. 

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Conclusion 

The need for lesbian health research is critical. There may be inexpensive interventions identified by this research that will decrease disease burden for lesbians and contribute to their 

improved quality of life. These interventions may well reduce healthcare costs for society from 

delay in seeking care. We have identified several areas of consensus from researchers and clinicians. We have expert researchers who are poised to do lesbian health research, and simply 

need the funding to accomplish this research. Thank you very much for your attention, and we 

hope that you will partner with us to better the health and quality of life for the millions of lesbians in the United States. 

Authors 

Patricia A. Robertson, M.D., is Professor in the Department of Obstetrics, Gynecology, and 

Reproductive Sciences, School of Medicine at the University of California–San Francisco. In 

1978, she cofounded Lyon-Martin Clinic, a full-service clinic for lesbians and other women in 

San Francisco. She was Cofounder of the Women in Medicine retreat in 1985, an annual scientific meeting for lesbian physicians and she currently serves on its board. Since the creation of 

the Lesbian Health Fund in 1992, she has been on its board, serving as Grants Committee Chair 

for 9 years. In 1999, she was Founding Codirector for the Lesbian Health and Research Center 

at the University of California–San Francisco until 2007; she continues to serve on its National 

Advisory Board. She is currently coediting, with Dr. Dibble, the first textbook on lesbian health, 

Lesbian Health 101: A Guide for Clinicians, which is expected to be published fall 2010. 

Suzanne L. Dibble, D.N.Sc., RN, is Professor at the Institute for Health & Aging, School of 

Nursing at the University of California–San Francisco (UCSF). She has conducted numerous 

research studies, written more than 100 database articles and coedited two books—Culture & 

Nursing Care, published in 1996, and Culture & Clinical Care, published in 2005. She cofounded 

the Lesbian Health & Research Center at UCSF in 1999 and codirected the Center until 2007 

when she retired from the University. Recently, she was recalled to the University to work on 

a State-funded research grant. Her newest book, LGBTQ Cultures: What Health Professionals Need To Know About Sexual and Gender Diversity, written by Eliason, Dibble, DeJoseph, & 

Chinn, was published by Lippincott in 2009. 

TRACEY J. WOODRUFF, PH.D., M.P.H. 

University of California, San Francisco 

Improving the Quality of Maternity Care 

Greetings. My name is Tracey Woodruff and I am an associate professor in the Department 

of Obstetrics, Gynecology, and Reproductive Sciences and Pediatrics and the director of the 

Program on Reproductive Health and the Environment at the University of California–San 

Francisco. The Program on Reproductive Health and the Environment (PRHE) is dedicated to 

creating a healthier environment for human reproduction and development by advancing scientific inquiry, clinical care, and health policies that prevent exposures to harmful chemicals 

in our environment. We focus on the intersection of science, medicine, policy, and community 

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engagement in each of our areas of activity: targeted research, expanding clinical practice, 

and advancing science-based policy solutions. I am here to submit comments on a research 

agenda for women’s health that will significantly improve the lives of women and ultimately 

families by preventing exposure to harmful chemicals in our environment. 

At the beginning of the 21st century, we are in a unique but precarious position. Economic globalization, accelerating technological change, expanding industrialization, and shifting political 

and religious forces have provided great opportunities and challenges. Equally important, 

our reproductive health, and ultimately, our reproductive capacity are under strain, as demonstrated by the growing compilation of scientific findings and books on this subject, and as 

reflected by indicators of declining reproductive function and increasing rates of reproductive 

illnesses since the mid-20th century.1-4 

Over roughly the same period, human exposure to both natural and synthetic chemicals has 

dramatically increased. Approximately 87,000 chemical substances were registered for use in 

U.S. commerce as of 2006, with about 3,000 chemicals manufactured or imported in excess 

of 1 million pounds each.5 These chemicals pollute our air, water, and food supply; we are also 

exposed through the use of a wide range of consumer and personal care products. Data from 

the National Health and Nutrition Examination Survey show that everyone in the United States 

has measurable levels of multiple environmental contaminants in her body.6 

The power of environmental chemicals to impact reproductive health, an integral part of 

womens’ health, has been dramatically demonstrated through tragic episodes of extreme 

exposures to chemicals, such as food contamination, resulting in severe neurological, reproductive, and developmental effects caused by mercury and polychlorinated biphenyl (PCB) 

poisonings in Japan and Taiwan.7-9 

More recently, attention has been placed on evaluating the effects of everyday exposures 

to environmental contaminants, particularly in light of the declining trends in reproductive 

health. For example, there has been a 40 percent increase, to about 11 percent, in the percent 

of U.S. women who report difficulty in conceiving and maintaining pregnancy.10 In addition, 

between 1982 and 2002, the percent of young women under the age of 25, a peak time of fertility, reporting difficulty in conceiving and maintaining pregnancy doubled from 4.3 percent 

to 8.3 percent.10,11 There has been a decline in the age of onset of puberty, as marked by breast 

development and onset of menarche, for girls in the United States between the 1940s and 

the mid-1990s.12 And women’s health is critical to the health of their families. We have seen 

increasing manifestations of adverse health among infants and children, many conditions that 

originate in the womb. Thirty percent more babies are born prematurely, and the expected 

gestational age of babies delivered without medical intervention is 1 week earlier now than 15 

years ago.13 There are increases in certain birth defects and other adverse birth outcomes, such 

as gastroschisis (three-fold over the past 20 years in California) and hypothyroidism (138 percent over the past 20 years in New York).14,15 And several childhood illnesses, including certain 

childhood cancers and neurodevelopment disorders, such as autism, have been reported to be 

increasing,16 as well.17 

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This growing science shows that reproductive health is particularly susceptible to disruption 

by environmental contaminants during key periods of development, during which extensive 

physiological events, such as cellular proliferation and differentiation and rapid shifts in metabolic and hormonal capabilities, occur. Exposures during any of these periods may result 

in permanent and irreversible adverse effects that can manifest immediately or later in life 

(labeled the fetal origin of adult disease18) and even in subsequent generations. 

Environmental reproductive health research has also recently expanded its focus on genotoxic 

or mutagenic chemicals to include effects on gene expression, or epigenetics. Increasing attention has also been placed on a class of chemicals called endocrine-disrupting chemicals, which 

interfere with the production, release, transport, metabolism, binding, action, or elimination of 

natural hormones in the body. This research has also strengthened our recognition that exposure 

to low doses of chemicals can adversely impact reproductive health, that exposure to mixtures 

of chemicals can have a cumulative effect, and that these types of exposures must therefore be 

studied and considered in chemicals policy.19,20 Lastly, the detection of more than 200 chemicals 

in the U.S. population has raised the question of how, exactly, we are being exposed. 

Like many other aspects of the 21st century, the current state of women’s health and environmental reproductive health research presents great opportunities and challenges. If elements 

of the environment we create are contributing to the decline in our reproductive health and 

capacity, then we have, in our hands, the ability to reverse this trend. But to identify these elements, we must overcome the challenges of studying effects on women’s reproductive health 

over lifetimes and multiple generations; of identifying and understanding both the interrelationships between the reproductive, immune, and nervous systems in guiding development 

and determining reproductive success and how this can be perturbed by chemical exposures; 

of identifying major routes through which humans are exposed to chemicals that are pervasive in our environment; and of understanding how scientific information is most effectively 

translated and used for individual, community, and society-wide efforts to prevent harmful 

exposures. It is toward these goals that we recommend the following research program for 

women’s environmental health, which integrates and builds upon a number of recent research 

agendas in related disciplines.2,3,21,22 

Identifying Environmental Contaminant Risk 

• Rapid-screening techniques for identifying potential harmful chemicals. Rapid-screening 

techniques are needed to identify the potential health effects of the thousands of chemicals for which only sparse toxicological data exist, and to identify emerging chemicals 

of concern. One particularly promising screening method involves the use of stem cells 

for predictive toxicology. In vitro toxicology assays based on human stem cells and their 

derivatives would offer significant advantages over current animal models and assays 

based on primary and/or transformed cell lines, largely due to their improved relevance 

and greater versatility.22 

• Reproductive diseases and function surveillance. Data from cancer registries show 

that rates of hormonally related cancers (e.g., breast) have increased dramatically 

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over the past 50 years, yet we have only sparse data on potentially related women’s 

nonmalignant conditions, such as fibroids, endometriosis, and infertility. Information on 

trends in all types of reproductive disease and disorders is essential to detecting problems, to developing and testing research hypotheses, and to identifying successful 

prevention activities. 

• Biomarkers of exposure and preclinical indicators of disease. Biomarkers of exposure 

and preclinical disease will help to overcome the time and resource challenges of studying the entire lifespan because they would lessen the need to track exposure and disease 

outcomes over extended periods of time and would provide early indicators of overt 

disease. Support for expanding our understanding of disease mechanisms, including epigenetics, proteomics, and metabolomics, will be essential to this process. 

• Effects from low-dose exposure to mixtures of chemicals. Research on the effects from 

human-relevant doses of exposure and from exposure to mixtures of chemicals must be 

expanded if we are to understand the true risks of our low level and simultaneous exposure to hundreds of chemicals. 

• Lifespan and transgenerational research. Experiences such as the aforementioned mercury and PCB poisonings, combined with the growing evidence of the fetal origins of adult 

disease, emphasize the importance of considering and studying the entire lifespan, as 

well as multiple generations. In particular, continuing research on existing human cohorts 

such as the diethylstilbestrol (DES) Combined Cohort Followup Study (www.desfollowupstudy.org) and initiating new cohorts, such as the National Children’s Study (www. 

nationalchildrensstudy.gov), are valuable and unique investments that must be continued 

and expanded upon. 

Assessing Exposure 

• Rapid, low-cost, easy-to-use, real-time methods for measuring environmental contaminants in environmental media and human biological samples. Development of these tools 

will provide the data necessary for epidemiologic and exposure assessment studies to 

identify leading sources of exposure contributing to our chemical body burden. 

• Expanded chemical biomonitoring programs. In addition to expanding the number of 

chemicals measured, support is necessary for ongoing biomonitoring of subpopulations 

known to be particularly vulnerable to effects from chemical exposures, including pregnant women, infants, children, and elderly populations. 

Enhancing Research Productivity 

• Minor investments to amplify research gains. Minor investments in tools to support 

materials-sharing between investigators—for example, support for biological specimen 

banks, tissue-sharing efforts, and expansion of national surveys to include measures of 

reproductive health—will vastly expand the amount we can learn from existing research 

studies at a comparatively minimal cost. 

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• Technologies to support multidisciplinary and multistakeholder consortiums. Real-time, 

interactive, flexible, low-cost and more environmentally neutral technologies, such as 

wikis, blogs, and Web conferencing, offer unprecedented opportunities to form collaborations and share information with geographically disparate members of multidisciplinary 

teams. For example, investing in virtual consortiums that leverage existing research programs across multiple locations to remove geographic barriers and enhance research 

collaborations through virtual collaborations is one such idea. 

Making the Findings Matter 

• Research on effective public and economic policies. Support for research that identifies 

and evaluates interventions that influence market changes, public policies that contribute 

to effective chemical management, and barriers to effective chemical policy development will support more informed and effective policy and decisionmaking. 

• Research on translating environmental reproductive health. Identifying the most effective 

means of educating and translating environmental health information from the scientific 

and research arenas to policymakers, clinicians, and the general public will enable scientific discoveries to make broader contributions to our health. 

Communication and Collaboration 

We are fortunate that the ability to lessen the detrimental impact that environmental contaminants have on our reproductive health lies within our hands. Stakeholders who must work 

together in this process—researchers, healthcare providers, policymakers, community and 

advocacy groups, and national and international agencies—have traditionally been separated 

by institutional and cultural divides. Each of these fields speaks a different, highly specialized 

language and communicates in a way that assumes a background expertise. Communication 

and collaboration are therefore as essential as the pursuit of knowledge and understanding 

through research. Overcoming the lack of common frameworks, language, expertise, and cultural barriers requires substantial effort, commitment, time, and resources. But this challenge 

must be pursued if we are to achieve an informed and adequately protective society in which 

women’s health and ultimately future generations thrive. 

References 

1. Colborn, T., Dumanoski, D., & Myers, J. P. (1996). Our stolen future. New York: Penguin 

Group (USA), Inc. 

2. Crain, D. A., Janssen, S. J., Edwards, T. M., Heindel, J., Ho, S. M., Hunt, P., . . . Guillette, L. 

J., Jr. (2008). Female reproductive disorders: The roles of endocrine-disrupting compounds and developmental timing. Fertility and Sterility, 90, 911–940. 

3. Woodruff, T. J., Carlson, A., Schwartz, J. M., & Giudice, L. C. Proceedings of the Summit 

on Environmental Challenges to Reproductive Health and Fertility: Executive summary. 

Fertility and Sterility, 89, e1–e20. 

4. Schettler, T., Solomon, G., Valenti, M., & Huddle, A. (1999). Generations at risk: Reproductive health and the environment. Cambridge, MA: MIT Press. 

234
5. U.S. Environmental Protection Agency. (2006). What is the TSCA chemical substance 

inventory? Washington, DC: Author. 

6. Centers for Disease Control and Prevention. (2005). Third national report on human 

exposure to environmental chemicals. Atlanta, GA: Author. 

7. Rusyniak, D. E., Furbee, R. B., & Pascuzzi, R. (2005). Historical neurotoxins: What we 

have learned from toxins of the past about diseases of the present. Neurologic Clinics, 

23, 337–352. 

8. Guo, Y. L., Lambert, G. H., Hsu, C. C., & Hsu, M. M. (2004). Yucheng: Health effects 

of prenatal exposure to polychlorinated biphenyls and dibenzofurans. International 

Archives of Occupational and Environmental Health, 77, 153–158. 

9. Teitelbaum, D. T. (1999). The toxicology of 1, 2-dibromo-3-chloropropane (DBCP): A 

brief review. International Journal of Occupational and Environmental Health, 5, 122–126. 

10. Chandra, A., Martinez, G., Mosher, W., Abma, J. C., & Jones, J. (2005). Fertility, family 

planning, and reproductive health of U.S. women: Data from the 2002 National Survey 

of Family Growth. Vital Health Statistics, 23(25), 1–160. 

11. Brett, K. (2008). Fecundity in 2002 NSFG women 15–24 years of age [Personal communication]. National Center for Health Statistics, Hyattsville, MD. 

12. Euling, S. Y., Selevan, S. G., Pescovitz, O. H., Skakkebaek, N. E. (2008). Role of environmental factors in the timing of puberty. Pediatrics, 121 Suppl 3, S167–171. 

13. Davidoff, M. J., Dias, T., Damus, K., Russell, R., Bettegowda, V. R., Dolan, S., . . . Petrini, J. 

(2006). Changes in the gestational age distribution among U.S. singleton births: Impact 

on rates of late preterm birth, 1992 to 2002. Seminars in Perinatology, 30, 8–15. 

14. Harris, K. B., & Pass, K. A. (2007). Increase in congenital hypothyroidism in New York 

State and in the United States. Molecular Genetics and Metabolism, 91, 268–277. 

15. Vu, L. T., Nobuhara, K. K., Laurent, C., & Shaw, G. M. (2008). Increasing prevalence 

of gastroschisis: Population-based study in California. The Journal of Pediatrics, 152, 

807–811. 

16. Newschaffer, C. J., Falb, M. D., & Gurney, J. G. (2005). National autism prevalence trends 

from United States special education data. Pediatrics, 115, e277–e282. 

17. Woodruff, T. J., Schwartz, J., & Giudice, L. Research agenda for reproductive environmental health in the 21st Century. Manuscript submitted for publication. 

18. Gluckman, P. D., & Hanson, M. A. (2004). Living with the past: Evolution, development, 

and patterns of disease. Science, 305, 1733–1736. 

19. National Research Council. (2008). Science and decisions: Advancing risk assessment. 

Washington, DC: The National Academies Press. 

20.National Research Council. (2008). Phthalates and cumulative risk assessment: The task 

ahead. Washington, DC: The National Academies Press. 

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21. Woodruff, T. J., Zeise, L., Axelrad, D. A., Guyton, K. Z., Janssen, S., Miller, M., . . . Zoeller, 

R. T., (2008). Meeting report: Moving upstream—Evaluating adverse upstream end 

points for improved risk assessment and decision-making. Environmental Health Perspectives, 116, 1568–1575. 

22.California Institute for Regenerative Medicine. (2008). Stem cells in predictive toxicology. San Francisco: Author. 

AMY LEVINE, ED.D. 

University of California, San Francisco Center for Gender Equity 

University of California Diversity Pipeline Initiative Leadership Conference 

Data show that women of color are not well represented in ladder-track positions at University 

of California (UC) health professional schools. The University of California Diversity Pipeline 

Initiative conference was designed to encourage underrepresented women-of-color students 

in the health sciences to consider careers in academia. In other words, the goal of the initiative 

is to “grow our own.” Held three times since 2007, the conference is sponsored by the University of California, San Francisco (UCSF) Center for Gender Equity, the UCSF Student Activity 

Center, and the UC Office of the President (UCOP). 

As the most populous and most ethnically and culturally diverse State in the Nation, California faces unique challenges in its efforts to improve access to care and health outcomes for its 

citizens. In California and nationally, race- and ethnicity-based disparities in health status are 

compounded by reduced access to health services, lack of adequate health insurance, and the 

maldistribution of physicians and other health professionals. More than 165 areas in the State 

are designated by governmental agencies as medically underserved or as health-professional 

shortage areas; these shortage areas are disproportionately home to poor and minority Californians. Latinos and African Americans are greatly underrepresented in California’s physician 

workforce; for example, although Latinos constitute one-third of the population, they account 

for only 5 percent of the physician workforce. Other ethnicities are similarly underrepresented, 

and according to the March 2008 report, Physician Diversity in California: New Findings from 

the California Medical Board Survey and many other studies, should be more actively recruited. 

Evidence also shows that California’s health providers are not adequately prepared to meet 

the needs of the State’s diverse medically underserved communities, and that these health 

disparities will persist and likely intensify in the years ahead. Recognizing the importance of 

mitigating these disparities, the University of California’s health sciences schools are increasing their efforts to improve the cultural competency of all graduates with respect to the needs 

of medically underserved groups and communities. These efforts include increased teaching 

about cultural and socioeconomic factors that influence health status; enhanced training on the 

importance of cultural and linguistic competence; and increased involvement in educational and 

research initiatives aimed at reducing health disparities and improving health outcomes. 

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As the University expands its efforts to increase diversity, improve the cultural competence 

of providers, and increase enrollment of students with an interest in working in underserved 

communities, the presence of a diverse faculty emerges as a critical factor in training future 

clinicians to address California’s needs. A diverse faculty in the health sciences establishes a 

context in which both students and fellow faculty have the opportunity to interact with professors and colleagues from different backgrounds and with varied perspectives on health care. 

In addition to serving as role models and mentors, underrepresented minority (URM) faculty 

may influence curriculum design, provide students and faculty with a perspective on the needs 

of a culturally diverse patient population, promote better understanding of the cultural beliefs 

of others, and establish relationships with communities that are often not connected to universities. A diverse faculty may also introduce new kinds of scholarship to the institution and 

increase and strengthen bench research, translational research, clinical studies, and interventions that address health disparities. 

Based on data from the University of California Faculty Diversity in the Health Sciences Report 

(2006–2007) presented during one of the conference workshops, the following findings emerged: 

• Tenure-track hiring of URMs in UC’s schools of medicine between 1996–1997 and 2005– 

2006 is nearly nonexistent, at less than 5 percent over the entire time span. 

• Women represent more than 93 percent of tenure-track faculty in the schools of nursing, but in the schools of pharmacy, their representation falls to 39.4 percent, while in the 

schools of medicine, only 20 percent of tenure-track faculty were women in 2006. 

• Although 49 percent of UC medical residents are women, only 24 percent of the faculty 

are women. 

• Only 9 percent of UC medical residents are URMs of either gender, and only 5 percent of 

faculty are URMs. 

Over the next 10 years, large numbers of current ladder-track faculty will reach retirement age, 

leaving the university with a crisis of leadership. However, this situation offers the university a 

golden opportunity to bring minority representation among faculty more closely in line with 

the student population. 

In light of these facts, the UCSF Center for Gender Equity, the UCSF Student Activity Center, 

and the UC Office of the President (UCOP) developed a conference/initiative geared toward 

the most underrepresented group among the university’s health sciences faculty—women of 

color—to provide them with information about academic careers in the health sciences. Students from each of the 15 health sciences schools were nominated by their respective deans 

based on academic merit and their potential interest in such a career; their expenses were 

paid by the conference and by their deans. One hundred and seventy students have attended 

the conference since its inception in 2007. The conference design provided mentoring and 

role models from among faculty women-of-color in the health sciences, as well as a series of 

skill-building workshops to help students build professional skills that would be important 

regardless of their career choice. Panel discussions featured faculty women of color from various UC schools, who discussed real and perceived barriers to achieving academic careers 

237
in the health sciences and freely shared their own career journeys. From the opening dinner 

through the closing luncheon, the energy and enthusiasm of both students and faculty created 

a highly charged atmosphere in which students could focus on issues vital to their lives and 

careers. Designated “self-care” times were set aside throughout the conference to reinforce 

the concept of balancing work and personal time. 

The conference has been attended by a highly diverse group of students including African 

Americans, Asian Americans or Asian/Pacific Islanders, Latinas, Caucasians, and Native Americans. A number of the students also indicated that they were of more than one ethnicity. All 15 

of UC’s health sciences schools have been represented. At the conclusion of the conference in 

2009, students were asked to rate their interest in an academic career on a 1–5 scale, 5 being 

highest; the average rating of their interest before the conference was 2.7; that number had 

risen to an average of 4.0 after the conference. The overall rating for the conference was 4.7 

out of 5 with 94 percent stating that the conference provided greater clarity about the academic career path. 

On behalf of the planning committee of the UC Diversity Pipeline Initiative, we would like to 

suggest that a focus be placed on increasing representation of women of color in ladder-track 

positions at UC health professional schools. Encouraging underrepresented, women-of-color 

students to pursue academic careers in health and educating them about the benefits and 

rewards of such careers is one strategy to accomplish this goal. Financial support for the UC 

Diversity Pipeline Initiative conference would allow us to continue this crucial work. 

MARGARET KRISTOF, M.A. 

UCSF–Kaiser BIRCWH Program 

UCSF–Kaiser Building Interdisciplinary Research Careers in Women’s Health (BIRCWH): 

Testimony from Three Scholars: Valerie Flaherman, M.D.; Yoshimi Fukuoka, Ph.D., RN; Wendy 

Katzman, D.P.T.Sc., PT, OCS 

Testimony of Valerie Flaherman, M.D., M.P.H. 

The BIRCWH program has had a major impact on improving research in women’s health by 

encouraging interdisciplinary collaboration in women’s health issues. I am a pediatrician with 

a research focus on breastfeeding. In my field, research often focuses on infant benefits of 

breastfeeding, but the BIRCWH program has allowed me to focus on the maternal benefits as 

well, including significant reduction in maternal risk of breast cancer and ovarian cancer from 

improved breastfeeding duration. 

BIRCWH has allowed me to collaborate with other experts in women’s health and to access 

sources of internal funding available for women’s health. In addition, being a BIRCWH scholar 

has given me access to extensive advice and guidance from Dr. Deborah Grady, BIRCWH codirector. Dr. Grady has been inspirational in encouraging me to seek multiple sources of grant 

funding, and I have had great success at fundraising this year due to her encouragement. In 

addition, Dr. Grady has identified several collaborative opportunities for me outside of pediatrics. I would not have made these contacts without her guidance. 

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In my first 11 months in the BIRCWH program, I have been able to complete a randomized trial 

comparing breast pumping to manual milk expression for mothers of healthy term infants who 

are not latching well at 12–36 hours of age. I have begun preliminary analysis of the data and 

I hope to be able to contribute to the literature by reporting on the efficacy of these interventions for this group. In addition, I have completed 7 of 10 scheduled focus groups to examine 

maternal attitudes toward provider recommendations regarding breastfeeding for mothers 

who have concerns about low milk supply. We hope to be able to inform clinical recommendations based on this research in future papers. 

My relationship with my BIRCWH mentors and advisors has allowed me to move forward 

much more rapidly on the path to independent clinical research. With the help of the BIRCWH 

program, I hope I can contribute to women’s health by improving breastfeeding duration for 

mothers who have started breastfeeding, and thereby reduce both infant illness and maternal 

cancer risk. Thank you very much. 

Testimony of Yoshimi Fukuoka, Ph.D. 

The BIRCWH program has given me tremendous opportunities to be an independent 

researcher in women’s health. I would like to highlight a few of these opportunities during 

the program. I am an assistant professor in the School of Nursing, University of California. My 

research focuses on primary and secondary prevention of heart disease in women. Heart disease continues to be the leading cause of death among women in the United States, despite 

efforts in reducing its risk factors. 

During the BIRCWH program, I was able to develop and test an innovative cell phone based 

physical activity program for sedentary women. The study results were positive. More importantly, no participants dropped out from our study. I have submitted three grant applications 

to conduct a large-scale clinical trial to further test this cell phone based physical activity 

program in sedentary women. If this cell phone physical active program is effective, it could 

potentially be administered to a large number of women. Clearly, the BIRCWH program provided me with an opportunity to transform my ideas to a research study in a timely manner. 

Another important opportunity during my BIRCWH program is that I was able to establish an 

interdisciplinary research collaboration involving an exercise physiologist, computer scientists, 

nurses, physicians, psychologists, and industry. These collaborations will allow me to further develop a creative and innovative prevention program for heart disease in women in the 

future. I hope my research contributes to the advancement of women’s health research, and 

ultimately to the improvement of women’s health. 

Testimony of Wendy B. Katzman, D.P.T.Sc., PT, OCS 

I agree with my colleague, Valerie, that the BIRCWH program has had a major impact on 

improving research in women’s health by encouraging interdisciplinary collaboration in women’s health. I am a physical therapist with a research focus on postural changes in women with 

aging. Most people believe that hyperkyphosis, also known as stooped posture, is an inevitable 

consequence of aging. My research focuses on the things we can do to prevent hyperkyphosis 

and understanding how this impacts our physical function and mobility. 

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Prior to BIRCWH, I did not have access to mentors to help me develop my research career. There 

is a paucity of experienced researchers in my field, both locally and nationally. My interdisciplinary mentoring team has been invaluable in helping me conceptualize the scope and definition of 

my research. They are role models to me, exemplifying how to build a career in clinical research 

and develop relationships with experts in the field of hyperkyphosis. They introduced me to Dr. 

Deborah Kado at University of California–Los Angeles, a renowned expert on hyperkyphosis, and 

that relationship has already resulted in collaboration on a kyphosis project. 

BIRCWH has allowed me to enroll in a 1-year program for advanced training in clinical research 

to develop my skills as a clinical researcher. I have been studying epidemiology, biostatistics, 

and clinical research design and implementation. 

As a BIRCWH fellow, I have access to several databases that allow me to answer important 

questions related to hyperkyphosis. During this first project year, I have completed an initial 

analysis of hyperkyphosis as a predictor of impaired mobility among more than 3,000 older 

community-dwelling women. This is the first longitudinal study that has found hyperkyphosis predicts impairment over time. I received funding to complete an analysis of hyperkyphosis 

among healthy community-dwelling adults in the “Healthy Aging and Body Composition” longitudinal cohort study. Besides completing this project, my plans for the next year include 

obtaining additional funding to conduct a randomized controlled trial of exercise to reduce 

hyperkyphosis and determine its impact on physical function and mobility. 

I am honored to have the opportunity that BIRCWH has provided me. As the first physical 

therapist at the University of California–San Francisco to get this award, and one of a small 

number of physical therapists doing clinical research in the country, I plan to bring a new perspective that contributes to the health and well-being of women as we age. 

ALEXANDRA SCRANTON, M.S. 

Women’s Voices for the Earth 

More Research Needed on Women’s Health and the Environment 

We appreciate the opportunity to provide input on the formation of a research agenda for 

the Office of Research on Women’s Health. We are pleased to see that women’s health and 

the environment is a current focus area for ORWH. We believe there is important research in 

this area that needs to be done to help protect women’s health from the significant burden of 

environmental chemical exposure. 

Women’s Voices for the Earth (WVE) is a national organization that engages women to 

advocate for the right to live in a healthy environment. WVE seeks to reduce and ultimately 

eliminate environmental pollutants that are linked to health problems for women, their families, and their communities. WVE’s goal is to educate the public about the harmful effects of 

chemicals, particularly those that affect women, and provide them with the tools they need to 

protect themselves and effectively advocate for a healthy environment. To this end, WVE creates opportunities for women to influence environmental decisionmaking. 

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In our work, there are too many unanswered questions about the true impacts of chemical 

exposure and the proportion of disease that can be attributed to it. We do know, however, that 

much of the chemical exposure risk women experience is both unnecessary and avoidable. 

Public education for individuals on how to personally avoid chemical exposure is important, 

but it is only part of the solution. We have a societal responsibility to create and implement 

policy and structural changes that make our world inherently safer to live in. Appropriate 

research in the area of women’s health and the environment is crucial to help drive these 

changes, aiding in the prioritization of needed actions and providing the rationale 

for implementation. 

Research we would like to see would include the following: 

1. More comprehensive biomonitoring to determine which chemicals are found at 

significantly higher levels in women. In 2003, the Centers for Disease Control and 

Prevention (CDC) tested thousands of Americans for the presence of 116 toxic chemicals. Ten of those chemicals were found to be present at significantly higher levels in 

women than in men. Only one of the 116 chemicals was found present at significantly 

higher levels in men.1 

2. Exposure analyses to help determine where and how women are being disproportionately exposed. The 2003 CDC testing also found that women had significantly higher 

levels of phthalates in their bodies than men. It has been theorized that the prevalent 

use of phthalates in cosmetics and beauty products has led to a disproportionate 

exposure in women, who tend to use these products at greater rates than men. In our 

work, we have also been concerned with the impact of chemicals found in household 

cleaning products. Women are still doing more than 70 percent of the housework in the 

average home.2

 Women also represent a larger proportion of cleaning workers (particularly maids and housekeepers) than men. Research is needed to better understand the 

disproportionate impact on women from chemicals found in these household products 

women are exposed to every day. 

3. Improved tracking to provide a better understanding of racial disparities in women’s 

health, and the factors (particularly environmental factors) driving these disparities. 

For several health outcomes, it has been shown that women of color bear a disproportionate burden of disease. There are numerous other health conditions, particularly in 

the area of reproductive health, where these disparities appear to be present, but the 

national tracking is not in place to confirm or provide additional information. Better 

understanding of these underreported or unreported conditions, particularly as they 

affect women of color, could drive changes to help better protect women’s health 

across the board. 

These are just some of the many avenues of research we would like to see pursued. We look 

forward to following the progress of this conference and the research agenda that is created. 

Again, we greatly appreciate the opportunity to provide input on this important undertaking. 

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References 

1. Centers for Disease Control and Prevention. (2003). Second national report on human 

exposure to environmental chemicals (NCEH Pub. No. 02-0716). Washington, DC: U.S. 

Department of Health and Human Services. 

2. Bird, C. (1999). Gender, household labor, and psychological distress: The impact of the 

amount and division of housework. Journal of Health and Social Behavior, 40, 32–45. 

LOREEN WILLENBERG 

Zephyr L.T.N.P. Foundation, Inc. 

Testimony of Loreen Willenberg, Sacramento, California 

I welcome the opportunity to provide input to the National Institutes of Health (NIH) Public 

Hearing on the Women’s Health Research Agenda. As a woman who has lived with human 

immunodeficiency virus (HIV) infection for 17 years, I have a vested interest in this discussion. As a human subject in several clinical research studies, including one conducted by the 

NIH, I can share a unique perspective on the topic. Due to my work as a community-based 

and publicly vocal advocate for HIV treatment and vaccine research, I am a definite stakeholder in the conversation. 

Women have consistently been underrepresented in clinical research trials and studies since 

the beginning of the HIV/AIDS epidemic. When I tested positive for HIV in 1992, I was surprised to learn that little was known about the effects of the disease on women due to a lack 

of clinical research. My physician, a Stanford University-educated internist practicing in Sacramento, CA, confirmed this fact. As my knowledge base increased about HIV/AIDS during those 

first few years, thanks to books, my physician, and information shared by the Project Inform 

Hotline volunteers in San Francisco, I became increasingly frustrated by the lack of information 

specifically oriented to women and HIV. 

It is important to note that I resided in a small Sierra Nevada foothills town at the time of my 

diagnosis. Support services were nonexistent for HIV-women, and I did not have the benefit of 

accessing information from any clinic providing services to the HIV/AIDS community nor the 

ability to connect with other women through women’s support groups. I felt very isolated and 

alone for many years, and, because I was a self-employed professional with concerns about 

the potential loss of business should my HIV status become known, I kept my HIV status to 

myself and sought medical care 35 miles away where my anonymity was assured. 

During this time, I was deeply affected by a book entitled, The Invisible Epidemic: The Story 

of Women and AIDS, written by Gena Corea. A review by Barbara M. Bibel of Reed Business 

Information, Inc., (publisher), describes the book best: “In this important book, Corea offers 

a chronology of the impact of the epidemic on the female population. In doing so, she brings 

to light an even greater problem—the fact that women have been systematically ignored and 

neglected by the medical establishment in both research and the provision of health services.” 

I learned that the medical community—predominantly composed of men—was generally 

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squeamish about “women’s biology” and that the fields of gynecology and obstetrics 

remained outside of the generally accepted view of “medicine.” I was dismayed as I read the 

story about a courageous group of women clinicians who attempted to alert their colleagues 

to the increasing and extraordinary gynecological symptoms presented by female patients 

during the early days of the epidemic, their concerns dismissed as evidence of “hysteria.” 

While it is encouraging that more women are now involved in the medical field and research 

arena, and programs and services for HIV-positive women have been expanded throughout 

the Nation, what is not encouraging is the rise of infections in women. Today, women account 

for 27 percent of all HIV infections in the United States, a fourfold increase since 1988, yet they 

account for only 17 percent of HIV/AIDS clinical research study subjects. “Over half of all adults 

living with HIV/AIDS in the world are women, a fact of HIV epidemiology inadequately represented in disease and treatment research. The inclusion of women in clinical trials remains 

consistently insufficient for meaningful evaluation of gender-based implications of drug therapy, immune function, and disease pathogenesis.” (From the AIDS Treatment Activist Coalition 

[ATAC] position paper on women.) The chronic underenrollment of women in research contributes to a continued lack of accurate information in these areas: gender-based differences 

in biology; the effect of infection and its treatments on hormones in women (especially menopausal women); treatment dosage, efficacy, tolerability, and toxicity; anemia; cardio-vascular 

events or kidney-associated side effects; coinfections; yeast infections; human papillomavirus; 

cervical cancer; and the many issues facing women who are aging while living with HIV. 

My journey as a subject in clinical research studies began in 2004, when I noticed an advertisement in POZ, a popular HIV/AIDS magazine, placed by a team of researchers in Boston 

called Partners AIDS Research Group (affiliated with Harvard Medical School and the Massachusetts General Hospital). The team, led by Dr. Bruce Walker, was seeking HIV-positive 

individuals called “long-term nonprogressors” (LTNPs) for recruitment into their study. My 

physician was convinced that I was a member of this unique group of HIV-infected individuals who spontaneously controlled HIV, without aid of medications and without symptoms, for 

long periods of time. We immediately contacted the study, and shipped blood samples to Boston via overnight express. It would be a full 4 months before we received a confirmation, and 

by spring the following year, my status as an LTNP was confirmed. 

The most surprising thing I heard, however, was that the team lacked the resources to purchase a round-trip plane ticket for me to travel to Boston and provide a fresh blood sample 

to the study, despite the difficulty in locating candidates. The study team representative suggested that I attempt to find my own sponsor for the ticket and lodging costs. This was my 

first introduction to the lack of funds available for research, an arena I was completely unfamiliar with. Out of naiveté, I actually began making calls to AIDS Service Organizations in 

Sacramento, and eventually connected with a research coordinator at the University of California–Davis, at the Department of Infectious Diseases. 

After listening to me explain the reason for my call, the kind woman on the other end of the 

phone said that while the university did not sponsor individuals in this manner, might I be 

interested in joining one of their studies, which focused on people like me? Within 2 months, 

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I enrolled in two clinical studies: Mucosal immune response, Richard Pollard, M.D., Primary 

Investigator, and cell-mediated immune responses to HIV-1 in gut-associated lymphoid tissue, 

Barbara L. Shacklett, Ph.D., Investigator. I signed my very first consent form to participate in 

a research study on April 7, 2005, and entered the world of scientific research with awe. I was 

pleased to contribute samples of blood, cells, and tissues to advance the researchers’ knowledge, understanding that without study, the virus would continue to ravage people’s lives. 

I was fascinated with the focal points of each study, and the staff was incredibly generous 

with their time and knowledge as they taught me specifics about the science. I began to feel 

less isolated because I was helping to peel back the onion, so to speak, and shed light on this 

insipid virus through my contributions to the studies. 

Eventually, the trip to Boston did happen. Dr. Walker had received funding through a private 

donation that enabled the study to cover the cost of the plane ticket and two nights at a hotel. 

My first meeting with Dr. Walker took place in December 2005, following a tour through the 

research laboratory in Charlestown, MA. It would be my very first look at the equipment, and 

the people who were working hard to discover the mechanisms of control exhibited by LTNPs. 

The trip was a cathartic experience for me, because it propelled me forward into the field of 

treatment and research advocacy on a fulltime basis and inspired me to fully disclose my status 

as an HIV-positive woman to speak out for those women who could not speak for themselves. 

I cannot explain why I was so compelled to dive into the biomedical field when I didn’t have 

any background or training in it. I was tired of having questions that my physicians could 

not answer, and due to a highly inquisitive mind, wanted to know more about the virus that 

was residing inside my body. As the years have passed, I have literally spoken to hundreds of 

women who do not understand what is happening to their bodies because of the infection, 

and they remain intimidated by the medical profession. They rely on their doctors (if they have 

them) for current information on their symptoms or about the medications that can extend 

their lives, but they hesitate because they feel overwhelmed by the sheer volume of information surrounding these issues and have concerns about appearing ignorant. Many women are 

very concerned about being judged by their physicians should they try to speak frankly about 

their sexual practices, and most are frustrated by the lack of products available to them that 

could provide an alternative to the use of condoms to prevent the transmission of HIV. And, 

while several women have expressed the desire to enroll into clinical research studies to contribute in some way, the process of participation can be confusing with all of the scientific 

jargon used in consent forms, or by the lack of accessibility of the site itself. Additional barriers 

to participation in clinical research studies exist: lack of childcare, loss of wages, out-of-pocket 

expenses related to travel, and restrictive reimbursement policies. 

I would like to draw this panel’s attention to an initiative launched in 2003 by the Atlantabased organization, The Well Project, to address these problems. Called The Women’s 

Research Initiative (WRI), this collaborative body is made up of nearly 60 experts across disciplines and sectors representing research institutions, clinics, Government agencies, advocacy 

organizations, and pharmaceutical companies. The core mission of the group is to “promote 

and facilitate expedience and efficiency in research about HIV disease in women by producing a coordinated effort across disciplines and organizations.” (Core mission statement copied 

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from The Well Project Web site.) While attending my first WRI meeting in Salt Lake City, Utah, 

in the fall of 2007, I gained a better understanding of the work being endeavored to shift the 

paradigm toward a more equitable representation of women in studies. (A recent correspondence with The Well Project indicated the release of a white paper on these accomplishments 

is anticipated this summer.) However, I left that workshop asking a question: “How do we 

communicate the value of clinical studies to HIV-positive women?” These, and other important questions, are on the minds of advocates on a daily basis. Our concerns are aptly stated 

by David Gilden, author of an excellent “backgrounder” for the WRI: “From bench science to 

postmarketing trials, lack of research on AIDS in women hobbles our efforts to halt the HIV 

epidemic. Whereas activists once saw such studies as a way to achieve early access to experimental treatments when those were our only hope, now we can see this research as a matter 

of scientific equity.” 

My personal journey continues as a human subject of five separate clinical research studies. 

I am grateful to those professionals who have been generous with their knowledge and their 

time to help me understand more about the science behind the research, HIV, and the industry. 

I appreciate the dedication and determination they apply to make discoveries toward unveiling 

the mysteries of HIV and the challenge it poses to the human immune system. I am aware of 

the constraints due to funding issues faced by many research entities, and am pleased to learn 

about recent increases to the NIH budget from the Congress. And, for each news release about 

the inflow of private funds from the Gates Foundation toward vaccine research and development, or the remarkable donation made earlier this year to Massachusetts General Hospital for 

the creation its new Ragon AIDS Vaccine Institute, I feel as if we are witnessing a golden age 

of research in this 30th year of the epidemic. 

In summary, these are my recommendations to the NIH: 

• Support clinical trial or study sites to provide necessary means to improve participation 

of women. 

• Establish statistically meaningful enrollment targets for studies of particular relevance 

to women. 

• Increase the amount of funding necessary to support research to develop a microbicide. 

• Implement policies that reduce the income and education inequalities on health care and 

that narrow gender disparity. 

• Design studies to overcome historical barriers to enrollment of women using novel strategies that minimize financial burdens with per diems for childcare and travel. 

• Establish novel recruitment and retention strategies similar to those employed by the 

GRACE Study.1 

• Increase studies on the susceptibility influences of HIV in women, i.e. hormonal, cellular 

signaling, cytokines, and the like. 

• Mandate that consent forms be composed at an 8th grade level of comprehension, with 

culturally relevant and appropriate language. 

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• Advocate for the education of clinicians and encourage their “Internet savvy.” 

• Collaborate with the advocacy community on trial/study design and invite their input in Protocol Team Investigator Meetings and participation on Data Safety Monitoring 

Boards (DSMBs). 

• Ask the question: “Do women progress to AIDS faster than men?” 

Loreen Willenberg is the Founder and President of the Zephyr L.T.N.P. Foundation, Inc., a 

community-based organization headquartered in Sacramento, California. The foundation is 

established to assist scientific investigators in their search for HIV controllers, provide assistance to the HIV Controller community who wish to contribute to clinical research studies to 

advance developments toward a therapeutic vaccine for HIV infection, foster community and 

connectivity within the HIV Controller subgroup, and maintain the HIV Controller topic in the 

public view. For more information about this effort, please visit the foundation Web site at 

http://www.zephyrfoundation.org. 

Reference 

1. Hagins, D., Currier, J., Bridge, D. A., Rinehart, A., Falcon, R., Tennenberg, A., & Squires, 

K. (2007, November). Recruitment and retention strategies for GRACE: A unique clinical 

trial in treatment-experienced women with HIV. Poster presented at the United States 

Conference on AIDS, Palm Spring, CA. 

KEN CHISHOLM 

Self 

The Prevalence of Dismissive Tendencies by Physicians in Assessing and Rendering Inaccurate 

Diagnosis Leading to Irreversible Illness in Women Based on Their Age and Sex Demographics 

I have nearly 25 years’ experience in orthopedic medicine, clinical and surgical. I am also the 

husband and caretaker of my wife, who has disseminated Lyme disease and its coinfections, 

babesiosis and ehrlichiosis, for 8 years. 

We spent the first 2 years going from M.D. to M.D. (male and female), searching for a diagnosis or even a viable “differential” to pursue. All but one dismissed her as being a middle-aged 

hyper-hormonal female with “psychosomatic” based health issues! The “best” they could do 

was to recommend a psychologist. 

So our entire lives have been devastated by the following: 

• Incompetent physicians 

• Sex prejudice 

• Lack of “cookbook and recipe” medicine 

• Inability to think beyond what was taught in medical school 

• Lack of initiative to open a book, conceding the notion they don’t know it all 

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I found the entry for Lyme disease in a 10-year-old University of California–San Diego 

discarded spiral-bound “clinical therapeutics” companion book, as being noted in the “differential” for a patient presenting with her array of symptoms. 

Is it asking too much of physicians to listen to subjective complaints, take a good history, and 

ask questions in a manner such that psychiatric patients can be filtered out? This mentality 

is disgusting, ridiculous for our nation, and devastating to all connected with “middle-aged, 

hyper-hormonal” women. 

Finally, given all the above, I put her on a plane from San Diego to Boston, based on that outdated medical therapeutic manual, my observations, and despite repeatedly being told “there 

is no Lyme disease in California!” We’ve been through hell with this disease, based on the simple-minded bias of physicians noted above. 

She recently fell, suffered C-1 and C-2 spinal and anatomic neck of the humerus fractures stemming from Lyme encephalopathy, a condition one of the “brilliant” neurologists who saw her 

during her 2-week stay in the intensive care unit (ICU) for uncontrollable seizures concluded 

was, “not possible for patients who take their anti-seizure meds properly.” 

Only problem with that theory: She was in ICU getting all her medications from them for those 

2 weeks! 

BEVERLY SANTOS 

Self 

Women’s Health Should Include Lyme Disease and Associated Tick Coinfections 

Lyme Disease Rocked My World—And Not in a Good Way! 

I am writing to all the local newspapers today with this new information on Lyme disease and 

tick-borne coinfections. This news is very important to all Lyme disease patients and to anyone 

who suspect they may have the disease. I have lived in Tulare County for more than 30 years. 

I worked with veterinarians for all of those years. We treated hunting dogs and everything in 

between. I was also an avid camper/hiker in the Sierras and all over the State of California. I 

was an involved athlete, participating in activities such as snow skiing, water skiing, and softball. I have spent at least the past 20 years going from one doctor to another in the area trying 

to figure out what was wrong with me. I have been told everything from it being all in my head 

and just learn to live with the pain, to arthritis, to multiple sclerosis, to fibromyalgia, and several 

other things in between. Because I have some medical background, I had a hard time believing these. I ended up being labeled with fibromyalgia, which I don’t believe is a disease. It is 

a group of symptoms that doctors cannot explain so they labeled it. That way, doctors don’t 

have to think about it anymore. While a lot of people may believe this diagnosis, I do NOT and 

have continually kept vigilant on finding an answer. I was about to give up after visiting a highly 

respected clinic in Santa Barbara that gave me the same diagnosis. I came home depressed and 

resigned to being dismissed and figured I’d just die without knowing, until I happened to watch 

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a TV program called “Mystery Diagnosis” on TNT. I had all the symptoms and thought, “What 

the heck?” I have nothing to lose by going to one last doctor. The doctor was in New York City. 

I made an appointment and went with nervousness and trepidation. I told him my life history 

(an hour and a half appointment) and he discussed how we should proceed. This disease is 

VERY hard to diagnose. The laboratory testing that is used by most doctors is NOT effective. 

Therefore, diagnosis must be made by patient clinical symptoms and patient history along with 

laboratory tests. There are very few labs that check the proper tests and Igenex lab is one. To 

make a long story short, my western blot was positive. So I finally had a diagnosis. 

Now I have a diagnosis! Yippee! Well, that’s what I thought until I started finding out that 

there are very few doctors who actually treat this horrible disease. Not only that, but there is a 

terrible political battle going on between infectious disease doctors and the Lyme-literate doctors. The Centers for Disease Control and Prevention (CDC) is also involved and sides with the 

infectious disease society, whose insurance standards guidelines go by. This makes our treatment protocol mostly out-of-pocket costs even when we have “good” insurance. The insurance 

companies deny doctor visits and services and a lot of drugs that are vital to our improvement. Sufferers know that we will never be totally cured of the disease, but we can get better 

(remission), hopefully, enough to have decent quality of life. 

I am attempting to educate the people of California and Tulare County, specifically. There are 

numerous people in the area who have been successfully diagnosed and yet the doctors in 

the area continue to tell people that California doesn’t have a problem with these diseases. 

For more information, you can check out several Web sites with very good information, keeping in mind that government agencies will suggest that the occurrence is low, but that is 

wrong. The CDC admits only 10 percent of cases are reported. See the following Web sites for 

more information: 

http://www.lymedisease.org, http://www.ilads.org, http://www.lymenet.org 

LYNN SHEPLER, M.D., J.D. 

Self 

Recommendations for Research for the Next Decade 

I am writing pursuant to your call for recommendations for research for the next decade. I 

have three concerns: 1) chronic fatigue syndrome; 2) Lyme disease; and 3) the lack of advancement of women physicians in academic departments. I am a Yale-trained psychiatrist, and 

formerly practiced on Cape Cod in private practice until I acquired Lyme disease in 1996. I am 

presently disabled from Lyme disease. 

Chronic Fatigue Syndrome (CFS) Is not a Psychological Disorder 

I am concerned that there are those who seek to make chronic fatigue and immune dysfunction syndrome into a psychological disorder and do not want to pursue other paths looking for 

a physical cause for this illness. I particularly do not like the research that has been coming out 

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of University of Medicine and Dentistry of New Jersey. I have read some of the research on this 

disease, and other research clearly points to immunological changes and underlying viral reactivation. The reason is, why? It is very destructive to have this line of research that speculates 

about a psychological cause. But please note that UMDNJ has a large employment health section that receives large monetary contributions from insurance companies and employers. It 

seems to me that UMDNJ, as an institution, has undeclared conflicts of interest because they 

take insurance money. New Jersey is the capital for many insurance companies, particularly 

disability insurance companies. 

If CFS is “determined” to be caused by psychological factors, then disability insurers are off 

the hook. Most disability policies state that they have no obligation to pay longer than 2 years 

for disease states that are caused by psychological factors. Thus, many of these patients with 

CFS—who have a disease truly caused by physical factors, but the etiology has yet not been 

well described—will be denied disability insurance benefits. This is something the NIH needs to 

keep in mind. 

In the past, when women’s diseases have been poorly understood, they have been typically 

attributed to psychological etiologies. 

I recall when menstrual cramps were not understood, that the standard textbook on Ob/Gyn 

written by Ralph Wynn, M.D., stated that menstrual cramps were caused by psychological factors, i.e., that a woman had psychological conflicts about being a woman, that she did not 

want to be a woman, and that she should thus be sent off to a psychiatrist. 

Later it was discovered that, after putting pressure gauges in women’s uteri, menstrual cramps 

were associated with very high uterine pressures. This was around the time that Motrin was 

discovered, as was the physiology of prostaglandins. Women with menstrual cramps were also 

found to have high prostaglandin levels. Therefore, they were administered Motrin and other 

nonsteroidal anti-inflammatory drugs, and lo and behold, menstrual cramps were ameliorated! 

They were eventually found to have a physical etiology. 

It is sad that women had to endure that physicians projected onto them a “psychological” 

basis for these physical problems, but that is sexism in medicine in the 20th century. 

Now we are facing sexism in the 21st century, by physicians and other practitioners trying to 

make CFS into a psychological disorder. I could not disagree more with this line of speculation. 

Lyme Disease Is a Women’s Health Issue 

Unfortunately, virtually all of the researchers or “thought leaders” on Lyme disease are male. 

There have been no studies looking for sex differences in Lyme disease. Yet, I believe they 

exist, particularly in adults. As you know, there are Federal laws requiring that sex differences 

be looked for with respect to new drugs on the market; however, there are no Federal regulations that mandate that researchers look for sex differences in laboratory test kits that are 

submitted to the Food and Drug Administration. This needs to change. 

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Based on what I observed in my medical practice on Cape Cod, I am concerned that adult 

females may not have as vigorous an antibody response to the disease as do males. I am also 

concerned that there are more females than males who are disabled from chronic manifestations of the disease. No one is studying this or is interested in studying this. 

I believe none of the “thought leaders” on Lyme disease are interested in studying this 

because virtually all of them are involved in doing consulting work for pharmaceutical companies, and/or the NIH on Lyme disease vaccines. If they discovered there are sex differences, for 

example, in Lyme disease testing, this would complicate the model they have for rolling out a 

Lyme disease vaccine. 

In conducting an experimental Lyme disease vaccine trial, first one must determine whether 

someone is infected with the organism. This is very difficult to determine at present, given the 

inaccuracies of the testing. But if there were sex differences in the testing, this would complicate the issue further. 

The “thought leaders” are also trying to do away with the category of “chronic Lyme disease” because it does not fit with their business model of the disease. Chronic Lyme disease 

assumes there is such a thing as persistent infection in the face of antibiotic administration. 

This also complicates their business model for the Lyme disease because the “thought leaders” would like to be able to assume that every person who lines up to take an experimental 

Lyme disease vaccine has no infection with the organism, whether infection by asymptomatic, 

subclinical, or clinical in nature. This is because in the previous Lyme disease vaccine trials, 

many people who were already infected with the organism became ill after infection with the 

vaccine antigen; some became extremely ill. 

It was postulated that injection with the experimental antigen caused a latent disease to 

become reactivated. 

I have always watched Lyme disease support groups and noted that they are dominated by 

females. Most of these people are chronically ill with tick-borne illness. Few are males. I believe 

there needs to be an honest study of this population. 

A researcher named Brian Fallon, M.D., an associate professor at Columbia University, has 

noted sex differences in patients with chronic Lyme disease. He is the only researcher to have 

looked at this issue. 

Lack of Advancement for Women Physicians in Receiving Federally 

Funded Extramural Research 

I do not know what the statistics show about the percentage of females receiving federally funded, extramural research dollars, but I do know that not enough female physicians 

are advancing in their careers. This may be for complicated reasons, but it is disappointing to 

observe. The Office of Research on Women’s Health should do what it can to change this. 

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Summary 

1. CFIDS is not a psychological disease, and NIH funding should not be spent on pursuing 

research that is trying to make this the dominant paradigm. 

2. The Office of Research on Women’s Health should take a look at Lyme disease and 

foster examination of whether there are sex differences in the disease, particularly 

laboratory testing for Lyme disease, and for those who are disabled from Chronic 

Lyme disease. 

3. The ORWH should do what it can to increase the number of female physicians who 

receive Federal funds for extramural research. 

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Public Testimony 

The Warren Alpert Medical School of Brown University 

Providence, Rhode Island 

September 21, 2009 

Sabrina McCormick, Ph.D. 

American Academy for the Advancement of Science, Fellow 

Scott L. Tomar, D.M.D., Dr.P.H. 

American Association of Public Health Dentistry 

Virginia T. Ladd, RT 

American Autoimmune Related Diseases Association 

Holly Kennedy, Ph.D., CNM, FACNM, FAAN 

American College of Nurse-Midwives 

Thomas C. Wright, Jr., M.D. 

American Society for Colposcopy & Cervical Pathology 

Rebecca Allen, M.D. 

Association of Reproductive Health Professionals 

Mimi Pomerleau, DNP, WHNP-BC, RNC-OB 

Association of Women’s Health, Obstetric and Neonatal Nurses 

Deborah N. Pearlman, Ph.D. 

Brown University 

Michelle Cortes-Harkins 

Center for Hispanic Policy & Advocacy 

Dixie Mills, M.D. 

Dr. Susan Love Research Foundation/Army of Women 

Patricia Paluzzi, Dr.P.H., CNM 

Healthy Teen Network 

Alessandra Rellini, Ph.D. 

International Society for the Study of Women’s Sexual Health 

Erin Boles, M.S.W. 

Massachusetts Breast Cancer Coalition 

Nancy Muller, M.B.A. 

National Association For Continence 

Liza Fuentes 

National Latina Institute for Reproductive Health 

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Christin Veasley 

National Vulvodynia Association 

Stefanie Russell, D.D.S., Ph.D., M.P.H. 

New York University College of Dentistry 

Marlene McCarthy, H.L.D. 

Rhode Island Breast Cancer Coalition 

Katherine Silberman, J.D. 

Science & Environmental Health Network 

Julia Brody, Ph.D. 

Silent Spring Institute 

Rebecca Gasior Altman, Ph.D. 

Tufts University 

Maricel Maffini, Ph.D. 

Tufts University School of Medicine 

Cynthia Zembo, B.S.N., RN, IBCLC 

United States Breastfeeding Committee 

Christie Lancaster, M.D. 

University of Michigan 

Julia McQuillan, Ph.D. 

University of Nebraska-Lincoln 

William Burlingham, Ph.D. 

University of Wisconsin 

Francois Luks, M.D., Ph.D. 

The Warren Alpert Medical School of Brown University 

Sarah D. Fox, M.D. 

The Warren Alpert Medical School of Brown University 

SABRINA MCCORMICK, PH.D. 

American Academy for the Advancement of Science, Fellow 

Environmental Risks to Women’s Health 

Today in the United States, a woman is diagnosed with breast cancer every 3 minutes. Another 

woman will die every 11 minutes.1

 The epidemic has been rising for the past 60 years.2 Not 

slowly, but rapidly, breast cancer has taken an increasing number of women’s lives—not only 

the old and frail, but also the young and healthy, mothers with small children, and leaders in 

every field. In 1940, around 1 in 24 women who lived to be 80 was afflicted. In 1964, 1 in 20 

women who lived to be 80 would get the disease.1

 By 2006, that number reached 1 in 8. Breast 

cancer is the most common killer of middle-aged women in the United States, Canada, and 

northern Europe. There were an estimated 184,450 cases of invasive breast cancer diagnosed 

in 2008 alone. 

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As a society, we face a mandate to heal the many women and men who get sick each year. 

Yet, breast cancer is only one of many illnesses that women face that is linked to a rising tide 

of environmental exposures. Chemicals are ubiquitous in our environment. Eighty thousand 

chemicals are currently in use today. Approximately 2 percent of them have been tested for 

safety.3

 Our massive exposure to chemicals causes cancers, brain disorders, nervous system 

malfunction, autism, skin rashes, respiratory problems—an endless number of illnesses. Recent 

research has shown that these exposures are particularly potent when encountered in utero, 

infancy, early childhood, or adolescence. Toxins add up in individuals and in entire populations. 

However, as Rose4 claims, “current policy assumes that this is not the case.” In other words, 

most research and policy treats the individual as an isolated case. This trend is now shifting 

toward an even more minute level, to genetics, drawing farther away from the environmental 

factors that flip genetic switches. A vastly disproportionate amount of funding is funneled into 

these topics, while work directed at public health and environmental exposures has been marginalized. The vast majority of the research stimulated by Nixon’s 1972 call to battle a “war” 

against cancer has used a biomedical approach. It puts most stock in individual-level risk factors for breast cancer like genetics and lifestyle. What this approach misses, however, is the 

fact that genes do not function in isolation of their environment. Genetic mutations that are 

the cause of illness are generally triggered by something in the environment, either in utero 

or during a person’s lifetime. Without knowing what triggers a genetic change, knowledge of 

genes may be useless. 

Environmental studies are harder to conduct, are harder to draw conclusions from, and therefore win fewer prizes and gain less of the elusive grant money on which scientists depend. 

But scientists are attempting to move in new directions, constructing new tools, testing new 

hypotheses, and discovering new toxics. Their research has received harsh criticism, and their 

professional credibility has been challenged. They need the support of the Federal Government to conduct this risky work. Now is the time to support increased funding for research 

that investigates the environmental links to breast cancer and to answering questions about 

what exposures in our environment are causing illnesses in women’s bodies. Only with this 

research can a stronger case be made about the importance of regulation. 

References 

1. Evans, N. (2006). The state of the evidence: What is the connection between breast 

cancer and the environment? San Francisco: The Breast Cancer Fund. 

2. DeBruin, L. S., & Josephy, P. D. (2002). Perspectives on the chemical etiology of breast 

cancer. Environmental Health Perspectives, 110, 119–128. 

3. Kroll-Smith, S., Brown, P., & Gunter, V. (2000). Illness and the environment: A reader in 

contested medicine. New York: New York University Press. 

4. Rose, G. (1992). The strategy of preventive medicine. Oxford: Oxford University Press. 

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SCOTT L. TOMAR, D.M.D., DR.P.H. 

American Association of Public Health Dentistry 

The Importance of Oral Health to Women’s Health 

The mission of the American Association of Public Health Dentistry (AAPHD) is to improve the 

oral health of the public through education and leadership based on the principles of dental 

public health. The major goals are as follows: 

• To promote and support new and existing educational and other programs and policies that are effective in oral disease prevention, health promotion, and the provision 

of services 

• To promote and support education about the importance of oral health and its relation to 

overall health and well-being 

• To develop and maintain competency in the practice of dental public health and to provide continuing dental education opportunities for association members, residents, and 

graduate students in dental public health 

• To promote and support the expansion of the knowledge base for the practice of dental 

public health, to encourage studies relevant to dental public health, and to support the 

American Board of Dental Public Health 

• The Association’s standing Committee on Science and Education serves with the 

following roles: 

− To lead the reviews of policies and papers requested by professional organizations 

and government agencies 

− To seek out opportunities for the AAPHD to comment on policies and papers developed by other organizations and government agencies 

− To assess current evidence and suggest topics for future policies and position papers 

that AAPHD should consider developing 

The Association is also the sponsoring organization for the Journal of Public Health Dentistry. 

The above information is provided to help place in context the seriousness of AAPHD’s role in 

the oral health status and determining factors for populations toward achieving optimal oral 

health for all in the United States. 

Women and Oral Health 

A number of reports and studies have shown that women have special oral health needs and 

considerations. Hormonal fluctuations have a surprisingly strong influence on the oral cavity. 

Puberty, menses, pregnancy, menopause, and use of contraceptive medications all influence 

women’s oral health and the way in which a dentist should approach treatment. 

While women tend to take better care of their oral health than men do, women’s oral health is 

not markedly better than men’s. This is because hormonal fluctuations throughout a woman’s 

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life can affect many tissues, including gum tissue. During puberty, fluctuations in hormones can 

make gums more susceptible to gingivitis. As a result, the gums may appear red and swollen, 

and they can bleed. During menstruation, women who have a tendency to develop canker sores 

and cold sores may develop a pattern in which these sores recur during every menstrual cycle. 

A study published in the January 1999 issue of the Journal of Periodontology reports that at 

least 23 percent of women ages 30 to 54 have periodontitis (an advanced state of periodontal 

disease in which there is active destruction of the periodontal supporting tissues). In addition, 

44 percent of women ages 55 to 90 who still have their teeth have periodontitis. 

Because periodontal disease is often a “silent” disease, many women do not realize they have 

it until it reaches an advanced state. During pregnancy, gingivitis may develop. In fact, gingivitis is the most common oral condition associated with being pregnant. Also during pregnancy, 

the chemical composition of saliva changes, thus reducing saliva’s antimicrobial capacity. 

Sometimes, however, women will avoid dental checkups for fear that treatment might harm 

the developing baby. In fact, untreated decayed teeth can put a mother and her baby at risk 

for infection. 

Men, Women, Children, and Oral Health 

Oral health is a critical component of overall health1 and AAPHD is working diligently to see 

that it is included in any efforts to reform the healthcare system. 

According to the Centers for Disease Control and Prevention (CDC), dental decay is the 

most common chronic disease in children, and 92 percent of adults age 20 to 64 have 

decay.2 The irony is that dental disease is largely preventable. This problem has been 

ignored for far too long. 

Oral health problems cause pain; impact our ability to eat, sleep, work or get a job, and concentrate in school. Evidence suggests that poor oral health can complicate or is linked to 

diabetes; heart disease; pneumonia; stroke; and preterm, low birthweight babies.3 

Unlike many medical conditions that are self-limiting (i.e., they run their course without the 

necessity of a medical intervention), untreated oral diseases typically become more serious, 

more difficult, and more expensive to treat. The consequences of not treating oral disease 

extend well beyond the more obvious oral health consequences such as the severe pain of a 

toothache (which has been characterized as one of the most excruciating types of pain) and 

inability to chew food, to the more serious general health consequences of severe systemic 

infections, psychosocial problems, impaired nutrition and weight loss, severe disfigurement, 

and even death. 

Because the earliest manifestations of HIV disease often occur in the mouth, dental professionals play a critically important role in the early detection of this disease. Early detection 

means earlier therapeutic intervention is possible, thus extending the productive lifespans of 

affected individuals and improving their quality of life. Early detection also reduces the opportunity for further transmission of HIV. Not covering adult dental benefits will decrease the 

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likelihood of early detection of HIV and increase the likelihood of less productive lifespans and 

decreased quality of life for HIV-infected individuals. 

Oral cancer is more common in older Americans than leukemia; melanoma; Hodgkin’s disease; and cancers of the brain, liver, bone, thyroid, stomach, and ovaries. Oral cancer kills more 

Americans every year than cervical cancer.4 

People with disabilities are at greater risk for oral diseases and are less likely to be treated. 

One of two persons with a significant disability cannot find a professional resource to provide 

appropriate and necessary dental care.5 

Universal coverage must include universal dental coverage for both children and adults. For 

every child without “health” insurance, 2.6 are without dental insurance. For every adult without health insurance, three are without dental insurance. We cannot improve access to care 

without enhancing coverage.6 

The mouth is the only part of the body the care for which a physician is not responsible, 

yet it is only because of an accident of history that medicine and dentistry became unique 

professions. It is irrational to reject coverage of one part of the body because the health 

professionals most qualified to diagnose and treat it are dental professionals. Only dental professionals are qualified to diagnose and treat the pain and infection of conditions arising in the 

mouth. When an individual presenting with pain or a dental infection is seen by a physician in 

a hospital emergency room, typically the treatment provided is prescription of an antibiotic 

and pain medication. Such treatment does not address the underlying condition and serves 

only to delay definitive treatment, thereby making it more difficult and costly to treat. 

Less than one in four (24 percent) Americans ages 65 and older are covered by private dental 

insurance. Most seniors have no dental coverage since Medicare doesn’t offer a dental benefit.7 

Because the Federal Government defines adult dental services in Medicaid as “optional,” most 

States don’t cover adult dental services through Medicaid, and of those few that do cover 

them, many are eliminating these benefits in the face of severe budget shortfalls. In 2007, only 

16 State Medicaid programs offered reasonably comprehensive dental benefits to adults, 16 

offered only emergency dental services, and 6 provided no benefits at all.8

 Since then, more 

States have cut adult benefits. As of July 1, California cut most dental benefits for adults, 

affecting some 3 million Medicaid beneficiaries. 

Veterans have no access to oral health care through the U.S. Department of Veterans Affairs 

system unless they have a service-related oral injury. The fact that many of them started 

smoking while in the service and thus face much higher risk for tooth loss and mouth cancer 

is not considered. 

Millions of dollars are wasted by inappropriate visits to hospital emergency rooms for dental 

pain and infection. These visits do not result in dental treatment, and only contribute to overuse of antibiotics and pain medications. 

257
If an adult has an infection on an arm, leg, neck, or even inside the mouth on the tonsils, their 

medical insurance and the health coverage that would be available to all adults under healthcare reform would cover it. If the same adult has an infection on the gums, an inch away from 

the tonsils, and inches away from the brain, and it requires treatment by a dentist, it wouldn’t 

be covered. A rational health system would not ration care based on parts of the body. 

Clearly much work is needed if we are truly committed to eliminating oral health disparities 

in this country. However, the more than 1,000 members of the American Association of Public 

Health Dentistry believe it can be done and stand ready to make it happen! 

References 

1. U.S. Department of Health and Human Services. (2000). Oral health in America: A 

report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human 

Services, National Institute of Dental and Craniofacial Research, National Institutes 

of Health. 

2. National Institute of Dental and Craniofacial Research. (2010). Dental caries (tooth 

decay) in adults (age 20 to 64) [Report]. Retrieved from http://www.nidcr.nih.gov/DataStatistics/FindDataByTopic/DentalCaries/DentalCariesAdults20to64.htm 

3. National Institute of Dental and Craniofacial Research. (n.d.) The oral-systemic health 

connection. [Spectrum Series]. Available at http://www2.nidcr.nih.gov/spectrum/ 

NIDCR2/2menu.htm 

4. Oral Cancer Foundation. (2010). Oral cancer facts [Fact sheet]. Retrieved from 

http://www.oralcancerfoundation.org/facts/index.htm
�

5. Fenton, S. J. (1993). Universal access: Are we ready? [editorial]. Special Care Dentistry, 

13, 94. 

6. U.S. Department of Health and Human Services. (2000). Oral health in America: A 

report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human 

Services, National Institute of Dental and Craniofacial Research, National Institutes 

of Health. 

7. Manski, R. J., & Brown, E. (2007). Dental use, expenses, private dental coverage, and 

changes, 1996 and 2004 [Agency for Healthcare Research and Quality; MEPS Chartbook 

No.17]. Retrieved from http://www.meps.ahrq.gov/mepsweb/data_files/publications/ 

cb17/cb17.pdf 

8. McGinn-Shapiro, M. (2008). Medicaid coverage of adult dental services [State Health 

Policy Monitor, National Academy for State Health Policy]. Retrieved from http://www. 

nashp.org/files/Adult percent20Dental percent20Monitor.pdf 

258
VIRGINIA T. LADD, RT 

American Autoimmune Related Diseases Association 

Reproductive Health and the Environment 

Introduction 

As a disease category, autoimmune diseases are currently all in the top 10 leading causes of 

death in women from the ages of 15 to 64. While these diseases do affect men also, the ratio 

is highly disproportionate, with autoimmune diseases affecting women 75 percent more often 

than men. 

According to the National Institutes of Health (NIH), 23.5 million Americans suffer from some 

form of autoimmune disease, of which there are more than 80. These include lupus, type 1 diabetes, celiac disease, multiple sclerosis, and Crohn’s disease. Autoimmune diseases can affect 

every system in the body. While all are connected by the common thread of autoimmunity, 

their symptoms can vary widely from disease to disease and often within a single disease as 

well, making them difficult to diagnose and often overlooked until the damage has become 

terminal or has irreversibly affected a patient’s quality of life. 

Today, too little is known about autoimmune diseases and their common pathogenesis of 

autoimmunity. As the NIH and the Office of Research on Women’s Health (ORWH) explore 

areas of greatest concern for women, the American Autoimmune Related Diseases Association 

(AARDA) implores you to include autoimmune diseases as one of your primary platforms for 

future research and exploration. 

While there is a fundamental need for increased research across the board for the general 

pathogenesis of autoimmunity that connects these more than 80 diseases, AARDA particularly 

would like to see increased evaluation and research in the following areas: 

Current research tells us that autoimmune diseases are on the rise in the United States as well 

as around the world. More work needs to be done to investigate the cause of such increases, 

which include genetic predisposition and environmental triggers. Consistently, autoimmune 

diseases continue to be a major health concern for women at a higher incidence than for men, 

and too little is known about why women are affected in such disproportionate numbers. Much 

more work needs to be done to investigate another disparity of why certain autoimmune diseases, especially among women, affect minority populations at higher rates, as well as higher 

levels of severity, than are experienced by other populations. 

More research and investigation are needed to analyze the effects of pregnancy, infertility, and 

lactation as they relate to autoimmune diseases, as well as the relationship of endocrine disorders and autoimmune diseases. 

Autoimmune Diseases on the Rise 

According to several studies conducted in the United States and around the globe, the 

incidence of many autoimmune diseases is rising. A study titled, Incidence of polymyositis-dermatomyositis: A 20-year study of hospital diagnosed cases in Allegheny County, PA 

259
1963–19821

 showed the incidence of polymyositis-dermatomyositis more than tripled during 

this time period, and notably, the most substantial increase took place among African-American women. In another study, Increasing prevalence and incidence of multiple sclerosis in South 

East Wales,

2

 the prevalence of multiple sclerosis was found to have increased 45 percent over 

the past 20 years. Additionally, a study found that the overall incidence of systemic lupus erythematosus (SLE) in Maryland had increased twofold over a comparable study done in New 

York City 15 years ago.3

 In Finland, type 1 diabetes has more than doubled in children in the 

past 30 years;4 and in the United States, a Mayo Clinic study found that celiac disease today is 

more than four times more common as it was in the 1950s.5 

This growing trend should be of great concern because while there is revealing evidence that 

autoimmune diseases are increasing in frequency, still very little is known as to why. Compelling past research has shown that autoimmune diseases may be on the rise due to triggers in 

our environment in those who have a genetic predisposition to the development of autoimmune diseases. 

Genetic Predisposition and External Triggers 

All autoimmune diseases are genetically interrelated, tending to cluster in individuals and families. An individual’s susceptibility to autoimmune diseases is determined by his/her set of 

genes. However, studies on identical twins show only a 30–50 percent concordance in autoimmune disease expression. Therefore, genetic makeup alone does not determine whether 

someone will “get” an autoimmune disease. There are other risk factors, external to the body, 

involved in initiating and exacerbating the disease process. As we have shown through current 

research trends, it is a common belief that autoimmunity is, in fact, on the rise. While one-third 

of the risk of developing an autoimmune disorder lies in one’s genetic makeup, the remaining causes are thought to be noninherited and may contain several environmental factors. For 

example, exposure to certain metals, such as mercury, gold salts, and silver, are thought to 

induce lymphocyte proliferation and subsequent autoimmunity. 

While our current understanding of the role that environmental factors play in the autoimmune attack remains rudimentary, a wide range of triggers have been implicated in 

autoimmune disease expression, including the following: 

• Viral and infectious agents 

• Broad groups of chemicals 

• Heavy metals 

• Iodine 

• Organic compounds (including PCBs and estrogenic compounds) 

• Phthalates 

• Pharmaceuticals 

• Pesticides 

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• Some foods such as cow’s milk 

• Ultraviolet radiation 

More research in this area is required to fully understand this relationship, which affects millions of Americans at an increasingly higher rate each year. It is imperative that we understand 

the full range of environmental triggers and the role they play in the autoimmune process. 

Understanding how environmental factors fit into the autoimmune attack puzzle may provide approaches to preventing these diseases or reducing their severity. This is certainly more 

desirable than trying to control an ongoing autoimmune attack with immunosuppressive 

drugs that expose patients to many well-known serious side effects. 

AARDA, therefore, strongly recommends to the ORWH/NIH that a coordinated research program be initiated to better understand the role of environmental triggers across the family of 

autoimmune diseases. The ultimate goal of this program is the development of approaches to 

prevent autoimmune diseases or decrease their severity, thereby minimizing the very serious 

financial and societal burdens they place on our healthcare system and on afflicted individuals 

and their families. 

Women and Autoimmunity 

Autoimmune diseases affect women disproportionately more often than men, some diseases 

as high as 9:1. Although there has been some research into sex bias differences in autoimmune 

disorders, there is no substantial research into this area. It is commonly thought that hormones 

may play a significant role in the unbalanced nature of the diseases in women in comparison to men. For example, many autoimmune diseases seem to occur more often in women at 

puberty and at menopause and other disorders may significantly improve during pregnancy 

with no outward provocation. Although these findings seem to point to an obvious link, the 

role of hormones in autoimmune disorders has not been conclusively proven. Recent findings 

indicate a need for more research concerning pregnancy influences on the incidence and natural history of autoimmune diseases. 

Hormones, Women, and Autoimmune Diseases 

Women are affected by autoimmune diseases 75 percent more often than men, and while this 

is common knowledge, still very little is known about why. Sex hormones, including estrogen, 

prolactin, and testosterone, have been found to play an important role in triggering these diseases. While researchers have some understanding that hormones like estrogen can enhance 

autoimmunity and have various effects on the immune system, its behavior in response to certain autoimmune diseases is not clear. 

For example, one study found that a small increased risk of mild/moderate flares in women 

with SLE who were taking hormone replacement therapy (HRT). However, there seems to be 

no increased risk of major flare ups in SLE patients taking HRT. In addition, in patients with 

rheumatoid arthritis, HRT is not associated with an increased risk of disease flare and may 

actually improve disease activity. 

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Additionally, another study analyzed the effects of prolactin production in breastfeeding 

women. Persistent mild to moderate elevations in serum prolactin were found to have been 

the cause of a break in self-tolerance in female mice, showing a possibility that women producing prolactin could be at risk of overactive autoimmunity. Additionally, some autoimmune 

diseases have been shown to improve during pregnancy, while others show significant flares 

after pregnancy. For example, women with autoimmune disease and become pregnant can 

experience amelioration of the mother’s disease, such as rheumatoid arthritis, while the pregnancy exacerbates or has no effect on a disease like SLE. 

Clearly, hormones have a role to play in the triggering of an autoimmune reaction that leads 

to an autoimmune disease. Because of the overwhelming disproportionate ratio of women to 

men in autoimmune diseases, in women it is imperative that more work be done in research to 

uncover how these diseases are being triggered and what we can do to inhibit those reactions. 

Endocrine Disruptors and Autoimmune Disease 

Further evidence that hormones may play a major role in the increased incidence of women 

with autoimmune diseases lies in data that suggest endocrine disruptors affect both the 

reproductive system and the immune system, according to a study, Endocrine disruptors (environmental estrogens) enhance autoantibody production by B1 cells.

6

 The results of this study 

indicate that endocrine disruptors are, in fact, involved in autoantibody production by B1 cells 

and may be an etiologic factor in the development of autoimmune diseases. Endocrine disruptors such as BPA enhance autoantibody production by B1 cells, both in vitro and in vivo. 

In addition, another commonly found endocrine disruptor, diethylstilbestrol (DES), has been 

linked to increased levels of arthritis and lupus where there has been prenatal exposure to DES 

leading to immune impairment. In general, research has found that women prenatally exposed 

to DES appear to have a higher incidence of autoimmune diseases when various autoimmune diseases are grouped (S. Ansar Ahmed). Since DES was most commonly prescribed for 

women to treat gonorrheal vaginitis, atrophic vaginitis, menopausal symptoms, and postpartum lactation suppression to prevent breast engorgement, there is ample evidence that it has 

led, in part, to the disproportionate rate at which women develop autoimmune diseases. 

As autoimmune diseases increase in the United States and around the world, this problem 

requires an increased level of research and investigation into known hormonal triggers such as 

BPA and DES. 

Infertility and Autoimmune Diseases 

Autoimmune disease is a major cause of pregnancy loss and infertility among women in the 

United States. Studies have investigated many of the factors surrounding infertility and autoimmune diseases, such as antiphospholipid antibodies, antithyroid antibodies, antinuclear 

antibodies, antisperm antibodies, and antiovarian antibodies. 

Antiphospholipid antibodies and recurrent pregnancy loss is an established connection with 

treatment options available for women. However, much work is still needed to analyze this as 

262
well as other autoimmune factors and their repercussions for infertility, pregnancy loss, and invitro fertilization. 

One study, Antiphospholipid syndrome and recurrent miscarriages,

7

 posits that 7–25 percent of 

recurrent spontaneous abortions (RSA) can be accounted for by antiphospholipid syndrome 

(APS) as the main risk factor. Additional studies have found that APS is not only associated with RSA, but also with infertility. New mechanisms are described in this study by which 

antiphospholipid antibodies (aPLs) could cause placental thrombosis and infarction, acting 

directly on the surface anticoagulant expressed on trophoblastic cells. It was found that testing for additional aPLs remains an important objective to understanding their role in RSA. 

Another study analyzing the role of antiphospholipid antibody-mediated recurrent pregnancy loss has shown that there is an evident association in both humans and murine models. 

The study found that pregnancy loss could result from diverse autoimmune factors, such as 

inflammation. 

When analyzing whether there is a role in autoimmunity in implantation failure after in-vitro 

fertilization, scientists found that antinuclear antibodies may be a marker for underlying autoimmune disease when coupled with certain signs and symptoms. Additionally, the study found 

that antisperm antibodies are associated with fertilization failure when found in high titers in 

seminal plasma, in sperm, or in the mucosal immune system of women. Antisperm antibodies 

are uncommon generally; however, they are most often associated with ovarian hypofunction. 

Clearly, there is a fundamental role played by autoimmunity in the infertility and pregnancy 

loss of women and more work needs to be applied here by ORWH to explore further what 

these and other studies of their kind are beginning to discover. A study titled, Bidirectional 

effects on autoimmunity and reproduction8

 came to the following conclusion, which AARDA 

fully agrees with: “Integration of mechanistic and clinical information by multidisciplinary 

teams is needed to manage reproductive issues in women with autoimmune diseases.” 

Autoimmune Diseases in Minority Populations 

Another area of increasing concern that has been under-studied and under-analyzed is the 

question of why some minority populations are disproportionately affected by certain autoimmune diseases. For example, research has shown that lupus nephritis is found to be more 

common, with increased levels of severity, in African-American women. Additionally, despite 

aggressive immunosuppressive therapies employed in lupus nephritis in this patient population, there is also a higher incidence of progression to end-stage renal disease according to 

the study, Lupus nephritis in African Americans.

9

 Factors such as genetics have been found to 

play a role in explaining why African-Americans appear to be at higher risk for lupus nephritis. 

Research supported by NIH found that African Americans are more likely to have a less efficient Fc receptor gene. This work will greatly increase the ability of scientists to begin 

studying ways to better predict those who have a higher level of susceptibility to lupus nephritis. This is an area where additional research could lead to viable options for treatment and 

early detection. Discovery of a genetic explanation for the disproportionate rate at which 

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African Americans are affected by lupus nephritis is groundbreaking; however, still too little is 

known regarding the effect environmental triggers have on those with a genetic predisposition to autoimmune disease. Further study in this area could also help to discern the increased 

levels of severity of lupus nephritis in African Americans. 

In a recent study, Nursing home residents with multiple sclerosis: Comparisons of AfricanAmerican residents to White residents at admission,10 it was found that African-American 

patients admitted to nursing homes with multiple sclerosis (MS) were found to be significantly 

younger, have a higher degree of cognitive impairment, and be considerably more physically 

disabled than White residents. The study also found that while the differences in the White 

and African-American MS populations were vastly different in severity, there was no notable 

difference in the use of various therapies provided by quality therapists. The outcomes of this 

study require a great deal of additional research that AARDA would encourage the National 

Institutes of Health to support. 

More research and collaboration is needed in the areas of genetics, immunology, epidemiology, and virology to determine the pathophysiology of MS and its possible different effects 

on minority populations. Additionally, further research could uncover the possible need for 

outreach into the African-American community for disparities in MS-related care, thereby 

increasing treatment outcomes for this population. 

While we have described very specific scenarios in which disease outcomes vary by race in 

both lupus nephritis and MS, we believe that this is an area that requires more attention. Both 

the preceding studies are further examples of the need to develop fully new and innovative 

tools such as personalized medicine to treat disease. Further research into locating and chronicling disease biomarkers in patients would help us to better predetermine treatment outcomes 

for various populations and could be the key to closing some of the racial disparities in treatments for autoimmune diseases. 

Autoimmune Disease Biomarkers 

AARDA asks that NIH focus considerable efforts into research on biomarkers for the more than 

80 autoimmune diseases. There is a critical need for the creation of a database of autoimmune 

disease biomarkers. This database would assist in tracking the relation of biomarkers to disease severity. In addition, there is a need to develop a differential diagnostic technique to use 

groups of biomarkers to determine the presence of specific autoimmune diseases. This suggestion is based on the concept that autoimmune diseases can be determined by looking for 

groups of biomarkers as though they were chords played on a piano. There is also a need to 

expand autoimmune disease research to include the relationship between these diseases and 

other serious health conditions. 

Awareness Through Education 

We recommend that the NIH ORWH sponsor a cross-Institute scientific meeting to examine 

the latest in research on the issues discussed in this paper in order to identify additional areas 

of opportunity in autoimmune disease research. 

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About the American Autoimmune Related Diseases Association 

The American Autoimmune Related Diseases Association is dedicated to the eradication of 

autoimmune diseases and the alleviation of suffering and the socioeconomic impact of autoimmunity through fostering and facilitating collaboration in the areas of education, public 

awareness, research, and patient services in an effective, ethical, and efficient manner. 

AARDA is the only national nonprofit health agency dedicated to bringing a national focus to 

autoimmunity, the major cause of serious chronic diseases. Approximately 23.5 million Americans suffer from autoimmune diseases. Women are more likely than men to be affected; some 

estimates say that 75 percent of those affected are women. Still, with these statistics, autoimmunity is rarely discussed as a women’s health issue. 

Autoimmunity is a result of a misdirected immune system that causes one’s own immune system to attack the self. There are more than 80 known autoimmune diseases; and unlike the 

many forms of cancer that are recognized as being part of the general term “cancer,” autoimmune diseases are recognized singularly rather than in the overall category of autoimmunity. 

The public in general is unaware of the autoimmune nature of these diseases. When most people hear one of these diseases referred to as an autoimmune disease, they incorrectly confuse 

the term “autoimmune” with acquired immune deficiency syndrome, or they think it is a form 

of cancer. 

This lack of knowledge and collaborative effort result in untold suffering for persons with autoimmune diseases due to misdiagnosis and delayed diagnosis, which may result in damage to 

vital organs. The need to bring a national focus to autoimmunity as the common factor in all 

autoimmune diseases is vital in order to bring a collaborative effort to research, funding, early 

detection, and eventually, prevention and cure for all autoimmune diseases. 

Some of the more than 80 autoimmune diseases are lupus, type I diabetes, scleroderma, 

celiac, multiple sclerosis, Crohn’s disease, autoimmune hepatitis, rheumatoid arthritis, Graves’ 

disease, myasthenia gravis, myositis, antiphospholipid syndrome, Sjögren’s syndrome, uveitis, 

polymyositis, Raynaud’s phenomenon, and demyelinating neuropathies. 

References 

1. Oddis, C. V., Conte, C. G., Steen, V. D., & Medsger, T. A., Jr. (1990). Incidence of polymyositis-dermatomyositis: A 20-year study of hospital diagnosed cases in Allegheny 

County, PA 1963-1982. Journal of Rheumatology, 17, 1329–1334. 

2. Hirst, C., Ingram, G., Pickersqill, T., Swingler, R., Compston, D. A., & Robertson, N. P. 

(2009). Increasing prevalence and incidence of multiple sclerosis in South East Wales. 

Journal of Neurology, Neurosurgery, and Psychiatry, 80, 386–391. 

3. Hochberg, M. C., (1985). The incidence of systemic lupus erythematosus in Baltimore, 

Maryland, 1970–1977. Arthritis and Rheumatism, 28, 80–86. 

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4. Harjutsalo, V., Sjöberg, L., & Tuomilehto, J. (2008). Time trends in the incidence of type 1 

diabetes in Finnish children: a cohort study. Lancet, 371, 1777–1782. 

5. Rubio-Tapia, A., Kyle, R. A., Kaplan, E. L., Johnson, D. R., Page, W., Erdtmann, F., . . . 

Murray, J. A. (2009). Increased prevalence and mortality in undiagnosed celiac disease. 

Gastroenterology, 137, 88–93. 

6. Yurino, H., Ishikawa, S., Sato, T., Akadegawa, K., Ito, T., Ueha, S., . . . Matsushima, K. 

(2004). Endocrine disruptors (environmental estrogens) enhance autoantibody production by B1 cells. Toxicological Sciences, 81, 139–147. 

7. Vinatier, D., Dufour, P., Cosson, M., & Houpeau, J. L. (2001). Antiphospholipid syndrome 

and recurrent miscarriages. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 96, 37–50. 

8. Cervera, R., & Balasch, J. (2008). Bidirectional effects on autoimmunity and reproduction. Human Reproduction Update, 14, 359–366. 

9. Lea, J. P., (2002). Lupus nephritis in African Americans. American Journal of the Medical 

Sciences, 323 (2), 85–89. 

10. Buchanan, R. J., Martin, R. A., Zuniga, M., Wang, S., & Kim, M. (2004). Nursing home 

residents with multiple sclerosis: Comparisons of African American residents to white 

residents at admission. Multiple Sclerosis, 10, 660–667. 

HOLLY KENNEDY, PH.D., CNM, FACNM, FAAN 

American College of Nurse–Midwives 

Supporting Women Across the Lifespan Through Research 

The American College of Nurse–Midwives (ACNM) is pleased to provide testimony at this conference sponsored by the Office of Research on Women’s Health (ORWH). ORWH lists many 

areas for future research consideration. We will specifically respond to the renewed emphasis on normal processes and therapeutic strategies of healthcare delivery. We will discuss how 

these may affect health during pregnancy, childbirth, and throughout a woman’s lifespan. This 

testimony was written by representative leaders of the ACNM and reviewed by their Division 

of Research. 

The mission of the ACNM is to promote the health and well-being of women and newborns 

within their families and communities through the development and support of the profession of 

midwifery as practiced by certified nurse–midwives and certified midwives. We affirm the power 

and strength of women and the importance of their health in the well-being of families, communities, and nations. Our philosophy supports the normalcy of women’s lifecycle events, including 

watchful waiting and nonintervention in normal processes, and appropriate use of interventions 

and technology for current or potential health problems. However, the ability to support normal, 

physiologic processes in childbirth is becoming increasing difficult in our healthcare arena and 

deserves discussion before we suggest recommendations for future research. 

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Background 

Current United States obstetrical practice follows the “1 percent” doctrine, focusing on the 

use of maximal resources to prevent extremely rare but disastrous outcomes.1,2 Rosenblatt3 

describes this as the “perinatal paradox,” where attention is focused on deviation from the 

physiologic norm rather than on elements relevant to everyday maternal and infant outcomes. 

This paradox has resulted in progressively more technology-focused birth care, but with mixed 

returns on investments. The mid-course review of the U.S. Healthy People 2010 goals shows 

we are actually moving away from projected targets in the rate of cesarean sections, both primary and repeat, in low-risk women; maternal complications during labor and delivery; low 

birthweight and very low birthweight infants; and preterm births.4 High disparate racial and 

ethnic birth outcomes continue, and maternal mortality is rising.5 

There is strong evidence to suggest that we widely overuse interventions with minimal beneficial effect and underuse those that are helpful.6

 Beneficial care practices supported by 

evidence include 1) unrestricted access to birth companions of the mother’s choice, with 

emphasis on continuous emotional and physical support from a skilled woman and access 

to midwifery-led care; 2) freedom to walk, move about, and assume positions of choice during labor and birth and discouragement of the lithotomy position; and 3) nonpharmacologic 

methods of pain relief such as massage, hypnosis, and hydrotherapy.7,8 Yet women are not routinely provided with these services and report experiences that reflect a growing trend of 

childbirth intervention.9

 The rate of labor induction has doubled since 1990 and the cesarean 

birth rate is at an all-time high of 31.8 percent.10 

Although interventions are necessary for some labors and births, there is evidence to support that models of care in which these are minimized achieve superior outcomes to those 

commonly found in U.S. birth settings. A recent Cochrane systematic review of midwiferyled care across 11 randomized controlled trials (RCT) with 12,276 women suggests that the 

“type” of provider is associated with positive childbearing outcomes and decreased interventions. Women cared for in midwifery-led units were more likely to have a spontaneous vaginal 

birth, know their midwife, feel in control during labor, and initiate breastfeeding.8

 They were 

less likely to have regional analgesia, an episiotomy, or loss of an infant before 24 weeks. 

A randomized clinical trial of group prenatal care demonstrated a significant risk reduction 

in preterm birth, especially in the African-American population.11 Washington DC’s Family 

Health and Birth Center (FHBC) serves medically underserved, at-risk women in the heart of 

the District. An audit of their first 6 years showed substantial lowering of preterm birth, low 

birthweight, and cesarean birth rates, compared to those of the District at large (Ruth Lubic, 

personal communication, 2009). Comparative birth outcomes for African-American women 

were as follows: preterm birth (District: 15.5/ FHBC: 5 percent); low birthweight at term (District: 14.5/ FHBC: 3 percent); and cesarean birth rates (District: 31.5/ FHBC: 10 percent). Not 

only does this demonstrate substantial progress in decreasing disparate racial outcomes, 

it also represents a total cost savings of $1,635,248.12,13 These models maximize perinatal 

outcomes through a focus on relationships between the clinician and the woman, and by 

supporting the normal, physiologic processes of childbirth. 

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Pregnancy, labor, and birth are just the beginning steps of becoming a mother and are placed 

within the spectrum of her life as a woman. Research indicates that the healthiest pregnancies occur when the pregnancy is desired and there is an appropriate interval since the last 

pregnancy. Thus, access to contraception and preconception planning are important contributors to healthy pregnancy outcomes. Maternal childbirth experiences can influence women’s 

long-term emotional well-being and their ability to care for their infant. Our current childbirth practices are not associated with better psychological outcomes. Posttraumatic stress 

disorder (PTSD) is documented in almost 6 percent of women who indicate their birth experiences left deep, emotional scars.14 United States surveillance data from 2000 of more than 

400,000 women revealed that 50 percent reported low to moderate depression and 7.1 percent reported severe depression in the first months after giving birth.15 This postpartum mental 

health morbidity also disparately affects minority women and those experiencing high levels 

of psychosocial stress during pregnancy.16 It can illustrate how women’s responses to interventions may link with their subsequent mental health. 

A recent study by Declercq and colleagues9

 of 1,573 women found those who had cesareans 

were significantly more likely to have felt overwhelmed, weak, agitated, afraid, groggy, helpless, and less powerful during the birth process than those who did not. Less than half of the 

women recalled feeling confident or capable. Cesarean incision pain was cited as a major 

problem for 33 percent of the women at 2 months and 18 percent at 6 months postpartum. 

Another troubling finding was that many women were unaware, or had an incomplete understanding, of potential complications from childbirth interventions, including those that often 

are not medically indicated. Simkin17,18 found that women’s written accounts shortly after birth 

were strongly correlated with their memories 20 years later. Women with the highest levels of 

satisfaction felt more in control and believed that the experience contributed to their self-confidence and self-esteem. Satisfaction during childbirth has been associated with 1) personal 

expectations, 2) amount of support from caregivers, 3) quality of the caregiver-patient relationship, and 4) involvement in decisionmaking.19 This suggests that it is not about what was 

done, but about how the women felt in terms of support and personal control. 

Despite professional organizations’ statements espousing evidence-based practice, care strategies supporting nonintervention in straightforward, healthy, physiologic labors and births are 

not widely used. Supporting low-technology, noninterventive birth care in today’s healthcare 

arena is complex. Institutional childbearing care policies reflect far more than just the translation of research into practice. They are influenced by clinicians’ attitudes and values, medical 

and malpractice insurers, administrative initiatives, and economics. A key variable in most birth 

settings is defining safe care and it remains an ongoing debate.20,21 The Agency for Healthcare 

Research and Quality (AHRQ) defines “patient safety indicators” as problems experienced 

by patients resulting from healthcare exposures that are amenable to prevention.22 One perspective rarely raised in maternity care is that unnecessary intervention in physiologic low-risk 

childbirth is potentially harmful, and therefore, can be identified as a safety risk. Thus, to effectively improve childbearing care and outcomes, it is essential to systematically examine the 

multilayered and multidisciplinary systems that comprise birth culture. There must be a commitment to “work with all of the stakeholders to implement comprehensive changes to the 

routine care of women during labor and birth” (p. 1380).23 The challenge is to understand how 

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to provide safe, high-quality childbearing care without following the 1 percent doctrine of high 

technology for all. This includes providing skilled care in all aspects of childbearing, including perinatology for a woman carrying triplets; effective psychological care for a woman with 

PTSD; and skill in supporting normal, physiologic birth processes. 

In response to the steady increase in technological interventions and operative births, particularly among women who choose elective primary cesarean, the National Institutes of Health 

(NIH) has recommended “increased research devoted to strategies to predict and influence 

the likelihood of successful vaginal birth, particularly in the first pregnancy” (p. 1393).24 We 

believe this should be expanded to incorporate a life course perspective, in which short- and 

long-term benefits are considered when planning care for women, babies, and families to 

avoid harmful interventions.6

 This should not only support the “innate physiologic capacities of 

the childbearing process” (p. 29), but also must encompass a broader understanding of how 

to support normal, healthy physiology throughout a woman’s lifespan. 

As a nation, we are at the bottom tier of infant birth outcomes, despite spending more than 

any other country on health care. Models of care associated with best outcomes are not widely 

implemented. The health of our nation begins at birth and is fostered through family health; 

thus, research must be supported to understand how to best implement evidence and models 

of care to achieve our Healthy People 2010 goals, and beyond. 

Recommendations 

Our recommendations support a broad-based approach to examining strategies that foster 

the health of women across the lifespan, their infants, and their families. This includes understanding how to support their normal, physiologic processes and capacities, and implementing 

appropriate, evidence-based interventions when needed. 

The ACNM participated in the Institute of Medicine’s call for Comparative Effectiveness 

Research and supports the following priorities: 

• Compare the effectiveness of interventions (e.g., community-based multilevel interventions, simple health education, and usual care to reduce health disparities in 

cardiovascular disease, diabetes, cancer, musculoskeletal diseases, and birth outcomes 

• Compare the effectiveness of clinical interventions (e.g., prenatal care, nutritional counseling, smoking cessation, substance abuse treatment, and combinations of these 

interventions) to reduce incidences of infant mortality, preterm births, and low birthweight rates, especially among African-American women 

• Compare the effectiveness of birthing care in freestanding birth centers and usual care of 

childbearing women at low and moderate risk 

• Compare the effectiveness of innovative strategies for preventing unintended pregnancies (e.g., providing over-the counter access to oral contraceptives or other hormonal 

methods; expanding access to long-acting methods for young women; providing free 

contraceptive methods at public clinics, pharmacies, or other locations) 

269
The ACNM further recommends that the NIH/ORWH support research that specifically does 

the following: 

1. Examines care strategies that support the normal, physiologic processes of birth and 

their effects on short- and long-term maternal, infant, and family health outcomes 

2. Identifies and conducts research to replicate exemplar U.S. models successful in 

decreasing the racial disparity in birth outcomes
�

3. Examines care strategies that support the normal, physiologic health of women 

throughout the lifespan
�

4. Fosters a national, standard, and systematic collection of data on childbearing care 

and outcomes 

5. Examines women’s decisionmaking processes on selection of providers and interventions during maternity and gynecologic care, with an emphasis on informed choice 

6. Describes and replicates exemplar models in the effective translation of evidence 

into practice 

7. Identifies legislative, political, and legal policies that promote or hinder the practice of 

midwifery to enhance access of care for all women in the United States 

References 

1. Declercq, E. & Norsigian, J. (2007, August 6). The folly of 1 percent policy. The Boston 

Globe, pp. 11. 

2. Suskind, D. (2006). The one percent doctrine. Deep inside America’s pursuit of enemies 

since 9/11. New York: Simon & Schuster. 

3. Rosenblatt, R. A. (1989). The perinatal paradox: Doing more and accomplishing less. 

Health Affairs, 8(3), 158–168. 

4. U.S. Department of Health and Human Services. (2006). Healthy People 2010 midcourse 

review [Report]. Retrieved from http://www.healthypeople.gov/data/midcourse/default. 

htm#pubs 

5. Hoyert, D. L. (2007). Maternal mortality and related concepts. National Center for 

Health Statistics. Vital Health Statistics, 3(3). 

6. Sakala, C. & Corry, M. P. (2008). Evidence-based maternity care: What it is and what it 

can achieve. New York: Milbank Memorial Fund. 

7. Lothian, J. A. (2007). The coalition for improving maternity services: Introduction. Journal of Perinatal Education, 16(1-supplement), 1S–4S. 

8. Hatem, M., Sandall, J., Devane, D., Soltani, H., & Gates, S. (2008). Midwife-led versus 

other models of care for childbearing women. Cochrane Database of Systematic Reviews, 4, Art. No.: CD004667. doi:10.1002/14651858.CD004667.pub2 

270
9. Declercq, E. R., Sakala, C., Corry, M. P., & Applebaum, S. (2006). Listening to mothers II: 

Report of the second national U.S. survey of women’s childbearing experiences [Report]. 

Retrieved from http://www.childbirthconnection.org/ 

article.asp?ClickedLink=751&ck=10396&area=2 

10. Hamilton, B. E., Martin, J. A., & Ventura, S. J. (2009). Births: Preliminary data for 2007. 

National Vital Statistics Reports, 57(12). Hyattsville, MD: National Center for Health 

Statistics. 

11. Ickovics, J. R., Kershaw, T. S., Westdahl, C., Magriples, U., Massey, Z., Reynolds, H., & 

Rising, SS. (2007). Group prenatal care and perinatal outcomes: A randomized controlled trial. Obstetrics & Gynecology, 110(2 Pt 1), 330–339. 

12. Institute of Medicine. (2006). Preterm birth: Causes, consequences, and prevention. 

Washington, DC: Author. 

13. Environmental Protection Agency. (2009). Cost of illness handbook [Handbook]. 

Retrieved from http://www.epa.gov/oppt/coi/pubs/toc.html 

14. Beck, C. T. (2009). Birth trauma and its sequelae. Journal of Trauma Dissociation, 10(2), 

189–203. 

15. Centers for Disease Control and Prevention. (2009). Pregnancy risk assessment monitoring system (PRAMS): PRAMS and postpartum depression [Report]. Retrieved from 

http://www.cdc.gov/PRAMS/PPD.htm#Tablepercent202 

16. Gross, K. H., Wells, C. S., Radigan-Garcia, A., & Dietz, P. M. (2002). Correlates of self-reports of being very depressed in the months after delivery: Results from the pregnancy 

risk assessment monitoring system. Maternal Child Health Journal, 6(4), 247–253. 

17. Simkin, P. (1992). Just another day in a woman’s life? Part II. Nature and consistency of 

women’s long-term memories of their first birth experiences. Birth, 19(2), 64–81. 

18. Simkin, P. (1991). Just another day in a woman’s life? Women’s long-term perceptions of 

their first birth experience. Part 1. Birth, 18(4), 203–210. 

19. Hodnett, E. (2002). Pain and women’s satisfaction with the experience of childbirth: A 

systematic review. American Journal of Obstetrics & Gynecology, 186, 160–172. 

20.Grobman, W. A., Feinglass, J., & Murthy, S. (2006). Are the agency for healthcare 

research and quality obstetric trauma indicators valid measures of hospital safety? 

American Journal of Obstetrics & Gynecology, 195, 868–874. 

21. Sexton, J. B., & Thomas, E. J. (2003). Safety attitudes questionnaire (SAQ) guidelines 

for administration (Technical Report No. 03-03; AHRQ grant # 1PO1HS1154401 and 

Ui8HS1116401). Houston: The University of Texas Center of Excellence for Patient Safety 

Research and Practice. 

22.Agency for Healthcare Research and Quality. (2007). AHRQ guide to patient safety 

indicators [Version 3.1, March 12, 2007]. Retrieved from http://www.qualityindicators. 

ahrq.gov 

271
23.Hodnett, E. D., Hofmeyr, G. J., & Sakala, C. (2007). Continuous support for women 

during childbirth. Cochrane Database of Systematic Reviews, 3, Art. No.: CD003766. 

doi:10.1002/14651858. CD003766.pub2 

24.National Institutes of Health. (2006). NIH state-of-the-science conference statement on 

cesarean delivery on maternal request. NIH Consensus State-of-the-Science Statements, 

23(1), 1–29. 

THOMAS C. WRIGHT, JR., M.D. 

American Society for Colposcopy & Cervical Pathology 

ASCCP Testimonial on Management of Cervical Abnormalities in Adolescents 

A 11⁄2-day symposium with delegates from 22 organizations was held in Bethesda, MD, at the 

National Institutes of Health (NIH), under the sponsorship of the American Society for Colposcopy and Cervical Pathology (ASCCP) and in partnership with the American Cancer Society 

(ACS). The primary goal of the symposium was to identify strategies to increase the adoption 

of evidence-based consensus guidelines for cervical cancer screening and the management 

of abnormal cervical cytology and histology in adolescents and to identify key research areas. 

Both anecdotal reports and surveys of clinicians have verified an inadequate uptake of the 

2002 ACS1

 and 2003 American College of Obstetricians and Gynecologists (ACOG) guidelines2 

on when to begin screening, and the 2006 ASCCP management guidelines pertaining to adolescents.3-5The guidelines specifically identified adolescents as a special population warranting 

different interventions based on published evidence that the natural history of abnormal cytology is different in adolescents than in adults. Adolescents were defined as women and girls 

under the age of 21. 

Guidelines 

The current guideline key messages are 1) human papillomavirus (HPV) testing is not recommended under any circumstances in screening or management of adolescents; 2) atypical 

squamous cells–undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LSIL) should be managed similarly by repeat cytology only at 12-month intervals 

instead of immediate referral for colposcopy or HPV DNA testing; 3) cervical intraepithelial 

neoplasia (CIN) 1, CIN 2, and CIN 2/3 can be followed with observation rather than invasive 

therapies, whereas CIN 3 should be treated. 

Evidence for Guidelines 

HPV infections and LSIL are both extremely common in adolescent populations and commonly 

appear shortly after the onset of sexual activity.6 There is now good evidence that in adolescents, more than 90 percent of HPV infections, LSIL cytology, and CIN 1 lesions will regress 

within 3 years.7 This epidemiologic evidence strongly supports observation rather than intervention for adolescents with LSIL and CIN 1. In addition, papers showing that more than 70 

percent of adolescents with ASC-US are HPV-positive8 support the lack of evidence for using 

HPV testing that is not type-specific in any circumstance in adolescent populations. Evidence 

exists for the high rate of CIN 2 regression among adolescent populations9 (A. B. Moscicki, 

272
personal communication, 2009), with 60 percent showing regression within 3 years. Progression to cancer, even among those with CIN 3 appears to be negligible, as there are no published 

natural history studies in adolescents showing progression from CIN 2/3 to cancer. Published 

data show that adolescents have the highest rates of high-risk (HR) HPV-positive ASC-US and 

LSIL on cytology and the lowest rate of cervical cancer. SEER statistics show that between 1998 

and 2006, an average of 14 cervical cancers occurred annually in girls aged 15–19 years, an incidence rate of 0.1 per 100,000.10 This incidence rate is unchanged from that reported in the 

1973–1977 period, which preceded the change in age to start screening to 18 or at first intercourse, whichever occurred first.11 Because of this change in age to begin screening, adolescent 

populations went from no screening to considerable screening. There are also no data available 

to show that screening women less than 21 years of age impacts future rates of CIN 2/3. 

A recent study in England showed that screening women aged 20–24 years old had no detectable impact on reducing cervical cancer rates in women under the age of 30 years.12 This is 

consistent with previous studies demonstrating no change in cervical cancer rates in women 

under this age in numerous countries in the decades following introduction of cervical screening, compared to the dramatic reduction noted for all other age groups.13 

Additionally, although incidence rates for cervical cancer peak at different ages for White, 

Black, and Hispanic women, all ages and races showed significant decreases in incidence 

between 1995–1999 and 2000–2004 for any of the race/ethnicity categories except for two 

subcategories: all-races women aged 15–24 and non-Hispanic/other women aged 25–34.14 This 

underscores the fact that cervical cancer in adolescents and young women is not thought to 

be prevented by cytology screening. The reasons that screening appears ineffective in these 

age groups are not clear, but one possible explanation is that cervical precancer arising in 

adolescents transits to invasion so quickly and with such aggressive lesions that screening 

does not make a difference. As a result of these issues, and harm that can occur secondary 

to screening and aggressive management of CIN in adolescents and young women, a special 

advisory committee in England recently recommended that the first invitation to screening not 

be before age 24.5, with the target for screening to begin at age 25.12 

Strong evidence showed that conization can be quite harmful secondary to risk of premature 

delivery and low birthweight babies.15-18 The majority of studies on pregnancy outcomes following loop electrosurgical excision procedure (LEEP) have demonstrated a two- to three fold 

increase in adverse pregnancy outcomes.15-18 

Adverse psychological sequelae as a result of cervical cancer screening, evaluation of abnormal cytology results, and treatment of CIN have been consistently reported,19,20 including 

negative effects on sexual functioning.21 Data from the ALTS trial show that a large number 

of women who receive LEEP do so unnecessarily since the lesions were either so small that 

they were biopsied off at the time of colposcopy or had regressed by the time women were 

scheduled for treatment.22,23More recent data indicate the likelihood that more than 50 percent of CIN 2/3 treated in women ages 20–24 would have spontaneously regressed by age 25 

without treatment.12 

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Guidelines and Special Populations 

Strong evidence now shows that HPV-induced cancers (including cervical, vulvar, vaginal, 

and anal) are more common in immunosuppressed individuals than in the general population.24 Unfortunately, recurrence after treatment, despite highly active antiretroviral therapy, 

is extremely common, with few options for treatment except for repeat LEEP, resulting in 

increased risks for adverse events. 

Other HPV Diseases and Guidelines 

Genital warts are very common in adolescent and young women and men. Although it may 

be presumed that when treatment is successful, more rapid resolution of HPV lesions may 

shorten the period of transmissibility, treatment is nevertheless primarily aesthetic and based 

on psychological needs. Several options for treatment exist, including self-applied and provider-applied. Cognitive ability to understand treatment options along with personal choice 

should be explored when discussing treatment of genital warts with adolescents. It is important to note that the presence of genital warts does not change the natural history of CIN 

lesions. Hence, recommendations on when to begin screening and on screening interval do 

not change, nor should management of abnormal cytology results be altered in adolescents 

with genital warts.3

 Vulvar intraepithelial neoplasia (VIN) in adolescents is not uncommon, but 

vulvar cancer is virtually nonexistent. Although there are limited data on VIN in adolescents, 

anecdotal reports and one study support conservative followup or therapy for VIN, with topical wart therapies being commonly used, including trichoroacetic acid and imiquimod. 

Challenges to Implementing Guidelines 

The challenges to implementing the guidelines are huge. In a provider survey conducted by 

the CDC, 50 percent of providers were screening 18-year-old virgins and 80 percent were 

screening 18-year-olds who had initiated sex within the past month. When women were asked 

about cervical cancer screening, 60 percent of women who had initiated sex fewer than 3 

years ago reported that they had had cervical cancer screening.25,26 These data clearly show 

that guidelines for initiating screening are not well adhered to. Obstacles to adherence to 

guidelines include stakeholders such as industry, government, and healthcare systems. Healthcare provider obstacles include lack of awareness of guidelines, rejection of the evidence, 

impact of personal experiences, loss of pretext for health screening, concern that clinicalpatient relations may be altered with extended interval screening, time constraints, guidelines 

don’t apply to the provider’s population, underestimation of harm secondary to screening too 

early, low esteem for guidelines, medical-legal ramifications if the cancer is missed, marketing, 

and economic benefits/threats. Important influences might include validation of success, positive peer pressure/educators, and financial. Negative reinforcements may include poor report 

cards, peer pressure, financial penalties, and sanctions. The barriers to adoption are multiple, 

but economics, tradition, and fear of change are dominant. Solutions require multiple-level 

interventions, including education, incentives, and penalties, as well as consumer education. 

HPV Vaccination and Guidelines 

The clinical trials data clearly demonstrate the high effectiveness of the vaccine in HPV-naïve 

women. However, the data clearly demonstrate that there is no prophylactic, therapeutic 

274
benefit for women already infected with HPV vaccine types.27 Women who were either HPVpositive by DNA testing or serology for the vaccine-targeted HPV types at baseline did not 

benefit from the vaccine. Consequently, guidelines to immunize should focus on pre-sexually 

active children and adolescents, thereby optimizing the impact of the vaccine from a public 

health perspective.22,28 Unfortunately, the current Centers for Disease Control and Prevention 

(CDC) data show less than 35 percent of the target group has been vaccinated to date, and 

less than 25 percent have received the full schedule of three vaccinations.29 By removing the 

most evident and threatening cytologic, colposcopic, and HPV testing results from cervical 

cancer prevention programs, vaccination will leave behind more equivocal and less predictive 

abnormalities and it will become increasingly expensive to find important lesions.30 Hence, it 

will not be cost-effective to add HPV vaccination without eventually adjusting the rest of the 

cervical cancer prevention program. However, because current vaccine coverage is suboptimal, 

screening guidelines are unlikely to change in the foreseeable future since changes in screening would need to be directed toward the fully vaccinated, requiring different guidelines for 

different groups, an untenable situation.31 

Additionally, documentation of vaccination will be difficult, and often impossible, given the 

lack of national vaccine registries. As an increasing proportion of the population becomes vaccinated, the incidence and prevalence of CIN 2/3 and adenocarcinoma in situ will decrease, 

resulting in an increase in the negative predictive value of present screening strategies, but a 

decrease in the positive predictive value.30,32 These changes are independent of any changes 

occurring with the screening test itself and are purely due to the underlying prevalence of CIN 

2+. As a result, if the screening intervals are not lengthened, or a more specific test is not used, 

the number of false positive results will increase and the number of false negative results will 

decrease.33 Evidence-based modeling studies suggest that high vaccination rates would therefore promote starting screening later, screening less often, and moving toward screening with 

virologic tests that are more specific for risk.33,34 

Conclusions 

In summary, data do not support cervical screening of girls and young women under 21 years 

of age. Rates of cancer in this age group have not changed with the changes in screening 

age that have occurred over time. The current management guidelines for adolescents with 

abnormal cervical cytology were made to increase observation by repeat cytology rather than 

colposcopy and treatment of screen-detected CIN; therefore, the reason for screening anyone in this age group comes into question. Adolescent guidelines have been confusing and 

uptake slow because these guidelines are so diametrically different than recommendations for 

the management of abnormal cervical cytology in adult women. Consequently, the workshop 

members voted on these key messages: 

1. Adolescent cervical cancer prevention programs should focus on prevention of HPV 

infection through universal HPV vaccination. 

2. Screening should start at age 21 years. Screening of adolescents (age 20 and under) is 

potentially harmful because it can lead to unnecessary evaluation and treatment. 

275
3. It is very important for adolescents to have access to family planning and to prevention 

of acquisition and harmful sequelae of sexually transmitted infections other than HPV. 

The following were key research areas: 

Cytology Guidelines 

• Randomized trials for ASC, LSIL, and CIN 2 management are needed. 

• Trials of atypical squamous cells, which cannot exclude high-grade squamous lesion 

(HSIL) (ASC-H), and atypical glandular cells (AGC) in adolescents are needed, as well as 

a randomized trial of HSIL management. 

Natural History of HPV 

• Additional epidemiology studies of CIN 2, CIN 2/3, and CIN 3 in adolescents are needed. 

• Better biomarkers of progression of CIN 2 are needed. 

• Studies of HPV 16/18 in triage of CIN 2 are needed. Should management be based on age 

of onset of intercourse rather than age? 

Burdens & Challenges: Colposcopy, Cytology, and Histology in Adolescents 

• Registries are needed to document changes in prevalence of lesions identified on colposcopy, cytology, and histology with increasing penetration of HPV vaccine(s) and to 

document changes in Pap test characteristics (sensitivity, specificity, positive predictive 

value, negative predictive value, etc.) with increasing penetration of HPV vaccine(s). 

• Epidemiology of studies in AGC in adolescents are sorely needed. Additional biomarkers 

and other diagnostic tests are needed for screening. 

Risks of Over-Management and Over-Treatment of Adolescents 

• Should CIN 2/3 in adolescents be tested for HPV 16 and HPV 16+ lesions managed as 

CIN 3? 

• What is the effect of cone height (or volume or tissue removed) on obstetrical outcome? 

• Should CIN 2/3 treatment in adolescents be managed differently in “reliable” adolescents 

than “unreliable”? 

• There is a need to determine who is “reliable.” Are there specific interventions that can 

reliably reduce outcome and procedure-related anxiety (across multiple populations)? 

HPV-Associated Cancers and HIV 

• There is a need for vaccine efficacy in HIV+, both prevention of initial and latent infections. 

• There is a need for perinatal studies (longitudinal followup of children exposed to HPV at 

birth) and better treatment options. 

276
Genital Warts and HPV-Induced VIN in Adolescents 

• Is the natural history of external genital warts in adolescents different than in adults? 

• What is the recurrence rate of disease in adolescents after treatment? 

• What methods for the treatment of external genital warts are most successful and most 

acceptable for adolescents? What methods for the treatment of high-risk type external genital lesions (VIN) are most successful? Can these lesions be treated with the same 

methods used to treat low-risk HPV-type genital warts? 

Implementation of Practice Guidelines: Barriers and Solutions 

• Benchmark performance thresholds need to be established (i.e., mean and “upper limit” 

Pap intervals in adolescents and cervical treatment rates in adolescents and young women with abnormal Pap results). 

• There is a need to track adoption of guidelines by individuals, provider groups, and 

health plans. Consumer-based research is needed regarding attitudes and practices in 

adoption of guidelines. 

HPV Vaccination: Potential Impact on Screening 

• What is an appropriate screening test and screening interval in vaccinated women? 

• What is the best age to begin screening in vaccinated women? 

• What percentage of adolescents has received all three shots? Two shots? One shot? How 

much protection does one or two dosages provide? 

HPV Vaccination: Potential Impact on Screening 

• Durability of responses—are boosters needed and what will be their coverage? 

• How far “off schedule” is still effective? 

• Will there be niche replacement and unmasking? If so, what are the disease implications? 

How much will cross-protection influence disease rates and screening and management? 

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impact of HPV vaccination on the accuracy of cervical cancer screening: The need for a 

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33.Goldie, S. J., & Kuntz, K. M. (2003). A potential error in evaluating cancer screening: 

A comparison of 2 approaches for modeling underlying disease progression. Medical 

Decision Making, 23, 232–241. 

34.Goldhaber-Fiebert, J. D., Stout, N. K., Salomon, J. A., Kuntz, K. M., & Goldie, S. J. (2008). 

Cost-effectiveness of cervical cancer screening with human papillomavirus DNA testing 

and HPV-16,18 vaccination. Journal of the National Cancer Institute, 100, 308–320. 

THOMAS C. WRIGHT, JR., M.D. 

American Society for Colposcopy & Cervical Pathology 

ASCCP Testimony on Cervical Cancer Screening, Guidelines for the Management of Abnormal 

Cervical Cytology Results and CIN/AIS, and Issues Pertaining to HPV and HPV Vaccination 

ASCCP is a 3,200-member medical specialty society. The educational mission of the ASCCP is 

to improve clinician competence and performance and patient outcomes through educational 

activities focused around the study, prevention, diagnosis, and management of lower genital tract disorders. In 2001 and 2006, ASCCP convened consensus conferences of the 29 major 

medical organizations and Federal agencies to develop the national guidelines on the management of women with abnormal cervical cancer screening tests and the management of 

women with cervical intraepithelial neoplasia (CIN)/adenocarcinoma in situ. 

ASCCP strongly recommends the National Institutes of Health consider the following research 

activities and priorities in the coming years: 

1. Continuation of multidisciplinary national guidelines for management of abnormal 

cervical cytology 

2. Federally funded large national clinical trial to evaluate different cervical cancer 

screening strategies 

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3. Federally funded evaluation of teaching tools to improve the adherence of practitioners 

to national guidelines for cervical cancer screening and the management of abnormal 

screening tests 

4. Federally funded trial to address the concerns relating to the performance of colposcopy, especially in a real world setting and impact of additional biopsies on false positive 

and false negative rates 

5. Studies to assess patient and provider perception of risk associated with delayed diagnosis of CIN 2+, obstetrical complications of treatment, and screening intervals 

6. Studies to assess factors and biomarkers that predict the true premalignant potential 

of CIN 2 

7. Federally funded large evaluation to determine risks of obstetrical complications associated with loop electrosurgical excision procedure as performed in the United States 

8. Enhanced funding for surveillance to monitor the impact of HPV vaccination on specific 

HPV infections, cytological abnormalities, CIN 2+, and cancer. (The United States needs 

the capacity to monitor changes not only in disease prevalence, but also the potential 

for niche replacement by other high-risk types of HPV.) 

9. Federally funded evaluation of the immunologic and other determinants of HPV clearance/persistence 

10. Strategies devised to address disparities in cervical cancer rates among women from 

different ethnic, rural/urban, and socioeconomic groups 

REBECCA ALLEN, M.D. 

Association of Reproductive Health Professionals 

The Association of Reproductive Health Professionals’ Statement to the Office of Research on 

Women’s Health and the National Institutes of Health 

Good afternoon. My name is Dr. Rebecca Allen. I am a member of the Association of Reproductive Health Professionals (ARHP) and serve as Assistant Professor of Obstetrics and 

Gynecology at the Warren Alpert Medical School at Brown University. I also work here at 

Women and Infants’ Hospital in the Division of Ambulatory Care. I am presenting comments 

on behalf of ARHP. 

ARHP was founded in 1963 and is a multidisciplinary professional association with more than 

12,000 reproductive health professional members who provide direct services, conduct reproductive research, and influence public policy. ARHP is offering comments today because we 

value evidence-based science and serve as a trusted resource for reproductive and sexual 

health education and information. We meet our educational mission through a variety of educational programs, meetings, publications, and Web-based activities. Through professional 

education, ARHP helps translate cutting-edge science for reproductive healthcare providers to 

improve patient care. 

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On behalf of ARHP and its members, I thank the Office of Research on Women’s Health 

(ORWH) and the National Institutes of Health (NIH) for holding these meetings on new dimensions and strategies for women’s health research, and for the opportunity to offer comments 

this afternoon. ARHP would like to take this opportunity to focus on several key issues that 

present opportunities for the ORWH and NIH: 

1. Identifying research gaps that need immediate attention 

2. Translating evidence-based science into continuing education for healthcare providers 

to improve clinical practices and patient care with Federal funding support 

3. Promoting regular cross-agency and intradepartmental collaboration on reproductive 

and sexual health topics to develop innovative strategies 

Of the many key aspects of reproductive and sexual health, these two are of particular 

importance: 

1. The effective translation of the latest clinical recommendations into the best 

clinical practice
�

2. The development of additional safe and effective forms of long-acting reversible 

contraception, or LARC 

3. For efficiency and potential impact, more research is needed on effective translation of reproductive health-related science into practice. Unless research findings are 

converted into practice change, the intention of conducting research to inform clinical 

practice and patient care is lost. To truly improve patient care, it is important to identify professional education platforms that work. This can be accomplished through the 

development of comprehensive evidence-based guidelines, well-designed continuing 

education and training programs, and tools to evaluate their implementation. 

For the development of innovative strategies and solutions, cross-agency and intra-departmental collaboration should be encouraged in order to develop better and more innovative 

strategies. Currently, different health topics are housed in different agencies or departments, 

and collaboration seems very challenging. This means, for example, that logically linked topics 

such as maternal and child health and reproductive health are studied independently by separate agencies or departments. By including a focus on maternal child health in a discussion 

of reproductive health, for example, important life-saving, health-promoting aspects of family 

planning emerge to improve maternal child health. By working within and across departments 

and agencies, redundancies can be reduced, efficiency improved, and costs cut. 

As the Obama administration investigates ways to reduce abortion and unintended pregnancy rates, the Centers for Disease Control and Prevention (CDC) and NIH have collaborated 

on issues related to preterm birth and unintended pregnancy. The discussion and research 

occurring between these two agencies has the potential to make a dramatic impact on 

both preterm birth and unintended pregnancy rates. Further cooperation and communication between departments and agencies can only enhance and strengthen programs already 

proven to work. 

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The work currently being done around preterm birth highlights the need not only for continuing education to implement practice change, but also the need for Federal funding to be 

available to ensure evidence-based scientific findings are incorporated into clinical practice. 

Unlike the many mechanisms now in place to support scientific research, there is no federally 

funded system designed to fund the translation of that research into practice. Now is the time 

to establish clear Federal funding mechanisms for the development of continuing education 

and health professions training curricula in reproductive health. This is a “fast track” solution to 

reducing health disparities and improving patient care. 

For the sexual and reproductive health field, this would mean addressing the linked issues of 

contraception, sexuality, abortion, human immunodeficiency virus and sexually transmitted 

infections, pregnancy, and maternal and child health, as well as increasing provider knowledge, 

skills, and understanding of these areas. Through adequate education and training of all clinicians, evidence-based, comprehensive sexual and reproductive health care can be brought 

directly to the patients, which is the primary goal of conducting meaningful research. 

Recently, the National Institutes of Health and industry research have moved away from developing female contraceptive methods to a new focus on developing contraceptives for men. 

This research is important and should continue, but NIH should also maintain a focus on 

researching new safe, effective contraceptive methods for women, especially new LARC methods. ARHP advocates for the availability of as many safe and effective contraceptive methods 

as possible to meet the wide variety of needs of American women and men. 

ARHP is encouraged by NIH’s collaborative work with the CDC and hopes that cross-agency 

and intradepartmental collaboration continues to develop in order to improve efficiency, 

reduce redundancies, and cut costs. An investment of Federal funding to develop and expand 

sexual and reproductive health continuing education for all providers throughout their careers 

would aid in the achievement of these goals. 

MIMI POMERLEAU, DNP, WHNP-BC, RNC-OB 

Association of Women’s Health, Obstetric, and Neonatal Nurses 

Future Research Direction: Preterm Birth 

Introduction 

Good afternoon. I am Dr. Mimi Pomerleau, an advanced practice nurse. Thank you for the 

opportunity to provide testimony. I am here today on behalf of the 23,000 members of the 

Association of Women’s Health, Obstetric, and Neonatal Nurses, also known as AWHONN. 

AWHONN is a nonprofit membership organization committed to promoting the health of 

women and newborns. We applaud your efforts to ensure that future women’s health research 

anticipates new dimensions of health and incorporates innovative and successful strategies. 

Nurses are typically the first and most consistent point of contact in the healthcare setting. 

Evidence suggests that nurses spend more time with patients—up to four times on average—than any other healthcare provider. As a result, we have a unique perspective on the 

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healthcare system—on the way care is and the way care should be provided to women; and 

we are ideally positioned to conduct research and translate it into innovative, evidence-based 

care practices. 

AWHONN produces a number of resources, publications, Webinars, and educational offerings 

that are evidence-based and available for nurses to use in their everyday practice. AWHONN also 

promotes nurse-led research through its two journals, the Journal of Obstetric, Gynecologic, and 

Neonatal Nursing and Nursing for Women’s Health. Additionally, the organization acknowledges, 

each year at its annual convention, its most distinguished writers and researchers. 

Personally, as a doctorally prepared nurse, I am an educator, researcher, and clinician. In my 

clinical practice as a staff nurse and nurse practitioner on a postpartum unit, I care for women 

and newborns and I am often challenged to find the research to support common nursing care 

practices. As a nursing educator, I encourage students to examine and evaluate these practices 

to provide optimal care to childbearing families. AWHONN is resource for students and experienced nurses. 

Late Preterm Infant Initiative 

AWHONN is known as a leader among nursing organizations for its work to promote evidence-based practice. As an example of this leadership, AWHONN periodically conducts 

research-based practice projects that are designed to evaluate AWHONN evidence-based 

protocols and ultimately to facilitate the translation of research into clinical nursing practice. 

AWHONN’s Research Advisory Panel and other clinically focused advisory panels recommend topics appropriate for development as research-based practice projects. From there, 

nurse experts are identified to form a project Science Team. Each Science Team completes a 

systematic and comprehensive review of literature on the identified topic and develops a protocol. This evidence-based clinical protocol is then implemented in multiple clinical sites. Data 

are gathered and evaluated during the project term and disseminated via published outcomes 

articles and a final refined evidence-based clinical practice guideline. An ongoing ResearchBased Practice Project that relates to women’s health and the priorities that will be discussed 

at this meeting is our Late Preterm Infant Initiative, or the LPI Initiative. 

In the United States, nearly 13 percent of all of babies are born preterm. Premature babies 

are at risk for a number of complications immediately following birth, such as respiratory distress, infections, and even death. These vulnerable newborns often require highly specialized 

and costly care. Premature babies are also at risk of experiencing long-term complications, 

including potentially lifelong debilitating physical and developmental disabilities. Again, these 

complications can be costly and potentially life threatening. 

Premature infants can be subdivided by gestational age into categories. One category, known 

as late preterm infants, comprises infants born between 34 and 36 completed weeks of gestation. More than 70 percent of preterm births occur in this gestational age category. These 

infants often look and act like full term infants and are usually larger than very premature newborns. However, late preterm infants have many of the same physiologic vulnerabilities and 

unique health considerations as smaller preterm babies, such as increased risk for respiratory 

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distress, immature suck and swallow reflexes that can impair feeding efforts, and jaundice, 

which if not aggressively treated, can result in significant and irreversible neonatal morbidity. 

AWHONN is among the first professional organizations to recognize the importance of 

increasing awareness of late preterm infants’ special needs. As such, AWHONN launched its 

Late Preterm Infant Initiative in 2005 as a multiyear education and awareness project focused 

on issues related to nursing care of this special population of newborns. The AWHONN Late 

Preterm Research-Based Practice Project (known as the late preterm RBP) is currently a major 

focus of the Initiative. This project is a multiyear descriptive research study launched in late 

2007 and is aimed at increasing our understanding of the special needs of late preterm newborns and their risks for complications. Additional study objectives include evaluating change 

in nurses’ knowledge about late preterm birth and how implementation of AWHONN’s evidence-based project guideline changes their assessment and care of late preterm newborns. 

A knowledge perception survey will also be administered to consenting mothers to assess 

their knowledge of the special needs of their late preterm newborns. The project will be implemented in 15 hospitals in the United States and in Canada. We look forward to completing the 

project and disseminating results in 2010. 

The causes for preterm labor and birth are complex and not fully understood. Some general 

health and pregnancy-related issues (e.g., multiples, infection, and high blood pressure) and 

lifestyle choices (e.g., smoking, lack of prenatal care) are known to be risk factors for preterm 

birth. And women who have had one preterm baby are at a significantly high risk of having a 

subsequent preterm birth. However, any pregnant woman can be affected; and it is estimated 

that approximately half of all preterm births occur in women who have no clearly identifiable 

risk factors. It is disturbing to note that according to the 2008 National Vital Statistics Report, 

the rate of premature birth has increased in the United States by 36 percent since the early 

1980s. Despite many best efforts by nurses, physicians, and other perinatal researchers alike, 

we have not been able to stem the tide of this critical healthcare problem. 

Future Research Priorities 

It is critical that the National Institutes of Health prioritize the issue of prematurity, with a special focus on late preterm birth in future years. We need more information on what causes 

preterm birth, how it might be prevented, and how to best care for preterm infants to reduce 

morbidity and mortality. 

For example, recent research suggests that successful initiation of breastfeeding is significant 

to the health of preterm infants because it is now documented that providing mother’s breast 

milk to these babies can help decrease infant morbidity and mortality risk. In addition, the provision of breast milk to these infants not only has nutritional benefit, but also has therapeutic 

immunologic support benefits that reduce the risk of diseases common among preterm newborns, such as necrotizing enterocolitis and sepsis. Research has shown that these vulnerable 

newborns are usually physiologically more stable during the act of breastfeeding compared 

to infants feeding from a bottle or other source. Providing the preterm newborn with mother’s 

milk can also enhance maternal-infant attachment and provides the mother an opportunity to 

play an active role in her preterm newborn’s care. 

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Further investigation of this low-cost, potentially high-impact intervention is exactly the type 

of research that should be expanded moving forward. Another example of such research 

relates to a method of holding a baby, called kangaroo care. Kangaroo care involves skinto-skin contact; the parent holds the baby, in just a diaper, against her bare chest. Research 

demonstrates that there are significant benefits for preterm infants who are held this way for 

several hours each day, including improved breathing, stabilization of the baby’s heart rate and 

temperature, more rapid weight gain, and earlier hospital discharge. Nurses are leading much 

of the current research related to kangaroo care, exploring additional benefits for both the 

parent and the infant. In addition, nurses are often the healthcare provider implementing this 

practice in the hospital setting and educating new parents on the value of kangaroo care. 

Nurses and other pregnancy care providers must have access to the latest science and information available in the care of women and infants. Nurses, who are already doing research in 

this field, are well-suited to implement new findings, pose innovative research questions, and 

help combat this serious problem for women and their families. 

DEBORAH N. PEARLMAN, PH.D. 

Brown University 

Testimony of Deborah N. Pearlman 

This year, almost half a million women in the United States will die of cardiovascular diseases. 

While cardiovascular diseases are the number one killer of American women, only 13 percent 

of women in the United States see heart disease as the greatest threat to their health. Even 

more surprising, fewer than one in five physicians know that more women than men die of 

heart disease each year—and only 8 percent of primary care physicians are aware of this fact. 

Cardiovascular gender differences are apparent long before a cardiovascular disease event is 

diagnosed in women and men. Improved understanding of the biology underlying these differences has the potential to advance the diagnosis and treatment of cardiovascular diseases 

in women.1 

Other areas of research needed in the area of women’s health/cardiovascular diseases include 

the following: 

• Are there significant gender, racial/ethnic, and socioeconomic (SES) differences in the 

patterns of health and illness that may affect the diagnosis, treatment, and survival of 

women who experience a cardiovascular disease event? 

• Are there significant gender, racial/ethnic, and SES differences in the use of health services that may affect the diagnosis, treatment, and survival of women who experience a 

cardiovascular disease event? 

• How can care and treatments developed for women improve their health outcomes after 

a cardiovascular disease event? 

• How do economic resources and other determinants affect women’s health, especially in 

relation to the prevention of cardiovascular diseases? 

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• How can a multilevel framework, one that focuses on individual-level risk factors, family 

factors, and the broader social context in which women live advance epidemiologic research on disparities in primary and secondary prevention of cardiovascular diseases? 

• What are the evidence-based programs and policies that have been shown to positively impact women’s active involvement in reducing metabolic risk factors (e.g., increased 

blood pressure, and cholesterol and glucose concentrations) and lifestyle risk factors 

(e.g., smoking, poor diet, physical inactivity, adiposity) shown to increase the risk of developing and dying from cardiovascular diseases? 

Reference 

1. Mendelsohn, M. E., & Karas, R. H. (2005). Molecular and cellular basis of cardiovascular 

gender differences. Science, 308, 1583–1587. 

MICHELLE CORTES-HARKINS 

Center for Hispanic Policy & Advocacy 

Center for Hispanic Policy & Advocacy’s NIH Testimony 

The Center for Hispanic Policy & Advocacy (CHisPA) is pleased to submit written testimony to 

help inform future women’s health priorities at the National Institutes for Health (NIH). CHisPA 

is a bilingual, Latino community-based, nonprofit organization located in Providence, Rhode 

Island, dedicated to improving the quality of life for Latinos by providing a variety of programs 

and services. CHisPA’s goal is to empower Latino families and individuals to achieve their full 

potential as productive members of the Rhode Island community. CHisPA houses the Promotores de Salud/Health Promoters program—a community-based health literacy/outreach 

program that provides culturally appropriate and accessible health education and information. 

A majority of our clients are Latinas (70 percent) and intersect with the agency through programs on cardiovascular disease, reproductive health, and domestic violence. Pulling from 

our experience in working with the Latino community in Providence and because the Latino 

population has been disproportionately affected by the obesity epidemic, we have primarily 

focused on this health disparity. Research and our own data show that factors also contributing to the high rates of obesity and overweight among Latinos include poor diets affected by 

acculturation, sedentary lifestyles, and low socioeconomic status. 

The Promotores de Salud/Health Promoters have been coordinating the Latino Health Promotion Center with funding from the Rhode Island Office of Minority Health since 2004. 

Promotores receive intensive training in community and health outreach. Promotores de Salud 

conduct outreach in the community and provide vital health information on topics such as cancer, heart disease, diabetes, HIV/AIDS prevention, the HIV Vaccine Communication Campaign, 

nutrition, and access to basic health care. This model empowers natural leaders in the Rhode 

Island Latina community with the resources and knowledge of where to go and what to do for 

health services. In turn, Promotores help others access needed health services and educate 

the community on important health issues. In doing so, the lay health promoters facilitate the 

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health and wellness of the entire Latino community. Potential lay health promoters are carefully recruited to participate in the program. The program consists of 1-day training and other 

sessions on specific health topics. It has two major components: knowledge and skills. The 

knowledge component focuses on health topics and behaviors that have been identified as relevant by our Latina clients. The skills component focuses on skills necessary to carry out the 

outreach activities such as communication skills, problem solving, etc. Each promoter has a 

resource manual filled with information regarding services and health topics. Currently, CHisPA’s 

Promotores are providing education and prevention on cardiovascular disease, nutrition, and 

domestic violence. According to demographics collected by CHisPA during the previous years 

of program implementation (July–June 2008), Promotores de Salud achieved the following: 

• Two hundred educational workshops in Spanish on various health topics were presented 

and attended by approximately 1,786 Latino individuals. All participants showed an increase in their knowledge about the topic presented, as measured by the pre/post tests 

developed for each topic. 

• Three hundred and ninety individuals completed the training Salud Para su Corazon/ 

Health for your Heart. 

• One thousand one hundred and five referrals for free screenings and other healthcare 

services were made. Some of these services were provided onsite at CHisPA by collaborating with community agencies such as The Family Van and Lifespan Community Health 

Services. 

• One hundred twenty-seven community events were covered and allowed Promotores de 

Salud/Health Promoters to have direct contact with approximately 3,261 individuals; approximately 21,895 pieces of educational material in Spanish were distributed. 

• Four CHisPA Annual Health Fairs were organized, reaching 468 individuals. 

From our experience within the Latino community, and more specifically around the area of 

women’s health, CHisPA is making the following recommendations: 

Health Literacy 

Literacy levels, in addition to language, must be addressed. As defined by Healthy People 

2010, health literacy is the degree to which individuals have the capacity to obtain, process, 

and understand basic health information and services needed to make appropriate health 

decisions. Latin-American immigrants from rural areas may not have had opportunities for 

basic education and consequently have low literacy levels in their primary language. From the 

Harvard School of Public Health, we know that, nationally, 56 percent of Latinos residing in 

the United States are functionally or marginally illiterate. Their information needs must be met 

with different media that address low-literacy levels, such as radio and television. Other areas 

we have found where this is critical is in health brochures, care instructions, and even oneon-one interaction with healthcare providers. Limited English language and literacy skills can 

have a significant impact on one’s health. CHisPA believes that additional NIH research in the 

area of health literacy to develop science-based approaches will greatly benefit and impact 

the disparities now seen in health outcomes among Latinas. From our experience, we know 

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that literacy affects how health services are utilized, particularly around prevention, and in how 

self-care instructions are carried out. 

Culturally Appropriate Practices 

When treating a Latina patient, the level of acculturation needs to be assessed and the treatment adjusted accordingly. For non-English-speaking persons, bicultural or bilingual staff 

like the Promotores de Salud and/or medical translators are necessary. Determining the individual’s primary language is a first step in this direction. As the Center for Hispanic Policy & 

Advocacy’s experience has shown, it is not enough to merely translate the messages on prevention and treatment, but the Latina population needs and desires a community-based 

model. An additional layer is that within the Latina community, the country of origin influences 

the approaches to be used. In the Northeast, there is a heavy concentration of Latinos from 

the Caribbean who have different cultural and language needs than Latinos from the Central 

and South American countries. Also, Latinas who are born in the United States versus those 

who are born outside the country increases cultural variability and affects health behaviors. 

A unique characteristic of the Latino community is the importance of acquiring information 

through word-of-mouth. Our experience has shown that Latinas will share information they 

have learned about healthy behaviors, prevention, and care with friends in their neighborhood, friends in other cities, friends in their country of birth, relatives in their country of birth, 

or people at work. 

Research Practices 

Effective and meaningful research to address minority health disparities lies in the ability 

for research organizations to link to and work with community-based organizations such as 

CHisPA. This approach not only empowers the Latino community, but also allows for accurate input. Our experience has shown that a majority of research is conducted in English, but 

the materials used to capture information are not translated. In action, this allows limited 

access to Latino views and experiences. In addition, it is important for the Latina community 

to understand why and how research is being conducted and to get a better understanding 

of why it is important to be counted in studies on issues affecting their lives. More of a buyin provides opportunities for research and interventions to become sustainable community 

change. Recruitment for studies also involves having a level of trust that an organization such 

as CHisPA has already established. Barriers such as language, immigration status, and distrust 

of mainstream institutions can affect recruitment for newly arrived immigrants and even those 

already settled in the United States for a number of years. 

As an organization that primarily works with Latinas, CHisPA believes that participatory 

research efforts through the NIH would allow for a collaborative and symbiotic relationship 

of trust to be developed. This approach would also allow for the validation and examination 

of everyday practices that have been effective, but perhaps not studied within Latino-population-serving, community-based organizations. Oftentimes, perceptions of areas to research 

may not be in sync with what is considered relevant to Latinas and their specific health needs. 

We also believe that once a study is completed, an open forum within the community to discuss findings brings a sense of balance to the process and allows for future studies to be 

received more openly. 

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DIXIE MILLS, M.D. 

Dr. Susan Love Research Foundation/Army of Women 

The Love/Avon Army of Women: A Paradigm-Changing Research Resource—A New Breast 

Cancer Initiative Creates Partnership Between Scientists and Women 

We are honored to have been asked to submit testimony regarding new strategies and direction for the Office of Research on Women’s Health (ORWH). We would like to describe our 

exciting national initiative, its successes to date, and future goals. Being an innovative research 

project, the Love/Avon Army of Women (AOW) would seem to fit perfectly into the scope of 

the ORWH’s research agenda for the coming decade. We would like to share how this novel 

program can easily enhance research projects’ recruitment efforts and accelerate discovery 

of the cause and prevention of breast cancer and other women’s health issues. The Dr. Susan 

Love Research Foundation and the Avon Foundation for Women, a global leader in breast cancer research, have joined forces to launch a revolutionary new program: the Love/Avon Army 

of Women. This groundbreaking initiative is designed to accelerate breast cancer research by 

providing a 21st Century model of a “just in time” online resource of volunteers that will allow 

scientists to recruit women for research studies aimed at finding the cause of breast cancer 

and ways to prevent it. It also allows collaboration among scientists accessing the data, asking 

new questions, and then sharing it back with the research participants. 

“Women have repeatedly demonstrated through their fundraising and advocacy their dedication to ending this disease,” said Dr. Susan Love, one of the founding mothers of the breast 

cancer advocacy movement. “This new initiative gives women the opportunity to take the 

next steps and be part of the research itself.” Dr. Love, a renowned breast cancer surgeon and 

respected expert in the field, is also the author of the best-selling Dr. Susan Love’s Breast Book 

and the president of the Dr. Susan Love Research Foundation. 

“Avon is itself an ‘army of women,’ and we are committed to being the company and the foundation for women,” explained Andrea Jung, Chairman and Chief Executive Officer of Avon 

Products, Inc. “The Army of Women is a perfect marriage of our global leadership in the breast 

cancer cause and our grassroots access to women across the country.” 

The Army of Women intends to recruit 1 million women—healthy women who have never had 

cancer, high-risk women, and breast cancer survivors—who are interested in partnering with 

scientists by taking part in research studies. The AOW is not a clinical trials matching service, 

nor is it a tissue bank. And it does not provide funding. It was developed with the sole intent 

of promoting research studies utilizing women to research the etiology, causes, and prevention 

of breast cancer by providing scientists a vehicle to access volunteers they need. 

Women who are interested register on the Army of Women Web site, http://www.armyofwomen.org, providing year of birth, Zip code, and ethnicity. Launched in October 2008 on 

national media, the Army of Women now has more than 305,000 members, the majority 

of whom do not have personal experience with the disease but have the desire to participate in research to discover its causes. Women from around the world and from every State 

in the United States have joined. Of these women, 85 percent are Caucasian and ages range 

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from 18 to 99 years with a mean age of 56. We have started efforts to increase our minority 

membership. 

Research scientists register with the Army of Women online at http://www.armyofwomen.org 

for the opportunity to submit project proposals to recruit volunteers for their studies. Studies 

are reviewed by a Scientific Advisory Committee and are held to the highest ethical standards before being released to the Army of Women. All studies have institutional review-board 

approval before being sent out to AOW members. 

After a research proposal has been accepted, the Army of Women sends out an e-mail notice 

to all Army volunteers that describes the study, eligibility, and what participation will involve. 

Women self-select the studies that interest them and for which they are eligible. They can also 

forward the e-mail to someone else they think might be eligible. Army of Women staff coordinate the tissue collection process with either the scientist or an Army of Women collection 

center where volunteers can go to give a blood, urine, breast fluid, or breast tissue sample. 

Researchers can also use the Army of Women for epidemiology studies or recruitment for prevention research. To date, 14 studies, approximately 2 a month, have been sent out via e-mail: 

6 are now closed and 8 are still open. The first study sent out in October 2008 to recruit 

women for the Sister Study, a large national effort, was able to recruit nearly 4,000 qualified 

women in 2 weeks and to successfully close the study, which began in 2003. “The Army of 

Women is an important step in empowering women to participate in research and ensure that 

study results apply to all women. The Sister Study is thrilled to be included in the Love/Avon 

Army of Women!” said Dr. Dale Sandler, of the National Institute of Environmental Health Sciences of the National Institutes of Health. Studies sent out have recruited more women than 

the researchers had anticipated and in a much shorter time. To date, nearly 12,000 women are 

now or have participated in the clinical research process. 

AOW members can also apply to participate in our “foot soldier” program and act as spokespeople at local events to raise awareness about the Army of Women and research efforts. 

Beginning in October 2009, to celebrate the first anniversary of the Army of Women, efforts 

were underway to launch a large longitudinal cohort study of AOW members, to be called the 

Health of Women or HOW Study. The study is being conducted in collaboration with the NCI’s 

caBIG (Cancer Biomedical Informatics Grid) and the City of Hope’s epidemiology team of 

Drs. Leslie Bernstein and Katherine Henderson. Online surveys will be sent to AOW members 

every 3 to 4 months for the next several years. We see this as the largest cohort study to date 

that will be done totally online and the results shared with other qualified researchers. Our 

goal is to have 1 million women and because we are doing it online, we should be able to be 

fairly nimble about what we can do and what questions we can ask. We hope to demonstrate 

a new 21st Century model of research that is empowering to consumers and that is technology enabled. Utilizing Web technology, we can facilitate women signing up and responding 

to secure online questionnaires and then facilitate authorized researchers to access this information. The Web-based software will allow the infrastructure to be immensely dynamic, cost 

efficient, and time sensitive. We see this specific platform eventually having the capacity to 

look at other forms of cancer or other diseases. 

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Breast cancer research at this time is concentrated primarily on improving imaging devices 

that can detect tumors early, developing drugs to kill cancer cells, and understanding why 

cancer cells become resistant to existing drugs. The Army of Women will encourage researchers to shift their focus from developing new treatments to understanding what causes normal 

human cells to become cancer cells in the first place. In addition, by providing scientists with 

the healthy women they need, but often have difficulty finding, the Army of Women will make 

it possible for them to shift their focus from the lab, where much of the molecular work is currently being conducted on mice or in cell culture, to real women. 

Scientists throughout the United States have already expressed their interest in partnering 

with the Army of Women. “The Army of Women is going to revolutionize the way biologists 

do research,” said Dr. Thea Tlsty, a pathologist and cancer researcher at the University of California, San Francisco. “I’m eager to submit a proposal and to begin doing work with Army of 

Women volunteers.” 

We are currently looking for more scientists who have projects needing human breast tissue, 

ductal fluid, urine, saliva, or blood as well as data for epidemiology. Army of Women Collection 

Centers for tissue specimens have been set up in various geographic areas if researchers are 

not able to collect specimens themselves or desire faster accrual. 

The National Breast Cancer Coalition, a grassroots advocacy organization, and the American 

Association of Cancer Research, a scientific organization focused on high-quality, innovative 

cancer research, have agreed to partner with the Army of Women in directing and supporting 

this initiative. The organizations will represent the concerns of scientists and advocates as well 

as help in their recruitment. 

We again thank you for this opportunity to better explain our program. We are confident that 

its success can translate to other disciplines in the future and can become the mainstay of 

recruitment and collaboration for clinical research. 

To find out more about the Love/Avon Army of Women, please visit 

http://www.armyofwomen.org. 

PATRICIA PALUZZI, DR.P.H., CNM 

Healthy Teen Network 

Future Research on Adolescent Sexuality and Parenting 

Healthy Teen Network is the only national nonprofit organization focused on both preventing 

teen pregnancy and supporting pregnant and parenting teens. Our work began 30 years ago 

when teen pregnancy was first recognized as a public health issue that impacts the well-being 

of the mother, father, and child, as well as the financial stability and future of communities. 

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Senator Edward Kennedy introduced the first legislation to support the education of pregnant 

and parenting teens in 1976. While this legislation did not pass, it started the conversation on 

how best to ensure that pregnant and parenting teens receive the education they need to gain 

employment and break the cycle of poverty they are so often prone to. For the subsequent 

decade or so, through Title IX and other avenues, supports for pregnant and parenting teens 

were pursued in many communities and schools. 

The tide changed quickly, however, with the advent of newer and more contraceptive methods 

and sexuality education. These two advances are credited, in part, with the ever-decreasing 

rate of teen births seen in the United States between the 1970s and 2005. While not enough 

good can be said about these advances, the pregnant and parenting teen soon became a persona non grata in the United States, resulting in essentially no advances in science or proven 

effective interventions for this population. And as more recent data have shown, education 

and contraception are essential, but not sufficient, in preventing teen pregnancies, as rates 

have climbed since 2005. 

There are some known and many yet-to-be proven reasons for both the increase in teen pregnancy and the lack of support for pregnant and parenting teens. The research agenda I am 

about to offer for the National Institutes of Health (NIH) to consider builds on both what we 

do know and what we have yet to learn. 

1. Access is a multifaceted concept that plays a large role in both availability and use of 

education and services that support teen pregnancy prevention. Research questions to 

consider follow: 

a. How can we separate emotional responses from professional duty to improve 

providers’ willingness to offer appropriate education and services regarding teen 

sexual health? 

b. How do we reframe teen pregnancy prevention as a public health issue that 

impacts the well-being of our communities—and future—so that we gain more 

widespread support? 

c.	� What do youth say about accessing education and services? 

d. Why do they not access these services even if they are available and confidential? 

2. Teen pregnancy prevention is a complex issue impacted by race/ethnicity, socioeconomic status, family, and community, as well as societal regard for and treatment of 

youth, especially marginalized youth. Research questions to consider follow: 

a.	�Can the various levels of influence on teen sexuality and reproductive decisions 

be quantified? 

b.	�How can what we have learned about brain development be translated 

into interventions?
�

c.	� How can the effects of racism and classism be measured and quantified so that 

interventions can be developed? 

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d. How can cultural beliefs be addressed positively within teen pregnancy 

prevention strategies? 

e. What approaches work best for connecting youth with caring adults 

and/or community?
�

3. Pregnant and parenting teens are a vilified population in the United States, resulting in 

a dearth of research and effective interventions. Research questions to consider follow: 

a.	�What frame works best to gain support for pregnant and parenting teens? 

b.	�What are the essential program components for pregnant and parenting teens that 

promote educational gains, livable wage employment, effective parenting, and 

healthy relationships? 

c.	� What policies currently in place help or hinder positive outcomes for teen parents 

and their children? 

I recognize that many of these questions may be “soft” and not the type of research that NIH 

excels in. However, mixed methodologies are needed to shed more light on how we can support all youth in delaying parenting or attaining successful adult lives when faced with early 

parenting. Perhaps NIH will consider partnering with other agencies to explore some of this 

much-needed research so youth can be more effectively served. 

ALESSANDRA RELLINI, PH.D. 

International Society for the Study of Women’s Sexual Health 

Focus on Female Sexual Health 

As far back as the 1950s, one of the country’s most recognized sexologists, Alfred Kinsey, 

argued for the need for government-sponsored studies on human sexuality. He pointed out 

the absurdity that we had more knowledge about the sexual behavior of insects than we had 

about sexuality in humans. Fast forward more than 50 years and we can claim better understanding of male erection and ejaculation. Unfortunately, we cannot say the same for female 

sexuality. We have mapped almost all neurotransmitters in the peripheral and the central 

nervous system pathways involved with erection. We have effective pharmacological and 

behavioral treatments for erectile dysfunction and for premature ejaculation. But we are very 

far from understanding even the basic mechanisms involved in female sexuality, including sexual desire, arousal, and satisfaction. What we have been able to solidly establish in the past 

two decades is that we cannot assume that the mechanisms behind the sexuality of women 

are the same as those for men. This information does not help us much in the clinic when 

we are treating women with sexual dysfunctions. It is unreasonable to expect to be able to 

improve the sexual health of women if we are not willing, as a society, to invest our time and 

resources in this topic. At the last Consultation Meeting for the International Urology Association (July 2009), experts provided a bleak review of the evidence available for treatment 

of female sexual dysfunction. We still do not have empirically validated treatments for any 

of the female sexual dysfunctions, except for primary anorgasmia, a relatively rare condition 

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experienced by young adult women who need to become more comfortable and knowledgeable of their bodies. The lack of advancement in this topic is not surprising given that, 

in the past three decades, only a handful of clinically controlled trials have been conducted 

on female sexual dysfunction and all of them were underpowered because of the lack of sufficient funding. Perhaps a lack of interest in female sexuality would be okay in a society that 

endorsed the belief that sex is not an important aspect of women’s lives, but we are not that 

society, or at least, we are no longer that society. Sexual satisfaction, sexual function, and sexual behavior are a common theme of conversation; female sexuality is part of most movies, 

shows, and magazines; and it is on the cover page of most magazines that target women’s 

health. In this testimony, I will present three main reasons why focusing on female sexuality 

should be put on the cover page of the National Institutes of Health (NIH) research agenda: 

1. Research on female sexual function and satisfaction can improve patients’ compliance 

for treatments that have sexual side effects. 

2. We need to move toward the development of treatments that improve quality of life 

and not simply reduce symptoms, and in this case I am referring to sexual quality of life, 

which the World Health Organization (WHO) considers a basic human right. 

3. A more comprehensive understanding of sexual behaviors can lead to more effective 

prevention programs for human immunodeficiency (HIV)/acquired immune deficiency 

syndrome (AIDS) infection and transmission. 

Treatment Compliance 

Our patients keep telling us with their actions that treatment efficacy is not sufficient for 

them to maintain compliance with our treatment recommendations. Every day, physicians are 

pressured to choose a less effective intervention due to patients refusing to take medications 

with side effects. This is particularly true for antidepressants and their sexual side effects. The 

WHO collaboration center for international drug monitoring has reported that out of nearly 

215,000 reported adverse effects of antidepressant medications during the period 1968 to 

1997, 5,000 were sexual in nature.1 Of 258 individuals utilizing antidepressants, 33 percent discontinued the medication because of side effects, and sexual difficulties were ranked second 

on the list of these side effects.2 Furthermore, a reduction in sexual desire is one of the most 

commonly reported reasons for the discontinuation of oral contraceptives in young women 

who are at high risk for unwanted pregnancy. Efficacy of treatments has been the focus of 

our research endeavors for years, but efficacy alone is futile if the treatment is undermined 

by lack of compliance. 

We need to monitor side effects of treatments, and we need ancillary interventions for the 

prevention and the improvement of side effects to reduce treatment discontinuation. Specific 

efforts in developing ancillary treatments that focus on side effects reduction (including sexual 

side effects) need to be developed, tested, and finally integrated in our clinics and hospitals. 

Only in this way will we be able to have a more holistic approach to the treatment of the individual and this will lead to a greater effectiveness of our medicine. 

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Quality of Life 

The first goal of the Healthy People 2010 initiative is to increase the quality and the number 

of healthy years, suggesting that, as a society, we are starting to look at science and medicine 

for ways to improve not only the years we live, but the quality of these years. Our research 

efforts in the past century have allowed us to make incredible strides in the reduction of symptoms and the increase in life expectancy. Because of advancements in treatments of illnesses 

and disorders that would previously have led to certain death, women with breast and gynecological cancer are now able to live longer. Improvements in the detection and prevention of 

heart attacks allow more women to live longer, and improvements in gynecological care have 

significantly reduced the mortality associated with giving birth. Improvements in the prevention and treatment of illnesses/disorders certainly require continuous attention, but we agree 

with the goals set by Healthy People 2010 that a longer life is not enough—we now need to 

focus on the quality of the life women lead, and sexual satisfaction is an essential aspect of 

quality of life. Indeed, sexual activities are listed as part of one of the five domains of quality 

of life identified by the WHO Quality of Life assessment.3 Despite the undeniable importance 

of sex in people’s lives, the main thrust of government-supported research for the past 8 

years has focused almost exclusively on HIV/AIDS infection and transmission. Messages that 

sex is dangerous and needs to be avoided and that sex should be a behavior confined to the 

goal of procreation are not in synchrony with the way in which our society sees and values 

sexuality. For the past 8 years, I have worked to help survivors of sexual abuse to regain a satisfying sexual life. In my brief career, I have completed clinical interviews with more than 300 

women with a history of sexual abuse and at the end of each interview, I have invited them to 

share their personal views of their own sexuality and the importance they place on reclaiming 

healthy sexual function robbed from them by their trauma history. Some of my patients tell me 

that they have eliminated sex from their minds and they are too scared to even consider trying to repair this aspect of their lives that is now dead to them. However, for many women, sex 

is not dead and it is not only a means to have a child with their partner. These women would 

jump at the opportunity to have a satisfying intimate relationship with a loving partner and 

they feel high levels of distress because they are unable to perform what is considered a normal human function. They see themselves as damaged goods because they cannot feel and 

experience something that is part of a normal sexual response. These women are tired of the 

frustration that their impaired sexuality brings into their relationships and they fear that soon 

their partners will leave them because they are not “normal women.” 

One woman who was suffering from severe post-traumatic stress disorder symptoms and 

night panic attacks looked at me in disbelief when I asked her whether her sexual problems 

were a priority, considering her other symptoms. She explained to me that if she could have 

her sexuality back, she would feel like a complete woman again and could find the motivation 

to fight to get the other symptoms under control, but as things were right now, she had nothing to look forward to, even if the post-traumatic stress disorder symptoms were gone. This 

woman’s response is not different from what the literature tells us about cancer survivors. 

In the first year after treatment for breast cancer, women are mostly concerned about 

their survival, and even if provided with information on techniques to prevent later sexual 

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dysfunction caused by the treatment, they often do not utilize these resources. However, as little as 1 year post-treatment, when they are no longer as worried about just survival, women 

are more interested in improving the quality of their lives and seek resources. We owe these 

women, and all women, to improve our knowledge for the treatment and management of 

female sexual dysfunction and ensure dissemination of this information to trained gynecologists and other professionals who provide health care to women. Indeed, a secondary problem 

for the treatment of female sexual dysfunctions is the lack of trained health professionals 

who take on the responsibility of asking women about their sexual health. While urologists 

have been providing support to men with sexual health for decades, women do not have the 

same availability of professional help. Thus, female sexual health is a topic that has long been 

ignored not only by basic science, but also in clinical practice. 

Our goal to reduce disparities in health between men and women should seriously consider how to narrow the gap in the lack of sexual health care for women. If we do not provide 

evidence-based treatment options, women will seek remedies on their own and may put 

themselves at risk for other health problems and sexual problems by trying risky off-label 

treatments. We are already seeing the market for “sexual remedies” providing alternatives 

such as plastic surgery to the genitalia, something that could lead to serious health problems for women. Because of the lack of solid research on even the basics of female anatomy, 

women have often been seeking these surgeries at a great cost both financially and emotionally, and despite the complete lack of scientific evidence for efficacy of any measure of 

satisfaction and function. 

A More Comprehensive View of Sexual Behaviors 

It is ironic that research on sexuality has been underrepresented for the past several decades 

while sex is one of the strongest motivators for human behavior. Indeed, the motivation is so 

strong that many individuals put their lives at risk and engage in activities that could lead to 

the contraction of HIV/AIDS and other sexually transmitted infections. As clearly indicated by 

countless studies within the past decade, abstinence only is not an effective way to prevent 

the spread of HIV/AIDS. Women, and especially women with a history of sexual abuse, are at 

high risk for HIV/AIDS infection. Despite public health efforts, the incidence of HIV infection in 

the United States has remained constant since 1999.4 Heterosexual encounters account for 30 

percent of the new cases of HIV and within these relationships, the woman is at significantly 

higher risk of infection. Studies on HIV have been focusing on education and motivation for 

abstinence, but a better outcome may be achieved if research could be financed to study all 

aspects of the sexual interaction that leads to HIV/AIDS, including aspects of sexual satisfaction and sexual function. Therefore, I suggest we include in our agenda basic sex research that 

looks at sexual function, sexual pleasure, and sexual satisfaction to better understand the risk 

factors that can be addressed in future prevention programs for HIV/AIDS infection and transmission. Congress itself lost such an opportunity back in 2003, when it decided to pull three 

grants because they investigated differences in physiological responsivity and pleasure in sexual activities when a man utilized a condom. Because of this history, sex researchers are wary 

of submitting grant proposals on topics that are directly related to sexual pleasure and sexual 

responses. However, we need this research, and the only way we can have this research return 

in our agenda is if we explicitly call for proposals for these topics. 

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In conclusion, sexual health is a key aspect of women’s lives that we have neglected, and that 

directly and indirectly affects the quality of life and the overall health of women throughout the Nation. Women are in need of answers to their sexual health problems and unless 

NIH includes in their agenda resources to study these issues, women will continue to resort to 

untested treatments that, at best, will perpetuate their sexual difficulties and, at worst, will put 

other aspects of their lives at great risk. We have an opportunity at this point to support the 

scientific development of treatments that can positively affect a large portion of women. As 

sex researchers, we are ready to take on this challenge and work together with clinicians and 

researchers from other fields to ensure that women across the Nation can lead more satisfying 

lives. But we will need NIH to put female sexual health on their map. We cannot accomplish 

this goal without government funding, especially in the current economic crisis that has minimized even further the existing small pool of funding from private foundations that used to be 

available for sex research. 

References 

1. Lundberg, P. O., & Biriell, C. (1998). Sexual dysfunction as a suspected adverse reaction 

to antidepressant drugs. Scandinavian Journal of Sexology, 1, 97–105. 

2. van Geffen, E. C. G., van der Wal, S. W., van Hulten, R., de Groot, M. C. H., Egberts, A. C. 

G., & Heerdink, E. R. (2007). Evaluation of patients’ experiences with antidepressants 

reported by means of a medicine reporting system. European Journal of Clinical Pharmacology, 63, 1193–1199. 

3. WHOQOL Group. (1995). The World Health Organization quality of life assessment 

(WHOQOL): Position paper from the World Health Organization. Social Science and 

Medicine, 41, 1403–1409. 

4. Hall, H. I., Song, R., Rhodes, P., Prejean, J., An, Q., Lee, L. M., . . . Janssen, R. S.; HIV 

Incidence Surveillance Group. (2008). Estimation of HIV incidence in the United States. 

Journal of the American Medical Association, 300, 520–529. 

ERIN BOLES, M.S.W. 

Massachusetts Breast Cancer Coalition 

The mission of MBCC is to challenge all obstacles to the eradication of breast cancer. Of primary concern to our over 10,000 members is the interaction between environmental toxins 

and the unnaturally high rate of breast cancer in the United States. It is our hope that in the 

upcoming decade, the National Institute of Health (NIH) will prioritize funding for research 

investigating primary prevention of breast cancer, particularly focused on possible environmental links to the disease. 

In 1940, it is estimated that 1 in 20 women were at risk for developing breast cancer, that rate 

today is between 1 in 7 and 1 in 8. While we are optimistic that the rate of the disease has temporarily leveled off in recent years, it is important to keep in mind the historical context of that 

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data so as not to feel overly victorious of that success or assume that the work of fighting 

breast cancer is over. 

In 2007, 240,510 women were diagnosed with various forms of breast cancer and underwent 

months or years of treatment and surgery to halt the disease. And 40,460 women died from 

breast cancer the same year. While only 5-10% of breast cancer can be attributed to a family 

history of the disease and approximately another 10% to lifestyle factors such as diet and exercise, 80% of breast cancer diagnoses go unexplained. With so many women’s lives at risk, it is 

vital to prioritize research pertaining to primary prevention of the disease. 

When looking at breast cancer rates over time, it becomes clear that there is much to be done 

to prevent breast cancer before it starts. With less than 1% of all breast cancer research funding dedicated to studying primary prevention of the disease, these women and their families 

must prioritize research aimed at stopping breast cancer before it starts. With 50% of research 

funding for breast cancer dedicated to research directed at preventing breast cancer and 

exploring the link between environmental toxins and the disease, rates of the disease could 

potentially drop 80% or more. 

Research and data conducted over the past two decades indicate that there may be an environmental link to the development of breast cancer. Scientists are better understanding the 

connection between the damaging impact of endocrine disrupting compounds (EDC’s), 

chemicals commonly found in everyday consumer products and industrial materials, and carcinogens on mammary cells. These various compounds, persistent in our environment, are 

found to trigger mammary tumor growth in laboratory experiments. 

For instance, research from scientists at Tufts University Medical School conclude that exposure to the endocrine disrupting compound Bisphenol-A to female mice in utero results in 

higher breast cancer rates later on. And research by Silent Spring Institute on Cape Cod in 

Massachusetts, a location with among the highest breast cancer rates in the country, revealed 

substantially high levels of endocrine disrupting compounds in groundwater. Emerging science 

even indicates that these potent chemicals may interfere with the effectiveness of chemotherapy in breast cancer patients. More research in these areas is desperately needed. 

As state health departments begin to review the science and determine these chemicals 

harmful enough to ban chemicals and issue warnings, such as the warning issued by the Massachusetts Department of Public Health against the use of products containing the endocrine 

disruptor Bisphenol A by chemotherapy patients, mothers and children, it is time for the 

nation’s leading health research institute to provide greater access to research funding promoting further study on the impact of environmental toxins on health. 

Therefore, Massachusetts Breast Cancer Coalition requests that NIH consider dedicating 50% 

of its funding for breast cancer research over the next decade towards primary prevention and 

environmental links to the disease, a percentage that, anecdotally, breast cancer survivors and 

family members believe to be necessary to stop the disease. 

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NANCY MULLER, M.B.A. 

National Association for Continence 

Female Pelvic Health Needs for Bladder and Bowel Control and Related 

Pelvic Floor Disorders 

Thank you for receiving testimony from the National Association For Continence (NAFC) 

for the September 2009 public hearing of the Office of Research on Women’s Health at the 

National Institutes of Health. I am Nancy Muller, Executive Director of NAFC. I have worked in 

this capacity for the past 10 years, serving on the organization’s Board of Directors as far back 

as 1996. I am a graduate of Duke University and have my M.B.A. from the University of Virginia. 

I am currently a Ph.D. candidate in health services research and administration at Virginia 

Commonwealth University. 

NAFC is a 501(c)3 corporation headquartered in Charleston, South Carolina. Our mission 

is threefold: 

To educate the public about the causes, diagnosis categories, treatment options, and management alternatives for bladder and bowel control problems; nocturnal enuresis; voiding 

dysfunction, such as retention; and related pelvic floor disorders, including prolapse 

1. To network with other organizations to elevate visibility and give priority to these 

health concerns 

2. To advocate on behalf of consumers who suffer from symptoms as a result of disease 

or other illness; obstetrical, surgical, or other trauma; or deterioration due to the aging 

process itself. 

3. NAFC is broadly funded by consumers, healthcare professionals, and industry. In 

existence for more than 25 years, it is among the largest and most prolific consumer 

education and advocacy organizations devoted exclusively to this field. More information can be found at our Web site: http://www.nafc.org 

The constituency of women we serve, primarily those who are peri- or postmenopausal, 

remains frustrated with the lack of assurance that treatment for pelvic organ prolapse and 

stress urinary incontinence (SUI) will be successful. Many women avoid surgery altogether, 

they tell us, because they hear experiences of repeat surgeries after 5, 10, or 15 years from 

friends who have undergone surgery for similar diagnoses. For at least a third who elect surgery for SUI, symptoms either continue afterwards or grow worse. Even aside from the risk of 

immediate complications such as retention, pelvic pain and discomfort, urgency, and urinary 

tract infections, the promise that recovery will be fast and normalcy will be restored remains 

elusive for many. Women feel betrayed and disappointed. We need both additional innovation 

and clinical research to deliver an improvement in outcomes with the duration from surgical 

intervention that women deserve, while reducing the risks of adverse events. 

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We have far too much experimentation on women in everyday clinical practice, without evidence or direction of what is best for particular cases. Women often report when contacting 

the NAFC for guidance that they feel bewildered by the options presented to them. Others are 

understandably fearful of the lack of experience that some doctors actually have with a particular implantable device or the history of its use on other patients. The outcomes data that are 

quoted are also rarely relevant or understandable to the layperson. 

Research is sorely needed to better identify those women at greatest risk of experiencing pelvic organ prolapse and stress urinary incontinence as they age, as well as the strategies they, 

as younger individuals, can undertake to best protect themselves against such occurrences. 

Based on our own consumer research, women with such diagnoses are equally divided on 

whether they feel a national research priority should be on finding the best treatment or how 

to prevent the problem in the first place. 

A good example of the kind of research that is best suited to prevention is the work published 

recently by the UCSF Women’s Continence Center/Center of Excellence documenting the correlation of obesity and weight loss with a significant reduction in symptoms of SUI in women. 

Findings like these, to be meaningful, need to be put into action by being translated into public policy and public education initiatives as well as public–private partnerships with healthcare 

payers and providers. Funding from the National Institutes of Health and the Centers for Disease Control and Prevention for such projects calls for careful coordination still missing from 

our fragmented approach to research, provider education, public health communication, and 

the application into practice of research findings. 

Because of the barriers and frustrations encountered by women seeking diagnosis for SUI and 

pelvic floor dysfunction, including prolapse, the country deserves a public health education 

platform to improve everyone’s understanding of the problem. Followup research is needed 

to identify the most effective and cost-efficient means of educating primary care providers 

and women in general on such topics, beginning early in a woman’s life during maternal health 

engagement with her OB-GYN or family practice provider. NAFC’s findings from our recent 

consumer research additionally call for the development of an instrument to assess consumer 

attempts to access diagnosis and intervention for pelvic organ prolapse specifically within the 

U.S. healthcare delivery system. Today, that effort is abysmal and embarrassing, as women 

repeatedly encounter closed doors, myths, and poor guidance from their doctors. Such an 

undertaking will help identify where communication is breaking down and most needed 

between patient and provider, as well as what messaging may be most effective in promoting 

self-advocacy on the part of the consumer as patient. 

Funding priorities are desperately needed for additional research, heightened public health 

policy and education initiatives, and improved professional education of primary care providers. In addition, we need tighter practice standards by doctors and better tracking of devices 

and all procedural outcomes. Until such activities are better coordinated and more integrated 

across agencies, institutions, organizations, and companies, they will fail to be effective and 

meaningful for patients. American women will otherwise continue to live in the Dark Ages with 

respect to their female pelvic health, robbed of the quality-of-life freedoms they deserve. 

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LIZA FUENTES 

National Latina Institute for Reproductive Health 

National Latina Institute for Reproductive Health—Recommendation to the NIH on Priorities for 

Research on Women’s Health 

National Latina Institute for Reproductive Health (NLIRH) works to ensure the fundamental 

human right to reproductive health and justice for Latinas, their families, and their communities through research, community mobilization, and policy advocacy. NLIRH is a national 

organization with offices in New York, NY, and Washington, DC. 

It is imperative that the National Institutes of Health (NIH) fund research and career development that includes and advances the role of Latinas in women’s health research. Latinas are a 

significant and diverse portion of American women, but have significantly worse health outcomes compared to White women on many key health measures. The NIH must prioritize 

initiatives in women’s health research that contribute to the elimination of health disparities 

in concrete and immediate ways. In order to do so, the NLIRH recommends that NIH prioritize 

and fund research on women’s health in three main ways: 

1. Prioritize research in social psychology, sociology, and public health that seeks to 

improve adolescent reproductive health outcomes, such as improved prevention and 

treatment of sexually transmitted infections, pregnancy prevention and planning, and 

the elimination of intimate partner violence. 

Social science research on the health of adolescent women is a critical priority. In 

2006, Latina adolescents gave birth at more than twice the rate of White adolescents, 

although White and Latina young women do not have significantly different rates 

of reported sexual activity.1 Specifically, Latinas’ use of birth control pills declined 

dramatically between 1991 and 2007, and they are more likely than White and AfricanAmerican girls to use “no method” of pregnancy prevention when having sex. The 

causes of these disparities are not as simple as Latinas’ versus White girls’ preferences 

for using contraception, but instead are closely connected to social and economic 

inequity. For example, one study, using a nationally representative longitudinal survey, 

found no racial or ethnic differences in teen birth rates among adolescents in the same 

socioeconomic quartile.2 

The difficulties Latina adolescents face that place them at higher risk for unplanned 

pregnancy are connected both to economic and immigration status issues. Latina 

adolescents are more likely than White adolescents to live in areas with poor access 

to family planning services. Neighborhood-level variables, including higher median 

household income and access to family-planning services are predictors of higher contraceptive use among adolescent women. Latina adolescents are more likely than their 

White counterparts to be without insurance; 20 percent of Latinos age 17 and under 

have no health insurance, a figure three times higher than the percentage of uninsured 

White youth.3 

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NIH research funding on adolescent women’s health should focus on understanding and 

eliminating adolescent health disparities by reflecting the diversity of nationality, ethnic/ 

racial background, cultural practices, language preferences, and immigration status of 

not only adolescent women themselves, but also their communities. This includes supporting a robust stream of policy research that evaluates the impact of specific policies 

on reproductive health outcomes for adolescent women. For example, research can provide a better understanding of the impact of laws requiring adolescents to seek parents’ 

permission to receive sexual and reproductive health care. Similarly, policy research can 

document and propose changes for ensuring Medicaid coverage for emergency contraception and whether hospitals routinely provide emergency contraception to sexual 

assault victims. 

This also includes prioritizing proposals that investigate not only overarching issues 

such as contraception use, but also their intersection and impact on other adolescent 

women’s health issues like intimate partner violence or depression. For example, adolescent sexual health programs must be evaluated not only by the curricula content and 

services offered, but also if and how they take into account factors such as the immigration status and health insurance status of the youth involved. 

2. Expand efforts to foster women’s presence in health provider-scientist roles by supporting science education opportunities at multiple levels and by specifically supporting opportunities for women of color to become scientists. 

Women of color, and Latinas specifically, are highly under-represented in healthcare 

provider professions and research positions. In 2006–2007, Latinos earned just 5 

percent of doctoral degree awarded, despite making up 14 percent of the U.S. population; only 21 percent of doctorates earned by Latinos were in the life sciences.4 In 2004, 

Latinos accounted for 14 percent of the total United States population, but were only 

3.2 percent of physicians. Similarly, Latinos only represent 4.3 percent of nurses and 2.8 

percent of pharmacists. 

According to the United States Office of Minority Health, healthcare organizations 

should “ensure that patients/consumers receive from all staff members effective, 

understandable, and respectful care that is provided in a manner compatible with their 

cultural health beliefs and practices and preferred language.” Additionally, these organizations should “implement strategies to recruit, retain, and promote at all levels of the 

organization a diverse staff and leadership that are representative of the demographic 

characteristics of the service area.”5

 These essential principles of care must be extended 

to research on women’s health because women of color are particularly negatively 

affected by health disparities. Health services research can and should contribute to 

strategies for ensuring these principles of care are met. The dynamic and diverse Latina 

population in the United States means that women’s health and minority health intersect and are inextricably linked for millions of Americans; NIH research priorities for 

women’s health must reflect this demographic and social reality. 

Many healthcare organizations are unable to fulfill these standards because women 

of color in general, and Latinas in particular, are drastically underrepresented both as 

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medical practitioners and researchers. The NIH explains that “Ensuring a diverse pool 

of physician-scientists and clinical investigators is an essential step in eliminating health 

disparities.”6

 Recruiting more Latina healthcare researchers and providers will thus 

serve as a crucial step in providing better health care for Latinas, evidenced by the fact 

that Latino medical students are almost twice as likely as White medical students to 

plan to serve in underserved communities.6 

Latino health personnel and healthcare researchers make health care more available 

and accessible as a result of their linguistic and cultural knowledge. While the data are 

discouraging, the strategies for solutions are exciting. In order to increase the number 

of Latinas, particularly those who are low income, and who are in the pipeline to do 

research on women’s health and to enter healthcare professions, four key strategies and 

policies should be enacted. 

• Federal, State, and local governments should create financial and social benefits to 

equalize access to training in health professions, with special attention paid to grants 

and scholarships at the high school, university, and graduate school level. 

• Federal and State governments should provide housing stipends that allow for fulltime 

study for student-parents or students who support other family members, provide 

health insurance for both students and their families, and subsidize on-campus childcare for student-parents. 

• Dedicate research funds to implement and evaluate community-based training programs for women in underserved communities who wish to become doulas; childbirth 

educators and peer breastfeeding counselors should be available in communities 

across the Nation. 

• The scope of and the eligibility for the National Health Service Corps should be expanded to increase the capacity of Latinas to serve not only as healthcare providers, 

but also as researchers in women’s health in exchange for educational support. 

• The funding and support that the NIH has already dedicated to community-based 

participatory research (CBPR) should include and specifically focus on research on 

women’s sexual and reproductive health. 

3. One of CBPR’s great strengths is in identifying and carrying out research that leads to 

timely changes that lead to improved health. Further, because behavioral and biomedical research play powerful roles in shaping healthcare policy and in forming public 

health policies, the NIH should prioritize research that aims to improve standards of care, 

improve delivery systems, and create strategies for overcoming cultural and economic 

barriers to health care. In order to support the applied, service-based research necessary to immediately contribute to the elimination of reproductive health inequities, the 

NIH should dedicate a portion of its CBPR proposals to research on women’s sexual and 

reproductive health. Within a CBPR model, the determinants of reproductive health care 

and outcomes can be investigated in the context of critical but often overlooked experiences, like the need for immigrant healthcare service delivery and outcomes. 

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Further, innovative healthcare delivery models, like the promotoras de salud model, can 

be effectively implemented and evaluated through the CBPR model. Community health 

worker models, like promotoras de salud, have been shown to promote positive health 

behaviors, like vaccinations and cancer screenings, and connect underserved communities to services in a culturally and linguistically appropriate manner, but few of these programs have been evaluated for their impact on women’s sexual and reproductive health. 

Research funding for program designs and evaluations that are rigorous and systematic, 

but still culturally appropriate, can lead to the evidence on how to effectively utilize these 

programs. CBPR methods bring both the critical needs of rigor and community-identified 

and driven research, making it possible to respond to Latinas’ sexual and reproductive 

healthcare needs and invest in research that tells us what works and what doesn’t. 

References 

1. Martin, J. A., Brady, H. E., Sutton, P. D., Ventura, S. J., Menacker, F., Kirmeyer, S., & Matthews, T. J. (2009). Births: Final data for 2006. National Vital Statistics Report 57(7). 

2. Driscoll, A. K., Sugland, B. W., Manlove, J., & Papillo, A. R. (2005). Community opportunity, perceptions of opportunity, and the odds of an adolescent birth. Youth & Society, 

37, 33–61. 

3. Current Population Survey for the Annual Social and Economic Supplement [Table creator]. (2009). Washington, DC: U.S. Census Bureau. Retrieved from http://www.census. 

gov/hhes/www/cpstc/cps_table_creator.html 

4. National Science Foundation. Survey of earned doctorates factsheet. Retrieved from 

http://www.norc.uchicago.edu/sed 

5. U.S. Department of Health and Human Services, Office of Minority Health. (2001). 

National standards for culturally and linguistically appropriate services in health care. Retrieved from http://www.omhrc.gov/assets/pdf/checked/finalreport.pdf 

6. Association of American Medical Colleges. (2006). Diversity in the physician workforce: 

Facts & figures 2006. Washington, DC. 

CHRISTIN VEASLEY 

National Vulvodynia Association 

Chronic Vulvar Pain Over the Lifespan 

Millions of women suffer from vulvodynia, or chronic vulvar pain, and recent studies suggest that it can start as early as adolescence. The lack of scientific research in this field has 

perpetuated the misdiagnosis and inappropriate treatment of women suffering from the disorder. Since fiscal year (FY) 1998, the United States Congress has repeatedly called upon the 

National Institutes of Health (NIH) to fund more vulvodynia research. To date, only slightly 

more than $11 million, or a mere $1 million per fiscal year, has been allocated to research on the 

condition, funding only 12 studies in 11 years. Thus, the FY2010 NIH Appropriations Report contains the following language on vulvodynia: 

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The Committee remains concerned with the lack of progress in expanding research efforts 

on vulvodynia in recent years, and it strongly urges that the Eunice Kennedy Shriver National 

Institute of Child Health and Human Development (NICHD) employ a full range of award 

mechanisms to substantially increase the number of awards for vulvodynia studies in fiscal year 2010. In addition, new research indicates that chronic vulvovaginal pain is also highly 

prevalent in the adolescent population and has been documented in children as young as 4 

years of age; therefore, the Committee urges that consideration be given to collecting data 

on vulvodynia and related pain conditions in the National Children’s Study. The Committee 

notes the lack of vulvodynia experts on peer-review panels and again encourages the Director 

to work with the Center for Scientific Review and other Institutes and Centers to ensure their 

adequate representation. The Committee also calls upon the Institute to continue efforts with 

the Office of Research on Women’s Health (ORWH) on the vulvodynia educational campaign. 

Finally, the Committee notes that vulvodynia coexists with other persistent pain conditions, 

including interstitial cystitis, fibromyalgia, temporomandibular joint and muscles disorders, irritable bowel syndrome, endometriosis, and chronic fatigue syndrome. The Committee calls 

upon the NICHD to collaborate with the Office of the Director on a trans-NIH research initiative 

that will support studies aimed at identifying common etiological pathways among these disorders, with the goal of developing therapeutic targets. 

In prior testimony titled, The Need for an Expanded Research Effort on Vulvodynia—A Prevalent and Neglected Gynecological Pain Disorder, the National Vulvodynia Association 

summarized vulvodynia’s impact on women’s physical and emotional well-being, and provided 

broad research recommendations. What follows is a summary of the results of recent published epidemiological studies and specific research recommendations by age group. 

Reproductive Years 

Population-based studies that include a clinical confirmation component demonstrate that 

3–7 percent of reproductive-aged women suffer from chronic vulvar pain. Harlow and Stewart1 surveyed 3,358 women, aged 18 to 64, from five diverse ethnic and socioeconomic 

communities in Massachusetts; they found that, at some point in their lives, nearly 16 percent 

reported a history of chronic burning, knifelike or sharp pain, or pain on contact that lasted 

3 months or longer. Seven percent, or approximately 6 million women, currently experienced 

painful symptoms. Eighty percent of cases reported pain on contact only and 20 percent 

reported diffuse burning or knifelike pain. Ninety percent experienced ongoing pain for many 

years. Investigators performed a gynecological examination on a small subset of cases and 

confirmed a vulvodynia diagnosis in 80 percent. Caucasian and African-American women 

exhibited similar lifetime prevalence and Hispanic women were 80 percent more likely to 

experience symptoms compared to the other ethnic groups. Incidence of symptom onset 

was highest between the ages of 18 and 25, and lowest after age 35. Compared to controls, 

women with vulvar pain were seven times more likely to report difficulty and pain with their 

first tampon use. Nearly 40 percent never sought treatment; 60 percent of those who sought 

medical care reported visiting more than three providers and 40 percent remained undiagnosed after three medical consults. 

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Arnold2

 administered telephone surveys to 1,012 women between the ages of 18 and 80. Vulvodynia was defined as “vulvar discomfort, most often described as burning pain, occurring 

in the absence of relevant visible findings or a specific, identifiable neurologic disorder” and 

lasting at least 6 months. Lifetime prevalence was almost 10 percent, and point prevalence, 

i.e., the presence of symptoms within the 6 months preceding the survey, was almost 4 percent. Women reported a significant burden of illness that spanned across many facets of their 

lives. Sixty percent reported an overall compromised ability to enjoy life and 75 percent felt 

“out of control” of their bodies. Half reported moderate to severe impact on their sex lives, 

causing them to terminate sexual intercourse attempts or avoid sexual relations altogether. 

Compared to 325 controls, women with vulvodynia (n=100) were significantly more likely to 

report chronic medical conditions, including chronic fatigue syndrome (OR=2.78), fibromyalgia 

(OR=2.1), irritable bowel syndrome (OR=1.87), and depression (OR=2.99). Cases were twice as 

likely to report irregular menstruation, painful menses, and premenstrual syndrome; six times 

more likely to report three or more annual urinary tract infections; and four times as likely to 

report more than three annual yeast infections. One year later, investigators administered a 

followup questionnaire to 213 controls and 72 cases and found that nearly 5 percent of previously asymptomatic women now reported symptoms associated with vulvodynia.3 

Reed4 randomly surveyed 1,032 women between the ages of 18 and 85 through SurveySpot, an 

Internet survey panel, and found that a substantial number of women with a history of vulvodynia experience chronic intermittent pain. Almost 30 percent reported a history of pain in the 

vulvar vestibule (area surrounding vaginal opening) without accompanying “deep” pain. The 

prevalence of vestibular pain was similar for African-Americans and other ethnic groups. Eight 

percent reported experiencing pain within the past 6 months, 3 percent reported that the pain 

lasted more than 3 months, and almost 2 percent reported ongoing pain of 3 months or longer. If large studies uphold these estimates, approximately 2.4 million American women could 

have symptoms suggestive of vulvodynia. 

Reed5

 also conducted an Internet and written survey of 1,046 women (19–92 years) who were 

members of the University of Michigan’s Women’s Health Registry and lived in a five-county 

area in Southeast Michigan. Ten percent reported a history of vulvar pain lasting more than 3 

months; 3 percent were in remission and 7 percent were then currently experiencing symptoms. Twenty-eight patients and 34 pain-free controls underwent a gynecological examination 

and investigators confirmed a vulvodynia diagnosis in 90 percent of patient cases. Two years 

later, the investigators conducted a followup study of 744 of the surveyed women. Of the 372 

asymptomatic controls initially enrolled, 13 women (3.5 percent) had developed vulvodynia 

symptoms, and 9 (2.2 percent) had ongoing pain. If confirmed in larger population-based 

studies, these data suggest that there might be more than 1 million new cases of vulvodynia 

per year in the United States. Younger-age and post-intercourse pain were associated with 

vulvodynia incidence. Remission, experienced by 22 percent of the 45 women with vulvodynia 

at enrollment, was more common in those who did not experience pain after intercourse and 

in those with less severe pain upon enrollment.6 

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Research Recommendations 

• Large longitudinal population-based studies that include a clinical confirmation component are necessary to 1) confirm vulvodynia’s lifetime and point prevalence; 2) determine 

risk factors associated with its development, e.g., vulvovaginal infection, early age of first 

intercourse, and oral contraceptive use; 3) determine factors associated with failure to 

seek medical care; and 4) identify screening and preventive strategies. 

• Natural history studies of women with vulvodynia are necessary to 1) determine remission 

rates and factors associated with symptom improvement; 2) understand the difference 

between women with transient versus persistent pain; 3) assess the prevalence of other pain syndromes, including dysmenorrhea; and 4) investigate the difference between 

women with vulvodynia and women with vulvodynia plus a concurrent pain condition. 

• Natural history studies of women with chronic pain conditions or other chronic vulvovaginal disorders (e.g., recurrent vulvovaginal infection, vulvar dermatoses) are necessary 

to determine 1) the prevalence of concurrent vulvodynia; 2) the likelihood of developing 

vulvar pain in the future; 3) factors associated with a future vulvodynia diagnosis; and 

4) how women with one pain condition differ from those with multiple conditions. 

Menopausal Transition 

The prevalence of vulvodynia in postmenopausal women is unknown. Studies summarized 

in the above section included women up to age 92, but Harlow was the only investigator to 

report the age at symptom onset. Although reproductive status was not ascertained, he found 

that almost 4 percent of women between the ages of 45 and 54, and another 4 percent aged 

55 to 64 years, reported symptoms of vulvodynia, e.g., burning or knifelike vulvar pain or 

pain on contact; in 50 percent of these cases, pain limited sexual intercourse. Recent population-based studies, including some postmenopausal women who took hormone replacement 

medication, found that the prevalence of painful sexual intercourse ranged from 2 to 7 percent.7,8 In postmenopausal women, vulvovaginal pain is typically associated with declining 

estrogen and the ensuing tissue atrophy. Recent studies, however, suggest that a lack of 

estrogen is unlikely to be the sole cause of pain in postmenopausal women, i.e., estrogen supplementation does not alleviate vulvovaginal pain in all cases.9,10 To date, researchers have not 

studied other factors that might cause vulvodynia in postmenopausal women. 

Research Recommendations 

• Large, longitudinal population-based studies (of both users and nonusers of hormone replacement therapy), which include a clinical confirmation component, are necessary to 

determine the prevalence of vulvodynia; risk factors associated with its development 

(e.g., hormonal changes, pelvic floor abnormalities); and preventive strategies. 

• Natural history studies of perimenopausal women with vulvodynia are needed to determine factors associated with symptom improvement or exacerbation during the 

menopausal transition. 

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Childhood and Adolescence 

Only one retrospective case study of six girls between the ages of 4 and 9 has investigated 

vulvodynia in the preadolescent population. Most girls in this study reported relatively constant pain, similar to that experienced by adult women with generalized vulvodynia. This 

condition may be largely “hidden” in children, because young girls do not use tampons and, in 

general, are not sexually active. 

Researchers have not investigated the prevalence of chronic nonsexual vulvar pain in the adolescent population, and only a few have investigated painful intercourse. A cross-sectional 

study of 251 sexually active girls between the ages of 12 and 19 found that 20 percent reported 

chronic painful intercourse, i.e., lasting 6 months or longer.11 Nearly 70 percent reported that 

symptoms started with their first intercourse attempt; the most frequently reported site of 

pain was the area surrounding the vaginal opening. Girls who experienced severe pain with 

first tampon use were four times more likely to report chronic painful intercourse. Interestingly, 

this study found that adolescent females who experienced painful intercourse did not avoid 

future sexual activity. 

In an earlier study of 172 girls and young women (ages 12–26) who visited Swedish adolescent 

health centers, researchers found that 34 percent reported recurrent vulvar pain provoked by 

intercourse.12 The following factors increased the risk of vulvar pain: regular intercourse before 

age 16; oral contraceptive use for more than 2 years; and a history of vulvar irritation, itching, 

and fissures. In another Swedish study of girls and young women aged 13 to 21 years, researchers found that 49 percent of those who had intercourse in the previous month experienced 

pain or discomfort.13 

Research Recommendations 

• Large, longitudinal population-based studies that include a clinical confirmation component are necessary to 1) assess the prevalence of vulvodynia in children and adolescents; 

2) determine risk factors associated with its development, e.g., vulvovaginal infection, 

early intercourse, and early oral contraceptive use; and 3) identify screening and preventive strategies. 

• Natural history studies of children and adolescents with vulvodynia are necessary to determine factors associated with symptom improvement or worsening during the pubertal 

transition, and identify the immediate and long-term consequences of having vulvodynia 

(e.g., avoidance of pelvic exams). 

• Natural history studies of children and adolescents suffering from chronic vulvovaginal 

conditions (e.g., dermatological disorders, recurrent vulvovaginal infection) or chronic 

pain conditions are needed to determine the likelihood of future vulvar pain. 

• Once risk factors are established, educational initiatives should be developed and 

studied to determine if awareness can alter behavior associated with the development 

of vulvodynia. 

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Pregnancy and Postpartum 

Kennedy14 conducted a prospective, longitudinal descriptive study of 103 pregnant women, in 

which self-administered questionnaires were completed at each trimester and 3 months postpartum. The prevalence of vulvar burning, itching, and pain increased during pregnancy and 

improved postpartum; however, painful intercourse increased during pregnancy and remained 

elevated postpartum. Paterson15 was the first to investigate the prevalence of genital and pelvic 

pain in the second postpartum year. At an average of 14 months postpartum, 18 percent of 114 

women reported current genital and/or pelvic pain lasting 3 months or more, and 26 percent 

reported an episode of resolved pain. Nine percent continued to experience pain that began 

after the birth of their last child. Many factors, including maternal age and number of prior 

births, were assessed, but only a history of nongenital chronic pain (e.g., migraine, back pain) 

significantly correlated with persistent pregnancy- or postpartum-onset genital/pelvic pain. 

Research Recommendations 

• Large, longitudinal population-based studies that include a clinical confirmation component are necessary to assess the prevalence of chronic vulvar pain during pregnancy and 

12–24 months postpartum, as well as risk factors associated with its development. 

• Natural history studies of women with vulvodynia are necessary to determine which factors are associated with symptom improvement or worsening during pregnancy and 

postpartum (both immediate and long-term). 

• Longitudinal studies that follow women with various chronic pain conditions during 

pregnancy and 12–24 months postpartum are necessary to assess the risk of developing 

vulvodynia. 

About the National Vulvodynia Association (NVA) 

The NVA (www.nva.org) is the only international organization serving both vulvodynia sufferers and healthcare providers who treat the disorder. Created in 1994, the NVA’s mission is to 

improve vulvodynia sufferers’ quality of life through education, support, advocacy, and funding of scientific research. 

References 

1. Harlow, B. L., Stewart, E. G. (2003). A population-based assessment of chronic unexplained vulvar pain: Have we underestimated the prevalence of vulvodynia? Journal of 

the American Medical Women’s Association, 58, 82–88. 

2. Arnold, L. D., Bachmann, G. A., Rosen, R., & Rhoads, G. G. (2007). Assessment of vulvodynia symptoms in a sample of U.S. women: A prevalence survey with a nested case 

control study. American Journal of Obstetrics and Gynecology, 196, 128.e1–e6. 

3. Sutton, J. T., Bachmann, G. A., Arnold, L. D., Rhoads, G. G., & Rosen, R. C. (2008). Assessment of vulvodynia symptoms in a sample of U.S. women: A follow-up national 

incidence survey. Journal of Women’s Health (Larchmt), 17, 1285–1292. 

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4. Reed, B. D., Crawford, S., Couper, M., Cave, C., & Haefner, H. K. (2004). Pain at the vulvar 

vestibule: A Web-based survey. Journal of Lower Genital Tract Disease, 8, 48–57. 

5. Reed, B. D., Haefner, H. K., Harlow, S. D., Gorenflo, D. W., & Sen, A. (2006). Reliability 

and validity of self-reported symptoms for predicting vulvodynia. Obstetrics and Gynecology, 108, 906–913. 

6. Reed, B. D., Haefner, H. K., Sen, A., & Gorenflo, D. W. (2008). Vulvodynia incidence and 

remission rates among adult women: A 2-year follow-up study. Obstetrics and Gynecology, 112(2 Pt 1), 231–237. 

7. Barlow, D. H., Cardozo, L. D., Francis, R. M., Griffin, M., Hart, D. M., Stephens, E., & 

Sturdee, D. W. (1997). Urogenital ageing and its effect on sexual health in older British 

women. British Journal of Obstetrics and Gynaecology, 104, 87–91. 

8. Barlow, D. H., Samsioe, G., & van Geelen, J. M. (1997). Study of European women’s experience of the problems of urogenital ageing and its management. Maturitas, 27, 239–241. 

9. Simunic, V., Banovic, I., Ciglar, S., Jeren, L., Pavicic Baldani, D., & Sprem, M. (2003). Local estrogen treatment in patients with urogenital symptoms. International Journal of 

Gynaecology and Obstetrics, 82, 187–197. 

10. James, C. E., Breeson, A. J., Kovacs, G., Hill, J. G., Grant, C., Allen, K., . . . Baylis, E. M. 

(1984). The symptomatology of the climacteric in relation to hormonal and cytological 

factors. British Journal of Obstetrics and Gynaecology, 91, 56–62. 

11. Landry, T., & Bergeron, S. (2009). How young does vulvo-vaginal pain begin? Prevalence and characteristics of dyspareunia in adolescents. Journal of Sexual Medicine, 6, 

927–935. 

12. Berglund, A. L., Nigaard, L., & Rylander, E. (2002). Vulvar pain, sexual behavior and 

genital infections in a young population: A pilot study. Acta Obstetricia et Gynecologica 

Scandinavica, 81, 738–742. 

13. Elmerstig, E., Wijma, B., & Swahnberg, K. (2009). Young Swedish women’s experience 

of pain and discomfort during sexual intercourse. Acta Obstetricia et Gynecologica 

Scandinavica, 88, 98–103. 

14. Kennedy, C. M., Turcea, A. M., & Bradley, C. S. (2009). Prevalence of vulvar and vaginal 

symptoms during pregnancy and the puerperium. International Journal of Gynaecology 

and Obstetrics,105, 236–239. 

15. Paterson, L. Q., Davis, S. N., Khalifé, S., Amsel, R., & Binik, Y. M. (2009). Persistent genital 

and pelvic pain after childbirth. Journal of Sexual Medicine, 6, 215–221. 

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STEFANIE RUSSELL, D.D.S., PH.D., M.P.H. 

New York University College of Dentistry 

The Importance of Oral Health 

As was stated in the Surgeon General’s Report on Oral Health, “. . . oral health is integral to 

general health. You cannot be healthy without oral health. Oral health and general health 

should not be interpreted as separate entities.” Indeed, links between oral and systemic health 

are at this point not just conjecture, but have been verified by empirical evidence, much of it 

gained through NIH-funded research. 

Research in recent years that seeks to examine and clarify mechanisms of oral–systemic health 

links has tended to focus on the effects of oral health on systemic disease outcomes, including cardiovascular disease and preterm birth outcomes—diseases/conditions that are highly 

prevalent in women and justly deserving of attention. It is essential, however, that the bidirectionality of the oral-systemic relationship should not be forgotten or ignored; there are many 

systemic diseases, conditions, and medications/treatments for these diseases that can have 

profound oral effects. For example, osteoporosis and medications used to prevent and/or treat 

osteoporosis have been shown to adversely affect the oral cavity. Further research is certainly 

warranted to clarify the pathways by which osteoporosis and bisphosphonates affect oral disease progression, including periodontitis, and wound healing, including healing following tooth 

extraction. In addition, the effects of diabetes—including gestational diabetes, which places 

women at greater risk for diabetes later in life—on the oral health of women is an additional 

area where there is currently little data. 

Also, attention should be paid to the fact that gender, as opposed to sex, i.e., that a woman’s 

role in society as opposed to her biology, is likely to exert significant effects on her oral health. 

While it is well-established that the effects of hormonal alterations and fluctuations, including those during puberty, pregnancy, and menopause affect the oral tissues, what is less clear 

is how gender impacts issues that affect dental health—and the effects are likely to be no 

less than those that are biological in nature. For example, while it has been generally recognized that gender affects dental healthcare access and utilization, along with rates of dental 

health-promoting and health-damaging behaviors, research is seeking to illuminate the pathways by which these gender-specific behaviors affect oral disease rates. One area where there 

is urgent need for data is in the area of pregnancy and oral health. While it is recognized that 

the oral health needs of pregnant women are unique—that pregnant women may be at elevated risk of oral disease—there is little investigation in the area of examining issues of dental 

access and utilization by pregnant women. This fact is particularly worrisome, given that during this crucial time, dentists have been shown to be reluctant to treat pregnant women. What 

are the long-term effects of this reluctance, which paradoxically, comes at a time when women 

are likely to want to improve their own health—including their own dental health—in order to 

have a positive effect on their future children? 

Finally, it should be recognized that good oral heath is a goal in itself—not only in relation 

to the overall health of the individual women, but in its own right. Barriers and facilitators to 

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good oral health are likely to vary by gender, given the differing roles of men and women—and 

clarification of these factors would likely go far in helping to design, create, and test ways to 

improve the oral health of women. 

MARLENE MCCARTHY, H.L.D. 

Rhode Island Breast Cancer Coalition 

My name is Marlene McCarthy, Volunteer Chair of the Rhode Island Breast Cancer Coalition. 

My organization has been a part of the National Breast Cancer Coalition (NBCC) since its 

inception in 1992. I welcome the opportunity to present testimony on behalf of the National 

Breast Cancer Coalition (NBCC) and the Rhode Island Breast Cancer Coalition at this hearing 

on women’s health research. 

NBCC is a grassroots organization dedicated to ending breast cancer through action and 

advocacy. The Coalition’s main goals are to increase federal funding for breast cancer research 

and collaborate with the scientific community to implement new models of research; improve 

access to high quality health care and breast cancer clinical trials for all women; and expand 

the influence of breast cancer advocates wherever breast cancer decisions are made.  The 

NBCC has developed core values for breast cancer research that reflect its vision and are fundamental to all of its research-related work.  NBCC’s Position Statement on Core Values for 

Breast Cancer Research articulates and describes these values: integrity, impact, accountability, respect, beneficence, justice, shared decision-making, and flexibility.  These values can and 

should be applied to all forms of women’s health research. 

I commend the Office of Research on Women’s Health at NIH for embarking on this endeavor 

to collect information and solicit input from scientific and public policy experts, health care 

providers and advocacy organizations as it looks toward the next decade of women’s health 

research.  NBCC strongly believes that the enterprise of clinical and scientific research at NIH 

could be vastly improved with greater participation from educated health care consumers and 

trained advocates who can help to inform all aspects of decision making at the Office of Women’s Health Research and across the Institutes. 

NBCC also has deep concerns about the lack of transparency, external oversight and accountability in research priority-setting, decision-making and evaluation. What is important now is 

to determine the right process for and atmosphere within which women’s health research will 

be prioritized and conducted. We must make certain that the process maximizes our getting 

the right research done in the right way. 

Need for Greater Transparency, Oversight and Accountability 

During this era of change, all federal agencies, but particularly at the NIH, must embrace 

and incorporate greater transparency and public accountability at every level and in everything they do.  As our nation’s foremost biomedical research institution, NIH’s lack of diversity 

in stakeholder representation, dissenting viewpoints in evaluating programs and projects 

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is alarming.  For instance, when NCI decided to evaluate the cancer centers, the committee chosen had a significant number of cancer center directors as members.  The NIH Reform 

Act created the Scientific Management Review Board to conduct periodic reviews and issue 

reports on organizational issues at NIH. The NIH Director submitted the list of members of this 

Board to Congress, and its membership includes nine institute directors, several major institutions that receive significant funding from NIH and one industry representative. There were 

no consumer advocates as part of this Review Board. The Review Board clearly lacks independence and the ability to conduct meaningful oversight. 

While there is a great deal of discussion about reform and innovation, there does not appear 

to be an overarching framework or objectives and a strategy to analyze past funding and to 

govern funding going forward, at least not one that includes meaningful benchmarks and critical evaluations and is accessible by the public and policy makers.   

Taxpayers deserve to know that the agency tasked with charting scientific and medical breakthroughs is being prudent stewards of the billions being appropriated to its mission each year. 

Consumer Advocate Participation in Research Decision Making 

Consumers—lay advocates who are trained and educated—can play an integral role in ensuring that the research that is funded is responsive to needs of both the scientific and patient 

communities. Their perspective is necessary to ensure that the grants funded are meaningful 

and will have impact.  Consumer advocates bring a vitally important perspective to scientific 

research, and they keep the scientists on task.  Together, they can look at the current state of 

knowledge and then design appropriate and necessary mechanisms to allow scientists, in collaboration with advocates, to develop proposals to research the most important questions 

as well as advise on priorities for funding research.  The Department of Defense Peer Review 

Breast Cancer research program has proven that this is an effective and valuable model of scientist-advocate collaboration. 

The peer review process is the accepted method for identifying meritorious scientific trials and 

studies.  However, the peer review process has traditionally excluded those most affected by 

research—the patients themselves.   The peer review process is only enhanced by the involvement of advocate “peers”—activists outside the scientific and medical communities who bring 

a unique and important perspective to the scientific discussion.  Ideally educated advocates 

must be included on all research peer review panels in both the public and private sector. 

Clinical trials are another critical area for advocate involvement.  Advocates can provide 

important insights into the design of clinical trials and invaluable assistance in increasing 

awareness and knowledge of clinical trials.  They must be substantive collaborators in the 

research process. Moreover, it is important to have meaningful advocate involvement in scientific meetings in which the Office on Women’s Health is involved.  Advocates must be part of 

program planning committees and participate as session chairs or co-chairs.  There must be 

opportunities for interaction between scientists and advocates at discussion sessions and in 

mentoring programs.  Finally, advocates must be provided opportunities to present their work 

and their perspective at poster and platform sessions.  

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Educated advocates can have a meaningful impact on how best to communicate information 

and research findings to providers, patients and the public.  The NBCC framework for national 

health care reform calls for a national panel to be established to work with the public to review 

evidence and help design effective methods for communicating health care information to 

consumers, providers and plans. 

An example of where educated advocates played a critical part in the development and 

evolution of a research project is the Women’s Health Initiative (WHI).  As you are well 

aware, it is a large clinical trial, one part of which looked at a particular hormone replacement 

therapy—progestin plus estrogen vs. placebo—to determine the benefits and risks of that 

approach.  The trial was supposed to end in 2005, but it was stopped in 2002 because the 

overall health risks of HRT exceeded the benefits.  In fact, the trial showed an increased risk 

of breast cancer as well as heart disease, blood clots and stroke.  Women had taken HRT for 

years before the trial was conducted to look at these issues.  While the intervention aspect of 

the trial was stopped, that is, women were no longer given the drugs, HRT or placebo, as in 

any well-designed trial, the investigators continued to follow the women. 

After several years of following these women after the trial stopped, it was determined that the 

cardiovascular risks were no longer greater in the group of women who had taken HRT than 

in the women who received placebo. However, it appears that the breast cancer risk may continue. While the higher risk remained throughout the intervention and the follow up period, 

looking at the follow up period alone, the results were not statistically significant. What does 

that mean? Since we are not certain what drugs the women took after the trial was stopped— 

or what else changed in their lives—and because the follow up was only three years, we cannot 

yet say with certainty that the breast cancer risk continues. We can say that it is likely. 

It is important to keep in mind that the Women’s Health Initiative would not have happened 

without advocacy from the women’s community.  It is very important to remember that 

women took these drugs when there was no high level evidence they would benefit and not 

harm them. And it is extremely relevant to note that advocacy groups such as the National 

Breast Cancer Coalition questioned the lack of evidence behind these drugs for many years. 

Conclusion 

In summary, the agenda for women’s health research must be set and implemented in an 

atmosphere of transparency and through a process that is accountable and includes trained, 

educated advocates. 

We must make certain that the public can access and understand allocation of resources and 

the vast array of research projects being undertaken.  NIH must enhance its ability to conduct 

meaningful science through these changes. 

Again, I thank you for the opportunity to present these views and look forward to working 

with the Office of Women’s Health Research and others at NIH to transform the Institutes, conduct meaningful research and give the American public greater insight and involvement in 

women’s health research and biomedical research in general. 

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KATHERINE SILBERMAN, J.D. 

Science & Environmental Health Network 

Testimony of Katherine Silberman, Associate Director, Science and Environmental Health Network 

Thank you for giving me the opportunity to testify. My name is Katherine Silberman and I am 

the Associate Director of a national nonprofit organization, the Science and Environmental 

Health Network (SEHN), with an office here in Providence. 

SEHN is a grassroots-oriented think tank for the environmental movement, and a leader of the 

successful movement to reform environmental and public health policy from the community 

level up, based on the precautionary principle. SEHN is a communal think tank; our ideas come 

through work with real people working on real problems, and with government bodies committed to their role as protectors of the public’s well-being. We shape the ideas into usable 

forms as policies, arguments, and information; continue the dialog and learning with our many 

partners; and help implement the ideas in the real world. 

I am here today to urge the Office of Research on Women’s Health (ORWH) to consider women’s environmental health as a major research focus. Of the priorities outlined by ORWH for 

the next several years—including normal processes, aging, and emerging diseases—environmental health affects each one. Indeed, environmental factors are causally linked to disease 

across a women’s entire life cycle, from conception until death. Due to time constraints, I will 

only discuss a few examples, following the timeline of a woman’s life cycle. 

Reproductive Health 

Birth Defects 

Human life itself depends on women’s ability to bear healthy children. We know that birth 

defects are a major cause of miscarriage and fetal death, and that nearly half of all pregnancies today result in the loss of the embryo or fetus, often very early in pregnancy. Many of 

these losses are due to problems that would have resulted in birth defects. 

The cause of most birth defects is unknown, and many seem to be caused by some combination of genes and environment. But some direct correlations have been drawn between 

specific environmental chemicals and specific outcomes. Endocrine-disrupting chemicals such 

as Bisphenol-A can cause hypospadias in baby boys, a condition that has doubled in incidence 

in 20 years. A number of studies have linked pregnant women’s pesticide exposure to birth 

defects, including fetal death. Perhaps most alarmingly, recent studies have shown that certain 

chemical exposures in utero can actually change the genetic makeup of the baby, and can be 

passed down to that baby’s descendants—meaning that a single exposure might harm a family’s health for generations to come. 

Childhood 

Asthma 

The number of children with asthma in the United Sates has more than doubled since 1980. 

Although genetic factors are involved, environmental factors are almost certainly responsible 

for such dramatic increases in incidence rates. 

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In the United States, asthma is most common in African-American children living in urban 

areas. Ozone and fine-particle pollution from diesel engine exhaust have been causally linked 

to childhood asthma, and kids growing up along streets with heavy truck traffic are more likely 

to have asthma-related respiratory symptoms. 

Pesticide exposure has also been liked to asthma. A recent study found that infants exposed 

to herbicides and pesticides before age 1 were much more likely to develop early persistent 

asthma. Childhood asthma causes tremendous suffering for the kids, expense for the families 

and for society, and causes children to miss school. 

Neurological Disorders 

Childhood brain disorders such as learning disabilities, behavioral and emotional disorders, 

and autism have all been liked to environmental exposures. The developing brain is extraordinarily complex, and seems to be affected by some combination of genetic, environmental, and 

social factors. But several environmental chemicals have been causally linked to neurological 

damage, including lead, mercury, perchlorate, solvents, and some pesticides. 

Particularly concerning is the effect of environmental exposures on the developing brains of 

fetuses, babies, and children. Much is unknown about brain science, but we do know that the 

developing brain perinatally and during early childhood is exquisitely sensitive to chemical disruption, and that certain times of exposure are particularly dangerous. A chemical that could 

have no lasting effect on an adult brain could irreparably damage the brain of a developing 

fetus or toddler. 

Adulthood 

Breast Cancer 

Almost every single one of us now knows a woman who has had breast cancer. The rise in 

breast cancer incidence rates in recent years points to contributing environmental factors. 

We do know that more than 200 chemicals have been identified as mammary carcinogens 

by international agencies. Specific chemicals that have been linked to breast cancer include 

several pesticides, Bisphenol-A, polycylic aromatic hydrocarbons (which are products of combustion), dioxins, phthalates, and parabens. These latter two may be of particular concern 

because of their ubiquity in women’s personal care products, such as lotion and makeup that 

women spread on their bodies every day. 

Aging 

Parkinson’s Disease 

Like most neurological diseases, the causes of Parkinson’s Disease remain largely unknown. 

However, many studies point to the interaction of genes and environmental factors. Chemicals 

that have been causally linked to Parkinson’s include pesticides such as Rotenone and Paraquat, and heavy metals such as aluminum, iron, and lead. 

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Alzheimer’s Disease 

Alzheimer’s, like Parkinson’s, seems to be caused by the interaction of genetic, environmental, 

and social factors. Chemicals of concern include lead and other heavy metals, PCBs and other 

persistent organic pollutants, pesticides, and endocrine disruptors. But scientific evidence 

points to a more disturbing trend: Alzheimer’s disease seems to be linked to other serious 

diseases of modern times. Diabetes, obesity, hypertension, elevated blood lipids, and metabolic syndromes—like Parkinson’s and Alzheimer’s—appear to stem from inflammation and 

excessive oxidative stress. My organization, the Science and Environmental Health Network, 

recently released a report entitled, Environmental Threats to Healthy Aging: With a Closer Look 

at Alzheimer’s & Parkinson’s Diseases. The report calls this group of diseases the “Western Disease Cluster,” and explains how environmental factors are contributing to rising incidence rates 

and what policymakers can do to reverse the trends. I would like to submit the report to the 

panel today for your consideration. 

Conclusion 

In the interest of brevity and clarity, my remarks today have been limited to spotlighting 

specific chemicals that are causally linked to specific diseases across the female life cycle. 

Unfortunately, though, such one-to-one causation is not how any of us live in our daily lives. 

Instead, we are constantly exposed to thousands of chemicals—and perhaps most crucially, 

to the combined effects of several chemicals at once. Through a combination of the lack of 

sufficient regulatory laws and the slow pace of science, the health effects of most of these 

chemicals are largely unknown. The health effects of the combination of dozens or even hundreds of chemicals in our bodies—which is the situation many of us are in right now—are 

unfathomable. What we do know is that environmental links to women’s diseases are real, the 

science is catching up, and meanwhile the human, financial, and societal costs of these diseases are immense. 

I am speaking today in my professional capacity as Associate Director of a national advocacy organization. But I am also speaking as a mother and daughter who has experienced, 

within my own family, infertility, pregnancy loss, breast cancer, ovarian cancer, and other diseases that affect so many women’s lives. In both capacities, I urgently petition the ORWH to 

consider environmental factors in women’s health, and to take action to protect women and 

girls from developing diseases that we know can be preventable. In 12 years, you will be able 

to look back proudly and rightly claim your mantle as a leader in the field of environmental 

health science, knowing that you prevented suffering in women across the country. 

Notes 

• Scientific references may be found at the Web site of the Collaborative on Health and Environment: http://healthandenvironment.org/diseases, or by request. 

• Submission during oral testimony: Environmental Threats to Healthy Aging: With a Closer Look at Alzheimer’s & Parkinson’s Diseases (report by the Science and Environmental 

Health Network, 2008. Also available at http://www.agehealthy.org). 

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JULIA BRODY, PH.D. 

Silent Spring Institute 

Environmental Pollutants and Women’s Health: Research and Public Health Policies Affecting 

Exposures Across the Lifespan Hold Promise for Prevention of Breast Cancer and Other 

Hormonal Health Effects 

Thank you for the opportunity to testify today. My name is Julia Brody. I am the Executive Director of Silent Spring Institute and an Adjunct Assistant Professor in the Department 

of Pathology here at Brown Medical School and in the Department of Epidemiology at the 

Boston University School of Public Health. Silent Spring Institute is a nonprofit research organization founded by leaders of the Massachusetts Breast Cancer Coalition to study the links 

between the environment and women’s health, with a focus on breast cancer and a goal of 

prevention. Silent Spring Institute’s multidisciplinary scientific staff has conducted research in 

collaboration with researchers here at Brown University and at Harvard, Tufts, Boston University, the University of California–Berkeley, the U.S. Centers for Disease Control and Prevention, 

and elsewhere. Our research is funded by the National Institutes of Health, the National Science Foundation, and the Avon Foundation for Women, among others, and published in 

peer-reviewed scientific journals, including Cancer, Environmental Health Perspectives, Environmental Science & Technology, and American Journal of Public Health. 

Why Focus on Breast Cancer Prevention? 

Breast cancer is the most common invasive cancer in women worldwide and the leading cause 

of death for U.S. women from their late 30s to early 50s, years when they are raising children 

and contributing to their communities.1 Screening and improved treatment have improved survival, and incidence has dipped, since many women went off hormone replacement therapy. 

Although we hope and expect these trends to continue, treatment is likely to remain arduous 

and debilitating for the foreseeable future, with significant adverse effects. Financial costs of 

treatment are substantial, amounting to $8.1 billion in the United States in 2004, according to 

the National Cancer Institute. While these statistics represent the aggregated burden of breast 

cancer, no one in this room need look very far to see that burden personified in a mother, sister, 

daughter, friend, coworker, or neighbor. That’s why leaders of the Massachusetts Breast Cancer 

Coalition; the Breast Cancer Fund; Breast Cancer Action; women on Long Island, New York, and 

in Marin County, California; and in other breast cancer organizations across the country have 

called on our nation to tackle primary prevention as the goal—not just early detection, not just 

new chemotherapy, not chemoprevention with costly drugs that have their own downside, but 

fewer women getting sick because environmental causes of breast cancer have been controlled. 

The good news is that scientific evidence supports this ultimate goal as entirely realistic. 

Environmental Pollutants and Breast Cancer: What Do We Know Now? 

My remarks target the possible role of environmental pollutants and the need to uncover and 

address the effects of environmental pollution across the lifespan. While my focus is on breast 

cancer, the chemicals of interest for breast cancer are also relevant to other hormonal cancers 

(e.g., ovarian, endometrial), fertility, puberty, obesity, and other health outcomes of importance for girls and women. 

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I led a team of researchers from Silent Spring Institute, Harvard University, Roswell Park Cancer Institute, and the University of Southern California that reviewed the scientific literature on 

breast cancer and environmental pollutants in Cancer, a peer-reviewed journal of the American 

Cancer Society, and in an online database, which was highlighted as a “Net watch” selection 

by Science.1,2,3 This project, which also reviewed scientific evidence on breast cancer and physical activity, body size, diet, and early life exposures, was supported by Susan G. Komen for the 

Cure. You can access the published papers, database, and lay summaries at http://www.silentspring.org/sciencereview. 

Given that breast cancer is influenced by exposures that begin prenatally (for example, 

twinning and preeclampsia)4 and extend within the 5 years before diagnosis (for example, 

hormone replacement therapy), the task of identifying effects of environmental pollutants 

in human breast cancer studies is daunting, so we are wise to begin by assessing, first, the 

evidence from animal and cell studies of plausible biological mechanisms and, second, the evidence that people are substantially exposed.5

 I have previously discussed this line of reasoning 

at greater length in my invited testimony last year before the President’s Cancer Panel, which 

focused for the first time on environmental factors and cancer. 

Laboratory evidence supports at least three biological mechanisms that may link environmental pollutants and breast cancer: 1) chemicals that cause mammary gland tumors in animals 

are predominantly mutagens, acting as classic carcinogens that damage DNA; 2) chemicals 

called endocrine-disrupting compounds (EDCs) mimic or block hormones, including estrogen, 

a known breast cancer risk factor; and 3) developmental toxicants can divert development of 

the mammary gland in ways that may permanently increase susceptibility.6,5,3 

The chemicals that show these types of biological activity are ubiquitous environmental pollutants and are common in workplaces, consumer products, and building materials.7,8,9 Before I 

discuss examples, though, let me emphasize that most chemicals in use today have never been 

tested for these effects. 

Turning to chemicals that have been tested in animal cancer bioassays, 216 chemicals caused 

mammary gland tumors.9

 About 100 are common exposures: 73 have been present in consumer products or as contaminants in food; 35 are air pollutants; 25 have been associated 

with occupational exposures affecting more than 5,000 women a year; 29 are produced in the 

United States in large amounts, often exceeding 1 million pounds per year; and 47 are pharmaceuticals. Examples of mammary carcinogens include polycyclic aromatic hydrocarbons (PAHs, 

e.g., in air pollution, auto exhaust, tobacco smoke, and grilled and smoked food); mutagen X, 

a byproduct of drinking water chlorination; benzene, which is in gasoline; ethylene oxide, a 

common sterilant in healthcare and food processing; methylene chloride, an industrial solvent; 

amsonic acid, an optical brightener in laundry detergents; and some pesticides. A recent study 

by the Kaiser health plan in Northern California supported the relevance of the animal model 

to humans, finding that for three of six pharmaceuticals they evaluated from our review, breast 

cancer incidence was increased in women taking those medications.10 

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Estrogen mimics, chemicals that make human breast cancer cells proliferate in the laboratory, 

include Bisphenol A, the topic of numerous news stories last year about baby bottles, toys, 

sports water bottles, food can liners, and other products; many pesticides; and compounds in 

cleaners and personal care products, like hand lotions and make-up (ourstolenfuture.org). EDCs 

are now common pollutants in surface water and groundwater that supplies drinking water.7 

For endocrine-mediated developmental toxicants, diethylstilbestrol (DES) is an important 

model. We learned tragically that a mother’s exposure during pregnancy increases cancer risk, 

including breast cancer, in her offspring. Animal studies show stunted mammary gland development and increased susceptibility to mammary carcinogens following in utero exposure 

to the EDC dioxin, and evidence of similar effects on mammary gland development is accumulating for additional chemicals, including the pesticide, atrazine, widely used in the United 

States.12 Research showing that low doses of chemicals can distort development is one of the 

most troubling and rapidly growing fields of science, and it requires additional support. 

Turning to human exposure to chemicals that fit these three profiles, the National Report on 

Human Exposure to Environmental Chemicals13 is the best source of information on the typical exposure to environmental pollutants in the U.S. population. This resource is how we know 

that public health measures to reduce exposure to lead and environmental tobacco smoke are 

working. The study has tested for about 15 of the animal mammary gland carcinogens and 

for selected EDCs, including, for example, some pesticides and phthalates, dioxins, polychlorinated biphenyls, and brominated flame retardants. Because the Government has been so slow 

to address the health effects of environmental pollutants, a number of advocacy organizations have tested for these and additional chemicals in children and adults across the country. 

Results show that all of us carry residues of numerous toxic chemicals in our bodies, often at 

levels shown in other studies to be biologically relevant. 

My own research team has focused on understanding where these exposures come from 

through our study of 89 EDCs in 170 urban, suburban, and rural homes, located far from 

industry and in mostly nonagricultural areas.9,14 For 30 of the chemicals, our Cape Cod, Massachusetts, “Household Exposure Study” was the first report on levels indoors. We found 

67 different EDCs; the average home indoor air sample contained 19 different compounds. 

We found 27 different pesticides in house dust and indoor air. EDCs from sources like laundry detergent and cosmetics were among the most abundant chemicals detected and were 

found in nearly every home. We found DDT, banned in 1972, in two-thirds of the homes. The 

mundane ways in which high exposures arise is illustrated by our case studies of PCBs and 

brominated flame retardants. We unexpectedly found very high levels of PCBs in two homes 

with no obvious source; one home’s resident had higher blood levels than anyone in the CDC 

National Exposure Report. We discovered the likely cause was a common floor finish used in 

the 1950s and 1960s. This story is not simply the legacy of a bygone era. In our latest research, 

we found levels of brominated flame retardants in California blood samples and household 

air at 2 to 10 times the levels elsewhere, likely due to the State’s unique furniture flammability standard, which encourages use of these chemicals.15 These findings are the result of our 

unfortunate “innocent until proven guilty” approach to placing chemicals into widespread use. 

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The limited epidemiologic research on environmental pollutants and breast cancer reveals that 

very few of the chemicals identified as animal mammary gland carcinogens or EDCs have ever 

been included in a human breast cancer study.2

 Studies that have been done are often limited by lack of good measures of exposure. Nevertheless, the epidemiologic literature provides 

some evidence of associations between chemical exposures and breast cancer. Four studies of PCBs show higher breast cancer risk in women with a genetic variation that affects its 

metabolism.2

 A unique study with access to stored blood collected in young women in 1959– 

1967 found 5-times-higher breast cancer risk associated with higher DDT exposures before age 

14.16 Some studies of PAHs, air pollution indicators, environmental tobacco smoke, dioxin, and 

organic solvents provide evidence of increased risk, particularly in young women or with exposure at a young age.2 

Research and Public Health Implications 

Our current research and public health programs are not set up to identify and respond to 

potential health risks from numerous environmental pollutants and chemicals in commerce. I 

urge the Office of Research on Women’s Health to proactively work to incorporate research 

about environmental pollutants across the lifespan. I recommend to you the California Breast 

Cancer Research Program (CBCRP) Special Research Initiative17 as a model that begins to 

address the priorities for change that I outline below. 

Develop Research Funding Programs That Explicitly Focus on the Role of 

Environmental Pollutants in Disease Etiology 

We must expand our nation’s investment in prevention, including studies of environmental pollutants. For women’s health, priorities must include research to identify and understand chemicals 

that are mammary gland carcinogens, endocrine disruptors, and developmental toxicants. 

Develop and Apply Methods for Chemicals Screening 

Just as our medical research agenda includes translation of basic science into treatment 

protocols, environmental health research requires translation into evidence-based public 

health policies. In order to reduce harmful environmental exposures, we need to develop the 

research base for rational chemicals-use policies. That means we need methods, including 

high-throughput tests, to screen larger numbers of chemicals more thoroughly and at realistic costs for mutagenicity, carcinogenicity, endocrine disruption, and developmental toxicity. 

Pharmaceutical companies are using new technologies for drug discovery; we need public 

investments to apply these techniques to chemicals screening. 

Develop and Apply Methods for Exposure Assessment 

Similarly, we need new methods to measure exposure in environmental and biological samples 

and expanded laboratory capacity to evaluate samples from diverse communities and settings. 

New methods are needed to integrate effects of chemical mixtures. The National Exposure Report is an important monitoring tool that should be expanded to additional chemicals 

and more detailed subpopulation assessments, and we should immediately update the 1980s 

National Occupational Exposure Survey assessment of women’s workplace chemical exposures. 

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Work With and Advocate Increased Funding for Agencies With 

Environmental Science Expertise 

Government programs with the expertise to advance environmental health research and risk 

reduction are the National Institute of Environmental Health Sciences (NIEHS), including the 

National Toxicology Program; the U.S. Environmental Protection Agency; the National Center 

for Environmental Health at the U.S. Centers for Disease Control and Prevention; the National 

Institute for Occupational Safety and Health; and the intramural Occupational and Environmental Epidemiology Branch of the National Cancer Institute. 

Support Public Engagement 

In order to guide public interest in science and inspire public commitment to research and policy change, scientific leaders must take responsibility for forming research partnerships that 

engage, educate, and empower Americans to participate in environmental health science 

and policy development. These efforts should achieve the same standards of excellence we 

expect of technical science. The NIEHS community-based participatory research program and 

California Breast Cancer Research Program offer useful models and there is much room for 

expansion and further innovation. 

Support significant focus on environmental pollutants in the best cohort studies. The National 

Children’s Study, Sister Study, Agricultural Health Study, Breast Cancer and the Environment 

Research Centers, and studies of accidentally exposed cohorts are examples of important 

resources for our future that can expand research on environmental pollutants. 

Silent Spring Institute was named, of course, in honor of Rachel Carson and her pioneering 1962 book, Silent Spring, which reported on careful scientific observations of die-offs 

and deformities in fish, birds, insects, and amphibians to alert us to the dangers of releasing 

untested chemicals into the environment. Carson was one of very few women on the lists of 

the most important people of the 20th Century. She is a hero to girls everywhere who dream 

of scientific careers. She died of breast cancer just 2 years after publication of her worldchanging book. As she struggled through treatment for her own disease, she wrote in Silent 

Spring, “For those in whom cancer is already a hidden or a visible presence, efforts to find 

cures must of course continue. But for those not yet touched by the disease and certainly for 

the generations as yet unborn, prevention is the imperative need.” I hope you will heed her 

guidance as you set the research agendas that will determine the future for the next generations of girls. 

References 

(Selected bibliography as a resource for additional detail) 

1. Birnbaum, L. S., & Fenton, S. E. (2003). Cancer and developmental exposure to endocrine disruptors. Environmental Health Perspectives, 111, 389–394. 

2. Brody, J. G., Moysich, K. B., Humblet, O., Attfield, K. R., Beehler, G. P., & Rudel, R. A. 

(2007). Environmental pollutants and breast cancer: Epidemiologic studies. Cancer, 

109(12 Suppl), 2667–2711. 

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3. Brody, J. G., Rudel, R. A., Michels, K. B., Moysich, K. P., Bernstein, L., Attfield, K. R., & 

Gray, S. (2007). Environment and breast cancer—Where do we stand? Cancer, 109(S12), 

2627–2634. 

4. Brody, J. G., & Rudel, R. A. (2008). Environmental pollutants and breast cancer: The 

evidence from animal and human studies. Breast Diseases: A Year Book Quarterly, 19(1), 

17–19. 

5. California Breast Cancer Research Program. (n.d.). Special research initiatives [Fact 

sheet]. Retrieved from http://www.cbcrp.org/sri/ 

6. Centers for Disease Control and Prevention. (2009). National report on human exposure 

to environmental chemicals. Atlanta, GA: National Center for Environmental Health, 

Division of Laboratory Science. 

7. Cohn, B. A., Wolff, M. S., Cirillo, P. M., & Sholtz, R. I. (2007). DDT and breast cancer in 

young women: New data on the significance of age at exposure. Environmental Health 

Perspectives, 115, 1406–1414. 

8. Colborn, T., Dumanoski, D., & Myers, J. P. (n.d.). Our stolen future: Recent important scientific studies. Retrieved from http://www.ourstolenfuture.org/New/recentimportant.htm 

9. Friedman, G. D., Jiang, S. F., Udaltsova, N., Chan, J., Quesenberry, C. P., Jr., & Habel, L. 

A. (2009). Pharmaceuticals that cause mammary gland tumors in animals: Findings in 

women. Breast Cancer Research and Treatment, 116, 187–194. 

10. Kolpin, D. W., Furlong, E. T., Meyer, M. T., Thurman, E. M., Zaugg, S. D., Barber, L. B., 

& Buxton, H. T. (2002). Pharmaceuticals, hormones, and other organic wastewater 

contaminants in U.S. streams, 1999-2000: A national reconnaissance. Environmental 

Science & Technology, 36, 1202–1211. 

11. Rayner, J. L., Enoch, R. R., & Fenton, S. E. (2005). Adverse effects of prenatal exposure 

to atrazine during a critical period of mammary gland growth. Toxicological Sciences, 

87, 255–266. 

12. Rudel, R. A., & Perovich, L. J. (2009). Endocrine disrupting chemicals in indoor and 

outdoor air. Atmospheric Environment, 43, 170–181. 

13. Rudel, R. A., Seryak, L. M., & Brody, J.G. (2008). PCB-containing wood floor finish is a 

likely source of elevated PCBs in residents’ blood, household air and dust: A case study 

of exposure. Environmental Health, 7, 2. doi:10.1186/1476-069X-7-2. 

14. Rudel, R. A., Attfield, K. R., Schifano, J. N., & Brody, J. G. (2007). Chemicals causing 

mammary gland tumors in animals signal new directions for epidemiology, chemicals testing, and risk assessment for breast cancer prevention. Cancer, 109(12 Suppl), 

2635–2666. 

15. Rudel, R. A., Camann, D. E., Spengler, J. D., Korn, L. R., & Brody, J. G. (2003). Phthalates, alkylphenols, pesticides, polybrominated diphenyl ethers, and other endocrinedisrupting compounds in indoor air and dust. Environmental Science & Technology, 37, 

4543–4553. 

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16. Xue, R., & Michels, K. B. (2007). Intrauterine factors and risk of breast cancer: A systematic review and meta-analysis of current evidence. Lancet Oncology, 8, 1088–1100. 

17. Zota, A.R., Rudel, R. A., Morello-Frosch, R. A., & Brody, J.G. (2008). Elevated house dust 

and serum concentrations of PBDEs in California: Unintended consequences of furniture flammability standards? Environmental Science and Technology, 42, 8158–8164. 

doi:10.1021/es801792z. 

REBECCA GASIOR ALTMAN, PH.D. 

Tufts University 

Reproductive Health and the Environment 

In 2008, I earned my Ph.D. in sociology from Brown University, with a focus on the relationship between human health and the environment. I now teach part-time in the Community 

Health Program at Tufts University, while raising my son and writing about women’s health 

and chemical body burden, among other topics. I am grateful for the opportunity to submit 

testimony on behalf of myself to encourage the National Institutes of Health (NIH) Office of 

Research on Women’s Health to prioritize research on environmental health research, with a 

specific focus on the contribution of chemical pollution to women’s reproductive health. Based 

on my doctoral research, I suggest that special attention be afforded to those women who live 

in “hotspots” where chemical pollutants are used, stored, or unexpectedly accumulate, such as 

the circumpolar North. 

My testimony provides evidence that women’s environmental health, and particularly the field 

of reproductive environmental health, merits special attention by the NIH based upon prior 

research and consensus statements issued by experts in the field.1

 I conclude with a brief commentary about the value of involving impacted women and communities in future research, 

and on the need for translation of reproductive environmental health research to clinicians 

who treat women in OB/GYN practices, hospitals, and community health centers. 

A growing number of healthcare providers report a rise in patients seeking treatment 

for infertility and other reproductive health issues.2 While current research suggests that 

reproductive health may be supported or compromised by several factors, including 

age, genetics, nutritional health, stress, and pharmaceutical use,3 mounting scientific evidence also supports that environmental chemicals and contaminants commonly found in 

the human environment, drinking water, and food supply can influence human fertility and 

reproduction, albeit in complex, often poorly understood ways. Several symptoms or conditions that span a woman’s lifecycle have been linked, or are associated with, environmental 

exposures. These include the following:4 

• Malformed reproductive organs 

• Premature ovarian failure 

• Premature or delayed menarche5 

• Infertility or compromised fertility 

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• Recurrent pregnancy loss 

• Inability to carry baby to term, pregnancy compromise, birth defects, congenital 

abnormalities, and low birth weight
�

• Premature menopause 

• Uterine fibroids 

Researchers also report rising rates of diseases or conditions known to affect human fertility in 

which environmental exposures might also play a role in their etiology, including endometriosis and polycystic ovarian syndrome.1 

Though more research is critical, reproductive environmental health researchers agree there is 

already a substantial body of evidence implicating low-level exposures as a likely contributor 

to trends currently seen in reproductive outcomes.1 

Timing of Exposures 

Scientists now know that the placenta does not shield the developing fetus from chemicals 

or pollutants the mother encounters.6

 As a result, many conditions and diseases of women’s 

reproductive tracts have origins in exposures encountered during particular periods of 

fetal development.1 

The effect of in utero exposures was first seen among the children of women who were, beginning in the 1940s, prescribed DES, a synthetic estrogen, to prevent miscarriage. Though not 

apparent at first, as exposed children reached puberty, a pattern of reproductive health problems emerged. Followup research has confirmed a host of outcomes in both the male and 

female children of women who took DES, including rare reproductive cancers and malformed 

reproductive organs, menstrual irregularities, and infertility or subfertility, i.e., difficulty conceiving.7

 Today, DES serves as one model for how fetal exposures during critical periods of 

fetal development can affect reproductive health in later life stages. 

A body of evidence now demonstrates that many chemicals humans routinely encounter in 

the environment can mimic or interact with the endocrine system, and like DES, can affect the 

fertility and reproductive health of offspring, though through other biological mechanisms.6,8 

Synthetic or human-made substances can exhibit estrogenic, androgenic, or antiestrogenic 

and antiandrogenic properties. That is, they can act like hormones, or block normal hormone 

function, which in turn, affects reproductive development.6 

So-called “endocrine disruption” of human reproduction by environmental chemicals has been 

demonstrated in animals, but more recently in humans, as well. A 2003 study published in The 

Lancet found that women with higher in utero exposures to DDT—a pesticide banned from 

use in the United States, but still used in other countries and present in circumpolar ecosystems9,10—took longer to conceive once they reached reproductive maturity.11 

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Environmental chemicals also interfere with the fertility of subsequent generations by altering how genes direct key biological processes. Anway et al.12 found that when pregnant female 

mice were exposed to two commonly used pesticides, vinclozolin and methoxychlor, the exposures compromised the fertility of male offspring in three subsequent generations. This is the 

first study to find multigenerational effects. Although the study was performed on mice and 

involved exposures that are higher than humans might encounter, it is biologically plausible 

that similar trends might be seen among humans since genetic processes are known to be reasonably similar in both species.12 

Sources of Environmental Exposures 

In some instances, women are exposed by inhaling air or drinking water that is contaminated 

by pollutants. Exposures can occur at home or on the job, outdoors as well as indoors, as 

many reproductive toxicants found in building materials, furnishings, and consumer products 

can collect in household air and dust,13 a burgeoning area of environmental health science in 

women’s health. In some cases, exposures can occur when substances containing reproductive 

toxicants are absorbed into the skin, such as phthalates (pronounced ‘thal-lates’), which are 

commonly added to self-care and beauty products.13 

While researchers document these compounds in air, water, soil, foods, and consumer products, research also confirms that these substances enter the body. Ongoing population 

monitoring conducted by the U.S. Centers for Disease Control and Prevention (CDC) reports 

that the average American carries detectable levels of various reproductive toxicants that are 

also present in the environment.14 In general, many chemicals and pollutants, because of their 

chemical and physical characteristics, either build up in human systems rather than being 

excreted, or are ubiquitous so that, even if successfully excreted by the body, constant reexposure maintains elevated body levels. 

Sometimes these substances are detected in human bodies at levels known or suspected to 

affect the reproductive system, and at levels that have flagged the attention of researchers 

and healthcare providers alike.1 More commonly, however, at the low levels detected, scientists and government researchers are uncertain about whether and how such compounds 

affect the function of the human body15 and the reproductive system. This uncertainty, in part, 

stems from limited scientific research in this area. One recent tabulation concluded that less 

than 10 percent of the 100,000 chemicals currently registered for commercial use have been 

studied for their human health effects and in particular, for what reproductive effects they 

might pose.16 

Research To Eliminate Exposures in Chemical Hotspots 

Regarding exposures, special attention must be given to those women facing disproportionate 

exposure burdens in the United States. Here, I focus on the unique burdens borne by Alaska 

Native women, like women throughout the circumpolar region, who bear a disproportionate 

burden of environmental contaminants.17,18,19,20 In the United States, several known or suspected 

reproductive toxicants and endocrine-disrupting compounds, such as polychlorinated biphenyls (PCBs) and pesticides, have been detected in the Alaskan environment and food system, 

as well as in the blood of some Alaska Native people18,20,22 and other circumpolar populations.17 

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For women living in the Arctic and sub-Arctic regions of the United States, these chemicals 

and contaminants originate from both local and remote sources. Many chemicals and heavy 

metals are produced or released into the environment by industries located in the Lower 48 

States and throughout the world, but because they are slow to degrade, and can travel vast 

distances in air and water currents, they tend to condense, concentrate, and then persist in the 

cold, northern climate. As a result, the circumpolar Arctic region has become a hemispheric 

sink for many pollutants and chemicals that may pose reproductive risks.18,23 Local industries 

and formerly used defense sites are also likely sources of exposures to heavy metals (e.g., lead 

and mercury) and industrial chemicals (e.g., PCBs) in Alaska.24 PCB exposures, a particular 

concern in some regions of Alaska, may result not just from global transport, but also from formerly used defense sites in Alaska.21 

Persistent pollutants such as these enter the food chain, where they concentrate in the fatty 

tissues of predator species. As a result, many of these pollutants are found in the foods that 

sustain a significant portion of the Alaskan population.18,19,20,22 Although a significant public health concern, traditional foods remain the best source of sustenance for Alaska Native 

women, as they are both nutritionally rich and culturally essential. Thus, there is a critical need 

to reduce exposures to these chemicals before they are released into the environment and 

enter the food chain, and for research to help mitigate against current exposures in the immediate environment. Additionally, interventions with and translation to clinicians and health 

professionals would enable them to better track and treat women facing reproductive health 

issues with possible environmental contributions. 

Research Shift: From Studying Specific Chemicals in Isolate to 

Complex Mixtures 

In 2005, researchers working in reproductive environmental health identified the following 

compounds as high priority for research on reproductive effects:1 

• Commonly used agricultural and household pesticides 

• Plastics additives (used in production of plastics, e.g., Bisphenol A [BPA]) 

• Perfluorinated compounds (used in production of stain-resistant, water-repellant, or nonstick surfaces) 

• Chemical additives to beauty and self-care products 

• Polybrominated diphenyl ethers (PBDEs) (used as flame retardants in household upholstery and electronics) 

Although ongoing research focuses on the reproductive toxicity of these substances, new scientific evidence also advances our understanding of the reproductive concerns posed by 

PCBs, dichlorodiphenyltrichloroethane (DDT), and other organochlorine exposures. Thus, 

these, too, remain a priority concern, as scientists continue to specify what reproductive outcomes matter, how they affect the reproductive system, and at what levels. This also supports 

the need for exposure-reduction research. 

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However, most importantly, there is a critical need for more research on the reproductive 

risks posed by routine, low-level exposures to environmental chemicals. In particular, research 

needs to identify the effects of multiple, simultaneous exposures, which better account for the 

reality that women encounter reproductive toxicants and endocrine-disrupting compounds in 

complex mixtures.25 It is plausible that when substances interact, they may increase or mediate 

effects in unforeseen ways. Studying complex, low-dose mixtures, or “real-world” exposures is 

one of the most important, although challenging, research needs in the field of women’s environmental health. 

A Special Note on Research Process and Translation 

Much of the research I’ve done on human health and the environment followed research questions that were initially posed by communities, particularly by women facing environmental 

pollution. Moreover, women and the communities they represent became deeply involved 

in the research process by helping to shape its conduct and translation through, in many 

instances, community-based research grants funded by the National Institute of Environmental Health Sciences. Sociologists have documented the importance of community-based 

participatory research programs in this field of study as essential to designing and carrying 

out groundbreaking research.26,27 Therefore, I encourage future research to prioritize the deep 

involvement of women and impacted communities in all stages of the research process, as well 

as research that investigates the merits of this type of research in overall exposure reduction. 

And for women who participate in such studies, I also encourage research teams to provide 

women (and communities) the option to receive their results should they want them. My colleagues, research mentors, and I have documented that the women who participated in a 

novel personal-exposure study wanted to know more, not less, about the chemicals in their 

everyday environments and bodies, and wanted to understand the full ramifications of that 

reality, even if the health implications are not yet, or poorly, understood.28,29 

Second, I would encourage coordinated translation and outreach to medical professionals, 

healthcare providers, and community health workers who treat women with reproductive diseases, symptoms, and conditions with potential environmental links, but whose professional 

education, in general, offered little training in the area of environmental health. Specific translation projects of value include 1) organizing continuing education programs, grand rounds, 

professional conferences, and workshops on reproductive environmental health; 2) developing 

curricula for medical and professional schools in environmental health; 3) developing systematic ways to routinely collect environmental and occupational health histories; and 

4) fostering research that tracks infertility and reproductive outcomes, and analyzes trends in 

light of patterns of environmental exposures. (For more ideas, consult Schettler, Solomon, 

Valenti, and Huddle’s Generations at Risk: Reproductive Health and the Environment [1999], 

which includes a primer for clinicians [chapter 10].) 

References 

1. Giudice, L. C., Swan, S. H., Myers, J. P., & Carlson, A. (2005). Vallombrosa consensus statement on environmental contaminants and human fertility compromise [Report]. Retrieved from http://www.healthandenvironment.org/infertility/vallombrosa_documents 

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2. Giudice, L. C. 2006. Infertility and the environment: The medical context. Seminars in 

Reproductive Medicine, 24, 129–133. 

3. Schettler, T., Solomon, G., Valenti, M., & Huddle, A. (2000). Generations at risk: Reproductive health and the environment. Boston: First MIT Press. 

4. Buck, G. M., Lynch, C. D., & Cooney, M. A. (2006). Environmental influences on female 

fecundity and fertility. Seminars in Reproductive Medicine, 24, 147–155. 

5. Steingraber, S. (2007). The falling age of puberty in U.S. Girls: What we know, what we 

need to know [Report]. Retrieved from http://www.breastcancerfund.org 

6. Colborn, T., Dumanoski, D., & Myers, J. P. 1996. Our stolen future. New York: Penguin 

Books. 

7. Schrager, S., & Potter, B. E. (2004). Diethylstilbestrol exposure. American Family Physician, 69, 2395–2400. 

8. McLachlan, J. A. (2001). Environmental signaling: What embryos and evolution teach us 

about endocrine disrupting chemicals. Endocrine Reviews, 22, 319–341. 

9. van Oostdam, J. C., Dewailly, E., Gilman, A., Hansen, J. C., Odland, J. O., Chashchin, V., 

. . . Weber, J. P. (2004). Circumpolar maternal blood contaminant survey, 1994–1997: 

Organochlorine compounds. Science of the Total Environment, 330, 55–70. 

10. Simonetti, J., Berner, J., & Williams, K. (2001). Effects of p,p’-DDE on immature cells in 

culture at concentrations relevant to the Alaskan environment. Toxicology in Vitro, 15, 

169–179. 

11. Cohn, B. A., Cirillo, P. M., Wolff, M. S., Schwing, P. J., Cohen, R. D., Sholtz, R. I., . . . Siiteri, 

P. K. (2003). DDT and DDE exposure in mothers and time to pregnancy in daughters. 

The Lancet, 361, 2205–2206. 

12. Anway, M. D., Andrea, S., Cupp, M. U., & Skinner, M. K. (2005). Epigenetic transgenerational actions of endocrine disruptors and male fertility. Science, 308, 1466–1469. 

13. Rudel, R. A., Camann, D. E., Spengler, J. D., Korn, L. R., & Brody, J. G. (2003). Phthalates, alkylphenols, pesticides, polybrominated diphenyl ethers, and other endocrinedisrupting compounds in indoor air and dust. Environmental Science & Technology, 37, 

4543–4553. 

14. U.S. Centers for Disease Control and Prevention. (2005). Third national report on human 

exposure to environmental chemicals. Atlanta, GA: Centers for Disease Control and 

Prevention, National Center for Environmental Health. 

15. National Research Council of the National Academies, Committee on Human Biomonitoring for Environmental Toxicants, Board of Environmental Studies and Toxicology. 

(2006). Human biomonitoring for environmental chemicals. Washington, DC: National 

Academies Press. 

16. Davis, D. L., & Webster, P. (2002). The social context of science: Cancer and the environment. Annals of The American Academy of Political and Social Science, 584, 13. 13. 

330
17. Arctic Assessment Monitoring Programme. (1997). Arctic pollution issues: A state of the 

arctic environmental report [Report]. Retrieved from http://www.amap.no 

18. Arctic Assessment Monitoring Programme. 2004. AMAP assessment 2002: Persistent 

organic pollutants report—A state of the Arctic environment report [Report]. Retrieved 

from http://www.amap.no 

19. Berner, J. (1999). Contaminants and human health. In: Alaskan pollution issues. M. 

Bradley (Ed.). Anchorage, AK: Alaska Native Epidemiology Center. 

20.Chary, L. K. (2000). Persistent organic pollutants (POPs) in Alaska—What does science 

tell us? [Report of the Circumpolar Conservation Union with Alaska Community Action 

on Toxics]. Retrieved from http://www.circumpolar.org 

21. Carpenter, D.O., DeCaprio, A. P., O’Hehir, D., Akhtar, F., Johnson, G., Scrudato, R. J., . . . 

Eckstein, L. (2005). Polychlorinated biphenyls in serum of the Siberian Yupik People 

from St. Lawrence Island, Alaska. International Journal of Circumpolar Health, 64, 

322–335. 

22.Middaugh, J., Verbrugge, L., Haars, L., Schloss, M., & Yett, G. (2000). Assessment of 

exposure to POPs in 5 Aleutian and Pribilof villages. State of Alaska Epidemiology 

Bulletin 4(1). 

23.Tenenbaum, D. J. (1998). Northern overexposure. Environmental Health Perspectives 

106(2). Retrieved from http://www.ehponline.org/qa/106-2focus/ focus.html 

24.Button, K. (2002). It’s your right-to-know your community’s exposure to toxics: An 

Alaskan’s guide to the community right-to-know law. [Guide by the Alaska Community 

Action on Toxics]. Retrieved from http://www.akaction.org/REPORTS/ 

ACAT_RTK_09_10_02.pdf. 

25.Denham, M., Schell, L. M., Deane, G., Gallo, M. B., Ravenscroft, J., DeCaprio, A. P., & the 

Akwesasne Task Force on the Environment. (2005). Relationship of lead, mercury, 

mirex, dichlorodiphenyldichloro-ethylene, hexachlorobenzene, and PCBs to timing of 

menarche among Akwesasne Mohawk girls. Pediatrics, 115, 127–134. 

26.Brown, P. (2007). Toxic exposures: Contested illnesses in the environmental health 

movement. New York: Columbia Press. 

27. McCormick, S. (2009). No family history: The environmental links to breast cancer. Lanham, MD: Rowan and Littlefield. 

28.Altman, R. G., Morello-Frosch, R., Brody, J. G., Rudel, R., Brown, P., & Averick, M. (2008). 

Pollution comes home and gets personal: Cape Cod women’s experiences of household 

toxic exposure. Journal of Health and Social Behavior, 49, 417–435. 

29.Brody, J. G., Brown, P., Rudel, R. A., Morello-Frosch, R., Altman, R. G., Frye, M., . . Seryak, 

L. (2007). Improving disclosure and consent: Is it safe? The new ethics for reporting 

personal environmental and biological exposures to study participants. The American 

Journal of Public Health, 97, 1547–1554. 

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For more information, see the following: 

1. Faroon, O. M., Keith, S., Jones, D., & de Rosa, C. (2001). Effects of polychlorinated biphenyls on development and reproduction. Toxicological and Industrial Health, 17, 63–93. 

2. Luoma, Jon R. 2005. Challenged conceptions: Environmental chemicals and fertility 

[Report prepared following the workshop, Understanding Environmental Contaminants 

and Human Fertility: Science and Strategy, Vallombrosa Retreat Center, Menlo Park, 

CA; Stanford University School of Medicine, Department of Women’s Health and The 

Collaborative on Health and the Environment]. Retrieved from http://www.healthandenvironment.org/infertility/ vallombrosa_documents 

MARICEL MAFFINI, PH.D. 

Tufts University School of Medicine 

Endocrine Disruptors and Reproductive Health: The Case of Bisphenol A 

My name is Maricel V. Maffini and I am representing a research group at Tufts University School 

of Medicine (Boston, MA) that has spent more than a decade investigating the effects of exposure to the synthetic estrogen, Bisphenol-A (BPA), during early development. Our research 

on BPA is funded by the Federal Government through the National Institute of Environmental 

Health Sciences and we do not have any conflict of interest or financial disclosure to reveal. 

The data we and other independent, Government-funded researchers have collected thus far 

in the field of environmental toxicology are sufficiently robust to raise concerns about the 

potentially deleterious impact of this endocrine-disrupting chemical on human development. 

A 2008 study from the U.S. Centers for Disease Control and Prevention (CDC) found that 92.6 

percent of 2,500 Americans tested have detectable levels of BPA in their urine. The highest 

levels were found in children and adolescents. BPA has also been found in breast milk, amniotic fluid, and serum from pregnant women and fetuses, providing evidence that this chemical 

crosses the placental barrier. Although the majority of human exposure is through food and 

drinks, a study conducted in intensive-care-unit-bound babies showed that these vulnerable individuals have 10 times more BPA in their urine than adults; BPA has been found to leach 

from plastic tubing and drug delivery devices, as well. Oral exposures occur because BPA 

leaches from metallic food and beverage cans coated with a protective resin containing BPA, 

polycarbonate baby bottles, and reusable water bottles, as well as paper and cardboard used 

as food containers. These are just a few examples of consumer products leaching BPA. 

Human populations, including unborn babies, infants, children and adults, are regularly 

exposed to low doses of BPA. A recent large epidemiological study revealed positive correlations between urinary BPA concentrations and the prevalence of diabetes, heart disease, and 

liver toxicity. Recently, studies using human breast cancer cells revealed that BPA interferes 

with chemotherapeutic agents commonly used to treat breast cancer patients. In addition, animal studies indicate that developmental exposure to environmentally relevant levels of BPA 

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alters development of the brain, the male and female reproductive tracts, the mammary gland, 

and other organ systems. More importantly, BPA exposure increases the risk and incidence 

of prostate and mammary cancers in rodents. In other words, animals exposed during critical 

periods of development will develop a variety of chronic diseases that usually manifest many 

months after the exposure has ended. 

The consequences of BPA exposure are long-lasting in laboratory animals and there is no reason 

to doubt that this is also the case for humans. Based on the results obtained using laboratory 

animals exposed to low doses of BPA during perinatal development, we are confident that the 

conclusions drawn by us and others are relevant to the human population at large. Ignoring the 

data collected using animal models will not stop endocrine disruptors from causing harm to 

human populations. 

For all the aforementioned reasons, I would like to recommend banning BPA, in particular in 

all children’s products; educating pregnant women and their partners, and those wishing to 

become pregnant to avoid exposure to BPA-containing products; and educating the public at 

large on the risks of exposure to commonly used chemicals that interfere with endocrine system. 

The time has come to discuss in depth this very important public health issue. Thank you very 

much for your attention to this matter. 

CYNTHIA ZEMBO, B.S.N., RN, IBCLC 

United States Breastfeeding Committee 

Moving from Why to How in the Protection, Promotion, and Support of Breastfeeding for 

Optimal Health Outcomes 

Thank you for the opportunity to present testimony regarding women’s health research 

priorities for the next decade. My name is Cynthia Zembo. I am a registered nurse and a boardcertified lactation consultant (IBCLC). I am honored today to speak to you as a representative 

of the United States Breastfeeding Committee (USBC). The USBC is an independent nonprofit 

coalition of 41 nationally influential professional, educational, and governmental organizations 

representing over half a million concerned professionals and the families they serve. The USBC 

and its member organizations share a common mission to improve the Nation’s health by 

working collaboratively to protect, promote, and support breastfeeding. 

What We Know About Breastfeeding 

1. Breastfeeding is associated with significantly reduced risk of acute and chronic illness 

for infants and children in developed countries. This includes decreased incidence of 

acute otitis media, nonspecific gastroenteritis, severe lower respiratory tract infections, 

atopic dermatitis, asthma, obesity, type 1 and type 2 diabetes, childhood leukemia, sudden infant death syndrome (SIDS), and necrotizing enterocolitis.1 

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2. Reduced risk of illness is also documented for women who breastfeed. Women who 

breastfeed are less likely to develop cardiovascular disease,2

 metabolic syndrome,3 

rheumatoid arthritis,4 type 2 diabetes, and breast and ovarian cancer.1 Limited or no 

breastfeeding is associated with an increased risk of maternal postpartum depression.1 

3. Health advantages of breastfeeding continue beyond weaning for both mother and 

child. Breastfeeding and lactation may therefore impact the health of women and their 

children across the lifespan for both females and males. 

4. A dose-response relationship exists between breastfeeding and reduced risk of disease for both women who breastfeed and their children. Duration and exclusivity of 

breastfeeding are important variables in maternal and child health outcomes. A greater 

number of cumulative total months of lactation are associated with decreased risk of 

cardiovascular disease, type 2 diabetes, and breast cancer for women.1,2,3 

5. Based on the strength of existing evidence, exclusive breastfeeding for the first 6 

months is recommended for healthy-term infants by numerous health authorities, agencies, and professional organizations, including the United States Department of Health 

and Human Services, United States Agency for International Development, American 

Academy of Pediatrics, American Academy of Family Physicians, Academy of Breastfeeding Medicine, American Dietetic Association, American College of Obstetricians 

and Gynecologists, National Association of Pediatric Nurse Practitioners, International 

Lactation Consultant Association, and others.5 

6. Since infants who are not breastfed have more frequent illnesses in the first year of 

life, the cost of not breastfeeding is sizable and impacts not only the individual family budget, but also healthcare costs associated with increased illness, and lost wages 

and worker productivity when parents must care for children who are sick. Commercial 

infant formula for a year costs at least twice the expense of the additional food a lactating mother is advised to consume. Increased healthcare costs associated with greater 

illness among formula-fed infants has been estimated at $331–$475 per never-breastfed 

infant in the first year of life.6

 An estimated $3.6 billion dollars could be saved annually 

for treatment of just three childhood ailments (otitis media, diarrhea, and necrotizing 

enterocolitis) if the HP 2010 goals for breastfeeding initiation, duration, and exclusivity 

were met.7 

7. The healthcare costs associated with increased chronic illnesses among women who do 

not breastfeed have not been calculated or published to date, although are undoubtedly as significant if not greater than figures calculated for the increased illnesses among 

children not breastfed. 

8. The nationwide breastfeeding initiation rate of 73.9 percent is approaching the 

Healthy People 2010 goal of 75 percent. However, even with modest gains in the past 

decade, the number of infants continuing to be breastfed at 6 and 12 months, as well 

as the rates for exclusive breastfeeding at 3 and 6 months, are not yet at the national 

health goals.8 

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9. Breastfeeding initiation, duration, and exclusivity rates are significantly lower and furthest 

from the Healthy People 2010 goals among women who are unmarried, under 20 years 

of age, those with a high school education or less, as well as for non-Hispanic Black and 

Native American women, and those living in southern U.S. States and more rural areas.9 

10. It is notable also that 60 percent of U.S. women report that they were unable to meet 

their own breastfeeding goals.10 

11. Hospital birthing and postpartum practices impact breastfeeding initiation duration and 

exclusivity rates. Maternity care practices associated with improved breastfeeding duration and exclusivity include initiation of breastfeeding within 1 hour of birth, use of only 

human-milk feeds, assistance with positioning to avoid sore nipples, use of rooming-in, 

on-demand feeding, no use of pacifiers, no offer of formula gifts upon hospital discharge, and connection to post-discharge breastfeeding support. 

12. Mothers who experience a greater number of these maternity-care practices consistent 

with the evidence-based 10 Steps to Successful Breastfeeding outlined by UNICEF and 

WHO are significantly more likely to initiate and sustain higher rates of breastfeeding11,12,13,14,15 even among population subgroups with traditionally low breastfeeding rates.16 

13. Only 2.6 percent of U.S. births occur in hospitals/birth centers that have been independently assessed and found to consistently practice all 10 Steps to Successful 

Breastfeeding.17 

14. Research to date has focused largely on the physiology of lactation and the nutritional 

and immunological components of human milk. Since the mid-1990s, a minority of federally funded research projects in the categories of infant nutrition, breastfeeding, and 

lactation have been directly or indirectly related to improving breastfeeding rates in this 

country. Only 13.7 percent of funding in years 1994 to 1996 went to projects involved in 

increasing breastfeeding rates.18 Of 426 research projects in the categories of infant nutrition, breastfeeding and lactation that were awarded Federal funding between 2003 

and 2006, less than 1 percent addressed the Healthy People 2010 Goals of increasing 

exclusive breastfeeding rates.19 

15. The most common reasons women report that they stop breastfeeding before they intended to are inadequate milk supply (real and perceived), inability to satisfy infant with 

breastfeeding, latch difficulties, nipple pain/damage, and return to work or school.20,21,22 

16. Maternal risk factors for delayed and/or inadequate milk production include mechanical 

issues that prevent adequate emptying of the breast such as difficulty latching the baby 

correctly, and medical issues such as diabetes, obesity, excessive gestational weight 

gain, traumatic birth experience, cesarean section, smoking, preterm delivery, polycystic 

ovarian syndrome, and previous breast surgery.5 

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What We Need to Know about Breastfeeding: Research Priorities for 

Breastfeeding, Lactation, and Optimal Women’s Health 

The majority of new mothers in the United States today choose to breastfeed. Unfortunately, 

most of these women fall short of their own desired goals for how long and how exclusively 

they are able to breastfeed their infants. Many stop in the first weeks after birth. Increased 

funding for applied research is needed to determine and evaluate innovative delivery models 

and interventions to more effectively support breastfeeding across all segments of the birthing population.18 So that the long-term disease prevention and cost savings associated with 

the normal physiologic process of breastfeeding are more widely appreciated by our nation’s 

women and their children, the following gaps in knowledge must be addressed: 

1. Identify effective strategies to reduce disparities in breastfeeding initiation, duration, and 

exclusivity rates across socioeconomic status, race/ethnicity, education, and geography 

• Assess and ensure consistent advice, strategies, and support for exclusive breastfeeding from healthcare providers 

• Assess cultural competency of healthcare providers regarding breastfeeding 

practices/values 

2. Identify strategies to increase exclusive breastfeeding among women who both breast 

and formula feed 

• Identify effective methods to educate parents about normal infant sleep patterns/ 

behaviors in exclusively breastfed infants 

• Identify effective interventions to maximize milk production and breastfeeding duration for women with known risk factors for lowered milk supply 

• Examine the effects of hormonal birth control methods on milk production of women 

with adequate breastfeeding support, both in the hospital and as out patients 

3. Identify and ensure consistent definitions and measurements for breastfeeding (exclusive, partial, minimal, none) across funded research projects 

• Delineate any differences in health outcomes related to exclusive versus partial breastfeeding and direct breastfeeding versus the feeding of expressed human milk 

4. Identify effective preservice training methods to ensure core competencies in breastfeeding support/lactation management for all categories of healthcare providers working with women of reproductive age 

• Identify strategies to address healthcare-provider barriers to adopting evidence-based 

breastfeeding management practices 

5. Examine effect of birth interventions (anesthesia/analgesia/instrumental delivery, 

induction of labor, cesarean delivery) on infant suck, establishment of milk supply 

(lactogenesis II), breastfeeding duration, and exclusivity 

6. Examine cost-effectiveness of implementing 10 Steps to Successful Breastfeeding/Baby 

Friendly Hospital Practices for Birthing Facilities 

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7. Examine the cost-effectiveness of IBCLC breastfeeding care 

• Evaluate optimal lactation consultant: Patient ratios for inpatient, outpatient and 

community settings as they relate to exclusive breastfeeding duration rates and 

health outcomes 

8. Examine expanded use of donor human milk and updated technologies for donor 

milk banking 

References 

1. Ip, S., Chung, M., Raman, G., Chew, P., Magula, N., DeVine, D., . . . Lau, J. (2007). Breastfeeding and maternal and infant health outcomes in developed countries (Evidence Report/Technology Assessment No. 153). Rockville, MD: Agency for Healthcare Research 

and Quality. 

2. Schwarz, E. B., Ray, R. M., Stuebe, A. M., Allison, M. A., Ness, R. B., Freiberg, M. S., & 

Cauley, J. A., (2009). Duration of lactation and risk factors for maternal cardiovascular 

disease. Obstetrics & Gynecology, 113, 974–982. 

3. Ram, K. T., Bobby, P., Hailpern, S. M., Lo, J. C., Schocken, M., Skurnick, J., & Santoro, 

N. (2008). Duration of lactation is associated with lower prevalence of the metabolic 

syndrome in midlife-SWAN, the study of women’s health across the nation. American 

Journal of Obstetrics & Gynecology, 198, 268, e1–6. 

4. Karlson, E. W., Mandl, L. A., Hankinson, S. E., & Grodstein, F. (2004). Do breastfeeding 

and other reproductive factors influence future risk of rheumatoid arthritis? Results 

from the nurses’ health study. Arthritis & Rheumatism, 50, 3458–3467. 

5. Labbok, M., & Taylor, E. (2008). Achieving exclusive breastfeeding in the United 

States: Findings and recommendations. Washington, DC: United States 

Breastfeeding Committee. 

6. Ball, T. M., & Bennett, D. M. (2001). The economic impact of breastfeeding. Pediatric 

Clinics of North America, 48, 253–262. 

7. Weimer, J. (2001). The economic benefits of breastfeeding: A review and analysis (ERS 

Food Assistance and Nutrition Research Report No.13). Washington, DC: U.S. Department of Agriculture. 

8. U.S. Department of Health and Human Services, Centers for Disease Control and 

Prevention. (2009). Breastfeeding report card, United States: Outcome indicators [Fact 

sheet]. Retrieved from http://www.cdc.gov/breastfeeding/data/report_card2.thm 

9. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2006). Breastfeeding data and statistics: National Immunization Survey (NIS) 

[Fact sheet]. Retrieved from http://www.cdc.gov/breastfeeding/data/NIS_data/ 

2006/socio-demographic_any.htm 

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10. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. (2009). Infant feeding practices study II [Report]. Retrieved from http://www. 

cdc.gov/ifps/ 

11. DiGirolamo, A. M., Grummer-Strawn, L. M., & Fein, S. B. (2008). Effect of maternity-care 

practices on breastfeeding. Pediatrics, 122(Suppl 2), S43–S49. 

12. Murray, E. K., Ricketts, S., & Dellaport, J. (2007). Hospital practices that increase breastfeeding duration: Results from a population-based study. Birth, 34, 202–211. 

13. Broadfoot, M., Britten, J., Tappin, D. M., & MacKenzie, J. M. (2005). The Baby Friendly 

Hospital Initiative and breastfeeding rates in Scotland. Archives of Disease in Childhood. 

Fetal and Neonatal Edition, 90, F114–F116. 

14. Merten, S., Dratva, J., & Ackerman-Liebrich, U. (2005). Do baby-friendly hospitals influence breastfeeding duration on a national level? Pediatrics, 116(5), e702–e708. 

15. Declerque, E., Labbok, M. H., Sakala, C., & O’Hara, M. (2009). Hospital practices and 

women’s likelihood of fulfilling their intention to exclusively breastfeed. American Journal of Public Health, 99, 929–935. 

16. Phillips, B. L., Malone, K. L., Cimo, S., & Merewood, A. (2003). Sustained breastfeeding 

rates at a U.S. baby-friendly hospital. Pediatrics, 112(3, pt 1), e234–e236. 

17. Baby Friendly USA. (2009). 83 U.S. baby-friendly hospitals and birth centers as of July 

2009 [Fact sheet]. Retrieved from http://www.babyfriendlyusa.org 

18. Brown, L. P., Bair, A. H., & Meier, P. P. (2003). Does federal funding for breastfeeding 

research target our national health objectives? Pediatrics, 111, e360–e364. 

19. Bonuck, K. A. (2007). Paucity of evidence based research on how to achieve the 

Healthy People 2010 goal of exclusive breastfeeding. Pediatrics, 120, 248–249. 

20.Gatti, L. (2008). Maternal perceptions of insufficient milk supply in breastfeeding. Journal of Nursing Scholarship, 40, 355–363. 

21. Ahluwalia, I. B., Morrow, B., & Hsia, J. (2005). Why do women stop breastfeeding? 

Findings from the pregnancy risk assessment and monitoring system. Pediatrics, 116, 

1408–1412. 

22.Hill, P. D., & Aldag, J. C. (2007). Predictors of term infant feeding at week 12 postpartum. Journal of Perinatal and Neonatal Nursing, 21, 250–255. 

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CHRISTIE LANCASTER, M.D. 

University of Michigan 

Future Directions in Perinatal Mental Health 

Thank you for the opportunity to present our testimony. I am presenting as a representative 

from the Women’s Mental Health Program at the University of Michigan to discuss future directions for the national research agenda in the area of perinatal mental health. The Women’s 

Mental Health Program is a multidisciplinary team of psychiatrists, psychologists, social workers, pediatricians, and obstetricians with a shared mission to advance clinical care, research, and 

teaching in the area of mental health throughout a woman’s lifespan. Our group has a particular 

focus on perinatal mental health. 

Why discuss perinatal mental health? 

• Psychiatric illnesses during pregnancy and the postpartum are common, detectable, 

and treatable. 

• These disorders represent some of the most common complications in pregnancy. For 

example, more than 1 in 10 pregnant women will suffer from major depression.1 In comparison, the prevalence of gestational diabetes is about 2–3 percent.2 

• The perinatal period provides a unique window in which providers can address mental 

health. We have already captured the target population for screening because most pregnant women will utilize prenatal care at some point in their pregnancies. Perinatal women 

also have repeated visits over a several-month span, providing many opportunities for intervention and followup. Also, obstetric practices are experienced with screening and 

management for other public health concerns. We have developed systems to screen and 

treat infectious diseases, genetic disorders, and gestational diabetes, just to name a few. 

• There is a growing recognition of the need to address perinatal mental health. This is evidenced by screening recommendations and new treatment algorithms from the American 

College of Obstetricians and Gynecologists and the American Psychiatric Association.3 

• Yet, despite this awareness, we know that perinatal mental health care is a relatively new, 

fast-paced field within obstetrics, psychiatry, and psychology. Translation of evidencebased practices into perinatal care faces many obstacles, including a limited evidence 

base from which to start. 

We applaud the release of program announcements such as Women’s Mental Health in Pregnancy and the Postpartum Period (PA-09-174) to broadly address this important problem for 

women in their reproductive years. And we would like to offer a few considerations for future 

directions in funding. 

How do you build shared decisionmaking models that are applicable to the clinical context? 

Psychiatric treatment during the perinatal period is a rapidly evolving field. Often the science, particularly in regard to antidepressant therapy, is developing so fast that providers and 

patients find it extremely difficult to stay current and accurately informed. 

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Unfortunately, most women with psychiatric illnesses during the perinatal period are not 

receiving treatment. If we take the example of depression, fewer than one in five women with 

depression receive any or adequate treatment around the time of childbearing.3

 And more 

than one-half of women with recent antidepressant use discontinue their medications directly 

as a result of conception.4 How can we improve engagement with care for women with perinatal mood disorders and for providers treating these patients? 

We feel that addressing mental health during the perinatal period should involve collaborative decisionmaking between the patient and provider. Tenets of this model include taking into 

account patient preferences and values, considering treatment options appropriate for the clinical situation, and balancing nonmedication treatment options with rational use of medications. 

However, our research has shown us that behind the development of such collaborative models 

lies a complex interplay of influencing factors as perceived by the patient and the clinician. 

For the patient, these factors include the following: 

• Practical considerations: Where will the treatment be located? What assistance do I have 

with the referral process? What are my treatment options? 

• Psychological factors: What do I know about my illness and my treatment? What will 

others think (concerns about stigma associated with treatment for depression)? 

• For providers, contextual factors include external influences such as training, resources, 

and system coordination. Providers are also affected by patient norms, such as the stigma of mental illness in motherhood, and healthcare system priorities. However, the most 

directly involved factors for providers include internal influences such as the following: 

− Familiarity: How well do I know the specialists in my region? Do I know my patient well 

enough to discuss mental health issues? 

− Feelings of certainty: Can I rely on my referral network for support and assistance? 

How do I build trust with my patient so that she will follow up? What am I comfortable 

with given the risks and benefits? How confident do I feel about this? 

− Role identity: How do I view my job description? What meaning does my role have? 

Whom am I responsible for? 

We feel that research directed at implementation science and decisionmaking models that 

are tailored to such contextual factors can improve treatment engagement and treatment 

adherence. Such research can improve the translation of evidence-based treatment recommendations into clinical practice. While our group is particularly interested in this type of 

model-building within the context of perinatal mental health, it has potential generalizability 

to other aspects of women’s health care, such as treatment of menopausal symptoms. 

The Importance of the Maternal-Infant Dyad 

The first year of life marks a dramatically shifting period of external to self-emotional regulation, 

which is facilitated by interactions with primary caregivers. Parents’ mental representations of 

the relationship with their infant may have particular impact on emotional development.5 

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On another note, given the pervasive concerns surrounding antidepressant use during the 

perinatal period, it is important to enhance the study of nonpharmacologic psychotherapeutic treatments. If you consider both of these factors together, the importance of interpersonal 

processes and the need for treatment alternatives, you can envision the particular role for 

dyadically-based depression interventions. We advocate for future funding goals to focus on 

the development and testing of these promising intervention models. 

We believe that mother-infant dyadic therapies are an important complement to individual psychotherapy. There is mounting evidence to suggest that such interventions are more 

efficacious than individual treatment in improving parenting and infant outcomes. Many of 

these dyadic therapies are rooted in psychodynamic and attachment theories. Others include 

alternative techniques, such as infant massage, structured developmental assessments, and 

progressive relaxation. 

By focusing future research efforts into the study of dyadic interventions, we can broaden the 

menu of safe and effective treatment options for women suffering from perinatal depression. 

In addition, we can study whether the use of such interventions can alter the intergenerational 

transmission of risk between parent and child. 

References 

1. O’Hara, M.W., & Swain, A. M. (1996). Rates and risk of postpartum depression: A metaanalysis. International Review of Psychiatry, 8, 37–54. 

2. Gabbe, S., Niebyl, J., & Simpson, J., (Eds.). (2007). Obstetrics: Normal and problem 

pregnancies. Philadelphia, PA: Churchill Livingstone/Elsevier. 

3. Yonkers, K. A., Wisner, K. L., Stewart, D. E., Oberlander, T. F., Dell, D. L., Stotland, N., . . . 

Lockwood, C. (2009). The management of depression during pregnancy: A report from 

the American Psychiatric Association and the American College of Obstetricians and 

Gynecologists. General Hospital Psychiatry, 31, 403–413. 

4. Flynn, H. A., Blow, F. C., & Marcus, S. M. (2006). Rates and predictors of depression 

treatment among pregnant women in hospital-affiliated obstetrics practices. General 

Hospital Psychiatry, 28, 289–295. 

5. Marcus, S. M., Flynn, H. A., Blow, F., & Barry, K. (2005). A screening study of antidepressant treatment rates and mood symptoms in pregnancy. Archives of Women’s Mental 

Health, 8, 25–27. 

6. Rosenblum, K. L., McDonough, S., Muzik, M., Miller, A., & Sameroff, A. (2002). Maternal 

representations of the infant: Associations with infant response to the still face. Child 

Development, 73, 999–1015. 

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JULIA MCQUILLAN, PH.D., M.A. 

University of Nebraska–Lincoln 

The Importance of Population-Based Research for Understanding Women’s Health Issues 

Good afternoon and thank you for this opportunity to talk about the future of research on 

women’s health. My name is Julia McQuillan. I am an Associate Professor of Sociology at the 

University of Nebraska–Lincoln (UNL), Director of the Bureau of Sociological Research at 

UNL, and a Co-Investigator on a Eunice Kennedy Shriver National Institute of Child Health and 

Human Development (NICHD) grant to study infertility pathways and psychosocial outcomes. 

My goal today is to use findings from our ongoing research to demonstrate the utility of learning about attitudes and experiences of the general population for a more comprehensive 

understanding of women’s health. 

My research team was fortunate to have UNL financial support to show the feasibility of studying infertility using population-based survey methods. That pilot project showed the feasibility 

and fruitfulness of studying fertility and infertility in the population as well as in medical clinics. Thus, the NICHD awarded us a grant to expand our research from 12 to 48 States, and to 

interview women and their partners twice. 

We use sociological perspectives to identify social structures that are taken for granted yet 

potentially modifiable that facilitate or inhibit women’s health. Our goal is to advance understanding of the complexities and subtleties of fertility experiences among women and couples. 

Research on patients in clinics provides rich insights about those who seek medical help, but 

studying only help seekers misses about half of the women who meet the medical criteria 

for infertility. Some health-related concerns (e.g., involuntary childlessness) do not have biomedical causes (e.g., when women face situational barriers to pregnancy). Some biomedical 

solutions (e.g., assisted reproductive technology) can solve nonbiologically-based problems 

(e.g., lack of a male partner who is willing or able to help a woman conceive a child). 

Our project is called the National Survey of Fertility Barriers; the first wave of data is publicly 

available at http://sodapop.pop.psu.edu/data-collections/nsfb. This population sample has 

revealed the great extent of fertility barriers among women between the ages of 25 and 45. 

Using telephone interviews, we obtained pregnancy histories, information on help-seeking for 

infertility, and psychosocial information on 4,712 women and 932 of their (mostly male) partners. Including both standard definitions of infertility (12 months of regular intercourse without 

contraception or conception), and broader conceptualizations of fertility barriers (including 

health problems that make pregnancy more difficult and social barriers such as not having 

a partner), we are developing a comprehensive portrait of the behavioral and psychosocial 

responses to fertility barriers among women in the United States. 

Several findings from the first wave demonstrate the utility of population-based research 

on fertility: 

• Women vary in the degree of planning they use for pregnancies. Changes in reproductive technology, laws, and social norms make it theoretically possible for most women in 

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the United States to plan their pregnancies—yet we find that many do not plan (for first 

pregnancies, about a third said that they were trying NOT to get pregnant, a third said 

that they were trying TO get pregnant, and another third said that they were “okay either way”). Some report later that they wish that they had had more information when 

they were younger, or that they had planned more. Other researchers have shown that 

barriers remain to full access to abortion, contraception, and reproductive care, but these 

do not fully account for the gap between fertility behavior and stated fertility intentions 

in the United States. It is reasonable to assume that women will make deliberate choices about and take specific actions to ensure reproductive preferences. Yet we find that a 

substantial proportion of women do not. 

• There is considerable ambiguity and complexity among women in their approaches to 

pregnancy. As is evident from the large percentage of women who are “okay either way” 

about getting pregnant, the conventional dichotomies of planned/unplanned, wanted/ 

unwanted pregnancies do not apply to many women. These findings suggest the importance of rethinking whether fertility “decisionmaking” is as purposive and conscious 

as is often assumed. This may be of particular concern when considering emotional and 

behavioral responses to fertility barriers. We have theoretically integrated infertility helpseeking pathways within larger life-course fertility pathways linked to fertility intentions 

and outcomes in response to our emerging findings. 

• According to the National Survey of Family Growth, 15 percent of U.S. women reported “impaired fecundity” in 2002.1 Wave 1 National Survey of Fertility Barriers data show 

that 46.3 percent of American women aged 25 to 45 reported infertility at some point in 

their lives. We measured additional fertility barrier categories such as sterilization regret, 

other physical health problems, miscarriages, and situational barriers. Approximately 68 

percent of women in this representative sample reported experiencing fertility barriers 

at some point. For example, 4 percent now regret surgical sterilization and 10.3 percent 

have had miscarriages but no other fertility barrier. Almost 7 percent have faced situational barriers to fertility, even though they have not faced biological barriers. Thus, fertility barriers have affected many American women at some point in their lives. 

• The medical definition of infertility implicitly assumes that women who have intercourse 

without protection intend to become pregnant. People seeking medical treatment for infertility are especially motivated to have children and are likely to say they are trying 

to get pregnant. Clinicians and researchers working with infertility help-seekers usually 

presume that intent to conceive is an integral and unambiguous part of the criteria for infertility. If we broaden the scope of our analysis to include nonhelp-seekers, we include 

women with 12 months of unprotected intercourse who answered “no” when asked, 

“Were you trying to get pregnant?” Because many people do not plan births or make 

other fertility decisions in the conscious ways researchers sometimes assume, we need 

to incorporate attitudes toward planning pregnancy and fertility intentions in research on 

infertility. We found in the initial interviews that 48.2 percent of infertile women said they 

tried to conceive for at least 12 months without conception at some point in their lives 

and that 51.8 percent of these infertile women reported having had unprotected intercourse without conception, but did not indicate they were consciously trying to conceive 

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at the time. We refer to the former group as “infertile with intent” and to the latter as “infertile without intent.” Only a little more than one-third (37.4 percent in Wave 1) of the 

women who met the medical criterion for infertility thought of themselves as having had 

fertility problems. 

• Descriptive research, primarily from women who self-identify as having fertility problems, presents a picture of infertility as a devastating experience, especially for women. 

In a review of infertility research, Greil2 noted a number of dominant themes, including 

infertility as a central focus for identity, feelings of alienation from the “fertile world,” a 

sense of social stigma, and immersion in the treatment process. More recent studies have 

confirmed and elaborated upon previous characterizations of the infertile, and shown the 

influence of the pronatalist context in the United States on women’s fertility experiences. 

A striking finding from our work is that the infertile with-intent score significantly higher 

on fertility-specific distress than do the infertile without intent. This suggests the importance of understanding the characteristics of those who suffer and those who do not 

suffer from involuntary childlessness. 

• Higher surgical sterilization regret among Native American and Hispanic women compared to White women suggests that approaches to reproductive care are inconsistent 

across racial groups, even statistically controlling for socioeconomic status. 

• We also found the need to rethink the meaning of secondary infertility for American 

women. The most common notion of primary infertility is infertility among women with 

no prior children. Yet many women have pregnancies without a live birth, either because 

of miscarriage, a stillbirth, or an abortion. Should women who have had a pregnancy but 

no live birth be classified as having primary or secondary infertility? This is an important question, because distress and help-seeking differ by primary/secondary status. Our 

findings suggest that women with a pregnancy—regardless of the outcome—are more 

similar to each other on measures of distress and medical help-seeking, and different 

from women who have not had a pregnancy. 

• Additionally, many women regret the fertility and infertility decisions that they have 

made. Because these decisions are often time-sensitive and irreversible, they are quite 

difficult to make. Women with insufficient information do not use birth control and then 

regret pregnancies, or get tubal ligations and then meet partners that they want to have 

children with. Making decisions about how far to go with medical help to have a child 

compared to seeking to adopt are quite challenging, and many people have little information regarding lifelong outcomes to help them with the decision. 

• Although infertility is conceptualized as a couple condition because either partner can be 

the “cause” of the problem, solutions to infertility often focus on women’s bodies. Therefore, it is unclear if medical help-seeking depends only upon women’s attitudes. Research 

from our couple sample suggests that both partners contribute to the decision to pursue 

medical help for infertility or not. 

Our population-based longitudinal study provides insights on the causes and consequences of 

help-seeking among infertile women. 

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Using the life-course perspective combined with a perspective of “constrained choices,” we 

see the benefits of integrating infertility help-seeking processes into broader models of fertility behavior, assessing links between fertility ideals, behavior, and intentions among fecund 

and infertile women and their effects on fertility and psychosocial outcomes. Although technological and medical changes have increased reproductive options for both the fecund and 

the infertile, fertility in the United States is far from a simple reflection of fertility desires and 

intentions. The high incidence of mistimed and unintended births among the fecund indicates 

that we still have an incomplete understanding of fertility pathways. 

Much research focuses on women’s and couples’ reproductive choices, but our previous work 

and current data suggest that there is a continuum of deliberation and planning toward reproduction. Women who are undecided about fertility intentions are more likely to delay and then 

forgo pregnancy. Similarly, they may be less likely to take effective steps to prevent pregnancy. 

Women who have weaker fertility intentions may not take actions to overcome fertility barriers, but it is equally possible that confronting fertility barriers will strengthen intentions. There 

are many other changes (e.g., divorce, marriage, job loss, and friends’ pregnancies) that could 

increase or decrease how deliberate women and couples are about pregnancy. 

Racial/ethnic, socioeconomic, and lifestyle variations in fertility trends and pathways are likely 

to condition responses to fertility barriers. Black and Hispanic women are more likely to experience infertility than non-Hispanic White women, but less likely to seek medical services for 

help getting pregnant. 

Help-seeking also varies by indicators of social class. For example, 56 percent of college graduates with fecundity impairments have sought help compared to 41 percent of those with less 

education; further, 47 percent of those with private health insurance have sought help compared to 28 percent without.3

 Lifestyle differences are also related to fecundity impairments. 

For example, sexually transmitted diseases and infections—known to vary by race, socioeconomic status, and union status—are associated with substantial increases in infertility for both 

men and women. 

On average, involuntary childlessness is more distressing for women than for men. Fertility researchers often measure only women’s intentions and expectations, but it is important 

to consider possible differences between partners and the implicit and explicit negotiations 

that take place between partners. Help-seeking pathways are complex and dynamic. Infertile 

individuals and couples are constantly weighing their options, rethinking their identities, and 

making new plans. During this process, distress levels and relationship satisfaction may well 

have an impact on infertility decisionmaking. 

Expanding infertility research to include a broader conceptualization of fertility barriers shows 

the benefits of a representative sampling approach linking fertility expectations and outcomes 

for better understanding responses to infertility. Women who meet the medical criteria for 

infertility have a biomedical cue to fecundity impairment. If they are not trying to get pregnant 

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at that time (fertility expectations), they would rarely be studied in clinic-based infertility 

research. Women who have fewer than their desired number of children or who have experienced miscarriages, health barriers to childbearing, sterilization regret, or see themselves as 

having a problem would be counted in clinic-based research only if they perceive and act upon 

the fertility problem. Women who face situational barriers to infertility, including lack of a suitable partner or marriage dissolution, will also only be identified in clinical research if they seek 

help conceiving to address circumstantial childlessness. 

The long-term consequences of fertility barriers are particularly important to assess because, 

unlike many reversible actions (e.g., delaying education), fertility pathways are time-specific 

and irreversible. Therefore, there is a need to study the consequences of fertility decisions for 

those who have passed reproductive age. These pathways are dynamic, involving changes 

over time. Biological limitations on the duration of female fertility mean that temporal elements are an ever-present feature of fertility pathways. Research suggests both social and 

biological limits to fertility postponement. 

Infertility is a general public health concern, with important psychosocial consequences for 

women and couples, which has been highlighted by NICHD as central to its health and social 

policy agenda. Fertility research is important to businesses, policymakers, and researchers 

to ensure fertility services, access, and support for the consequences of negative outcomes. 

Finishing the second wave of this study will illuminate the causal ordering of events and outcomes. With a third wave of data, we would gain insights from women who have completed 

their reproductive years. 

We see the need to place special emphasis on disparities in expectations, barriers, pathways, 

obstacles, and outcomes. In conclusion, findings from population-based longitudinal research 

show how crucial information outside clinical studies is for comprehensive understanding of 

and approaches to women’s health. 

References 

1. Chandra, A., Martinez, G., Mosher, W. D., Abma, J. C., & Jones, J. (2005). Fertility, family 

planning, and reproductive health of U.S. women: Data from the 2002 National Survey 

of Family Growth. Vital Health Statistics, 25. 

2. Greil, A. L. (1997). Infertility and psychological distress: A critical review of the literature. 

Social Science and Medicine, 45, 1679–1704. 

3. Stephen, E. H., & Chandra, A. (2000). Use of infertility services in the United States: 

1995. Family Planning Perspectives, 32, 132–137. 

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WILLIAM BURLINGHAM, PH.D. 

University of Wisconsin 

Letter in Support of Continued Research in the Area of Reproductive Immunology and 

Immunologic Tolerance 

Over the past several years, the Office of Research on Women’s Health (ORWH) has been a 

focal point for women’s health research at the National Institutes of Health (NIH) and has supported a vigorous research agenda in women’s health. I am happy to have been asked, as an 

immunologist working in the field of reproductive immunology and transplantation, to issue 

a challenge to the ORWH attendees at the conference in Providence, RI, to consider neonatal 

tolerance and maternal-fetal stem cell exchange as two of the critical areas for research into 

health and disease in the next 10 years. 

Over the past 20 years, my lab’s research has been primarily concerned with immunologic 

tolerance to transplants, that is, the ability of a patient, when given an organ transplant, to 

succeed in weaning himself or herself from all immunosuppressant drugs, relying only on the 

natural ability of the immune system to accommodate to the foreign tissue. Most of the time, 

this attempt ends in disaster, with the process of graft rejection eventually taking hold and 

destroying the transplanted organ. However, from the very beginning of our research, we saw 

exceptions to this rule. The first happened to be a kidney transplant from a mother to her firstborn son. This transplant lasted nearly 10 years, even though the son had discontinued all 

immunosuppression in year 2. We discovered that mother had transplanted more than her kidney. In fact her cells, although rare, had permeated her child’s immune system and were even 

present in his skin. This discovery coincided with the realization by Dr. Tom Starzl, pioneer 

transplant surgeon, that “microchimerism,” the migration of white blood cells from the graft 

into the recipient, was an important feature of successful transplantation. 

In 1995, we published our paper showing that maternal cells within the patient’s blood and tissues were able to inhibit the growth of killer cells that would have otherwise attacked his 

mother’s donated kidney. This inhibition coincided with a successful period of 7 years’ abstinence 

from all immunosuppression. Although eventually, the kidney did succumb to a delayed rejection process, we learned enough from this experience to explore in depth the effects of neonatal 

exposure to maternal antigens in kidney transplantation. The result was a paper that appeared in 

the New England Journal of Medicine in 1998, documenting a tolerogenic effect of maternal antigen exposure on kidney transplant survival in siblings at nine transplant centers in Europe and 

North America. At the time that our paper was published, we were not actively supported by 

the NIH for our research efforts in this area. However, due to active support of the NIH beginning 

in 1999, my lab has been able to continue this research and develop animal models that enable 

us to explore basic mechanisms of maternal-fetal tolerance. How mother maintains a close relationship with the immune system of her baby, using stem cell transfer and oral tolerance via the 

nursing of the infant to establish microchimerism, and how microchimerism induces tolerance to 

a subsequent transplant in the adult, are subjects of ongoing research in my laboratory. 

The decade of the 1990s was filled with remarkable discoveries regarding maternal and 

fetal relationships that changed many fundamental concepts of immunologic tolerance and 

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autoimmune disease. The work of Andrew Meller and David Munn established a tryptophandepleting enzyme called IDO that was essential for maintaining normal pregnancy, a finding 

that has opened whole new areas of cancer immunotherapy research. 

Dr. J. Lee Nelson and colleagues at Seattle firmly established a connection between fetal microchimerism in adult women who had given birth to sons earlier in life and the development of 

scleroderma, a disease of the skin and lungs that is often fatal in women. The immunologic balance that should normally be present allowing the persistence of cells from the baby in the 

mother without upsetting tolerance to self had broken down in these women and had led, in 

some way, to an aberrant reaction of the mother’s immune system to her own tissues. 

Recent work from Dr. Nelson’s lab has established that chimerism in the opposite direction, 

from mother to child, can lead either to a disruptive presence in the immune system of the 

offspring predisposing to autoimmunity or can be part of a restorative repair process in a 

child with a genetic anomaly. The importance of maternal-fetal chimerism and tolerance has 

recently come to the forefront in the field of cancer research. 

Work by Dr. Els Goulmy’s lab in Leiden has shown that healthy individuals are predisposed to 

either aggressive or suppressive responses toward antigens to which they have been naturally 

exposed during pregnancy or gestation, and via nursing. In collaboration with Els, we found 

that the presence of microchimerism from mother or offspring could trigger a type of suppressive T cell, which turned out to be a hallmark of long-term tolerance to an organ transplant in 

a woman who lived for 42 years after receiving a kidney graft from her sister. 

Maternal–fetal immunologic research has had a profound impact on our understanding of the 

development of the immune system. Most recently, work that was published in Science magazine in December 2008 highlighted the emerging field of human fetal immunology, showing 

that the fetal lymph node was, in fact, not at all a typical lymph node in the sense of a place 

for mobilization of defense against microbes, but was rather an immune, privileged site, 

designed to accommodate the presence of maternal cells in the offspring during gestation and 

throughout the birth process. This insight from Dr. McCune’s lab in California has made it certain that researchers are going to discover new things about the waves of stem cell migrations 

and the developmental pathways that lead to mutual tolerance between mother and child. In 

2007, Rachel Miller and colleagues reported that that immunization of mothers with influenza 

vaccine during pregnancy caused a transfer of immunity to the baby. These and other insights 

are all supported by the NIH and will play an important role both in women’s health and the 

health of the baby, which will impact society in the long term. 

Given that the healthcare system is increasingly under scrutiny for its lack of personalized medicine and over-reliance on prescription drugs, it seems an opportune time to consider the natural 

role of maternal–fetal cell exchanges in health and disease and to promote further research into 

the area of reproductive immunology. Grant support in the reproductive immunology field has the 

potential to impact immune tolerance, autoimmunity, transplantation, cancer, cancer immunity, 

and tissue regeneration. All of these areas, I think, have something to benefit from a continued 

focus on the natural immune acceptance between mother and baby in women’s health research. 

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SARAH D. FOX, PH.D. 

The Warren Alpert Medical School of Brown University 

Chronic Pelvic Pain: Common Pain, Uncommon Management 

One in seven women will experience chronic pelvic pain (CPP) at some point in her life.1

 CPP 

can be defined as pain that has been stable in location and of at least 6 months’ duration that 

localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, buttocks, or the vulva.2

 Causes can be varied, including gynecologic, urologic, 

gastroenterological, neurologic, and musculoskeletal sources. (See Table 1). Women may have 

more than one source of pain. Although this may present as two unrelated primary disease 

processes, more commonly, secondary pain sources are due to chronic muscle spasm, surgical complications, neuroplasticity, or pain referral patterns. In 1996, Mathias et al. published 

the classic study of prevalence, quality of life, and costs of CPP in the United States.1

 This telephone survey to 17,927 households identified 5,325 households with at least 1 woman aged 18 

to 50. Fourteen percent of women (773/5,325) reported in the past 3 months experiencing 

symptoms of pelvic pain with a duration of at least 6 months. Sixty percent of women noted 

that they did not have an established diagnosis. Women with CPP scored lower on quality-oflife scores compared to women in the survey without CPP. Further, respondents were asked 

about use of medical resources and missed work. Mathias estimated annual U.S. direct cost of 

physician visits to be $880 million and $555 million for lost work hours. 

Women with CPP report significant problems related to their illness. They may have trouble 

working, carrying out tasks of daily living, and keeping up important relationships. Women 

worry about future fertility, an overlooked cancer diagnosis, or simply that the pain may 

become worse and they may not be able to handle it. Often their doctors will tell them that “it 

is all in your head” or “you are fine, don’t worry about it.” Women naturally think that if they 

rest, they might feel better, but long-term inactivity leads to muscle weakness and increased 

musculoskeletal pain, as well as potential weight gain and the health problems that go along 

with obesity. Pain can lead to problems of insomnia and depression. For women with chronic 

abdominal pain, suicidal ideation and attempts were two to three times more common than in 

those without pain.3 

Best estimates indicate that many women with CPP will respond to traditional treatments, 

including medications such as nonsteroidal anti-inflammatory medications or birth control 

pills; and surgeries, from ablation of endometriosis to hysterectomy.4 However, response rates 

vary widely depending on the patient population, underlying disease processes, and individual coping methods. Most surgical studies estimate failure rates of 10–40 percent. Medication 

failure rates can be even higher. In one CPP clinic, 6-year followup of all patients with all diagnoses found that 70 percent of patients had persistent pain symptoms.5

 It is important to note 

that patients who present to CPP clinics may have a more severe or complicated disease. 

Further difficulties may arise as there are limited numbers of physicians who have an interest 

in caring for patients with CPP. It is widely accepted that a multidisciplinary approach, usually 

involving gynecology, physical therapy, behavioral therapy, gastroenterology, urology or urogynecology, anesthesia, acupuncture, and massage therapy is the most effective treatment 

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model.6

 Unfortunately, most patients do not have access to a multispecialty group with an 

interest in treating women with CPP. Many physicians feel uncomfortable caring for the complex patients with CPP who do not respond to basic treatments. Medical education about CPP 

tends to be limited, if it occurs at all. 

Given the tremendous cost to individuals with CPP and to society, there is surprisingly little research on the best treatment options. There are a number of reasons why it is difficult to 

study CPP. Most significant may be the fact that most women with CPP have more than one 

source of pain. It is difficult to find a large enough group of women to study that all have the 

same diagnoses. Even in a busy CPP service, it is unlikely to see more than a few women at 

any given time with the same underlying conditions. Although it is possible to study women 

with multiple underlying causes for their pain, it may blunt the effects of the intervention, 

leading to a need for even larger sample sizes. Second, pain tends to wax and wane over time 

in most of these syndromes. This means that it is necessary to study interventions for at least 

12 weeks to be able to pick up real improvements. And long-term followup is very important in a chronic condition. There is a significant placebo effect for many treatments, so future 

research will need to be placebo-controlled, especially surgical interventions. Studies may 

be complicated by high attrition rates, especially for treatments that are more time intensive 

or may have side effects. A multicenter database and research network would be crucial to 

improve evidence-based treatment recommendations. 

Another clinical issue that needs further investigation is the use of opioid pain medications. 

There are ample data demonstrating that these medications improve pain scores for acute 

pain processes. There are no data supporting the use of opioids long-term in patients with 

CPP. Given the potential side effects ranging from gonadal dysfunction, constipation, and 

sedation, to potential addiction, and given the expense of these medications, data on pain 

scores and quality of life would be very useful. CPP providers recognize that patients have a 

right to have their pain treated, but also recognize that without data, it is hard to recommend 

these medications. 

Further challenges include how little information we have on demographics and education. 

It has been almost 15 years since Mathias looked at the prevalence and impact of CPP in the 

United States. It is possible that there may be differences related to new treatments and to 

more Americans being uninsured. In Great Britain, Price looked at patients’ attitudes to the 

CPP consultation.7 Four major themes emerged as important in a successful consultation: 

wanting personal care, wanting to be taken seriously, wanting an explanation as much as care, 

and wanting reassurance. This type of needs assessment has not been performed in the United 

States, and would be valuable in developing treatment models. Further, there have not been 

assessments in the United States of the state of education in CPP for medical students or residents. Assessment of barriers that providers face when they manage women with CPP would 

also help in curriculum preparation. 

Basic tools that need to be developed include residency and postresidency educational objectives for the management of CPP, a research definition of CPP, and a validated measurement 

tool for outcomes that are important to women with CPP.8 

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Clearly CPP is a major problem for women and for healthcare providers. There is a shocking 

paucity of research on demographics, patients’ needs, educational needs and interventions, 

and treatment outcomes. I sincerely hope that you consider the scope of the problem, the significant impact on women with CPP, and the substantial cost of care when establishing future 

National Institutes of Health research priorities. 

Table 1: Common Causes of Chronic Pelvic Pain 

Gynecological: Urological: 

Gastroenterological: 

Neurological: 

Musculoskeletal: 

Endometriosis Interstitial cystitis 

Irritable bowel syndrome 

Inflammatory bowel disease Intestinal endometriosis 

Abdominal hernias Diverticular disease Colorectal 

carcinoma Chronic appendicitis Ischemic bowel 

Ilio-inguinal and ilio-hypogastric neuralgia 

Fibromyalgia 

Pelvic adhesive disease Urethral syndrome 

Infectious enterocolitis Proctalgia fugax 

Genito-femoral neuralgia 

Pelvic floor myalgias 

Ovarian cyst Renal lithiasis 

Pudendal neuralgia 

Coccygodynia 

Pelvic inflammatory disease Neoplasm 

Chronic regional pain 

syndrome 

Abdominal wall trigger 

points 

Dysmenorrhea 

Adenomyosis 

Pelvic congestion 

Leiomyomata 

Cervical stenosis 

Gynecologic malignancy 

Pelvic organ prolapse 

Vulvodynia 

References 

1. Mathias, S. D., Kuppermann, M., Liberman, R. F., Lipschutz, R. C., & Steege, J. F. (1996). 

Chronic pelvic pain: Prevalence, health-related quality of life, and economic correlates. 

Obstetrics and Gynecology, 87, 321–327. 

2. ACOG Committee on Practice Bulletins—Gynecology. (2004). ACOG practice bulletin 

number 51. Chronic pelvic pain. Obstetrics and Gynecology, 103, 589–605. 

3. Magni, G., Rigatti-Luchini, S., Fracca, F., & Merskey, H. (1998). Suicidality in chronic 

abdominal pain: An analysis of the Hispanic Health and Nutrition Examination Survey. 

Pain, 76, 137–144. 

4. Kjerulff, K. H., Langenberg, P. W., Rhodes, J. C., Harvey, L. A., Guzinski, G. M., & Stolley, P. 

D. (2000). Effectiveness of hysterectomy. Obstetrics and Gynecology, 95, 319–326. 

5. Weijenborg, P. T., Greeven, A., Dekker, F. W., Peters, A. A., & Ter Kuile, M. M. (2007). 

Clinical course of chronic pelvic pain in women. Pain, 132, S117–S123. 

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6. Steege, G. F., Levy, B., Meltzer, D., & Schmitt, W. (1998). Chronic pelvic pain: An integrated approach. Burlington, MA: Elsevier Health Sciences. 

7. Price, J., Farmer, G., Harris, J., Hope, T., Kennedy, S., & Mayou, R. (2006). Attitudes of 

women with chronic pelvic pain to the gynaecological consultation: A qualitative study. 

British Journal of Obstetrics and Gynecology, 113, 446–452. 

8. Lamvu, G. M. (2006). Basic tools absent from the field of Chronic Pelvic Pain: What we 

need to take better care of our patients. Vision: The International Pelvic Pain Society, 

14(4), 1–2. 

FRANCOIS LUKS, M.D., PH.D. 

The Warren Alpert Medical School of Brown University Program in Fetal Medicine 

The Future of Fetal Therapy 

We represent the Fetal Treatment Program, a multidisciplinary initiative that comprises more 

than 15 divisions and departments in two hospitals (Women & Infants’ Hospital and Hasbro 

Children’s/Rhode Island Hospital) and the Alpert Medical School of Brown University. The Fetal 

Treatment Program offers advanced therapy and support to the small portion of fetal patients 

that requires complex care, sophisticated collaboration between multiple services, and prolonged followup through the perinatal and neonatal period. This also includes invasive fetal 

therapy and fetal surgery. The Fetal Treatment Program is one of a small but growing group 

of such initiatives around the country. We are a founding member of the North American 

Fetal Therapy network, or NAFTNet, and we were an invited participant at the National Institutes of Health (NIH) Workshop on “Fetal Treatment: Needs Assessment and Future” in 2004. 

Ours was one of three fetal therapy program structures to be offered as national models. We 

have more recently acted as reviewers for technical briefs on Fetal Surgery for the Agency 

for Healthcare Research and Quality (AHRQ). We feel justified, therefore, in offering our recommendations regarding the future of fetal therapy and its place in the overall strategy for 

women’s health research priorities for the NIH in the coming decade. 

Fetal therapy is at an important crossroads. Whereas a decade ago, in-utero surgical intervention was semi-experimental and limited to less than a handful of specialized centers, there has 

been an explosion in the number of institutions offering this treatment and a rapid rise in the 

number of patients undergoing fetal surgery. While the early difficulties associated with such 

a new and perilous form of therapy and the high visibility of its pioneers provided some safeguards, the multiplication of fetal treatment centers around the country and the world has 

occurred virtually unchecked and without many guidelines. Oversight of fetal therapy is further complicated because it crosses disciplines, making specialty societies less able to provide 

enforceable directives. Furthermore, the makeup of each fetal therapy center often reflects local 

expertise, specific disorders that are being treated, referral patterns, and historical relationships 

between subspecialists. As a result, many different models of fetal therapy centers coexist. Our 

own Fetal Treatment Program has always prided itself in being truly interdisciplinary, based on 

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mutual respect and the goal to use the various strengths of each discipline to create an optimal 

approach to fetal therapy. Given the current trends in fetal medicine, we urge the NIH to take a 

leading role in developing guidelines for fetal therapy, and invasive fetal treatment in particular, 

that stress this collaborative environment. The Maternal-Fetal Medicine Network and Neonatal 

Network initiatives of the Eunice Kennedy Shriver National Institute of Child Health and Human 

Development (NICHD) have shown the benefits of NIH-directed merit-based participation in 

multicenter research. In the next decade, a similar initiative to regroup the most academic fetal 

therapy centers must be undertaken at the NIH level. Such an effort has already been started on 

this continent (the NAFTNet initiative, which directly followed the NIH consensus conference in 

2004), and was initiated more than a decade ago in Europe (Eurofoetus). 

The convergence of diagnostic accuracy in detecting fetal disorders and the technological 

advances that have made fetal intervention possible is unprecedented. Fetal therapy may still 

be a relatively rare occurrence, but it certainly is a new medical discipline. Just as the advent 

of neonatal intensive care units paved the way for the multidisciplinary care of the premature 

infant, its unborn counterpart can now benefit from greater knowledge and greater therapeutic opportunities to be considered and treated as a full patient. Because this is a relatively new 

development, however, current paradigms may not be ideally suited for this interdisciplinary approach. It is imperative, therefore, that the next generation of medical professionals be 

exposed to this new discipline. At the Alpert Medical School of Brown University, we have, for 

the past 6 years, offered a course in multidisciplinary fetal medicine with a faculty that crosses 

specialties. While this initiative has received accolades, it is still one of very few such initiatives in the country. We would urge the NIH to support innovative and effective educational 

programs that reflect the current status of fetal medicine at the undergraduate, graduate, and 

postgraduate levels. 

Because fetal therapy, by definition, only affects a very small minority of fetuses and pregnancies, it runs the risk of being bypassed as limited resources force the NIH to prioritize 

its budgets. The Food and Drug Administration already provides some solace through its 

Orphan Disease funding programs. However, these funds are insufficient and further marginalize rare disorders into competing against each other for attention and financial support. We 

understand that the difficulties arising from several recent fetal therapy grants, such as the 

twin-to-twin transfusion study, the congenital diaphragmatic hernia study before that, and the 

still-ongoing Management of Myelomeningocele Study, have reduced the NIH’s enthusiasm 

to fund future fetal surgery studies. Nevertheless, there remain substantial gaps in our knowledge of these conditions, even as the technical aspects of fetal intervention have improved. 

Endoscopic fetal surgery has become an accepted form of treatment for severe twin-to-twin 

transfusion syndrome, but patient selection remains very difficult, in part because of our lack 

of understanding of the pathophysiology of the disease. As a result and despite many clinical trials, outcome after fetal intervention is not much better than it was 10 years ago. For the 

next decade, we propose an increased effort into basic science research of placental vascular 

anomalies in twin gestations and other poorly understood fetal conditions. 

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Limited as the impact of fetal therapy studies may be within a wider public health context, 

their results can also have far-reaching spinoff effects on other diseases and conditions. Two 

decades of research into the technical aspects of open and endoscopic fetal surgery, itself 

a consequence of laparoscopic surgery developments, have advanced our knowledge and 

expertise in such areas as miniaturized endoscopy, ultrasound-guided interventions, management of preterm labor, and fetal lung development, all of which may ultimately benefit millions 

of Americans. Furthermore, research into epigenetics and fetal programming are unraveling 

the fetal origins of adult diseases. Recent studies emphasize the role of fetoplacental stress 

and the intrauterine environment on a variety of conditions of public health significance, 

including heart disease, diabetes, and obesity. Clearly, fetal medicine research does not exist in 

a vacuum and must become an integral part of public health policies and research planning. 

Fetal medicine, and fetal therapy in particular, remain fringe specialties, although their presence is growing very rapidly. It is important, therefore, that the following be undertaken: 

1. Guidelines and benchmarks be established, with particular attention to the interdisciplinary nature of this discipline 

2. Medical education and postgraduate training reflect the rapid changes in fetal medicine 

3. Despite current budget limitations, research funding for fetal medicine and fetal 

therapy initiatives not be ignored
�

We feel that the National Institutes of Health can, and should, play a major role in all three of 

these endeavors. 

354
Public Testimony 

Northwestern University School of Medicine 

Chicago, Illinois 

October 14, 2009 

Kristian Hurley 

American Autoimmune Related Diseases Association (AARDA) 

Lydia Buki, Ph.D. 

American Psychological Association 

Dee Fenner, M.D. 

American Urogynecologic Society 

Nicole Perez, M.A. 

Amigas Latinas 

Emily Godfrey, M.D., M.P.H. 

Association of Reproductive Health Professionals (ARHP) 

Simone Koehlinger, Psy.D. 

Chicago Department of Public Health 

Pamela McCann, M.S. 

Chicago Department of Public Health 

Carolyn Stern, M.D. 

DeafDOC.org 

Susan Love, M.D., M.B.A., FACS 

Dr. Susan Love Research Foundation/Army of Women 

Naomi Lynn Gerber, M.D. 

George Mason University 

Amber Hollibaugh 

Howard Brown Health Center 

Jennifer McGuire, M.S., RD 

National Fisheries Institute 

Pauline Maki, M.D. 

North American Menopause Society (NAMS) 

Riley D. Johnson, M.A. 

Queer People’s Health Collective 

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Colleen M. Fitzgerald, M.D. 

Rehabilitation Institute of Chicago 

Elizabeth Kissling, Ph.D. 

Society for Menstrual Cycle Research 

Annabelle S. Volgman, M.D., FACC 

WomenHeart: The National Coalition for Women with Heart Disease 

Lisa Martinez, J.D., RN 

The Women’s Sexual Health Foundation 

Kathie Duprey 

Self 

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KRISTIAN HURLEY 

American Autoimmune Related Diseases Association 

Autoimmune Diseases: A Major Women’s Health Issue 

Introduction 

As a disease category, autoimmune diseases are currently the eighth largest cause of death in 

women from the ages of 16 to 64. While these diseases do affect men also, the ratio is highly 

disproportionate with autoimmune diseases affecting women 78 percent1

 more often than 

men. By age 50, 1 in 10 to 1 in 20 women will have an autoimmune disease.1 

According to the National Institutes of Health (NIH), 23.5 million Americans are suffering from 

some form of autoimmune disease, of which there are more than 80. These include lupus, type 

1 diabetes, celiac, multiple sclerosis, and Crohn’s disease. Autoimmune diseases can affect 

every system in the body. While all are connected by the common thread of autoimmunity, 

their symptoms vary widely from disease to disease and often within a single disease as well, 

making them difficult to diagnose and often overlooked until the damage has become terminal or has irreversibly affected a patient’s quality of life. 

Today, too little is known about autoimmune diseases and their common pathogenesis of 

autoimmunity. As the NIH and the Office of Research on Women’s Health (ORWH) explore 

areas of the greatest concern for women, the American Autoimmune Related Diseases Association (AARDA) implores you to include autoimmune diseases as one of your primary platforms 

for future research and exploration. 

While there is a fundamental need for increased research across the board for the general 

pathogenesis of autoimmunity that connects these more than 80 diseases, AARDA particularly 

would like to see increased evaluation and research in the following areas: 

1. Current research tells us that autoimmune diseases are on the rise in the United States, 

as well as around the world. More work needs to be done to investigate the cause of 

such increases, such as genetic predisposition and environmental triggers. 

2. Consistently, autoimmune diseases continue to be a major health concern for women at 

a higher incidence than for men, and too little is known about why women are affected 

at such disproportionate numbers. 

3. Much more work needs to be done to investigate another disparity of why certain autoimmune diseases, especially among women, affect minority populations at higher rates 

as well as higher levels of severity than are experienced by other populations. 

4. More research and investigation are needed to analyze pregnancy, infertility, and lactation as they relate to autoimmune diseases as well as the relationship of endocrine 

disorders and autoimmune diseases. 

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Autoimmune Diseases on the Rise 

According to several studies conducted in the United States and around the globe, the 

incidence of many autoimmune diseases is rising. A study titled, Incidence of polymyositis-dermatomyositis: A 20-year study of hospital diagnosed cases in Allegheny County, PA 

1963–1982, showed the incidence of polymyositis-dermatomyositis more than tripled during 

this time period, and notably the most substantial increase took place amongst African-American women.2

 In another study, Increasing prevalence and incidence of multiple sclerosis in 

South East Wales, the prevalence of multiple sclerosis was found to have increased 45 percent over the past 20 years. Additionally, a study found that the overall incidence of systemic 

lupus erythematosus had increased twofold over a comparable study done in New York City 

15 years ago.3

 In Finland, type 1 diabetes has more than doubled in the past 30 years;4 and in 

the United States, a Mayo Clinic study found that celiac disease today is more than four times 

more common than it was 50 years ago.5 

This growing trend should be of great concern because while there is revealing evidence that 

autoimmune diseases are increasing in frequency, still very little is known as to why. Compelling past research has shown that autoimmune diseases may be on the rise due to triggers in 

our environment in those who have a genetic predisposition to the development of autoimmune diseases. 

Genetic Predisposition and External Triggers 

All autoimmune diseases are genetically interrelated, tending to cluster in individuals and families. An individual’s susceptibility to autoimmune diseases is determined by his/her set of 

genes. However, studies on identical twins show only a 30-50 percent concordance in autoimmune disease expression. Therefore, genetic makeup alone does not determine whether 

someone will “get” an autoimmune disease. There are other risk factors, external to the body, 

involved in initiating and exacerbating the disease process. 

As we have shown through current research trends, it is a common belief that autoimmunity 

is, in fact, on the rise. While one-third of the risk of developing an autoimmune disorder lies in 

one’s genetic makeup, the remaining causes are thought to be non inherited and may contain 

several environmental factors. For example, exposure to certain metals, such as mercury, gold 

and silver, are thought to induce lymphocyte proliferation and subsequent autoimmunity. 

While our current understanding of the role that environmental factors play in the autoimmune attack remains rudimentary, a wide range of triggers have been implicated in 

autoimmune disease expression, including the following: 

• Viral and infectious agents 

• Broad groups of chemicals 

• Heavy metals 

• Iodine 

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• Organic compounds (including PCBs and estrogenic compounds) 

• Phthalates 

• Pharmaceuticals 

• Pesticides 

• Some foods such as cow’s milk 

• Ultraviolet radiation 

More research in this area is required to fully understand this relationship, which affects millions of Americans at an increasingly higher rate each year. It is imperative that we understand 

the full range of environmental triggers and the role they play in the autoimmune process. 

Understanding how environmental factors fit into the autoimmune attack puzzle may provide approaches to preventing these diseases or reducing their severity. This is certainly more 

desirable than trying to control an ongoing autoimmune attack with immunosuppressive 

drugs that expose patients to many well-known serious side effects. 

AARDA, therefore, strongly recommends to the ORWH/NIH that a coordinated research program be initiated to better understand the role of environmental triggers across the family of 

autoimmune diseases. The ultimate goal of this program is the development of approaches to 

prevent autoimmune diseases or decrease their severity, thereby minimizing the very serious 

financial and societal burdens they place on our healthcare system and on afflicted individuals 

and their families. 

Women and Autoimmunity 

Autoimmune diseases affect women disproportionately more often than men, some as high 

as 9:1.6

 Although there has been some research into sex bias differences in autoimmune disorders, there is no substantial research into this area. It is commonly thought that hormones may 

play a significant role in the unbalanced nature of the diseases in women in comparison to 

men. For example, many autoimmune diseases seem to occur more often in women who have 

completed menopause, while other disorders may significantly improve during pregnancy with 

no outward provocation. Although these findings seem to point to an obvious link, the role of 

hormones in autoimmune disorders has not been conclusively proven. Recent findings indicate 

a need for more research concerning pregnancy influences on the incidence and natural history of autoimmune diseases. 

Hormones, Women, and Autoimmune Diseases 

Women are affected by autoimmune diseases 75 percent more often than men, and while this 

is common knowledge, still very little is known about why. Sex hormones, including estrogen, prolactin, and testosterone, all have been found to play an important role in triggering 

these diseases. While researchers have some understanding that hormones like estrogen 

can enhance autoimmunity and have various effects on the immune system, its behavior in 

response to certain autoimmune diseases is not linear. 

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For example, one study found a small increased risk of mild/moderate flares in women with 

systemic lupus erythematosus (SLE) who were taking hormone replacement therapy (HRT). 

However, there seems to be no increased risk of major flare ups in SLE patients taking HRT. In 

addition, in patients with rheumatoid arthritis, HRT is not associated with an increased risk of 

disease flare and may actually improve disease activity.7 

Additionally, another study analyzed the effects of prolactin production in breastfeeding 

women. Persistent mild to moderate elevations in serum prolactin were found to have been 

the cause of a break in self-tolerance in female mice, showing a possibility that women producing prolactin could be at risk of overactive autoimmunity.8 

Additionally, some autoimmune diseases have been shown to improve during pregnancy, 

while others show significant flares after pregnancy. For example, women with autoimmune 

disease who become pregnant can induce amelioration of the mother’s disease, such as in 

rheumatoid arthritis, while exacerbating or having no effect on diseases like systemic lupus 

erythematosus (SLE).9 

Clearly, hormones have a role to play in the triggering of an autoimmune reaction that leads 

to an autoimmune disease. Because of the overwhelming disproportionate ratio of women to 

men in autoimmune diseases, in women it is imperative that more work be done in research to 

uncover how these diseases are being triggered and what we can do to inhibit those reactions. 

Endocrine Disruptors and Autoimmune Disease 

Further evidence that hormones may play a major role in the increased incidence of women 

with autoimmune diseases lies in data that suggest endocrine disruptors affect both the 

reproductive system and the immune system; this is according to the study, Endocrine Disruptors (Environmental Estrogens) Enhance Autoantibody Production by B1 Cells. The results of 

this study indicate that endocrine disruptors are, in fact, involved in autoantibody production 

by B1 cells and may be an etiologic factor in the development of autoimmune diseases. Endocrine disruptors such as bisphenol-A (BPA) enhance autoantibody production by B1 cells both 

in vitro and in vivo.10 

In addition, another commonly found endocrine disruptor, diethylstilbestrol (DES), has been 

linked to increased levels of arthritis and lupus where there has been prenatal exposure to DES 

leading to immune impairment. In general, research has found that women prenatally exposed 

to DES appear to have a higher incidence of autoimmune diseases when various autoimmune 

diseases are grouped (S. Ansar Ahmed). Since DES has most commonly been prescribed for 

women to treat gonorrheal vaginitis, atrophic vaginitis, menopausal symptoms, and postpartum lactation suppression to prevent breast engorgement, there is ample evidence that it has 

led, in part, to the disproportionate nature by which women develop autoimmune diseases.11 

As autoimmune diseases increase in the U.S. and around the world, this problem requires 

an increased level of research and investigation into known hormonal triggers such as BPA 

and DES. 

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Infertility and Autoimmune Diseases 

Autoimmune disease is a major cause of pregnancy loss and infertility among women in the 

United States. Studies have investigated many of the factors surrounding infertility and autoimmune diseases, such as antiphospholipid antibodies, antithyroid antibodies, antinuclear 

antibodies, antisperm antibodies, and antiovarian antibodies. Antiphospholipid antibodies and 

recurrent pregnancy loss is an established connection with treatment options available for 

women; however, much work is still needed to analyze this as well as other autoimmune factors and their repercussions for infertility, pregnancy loss, and in vitro fertilization. 

One study, Antiphospholipid syndrome and recurrent miscarriages, posits that 7-25 percent of 

recurrent spontaneous abortions (RSA) can be accounted for by antiphospholipid syndrome 

(APS) as the main risk factor. Additional studies have found that APS is not only associated with RSA, but also with infertility. New mechanisms are described in this study by which 

antiphospholipid antibodies (aPLs) could cause placental thrombosis and infarction, acting 

directly on the surface anticoagulant expressed on trophoblastic cells. It was found that testing for additional aPLs remains an important objective to understanding their role in RSA.12 

Another study analyzing the role of antiphospholipid antibody–mediated recurrent pregnancy 

loss has shown that there is an evident association in both humans and murine models. The 

study found that pregnancy loss could result from diverse autoimmune factors, such as inflammation, involving different mechanisms that encompass pathogenic anti-PL Abs.13 

When analyzing whether there is a role in autoimmunity in implantation failure after in vitro 

fertilization, scientists found that antinuclear antibodies may be a marker for underlying autoimmune disease when coupled with certain signs and symptoms. Additionally, the study found 

that antisperm antibodies are associated with fertilization failure when found in high titers in 

seminal plasma, in sperm, or in the mucosal immune system of women. Antisperm antibodies 

are uncommon generally; however, they are most often associated with ovarian hypofunction.14 

Clearly, there is a fundamental role played by autoimmunity in the infertility and pregnancy 

loss of women, and more work needs to be applied here by ORWH to explore further what 

these and other studies of their kind are beginning to discover. A study titled, Bidirectional 

effects on autoimmunity and reproduction, came to the following conclusion, which AARDA 

fully agrees with: “Integration of mechanistic and clinical information by multidisciplinary 

teams is needed to manage reproductive issues in women with autoimmune diseases.” 

Autoimmune Diseases in Minority Populations 

Another area of increasing concern that has been under-studied and under-analyzed is 

the question of why some minority populations are disproportionately affected by certain 

autoimmune diseases. For example, research has shown that lupus nephritis is found to be 

more common and have increased levels of severity in African-American women. Additionally, despite aggressive immunosuppressive therapies employed in lupus nephritis in this 

patient population, there is also a higher incidence of progression to end-stage renal disease, according to a study, Lupus nephritis in African-Americans.

15 Factors such as genetics 

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have been found to play a role in explaining why African-Americans appear to be at higher 

risk for lupus nephritis. 

Research supported by NIH found that African-Americans were more likely to have a less 

efficient Fc receptor gene. This work will greatly increase the ability of scientists to begin 

studying ways to better predict those who have a higher level of susceptibility to lupus nephritis. This is an area where additional research could lead to viable options for treatment and 

early detection. In addition to the genetic finding surrounding lupus nephritis in African-Americans, still more work is necessary, as autoimmune disease often must be triggered even in 

those with proven genetic predisposition, and too little is still known about those triggers. 

Further study in this area may also help explain the severity levels of African-Americans with 

lupus nephritis. 

In a recent study, Nursing home residents with multiple sclerosis (MS): Comparisons of African American residents to White residents at admission,16 it was found that African-American 

patients admitted to nursing homes with MS were found to be significantly younger, had a 

higher degree of cognitive impairment, and were considerably more physically disabled. The 

study also found that while the differences in the White and African-American MS populations were vastly different in severity; there was no notable difference in the use of various 

therapies provided by quality therapists. The outcomes of this study require a great deal of 

additional research that AARDA compels the National Institutes of Health to support. More 

research and collaboration is needed in the areas of genetics, immunology, epidemiology, and 

virology to determine the pathophysiology of MS and its possible different effects on minority 

populations. Additionally, further research could uncover a possible need for outreach into the 

African-American community for disparities in MS-related care, increasing treatment outcomes 

for this population.16 

While we have demonstrated two very specific scenarios in which disease outcome varies by race in both lupus nephritis and MS, we believe that this is an area that requires more 

attention. Both the above studies are further examples of the need to fully develop new and 

innovative tools to treat disease, such as personalized medicine. Further research into locating 

and chronicling disease biomarkers in patients, helping us to better predetermine treatment 

outcomes for a various number of human populations, could be the key to closing some of the 

racial disparities in treatment for autoimmune diseases. 

Autoimmune Disease Biomarkers 

NIH should focus considerable efforts into research on biomarkers for the more than 100 autoimmune diseases. There is a critical need for the creation of a database of autoimmune disease 

biomarkers. This database would assist in tracking the relation of biomarkers to disease severity. In addition, there is a need to develop a differential diagnosis technique to use groups 

of biomarkers to determine the presence of specific autoimmune diseases. The last item is 

based on the concept that autoimmune diseases can be determined by looking for groups 

of biomarkers as though they were chords played on a piano. There is also a need to expand 

autoimmune disease research to include the relationship between these diseases and other 

serious health conditions. 

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Awareness Through Education 

Lastly, we recommend that the NIH Office of Research in Women’s Health sponsor a crossinstitute scientific meeting to examine the latest in research on the issues discussed above in 

order to identify additional areas of opportunity in autoimmune disorders research. 

About the American Autoimmune Related Diseases Association 

The American Autoimmune Related Diseases Association is dedicated to the eradication of 

autoimmune diseases, alleviation of suffering, and socioeconomic impact of autoimmunity 

through fostering and facilitating collaboration in the areas of education, public awareness, 

research, and patient services in an effective, ethical, and efficient manner. 

AARDA is the only national nonprofit health agency dedicated to bringing a national focus 

to autoimmunity, the major cause of serious chronic diseases. Approximately 50 million 

Americans, 20 percent of the population or 1 in 5 people, suffer from autoimmune diseases. 

Women are more likely than men to be affected; some estimates say that 75 percent of those 

affected—some 30 million people—are women. Still, with these statistics, autoimmunity is 

rarely discussed as a women’s health issue. 

Autoimmunity is a result of a misdirected immune system that causes one’s own immune system to attack the self. There are more than 80 known autoimmune diseases, and unlike the 

many forms of cancer that are recognized as being part of the general term “cancer,” autoimmune diseases are recognized singularly rather than in the overall category of autoimmunity. 

The public in general is unaware of the autoimmune nature of these diseases. When most people hear one of these diseases referred to as an autoimmune disease, they incorrectly confuse 

the term autoimmune with acquired immune deficiency syndrome (AIDS), or they think it is a 

form of cancer. 

This lack of knowledge and collaborative effort results in untold suffering for persons with 

autoimmune diseases due to misdiagnosis and delayed diagnosis, which may result in damage 

to vital organs. The need to bring a national focus to autoimmunity as the common factor in all 

autoimmune diseases is vital in order to bring a collaborative effort to research, funding, early 

detection, and eventually, prevention and cure for all autoimmune diseases. 

Some of the more than 80 autoimmune diseases are lupus, type I diabetes, scleroderma, 

celiac, multiple sclerosis, Crohn’s disease, autoimmune hepatitis, rheumatoid arthritis, Graves’ 

disease, myasthenia gravis, myositis, antiphospholipid syndrome, Sjögren’s syndrome, uveitis, 

polymyositis, Raynaud’s phenomenon, and demyelinating neuropathies. 

References 

1. Fairweather, D., Frisancho-Kiss, S., & Rose, N. R. (2008). Sex differences in autoimmune 

disease from a pathological perspective. American Journal of Pathology, 173, 600–609. 

2. Oddis C.V., Conte C. G., Steen V. D., & Medsger, T. A. (1990). Incidence of polymyositisdermatomyositis: A 20-Year study of hospital diagnosed cases in Allegheny County, PA, 

1963–1982. Journal of Rheumatology, 17, 1329–1334. 

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3. Hochberg, M. C., (1985). The incidence of systemic lupus erythematosus in Baltimore, 

Maryland, 1970–1977. American College of Rheumatology, 28, 80–86. 

4. Harjutsalo, V., Sjoberg, L., & Tuomilehto, J. (2008). Time trends in the incidence of type 1 

diabetes in Finnish Children: A cohort study. The Lancet, 371, 1777–1782. 

5. Rubio-Tapia, A., Kyle, R. A., Kaplan, E. L., Johnson, D. R., Page, W., Erdtmann, F., . . . 

Murray, J. A. (2009). Increased prevalence and mortality in undiagnosed celiac disease. 

Gastroenterology, 137, 88–93. 

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women [article]. Retrieved from http://www.aarda.org/women_and_autoimmunity.php 

7. Holroyd, C. R., & Edwards, C. J. (2009). The effects of hormone replacement therapy on 

autoimmune disease: rheumatoid arthritis and systemic lupus erythematosus. Climacteric, 12, 378–386. 

8. Saha, S., Gonzalez, J., Rosenfeld, G., Keiser, H., & Peeva, E. (2009). Prolactin alters the 

mechanisms of B cell tolerance induction. Arthritis and Rheumatism, 60, 1743–1752. 

9. Adams Waldorf, K. M., & Nelson, J. L. (2008). Autoimmune disease during pregnancy 

and the microchimerism legacy of pregnancy. Immunological Investigations, 37, 631–644. 

10. Yurino, H., Ishikawa, S., Sato, T., Akadegawa, K., Ito, T., Ueha, S., . . . Matsushima, K. 

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11. Ahmed, S. A., Hissong, B. D., Verthelyi, D., Donner, K., Becker, K., & Karpuzoglu-Sahin, 

E. Gender and risk of autoimmune diseases: Possible role of estrogenic compounds. 

Environmental Health Perspectives, 107 Suppl 5, 681–686. Review. 

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14. Lea, J. P., (2002). Lupus nephritis in African Americans. American Journal of the Medical 

Sciences, 323 (2), 85–89. 

15. Cline, A. M., & Kutteh, W. H. (2009). Is there a role of autoimmunity in implantation 

failure after in-vitro fertilization? Current Opinion in Obstetrics and Gynecology, 21, 

291–295. Review. 

16. Buchanan, R. J., Martin, R. A., Zuniga, M., Wang, S., & Kim, M. (2004). Nursing home 

residents with multiple sclerosis: Comparisons of African-American residents to White 

residents at admission. Multiple Sclerosis, 10, 660–667. 

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LYDIA BUKI, PH.D 

American Psychological Association 

Written Statement From the American Psychological Association (APA) and the APA Committee 

on Women in Psychology: Moving Into the Future—New Dimensions and Strategies for Women’s 

Health Research 

On behalf of the 150,000 members and affiliates of the American Psychological Association 

(APA), we thank you for holding this important series of hearings to discuss ways to update 

the research agenda of the Office of Research on Women’s Health (ORWH). 

APA is the largest scientific and professional organization representing psychology in the 

United States and is the world’s largest association of psychologists. Composed of researchers, 

educators, clinicians, consultants, and graduate students, APA works to advance psychology 

as a science, a profession, and a means of promoting health, education, and human welfare. 

APA acknowledges the important role of ORWH and its founding director in spurring interest in women’s health research. It is of paramount importance to promote women’s health. 

Through the years, advocates have focused on many critical issues in women’s health, including 

access to health care, health promotion across the lifespan, violence against women, genderbased research, and mental health. In addition, advocates and researchers have recognized that 

due to health inequities, women across various racial and ethnic groups, lesbian, bisexual, and 

transgender women, women with disabilities, and low-income women are bearing a disproportionate burden of disease; therefore, special attention is warranted for these populations. 

APA views ORWH as a valued partner and applauds the behavioral research that ORWH has 

funded or cofunded since its inception. Themes given emphasis in the Office’s Fiscal Year 

2009 priorities strike a resounding chord. APA particularly applauds the lifespan perspective 

and emphasis on quality of life. 

Women have traditionally experienced lower earning power than men, with a current gender 

gap of 23 percent.1

 This has resulted in a disproportionate number of women who are economically disadvantaged. Access to care is a key factor contributing to poorer health outcomes in 

economically disadvantaged individuals.2

 Therefore, research that contributes to public policy 

changes by eliminating barriers to care in women with low socioeconomic status will have a 

significant impact in terms of facilitating health promotion in all women. 

Health promotion for women includes attention to the entire spectrum of a woman’s life.3 During early childhood, health depends on proper nutrition and physical activity, immunizations, 

and the prevention of conditions, including osteoporosis and skin cancer. As girls move into 

the teen years and early adulthood, awareness, prevention and treatment for sexually transmitted infections (STIs), human immunodeficiency virus (HIV), acquired immune deficiency 

syndrome (AIDS), tobacco use, substance abuse, and violence become a concern. 

Women’s health needs change upon entering midlife. The management of cardiovascular and 

other chronic diseases is essential, as is screening for and knowledge about cancer, diabetes, 

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and a number of other important health conditions.4 Throughout a woman’s lifespan, mental 

health services greatly affect her overall health, as well as access to prescription drugs, longterm care facilities, and community-based care services during the later years of womanhood. 

We strongly support efforts made to educate women to be partners in their health and wellness, defined to include wellness in emotional, social, environmental, physical, intellectual and 

spiritual realms. 

Violence against women has become a global social epidemic that demands our attention 

through research and intervention. There is a growing body of evidence that indicates that 

gender-based violence is a risk factor for multiple physical, mental, reproductive, and psychosomatic disorders affecting women. Physical consequences include homicide, injuries during 

pregnancy, serious injuries, and vulnerability to disease. The psychological consequences are 

grave, ranging from suicide, depression, anxiety, posttraumatic stress disorder, eating disorders, and chemical dependency.5–7 

Additionally, the costs to society are significant. Direct costs include those incurred by police, 

courts, and legal services to prosecute perpetrators; the costs of treating offenders; the medical and mental healthcare costs of treating sexually and physically abused women; social 

service costs, including child protection services; and the loss of productivity and employment 

by abused women. To address this, APA recommends that ORWH partner with other Institutes 

and Centers, including the National Institute of Mental Health (NIMH), the National Institute 

on Aging, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Nursing Research, to help prevent and eliminate 

violence against women and address the ongoing patriarchal systems that institutionalize 

women’s diminished worth. 

The recognition that women’s health outcomes vary according to race and ethnicity has 

brought with it an increased effort on the part of the National Institutes of Health (NIH) to 

address these inequities.8

 We applaud these efforts and would like to see these sustained and 

expanded. We especially encourage additional grant mechanisms to support research at the 

community level with marginalized populations, including the use of novel, community-based, 

non-mainstream methodologies. We also support research studies focused on the cultural and 

conceptual aspects of health literacy and how these aspects are related to health promotion 

and health outcomes in women. 

This research is certainly relevant to healthcare reform discussions and to women who tend 

to make healthcare decisions for their families.9

 We recognize that at the NIH the number 

of studies examining health literacy and health disparities vary widely by Institute, and we 

encourage greater attention to mental health disparities, especially in marginalized and medically underserved populations. 

We also acknowledge that there has been a dearth of studies conducted with populations 

who have diverse sexual orientations. The lack of funding for large-scale studies with this 

population has significantly hampered efforts to promote the health of lesbian, bisexual, and 

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transgender women. Other populations traditionally neglected in research that should be a 

focus in future studies include American Indian women and immigrant populations (e.g., Asian 

and Pacific Islander [API] and Latino populations). A greater focus on API and the Latina population is consistent with demographic projections of a dramatic population growth for both 

populations, particularly at certain age ranges.10 

Gender-based research is also critical to the promotion of women’s health. There are women 

who may react differently than men to certain medications, yet often medications are tested 

on men. Women may also be more vulnerable to certain diseases, have different symptoms 

from men, and may respond differently to various diagnostic procedures. A focus on inclusion of women in clinical trials and on research to understand how biological differences 

affect health outcomes is warranted. ORWH is encouraged to participate in research designed 

to improve and/or assess the external validity in randomized clinical trials so that sampling, 

recruiting participants, and interpreting results of clinical trials important to women’s health 

may be improved. 

Furthermore, postpartum depression (PPD) is a serious mental health problem that can 

have significant consequences for both the new mother and family. For mothers, PPD can 

affect their ability to function in everyday life and increases their risk for anxiety, cognitive 

impairment, guilt, fear, sleep disturbance, and thoughts of hurting oneself and one’s child. 

Additionally, PPD may lead to difficulty in providing developmentally appropriate care to 

infants. As a result, children of mothers with PPD may experience problems in cognitive, social, 

and emotional development and have a higher risk of anxiety disorders and major depression 

in childhood and adolescence. APA supports research on the causes, differences among racial 

and ethnic groups, and treatments for PPD and encourages ORWH to seek opportunities to 

collaborate on this issue with NIMH and NICHD. 

In closing, the American Psychological Association would like to thank you for the opportunity 

to share our comments related to women’s health. We appreciate the NIH’s ongoing commitment to women’s health and look forward to serving as a resource and partner as you work on 

this and other important issues affecting women’s physical and psychological well-being. 

References 

1. Institute for Women’s Policy Research. (2009). The gender wage gap 2008 (Fact sheet). 

Retrieved from http://www.iwpr.org/pdf/C350.pdf 

2. Andrulis, D. P. (1998). Access to care is the centerpiece in the elimination of socioeconomic disparities in health. Annals of Internal Medicine, 129, 412–416. 

3. Alexander, L. L., LaRosa, J. H., Bader, H., & Garfield, S. (2007). New dimensions in 

women’s health (4th ed.). Sudbury, MA: Jones and Bartlett.
�

4. Torpy, J. M. (2006). Women’s health: Theme issue (Fact sheet). Retrieved from 

http:/jama.ama-assn.org/cgi/content/full/295/12/1474 

5. Parrot, A., & Cummings, N. (2008). Sexual enslavement of girls and women worldwide. 

Westport, CT: Praeger. 

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6. Astbury, J. (2006). Violence against women and girls: Mapping the health consequences. 

International Congress Series, 1287, 49–53. 

7. World Health Organization. (2008). Violence against women: Fact Sheet No. 239. Retrieved from http://www.who.int/mediacentre/factsheets/fs239/en/ 

8. Institute of Medicine. (2002). Unequal treatment: Confronting racial and ethnic disparities in health care. Washington, DC: National Academies Press. 

9. Institute of Medicine. (2004). Health literacy: A prescription to end confusion. Washington, DC: National Academies Press. 

10. U.S. Census Bureau. (2004). Census Bureau projects tripling of Hispanic and Asian 

populations in 50 years; non-Hispanic Whites may drop to half of total population (Press 

release). Retrieved from http://www.census.gov/Press-Release/www/releases/archives/ 

population/001720.html 

DEE FENNER, M.D. 

American Urogynecologic Society 

Importance of Supporting Research into the Causes and Treatment of Pelvic Floor Disorders 

The American Urogynecologic Society (AUGS) appreciates the opportunity to provide 

information to the Office of Research on Women’s Health (ORWH) on the importance of supporting research into the causes and treatment of pelvic floor disorders. AUGS is a healthcare 

organization composed of clinicians and scientists dedicated to advancing research, education, and patient care in pelvic floor disorders, a common but largely neglected and untreated 

constellation of disorders that disproportionately affects women. 

Pelvic floor disorders are a hidden epidemic. Women are reluctant to report symptoms, and 

providers are reluctant to ask about them. Urinary and anal incontinence and pelvic organ 

prolapse are conditions accompanied by shame and embarrassment; and, although they 

do not kill, they have a significant impact on women’s lives. Women with incontinence are 

known to have increased rates of depression, avoid work and social contact, as well as intimacy. A recent report from the Pelvic Floor Disorders Network, funded by the Eunice Kennedy 

Shriver National Institute of Child Health and Human Development (NICHD), and published 

in the Journal of the American Medical Association (JAMA), found that pelvic floor disorders commonly impact American women. The authors surveyed community-dwelling women 

and defined disease to include women with only moderate to severe symptoms. Despite rigorous definitions, 16 percent of women reported moderate to severe urinary incontinence; 

9 percent reported fecal incontinence; and nearly 3 percent had symptoms of severe pelvic organ prolapse. Increasing age leads to increasing prevalence, with half of all women over 

80 affected. Of those women with pelvic floor disorders, 1 out of 11 women will have symptoms severe enough to choose to undergo surgical treatment, and of those who choose 

surgery, 1 in 3 will have a second surgery. Nearly all pelvic floor disorders are amenable to 

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nonsurgical management; however, little data exists to guide clinical decision making. Exception to this includes a recent report in the New England Journal of Medicine that demonstrated 

that weight loss resulted in a 47 percent drop in weekly incontinence episodes, confirming 

that weight loss can be considered a first-line treatment for women with incontinence. Women 

deserve choice of treatments and better understanding of these common conditions; to make 

this a reality, increased research funding is urgently needed. 

There are four key areas where we believe increased funding for research could identify treatments and prevention strategies that would yield better outcomes and care for women who 

suffer from pelvic floor disorders. AUGS believes significant investment should be granted to 

research on pelvic floor disorders and is committed to ensuring that these investments would 

be well spent and would yield better patient outcomes. 

Stress Urinary Incontinence 

Of all pelvic floor disorders, urinary incontinence is the most common. Improvements in surgical treatment of urinary incontinence will improve the quality of life for American women and 

reduce associated healthcare costs. Surgery for treatment of stress urinary incontinence (SUI) 

is common and increasing, with 135,000 surgical procedures performed in the United States 

annually, an approximately 45 percent increase from 1988.1

 Ongoing efforts to select the most 

appropriate initial surgery and comparative trials to compare surgical therapies to nonsurgical 

treatments, including pelvic floor exercises, pessaries, and behavioral therapy are needed. 

Approximately 10-40 percent of women have recurrent or persistent SUI after a continence 

procedure, and therefore, reoperation rates after surgery for urinary incontinence are high.2,3 

Few data are available to guide surgical treatment of recurrent or persistent SUI, although 

it is commonly accepted that repeat continence procedures are associated with lower success rates than primary surgeries and that failure rates increase over time.4-6 Surgical trials are 

urgently needed to guide the care of women with persistent or recurrent SUI. 

The NIH has invested in comparative effectiveness trials for women with uncomplicated SUI. 

The National Institute of Diabetes and Digestive and Kidney Diseases funded Urinary Incontinence Treatment Network recently reported in the SISTER Trial that cure rates after continence 

surgery are considerably lower than previously reported.7

 Unfortunately, only a small minority of women in this trial had undergone a prior continence surgery: 13 percent in the sling 

group and 15 percent in the Burch group. A second comparative effectiveness trial has just 

completed enrollment, but given the similarity in inclusion/exclusion criteria, it is likely that 

the network will enroll a similar percentage of women with recurrent or persistent SUI after a 

prior continence procedure, and it will also fail to provide data to guide clinical decisionmaking in women who have failed a first surgery. Therefore, despite the high urinary incontinence 

prevalence rates and high reoperation rates, there are no adequately powered randomized trials investigating the optimal method for treating SUI in this population of women. Without 

advanced understanding of the consequences and optimal surgical strategies for SUI, treatment in this important area of women’s health is advancing slowly. 

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Prolapse Surgery 

Three to 6 percent of women will develop pelvic organ prolapse during their lifetime, with half 

reporting significant impact on her quality of life.8

 Surgical therapy is the gold standard for the 

treatment of pelvic organ prolapse and is the main indication for hysterectomy in women over 

the age of 50. In 1997, approximately 225,000 surgeries were performed for pelvic organ prolapse in the United States with a direct cost of $1.12 billion.9

 Of women who choose surgery for 

treatment of their prolapse, one-third will have a second surgery. 

While numerous surgical options are available, few comparative trials have been performed 

to determine the best surgery for primary or recurrent prolapse. In a recent Cochrane review, 

only 22 studies with fewer than 3,000 evaluable patients compared the effectiveness of different surgeries for pelvic organ prolapse.10 Many more studies with adequate power are needed. 

In particular, randomized trials with adequate long-term followup that access indications, cure, 

risks for failure, and complications are drastically needed. In addition to surgical therapies, 

prolapse can also be treated with the use of pessaries. To date, a single trial has compared two 

types of pessary and no trials compare nonsurgical to surgical management of women with 

prolapse. Increased funding into both surgical and nonsurgical treatments for prolapse will 

allow women to make informed decisions regarding their care. 

Randomized Trials and Mesh Registry 

In an attempt to improve surgical repairs of pelvic organ prolapse, many surgeons use vaginally 

placed mesh to attempt to strengthen native tissues. Little data exist to support this treatment 

option, yet its use is growing in popularity, in part driven by the medical device industry. In 

November 2008, the Federal Drug Administration issued a warning regarding the use of these 

permanent mesh materials in response to a large number of complications reported on the 

MAUDE Web site, a voluntary reporting system for mishaps with medical devices. 

Research dollars are needed to support randomized surgical trials, as well as the development of clinical registries to accurately report surgical mesh use, as well as its complications. 

Establishing a national registry is a huge undertaking and one that cannot be done by one 

organization alone. AUGS would like to work with NIH and partner with the Food and Drug 

Administration and the Centers for Medicare and Medicaid Services (CMS) to create a mesh 

registry that accurately reports use and outcomes with novel surgical devices so that unnecessary harm to women does not occur. 

Prevention of Pelvic Floor Disorders 

While data are sparse that guide clinical decisionmaking in the treatment of pelvic floor disorders, even less is known regarding the prevention of these problems as well as simple health 

care measures that women can implement to prevent their development. While pelvic floor 

exercises (aka “Kegels”) are commonly proscribed to young women, little to no data support their use as a prevention strategy. Research funding is urgently needed to not only better 

understand the causes and treatments of pelvic floor disorders, but also to find prevention 

strategies for these common problems. 

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Conclusion 

AUGS sincerely appreciates the support many of our members have received from the NIH 

and the work we have been able to accomplish with government supported grants. Millions of 

women are impacted by pelvic floor disorders. Rigorous research is needed to determine best 

practices and therapeutic options for these life limiting disorders. Thank you for your attention 

to our requests and this important area of research in women’s health. 

References 

1. Waetjen, L. E., Subak, L. L., Shen, H., Lin, F., Wang, T. H., Vittinghoff, E., & Brown, J. S. 

(2003). Stress urinary incontinence surgery in the United States. Obstetrics and 

Gynecology, 101, 671–676. 

2. Olsen, A. L., Smith, V. J., Bergstrom, J. O., Colling, J. C., & Clark, A. L. (1997). Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstetrics 

and Gynecology, 89, 501–506. 

3. Schaeffer, A. J. (1984). Treatment of recurrent urinary incontinence. Clinical Obstetrics 

and Gynecology, 27, 459–473. 

4. Amaye-Obu, F. A., & Drutz, H. P. (1999). Surgical management of recurrent stress 

urinary incontinence: A 12-year experience. American Journal of Obstetrics and Gynecology, 181, 1296–1307. 

5. Hodgkinson, C. P. (1978). Recurrent stress urinary incontinence. Clinical Obstetrics and 

Gynecology, 21, 787–796. 

6. Chin, Y. K., & Stanton, S. L. (1995). A follow up of silastic sling for genuine stress incontinence. British Journal of Obstetrics and Gynaecology, 102, 143–147. 

7. Albo, M. E., Richter, H. E., Brubaker, L., Norton, P., Kraus, S. R., Zimmern, P. E., . . . Steers, 

W.; Urinary Incontinence Treatment Network. (2007). Burch colposuspension versus 

fascial sling to reduce urinary stress incontinence. New England Journal of Medicine, 

356, 2143–2155. 

8. Rortveit, G., Brown, J. S., Thom, D. H., van den Eeden, S. K., Creasman, J. M., & Subak, L. 

L. (2007). Symptomatic pelvic organ prolapse: prevalence and risk factors in a population-based racially diverse cohort. Obstetrics and Gynecology, 109, 1396–1403. 

9. Subek, L. L., Waetjen, L. E., van den Eeden, S., Thom, D. H., Vittinghoff, E., & Brown, J. 

S. (2001). Cost of pelvic organ prolapse surgery in the United States. Obstetrics and 

Gynecology, 98, 646–651. 

10. Maher, C., Baessler, K., Glazener, C. M. A., Adams, E. I., & Hagen, S. (2008). Surgical management of pelvic organ prolapse in women: A short version Cochrane Review. Neurology and Urodynamics, 27, 9–12. 

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NICOLE PEREZ, M.A. 

Amigas Latinas 

Disparities in LGBTQQ Women’s Health 

This testimony is presented on behalf of Amigas Latinas (AL), a not-for-profit organization 

located in Chicago, IL. Over the past 12 years, Amigas Latinas has established itself as a vibrant 

and visible organization that advocates for Latina lesbian, gay, bisexual, transgender, queer, 

and questioning (LGBTQQ) communities in Chicago. Through sustained programming, leadership development, and advocacy, AL works to educate and empower Latina LGBTQQ women, 

as well as to educate service providers, the Latino community, the mainstream gay community, and legislators about the issues relevant to the Latina LGBTQQ community. As part of this 

effort, AL conducted the ground-breaking Proyecto Latina (PL) survey, which is the first project of its kind in Chicago to provide critical information about a community that has been 

ignored in research and scholarship for far too long. 

Studies that specifically focus on examining the lives and challenges of Latina LGBTQQ women 

are practically nonexistent. The scarce literature that does exist reveals that this population 

is underserved and neglected in research studies and publications throughout the Nation. In 

recent years, there has been an increase in data on Latinos and on LGBTQQ lives and experiences. However, the data are primarily about White gays and lesbians, and among Latino 

publications, the experiences of LGBTQQ women are often ignored. In 2006, responding to 

this lack of information, the board of directors of AL initiated the Proyecto Latina: Descubriéndonos Survey Project in order to document and make visible the unique experiences of Latina 

LGBTQQ women in the Chicago metropolitan area. 

Having run from January 12 through July 30, 2007, The Proyecto Latina: Descubriéndonos survey project involved the distribution of an extensive survey tool (299 questions) available in 

English and Spanish. The objectives of the survey project were as follows: 

• Assess the experiences that Latina LGBTQQ women have with oppression, violence, 

and discrimination 

• Address issues of accessibility (or inaccessibility) to health care 

• Address issues related to physical and mental health among LGBTQQ Latinas 

• Provide information to service providers and policymakers both in the Chicagoland area 

and nationally 

• Generate a number of publications in an attempt to inform a wider audience of 

these issues 

• Spark critical dialogues and raise consciousness of issues among community members 

• Help Amigas Latinas to identify and meet the needs of its members and underserved 

populations (i.e., transgender and bisexual women) 

A total of 305 people between the ages of 13 and 60 years old completed the survey (262 in 

English and 43 in Spanish). The results of the PL survey project revealed that Latina LGBTQQ 

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women in the Chicagoland area had significant experiences with discrimination, oppression, 

and violence/assault throughout their lives. The data speak to the prevalence of racism, sexism, and homophobia/heterosexism in women’s lives, and suggests that LGBTQQ Latinas 

experience these harmful attitudes and behaviors from numerous communities and environments. In the survey, participants also identified the negative impact that prolonged exposure 

to oppression has had on their overall mental, emotional, and physical well-being; participants 

identified internalizing these harmful attitudes/actions and reported experiencing aboveaverage levels of stress (48%), poor emotional health (21%), depression (21%), loneliness and 

isolation (49%), and suicidality (34%). 

A persistent theme from PL survey respondents involved negative experiences with various 

institutions and physical and mental healthcare providers. LGBTQQ Latinas reported significant experiences of racism and homophobia/heterosexism in particular from hospitals, 

medical professionals, social service providers, and from governmental agencies. Such prevalent and recurring experiences with discrimination in this area serves as a barrier to LGBTQQ 

Latinas accessing physical and mental health care services, and consequently results in health 

disparities and decreased rates of participation in life-saving health screenings (such as mammograms, pap tests, colonoscopies, etc.). For example, 28 percent of respondents identified 

not disclosing their sexual orientation to their healthcare providers out of fear of rejection or 

negative treatment; among participants who have disclosed, nearly 15 percent reported that 

upon this disclosure, they experienced a negative reaction that added to the stress of their 

already existing illness or condition. These findings indicate that despite the implementation 

(on Federal and local levels) of antidiscrimination laws and policies, the presence of discrimination in health care and social service institutions continues to prevent access to adequate 

care for LGBTQQ Latinas. 

In addition, the PL survey data also revealed that Latina LGBTQQ women also experience significant amounts of same-sex domestic violence. Forty-three percent of participants reported 

that a female partner had pushed or hit them, and 31 percent reported that a partner had 

threatened to kill them. Although the Illinois Domestic Violence Act theoretically serves everyone regardless of sexual orientation, Latina LGBTQQ women who are victims of violence and 

assault face many obstacles as they consider whether or not it is safe to attempt to get help. 

They may be reluctant to seek help because of the long history of racism and homophobia of 

the police and other legal institutions. Law enforcement agents often do not take complaints 

of violence from LGBTQQ women seriously. Many also face language barriers or may be reluctant to turn to the law because of their immigration status. Closeted LGBTQQ Latinas might 

also fear being outed by legal institutions or officers of the court. Additionally, queer women 

who are not out to their families or whose families are not accepting of their sexual identity may not feel that they can even turn to their families for help. These factors can create a 

devastating sense of fear and hopelessness for Latina LGBTQQ women who are survivors of 

violence. The need for funding to create LGBTQQ-friendly and competent social services and 

programs that adequately address violence and abuse experienced by Latina LGBTQQ women 

is evident and vitally needed. Nearly a quarter of PL survey respondents indicated the need for 

additional programming and services that LGBTQQ Latina survivors of violence and abuse can 

access for support. 

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In addition to PL, several recent studies have also pointed to the need to address issues of sexual and reproductive health of LGBTQQ women, particularly young queer women. Findings 

from studies conducted by AL, Affinity Community Services, the Young Women’s Empowerment Project, and Howard Brown Health Center/Broadway Youth Center all indicate that a 

majority of LGBTQQ women are not having protected sex with female partners, and many are 

also engaging in sex (protected and unprotected) with men. Despite the common perception that young women who have sex with women are at reduced risk of sexually transmitted 

diseases (STDs) and pregnancy in comparison to other young women, recent preliminary evidence from these studies indicates that they actually may be just as, or even more likely, to 

practice sexual risk behavior, to engage in the sex trade, and to experience both STD and 

unwanted pregnancy outcomes. Very little research has been done to date that might help to 

explain this disproportionate risk. 

The results of these studies point to the need for funding for additional research to assess 

LGBTQQ women’s mental, physical, sexual, and reproductive health, and to explore potential 

points of intervention and support. The majority of funding sources available to researchers 

and social service agencies are to provide HIV intervention programs for men who have sex 

with men. Although these programs are vital, the health and well-being of LGBTQQ women, 

particularly women of color, are being ignored by scholars and providers, and the above-mentioned health disparities are consequently the result. Funding is needed for both individual 

behavioral as well as structural interventions and programs to adequately address the disparities and issues impacting LGBTQQ women. As the little data that are available has shown us, 

it is vitally important to create programs aimed at increasing the self-worth and reducing the 

prevalence of depression and suicidality among LGBTQQ women, because the increasing selfworth has shown a decrease in risk-taking behaviors and a positive impact on overall health. 

It is also equally important to create structural interventions to hold systems and institutions 

accountable for reducing barriers to care for LGBTQQ women and to create culturally competent services that are prepared to adequately address their needs. 

EMILY GODFREY, M.D., M.P.H. 

Association of Reproductive Health Professionals 

Statement to Office of Research on Women’s Health & National Institute of Health 

Testimony Description 

Good afternoon. My name is Dr. Emily Godfrey. I am a Board Member of the Association of 

Reproductive Health Professionals (ARHP) and serve as assistant professor of Family Medicine 

at the University of Illinois-Chicago. I also work here at Stroger Hospital of Cook County in the 

Division of Family Planning. I am presenting comments on behalf of ARHP. 

ARHP was founded in 1963 and is a multidisciplinary professional association with over 12,000 

reproductive health professional members who provide direct services, conduct reproductive research, and influence public policy. ARHP is offering comments today because we value 

evidence-based science and serve as a trusted resource for reproductive and sexual health 

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education and information. We meet our educational mission through a variety of educational 

programs, meetings, publications, and web-based activities. Through professional education, 

ARHP helps translate cutting-edge science for reproductive health care providers to improve 

patient care. 

On behalf of ARHP and its members, I thank the Office of Research on Women’s Health and 

the National Institute of Health for holding these meetings on new dimensions and strategies 

for women’s health research and for the opportunity to offer comments this afternoon. 

ARHP would like to take this opportunity to focus on several key issues that present 

opportunities for the ORWH and NIH— 

1. Identifying research gaps that need immediate attention 

2. Translating evidence-based science into continuing education for health care providers 

to improve clinical practices and patient care with Federal funding support 

3. Promoting regular cross-agency and intra-departmental collaboration on reproductive 

and sexual health topics to develop innovative strategies 

Of the many key aspects of reproductive and sexual health these two are of particular 

importance: 

1. The effective translation of the latest clinical recommendations into the best clinical 

practice 

2. The development of additional safe and effective forms of long-acting reversible contraception, or LARC 

For efficiency and potential impact, more research is needed on effective translation of reproductive health-related science into practice. Unless research findings are converted into 

practice change, the intention of conducting research to inform clinical practice and patient 

care is lost. To truly improve patient care, it is important to identify professional education 

platforms that work. This can be accomplished through the development of comprehensive 

evidence-based guidelines, well-designed continuing education and training programs, and 

tools to evaluate their implementation. 

For the development of innovative strategies and solutions, cross-agency and intra-departmental collaboration should be encouraged in order to develop better and more innovative 

strategies. Currently, different health topics are housed in different agencies or departments, 

and collaboration seems very challenging. This means, for example, that logically linked topics 

such as maternal and child health and reproductive health are studied independently by separate agencies or departments. By including a focus on maternal child health in a discussion 

of reproductive health, for example, important life-saving, health-promoting aspects of family 

planning emerge to improve maternal child health. By working within and across departments 

and agencies, redundancies can be reduced, efficiency improved, and costs cut. 

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As the Obama administration investigates ways to reduce abortion and unintended pregnancy 

rates, the CDC and NIH have collaborated on issues related to pre-term birth and unintended pregnancy. The discussion and research occurring between these two agencies has 

the potential to make a dramatic impact on both pre-term birth and unintended pregnancy 

rates. Further cooperation and communication between departments and agencies can only 

enhance and strengthen programs already proven to work. 

The work currently being done around pre-term birth highlights the need not only for continuing education to implement practice change, but also the need for Federal funding to be 

available to ensure evidence-based scientific findings are incorporated into clinical practice. 

Unlike the many mechanisms now in place to support scientific research, there is no federally 

funded system designed to fund the translation of that research into practice. Now is the time 

to establish clear Federal funding mechanisms for the development of continuing education 

and health professions training curricula in reproductive health. This is a “fast track” solution to 

reducing health disparities and improving patient care. 

For the sexual and reproductive health field, this would mean addressing the linked issues of 

contraception, sexuality, abortion, HIV and sexually transmitted infections, pregnancy, and 

maternal and child health, as well as increasing provider knowledge, skills, and understanding of these areas. Through adequate education and training of all clinicians, evidence-based, 

comprehensive sexual and reproductive health care can be brought directly to the patients, 

which is the primary goal of conducting meaningful research. 

Recently, the National Institutes of Health and industry research have moved away from developing female contraceptive methods to a new focus on developing contraceptives for men. 

This research is important and should continue, but NIH should also maintain a focus on 

researching new safe, effective contraceptive methods for women, especially new LARC methods. ARHP advocates for the availability of as many safe and effective contraceptive methods 

as possible to meet the wide variety of needs of American women and men. 

ARHP is encouraged by NIH’s collaborative work with the CDC and hopes that cross-agency 

and intra-departmental collaboration continues to develop in order to improve efficiency, 

reduce redundancies and cut costs. An investment of Federal funding to develop and expand 

sexual and reproductive health continuing education for all providers throughout their careers 

would aid in the achievement of these goals. 

Thank you again for the opportunity to present these comments. I welcome any questions you 

may have. 

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SIMONE KOEHLINGER 

Chicago Department of Public Health 

Improving the Knowledge Base of Lesbian, Bisexual, and Transgender Women’s Health 

1. The knowledge base of lesbian, bisexual, and transgender (LBT) women’s health must 

be improved. 

2. Research is needed to identify appropriate and accurate investigation tools, which 

include the following: 

• Survey and data collection items for sexual orientation and gender identity, including 

feasibility of including these items in research conducted with the general population 

• Mechanisms for LBT women to safely and accurately identify themselves 

• Recruitment and marketing methods to reach LBT women who are not tied to community organizations or events 

3. Federal funding for longitudinal studies of LBT women is needed. 

4. Research is needed that considers the following: 

• The holistic health of LBT women 

• The impact of stigma and discrimination on health 

5. Regular national events to disseminate and process LBT women’s health research need 

to be held. 

PAMELA MCCANN, M.S. 

Chicago Department of Public Health 

A Research Imperative for Transgender Health—Population Definition 

The “Research Invisibility” of the transgender populations is rooted in a lack of a rigorous 

definition of the populations for research purposes. The transgender community, when it is 

studied as a discrete population, is identified only by its presence at locations or by sexual 

behaviors linked to subject’s stated gender dysphoria. 

This lack of a definition too often means that studies cannot be duplicated, only simulated, 

that significant segments of those who identify as gender dysphoric are not included in studies because they do not exhibit a specific, usually sexual, behavior. A more subtle side effect 

of this lack of definition is the tendency to identify the population by its morbidities, and to 

group subpopulations together that may only share a risk behavior and call that assemblage 

the “transgender” population. 

The transgender population is divided up several ways. The first is by “birth sex,” ascertained 

most often by visual inspection of genitalia and gross anatomical form, creating categories 

of male-to-female (MTF) transgender persons and female-to-male (FTM) persons. A second 

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division of the transgender population is linked to sexual orientation (I will define sexual orientation from the perspective of the individual’s stated gender identify, but this technique itself is not 

defined for research purposes!) into heterosexual, homosexual, and bisexual populations. These 

populations have many non-shared behaviors. For the transgender population, there is another 

dimension to the sexual scale that may constitute a third major division to the population, and 

that is the libido itself. This dimension was once considered so prominent among male-to-female 

transgender persons that it was used as a verification of a transgender diagnosis. 

Most studies of the transgender population that I am familiar with identify subjects by birth 

sex. Fewer studies separate their subjects by true sexual orientation; most use the Centers for 

Disease Control and Prevention definition of men-who-have-sex-with-men, MSM for male-born 

individuals, however, I have not seen a distinction for female-born populations. The obvious 

problem with this approach for MTF transgender persons is combining them with the broader 

MSM population who do not share a gender identity issue. 

The research imperative is to identify a set of qualifying transgender traits for MTF and FTM 

persons that is distinguished from the pathology being studied and allows for the random 

inclusion of individuals who are healthy (do not share the pathology of interest, most often 

human immunodeficiency virus/sexually transmitted infections, substance abuse, poverty, etc.). 

The transgender population is more diverse than a limited set of sexual behaviors or clothing 

choices, and researchers will benefit from better identifying members of this population. 

CAROLYN STERN, M.D. 

DeafDOC.org 

Recommendations for Future Priorities in Women’s Health Research Regarding Disparities 

& Diversity for Women who are Deaf/Hard of Hearing or Have Other Disabilities in the 

Coming Decade 

For public testimony, I will focus primarily on women with disabilities; my emphasis will be on 

those who are deaf or hard of hearing (D/HH). There are significant overarching health disparities and diversity issues that need to be addressed to improve health outcomes for the 

upcoming decade. 

First, I would like to give you a little personal background information; I will then address 

future concerns for research and women’s health in the next 10 years. 

I am a family physician, and as you can see, a woman. At birth, I had a severe-to-profound 

hearing loss due to maternal rubella; when I was 25, I became completely deaf due either to 

Meniere’s or a vestibular neuritis. 

As a deaf individual, I believe I have been very fortunate. Growing up, the word “can’t” was not 

in my dictionary. I have always been encouraged by family and others to try new experiences 

and participate in activities, just like any other kid who CAN hear. I learned how to play violin, 

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dance, perform on stage, travel alone and with groups outside the United States, go to camp, 

and more. My family supported my auditory development. I was mainstreamed (placed in my 

home school district) and received years of auditory training and speech therapy. My education was not limited to school alone; I participated in many extracurricular activities and got 

jobs in research labs and other businesses. 

One of my many challenges growing up was the lack of mentorship. My first mentor was a 

high school biology teacher who had epilepsy. It was not until my last year of high school that 

I met other deaf/hard-of-hearing individuals who were similar to me, yet I still had not heard 

of anyone in the medical field.
�

Thanks to several organizations—one was the American Association for the Advancement of 

Science (AAAS)—I realized there were other deaf/hard of hearing persons and scientists with disabilities in healthcare careers. I felt hope, even though their hearing loss or disability and career 

choices were different from mine. I knew I would need to “blaze a trail” so others could follow.
�

When my biology teacher explained about his epilepsy, I was the first to raise my hand and 

volunteer. I had the highest respect for him. Little did I realize just how much courage and 

strength it took to mention his hidden disability. It was not until college that my mentor’s 

first words about his disability in class would have an impact. My professor asked me to talk 

about my hearing loss to my class in “Abnormal Psychology,” and to explain what it was like to 

live with a hearing loss. As I went back to my seat, two people that had missed class the day 

before came up to me and asked if they could borrow my notes! I guessed that because I sat 

up front, I was considered a good student!
�

The point is clear and needs emphasis. Many do not understand the needs of a person with 

a disability.
�

Just as my family and extended network have supported me, I feel strongly about giving back. 

Medical school would prove to be the place to pave the way. Due to my advocacy efforts, as 

I graduated school only a few months before the Americans with Disabilities Act was signed, 

my efforts led to the formation of an Office for Students with Disabilities for the entire University—NOT just the medical school. I graduated from Northwestern University Medical School 

with family medicine as my chosen career. 

Little did I realize my residency would prove to be another challenge! Two months into my 

training, I lost what hearing I had left. I would have good days (I heard as I did before) and bad 

days (I did not hear at all). In addition, I developed vertigo and tinnitus. After a year of fluctuating hearing loss, I received a cochlear implant, as my hearing aid no longer worked for me. 

Interestingly, it was not until I received my implant that I realized my “calling.” I would become 

a primary care physician for the deaf/hard of hearing community. (I did not discriminate 

against those who could hear)! To this end, I immersed myself in the community and culture 

and gained fluency in American Sign Language. My loss became my gain—I now knew three 

languages: English, ASL, and Spanish! I gained awareness of a culture that I had not been 

aware of before, and through the years, value what deaf culture has to offer others. While 

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there is no hard-of-hearing “culture,” hard of hearing people represent the majority of those 

with hearing loss. 

I have now worked in the deaf/hard of hearing community for the last 18 years both nationally and internationally; I have cared for thousands of patients, worked with many interpreters, 

blazed trails in medical school and continuing medical education, and mentored many deaf/ 

hard of hearing persons interested in and who have pursued health careers. 

I would also like to bring my experience as a founding partner of my Web site, http://www. 

deafdoc.org and work with many other organizations that have formed my perspective. These 

organizations include the NIDCD as a co-chair of the task force on Communicating Informed 

Consent to Individuals Who Are Deaf or Hard of Hearing, in May 1999, and on a task force on 

Biomedical & Behavioral Research Career Opportunities for Deaf Individuals, in 2001. Many 

other organizations have been a strong part to my personal experience, and here is just a 

small sampling of who they are (If I have not mentioned an organization or individual, my 

apologies): 

Nationally: Rochester and Illinois Schools for the Deaf; Advocate Medical Group; the Rehab 

Institute of Chicago; National Technical Institute for the Deaf/Rochester Institute of Technology—Post Secondary Network (PEN) International and the Community Interpreter Grant; the 

National Center for Deaf Health Research; the Accreditation Council for Continuing Medical Education; the American Academy of Family Physicians; the Joint Commission—Hospitals, 

Language, and Culture section; the National Center for Deaf Health Research at the University of Rochester; the University of California, Los Angeles and the Greater Los Angeles 

Association of the Deaf; Washington State Office of the Deaf and Hard of Hearing; Gallaudet 

University; the Association of Medical Professionals with Hearing Loss; and others. 

Internationally: National University Corporation, Tsukuba University of Technology and other 

medical schools in Japan, USA Deaflympics, and PEN International-China. 

Based on these experiences, here are the critical areas that need to be addressed in terms of 

health disparities and diversity within the disability community. 

Before I delve into health disparities, we must understand what the issues are, so we can start 

when the child is first born with (or first acquires) a hearing loss or other disability. One of 

our biggest challenges in caring for a population with a disability is the lack of good statistical data. The data I will present are the most widely accepted and researched data. Most deaf/ 

hard-of-hearing persons are born to parents who can hear (90 percent). It is also the most 

prevalent chronic disability (about 1-2/1000 births [1991 & 2000 data]). While universal hearing screening helps, the average age of diagnosis is still somewhere between 2–3 years of age. 

Part of the difficulty with hearing screening is loss to followup care. If a screen is abnormal, the 

family needs to return several times for reevaluation and assessment. 

Yet another difficulty is language and language access for children with a hearing loss. A hearing aid or even a cochlear implant does NOT work the same as glasses do for most of us. It 

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takes years of therapy and for some, learning a new language, all while they are trying to raise 

a family. Ambient information, that most take for granted, is often not reiterated or relayed to 

the child with a hearing loss. As a result, many with hearing losses have significant delays in 

language and fund-of-information deficits. 

To continue with some more statistics, about 1 in 10 persons, or about 30 million Americans has 

a hearing loss (2000 census), and the incidence of hearing loss increases with age. Most are 

hard of hearing and use various methods to communicate with others. Of the approximately 30 

million, it has been estimated that somewhere between 400,000 and 1.5 million are deaf and 

prefer American Sign Language as their primary (not only) method of communication. 

For those who are considered deaf, if the child has a hearing loss before the age of 3, they are 

considered “pre-lingually deaf.” In the medical community, they have the health status similar to other language minorities. They often have poorer health status and see the doctor less 

often for preventive or ongoing care. Those who are “post-lingually deaf,” or deaf after the age 

of 3, have the health status similar to those with a chronic illness. In general, they have poorer 

health, see the doctor less often, and receive less preventive services. In general, both groups 

have a lower socioeconomic status and are less likely to get higher education. They also have 

poor literacy skills, including health literacy. Job opportunities are often limited due to the language barrier and prejudice. 

In general, women and others with disabilities have lower employment opportunities and status due to their disability and other issues. 

Therefore, I propose these critical areas that need help from ORWH to improve health disparities for women with hearing losses and other disabilities. 

1. Get good data about women with hearing losses and other disabilities. What is necessary for them to function fully in our society, and what we can do as a society to 

change to improve lives for those with hearing losses and other disabilities? Universal 

design is one such concept, but how can we make it cost effective and universally 

accepted as a mechanism to improve access for all? 

2. Get data on health disparities in women with disabilities, especially those who are deaf/ 

hard of hearing. We have little data on how many have diabetes, for example. We are 

getting some data on heart disease in deaf individuals, but so far, this is just the general 

deaf community. We need to find out from persons who are hard of hearing what their 

health care and access issues are. 

3. Find ways to support women at all stages in life so they can pursue higher education, 

health and science careers. One critical concern is for those women who have either 

left the job market or for those women who wish to change careers or take on another 

opportunity. Find ways for funding for those who want to enter research without taking 

a significant pay cut as they try to support their families at the same time. 

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4. Language barriers need to be broken down and understood. Language access should 

be a separate budget item, for conferences, research grants, and other programs 

offered. One or two people need to be responsible for language access, training of 

interpreters (if required), or materials needed for quality access to critical programs 

if research careers are an interest of the ORWH. As an example, I attended a health 

conference recently with three other deaf health professionals. Each of us requested 

an interpreter separately to be able to participate in the conference. This conference 

offered the opportunity to learn about grants and the process. When we arrived at the 

conference, there were only two interpreters...and not until the afternoon! In short, our 

time and money to come to the conference was wasted, since none of us were able to 

attend any of the break-out sessions we wished to attend. No one from the organizing 

committee contacted us to find out what we needed or how they could make it work 

for the best possible conference. 

5. Increase research fellowship opportunities with matching funds; for example, increase 

salaries for those already in health careers who wish to return and pursue academia or 

research. Currently, pay scales stop at 5 to 7 years into the original career. However, for 

researchers, the top salary is one third of what physicians make. More women are supporting families or are head of households; to take a severe cut in pay is a challenge for 

women to pursue research careers. 

6. Training programs need to be developed for interpreters and “real time captioners” or 

CART translators, so they can better negotiate the academic/research/scientific landscape and jargon necessary for deaf individuals to be successful in these careers. 

7. Work with communities and schools to improve health education and literacy. Work 

with guidance and other school personnel to teach them about research, researchers, 

and career opportunities. 

8. Work with academic institutions and hiring organizations (i.e., businesses/academic 

centers) to improve awareness of interpreter and other support services, either with 

incentives, or education regarding funding for services (tax credits/breaks). 

9. Work with academic institutions and hiring organizations (i.e., businesses/academic 

centers) to improve access for those with hearing losses or other disabilities, to teach 

AND hire those with disabilities, particularly those who are deaf/hard of hearing. 

Develop a list of companies that have hired persons with disabilities and which companies/organizations people have worked with to ensure that persons with disabilities can 

get jobs. 

10. Make sure there are career opportunities in health care and health research for women 

with hearing loss and other disabilities. 

11. Research best practices for patient care for persons with disabilities, as well as health 

care providers with disabilities. How can we make universal design a reality? 

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12. Make the ORWH Web site fully accessible! If a video is shown, provide captions, and 

where possible, ASL interpretation. 

13. Provide more opportunities to include people with disabilities in research studies by 

including funding sources for language services, transportation, and a guide to help 

emphasize the importance of including those with disabilities or hearing losses. Make 

sure researchers are aware of communication methods and needs for those who are 

deaf/hard of hearing. 

14. Frequently, ethnic and racial minorities have taken precedence. In Healthy People 2010 

and 2020, people with disabilities need improvement in health care and health care 

access. There are many racial and ethnic minorities in the deaf/hard of hearing community, as well. 

15. Include interpreters, the deaf/hard of hearing, and others with disabilities as part of 

community based participatory research, to improve recruitment, retention in research 

and health care in general. 

16. Improve health education for those who are deaf/hard of hearing, have limited English 

proficiency, and for those with disabilities by offering multiple formats for receiving and 

learning information. 

17. Improve mentorship, networking opportunities and ways to publicly role model successful women with hearing losses and other disabilities in their careers. 

18. While I realize that many in NIH prefer seasoned grant writers, offer opportunities for 

women with disabilities and hearing losses to work with someone either within NIH or 

within a nearby University to be able to perform research both within and without the 

research sector. Another possibility is to offer online or teleconferencing or e-learning 

opportunities and peer mentorship to pursue grants and research. Make sure these 

opportunities are accessible to all. 

19. The grant opportunities are often written in complex language with jargon, and it is 

not easy to find out the information; often those with hearing loss are left behind. Offer 

ways for the deaf/hard-of-hearing researcher or one interested in research the opportunity, just like everyone else, to find out information. 

We have come a long way since the Americans with Disabilities Act of 1990 and before that 

Sections 504 and 503 of Civil Rights legislation. We still have more to do! The expression goes, 

“If we feed a man fish, we have taken care of him for one day, but if we teach a man to fish, he 

can be successful for a whole lifetime.” The same holds true for working with those who are 

deaf/hard-of-hearing or have other disabilities. If we educate now, work together with communities, academia, and businesses to provide career, research, and other opportunities, we 

prevent many problems and have engendered success for a lifetime. A mind is truly a terrible 

thing to waste. 

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SUSAN LOVE, M.D., M.B.A., FACS 

Dr. Susan Love Research Foundation/Army of Women 

New Breast Cancer Initiative Creates Partnership Between Scientists and Women: The Love/ 

Avon Army of Women: A Paradigm-Changing Research Resource 

We are honored to have been asked to submit testimony regarding new strategies and direction for the Office of Research on Women’s Health. We would like to describe our exciting 

national initiative and its successes to date and future goals. Being an innovative research project, the Love/Avon Army of Women would seem to fit perfectly into the scope of the ORWH’s 

research agenda for the coming decade. We would like to share how this novel program can 

easily enhance research projects’ recruitment efforts and accelerate discovery into the cause 

and prevention of breast cancer and other women’s health issues. The Dr. Susan Love Research 

Foundation and the Avon Foundation for Women, a global leader in breast cancer research, 

have joined forces to launch a revolutionary new program: the Love/Avon Army of Women 

(AOW). This groundbreaking initiative is designed to accelerate breast cancer research by providing a 21st century model of a “just in time” online resource of volunteers that will allow 

scientists to recruit women for research studies aimed at finding the cause of breast cancer 

and how to prevent it. It also allows collaboration among scientists accessing the data, asking 

new questions, then sharing it back with the research participants. 

“Women have repeatedly demonstrated through their fundraising and advocacy their dedication to ending this disease,” says Dr. Susan Love, one of the founding mothers of the breast 

cancer advocacy movement. “This new initiative gives women the opportunity to take the 

next steps and be part of the research itself.” Dr. Love, a renowned breast cancer surgeon and 

respected expert in the field, is also the author of the best-selling Dr. Susan Love’s Breast Book 

and is president of the Dr. Susan Love Research Foundation. 

“Avon is itself an ‘army of women,’ and we are committed to being the company and the foundation for women,” explained Andrea Jung, Chairman and Chief Executive Officer of Avon 

Products, Inc. “The Army of Women is a perfect marriage of our global leadership in the breast 

cancer cause and our grassroots access to women across the country.” 

The Army of Women intends to recruit 1 million women—healthy women who have never had 

cancer, high-risk women, and breast cancer survivors—who are interested in partnering with 

scientists by taking part in research studies. The AOW is neither a clinical trials matching service, nor is it a tissue bank. And it does not provide funding. It was developed with the sole 

intent of promoting research studies utilizing women to research the etiology, causes, and prevention of breast cancer by providing scientists a vehicle to access volunteers they need. 

Women who are interested register on the Army of Women Web site, http://www.armyofwomen.org, providing year of birth, Zip code, and ethnicity. Launched in October of 2008 on 

national media, the Army of Women now has more than 310,000 members—the majority of 

whom do not have personal experience with the disease but have the desire to participate in 

research to discover its causes. Women from around the world and from every State in the 

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United States have joined. Eighty-five percent are Caucasian, and ages range from 18 to 99 

years with a mean age of 56. We have started efforts to increase our minority membership. 

Research scientists register with the Army of Women online at http://www.armyofwomen.org 

for the opportunity to submit project proposals to recruit volunteers for their studies. Studies 

are reviewed by a Scientific Advisory Committee and are held to the highest ethical standards 

before being released to the Army of Women. All studies have institutional review board (IRB) 

approval before being sent out to AOW members. 

After a research proposal has been accepted, the Army of Women sends out an e-mail notice 

to all Army volunteers that describes the study, eligibility, and what participation will involve. 

Women self-select the studies that interest them and for which they are eligible. They can 

also forward on the e-mail to someone else they think might be eligible. Army of Women staff 

coordinate the tissue collection process with either the scientist or an Army of Women collection center where volunteers can go to give a blood, urine, breast fluid, or breast tissue 

sample. Researchers can also use the Army of Women for epidemiology studies or recruitment for prevention research. To date, 14 studies, approximately 2 a month, have been sent 

out via e-mail; 6 are now closed and 8 are still open. The first study sent out in October 2008 

to recruit women for the Sister Study, a large national effort, was able to recruit nearly 4,000 

qualified women in 2 weeks and to successfully close the study, which began in 2003. “The 

Army of Women is an important step in empowering women to participate in research and 

ensure that study results apply to all women. The Sister Study is thrilled to be included in the 

Love/Avon Army of Women!” says Dale Sandler, Ph.D., of the National Institute of Environmental Health Sciences of the National Institutes of Health. Studies sent out have accrued 

more women than the researchers had anticipated and in a much shorter time. To date, nearly 

12,000 women are or have now participated in the clinical research process. 

AOW members can also apply to participate in our “foot soldier” program and act as spokespeople at local events to raise awareness about the Army of Women and research efforts. 

In October 2009, to celebrate the first anniversary of the Army of Women, efforts are underway to launch a large longitudinal cohort study of AOW members, to be called the Health 

of Women or HOW Study. The study is being conducted in collaboration with the National 

Cancer Institute’s CaBIG (Cancer Biomedical Informatics Grid) and the City of Hope’s epidemiology team of Drs. Leslie Bernstein and Katherine Henderson. Online surveys will be sent 

to AOW members every 3 to 4 months for the next several years. We see this as the largest cohort study to date that will be totally done online, and the results can be shared with 

other qualified researchers. Our goal is to have 1 million women, and because we are doing it 

online, we should be able to be fairly nimble about what we can do and what questions we 

can ask. We hope to demonstrate a new 21st Century model of research, one that is empowering of consumers and one that is technology-enabled. Utilizing Web technology, we can 

facilitate women signing up and responding to secure online questionnaires and then facilitate authorized researchers to access this information. The Web-based software will allow the 

infrastructure to be immensely dynamic, cost efficient, and time sensitive. We see this specific 

platform as eventually having the capacity to look at other forms of cancer or other diseases. 

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Breast cancer research at this time is concentrated primarily on improving imaging devices 

that can detect tumors early, developing drugs to kill cancer cells, and understanding why 

cancer cells become resistant to existing drugs. The Army of Women will encourage researchers to shift their focus from developing new treatments to understanding what causes normal 

human cells to become cancer cells in the first place. In addition, by providing scientists with 

the healthy women they need but often have difficulty finding, the Army of Women will make 

it possible for them to shift their focus from the lab, where much of the molecular work is currently being conducted on mice or in cell culture, to real women. 

Scientists throughout the United States have already expressed their interest in partnering 

with the Army of Women. “The Army of Women is going to revolutionize the way biologists 

do research,” says Thea Tlsty, Ph.D., a pathologist and cancer researcher at the University of 

California–San Francisco. “I’m eager to submit a proposal and to begin doing work with Army 

of Women volunteers.” 

Here in Chicago this July, the AOW recruited the 300 women for Northwestern University’s 

BEAM (Breast Estrogen and Methylation) Study in 1 month. 

We are currently looking for more scientists who have projects needing human breast tissue, 

ductal fluid, urine, saliva, or blood as well as data for epidemiology. Army of Women Collection 

Centers for tissue specimens have been set up in various geographic areas if researchers are 

not able to collect specimens themselves or desire faster accrual. 

The National Breast Cancer Coalition, a grassroots advocacy organization, and the American 

Association of Cancer Research, a scientific organization focused on high-quality, innovative 

cancer research, have agreed to partner with the Army of Women in directing and supporting 

this initiative. The organizations will represent the concerns of scientists and advocates as well 

as help in their recruitment. 

We again thank you for this opportunity to better explain our program. We are confident that 

its success can translate to other disciplines in the future and can become the mainstay of 

recruitment and collaboration for clinical research. 

To find out more about the Love/Avon Army of Women, please visit 

http://www.armyofwomen.org 

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NAOMI LYNN GERBER, M.D. 

George Mason University 

Statement to Office of Research on Women’s Health & National Institute of Health 

Testimony Description 

Thank you for the opportunity to present some ideas for the strategic planning initiative of the 

Office for Research in Women’s Health. My name is Naomi Lynn Gerber, I am a rheumatologist 

and physiatrist who has spent my entire career in a biomedical research facility trying to study 

contributors to disability, how to prevent it, ameliorate it and restore function. My research, 

and that of the center at George Mason, is aimed at understanding the linkages between 

chronic illness and disability. 

I wish to address my comments to two aspects of the goals of this conference: 

1. How can we best prepare women for the future, with regard to health and wellbeing? 

2. How can we proceed in the most efficient, cost-effective and valid ways to do that? 

What will the future bring? I certainly do not know the answer. However, we know that there 

is a major drive towards personalized care and more sophisticated, complex and possibly 

confusing practices. Women have substantial needs if they are to successfully navigate these 

likely trends. 

Generally, they are consumers for themselves and their families on both ends of the spectrum. 

They need to be well educated, and this needs to start early in life. 

This includes achieving scientific literacy, in order to wade through tantalizing opportunities for 

genetic screening and decision making about life-prolonging or life-ending interventions etc. This 

also includes managerial skills to help coordinate increasingly complex care plans for themselves 

and family. The impact of personalized medicine opens up great opportunities, but also challenges that will require a concerted effort to educate and assist with needed behavioral change to 

martial our best efforts at prevention, early intervention and sensible treatment choice. 

Specific areas for surveillance, education and early detection in the promotion of women’s 

health include: 

1. Addressing issues of addiction. Alcoholism, for example is on the rise in women, and 

motor vehicle fatalities are up 30 percent in the last decade attributable to female 

drunk drivers. What is the sociobiology of this? To what key factors can we attribute 

this trend? 

2. Addressing tumors whose course/frequency or severity are putting women at significant risk. Lung cancer, head/neck tumors: Women are facing both small and non-small 

cell lung tumors. Head/neck tumors are increasing in women, possibly due to human 

papilloma virus virulent strains. Do adult women need to be immunized against HPV? 

What is the sociobiology of these? 

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3. Addressing issues of decrepitude and frailty, social and medical problems particularly 

important to women, whose life expectancy is longer than med. As a rehabilitation 

physician, the loss of bone and muscle mass is a critical problem. Muscle is replaced by 

fat as we age, and we have very little we can do to stem this tide. Why? Are questions 

of energy production, energy consumption and fat storage central to maintaining or 

increasing lean mass and in what way? Building mass in the young, maintaining it in the 

adult years and blocking its replacement with fat in the later years should be a research 

priority for women’s health. 

4. The application of technology presents new and exciting opportunities for the disabled. 

Women, in particular, are likely to require assistance in daily living as they age alone. 

In addition, haptic and robotic devices may assist in helping teach motor and cognitive 

tasks. These devices can help with the delivery of care remotely, using tele-medicine 

and tele-rehabilitation approaches. There is need for these devices and for the exploration of how they can be used to monitor the status of individuals living independently 

as well as deliver assistance. Support for miniaturization of equipment, development of 

longer more powerful batteries and environmental adaptation to improve safety for the 

elderly living alone should be a priority. 

5. The last decade has seen significant improvement in health outcomes, in part because 

of successful campaigns to change behavior. Examples include use of seatbelts, reduction in smoking, obtaining screening mammograms and colonoscopy. We need to 

study the mechanisms by which these programs have succeeded in changing behavior. 

Models for this could be tried in some of our most challenging areas that are in need of 

such behavioral change. For women, this includes weight control, addiction management, and adherence to exercise/activity programs throughout the life span. Behavioral 

change is one of the most difficult things to accomplish; studies into how this is accomplished and reinforced over time is critical to health of women. 

How will we know we are effective? 

New approaches to assuring quality health care delivery are on the agendas of consumers, health care providers, legislators and Federal regulators. There has been a considerable 

amount of discussion about the importance of measuring the performance of health care providers. The Centers for Medicare and Medicaid Services have been developing a system of pay 

for performance in an effort to improve quality care and control costs. In addition, the NIH has 

committed a considerable amount of resource to developing reliable patient reported outcomes 

in an effort to standardize these measures and reduce redundancy in self-reports performed 

in many clinical trials. Scientists have acknowledged the importance of self-reports, which are 

often the only way to assess symptoms. Issues remain to be addressed in selecting proper outcome measures for clinical trials as well as for routine treatment. Most physicians, patients and 

biomedical researchers are not willing to accept a lab value as the only outcome for a treatment intervention. Yet, many are uncertain about the validity and usefulness of measures that 

are not objective. While improvement in laboratory profiles are often necessary conditions for 

health, and we aim to achieve normal values, the measure of independence, mood, affect, life 

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satisfaction, control of pain and fatigue are often among the most important outcomes sought 

by patients, their families and health professionals. Instruments to measure these latter, efficiently, with the least redundancy and the least burden in terms of time and intrusiveness, are 

still fairly insensitive and difficult to verify with objective measures. We should aim to develop 

measures and approaches to measurements that will provide this kind of information. The 

application of computer technologies, medical informatics and item response theory, holds 

promise for achieving these goals. The use of valid, sensitive, easily administered outcome measures are needed to demonstrate comparative efficacy of treatments, and to help patients make 

informed choices. Women, who often have to make decisions for children and parents, stand 

to benefit significantly from improving this methodology. New instruments must be developed 

to extend our assessments beyond physical findings and biological measures, into the areas 

of function, physical activity, societal integration and participation. Our definition of health 

has broadened to include the interactions of whole persons with their environment, and has 

acknowledged the value of measure life satisfaction and quality. We must add these measures 

to those we aim to capture describing genetic, epigenetic, molecular and physiological processes that support human behavior and activity. 

AMBER HOLLIBAUGH 

Howard Brown Health Center 

A Public Testimony of Howard Brown Health Center Before the Office of Research on Women’s 

Health, October 2009 

My name is Amber Hollibaugh, and I am the Chief Officer of Elder and Lesbian, Bisexual, 

Transgender, and Intersexual (LBTI) Women’s Services at Howard Brown Health Center. I am 

presenting this testimony on behalf of Howard Brown Health Center, the largest lesbian, gay, 

bisexual, and transgender (LGBT) organization in the Midwest, serving more than 36,000 people each year. Our diverse health and social service delivery system is focused around eight 

major programmatic divisions, including primary medical care, behavioral health, research, 

human immunodeficiency virus/sexually transmitted diseases prevention, youth services, 

elder services, LBTI women’s services, and community initiatives. Howard Brown designed 

these programs to serve the LGBT community in a confidential, supportive, and nurturing 

environment. 

Howard Brown’s Research Department is not only our largest division, but also has a long 

tradition of participating in federally funded research initiatives. In the 1970s, Howard Brown 

gained national prominence through its involvement in the Hepatitis B vaccine trials, which led 

to the development and testing of an effective vaccine. For our work as one of the lead agencies in the Multicenter AIDS Cohort Study, a longitudinal study of the natural history of AIDS in 

gay and bisexual men, we continue to receive national recognition. Currently, Howard Brown 

collaborates with local universities, area hospitals, and other community-based organizations 

and receives approximately $5.5 million from the National Institutes of Health (NIH) and the 

Centers for Disease Control and Prevention (CDC), either directly or through subcontracts, to 

conduct groundbreaking research on LGBT populations. 

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Our research program focuses primarily on men, not because we do not recognize critical 

areas of health disparity among sexual minority women, but because funding is scarce. Of the 

$5.5 million that our research department receives from the NIH and CDC, only a little more 

than $100,000 is devoted to exploring the health issues and needs of sexual minority women. 

In 1997, the Office of Research on Women’s Health (ORWH), the CDC, and the NIH convened 

the Institute of Medicine Committee on Lesbian Health Research Priorities. I am proud to say 

that I participated in and testified at that historic meeting to argue at that time for the importance of research focused on sexual minority women. From that hearing, the Committee 

recommended that the Federal Government provide funding to further the knowledge about 

risk and protective factors among these women, to improve research methods for studying lesbian health, to increase understanding of the diversity among lesbian women, and to 

improve lesbians’ access to health care. 

Now, more than 10 years later, I am here again. And while we have a greater appreciation for 

the diversity of needs among sexual minority women, including not only lesbians, but also 

bisexual and transgender individuals’ health needs, we still do not have adequate funding 

to advance scientific knowledge on sexual minority women’s health. We still lack data about 

women in our community, which hampers our ability to create evidence-based health programs and interventions to address areas of need, including disparate rates of breast and 

cervical cancer, overweight and obesity, smoking, alcohol use, suicide, STDs, and HIV infection 

among high-risk women, disparities which stem, in part, from the social marginalization associated with sexual and gender minority status. 

As an organization trusted and respected by the LGBT community, we see women everyday in 

our health and social service programs who are negatively impacted by these conditions, individuals who often remain hidden to other service providers. To fulfill our commitment to their 

health and wellbeing, and in recognition of their specific health needs, we renew the call for 

Federal funding to develop more sophisticated studies of sexual minority women, to advanced 

related research methodologies, and to routinely include sexual orientation and gender identity in studies of the health status of women. We strongly encourage the development of 

specific Federal funding mechanisms to support these efforts. 

I want to end by commending the NIH/ORWH for its ongoing recognition concerning the 

importance of research activities for this “understudied population” and in considering this 

population a significant area of focus as you work to develop the agenda for the next decade 

of research priorities by the NIH/ORWH. 

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JENNIFER MCGUIRE, M.S., RD 

National Fisheries Institute 

Research Needed To Understand the Consequences of a Low-Seafood Diet Among 

Pregnant Women 

Increasingly, scientists are pointing to a widespread deficiency of seafood and omega-3 fatty 

acids in Americans’ diets as a leading culprit in deadly heart disease and diseases related 

to brain and eye function, to name a few.1

 How this deficiency is impacting the population 

of pregnant women and their developing babies is less understood. I am writing to urge the 

Office of Research on Women’s Health (ORWH) to consider new research to better understand 

the emerging role of seafood, the only natural source of essential omega-3s in the diet, in the 

best possible pregnancy outcomes for both mother and child. 

We know that during the last trimester of pregnancy, a fetus’s brain and nervous system rapidly develops, requiring about 65 mg/day of a type of omega-3 fat called docosahexaenoic 

acid (DHA).2

 DHA is essential, meaning the body does not make it and it must come from the 

diet. Therefore, a developing baby is completely dependant on what its mother eats for the 

omega-3 DHA its growing brain and nervous system need.3 

These needs can be met by eating seafood, particularly oily fish like tuna or salmon, about 

two to three times a week, totaling approximately 12 ounces. But typically pregnant American women eat less than 1/6th this amount, according to the following data from the U.S. Food 

and Drug Administration Center for Food Safety and Applied Nutrition (FDA CFSAN):4 

• Pregnant women: 1.89 ounces seafood per week 

• Postpartum women: 2.17 ounces seafood per week 

• Nonpregnant women: 2.97 ounces seafood per week 

It is essential that we understand the full ramifications of this low-seafood diet because 

emerging science reveals measurable risks. For example, a number of recent studies suggest 

optimal brain and eye development in babies is at stake. And if babies aren’t getting enough 

of the nutrients from fish, namely omega-3s, it appears their mothers certainly aren’t, either. 

There is a growing body of evidence through the work of Dr. Carol Lammi-Keefe at Louisiana 

State University with women between 6 and 9 months pregnant that the state of pregnancy 

depletes omega-3 DHA in the mother to supply the fetus. Omega-3s are not replenished 

unless the mother eats enough foods with these essential fatty acids during and after 

pregnancy. Dr. Lammi-Keefe has found that macular pigment density, a marker for the development of age-related macular degeneration later in life, is related to how much fish expecting 

mothers eat during pregnancy.5 

The data also suggest the omega-3 deficiency brought on by a low-seafood diet may have 

some serious short-term consequences for pregnant mothers. Specifically, in a landmark study, 

researchers with the University of Bristol studied more than 14,000 women about 7 months 

into their pregnancies to determine if low seafood intake increases risk of depression. Results 

showed pregnant mothers who ate no seafood were nearly 50 percent more likely to have 

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symptoms of depression than pregnant mothers who ate the most seafood (at least three 

servings of fish a week). Researchers concluded in July’s edition of Epidemiology, that the 

FDA/Environmental Protection Agency (EPA) advice to eat no more than 2–3 servings of fish 

per week during pregnancy could increase the risk of depression among pregnant mothers.6 

A review from September’s edition of the Journal of the American Dietetic Association explored 

the rising prevalence of mental illness in the world, with a focus on perinatal depression. Conservative estimates of up to 20 percent and 16 percent of women experience depression during 

and after pregnancy, respectively. The article concludes “nutrient inadequacies in pregnant 

women who consume a typical western diet might be much more common than researchers 

and clinicians realize” and “depletion of nutrient reserves throughout pregnancy can increase 

a woman’s risk for maternal depression.” The authors find that science is just beginning to 

uncover the role of how food choices affect our mental health and mood, and while some 

relationships between diet and depression have been uncovered in the general population, 

disproportionately, little is known about nutrient deficiencies and maternal depression.7 

Ironically, most studies about diet and depression have specifically excluded pregnant women. 

But the understudied population of expecting moms is at increased risk for having dangerously low levels of nutrients like omega-3s and vitamin D due to their babies’ needs. According 

to the authors, “there is a compelling argument for longitudinal research that targets this 

important topic as its primary focus.”7 

New research is needed to measure the magnitude of diets void in seafood and omega-3s 

during pregnancy and expand our understanding of the resulting consequences to the nervous system such as perinatal depression. This research is required for effective science-based 

nutrition recommendations that result in optimal pregnancy outcomes. 

References 

1. Danaei, G., Ding, E. L., Mozaffarian, D., Taylor, B., Rehm, J., Murray, C. J., & Ezzati, M. 

(2009). The preventable causes of death in the United States: Comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Medicine, 6, e1000058. 

2. Makrides, M. (2008). Outcomes for mothers and their babies: Do n-3 long-chain polyunsaturated fatty acids and seafoods make a difference? Journal of the American Dietetic 

Association, 108, 1622–1626. 

3. Koletzo, B. (2007). Dietary fat intakes for pregnant and lactating women. British Journal 

of Nutrition, 98, 873–877. 

4. Choiniere, C. (2008, August). Fish consumption by women of childbearing age, pregnant 

women and mothers of infants. Poster presented at the International Association for 

Food Protection 2008, 95th Annual Meeting, Columbus, Ohio. 

5. Lammi-Keefe, C. J. (In press). Pregnancy as a risk factor for decreased macular pigment 

and macular degeneration: Protective potential for DHA/fish consumption. 

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6. Golding, J., Steer, C., Emmett, P., Davis, J. M., & Hibbeln, J. R. (2009). High levels of depressive symptoms in pregnancy with low omega-3 fatty acid intake from fish. Epidemiology, 20, 598–603. 

7. Leung, B., & Kaplan, B. (2009). Perinatal depression: Prevalence, risks, and the nutrition link—A review of the literature. Journal of the American Dietetic Association, 109, 

1566–1575. 

PAULINE MAKI, PH.D. 

North American Menopause Society (NAMS) 

Working With Researchers and Nonprofit Organizations To Identify and Treat Cognitive and 

Mood Symptoms During the Menopausal Transition 

My name is Dr. Pauline Maki. I am an Associate Professor of Psychiatry and Psychology at the 

University of Illinois at Chicago. I am a member of the Board of Trustees of the North American Menopause Society (NAMS) and a Chair-Elect of the NAMS Research Affairs Committee. 

I present my public testimony today as a member of NAMS and as a clinical researcher with a 

longstanding interest in menopause, cognition, and mood. 

The North American Menopause Society is a 20-year-old nonprofit organization dedicated to 

promoting the health and quality of life of women through an understanding of menopause. 

Its membership of about 2,000 interacts with women via many disciplines, including medicine, 

nursing, and research. The professional diversity of the NAMS membership provides a unique 

opportunity to highlight gaps in knowledge, identify research opportunities, translate and 

disseminate the best quality research on menopause, and ultimately improve the care of periand postmenopausal women. 

The diverse membership of NAMS has consistently identified the subject of mood and cognition as an important research topic and a subject for continuing education for menopause 

practitioners. Evidence that NAMS values the dissemination of research on cognition and 

mood comes from a review of publications in the official NAMS journal, Menopause. From the 

year 2000 to 2007, 18 percent of articles published in NAMS were on the topic of cognition 

and mood. 

The 2005 NIH State-of-the-Science Conference Statement on Management of MenopauseRelated Symptoms concluded that the evidence that the menopausal transition leads to mood 

changes was mixed, and evidence that the menopausal transition leads to cognitive changes 

was considered insufficient. Although evidence of cognitive changes remains inconclusive, 

research over the past 7 years has contributed to a profound shift in our understanding of the 

effects of menopause on depression. 

Now, at least four prospective studies have documented that there is an increased risk of clinically significant depressive symptoms in women as they transition from the premenopausal 

stage to the perimenopausal stage. The magnitude of this risk is substantial. Compared to 

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when she was premenopausal, a woman is two to four times as likely to have symptoms of 

depression during the perimenopausal stage. Importantly, this risk is observed in women who 

have no history of clinical depression. It is important to stress that the majority of women 

do not experience clinically significant depressive symptoms. However, as with premenstrual 

dysphoric disorder, commonly known as PMS, there appears to be a significant subgroup of 

women for whom the menopausal transition represents a period of increased vulnerability to 

clinically significant depressive symptoms. 

Clinical depression predisposes a woman not only to psychiatric complications, but also to the 

development of cardiovascular disease and dementia. In 2002, the U.S. Preventive Services 

Task Force concluded that one-time screening for depressive disorders in adults, when combined with effective followup, reduces the risk for persistent depression. In addition, the task 

force concluded that such screening programs are as cost-effective as mammography screening of women over age 50 or treatment of mild-to-moderate hypertension. Therefore, it is 

critically important that menopausal practitioners are able to identify and treat depression in 

their patients. 

To that end, I would like to express my gratitude to the Office of Research on Women’s Health 

(ORWH), the National Institute on Aging, and the National Institutes of Health for supporting the sold-out NAMS Symposium entitled, “Depressive Symptoms and Cognitive Complaints 

in the Menopause Transition.” That Symposium translated the recent scientific literature on 

depression to an audience composed primarily of menopause practitioners. The ORWH and 

the NIH also support the Study of Women’s Health Across the Nation, which has yielded 

more than 200 publications on the natural and treated history of the menopause, and several 

impactful publications on menopause and depressive symptoms. The NIH also supports the 

ongoing MS-FLASH project, which seeks alternative treatments for menopausal symptoms. 

Despite these notable successes, much more research needs to be done to further our understanding of the psychological symptoms of the menopausal transition. For today, I will 

conclude my testimony by noting just three of the many topics in need of further research. The 

first topic is depressive disorders. We are beginning to appreciate that a subset of women are 

at risk for depression as they transition through the menopause, but we do not yet know how 

to best identify them in order to prevent or treat their perimenopausal depression. The second 

topic is anxiety disorders. Our understanding of anxiety disorders in the menopausal transition is especially poor, though a recent study from the Mayo Clinic demonstrated a 50 percent 

increased risk for anxiety disorders in women who had their ovaries removed before the 

menopause. The third topic is cognitive function. Clinical trials have demonstrated that certain forms of combination (estrogen plus progesterone) hormone therapy effectively treat hot 

flashes but lower memory performance, even when administered to younger postmenopausal 

women with moderate to severe hot flashes. To date, there have been no head-to-head clinical 

trials to guide treatment decisions about which forms of combination hormone therapy have 

neutral, or possibly beneficial, effects on cognitive function. Such trials are needed because 

the majority of women who receive hormone therapy receive combination hormone therapy. 

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In summary, I would like to thank the ORWH, the NIA, and the NIH for their strong support of 

research on psychological risk factors of menopause. I would also like to encourage them to 

continue to work with the North American Menopause Society and other nonprofit organizations to improve the lives of women by translating new research findings to clinical practice. 

RILEY D. JOHNSON, M.A. 

Queer People’s Health Collective 

Unknown and Unresearched: The Transgender and Transsexual Community of the United States 

This testimony is presented on behalf of my initiatives, Queer People’s Health Collective 

(QPHC) and the Trans Gynecology Access Program (TGAP). QPHC seeks to educate Lesbian/ 

Gay/Bisexual/Transgender/Queer people about their bodies and their health options and to 

work with providers to better serve their LGBTQ clients. TGAP is a joint endeavor between 

QPHC and the Chicago Women’s Health Center to provide transmasculine clients with the 

option of being accompanied by a transman health educator during any part of their exam 

experience. In addition, this testimony is informed by my continued research on transmen’s 

health experiences as a part of my graduate degree program at DePaul University. 

Health obstacles continue to be faced by LGBTQ people, and effects remain unstudied. Given 

that identity does not necessarily equal behavior (and vice versa), pinpointing the population 

size of LGBTQ people in the United States is next to impossible, but recent estimates place lesbian/gay/bisexual people at 3 of 100 individuals, conservatively, and trans people at 1 of 500 

births overall. 

Transgender and transsexual people face a unique research dilemma in that the complexities of our legal, social, and biological realities are neither observed nor properly understood. 

A study by Ulrike Boehmer1

 examined the MEDLINE database and found that, despite nearly 

4 million articles over the 20 year period from 1980 to1999, only 346 articles in any way mentioned transgender or transsexual people. As a result of the overall lack of research, we lack 

the data to create and sustain larger public health efforts and must instead enact culturally 

appropriate healthcare on more of an ad hoc basis. Additionally, if they exist, ad hoc programs 

like TGAP are mostly found in metropolitan areas, and those living outside the urban area 

must either travel considerable distances for services or go without them. When coupled with 

demonstrated trends of greater substance abuse, violence, and suicide in addition to fewer 

preventative screenings, these barriers to culturally appropriate care are a clear indicator that 

inclusive research is crucial to the planning of public health efforts, and in turn, the longevity of our communities. To be specific, QPHC would like to see the following research topics 

investigated: the mental and physical health impacts of violence and threats of violence, issues 

related to insurance coverage for trans clients (including lack of insurance coverage, insurance 

denials for trans health services, insurance denials for traditional health services [e.g., a broken 

arm] when the client happens to be transgender/transsexual), and the research impact of the 

continued use of the misapplied men-who-have-sex-with-men category for male-to-female 

spectrum clients. 

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QPHC strongly urges research inquiry into conditions that affect transgender and transsexual people at greater rates, particularly the impact of long-term cross-gender hormone usage, 

the higher occurrence of polycystic ovarian disease (PCOS) within female to male spectrum 

populations, and the practice of engaging in high-risk sexual behavior as a means of social 

belonging acknowledged thus far anecdotally in gay/bi/queer identified female to male spectrum populations. These topics and others have not been adequately studied, leaving health 

workers and clients alike wondering how best to proceed. 

Like the lesbian/gay/bisexual community, transgender and transsexual people have often 

served as both clients of and educators to providers. This practice, while sometimes necessary, 

can create problems—for example, when a transgender or transsexual client is misinformed or 

lacks a comprehensive understanding of the body’s physiology. QPHC was created to increase 

individual client knowledge as well as provide clients with pamphlets they can give to their 

provider to increase provider knowledge of LGBTQ realities. QPHC strongly recommends the 

full and routine inclusion of LGBTQ topics within preparatory programs for health and wellness 

workers. Sample curricula exist for LGBTQ health and mental health and can be easily implemented within existing medical, dental, pharmacy, psychological, nursing, and social work 

training programs. Panels of LGBTQ people willing to speak about their experiences should 

also supplement traditional academic curricula, blending both theory and praxis. 

Further, QPHC recommends the inclusion of questions concerning sexual orientation and gender identity within research protocols. The American Medical Association, American Public 

Health Association, and National Coalition for LGBT Health each recommend such inclusion, 

though there seem to be no methods of accountability and no knowledge whether it actually 

occurs within mainstream research. Additionally, we strongly urge researchers to create instruments and methods that can capture the complexity of transgender and transsexual legal, 

social, and physical realities. An example of the complexity is a female to male spectrum client who has identity documents that may or may not match his current physical presentation, 

despite living and working as a man, interacts with a gynecology researcher or health worker. 

While it would be easy for the outside viewer to say this example is purely an anomaly, within 

trans communities, this level of complexity is known to be quite common. 

In conclusion, my TGAP colleague, Terri Kapsalis, Ph.D., author of the book, Public Privates, has 

observed the obvious similarities between today’s trans community and the women’s community of the 1970s. We face some of the same challenges (lack of research, lack of access to 

information, and lack of inclusion in preparatory programs), and we have come up with some 

of the same solutions (e.g., the creation of ad hoc programs). Time will only tell if we are able 

to make the same sort of progress toward securing more sensitive, culturally appropriate, and 

affordable care for our communities. 

Reference 

1. Boehmer, U. (2002). Twenty years of public health research: Inclusion of lesbian, gay, 

bisexual, and transgender populations. American Journal of Public Health, 92, 1125–1130. 

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COLLEEN M. FITZGERALD, M.D. 

Rehabilitation Institute of Chicago 

Women’s Health Rehabilitation 

Testimony Description 

My name is Dr. Colleen Fitzgerald. I am currently an assistant professor in the Department of 

Physical Medicine and Rehabilitation at Northwestern University Feinberg School of Medicine, 

Medical Director of the Rehabilitation Institute of Chicago (RIC) Women’s Health Rehabilitation Program, and a current Building Interdisciplinary Research Careers in Women’s Health 

(BIRCWH) Scholar. I came to Northwestern in 1992 as a young medical student eager to care 

for patients and fulfill my lifelong dream of becoming a physician. Having grown up in Chicago, the oldest in a family of four sisters, I was always raised to believe that as a woman, 

there was nothing I couldn’t do. Between my first and second year of medical school in 1993, 

I did an externship at RIC–a choice that proved to be a pivotal point in my career. While there, 

I worked under Dr. Joanne Smith, a physician specializing in physical medicine and rehabilitation with a clinical interest in women’s health rehabilitation, who is now RIC’s President and 

Chief Executive Officer. Before knowing what specialty I would even choose, having witnessed 

the extraordinary care Dr. Smith provided, I asked Dr. Smith to be my medical school mentor. I 

did other rotations, but rehabilitation stuck with me. I felt like the physicians at RIC had a great 

opportunity to address difficult problems in unique ways that positively impacted a patient’s 

quality of life. 

I was fortunate enough to train in residency at RIC where I was exposed to an even greater 

breadth of women’s health issues. From sexuality in disability to hidden issues of pelvic pain 

and incontinence, I was moved by the lack of care available to women. In 2005 RIC supported 

the development of an official program in WH which offered a chance to provide rehabilitation care in way that no other providers were at that time. We began taking referrals from 

urologists, obstetricians/gynecologists, and gastroenterologists, focusing on pelvic medicine 

issues including pelvic pain and pelvic floor dysfunction. We also cared for the female athlete, 

osteoporosis, musculoskeletal issues in the aging female, and female cancer survivors left with 

lymphedema or pelvic issues related to radiation therapy. The program has grown and is comprised now of 6 rehabilitation physicians and 16 pelvic floor physical therapists. 

In my new practice, I realized there stunning statistics: (such as) 

• 50 percent of pregnant women experience pelvic girdle pain in pregnancy 

• One in four women suffer from some type of pelvic floor problem 

• 25 percent of women aged 18 to 50 years have chronic pelvic pain lasting > 6 months 

Yet when I researched the how and why, the medical literature offered little help. 

So I decided I would make it my mission to not only care for these underserved patients, 

but begin to study why they had problems. Our program obtained two small grants to study 

musculoskeletal causes of pelvic pain, but our research time was limited by our busy clinical 

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practice. The turning point in my career came in 2008. I myself was 9 months postpartum 

and learned about the BIRCWH scholarship through the university. Having been an attending 

physician already for 8 years, I felt poised to now research the burning clinical questions that 

predominated my practice. With overwhelming support from my team and my colleagues, I 

applied for the BIRCWH and was fortunate enough to be awarded the grant in July of 2008. 

My project is on the use of musculoskeletal ultrasound in the etiology of pelvic girdle pain 

in pregnancy. 

The BIRCWH has given me incredible opportunities. Seventy-five percent of my time is now 

protected to do research. I am currently enrolled in the NU Masters of Science in Clinical Investigation program to develop my skills in research. I have participated in the BIRCWH women’s 

health lecture series and journal club and the Northwestern K Grant writing seminars and 

study group. I have attended formal courses in ultrasound training, collaborated with colleagues in radiology, obstetrics, pain medicine, rheumatology, and urogynecology and visited 

an international mentor in the Netherlands. I have designed and completed a research protocol, constructed a database, and obtained supplementary grant funding for a new portable 

ultrasound machine for research purposes. I am currently in year 2 of the BIRCWH and I am 

deeply engrossed in recruitment and collection of data. I am in the process of writing a K23 

with the ultimate goal of RO1 funding to determine the mechanisms involved in the etiology 

of pelvic pain. My hope is that with such clarity we will provide mechanistic based treatments 

for patients and move towards early diagnosis and treatment of acute pelvic pain to prevent 

chronic pelvic pain. 

I am a physician, but I am also a mother, a daughter, a sister, and a wife and there are times 

when I too have been a patient. I am passionate about the profound women’s health issues we 

speak about today. I am a doctor that believes that women should not stand for lack of diagnoses and unclear explanations for problems. Women deserve to have all disabilities addressed, 

those that are visibly apparent and those that are hidden. I believe that to truly provide our 

patients with outstanding care, clinicians must persist in their pursuit of patient-oriented 

research. I will be forever grateful for the tremendous support of the Rehabilitation Institute of 

Chicago, Northwestern University BIRCWH program led by Drs. Dunaif, Woodruff, and Urbanek 

and to the NIH and the Office of Research on Women’s Health for supporting not only my 

research endeavors but the work of others who share with me this passion in women’s health. 

ELIZABETH KISSLING, PH.D. 

Society for Menstrual Cycle Research 

Society for Menstrual Cycle Research—Priorities for Women’s Health Research 

Preface: The Society for Menstrual Cycle Research 

Founded in 1979, the Society for Menstrual Cycle Research (SMCR) is a nonprofit, interdisciplinary research organization whose members have made significant contributions to 

menstruation research. We strive to be the source of guidance, expertise, and ethical considerations for researchers, practitioners, policymakers, and funding resources interested in the 

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menstrual cycle. Our membership spans discipline, professional responsibilities, and geography to provide woman-centered perspectives on menstrual experiences. The purposes of 

the society are to identify research priorities; to recommend research strategies; to promote 

interdisciplinary woman-centered research on the menstrual cycle; to provide a formal communication network to facilitate interdisciplinary dialogue about menstrual cycle research in 

the context of women’s health over the lifespan; to examine the practical, ethical, and policy issues surrounding menstrual cycle research; to generate and exchange information and to 

promote public discussion of issues related to the menstrual cycle; and to influence public policy for the enhancement of women’s health. 

We endorse the four overarching themes identified by NIH in 2009 for addressing research 

on women’s health: Lifespan, Sex/Gender Determinants, Health Disparities/Differences and 

Diversity, and Interdisciplinary Research. In SMCR, we are particularly aware of the stigma and 

silence surrounding menstruation and reproductive health issues. We believe that context, 

wellness, and prevention must be highlighted when priorities for women’s health are discussed 

and established in order to develop effective and realistic health strategies. 

SMCR Recommendations for Research Priorities 

Medical research on sex hormones must be seen in terms of women’s health, rather than disease. Menopause is not a disease of estrogen deficiency, but a normal phase of an adult 

woman’s life, nor is menstruation a disease requiring medication or other treatment. 

Menopause and Estrogen Therapy1 

The Women’s Health Initiative (WHI) research provided strong evidence that hormone therapies are not safe and effective for prevention of chronic illness and that menopause is not an 

estrogen-deficiency disease. Prior to WHI, many in the medical community had advocated use 

of hormones for disease prevention notwithstanding a lack of experimental data pertaining to 

this, based on weaker kinds of evidence and their professional judgment. WHI provided strong 

clinical trial evidence, using the hormones that were most commonly prescribed in the United 

States at the time of the study, that neither estrogen alone, nor in combination with a progestin, prevents heart disease. In addition, when several outcomes were considered together, 

overall harm outweighed overall benefit. The conviction that hormones prevent disease relied 

on the idea that menopause is a disease state in which estrogen deficiency creates vulnerability to a wide range of illnesses, including heart, bone, and brain disease. The WHI results 

therefore also supported SMCR’s position that menopause is a normal phase of a woman’s life 

and not an estrogen-deficiency disease that requires so-called hormone replacement to prevent serious chronic illnesses. 

A criticism of WHI that has been given great credence is the “timing hypothesis,” which 

asserts that significant disease prevention was not observed in this study because the participants were too old. In this view, hormone therapy must be begun soon after menopause (or 

even in perimenopause) in order to be effective for disease prevention; if women begin hormone therapy many years after menopause, it is believed to be already too late to be helpful 

and, because of incipient development of disease, can be actually harmful. This idea is being 

generalized to a variety of chronic illnesses of old age, including heart and brain disease. 

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SMCR regards the credence given this emerging estrogen “timing hypothesis” with alarm. 

Some professional groups have already incorporated this possibility into their recommendations (for example, the North American Menopause Society), and many professional articles 

reference it. Yet the research supporting the hypothesis is not strong data and often is not 

even acceptable as reliable data, when considered by the normal standards used by researchers. For example, conclusions are drawn from data that are not statistically significant or from 

research that is underpowered. Conclusions are drawn from markers of disease rather than 

from disease outcomes. Research data inconsistent with the hypothesis are not considered; for 

example, studies suggesting that younger women also have negative health effects from hormones. Data are inaccurately over-interpreted; for example, assuming that an observation in 

younger women will continue to be found as they age. Conclusions are drawn based on possible positive coronary artery outcomes while not simultaneously taking into account negative 

cardiovascular effects such as stroke and serious blood clots. Data on possible other negative 

outcomes like breast cancer are not given great credence. Further, the WHI study participants 

in fact reflected the demographic of hormone users when the study was started. 

Ironically, WHI showed that a set of hypotheses based on weak data, no matter how firmly 

believed, can turn out to be inaccurate when clinical trial data are collected. We believe that 

this lesson of WHI should be remembered. The continued belief in the underlying idea that 

menopause is an estrogen-deficiency disease, rather than strong evidence, has led to the 

hypothesis that hormone therapy immediately after menopause will prevent a broad variety 

of diseases. 

This shows that more work on the natural history of menstruation, ovulation, and changes 

throughout the menopause transition is needed; such research must be conducted in a population-based context. Understanding the natural history of menopausal symptoms requires 

long-term data on numerous women from diverse backgrounds. In addition, research on medications that could be prescribed to large numbers of otherwise healthy women must use 

randomized, placebo-controlled trials. 

SMCR advocates that avoiding harm should be a primary consideration in preventive health 

care and in research on preventive health. Even if it were true that hormone therapy could 

prevent heart and other chronic diseases, a prevention tool that requires medicating large 

numbers of women for long periods of time relative to the number of women who will benefit is not effective prevention. This is especially true if the medication in question carries risks 

of serious outcomes like strokes and blood clots. While risks are not large enough to preclude 

treating symptomatic women, these medications are inappropriate as a prevention tool. Further, research on estrogen progestin therapy and estrogen therapy for menopausal women has 

repeatedly caused harm to study participants, in WHI and in previous studies. 

A 2005 NIH State-of-the-Science conference recommended that menopause be de-medicalized. The conference statement read as follows: 

“Menopause is ‘medicalized’ in contemporary U.S. society. There is great need to develop and 

disseminate information that emphasizes menopause as a normal, healthy phase of women’s 

400
lives and promotes its demedicalization. Medical care and future clinical trials are best focused 

on women with the most severe and prolonged symptoms.”2 

The statement also asserted that much more research is needed to clearly define the natural history of menopause, associated symptoms, and effectiveness and safety of treatments 

for bothersome symptoms. Natural histories are important for both science and policy. Knowing how many women transit menopause with few or no symptoms and how many manage 

menopause largely on their own, can lead to public health information that empowers women 

and increases their self-reliance. 

We endorse these recommendations and believe they are crucial in studying the relationship of hormones and health. We also believe that menopause and aging need to be divorced 

in order to develop effective strategies for disease prevention and treatment, with continued 

research on lifestyle and other interventions. 

Cycle-Stopping Contraceptives3 

It is the position of the Society that menstruation is not a disease, and that further research 

on the potential health risks and long-term safety of cycle-stopping contraception is needed. 

While some research exists on endometrial safety and on patterns of unexpected and 

expected bleeding, long-term studies that address potential risks beyond the uterus, such as 

breast, bone, and cardiovascular health, are still needed. Furthermore, there is an urgent need 

for studies that address impacts on adolescent development and bone density over time, since 

young women and girls are a target market for cycle-stopping contraceptives. 

It is important to note that cycle-stopping contraceptives do not only reduce or eliminate 

menstrual bleeding, but also suppress the complex hormonal interplay of the menstrual cycle. 

The impact of this cycle on women’s health is not completely understood. 

It is also critical to address the social, psychological, and cultural implications of menstrual 

suppression as well as the biomedical effects. We remain concerned that campaigns used to 

market cycle-stopping contraception depict the menstrual cycle as abnormal, undesirable, 

unnecessary, and even unhealthy. Messages that women’s natural functions are defective or 

need to be medically controlled can lead to negative body image, especially in young women. 

Arguments for cycle-stopping contraception often describe debilitating menstrual cramps 

and heavy flow as indications, but promote routine use by all women who would prefer not to 

menstruate for matters of convenience. Cycle-stopping contraception may be useful for some 

medical conditions (such as severe endometriosis), but we caution against its use as “a lifestyle choice” until safety is firmly established. Although women in the United States have been 

using oral contraceptives for nearly 50 years with no large-scale disasters, there is no precedent for continuous use of such large doses of hormones from the teen years to menopause. 

Women currently use oral contraceptives from their teens until their late twenties or early thirties, when they typically complete their families, and then they choose a more permanent 

method of contraception (either tubal ligation or vasectomy for their male partners). 

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Hormonal contraception is a valid and appropriate choice for many women. But historically, 

nasty surprises with hormonal therapies for women (e.g., heart disease and hormone therapy 

for menopausal women, the link between oral contraceptives and blood clots, and between 

diethylstilbestrol and multiple health problems) have taken many years to surface. We note 

that Lybrel, Seasonale, and other contraceptives marketed for their cycle-stopping properties underwent clinical testing for only 1 year. Additionally, when any medication is evaluated 

for healthy women, the potential risks should be weighed more heavily than in situations when 

medication is considered to treat a disease. Menstruation is not a disease. 

Some have claimed that women should be “free” to choose cycle-stopping contraception. 

However, informed choices are only possible when reliable, accurate, and comprehensive information is widely available. 

Conclusions 

We appreciate the opportunity to present our positions on women’s health research to the 

ORWH at NIH. As indicated above, we endorse the four overarching themes identified by 

NIH in 2009 for addressing research on women’s health: Lifespan, Sex/Gender Determinants, 

Health Disparities/Differences and Diversity, and Interdisciplinary Research. Medical research 

on sex hormones must be seen in terms of women’s health, rather than disease. Future NIH 

research on women’s health must include increased attention to prevention and wellness and 

be appropriately situated in the diverse social and cultural contexts of women’s lives and 

women’s bodies. We in SMCR are keenly aware of the stigma and silence surrounding menstruation and related health issues and are concerned about the implications of such taboo for 

women’s access to accurate medical knowledge and health care. 

Ultimately, the evaluation of and recommendations for women’s health must be made on rigorous scientific standards, incorporate prevention and wellness along with diagnosis and 

treatment, and reject underlying or explicit assumptions that menstruation and menopause 

are diseases or deficiencies. 

References 

1. Society for Menstrual Cycle Research. (2007). Women’s Health Initiative and estrogen/ 

estrogen progestin therapy for prevention of chronic illness after menopause (Position statement). Retrieved from http://menstruationresearch.org/position-statements/ 

position-statement/womens-health-initative-ht-updated-2007/ 

2. National Institutes of Health. (2005). NIH state-of-the-science conference statement on 

management of menopause-related symptoms. Retrieved from http://consensus.nih.gov 

/2005/2005MenopausalSymptomsSOS025html.htm 

3. Society for Menstrual Cycle Research. (2007). Menstruation is not a disease (Position 

statement). Retrieved from http://menstruationresearch.org/position-statements/position-statement/menstrual-supression-2007/ 

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ANNABELLE S. VOLGMAN, M.D., FACC 

WomenHeart: The National Coalition for Women With Heart Disease 

Increasing the Participation of Women in Clinical Trials 

WomenHeart: The National Coalition for Women With Heart Disease was founded in 1999 

by three women heart attack survivors. WomenHeart is the Nation’s only patient-centered 

advocacy organization. Our mission is to improve the health and quality of life of women living with or at risk of heart disease and to advocate for their benefit. We advocate on policies 

affecting women with heart disease such as healthcare reform, research funding, and smokefree environments, and today urge you to take action to increase the participation of women 

in clinical trials. 

We’re the “boots on the ground” in the fight against heart disease. WomenHeart runs the 

only national network of patient-led support groups for women with heart disease. And, we 

educate tens of thousands of women annually through our national network of incredible, courageous patient volunteers—our WomenHeart Champions—who are trained in the science of 

heart disease, but utilize the power of their personal stories to reach other women in a way 

no one else can. There are 400 WomenHeart Champions trained nationwide, 17,000 members and electronic newsletter subscribers, a Web site with 125,000 unique visitors monthly, 

and an online patient community with more than 1,400 registered members. Our WomenHeart 

Champions run 62 local Support Networks, which meet monthly and are growing. Finally, 

WomenHeart is a founding partner of the National Heart, Lung, and Blood Institute’s The Heart 

Truth/Red Dress campaign. 

Our message is simple. Prevention and early detection, accurate diagnosis, and proper treatment for heart disease must be accessible to all women. WomenHeart educates women 

on the importance of taking charge of their heart health and trains WomenHeart Champions (all heart disease survivors) to carry this message to women in local communities and 

through the media. We support women living with heart disease and connect them with one 

another. We also advocate for research funding and policies that meet the needs of women 

with heart disease. 

WomenHeart provides education, training, and support through our key programs: 

1. Science & Leadership Symposium at the Mayo Clinic 

2. Community-based peer support networks, education, and outreach activities 

3. Online patient support services 

4. Red Bag of Courage® 

5. Advocacy institute and policy advocacy 

A decade ago, heart disease was primarily recognized as a man’s disease. Less than 30 percent of women surveyed knew that heart disease was the #1 killer of women. Even more 

disturbing, less than 17 percent of cardiologists were aware that cardiovascular disease (CVD) 

was the leading cause of death among women, and there were even fewer women than 

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there are now included in clinical trials. As a result, late detection, inaccurate diagnosis, and 

improper treatment were all too common among women. 

Recently published studies have underscored, yet again, that cardiovascular disease research 

must more effectively and aggressively target women if it is to produce results that lead 

to improved prevention and early detection, accurate diagnosis, and proper treatment for 

women. Specifically, one study found that women have been underrepresented in National 

Institutes of Health–supported cardiovascular randomized controlled trials conducted in the 

past 10 years, despite a 1993 Federal law requiring clinical trials to include a significant proportion of women. Through surveys and conversations with our members, we have identified 

specific barriers to the enrollment of women in clinical trials, ranging from a lack of information about the availability of clinical trials by women patients and their healthcare providers, to 

study designs that exclude women heart patients due to their medical conditions, medications, 

or history. Pragmatic concerns by women patients about how participation in a clinical trial will 

affect their health insurance coverage and the logistical difficulties of transportation and childcare also have an adverse effect on participation rates. 

The impact of failing to overcome these barriers and significantly increase the number of 

women in clinical trials has contributed to a substantial deficit of gender-based knowledge 

about everything from the “typical” heart attack symptoms in women to the risks and benefits of commonly used diagnostic tests and therapies. Exacerbating this problem are the 

serious lapses in the U.S. Food and Drug Administration’s enforcement of its own rule requiring new drug applicants to submit data by sex, age group, and race. Far too many applicants 

fail to comply, resulting in sorely inconclusive evidence of gender-specific disease indicators 

and inadequate guidelines for the clinical treatment of women. This translates to women being 

treated with drugs, procedures, and devices that have been shown to be effective in men but 

not studied in a sufficient number of women. 

Another new study reveals how this knowledge deficit contributes to persistent disparities 

in the care women heart patients receive as compared to men. The study shows that women 

experiencing a major cardiac event are 50 percent more likely than men to be delayed by 

emergency medical services (EMS) from reaching the hospital and receiving crucial treatment. 

The study authors suggest that these treatment delays may be due to women’s cardiac symptoms differing from men’s and that both women patients and emergency medical services 

personnel do not recognize the health event as cardiac related. Another study, published 

in 2009, showed that women with acute coronary syndrome were less likely than men to 

undergo cardiac catheterization and other therapies; receive beta-blockers, statins, and other 

medications; or be discharged with evidenced-based cardiac therapies. The reasons for these 

disparities in care are not insurmountable. Conducting research that accurately reflects the 

epidemiology of the disease in women, improving healthcare provider education, and engaging more informed and empowered women patients could translate into improved care 

outcomes, reduced hospital stays, and lives saved. 

404
As the Nation’s only patient-centered advocacy organization for women with heart disease, 

WomenHeart is committed to meeting these challenges in order to ensure that all women live 

longer, healthier lives. Community education, patient support, and advocacy are integral to our 

organization’s efforts. We depend heavily on a corps of 400 WomenHeart Champions volunteers, all heart disease survivors trained in a unique collaborative program with the Mayo Clinic 

to lead community-based, public education forums and discussions about cardiovascular 

health, lead local support groups across the country, and moderate online support programs 

to help women living with heart disease connect with and support each other. Together with 

our outreach efforts and active Web site, http://www.womenheart.org, we are working to 

inform all women about heart disease, empower them to reduce their risks, emphasize the 

importance of research by sharing latest findings, and urge more women to participate in 

clinical trials. 

WomenHeart is also a chief advocate for increased research and prevention funding and policies that will better address the needs of women with heart disease. We are making every 

effort to educate our members on the importance of research and encourage women to get 

involved in clinical trials. Through our Web site and newsletters, we disseminate the latest 

research findings to make the connection between data and its impact on quality of life. 

While the death rate for heart disease in men has declined by 17.5 percent over the past 25 

years, the rate for women declined by only 1.5 percent. The heart disease rate for women ages 

35 to 44 actually rose from 1997 to 2002. Here, the evidence is clear; we are losing ground in 

the fight against women’s heart disease. The action steps we must take, however, are equally 

clear, and WomenHeart is eager to partner with the translational research community to 

achieve them. We urge you to take the following steps to increase participation of women in 

clinical trials, which will ultimately decrease gender disparities in treatment. 

• Ensure that physicians and hospitals inform women about the availability of clinical trials 

and provide information regarding access 

• Target women’s heart programs for trial recruitment 

• Design and ensure that studies are sufficiently powered by women to allow statistical 

significant reporting of sex-specific outcomes 

• Ensure that gender use and applicability are examined in all phases of the clinical trial 

process for drugs, devices, and other treatments 

• Consider ways to increase the number of trials with appropriate gender representation 

• Require that federally reported healthcare data be stratified by gender, race, and ethnicity 

• Improve and expand screening for low-income women at risk for heart disease and 

stroke 

We look forward to working together to help all women improve their heart health. 

405
References 

(Selected bibliography as a resource for additional detail) 

1. Kim, E. S. H., Carrigan, T. P., & Menon, V. (2008). Enrollment of women in National Heart, 

Lung, and Blood Institute-funded cardiovascular randomized controlled trials fails to 

meet current federal mandates for inclusion. Journal of the American College of Cardiology, 52, 672–673. 

2. WomenHeart. (2008, December 9). The patient perspective on women in clinical trials. 

Presentation at WomenHeart. 

3. Hayes, S. N. & WomenHeart. (2009). Heart disease is not just a man’s disease. Heart to 

Heart, 8, 2. 

4. Government Accounting Office. (2001). Women’s heath: Women sufficiently represented 

in new drug testing but FDA oversight needs improvement [GAO Report GAO-01-754]. 

Washington, DC: Author. 

5. Concannon, T. W., Griffith, J. L., Kent, D. M., Normand, S. L., Newhouse, J. P., Atkins, J., . . 

. Selker, H. P. (2009). Elapsed time in emergency medical services for patients with cardiac complaints: Are some patients at greater risk for delay? Circulation: Cardiovascular 

Quality and Outcomes, 2, 9–15. 

6. Dey, S. Flather, M. D., Devlin G., Brieger, D., Gurfinkel, E. P., Steg, P. G., . . . Eagle, K. A.; 

Global Registry of Acute Coronary Events investigators. (2008). Sex-related differences 

in the presentation, treatment and outcomes among patients with acute coronary syndromes: the global registry of acute coronary events. Heart, 95, 20–26. 

7. Ford, E. S., & Capwell, S. (2007). Coronary heart disease mortality among young adults 

in the U.S. from 1980 through 2002: Concealed leveling of mortality rates. Journal of the 

American College of Cardiology, 50, 2128–2132. 

LISA MARTINEZ, J.D., RN 

The Women’s Sexual Health Foundation 

Sex Hormones and Disease and the Impact on Sexual Function 

There are many diseases and conditions that may be impacted by sex hormones. Furthermore, 

sex hormones and diseases can have a relationship to female sexual dysfunction, which often 

goes unrecognized. Female sexual dysfunction, known as FSD, is a relatively common health 

concern of women. The Mayo Clinic states that as many as 4 in 10 women may suffer from 

FSD.1

 Studies have shown that FSD and other sexual problems have been linked to a “diminished quality of life, low physical satisfaction, low emotional satisfaction, and low general 

happiness.”2

 Other health experts agree that “[f]emale sexual dysfunctions (FSDs) are very 

prevalent, multifaceted problems that continue to be under-recognized and undertreated.”3 

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Most healthcare providers do not address FSD with their female patients during regular medical visits. One study concluded that more than half of their respondents were not queried 

about their sexual health during their visit with their practitioner.4 In order to investigate this 

matter further, The Women’s Sexual Health Foundation (TWSHF) designed a survey that 

inquired about perceptions, emotional responses, and possible discussion of FSD during visits 

with their medical practitioner. The 18-item survey was posted on TWSHF’s website at http:// 

www.TWSHF.org. The survey contained demographic information and questions on women’s 

beliefs specific to communication with their provider and care relating to female sexual health 

problems. A total of 391 women responded to the survey. Women from ages 21 to 80 took 

the survey, and most of the women were well educated (college or above). According to this 

study, less than 9 percent of the respondents stated their healthcare provider always initiated 

questions about sexual health difficulties during an annual office visit. 

The results of this survey raised other questions relating to diseases, sex hormones, and sexual 

dysfunction, such as the impact of adjuvant hormonal therapy and chemotherapy on sexual 

function in the breast cancer patient. For many, breast cancer is a chronic disease with approximately 2,533,193 breast cancer survivors alive as of January 1, 2006, in the United States 

according to the National Cancer Institute data. However, one consequence of cancer treatment that is often not discussed with cancer survivors is that of sexual function and intimacy. 

Research shows that sexual dysfunction after various cancer treatments can range from 40 

percent to 100 percent.5

 Approximately 50 percent of female breast cancer survivors have 

long lasting sexual dysfunction.6,7 

Cancer and cancer treatments such as chemotherapy and adjuvant hormonal therapy can 

impact a woman’s ability to enjoy sex. These treatments can cause various side effects, from 

low desire, decreased arousal, urogenital atrophy, and vaginal dryness that leads to painful intercourse and even vaginal bleeding.8 Although sexual dysfunction as a result of vaginal 

dryness and dyspareunia is a common complaint of women who have experienced chemotherapy-induced menopause and those women who are receiving adjuvant hormonal therapy 

such as aromatase inhibitors and tamoxifen, there is no consensus as to whether vaginal estrogen products are safe to use in breast cancer patients with estrogen receptor positive tumors. 

Healthcare providers will recommend lubricants and nonhormonal vaginal moisturizers as a 

first-line therapy, but these products are not always effective in this patient population. There 

is a concern that it may be unwise to use topical vaginal estrogen in women who are taking 

aromatase inhibitors, where such concerns have not been raised in nonbreast cancer patients.9 

In the study by Kendall and his colleagues,9 they found estradiol levels increased from a mean 

baseline level of 5 pmol/l to a mean of 72 pmol/l at week 2, and then decreased at week 4 to 

a median of 16 pmol/l after the women in the study had been treated with Vagifem, a vaginal estrogen. Two women had high estradiol levels after 7 weeks in the study. Of concern is 

whether even minute changes in serum estradiol levels from vaginal absorption of topical 

estrogen replacement agents increase breast cancer recurrence. The use of aromatase inhibitors continues to increase and further studies are needed to assess the impact of the use of 

vaginal estrogens as it relates to the effective and safe management of a woman’s sexual and 

407
urogenital health in the breast cancer patient. Funding for such research is needed. These are 

important questions, and women have every right to have them addressed fully with evidencebased research. 

What We Hear From Women 

We have heard from many women and their partners relating to female sexual health problems. These stories are heart wrenching and have a common theme: women are devastated; 

suffer in silence; feel very much alone in their journey to find the right answers, care, and treatment; and wish that their sexual health would be taken seriously. 

For women who have had cancer, whether breast cancer, gynecological cancer or other cancers, the message that they are sometimes given is that they should be happy that they are 

alive. Yet the vast majority of these women will struggle with regaining their sexual health due 

to chemotherapy and adjuvant hormonal treatments. 

For women in relationships, this impacts not only them, but also their partners who often feel 

helpless and equally devastated, many times blaming themselves. Partners express the personal and emotional rejection they feel. Some keep this pain to themselves because it appears 

that there is no help available. 

Research 

Funding for research studies is needed to address the safety of the use of vaginal estrogens 

in breast cancer patients and to understand the impact of sex hormones in women in relationship to cancer treatments and female sexual dysfunction. 

About The Women’s Sexual Health Foundation 

The Women’s Sexual Health Foundation (TWSHF) was founded in 2003 as an international 

nonprofit organization with an Advisory Board of international experts in the field of sexuality 

and women’s sexual health. 

The mission of The Women’s Sexual Health Foundation is to provide support in the 

following ways: 

• Providing educational information on the causes, treatments, and latest research in 

sexual health issues to women and to healthcare professionals 

• Supporting a multidisciplinary approach in treating women’s sexual health concerns 

• Offering resources for women experiencing sexual health difficulties as well as for their 

partners, family, and friends 

• Advocating funding for research to advance knowledge in sexual medicine 

• Increasing worldwide awareness on the subject of women’s sexual health 

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To advance its mission of education and support, The Women’s Sexual Health Foundation 

maintains a Web site at http://www.TWSHF.org with multiple resources, including educational 

brochures in several languages on topics such as the various female sexual dysfunctions, how 

to speak with your healthcare provider about sexual health, and addressing low desire from a 

multidisciplinary approach. We have cohosted well-attended educational forums with Columbia University College of Physicians and Surgeon as CMEs for healthcare professionals and 

similar programs for the public. TWSHF presented its first media award in 2009. This award 

recognized an outstanding media professional whose work has broadened the knowledge and 

understanding of women’s sexual health. The Women’s Sexual Health Foundation collaborates 

with other patient advocacy organizations on issues related to female sexual health and various female sexual dysfunctions. 

References 

1. Mayo Foundation for Medical Education and Research. (2008). Female sexual dysfunction (article). Retrieved from http://www.mayoclinic.com/health/female-sexual-dysfunction/DS00701 

2. Sadovsky, R., & Nusbaum, M. (2006). Sexual health inquiry and support is a primary 

care priority. Journal of Sexual Medicine, 3, 3–11. 

3. Bachmann, G. (2006). Female sexuality and sexual dysfunction: Are we stuck on the 

learning curve? Journal of Sexual Medicine, 3, 639. 

4. Nusbaum, M., Gamble, G., & Pathman, D. (2002). Seeking medical help for sexual 

concerns: Frequency, barriers, and missed opportunities. Journal of Family Practices, 51. 

Retrieved from http://www.jfponline.com/pages.asp?aid=1262&UID= 

5. Derogatis, L. R., & Kourlesis, S. M. (1981). An approach to evaluation of sexual problems 

in the cancer patient. CA: A Cancer Journal for Clinicians, 31, 46–50. 

6. Ganz, P. A., Rowland, J. H., Desmond, K., Meyerowitz, B. E., & Wyatt, G. E. (1998). Life 

after breast cancer: Understanding women’s health-related quality of life and sexual 

functioning. Journal of Clinical Oncology, 16, 501–514. 

7. Schover, L. R., Montague, D. K., & Lakin, M. M. (1997). Sexual problems. In V. T. DeVita, 

Jr., S. Hellman, S. A. Rosenberg (Eds.), Cancer: Principles and practice of oncology. (5th 

ed., pp. 2857–2872). Philadelphia: Lippincott-Raven Publishers. 

8. Berglund, G., Nystedt, M., Bolund, C., Sjödén, P. O., & Rutquist, L. E. (2001). Effect of 

endocrine treatment on sexuality in premenopausal breast cancer patients: A prospective randomized study. Journal of Clinical Oncology, 19, 2788 –2796. 

9. Kendall, A., Dowsett, M., Folkerd, E., & Smith, I. (2006). Caution: Vaginal estradiol 

appears to be contraindicated in postmenopausal women on adjuvant aromatase 

inhibitors. Annals of Oncology, 17, 584e7. 

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KATHIE DUPREY 

Self 

Infectious Determinants of Chronic Disease 

The lives of women are multidimensional and so should be the research that affects them. 

While there are other agencies that cover psychosocial research, the National Institutes of 

Health (NIH) focus on biomedical research can and should be unparalleled. 

Although the “germ theory” may be widely disparaged in some circles, conflicting ideology 

should never be an excuse for the scientific failure to rigorously examine infectious determinants of complex and chronic diseases, immune-mediated diseases, and autoimmune diseases, 

many of which disproportionately affect women. 

Not all chronic conditions will have infectious agent roots, but the failure to fund such research 

based on past failures due to undeveloped technology or differing ideology runs the risk 

of slamming the door in the face of biomedical progress. Many a woman died of puerperal 

fever while the medical establishment continued to ignore the research of Ignaz Semmelweis, 

instead spouting their unproven theories of bad mother’s milk. Ignorance was not a viable 

excuse then and it shouldn’t be one now. 

Imagine a world where women and their organic diseases are taken seriously, where such 

diseases are not ascribed to unproven hypotheses of hysteria, “medicalization,” or “disease 

mongering,” but rather are thoroughly investigated without bias using modern techniques 

focusing specifically on women. 

Whether triggered by microbes through acute initial infection, chronicity related to the continuous reactivation of latent viruses, or even as a complication of disease, biomedical research 

has made great strides in detection and evidence of causation in the past decade. The NIH 

needs to build on that progress. 

This research, combined with immunology and genetics, has the potential to better the lives of 

not only women, but all people throughout the world. 

As Dr. Siobhan O’Connor of the Centers for Disease Control and Prevention (CDC) has noted, 

“...Not infrequently, infection may simply represent the first misstep along a continuum from 

health to long-term illness and disability. Preventing or treating infection or the immune 

response to infection offers a chance to disrupt the continuum, avoiding or minimizing a 

chronic outcome.” 

Women are much more than endocrine systems or baby machines. A recent study shows that 

women-owned firms have an economic impact of nearly $3 trillion. Women-owned businesses 

produce employment for 23 million people, 16 percent of all U.S. jobs, both direct and indirect. 

When their health prevents women from active participation in the economy, more than just 

women suffer. 

410
The rate of disability among working women in the United States has grown almost twice as 

fast as the rate among working males during the past decade (over 60 percent and 32 percent, respectively), according to Social Security Administration data. The financial risks of 

disability can be severe and long lasting. Disability is one of the leading causes of personal 

bankruptcies and mortgage foreclosures in America. 

Just as healthcare reform is more than just politics, both prevention and cure require more 

than just lip service. Unbiased biomedical research is an ethical and economic necessity. 

And it needs to happen now. The current NIH research funding process is far too cumbersome. 

Researchers and scientists are not bureaucrats, and their time is better spent on research than 

paper work. How many lives are diminished by disease; how much money is lost by our economy and; yes, even how many of the brightest scientific minds are lost to private enterprise 

while research proposals are tied up in red tape, bias, and narrow agendas month after month, 

year after year? 

Rather than let history determine that the NIH consistently ignored the impact of disease on 

women, failed to expedite biomedical research, or failed to fully investigate microbial causality, the ORWH and the NIH can choose to forge a future that precludes such a history. And the 

time to act is now. 

411
Public Testimony 

Emory University School of Medicine 

Atlanta, Georgia 

February 16, 2010 

Yuling Hong, M.D., Ph.D, M.Sc. 

Centers for Disease Control and Prevention 

Frances Henderson, Ed.D., RN 

Jackson Heart Study 

Sharonne Hayes, M.D. 

Mayo Clinic and Foundation 

Diana Bitner, M.D. 

Michigan State University College of Human Medicine 

Elvan Catherine Daniels, M.D., M.P.H. 

Morehouse School of Medicine 

Virginia Miller, Ph.D. 

Organization for the Study of Sex Difference 

E. Clinton Lawrence, M.D. 

Pulmonary Hypertension Association 

Mary Blades 

Scleroderma Foundation 

Viviana Simon 

Society for Women’s Health Research 

Jay Kaplan, Ph.D. 

Wake Forest University School of Medicine 

Lisa M. Tate 

WomenHeart: The National Coalition for Women with Heart Disease 

412
YULING HONG, M.D., PH.D., M.SC. 

Centers for Disease Control and Prevention 

The Well-Integrated Screening and Evaluation for Women Across the Nation 

(WISEWOMAN) Program 

To address the high burden of cardiovascular disease, the Centers for Disease Control and Prevention’s (CDC’s) Division for Heart Disease and Stroke Prevention (DHDSP) translates prevention 

research into public health practice and provides national and State leadership to help reduce the 

burden of heart disease and stroke. The Division currently funds health departments in 41 States 

and the District of Columbia to conduct heart disease and stroke prevention programs; another 

six States are also funded for Paul Coverdell National Acute Stroke Registries. DHDSP funds 21 

WISEWOMAN programs, operating in 20 States and inclusive of two tribal organizations. The 

Division also funds national data collection, applied research, and evaluation initiatives. 

Although WISEWOMAN originated as a research project, today it is a public health practice 

program. WISEWOMAN provides heart disease and stroke risk factor screenings, healthy lifestyle programs, and healthcare referral services to uninsured and underinsured women aged 

40–64 years. To be eligible, participants must first be enrolled in CDC’s National Breast and 

Cervical Cancer Early Detection Program. Local programs provide preventive health services 

that include screening for high blood pressure, high blood cholesterol, diabetes, smoking, and 

lifestyle interventions. WISEWOMAN programs partner with community-based organizations 

to help expand the reach of their services and coordinate patient healthcare referrals. 

The goals of the program include maximizing the reach of the program (to provide services 

to as many women as possible); decreasing the heart disease and stroke risk factors of the 

WISEWOMAN population; working to eliminate disparities (by serving those most in need); 

maximizing the number and variety of settings that deliver WISEWOMAN services; ensuring 

that WISEWOMAN is delivered as intended; and sustaining the benefits of WISEWOMAN over 

time. The program guidance provided to grantees occurs within a four-component framework; 

the components are program management, direct services, evaluation, and partnerships. 

WISEWOMAN Program Evolution 

Phase I: Research (1995–1998) 

Three research programs were funded to compare the effectiveness of enhanced lifestyle 

interventions (LSIs) and LSIs with minimal or usual care in reducing cardiovascular risk among 

low-income, under- or uninsured 40 to 64-year-old women. 

Phase II: Research and Public Health Practice (1999–2007) 

Congress authorized an expansion of WISEWOMAN that allowed CDC to fund up to 15 organizations. CDC began funding both research and nonresearch, or public health practice, 

WISEWOMAN programs. The research programs maintained their original design. In contrast, 

the nonresearch programs focused on service delivery and evaluated the feasibility of implementing evidence-informed lifestyle interventions in local settings; they did not use a control 

group as the research programs did. 

413
Phase III: Public Health Practice (2008–present) 

Under a new Funding Opportunity Announcement (FOA) in 2008, the program expanded to 

21 programs. Along with this FOA, the Program moved completely to a nonresearch, or public, 

health practice design that focused on delivery of a proven concept. 

A comprehensive program evaluation plan was developed in 2008, began implementation in 

2009, and will occur annually. The purpose of the evaluation is to generate results and recommendations to assess the outcomes and impact of the program, monitor the program’s 

progress toward reaching its goals, and uncover the program’s best practices and improvement strategies. This purpose corresponds to the three-pronged evaluation approach that 

includes the following: 

Comprehensive Evaluation 

• Demonstrates program outputs and outcomes 

• Tracks output and outcome indicators annually 

• Data sources: Minimum Data Elements (MDEs), Program records, performance assessment tool (PAT), and funded program evaluations 

Program Monitoring 

• Provides regular documentation of Program progress 

• Serves as a feedback mechanism 

• Offers Program oversight for purposes of management, improvement, and accountability 

• Data source: MDEs and PAT 

Program Progress and Effectiveness Assessment (PPEA) 

• Allows for in-depth assessment of program elements 

• Creates opportunity for program improvement or enhancement 

• Data Sources: Various situation-specific tools for looking at program characteristics, program effectiveness, best practices, and program improvement 

The evolution of the WISEWOMAN program from research to public health practice has 

resulted in a dedicated focus on program evaluation. However, the need continues to better understand women’s cardiovascular risks, associated behaviors, and effective lifestyle 

interventions, particularly with specific population groups. Additionally, understanding the 

relationship of the community and environment in reaching, screening, and intervening with 

the WISEWOMAN population for improved health outcomes, remains. 

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FRANCES HENDERSON, ED.D., RN 

Jackson Heart Study 

Strategies for Women’s Health Research: Moving Into the Future 

The Jackson Heart Study (JHS) is the largest single-site, prospective, epidemiologic investigation of cardiovascular disease among African-Americans that has ever been undertaken. It is a 

population-based, observational, longitudinal study. Since there is a greater prevalence of cardiovascular disease in African-Americans, the purpose of the Jackson Heart Study is to explore 

the reasons for this disparity and to uncover new approaches to reduce it. The primary objective of the Jackson Heart Study is to investigate the causes of cardiovascular disease (CVD) in 

African-Americans to learn how to best prevent this group of diseases in the future. The four 

major aims of the Jackson Heart Study are to accomplish the following: 

1. Establish a single-site epidemiological study of CVD in African-American men and 

women by including and expanding the Jackson Atherosclerosis Risk in Communities 

(ARIC) Study 

2. Identify risk factors or factors for development and progression of CVD with an 

emphasis on manifestations related to hypertension, (such as left ventricular 

hypertrophy, coronary heart disease, heart failure, stroke, and renovascular disease) 

in African-Americans 

3. Build research capabilities in minority institutions at the undergraduate and graduate 

levels by developing partnerships 

4. Develop programs to attract minority students and prepare them for careers in public 

health and epidemiology 

The Jackson Heart Study exemplifies a unique collaborative model among three institutional 

partners, the Jackson community, and the National Institutes of Health to discover and test 

best practices for eliminating health disparities. The partnering institutions are two historically Black institutions—Jackson State University, which is a State-supported urban university; 

and Tougaloo College, a private, church-supported college. The University of Mississippi Medical Center, the only medical center in the State, is the third partner. The Jackson Heart Study 

highly values the role of the community working in concert with the participating institutions, 

funding agencies, collaborators, and consultants; collectively, this makes the Jackson Heart 

Study, in the words of the Principal Investigator Dr. Herman Taylor, “a study for our time...It 

is possibly an evolving model for community-centered research into public health problems, 

a platform suitable for use in other communities, other populations, and other geographic 

regions. It is one answer to the call to action by the Centers for Disease Control and Prevention, the National Institutes of Health, and the American people to address disparities in 

cardiovascular health among American populations”1 

Mississippi, the home of the Jackson Heart Study, is the State with the Nation’s worst cardiovascular disease statistics. According to the Mississippi State Department of Health, 

“Cardiovascular disease, including heart disease and stroke, is the leading cause of death in 

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Mississippi, accounting for 43 percent of all deaths in 2001. More Mississippians die each year 

from cardiovascular disease than from all types of cancer, traffic injuries, suicides, and AIDS 

combined. Mississippi’s CVD mortality rate is, and has been for many years, the highest in the 

Nation” (http://www.msdh.State.ms.us/msdhsite/-static/43.0.91.149.html). Cardiovascular diseases are also leading causes of chronic ill health. 

According to the Cardiovascular Report Card for Mississippi 2005–2006 published by the Mississippi Department of Health, “African-American women who have the highest prevalence 

rates for five of the six major CVD risk factors need to be targeted urgently for intensive health 

education and promotion regarding CVD prevention. It is quite possible in the near future that 

CVD mortality rates for African-American women will exceed those for White men; and the 

trend lines for African-American women and White men will cross—despite the fact that the 

prevalence of cigarette smoking (the single most important risk factor for CVD) is much lower 

in African-American women.” (http://www.HealthyMS.com) 

Three counties—Hinds, Madison, and Rankin—make up the Jackson Mississippi metropolitan statistical area that is home to the 5,301 participants who were recruited into the study 

between September 2000 and March 2004. The Jackson Heart Study celebrates its 10th anniversary on September 25, 2010. The Study is now conducting the third in a series of three 

comprehensive exams. 

Phase One of the study began in September 2000 and ended in March 2004. The initial clinical examination comprised a physical assessment inclusive of blood pressure, sitting and 

ambulatory; body mass index; electrocardiography, echocardiography, and carotid ultrasound; 

pulmonary function; and blood and urine analysis. It also included a series of questionnaires 

inclusive of medical and family history, lifestyle factors such as diet and physical activity, and 

sociocultural factors such as stress and discrimination. Phase Two of the Jackson Heart Study 

began June 1, 2005, and extended though December 26, 2008. 

Phase Two, which began October 2005 and ended December 2008, comprised the assessment 

of blood pressure, height, weight, interim medical history, a medication survey, and venipuncture for glucose and cholesterol; spot urine; and a computed tomography scan of the chest and 

abdomen to assess coronary calcium and abdominal fat. Magnetic resonance imaging (MRI) is 

an additional component for Exam 2 and 3 that will assess cardiac structure and function. 

Phase Three began February 26, 2009, and will end May 31, 2012. It includes all of the same 

assessments as in phases one and two, in addition to MRI and selected questionnaires on cognitive function and sleep. 

The JHS includes 5,301 African-American men and women between the ages of 21 and 85. There 

are 3,395 (64 percent) African-American women and 1,907 (36 percent) African-American men 

in the cohort. The sample comprised four groups: a randomly selected sample of 921 participants 

(17 percent); a volunteer sample of 1,570 (30 percent); 1,185 (31 percent) previous Atherosclerosis 

Risk in Communities (ARIC) participants; and a family cohort of 1,626 (22 percent). 

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A thumbnail summary of findings from seven selected articles from among those published 

in 2007 through 2009 based on JHS data reveals some that are specific to women. Wyatt et 

al.2

 found that in a sample of 3,330 Jackson Heart Study women, hypertension prevalence was 

64.5 percent; awareness, 89.8 percent; treatment, 86.1 percent; and control, 69.3 percent. 

Talegawkar and colleagues3 found that more women than men reported taking supplements. 

Also, use of supplements containing beta carotene was higher in women compared with men. 

Women had higher serum concentrations of high-density lipoprotein cholesterol and total 

cholesterol compared with men. Fox et al.4 found that C-reactive protein concentration was 

significantly related to advancing age, female gender, higher blood pressure, larger body size, 

glucose measures, current cigarette smoking, higher lipid concentrations, medications for 

hypertension and high cholesterol, and prevalent cardiovascular disease. 

According to Samdarshi et al.,5

 the distribution of normal diastolic function and mild, moderate, and severe diastolic dysfunction was 70.4 percent, 18.0 percent, 10.6 percent, and 0.9 

percent, respectively. Participants classified as normal were approximately 9 years younger 

than those with mild diastolic dysfunction. The age of participants decreased with severity of 

diastolic dysfunction. There were more women than men who had normal diastolic function 

or had mild diastolic dysfunction; however, the reverse was true for those with moderate or 

severe diastolic dysfunction. Taylor et al.6 found that dyslipidemia was more common in men 

(compared with women) aged less than 50 years and increased with age in both genders. 

Hypercholesterolemia prevalence rates approached 50 percent in women aged more than 65 

years. The lifestyle-related attributes found to be related to prevalence were being overweight 

and less physically active. Awareness of hypercholesterolemia is approximately 55 percent or 

more in both men and women aged more than 35 years. Treatment rates lag far behind awareness, particularly in younger adult men, and less than 50 percent of women and men aged less 

than 65 years were treated for hypercholesterolemia. 

According to Liu et al.,7

 women had significantly higher levels of plasma leptin compared to 

men. The prevalence of hypertension, diabetes, and metabolic syndrome in women was higher 

than in men. High leptin level was significantly associated with stroke in women after adjustment for age, smoking, systolic blood pressure, body mass index, and waist circumference. No 

significant association was observed in men. No significant association was observed between 

leptin and coronary heart disease in both men and women. 

According to Hickson et al.,8

 among women, current asthma was significantly associated with 

lower socioeconomic status and pulmonary function, greater anthropometrics, obesity, fair-topoor perceived general health, hypertension medication use, and diabetes mellitus. In women, 

probable asthma was also related to lower levels of education and total household income, 

increased anthropometrics, global stress scores, hypertension medication use, and diabetes 

mellitus. Statistics and findings related to CVD indicate the need for a focus on the translation 

of research into practice and prevention for primary care professionals who provide primary 

care to women. Primary care professionals need to be provided with available resources based 

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on research to help their women patients modify and manage the risk factors for CVD. They 

need to have quick, user-friendly access to research findings in a format that is easily translated to patient management approaches. Study participants and the community at-large 

need to know how to use pertinent study findings in their day-to-day health-related activities 

to stay well, prevent disease, and prevent the complications of disease such as cardiovascular 

disease. For health professionals, practice refers to the process they use to assess, diagnose, 

treat, and refer their patients. For all groups, prevention refers to the use of health education to focus day-to-day health practices on behaviors that reduce or eliminate the risk factors 

related to CVD. 

In 2006, a pilot substudy was conducted that engaged 60 non-Jackson Heart Study community participants in a 6-week program of healthy lifestyle interventions and focus groups 

to identify the barriers and motivators for engaging in a self-managed program of positive lifestyle changes. While changes in knowledge, exercise behaviors, perception of 

health-related quality of life, and body weight were documented, seven barriers and eight 

motivators were identified. The seven barriers were habit/routine, time, making excuses, 

circumstances, cost, family, and self. The eight motivators were self-awareness/self-responsibility, knowledge in relation to power, self-monitoring of risk factors, family history, fear 

of consequences, reinforcing what is known, opportunities to pass on lessons learned, and 

health promotion/illness prevention. 

The following quotes from focus group participants, most of whom were women, indicate that 

the program did have an empowering effect: 

• “The program is long overdue because I know we oftentimes hear that knowledge 

is power, but application of knowledge is what is empowering, not just the 

knowledge itself.” 

• “That is access to the power, but the power of that knowledge comes in the application 

by implementing the things we learn to live longer and live long enough to translate that 

lifestyle into the next generation.” 

• “I think knowledge is power and the more we learn about our bodies and what we need 

to live healthier, we’ll do better.” 

Consistent with its valuing of the community, which it demonstrates by engaging community 

representation in activities throughout the study, the Jackson Heart Study applies several key 

principles of community-based participatory research. 

For example, community-based participatory research recognizes community as a unit of 

identity. It builds on strengths and resources within the community. It facilitates collaborative, 

equitable partnership in all phases of the research, involving an empowering and powersharing process that attends to social inequalities. Community-based participatory research 

promotes colearning and capacity-building among all partners. It integrates and achieves a 

balance between research and action for the mutual benefit of all partners. It emphasizes local 

relevance of public health problems and ecological perspectives that recognize and attend 

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to the multiple determinants of health and disease. Community-based participatory research 

involves systems development through a cyclical and iterative process. And it disseminates 

findings and knowledge gained to all partners and involves all partners in the dissemination 

process.9

 The community-based participatory approach, which is a work in progress for the 

JHS, could likely be one strategy that will work in engaging women across the lifespan and 

women from underserved populations in lifestyle behaviors that will reduce the modifiable 

risks for cardiovascular disease. 

The involvement of high school and undergraduate students in a population-based, epidemiological study is indeed novel. As well, it has been highly successful in increasing the number 

of women students who have been engaged in various aspects of the Jackson Heart Study 

Scholar’s program since 2003, who are enrolled in programs of study leading toward M.D. and/ 

or Ph.D. degrees, and careers in public health and research. Of the 56 Jackson Heart Study 

Scholars to date, 39 (70 percent) are women and 17 (30 percent) are men. Two women have 

earned M.D. degrees, while one has an earned Pharm.D. degree. One is enrolled in an M.D./ 

Ph.D. program and one in a Ph.D. program in pathobiology, both at Brown University. Twentyfour are enrolled in a variety of programs in research-related and health-related careers, 

including medicine, dentistry, pharmacy, nursing, optometry, public health chemistry, and biomedical research. 

This testimony is in firm support of including among the strategies for women’s health 

research for moving into the future, recommendations related to the following: 

1. Gender-specific data and State registries on incidence and prevalence of various 

types of cardiovascular diseases (we were unable to find these data among our 

sources in Mississippi) 

2. Translation of research into practice and prevention 

3. Community-based participatory approaches to engaging researchers and participants 

4. Qualitative methods of data collection and analysis 

5. Continued focus on building pipelines from high school to graduate and medical school 

to promote the engagement of women in careers in the biomedical sciences 

References 

1. Taylor, H. A., Jr. (2005). The Jackson Heart Study: An overview. Ethnicity & Disease, 15(4 

Suppl 6), S6–S3. 

2. Wyatt, S. B., Akylbekova, E. L., Wofford, M. R., Coady, S. A., Walker, E. R., Andrew, M. E., 

Jones, D. W. (2008). Prevalence, awareness, treatment, and control of hypertension in 

the Jackson Heart Study. Hypertension, 51, 650–656. 

3. Talegawkar, S. A., Johnson, E. J., Carithers, T. C., Taylor, H. A., Bogle, M. L., & Tucker, K. 

L. (2008). Carotenoid intakes, assessed by food-frequency questionnaires (FFQs), are 

associated with serum carotenoid concentrations in the Jackson Heart Study: Validation 

of the Jackson Heart Study Delta NIRI Adult FFQs. Public Health Nutrition, 11, 989–997. 

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4. Fox, E. R., Benjamin, E. J., Sarpong, D. F., Rotimi, C. N., Wilson, J. G., Steffes, M. W., Taylor, H. A., Jr. (2008). Epidemiology, heritability, and genetic linkage of c-reactive protein 

in African-Americans (from the Jackson Heart Study). American Journal of Cardiology, 

102, 835–841. 

5. Samdarshi, T. E., Taylor, H. A., Edwards, D. Q., Liebson, P. R., Sarpong, D. F., Shreenivas, 

S. S., Fox, E. R. (2009). Distribution and determinants of Doppler-derived diastolic flow 

indices in African-Americans: The Jackson Heart Study (JHS). American Heart Journal, 

158, 209–216. 

6. Taylor, H. A., Jr., Akylbekova, E. L., Garrison, R. J., Sarpong, D., Joe, J., Walker, E., Steffes, 

M. W. (2009). Dyslipidemia and the treatment of lipid disorders in African-Americans. 

American Journal of Medicine, 122, 454–463. 

7. Liu, J., Butler, K. R., Buxbaum, S. G., Sung, J. H., Campbell, B. W., & Taylor, H. A. (2009). 

Leptinemia and its association with stroke and coronary heart disease in the Jackson 

Heart Study. Clinical Endocrinology (Oxf), Epub May 16. 

8. Hickson, D. A., Wilhite, R. L., Petrini, M. F., White, W. B., & Burchfiel, C. (2009). Asthma 

and asthma severity among African-American adults in the Jackson Heart Study. Journal of Asthma, 46, 421–428. 

9. Minkler, M., & Wallerstein, N. (2003) Community-based participatory research for health. 

San Francisco: Jossey-Bass. 

SHARONNE HAYES, M.D. 

Mayo Clinic and Foundation 

Mayo Clinic Public Testimony on Priority Initiatives for Improving the Cardiovascular Health of 

Women for the Office of Research on Women’s Health 

I am Dr. Sharonne Hayes, representing the Women’s Heart Clinic and Office of Women’s Health 

at the Mayo Clinic, whose mission is to improve the health and care of women through clinical practice, education, and research. Mayo Clinic appreciates the opportunity to participate in 

this important conversation. Mayo Clinic and Foundation is a nonprofit, multidisciplinary, integrated practice with three primary locations in Rochester, Minnesota; Scottsdale, Arizona; and 

Jacksonville, Florida; and regional practices in the upper Midwest. As we evaluate the focus 

areas for discussion at this workshop, Mayo Clinic provides some unique resources and perspectives to women’s cardiovascular health, including the following: 

• A high-quality, high-volume comprehensive cardiovascular program, with clinical and 

research strengths in all relevant areas, including prevention, imaging, heart failure, intervention, cardiovascular surgery, and genomics 

• The Mayo Clinic Women’s Heart Clinic, specializing in clinical care and research on women 

• The long-standing longitudinal Olmsted County Heart Project 

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• The Rochester Epidemiology Project, which provides a unique integrated electronic 

medical record–linkage system for study of conditions and treatments in a well-defined 

stable population 

• Integration of research at multiple campuses that triangulate the country and reach 

unique patient groups, including underserved women in rural America 

• Center for Translational Science Activities and robust research programs for cardiovascular diseases and women’s health 

• Strong, longitudinal partnerships with community and patient organizations, e.g., 

WomenHeart: The National Coalition for Women with Heart Disease 

Cardiovascular disease remains the leading cause of morbidity and mortality in women. 

An overarching need, if we are to be successful in improving clinical care and cardiovascular 

outcomes in women, is to address the dearth of preclinical and basic science studies of cardiovascular disease models in female experimental animals. Although it has been 10 years since 

the Institute of Medicine Report, Sex Matters, the Biological Basis of Sex-Differences, basic science has failed to attend to sex differences in experimental design, and study sections have 

failed to value studies of sex differences. Study sections must become better equipped to 

evaluate such proposals of sex differences in cardiovascular disease, as these typically require 

complex integrative physiology utilizing a multidisciplinary approach. Implementing findings 

from basic science into the clinical arena will require investigators to develop new interdisciplinary approaches and funding to support these types of projects. 

The following represent high-priority areas for further study and enhanced funding in order to 

improve women’s cardiovascular health: 

1. Hypertensive disorders of pregnancy. These disorders affect the immediate health of the 

mother, but may also affect the future cardiovascular health of the mother and child. In 

order to understand these relationships further, we must extend current basic science 

and epidemiological investigations and create a national database for hypertensive 

disorders in pregnancy, not only to optimize the study of this condition in mothers, but 

also to understand the future implications of this condition on their offspring. Additional 

basic science work is required to provide a better understanding of how medications to 

treat or prevent hypertension might affect the fetus and future development of the child. 

2. Diagnosis, pathophysiology, and optimal management of spontaneous coronary artery 

dissection. This rare condition makes up only 0.2 percent of all myocardial infarctions, 

but has a mortality rate of almost 50 percent. Premenopausal women are disproportionately affected, often, tragically, in the immediate postpartum or peripartum period. 

The etiology, hormonal and genetic influences, risk factors, recurrence rates, and risks 

of subsequent pregnancies are unknown. A national database, with collection of biological specimens, hormone levels, and genetic material should be created to better understand this condition, since no single center has the patient volume to address these 

issues. Educational programs for obstetricians should be initiated, since a high index of 

suspicion is often the only way to make a timely diagnosis. 

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3. Optimal management and research into cardiovascular disease of the frail and elderly. 

Care for this growing, but underrepresented, population requires a better understanding 

of comorbid risks related to treatment, drug dosing and interactions, and the physiological and psychosocial barriers to rehabilitation following an adverse cardiovascular event. 

4. Microvascular disease. Although coronary microvascular disease and endothelial dysfunction are more common in women than in men, little is known about the etiology, 

optimal therapy, or the relationship of microvascular rarefaction to cardiac dysfunction 

in women (e.g., diastolic heart failure). Many preclinical studies of microvascular disease 

and animal models of heart failure have been conducted on male animals, so it is critical 

going forward that preclinical and basic science studies of the disorder include female 

animals. Extending the findings from the Women’s Ischemic Syndrome Evaluation 

(WISE) to determine optimal disease management and symptom relief is critical to 

reduce the economic and personal burden of this condition in women. 

5. Accurate cardiovascular risk assessment and diagnostic testing in women. There are 

important limitations of current tools to accurately predict and diagnose cardiovascular 

disease in women. Research into optimal predictive models and exploration of novel 

biomarkers to improve risk assessment are needed. Current American Heart Association/American College of Cardiology guidelines recommend the standard exercise 

treadmill test as the initial diagnostic test in women with chest pain, but no randomized 

data have demonstrated that outcomes are improved with this approach or with any 

other imaging modality. Additionally, a number of cardiovascular imaging modalities 

appear to perform differently in women and present their own sex-specific issues, such 

as radiation risk and nephrotoxicity. Improved techniques and assessment of comparative effectiveness in women are urgently needed. 

6. Challenges in prevention of cardiovascular disease and support of healthy lifestyle practices for women in rural America. In the United States, socioeconomic status and health 

are linked. Low-income individuals have higher morbidity and mortality and are less 

likely to have access to healthcare services. Rural poverty is less visible, more severe, 

and more persistent than urban poverty. Thus, more rural families than urban families 

experience poor health. They are also more likely to be uninsured or underinsured than 

their urban counterparts. Rural residents have higher rates of certain types of heart 

disease, more activity limitations due to chronic health problems, and higher rates of 

depression and suicide. Demonstration projects addressing the unique needs and challenges of rural women, including employment stability and access to health care and 

insurance, are critical to improve the overall health of rural women and their families. 

7. Assuring a rich and deep pool for future careers for women in science and technology. As the population ages and the number of women living with the burden of heart 

disease grows exponentially, a shortage of cardiologists and scientists is looming. The 

only viable way to meet the brain- and man-power need and to grow this critical workforce is to engage more women in science and cardiovascular medicine. This effort will 

require more aggressive and effective outreach to high-potential young women from 

diverse backgrounds, a reassessment of current training paradigms for medical and 

research education, assurance of parity in resources for academic advancement, and 

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support for innovation. New and flexible models of mentoring, career advancement, 

and tenure should be explored. 

Mayo Clinic is grateful for the opportunity to speak at this forum and contribute to improving 

care for women while reducing their cardiovascular risk into the future. Our dedicated clinicians and scientists are eager to develop collaborations toward these goals. 

DIANA BITNER, M.D. 

Michigan State University College of Human Medicine 

A Novel Approach of Community-Based and Patient-Directed Care Using Gender-Specific Risk 

Factor Identification 

I represent our community of physicians, midlevel providers, researchers, and students who 

provide gender-specific care. We are frustrated with the fact that heart disease is often preventable. Most of the 6 million women who present to the emergency room each year with 

chest pain had no idea they were at risk. I want all women to know their risk and to see fewer 

women having to make that visit. I would like to present a strategic vision of how the Office 

of Research on Women’s Health (ORWH) working with community systems could achieve 

these goals. 

If “frustration is the mother of invention,” then I find myself of late to be a voracious inventor. 

After 15 years of clinical practice, I am frustrated by the number of women who walk around 

with preventable illness and comorbidities. It is my duty as a physician to empower them to 

mitigate these disease processes, so as to improve their quality of life. Surprisingly, medicine 

remains an aggregate of diagnostic and treatment silos. Lack of information sharing and functional interoperability continue to represent a high hurdle to process improvement. Specifically 

with respect to women’s preventative health, I am frustrated with the slowness of primary care 

to adopt gender-specific guiding principles. I am frustrated that primary care residents and 

midlevel providers often receive minimal education regarding gender-specific concerns and 

are not taught how perimenopause needs to be seen as a period of “last chance.” My response 

has been to develop novel methods using gender-specific principles in a practical way to 

improve patient awareness of their potential for wellness, risks of disease, and the availability 

of gender-specific and evidence-based options to improve their quality of life. 

There is a gap in day-to-day practice between what is possible for our patients and what 

happens within the constraints of time, money, and system limitations. We need to bridge 

the gap. It is time for old wisdom: “To raise new questions, new possibilities, to regard old 

problems from a new angle, requires creative imagination and marks real advance in science.”—Albert Einstein. It is time to use facts to find new solutions and become creative within 

current restraints. In our own survey, most women said they had not considered their health 

future, but wished for advice on how to gain control. Most women stated they did not understand midlife changes, and most had unresolved symptoms such as weight gain, low energy, 

decreased libido, unwanted hair growth, surprising mood changes, sleep disturbances, and hot 

flashes or night sweats. Most revealed that such questions were the main topic of conversation 

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when together with friends at social gatherings, and no one seemed to have answers. Many 

thought such symptoms were the reason for disharmony in their relationships and suboptimal 

performance at work. I believe that if we are to make a real difference in the health of American women, we must connect with them at the most basic level of day-to-day habits and 

quality of life and use the symptoms of perimenopause to garner their attention and address 

their potential for future wellness. 

At this conference, we all know the statistics. Heart disease is the number one killer of 

women, and heart-related mortality among women is on the rise, due mostly in part to 

comorbidities such as smoking, obesity, diabetes, and metabolic syndrome. Efforts to combat 

these problems are also on the rise. Public awareness has increased with the Go Red Campaign, and ORWH working groups such as this demonstrate the goal of many in health care 

to make a difference in the health of women. While awareness is improving, I echo the goals 

of Dr. Carolyn Clancy, “Comparative patient-centered information is essential to translating 

new discoveries into better health outcomes. (We must) get the right treatment to the right 

patient at the right time.” 

In West Michigan, we have started a women’s health pilot program called, “W*A*I*PointesTM,” 

standing for “Who Am I?” A patient story will illustrate what we do. One woman in our program joined the pilot, drawn in by the question, “Do you have less energy than you expected 

at this point in your life?” At quick glance, she was relatively healthy. She works full-time and 

runs a household. She is socially connected and sees a good internist for regular check-ups. 

She is active but rarely does aerobic activity due to a busy schedule and fatigue. Her BMI was 

30 and her physical exam history was unremarkable. Her lipid profile demonstrated a low HDL 

and slightly high LDL. She had no real reason for her complaints except “maybe this is normal 

aging.” Within the Pilot, we took a detailed history, including basic habits and diet. Using gender-specific risk identification tools and stratification, including the Reynolds’s Score and the 

Gale Model for Breast Cancer and body fat analysis, she, in fact, scored high risk for heart disease, breast and colorectal cancer and was diagnosed with “pre-diabetes.” We were able to 

identify lifestyle modifications and treatment options that have made her more energetic, and 

very likely to have saved her from a heart event. She has been referred to specialists within the 

MMPC Women’s Health Network, who have assisted in her evaluation and treatment. She is 

thankful to the Pilot for “saving her life” and is already feeling better. 

Based on initial pilot data, we are ready to participate in the national conversation regarding solutions for preventable illness, including heart disease. We would like to suggest that the 

ORWH support comparative research in community-based programs and assist in the use of 

gender-specific risk identifiers to connect with patients, help them to understand their level 

of risk, and answer questions about daily symptoms. We believe having the support of the 

ORWH will assist in breaking down silos and open the conversation for new solutions despite 

the financial, logistical, and cultural barriers that exist. 

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ELVAN CATHERINE DANIELS, M.D., M.P.H. 

Morehouse School of Medicine 

Making Healthy Habits a Priority 

Good afternoon, I am Dr. Ellie Daniels, Associate Director of Community Oriented Primary Care 

at the National Center for Primary Care, Morehouse School of Medicine. We are dedicated to 

improving the health and well-being of individuals and communities; increasing the diversity 

of the health professional and scientific workforce; and addressing primary healthcare needs 

through programs in education, research, and service, with an emphasis on people of color 

and the underserved urban and rural populations in Georgia and the Nation. 

I stand before you today to make the case for educating and mobilizing communities as 

partners in health. We have strong relationships with community-based organizations and 

institutions such as churches, schools, federally qualified health centers, and other community-based clinicians. Through our work such as the Achieving Functional Health Literacy for 

ABCD conditions (ABCD Program), which trained church-based community health lay workers (98 percent female) to deliver cardiovascular risk reduction education to members of their 

congregations, we found that lay persons are eager to learn how to take a more active role 

in their health decisions. We found that when health conditions are explained in simple terms 

combined with interactive methods such as learning how to read food labels, home monitoring of blood pressure, and the like, there was a significant increase in cardiovascular disease 

risk–reduction knowledge after only 6 weeks. We believe that increasing health literacy—the 

degree to which individuals are able to obtain, process, and understand basic health information and services needed to make appropriate health decisions1

—is fundamental to primary 

and secondary prevention of chronic illnesses. Health literacy is a shared function of cultural, 

social, and individual factors impacted by family and community. 

As Americans, if we were to make healthy lifestyle decisions such as adhering to USDA recommended nutritional guidelines, participating in a regular program of physical activity, 

avoiding tobacco use and moderate consumption of alcohol, we could reduce the risk of our 

major causes of mortality by 87 percent.2

 I am urging the panel to consider including culturally 

tailored research focusing on developing healthy habits in early childhood, taking into context family and community. I would also like to encourage an integrated approach to health 

education and physical activity for school-aged children. Placing emphasis on primary prevention offers a great opportunity to reduce morbidity and mortality from chronic illnesses and 

improve quality of life. 

References 

1. Committee on Health Literacy, Institute of Medicine. (2004). Health literacy prescription 

to end confusion. National Academies Press. Washington, DC. 

2. Mokdad, A. H., Marks, J. S., Stroupe, D. F., & Gerberding, J. L. (2004). Actual causes of 

death in the United States, 2000. Journal of the American Medical Association, 291, 

1238–1245. 

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VIRGINIA MILLER, PH.D. 

Organization for the Study of Sex Differences 

The Organization for the Study of Sex Differences—Recommendations for New Dimensions and 

Strategies in Women’s Health Research 

The Organization for the Study of Sex Differences (OSSD) applauds the Office of Research 

on Women’s Health for highlighting sex disparities in cardiovascular disease as an important 

research agenda for the next decade. The OSSD is the Nation’s only interdisciplinary scientific 

society whose mission is to promote the interdisciplinary science of sex/gender differences 

to the scientific and medical community and the public through research, education, communication, translation, and advocacy. As cardiovascular disease is the number one killer of 

women, and more women than men die each year from cardiovascular disease, understanding 

the basic biology of the impact of sex/gender in the development, diagnosis, and treatment of 

cardiovascular disease is a paramount requirement for improving the health of women. 

Key areas that remain to be addressed include the following: 

• Increased understanding of the cellular and molecular basis of sex differences in the natural history of development and treatment for cardiovascular disease 

• Clearer definition of the impact of the hormonal milieu (natural transitions to puberty, 

long-term consequences of oral hormonal contraceptives, pregnancy, and menopausal 

hormonal treatments) on risk and progression of cardiovascular disease in women 

• An integrated approach to understanding how neurological/psychological factors impact 

development of cardiovascular disease in women 

To address these questions, a vital cadre of basic and clinical investigators interested in unraveling the biology of sex differences and funding to support their research are required. Design 

of basic science studies needs attention to sex and reproductive history of the animals and 

tissue used in basic science experiments. Furthermore, clinical healthcare data should be 

reported by sex so that databases can be used to better screen and treat women at risk for 

cardiovascular disease. The OSSD appreciates the opportunity to provide our recommendations to develop new strategies for women’s health research. Scientists and investigators of 

OSSD are eager to partner with the Office of Research on Women’s Heath to improve the cardiovascular health of women. 

E. CLINTON LAWRENCE, M.D. 

Pulmonary Hypertension Association 

Recommendations to the Office of Research on Women’s Health on Pulmonary Hypertension 

Thank you for the opportunity to provide the perspective of the Pulmonary Hypertension Association on one important area of investment for the Office of Research on Women’s Health. 

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I am honored to represent today the many thousands of Americans who are fighting a courageous battle against a devastating disease. Pulmonary hypertension (PH) is a fatal condition in 

which blood pressure in the lungs rises to dangerously high levels. In PH patients, the walls of 

the arteries that take blood from the right side of the heart to the lungs thicken and constrict. 

As a result, the right side of the heart has to pump harder to move blood into the lungs, causing it to enlarge and ultimately fail. I have been treating patients with PH since the early 1980s, 

when the only treatment available was heart–lung and later lung transplantation. I have been 

fortunate to witness over the past quarter century the development of several effective medical treatments for PH such that transplantation is needed far less frequently. Although much 

has been accomplished, much more needs to be done to cure this disease. 

PH can occur without a known cause or be secondary to other conditions, such as congenital 

heart disease (atrial and ventricular septal defects), collagen vascular diseases (i.e., scleroderma and lupus), liver disease, human immunodeficiency virus, sickle cell, or blood clots. 

Patients develop symptoms that include shortness of breath, fatigue, chest pain, dizziness, 

and fainting. Unfortunately, these symptoms in young patients are often thought to be panic 

attacks, and patients are frequently misdiagnosed unknowingly. Patients do not present to our 

specialty centers until late in the disease. By the time many patients receive the correct diagnosis, the disease has progressed to a late stage, requiring continued infusion therapy, and if 

the patient is a candidate, a lung transplant. 

PH occurs in individuals of all ages, races, and genders. However, women are more than twice 

as likely as men to develop PH. Women most often develop PH during their childbearing years. 

Pregnancy is contraindicated for PH patients because it is associated with life-threatening risks 

for both the mother and baby, with maternal mortality of 50 percent in the peri-partum period. 

Unfortunately, PH is sometimes first diagnosed late in pregnancy with devastating consequences. A vivid illustration of the latter scenario is my patient, Tavia Underwood, who 7 years 

ago, at age 30, was found be in decompensated heart failure from PH at 32 weeks of pregnancy. Her life and that of her son, Bo, was saved by intravenous Flolan. I understand that Bo 

recently attended his first Georgia Bulldog football game, with healthy-appearing Mom and 

proud Dad in tow. 

PH is chronic and incurable with a poor survival rate. Fortunately, new treatments are providing a significantly improved quality of life for patients. Recent data indicate that the length of 

survival is continuing to improve, especially in a small subset of patients who are responsive to 

calcium channel blockers or who are treated with continuous infusions. If patients are referred 

early, they have often managed the disorder for more than 10 years. 

Nineteen years ago, when three patients who were searching to end their own isolation 

founded the Pulmonary Hypertension Association, there were less than 200 diagnosed cases 

of the disease in the entire United States. It was virtually unknown among the general population and not well known to the medical community. The three patients’ desire to change this 

bleak picture led to their establishment of the Pulmonary Hypertension Association (PHA), 

headquartered in Silver Spring, Maryland. 

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PHA at a Glance 

• More than 10,000 patients, family members, and medical professionals as members and 

an additional 36,000 supporters and friends 

• A network of more than 200 patient support groups 

• An active and growing patient-to-patient telephone helpline 

• Three research programs that, through partnerships with the National Heart, Lung, and 

Blood Institute (NHLBI); and the American Thoracic Society, have directed nearly more 

than $9 million toward PH research 

• Numerous electronic and print publications, including the first medical journal devoted 

to pulmonary hypertension—published quarterly and distributed to all cardiologists, pulmonologists, and rheumatologists in the United States 

• A Web site dedicated to providing educational and support resources to patients, medical professionals, and the public that, over the past decade, has grown from receiving 

600 visits a month to now between 270,000 and 390,000 visits per month 

The Pulmonary Hypertension Community 

I would like to share with you the stories of two remarkable PH patients, Emily Stibbs and 

Charity Tillemann-Dick. Emily’s and Charity’s stories illustrate the impact of pulmonary hypertension not only on PH patients, but also on their family and friends. 

When their daughter, Emily, was five, Jack and Marcia Stibbs noticed that she could not keep 

up with the other children in the neighborhood. She seemed to lack the energy and strength 

to run and play. This condition worsened to the point where she would have to stop and rest 

after coming down the steps in the morning. Jack and Marcia noticed that when she was sitting on the bottom step in the morning, Emily’s lips appeared to have a bluish color. 

After pressing for an answer to these problems for several months, Emily was finally diagnosed with pulmonary hypertension, and the doctors told the Stibbs family that her probable 

remaining lifespan was 3 years. 

Charity Tillemann-Dick’s diagnosis with pulmonary hypertension took not months, but years. 

When Charity was in her late teens, she had the opportunity to travel abroad and share her 

considerable talents as a budding opera singer at her grandfather’s 75th birthday party in 

Budapest. Just before the performance, Charity collapsed, but the episode was explained 

away as a case of nerves. 

Over the next few years, Charity continued to have occasional fainting spells as well as a progressive loss in energy. She was diagnosed as being everything from deconditioned to anemic. 

When Charity finally received an accurate diagnosis, she had severe PH, limiting therapeutic choices and response. Recently, Charity received a lung transplant and is continuing the 

long and difficult recovery process. I am happy to report that Emily has outlived her 3-year 

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prognosis by 9 years and continues to thrive. There is still, however, no cure for PH. Courageous patients of every age lose their battle with PH each week. 

Thanks to congressional action, and to advances in medical research largely supported by the 

National Heart, Lung, and Blood Institute (NHLBI) and other government agencies, Emily and 

Charity have an increased chance of living with their PH for many more years. These advances 

are also impacting the prognosis for future generations of PH patients. Among the more significant findings is that of a genetic mutation responsible for the disease in the familial form of PH, 

and present in approximately one-quarter of patients with no family history. Findings such as 

these may lead to novel treatments with gene therapy, perhaps using stem cells derived from 

individual patients’ own blood. As is often the case, such targeted research has far broader 

applications in other diseases and human health in general. However, additional support is 

needed for research and related activities to continue to develop treatments that will extend 

the life expectancy of PH patients beyond the National Institutes of Health (NIH) estimate of 2.8 

years for 50 percent after diagnosis and to raise awareness of this rare, deadly condition. 

Recommendations 

In December 2006, the NHLBI and the NIH Office of Rare Diseases cosponsored a 2-day scientific conference on pulmonary hypertension. This important event provided an opportunity for 

leading PH researchers from the United States and abroad to discuss the state of the science 

in pulmonary hypertension and future research directions. The conference helped physicians 

collaborate and expand their knowledge and was extremely well received. Another conference 

would be beneficial as the field is on the verge of significant breakthroughs in our understanding of PH and the development of new and advanced treatments. 

Twelve years ago, a diagnosis of PH was a death sentence, with only one Food and Drug 

Administration (FDA)–approved treatment for the disease. Thanks to advancements made 

through the public and private sector, patients today are living longer with an improved quality of life, and with a choice of eight FDA-approved therapies. 

At a congressional hearing on pulmonary hypertension in December 2005, Dr. Mark Gladwin, 

who was then Chief of the Vascular Medicine Branch at NIH’s National, Heart, Lung, and Blood 

Institute, said, “I study what is happening in pulmonary hypertension as an example of what 

you can do with an orphan disease. With the combination of advocacy, industry involvement, 

and state-of-the-art basic science, they came together, in a perfect storm of opportunity.” 

Recognizing that we have made tremendous progress, we are also mindful that we are a long 

way from where we want to be in 1) the management of PH as a treatable chronic disease, 

and 2) a cure. Our needs are in both clinical research and public and medical professional 

education. PH patients typically visit three physicians before a fourth makes an accurate diagnosis—often losing a year or more and making their prognosis significantly less promising. 

With this in mind, the Pulmonary Hypertension Association respectfully requests that the 

Office of Research on Women’s Health make pulmonary hypertension a research priority now 

and in the future. 

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MARY BLADES 

Scleroderma Foundation 

Scleroderma 

Hello, my name is Mary Blades, and I have scleroderma. Scleroderma, although a big word to 

pronounce, is not unlike the ravage it can have on a person’s body. Sclero, meaning hard, and 

derma, meaning skin, is the interpretation of the word, but to those of us who have it, it is 

much, much more. It cannot only affect the skin, which in itself is frightening, but it can also 

affect internal organs, which can then be life-threatening. Scleroderma is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. Simply 

put, what is happening with scleroderma is that a protein called collagen that, under normal 

circumstances, heals a wound nicely, but for whatever reason with scleroderma patients, goes 

berserk and starts to reproduce and does not stop. There are an estimated 300,000 people in 

the United States who have scleroderma; 80 percent of those are women, usually diagnosed 

between the ages of 25 and 55. 

My personal story includes going from doctor to doctor, not knowing what was wrong with 

me until I went to the Mayo Clinic in Rochester, Minnesota, where I got a probable diagnosis. Scleroderma manifested itself 2 weeks after I got home. It was scary; I could feel my body 

changing from second to second. I would look in the mirror and my wrinkles would begin to 

diminish; my face began looking like a doll’s face; and the skin on my hands, arms, and legs 

was looking younger and was getting very, very hard. I couldn’t help but wonder what was 

happening to my internal organs, as I could feel my lungs becoming heavier with every breath. 

Thank goodness for the meds that slowed the collagen from producing quite so fast and 

relieved me of some of the hardness that had been occurring so quickly. In time, a combination of meds did indeed soften my skin everywhere but my fingers, and my labored breathing 

eased up.
�

What followed were several years of doctors monitoring my meds as to how they were affecting my kidneys or anything else they might be doing to my body. But at least I had something 

that was helping—only to have to go off them because my body rejected them. As you probably know, your body will only tolerate certain medicines for just a few years until you have to 

go looking for something else that will relieve symptoms because there just is no cure, yet!
�

Gastro esophageal reflux disease has been in my life since the inception of my scleroderma. 

I have been on one form or another of reflux medication for as long as I’ve had scleroderma. 

One of my doctors told me that she was taught in medical school that reflux should be treated 

aggressively due to the potential hazard of esophageal cancer. Okay—another big, huge worry 

for a scleroderma patient.
�

My fingers continue to turn from red to blue to white, which in turn, creates some terribly painful ulcers. This phenomenon is called Reynaud’s disease, which happens in most scleroderma 

patients. Doctors tell us they have not seen a patient with scleroderma who did not have Reynaud’s disease. Those who have severe cases of Reynaud’s lose digits and suffer extreme pain 

that never goes away. Early on in my disease, I was trying to braid my granddaughter’s hair 

430
and could not figure out why something I had always done with such ease was now causing 

me such grief. My fingers suffer from Raynaud’s, but they were and are constantly swollen, and 

the skin is hard. They also undergo a constant battle with ulcers. Thus, I can no longer braid 

her hair as I used to. This sounds trivial, but it is very disheartening for me. 

Fatigue is a big problem for scleroderma patients. It is a struggle to make myself do things 

that before scleroderma was a snap. I had a dozen things done by noon of each day and now 

am lucky to get a shower and a bed made. This is a real bummer because I feel I am a different 

person and one who is not as productive as I used to be. I am and always have been all about 

being productive. 

Although I do not struggle with depression, I know many scleroderma patients who does. 

Right now, I have a friend who has not answered her phone or looked at her e-mail because 

she just can’t bring herself to do so. Her husband shared this with us. She believes she is just 

fatigued, but we (Scleroderma Support Group) and her husband believe it is depression. We 

will continue to try to engage her, but it is very difficult. 

Pain is a big concern to many with scleroderma, as it has been with me. As we know, all people 

are different and some tolerate it better than others. Another friend of mine was in so much 

pain, she wondered why she continued to hang in there; she felt it was hopeless. Fortunately, 

we have been able to get her to a doctor who has found some medicines that has relieved 

some of the pain, and she is no longer in the extreme pain and dark side she was in. Others are 

just downright not so lucky. 

I work closely with the National Scleroderma Foundation, a nonprofit organization founded 

in 1998 whose mission is to provide support, education, and research. It exists for people with 

scleroderma, their friends, and families. We work hand in hand to give people the support they 

need through mutual support programs, peer counseling, physician referrals, and educational 

information. Education promotes public awareness and education through patient and health 

professional seminars, literature, and publicity campaigns. Research stimulates and supports 

improved treatment, which will ultimately lead to the cause of and cure for scleroderma and 

related diseases. The camaraderie from the Foundation and the people I have met has been 

therapy for myself; the support has been healing, and the caring has been a treatment. An 

added bonus is that they seek research dollars—research dollars to improve treatment and to 

find a cure. 

Finding a cure is important to me, not only for myself, but also for all those suffering with this 

cruel disease. 

When I first became involved to see what I could do to help others who were not as fortunate 

as myself and to be sure that research continues toward a cure, I was amazed at how little was 

known about scleroderma. Now things have changed somewhat, and more is known about it, 

but we still have a long way to go. 

431
Because this is mostly a women’s disease, as mentioned above, 80 percent of those diagnosed 

are women. The need to prioritize research on diseases that disproportionately affect women 

that have no approved therapies, like scleroderma, is imperative for those of us who suffer day 

in and day out. 

Thank you for this opportunity to speak regarding scleroderma and its characteristic of affecting mostly women. 

VIVIANA SIMON, PH.D. 

Society for Women’s Health Research 

The Isis Fund Cardiovascular Network Testimony 

The Isis Fund Cardiovascular Network, an international group of basic and clinical scientists, a 

program of the Society for Women’s Health Research to promote innovation in women’s cardiovascular health, welcomes the opportunity to contribute to recommendations that will form 

the basis for the women’s health research agenda in the next decade. In the era of individualized medicine, epigenetics, fetal programming, cell-based therapies, and outcomes research, 

the time is right to take a renewed and in-depth analysis of sex and hormones in basic and 

clinical investigations of cardiovascular disease (CVD) in women. Emerging questions that 

need to be addressed include the following: 

1. To what extent should sex and gender influence CVD prevention and management 

programs—including risk prediction, preclinical screening/detection, diagnostic testing, prognostic risk assessment, and angina and CVD management strategies—across 

multiple age groups? 

2. Why do women tend to develop relatively less obstructive coronary disease than men, 

greater coronary microvascular dysfunction, and diastolic heart failure? What are the 

risk factors, best methods for diagnosis, and the evidence-based management strategies for these conditions in women? 

3. Women have a relatively greater burden from angina and associated symptoms with 

and without obstructive coronary disease, with a lower quality of life and comorbidity 

compared to men. What are the causal mechanisms of this sex and gender difference; 

what evidence is needed to develop sex- and gender-based angina/coronary artery 

disease guidelines? 

4. What is the role of ovulatory function adequacy, use of contraceptive hormones during 

the premenopausal period, use of hormone therapy in the peri- and early postmenopausal therapy, and oral vs. transdermal preparations on CVD? 

5. Are there sex differences in the efficacy of cell-based therapies (stem cells or progenitor cells)? How does the biological sex of the donor or recipient affect the success of 

the therapy? 

432
6. Can the onset of CV risk factors and conditions diagnosed during pregnancy, such as 

metabolic syndrome, insulin resistance, and hypertension, be used for early preclinical 

disease prediction or to enhance risk factor scores (Framingham, Reynolds, others) to 

identify elevated risk for the purposes of sex-specific CVD prevention in women? 

To answer these questions will require interdisciplinary investigative teams and approaches. 

Nontraditional mechanisms will be needed to train such individuals and to promote and 

retain their expertise in challenging fiscal environments. Attention to sex, hormonal milieu, 

and reproductive history should be required for reporting in both basic science and clinical 

databases. Integrative approaches that account for physiological interactions of hormonal, 

neuronal, and developmental influences across the lifespan will need to be addressed. Innovative approaches to better define the biological basis of sex differences in cardiovascular 

disease will lead to a more rapid translation of discovery to the clinic. 

The Society for Women’s Health Research and the Isis Fund Cardiovascular Network welcome 

the opportunity to partner with the ORWH to advance and improve women’s cardiovascular 

health into the next decade. 

The Isis Fund Cardiovascular Network Members include the following: 

Jane F. Reckelhoff, Ph.D. 

University of Mississippi 

Department of Physiology and Biophysics 

Leslee J. Shaw, Ph.D. 

Emory Program in Cardiovascular Outcomes Research and Epidemiology 

Emory University 

Doris A. Taylor, Ph.D. 

University of Minnesota 

Stem Cell Institute 

R. Clinton Webb, Ph.D. 

Medical College of Georgia 

Department of Physiology 

Virginia M. Miller, Ph.D., M.B.A. 

Mayo Clinic and Foundation 

Departments of Surgery and Physiology and Bioengineering 

Nanette Wenger, M.D. 

Emory University 

School of Medicine 

433
Noel C. Bairey Merz, M.D., FACC, FAHA 

Cedars-Sinai Medical Center 

Woman’s Heart Center 

Meir Steiner, M.D., Ph.D., FRCPC 

McMaster University 

Psychiatry & Behavioral Neurosciences and Obstetrics & Gynecology 

Women’s Health Concerns Clinic 

JAY KAPLAN, PH.D. 

Wake Forest University School of Medicine 

The Use and Promise of Nonhuman Primates in Women’s Health Research 

Background 

Old World monkeys share with human beings 95 percent gene sequence identity; nearly identical reproductive physiology and endocrinology; and the full spectrum of chronic diseases 

affecting women across the lifespan, including diabetes and obesity,1

 polycystic ovarian syndrome associated with infertility,2

 hypothalamic anovulation associated with bone loss and 

precocious acceleration of atherosclerosis,3

 the perimenopausal transition,4 cardiovascular disease,5

 breast cancer,6 endometrial cancer,7 papillomavirus-induced cervical cancer,8 

postmenopausal osteoporosis,9 and age-related cognitive decline.10 Furthermore, the recent 

sequencing of the genomes of several Old World monkeys species and the development of 

primate-specific research tools such as gene expression arrays have resulted in extraordinary 

opportunities for new discoveries in women’s health in ways that are not possible in human 

trials due to logistical or ethical constraints, or in rodent studies owing to dissimilarities in 

reproductive and disease characteristics. 

Three Specific Examples of Contributions to Women’s Health at 

Midlife and Beyond 

1. Studies published in 1996 with cynomolgus monkeys (Macaca fascicularis) predicted 

that conjugated equine estrogens alone would not likely increase breast cancer risk but 

that the addition of a progestin would markedly exacerbate such risk.11 

2. Studies conducted on cynomolgus monkeys and published in 2002 predicted the 

cardiovascular outcomes of the Women’s Health Initiative prior to termination of the 

conjugated equine estrogens/medroxyprogesterone acetate arm of that trial (“Estrogens have beneficial effects in the early stages of atherogenesis, but have little or no 

beneficial effects in the final stages of plaque complications, instability, or coronary 

heart disease events”).12 

3. Additional studies conducted on cynomolgus monkeys demonstrate that disrupted 

ovarian function, which occurs in all women as they transition to menopause and in 

434
some women on repeated occasions during their reproductive years, accelerates bone 

loss and the development of atherosclerosis and provides a potential vulnerable period 

during which exogenous hormones might be used beneficially.3

 In other words, monkeys have contributed substantially to the current window of opportunity hypothesis 

for hormone therapy that is now being tested in two clinical trials (the Kronos Early 

Estrogen Prevention Study, KEEPS; the Early verses Late Intervention Trial with Estradiol, ELITE). 

Major Research Opportunities Using Monkeys 

1. Controlled trials of preventive and therapeutic interventions, including hormones 

2. Measurement of tissue-specific gene expression to illuminate expected and unanticipated mechanisms of action for hormonally active drugs, dietary supplements, and other 

agents to which women are exposed 

3. Identification of gene–environment interactions that result over time in differential 

vulnerability to risk for chronic disease 

Limitations to Studies Using Monkeys 

1. There is a lack of populations of monkeys at midlife and beyond that are consuming 

diets similar to those eaten by most women living in industrialized countries and that 

are dedicated to studies of women’s health. Such populations are critical for both interventional studies and investigations focused on understanding individual differences in 

trajectories of disease risk. 

2. There is a lack of funding opportunities (grant mechanisms) to support the integrated, 

multisystem studies that are necessary to understand the genetic and environmental 

factors underlying development of the major chronic and degenerative diseases impairing the lives of postmenopausal women. 

Recommendations 

1. Because primate studies are most efficiently done in multisystem investigations, the 

Office of Research on Women’s Health should partner with appropriate Institutes and 

Centers (ICs) to develop a Request for Applications for Specialized Centers of Research 

in Women’s Health Research that focuses on the development and use of nonhuman 

primate models in cross-disciplinary investigations. 

2. To provide opportunities for the wide range of investigators needed for women’s health 

research, the ORWH should partner with the ICs and the National Center for Research 

Resources (NCRR) to develop a program of partnership grants in women’s health designed to encourage the use of nonhuman primates in collaboration with the National 

Primate Research Centers and colonies maintained through the Animal and Biological 

Materials Resources program. 

435
3. The ORWH should partner with the NCRR to support female monkeys that have 

reached midlife and beyond and ensure that sufficient numbers are available for use in 

both interventional and observational (lifespan) studies. Nor should such primate resources be limited to a single species such as the rhesus monkey (M. mulatta), as there 

is abundant evidence that cynomolgus macaques, African green monkeys (Chlorocebus aethiops), and other Old World species are equally useful in modeling diseases of 

relevance to women. 

References 

1. Abbott, D. H., Foong, S. C., Barnett, D. K., & Dumesic, D. A. (2004). Nonhuman primates 

contribute unique understanding to anovulatory infertility in women. ILAR Journal, 45, 

116–131. 

2. Appt, S. E., Kaplan, J. R., Clarkson, T. B., Cline, J. M., Christian, P. J., & Hoyer, P. B. (2006). 

Destruction of primordial ovarian follicles in adult cynomolgus macaques after exposure 

to 4-vinylclohexene diepoxide: a nonhuman primate model of the menopausal transition. Fertility and Sterility, 86, 1210–1216. 

3. Clarkson, T. B., & Mehaffey, M. H. (2009). Coronary heart disease of females: lessons 

learned from nonhuman primates. American Journal of Primatology, 71, 785–793. 

4. Clarkson, T. B. (2002). The new conundrum: Do estrogens have any cardiovascular benefits? International Journal of Fertility, 47, 61–68. 

5. Cline, J. M., Wood, C. E., Vidal, J. D., Tarara, R. P., Buse, E., Weinbauer, G. F., . . . van Esch, 

E. (2008). Selected background findings and interpretation of common lesions in the 

female reproductive system in macaques. Toxicological Pathology, 36, 142S–163S. 

6. Cline, J. M., Soderqvist, G., von Schoultz, E., Skoog, L., & von Schoultz, B. (1996). Effects 

of hormone replacement therapy on the mammary gland of postmenopausal cynomolgus macaques. American Journal of Obstetrics and Gynecology, 174, 93–100. 

7. Kaplan, J. R., & Manuck, S. B. (2008). Ovarian dysfunction and the premenopausal origins of coronary heart disease. Menopause, 15, 768–776. 

8. Lees, C. J., Register, T. C., Turner, C. H., Wang, T., Stancill, M., & Jerome, C. P. (2002). 

Effects of raloxifene on bone density, biomarkers, and histomorphometric and biomechanical measures in ovariectomized cynomolgus monkeys. Menopause, 9, 320–328. 

9. Voytko, M. L., Murray, R., & Higgs, C. J. (2009). Executive function and attention are preserved in older surgically menopausal monkeys receiving estrogen plus progesterone. 

Journal of Neuroscience, 29, 10362–10370. 

10. Wagner, J. D., Kavanagh, K., Ward, G. M., Auerbach, B. J., Harwood, H. J., & Kaplan, J. R. 

(2006). Old World nonhuman primate models of Type 2 diabetes mellitus. ILAR Journal, 

47, 259–271. 

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11. Wood, C. E., Usborne, A. L., Starost, M. F., Tarara, R. P., Hill, L. R., Wilkinson, L. M., . . . 

Cline, J. M. (2006). Hyperplastic and neoplastic lesions of the mammary gland in macaques. Veterinary Pathology, 43, 471–483. 

12. Wood, C. E., Chen, Z., Cline, J. M., Miller, B. E., & Burk, R. D. (2007). Characterization and 

experimental transmission of an oncogenic papillomavirus in female macaques. Journal 

of Virology, 81, 6339–6345. 

LISA M. TATE 

WomenHeart: The National Coalition for Women With Heart Disease 

Correcting Disparities in Women’s Treatment and Outcome for Cardiovascular Disease 

WomenHeart: The National Coalition for Women With Heart Disease commends the Office of 

Research on Women’s Health (ORWH) for convening this meeting on research in women and 

cardiovascular health and disease. We applaud ORWH for highlighting cardiovascular disease, 

the number one killer of women, and committing to use the ideas and recommendations from 

this meeting to inform the National Institutes of Health (NIH) women’s health research agenda 

for the next decade. 

As the Nation’s only patient-centered advocacy organization serving the 42 million American 

women living with or at risk for heart disease, WomenHeart: The National Coalition for Women 

With Heart Disease is solely devoted to advancing women’s heart health through advocacy, 

community education, and patient support. WomenHeart is a coalition and a community of 

nearly 30,000 members nationwide, including women heart patients and their families, physicians, and health advocates, all committed to helping women live longer, healthier lives. 

In 2006, WomenHeart joined forces with the Society for Women’s Health Research (SWHR) to 

release The 10 Q Report, which identified the top 10 questions that needed to be answered if 

women were to receive optimal cardiovascular care and treatment.1

 The 10 questions covered 

differences in risk, effectiveness of risk assessment and diagnostic tools, and the effectiveness 

of therapies for men and women. The report highlighted the need for improved understanding of heart disease in women. The 10 Q Report has served as a powerful guide for the NIH, 

Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare and Medicaid Services, and other health research agencies to develop a research agenda. 

WomenHeart and SWHR are currently working with experts in women’s cardiovascular health 

to update this report to determine why disparities in women’s treatment and outcomes for 

cardiovascular disease still exist. Preliminary findings of the 10Q update are consistent with 

results of a survey and report released January 27, 2010, by the Society for Cardiovascular 

Angiography and Interventions (SCAI) entitled, Gender-Based Issues in Interventional Cardiology: A Consensus Statement from the Women in Innovations (WIN) Initiative.2

 The SCAI report 

highlights gender-based disparities in CVD treatment, outcomes, and research for women, 

which reinforce our recommendations for the ORWH research agenda. 

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The first step to improving the research agenda for cardiovascular disease in women is to 

increase the number of women participating in clinical trials. As cited in the aforementioned 

SCAI report, women account for only 20 to 25 percent of patients enrolled in most CVD clinical trials. In a survey of more than 300 members of WomenHeart, all heart disease survivors, 

80 percent of women who had CVD never considered participating in clinical trials because 

they were not aware clinical trials were recruiting patients (50 percent); they were concerned 

about the effects of treatment or lack of effects if given placebo (31 percent); or there were 

logistical issues such as transportation issues, geographic barriers, financial barriers, or lack of 

time (20 percent). In addition, only 10 percent of women said their physician spoke with them 

about participating in a clinical trial when they were first diagnosed with heart disease or a 

heart attack.2 Thus, “the majority of data from clinical trials is based on a population of mostly 

male participants, and as a result, women are being treated according to data based on men,” 

said Roxana Mehran, M.D., FSCAI, Director of Outcomes Research at the Center of Interventional Vascular Therapies at Columbia University, NY, and report coauthor.2 

Increasing the participation of women in clinical trials is a priority if we are to improve diagnosis and treatment outcomes. There are many reasons more female patients are not included in 

research studies, but none that can’t be addressed. We concur with the recommendations in 

the SCAI report that future clinical research includes a predefined number of women in all trials, so that future studies are adequately powered to address the applicability of the results to 

the female population.2

 WomenHeart is eager to partner with the translational research community to increase participation of women in clinical trials, which should result in a decrease in 

gender disparities. We recommend the following action steps: 

• Ensure that physicians and hospitals provide information to women about clinical trials 

• Target women’s heart centers for trial recruitment 

• Ensure that when a pharmaceutical or device reaches panel, gender use and applicability are examined 

• Consider incentives for trials with appropriate gender representation 

• Consider mandating that clinical trials have appropriate gender representation 

whenever possible 

• Consider requiring trial sponsors to set protocols/trial designs that report results by gender 

• Enforce requirements that federally reported healthcare data be stratified by gender, 

race, and ethnicity 

Identifying the areas where these troubling disparities exist and solving the scientific questions that underlie the basis for gender disparities are the next steps. The most urgent 

question to be answered is why more women die from heart disease than men. A research 

agenda that addresses gender-based disparities must investigate myriad issues, but the following are the most pressing, in our view: 

• Sex differences in the development, natural history, responses to treatment, and clinical 

outcomes with heart disease 

438
• Role of a woman’s reproductive history and menopausal hormone therapy in the development of heart disease 

• Risk factors for the cardiovascular disorders associated with pregnancy 

• Impact on heart disease of psychosocial issues such as depression and anxiety in women 

Designing research studies to determine the impact of sex differences on the natural development of heart disease and subsequent diagnosis and treatment is critical to eliminating 

disparities. Determining the unique effect that reproduction and menopausal hormone therapy 

have on a woman’s risk of heart disease should improve the care of women throughout their 

lifespan. Finally, becoming more familiar with the effect of psychosocial aspects of heart disease in women will make primary and secondary prevention and treatment more effective. 

The SCAI report also states that among women and healthcare providers, there is a lack of recognition of heart problems and subsequent treatment, which results in women not receiving 

early medical intervention.2 This delay in recognition of heart irregularities by healthcare providers and women themselves indicates the need for additional action: 

• Educate all healthcare providers to know the signs and symptoms of a heart attack, 

including atypical symptoms specific to women 

• Educate women to know the signs and symptoms of a heart attack, including atypical 

symptoms specific to women 

• Evaluate healthcare provider adherence with guidelines for care, including use of percutaneous coronary intervention, ACE inhibitors, lipid-lowering therapy, and even aspirin 

• Improve and expand screening for low-income women at risk for heart disease and stroke 

Our national network of incredible, courageous patient volunteers, our WomenHeart Champions, in conjunction with the only national network of patient-led support groups for women 

with heart disease, stand ready to assist you in the fight against heart disease. 

We appreciate this opportunity to provide our recommendations and look forward to working 

with you. 

References 

1. Resnick, E., Marts, S., Hayes, S., Wood, S., Camp, A., Wenger, N., Berra, K. (2006). The 

10 Q report: Advancing women’s heart health through improved research, diagnosis, and 

treatment. Washington, DC: WomenHeart: The National Coalition for Women with Heart 

Disease and the Society for Women’s Health Research. 

2. Chieffo, A., Hoye, A., Mauri, F., Mikhail, G. W., Ammerer, M., Grines, C., Mehran, R.; WIN 

Group. (2010). Gender-based issues in interventional cardiology: A consensus statement from the Women in Innovations (WIN) Initiative. Catheterization and Cardiovascular Interventions, 75, 145–152. 

439
TESTIMONY PROVIDERS BY NAME

Aldrighetti, Rino, 5, 49

Allen, Rebecca, 252, 281

Altman, Rebecca Gasior, 253

Arndorfer, Elizabeth, 108, 191

Artal, Raul, 6, 62

Baebler, Sue, 6, 59

Bair, Yali, 108, 178

Baker, Aspen, 107, 141

Besinque, Kathleen, 107, 124

Bichler, Joyce, 107, 129, 130

Bingham, Debra, 107, 135

Bitner, Diana, 412, 423

Blades, Mary, 6, 51, 412, 430

Boles, Erin, 252, 298

Brody, Julia, 253, 319

Brown, Hugh, 108

Buki, Lydia, 355

Burlingham, William, 253, 347

Catanzaro, Rosemary B., 6

Catina OíLeary, 6, 76

Chisholm, Ken, 109, 246

Chosid, Claire, 7, 100

Christianson, Kari, 107

Cora, Maria, 108, 174

Cortes-Harkins, Michelle, 252

Daniels, Elvan Catherine, 412

Duprey, Kathie, 356, 410

Eddy, Cathy, 108, 194

Fenner, Dee, 355, 368

Fitzgerald, Colleen M., 356

Flaherman, Valerie, 109, 238

Fox, Sarah D., 253, 349

Fuentes, Liza, 252, 302

Fukuoka, Yoshimi, 109, 238, 239

Garcia, Keith S., 6

Gerber, Naomi Lynn, 355, 387

Ghosh, Debabrata, 107, 110

Gianino, Paula, 5, 46

Gillespie, Katie, 108, 202

Godfrey, Emily, 355, 374

Goldstein, Sue, 108, 168

Goodman, Suzan, 107, 126

Gordon, Rivka, 107, 127

Hayes, Ericka, 6
�

Hayes, Sharonne, 412, 420

Healton, Cheryl, 5, 107

Heislen, Ellen, 7, 101

Henderson, Frances, 412, 415

Henderson, Jeffrey, 6, 73

Ho, Kasha, 107, 132

Hollibaugh, Amber, 355, 389

Hong, Yuling, 412, 413

Honikman, Jane, 108, 184

Humphreys, Janice, 107, 151

Hurley, Kristian, 5, 10, 355, 357

Jacoby, Vanessa, 108, 206

Jain, Raksha, 6, 75

Janssen, Sarah, 108, 176

Johnson, Riley D., 355, 395

Kaplan, Jay, 412, 434

Karan, Lori, 107

Katzman, Wendy B., 109, 239

Kennedy, Holly, 252, 266

Kissling, Elizabeth, 356, 398

Koehlinger, Simone, 355, 377

Kokenyesi, Robert, 7, 102

Kristof, Margaret, 109, 238

Ladd, Virginia T., 252, 259

440
Lancaster, Christie, 253

Lavender, Missy, 7

Lawrence, E. Clinton, 412

Ledger, William J., 7, 91

Levine, Amy, 109, 236

Levine, Deb, 108, 172

Love, Susan, 252, 290, 355, 384

Luks, Francois, 253

Madhivanan, Purnima, 109, 207

Maffini, Maricel, 332

Maki, Pauline, 355, 393

Malone, Ruth, 109, 209

Marsh, Patricia, 7, 103

Martinez, Lisa, 356, 406

Matallana, Lynne, 5

McCann, Pamela, 355

McCarthy, Marlene, 253, 313

McCormick, Sabrina, 252

McDaniel, Patricia A., 109

McGuire, Jennifer, 355

McKee, Colleen, 7, 103

McQuillan, Julia, 253, 342

Miller, Virginia, 412, 426, 433

Mills, Dixie, 252, 290

Mosier, Laura, 108, 156, 164

Muller, Nancy, 252, 300

Murray, Jane, 7, 92

Nolan, Madeline, 5, 34

Norian, Lyse, 6

Norton, Nancy, 5

Nussbaum, Rhoda, 108, 186

Ortiz, Deborah, 108, 180

Paluzzi, Patricia, 252, 292

Pearlman, Deborah N., 252, 286

Perez, Nicole, 355, 372

Peterson, Linda, 6, 80, 90

Pfefferle, Susan, 6, 66

Pierce-Weeks, Jennifer, 108

Pomerleau, Mimi, 252, 283

Rassmussen, Betsy, 107

Rellini, Alessandra, 252, 294

Riley, Elise, 109, 214

Riley, Joan, 6, 81, 90

Rinaudo, Paolo, 109, 224

Riordan, Maura, 7, 98

Robertson, Patricia A., 109, 230

Roney, Lynne, 5

Rubaii, Diane, 7, 105

Russell, Stefanie, 253, 312

Sallam, Hassan, 108, 197

Santos, Beverly, 109

Sarantis, Heather, 107, 137

Saxton, Claire, 5

Scranton, Alexandra, 109

Secura, Gina, 6, 83

Semenkovich, Clay, 6, 81

Shepler, Lynn, 109

Silberman, Katherine, 253, 316

Simon, Viviana, 412, 432

Stern, Carolyn, 355, 378

Tate, Lisa M., 412

Thomas, Danielle, 107, 146

Tomar, Scott L., 252

Underwood, Diana Hankey, 5, 26

Vallone, Donna, 5, 16

Veasley, Christin, 5, 253

Volgman, Annabelle S., 356, 403

Webb, Aretha, 7, 105

Whinery, Megan, 5, 22

Willenberg, Loreen, 109, 242, 246

Wood, Susan, 5, 24

Woodruff, Tracey, 109, 230

Wright, Thomas C., Jr., 252, 272, 280

Zamanian, Roham, 108, 188

Zembo, Cynthia, 253, 333

441
TESTIMONY PROVIDERS BY ORGANIZATION
�

AAUW of Missouri, 5, 8
�

All India Institute of Medical Sciences, 107, 

110
�

American Association of Public Health 

Dentistry, 252, 255, 258
�

American Autoimmune Related Diseases 

Association (AARDA), 11, 259, 355, 357
�

American College of Nurse-Midwives, 252
�

American Legacy Foundation, 5, 16, 18-20, 

107, 111, 113-116
�

American Psychological Association, 144, 

149, 355, 365, 367
�

American Society for Colposcopy & Cervical 

Pathology, 252, 272, 280
�

American Society of Addiction Medicine, 

107, 116, 123
�

American Urogynecologic Society, 26, 355, 

368
�

Amigas Latinas, 355, 372
�

Association of Reproductive Health 

Professionals (ARHP), 124, 126, 127, 281, 

355, 374
�

Association of Reproductive Health 

Professionals and USC School of 

Pharmacy, 107
�

Bladder Cancer Advocacy Network, 5, 21
�

Breast Cancer Action, 107, 129, 130, 132, 319
�

California Healthy Nail Salon Collaborative/
�

Breast Cancer Action, 107, 132
�

California Maternal Quality Care 

Collaborative, 107, 135
�

Center for Hispanic Policy & Advocacy, 252, 

287, 289
�

Centers for Disease Control and Prevention, 

16, 19, 20, 47, 68, 83, 111, 114, 115, 126, 154, 

159, 167, 168, 192, 193, 211, 212, 219, 235, 

241, 242, 248, 256, 271, 275, 279, 280, 

282, 301, 319, 323, 324, 327, 330, 332, 

337, 338, 378, 389, 410, 412, 413, 415
�

Chicago Department of Public Health, 355, 

377
�

Commonweal, 107, 137, 176
�

DeafDOC.org, 355, 378, 380
�

DES Action USA, 107, 138
�

Dr. Susan Love Research Foundation/Army 

of Women, 252, 290, 355, 384
�

Endometriosis Association, 5, 22-24, 107, 

140, 141
�

Exhale, 107, 141-144, 146-149, 151
�

George Mason University, 355, 387
�

Grace Anatomy, Inc., 5, 26, 29
�

Group of Concerned Nurse-Researchers, 107
�

Healthy Teen Network, 252, 292
�

HIV/AIDS Services for African Americans in 

Alaska, 108
�

Howard Brown Health Center, 355, 374, 389
�

Indiana State Department of Health, 108, 

156, 159, 160, 162
�

International Association of Forensic 

Nurses, 108, 164
�

International Foundation for Functional 

Gastrointestinal Disorders, 5, 29, 30
�

International Society for the Study of 

Women’s Sexual Health, 108, 168, 172, 

252, 294
�

ISIS, Inc. (Internet Sexuality Information 

Services), 108, 172
�

Jackson Heart Study, 412, 415-420
�

442
LAM Foundation, 5, 34 

Lesbian Health & Research Center at the 

University of California, San Francisco, 

108
�

Massachusetts Breast Cancer Coalition, 252, 

298, 299, 319
�

Mayo Clinic and Foundation, 412, 420, 433
�

Michigan State University College of Human 

Medicine, 412, 423
�

Morehouse School of Medicine, 412, 425
�

National Association for Continence, 26, 29, 

252, 300
�

National Fibromyalgia Association, 5, 35, 

37, 38
�

National Fisheries Institute, 355, 391
�

National Latina Institute for Reproductive 

Health, 252, 302
�

National Vulvodynia Association, 5, 38, 41, 

42, 253, 305, 306, 310
�

Natural Resources Defense Council, 108, 176
�

New York University College of Dentistry, 

253, 312
�

North American Menopause Society 

(NAMS), 93, 355, 393
�

Planned Parenthood Mar Monte, 108, 180, 

181
�

Planned Parenthood of the St. Louis Region 

and Southwest Missouri, 5, 46
�

Postpartum Support International, 108, 184, 

185
�

Prevention International: No Cervical 

Cancer, 108, 186, 187
�

Pulmonary Hypertension Association, 5, 49-

51, 108, 188, 189, 191, 412, 426, 427, 429
�

Queer People’s Health Collective, 355, 395
�

Rehabilitation Institute of Chicago, 356, 397, 

398
�

Reproductive Health Technologies Project, 

108, 182, 191
�

Rhode Island Breast Cancer Coalition, 253, 

313
�

Science & Environmental Health Network, 

253, 316
�

Scleroderma Foundation, 6, 51, 52, 108, 194, 

196, 412, 430, 431
�

Scleroderma Foundation, Northern 

California Chapter, 108, 194
�

Silent Spring Institute, 253, 299, 319, 320, 

323
�

Society for Menstrual Cycle Research, 356, 

398, 402
�

Society for Women’s Health Research, 6, 54, 

58, 412, 432, 433, 437, 439
�

St. Louis Breast Cancer Coalition, 6, 59
�

St. Louis University, 2, 6, 62
�

The George Washington University School 

of Public Health and Health Services, 5
�

The Suzanne Mubarak Regional Center for 

Women’s Health and Development, 108, 

196
�

The Warren Alpert Medical School of Brown 

University, 252, 253, 349, 352
�

The Women’s Sexual Health Foundation, 

356, 406-409
�

Tufts University, 253, 299, 319, 325, 332
�

Tufts University School of Medicine, 253, 

332
�

UCSF-Kaiser BIRCWH Program, 109
�

United States Breastfeeding Committee, 

253, 333, 337
�

University of Arizona, 108, 202
�

University of California, San Francisco, 2, 

107-109, 138, 142, 147, 174, 176, 180, 184, 

206, 207, 209, 214, 224, 225, 230, 236, 

240, 292, 386
�

University of Iowa College of Medicine, 6, 

64
�

University of Michigan, 253, 307, 339
�

University of Nebraska-Lincoln, 253
�

443
University of Wisconsin, 253, 347
�

Wake Forest University School of Medicine, 

412, 434
�

Washington University Pediatric HIV 

Program, 6, 67
�

Washington University School of Medicine, 

6, 69, 73, 75, 76, 80, 81, 83, 86-88
�

Washington University, George Warren 

Brown School of Social Work Research, 

6, 66
�

Weill Medical College of Cornell 

University, 7, 91
�

Women in Balance, 7, 92
�

Women Organized to Respond to LifeThreatening Diseases (WORLD), 7
�

Women’s Health Foundation, 7, 29, 96, 98
�

Women’s Voices for the Earth, 109, 240
�

WomenHeart: The National Coalition for 

Women with Heart Disease, 356, 403, 

412, 421, 437, 439
�

Zephyr L.T.N.P. Foundation, Inc., 109, 242, 

246
�

444
 
SUBJECT INDEX

acculturation, 287, 289 

Acquired Immune Deficiency Syndrome 

(AIDS), 14, 47, 68, 98-100, 105, 108, 152, 

155, 166, 167, 170, 181, 197, 209, 215, 219-

223, 242, 243, 245, 246, 287, 295-297, 

363, 365, 389, 416 

acupuncture, 349 

addiction, 55, 107, 116-124, 210, 214, 350, 387, 

388 

adjuvant therapy, 407 

adolescence, 67-69, 90, 102, 117, 118, 154, 167, 

180, 197, 212, 214, 225, 254, 272-278, 280, 

292, 302, 303, 305, 306, 309, 311, 332, 

367, 401 

African-American(s), 10, 16, 21, 40, 48, 76, 

92, 97, 99, 104, 106, 111, 135, 140, 155, 194, 

212, 215, 218, 260, 263, 264, 266, 267, 

269, 306, 307, 317, 358, 361, 362, 364, 

415, 416, 420 

age-related macular degeneration, 391 

aging, 24, 90, 98, 175, 226, 227, 230, 239, 

240, 243, 300, 316-318, 366, 394, 397, 

401, 424 

Alaska Native(s), 16, 111, 327, 328, 331 

alcohol use, 77, 118, 216, 390 

alcoholism, 76, 387 

allergies, 40 

alternative medicine, 37 

Alzheimer’s disease, 55, 175, 318 

American Indian, 16, 111, 203, 209, 367 

angina, 432 

anorexia nervosa, 55, 121 

antidepressant(s), 41, 70, 72, 104, 121, 226, 

295, 298, 339-341 

antiretroviral therapy, 214, 215, 217, 220-222, 

274 

anxiety disorder(s), 55, 120, 184, 222, 367, 

394 

aromatase inhibitors, 407, 409 

arthritis, 11, 14, 36, 37, 55, 75, 76, 226, 247, 

261, 262, 265, 334, 337, 360, 363, 364 

Asian(s), 10, 174, 197, 209, 238, 367, 368 

aspirin, 12, 53, 439 

assisted reproductive technologies, 83 

asthma, 34, 75, 122, 130, 132, 137, 182, 193, 

316, 317, 333, 417, 420 

atherosclerosis, 415, 416, 434, 435 

autoimmune disease, 10-15, 53, 55, 89, 259, 

260, 262-265, 348, 357, 358, 360-364 

back pain, 40, 310 

bioengineering, 433 

biomarker(s), 12, 66, 233, 264, 276, 281, 362, 

422, 436 

biomedical 

careers, 1, 25, 87 

bisexual, 16, 18, 111, 113, 174, 176, 225, 365, 

366, 372, 377, 378, 389, 390, 395, 396 

bladder cancer, 5, 21, 22 

blood 

clot(s), 12, 49, 61, 188, 315, 400, 402, 427 

disease(s), 61, 315 

body mass index, 160, 227, 228, 416, 417 

bone 

density, 171, 401, 436 

brain, 27, 38, 41, 55, 88, 101, 116-118, 121, 170, 

254, 257, 258, 293, 317, 333, 391, 399 

breast cancer, see ìcancersî 

screening, 132, 199, 394 

445
breastfeeding, 70, 72, 127, 238, 239, 253, 

262, 267, 285, 304, 333-338, 360 

Building Interdisciplinary Research Careers 

in Women’s Health (BIRCWH), 24, 64, 

65, 73, 74, 80-82, 86-91, 109, 238-240, 

397, 398 

calcium, 416, 427 

cancer(s) 

bladder, 5, 21, 22 

breast, 6, 10, 17, 18, 48, 52, 55, 59-61, 100, 

105, 107, 112, 114, 129-132, 134, 139, 140, 

170, 171, 181, 182, 191, 192, 194, 198, 200, 

209-211, 228, 238, 252-254, 290, 292, 

296, 298, 299, 313-315, 317-325, 331, 

332, 334, 384, 386, 400, 407-409, 

424, 434 

cervical, 48, 56, 108, 186-188, 198, 243, 

257, 272-275, 278, 280, 281, 390, 413, 

434 

colon, 30, 210, 213, 228 

colorectal, 424 

endometrial, 55, 228, 434 

lung, 16-18, 20, 56, 75, 112, 113, 115, 209-

211, 213, 228, 387 

ovarian, 139, 228, 238, 318, 334 

uterine, 30, 171, 209 

cardiovascular disease, 12, 55, 89, 209, 269, 

286-288, 312, 334, 337, 394, 403, 404, 

413, 415-419, 421, 422, 425, 426, 432-434, 

437, 438 

caregiver(s), 21, 105, 169, 203, 268, 340 

caregiving, 8 

Caucasian, 10, 21, 40, 92, 140, 226, 290, 306, 

385 

cervical cancer, 48, 56, 108, 186-188, 198, 

243, 257, 272-275, 278, 280, 281, 390, 

413, 434 

chemotherapy, 100, 299, 319, 407, 408 

chest pain, 49, 189, 422, 423, 427 

childbirth, 26, 28, 29, 66, 69, 110, 136, 137, 

266-268, 271, 272, 304, 311 

childhood, 31, 40, 44, 76, 118, 121, 137, 152, 

154, 165, 167, 168, 181, 192, 210, 222, 226, 

231, 254, 309, 316, 317, 333, 334, 338, 

365, 367, 425 

chlamydia, 47, 48, 67, 69, 76, 77, 83, 86 

cholesterol, 27, 193, 287, 413, 416, 417 

chronic 

fatigue syndrome, 40, 101, 102, 248, 306, 

307 

illness, 31, 33, 333, 381, 387, 399, 402 

obstructive pulmonary disease, 75, 209, 

228 

pain syndromes, 122 

clinical trial(s), 42, 54, 59-61, 128, 168, 169, 

207, 208, 239, 242, 243, 245, 246, 267, 

274, 280, 290, 313-315, 353, 367, 384, 

388, 394, 399-401, 403-406, 435, 438 

colon cancer, 30, 210, 213, 228 

colorectal cancer, 424 

complementary and alternative medicine, 

37 

computed tomography, 416 

contraception, 46-48, 85, 168, 171, 268, 282, 

283, 293, 302, 303, 342, 343, 375, 376, 

401, 402 

coronary 

artery disease, 432 

heart disease, 224, 406, 415, 417, 420, 

434, 436 

cytokine(s), 41, 44, 82, 245 

cytomegalovirus, 101 

cytotoxicity, 82 

dementia, 394 

dental and oral health, 163, 255-258, 312, 313 

depression, 52, 55, 66, 69-73, 76, 77, 87, 89, 

101, 103, 104, 122, 153, 169, 171, 174, 184, 

185, 196, 210, 217, 221, 226, 227, 229, 268, 

271, 303, 307, 334, 339-341, 349, 366-

368, 373, 374, 391-394, 422, 431, 439 

DES exposure, 126, 138, 139, 262, 360 

446
diabetes, 14, 30, 36, 55, 62, 64, 66, 76, 83, 

87, 89, 96, 105, 137, 156-161, 163, 164, 192, 

193, 202, 224, 226, 227, 256, 259, 260, 

265, 266, 269, 287, 312, 318, 332-335, 

339, 354, 357, 358, 363-365, 369, 381, 

413, 417, 424, 434, 436 

diet, 62-64, 130, 287, 299, 320, 391, 392, 416, 

424 

diethylstilbestrol, 138, 233, 262, 321, 330, 

360, 402 

digestive diseases, 30, 34 

dioxins, 140, 317, 321 

disadvantaged populations, 20, 115, 116 

disasters, 82, 347, 401 

discipline, 353, 354, 399 

disparity, 75, 154, 167, 206, 245, 259, 270, 

287, 357, 390, 415 

distress, 217, 242, 284, 285, 296, 344-346 

diversity, 1, 9, 59, 92, 180, 187, 203, 230, 236-

238, 303, 305, 313, 378, 380, 390, 393, 

399, 402, 425 

DNA repair, 56 

drinking, 76, 79, 320, 321, 325, 327, 387 

drug abuse, 55, 76, 122, 226 

dysmenorrhea, 23, 308, 351 

dyspareunia, 23, 311, 407 

E. coli, 90 

early detection, 14, 24, 198, 199, 256, 257, 

263, 265, 277, 319, 362, 363, 387, 403, 

404, 413 

early-onset, 75 

eating disorders, 116, 120, 121, 124, 366 

eclampsia, 199 

ectopic pregnancy, 47, 139, 209 

education and training, 174, 187, 282, 283, 

375, 376, 403 

elderly, 30-33, 228, 233, 388, 422 

embryo, 202, 316 

embryos, 224, 330 

emotion, 31, 147 

emotions, 142, 144, 147, 149 

employment, 19, 115, 123, 154, 167, 210, 216, 

228, 249, 293, 294, 366, 381, 410, 422 

endocrine-disrupting, 126, 129, 176, 177, 192, 

232, 234, 316, 320, 327, 329, 332 

endocrine-mediated, 321 

endocrinology, 10, 110, 420, 434 

endometrial cancer, 55, 228, 434 

endometriosis, 5, 22-24, 28, 40, 107, 110, 140, 

141, 177, 178, 191, 193, 199, 202, 233, 306, 

326, 349, 351, 401 

endometrium, 141 

environment, 2, 32, 65, 82, 86, 87, 90, 125, 

127, 129, 131, 137, 147, 176, 178, 181, 182, 192-

194, 211, 216, 217, 221, 230-232, 234, 240, 

241, 254, 259, 260, 299, 316, 318, 319, 

323-332, 353, 354, 358, 389, 414, 435 

environmental 

estrogens, 262, 266, 360 

factors, 13, 54, 58, 218, 235, 241, 254, 260, 

261, 316-318, 320, 358, 359, 435 

epidemiology, 36, 43, 66, 76, 89, 123, 186, 

206, 213, 222, 223, 240, 243, 264, 276, 

278, 291, 292, 319, 323, 324, 331, 362, 371, 

385, 386, 392, 393, 404, 415, 420, 421, 

433 

epigenetics, 141, 232, 233, 354, 432 

epilepsy, 379 

episiotomy, 33, 267 

Epstein-Barr virus, 101 

equality, 154, 167 

estradiol, 83, 93, 94, 96, 171, 407, 409, 435 

ethnic diversity, 180 

ethnicities, 24, 226, 236 

etiology, 39, 41, 75, 117, 208, 249, 254, 290, 

322, 326, 384, 398, 421, 422 

evidence-based, 41, 42, 47, 84, 121, 125, 127, 

129, 135-137, 156, 165, 169, 174, 186, 197, 

268-270, 272, 275, 281-285, 287, 297, 322, 

335, 336, 340, 350, 374-376, 390, 423, 

432 

447
extramural, 250, 251

family history, 104, 185, 299, 331, 416, 418, 

429 

fatty, 328, 391-393 

feasibility, 342, 377, 413 

fecal, 27, 28, 30-34, 368 

fecundity, 128, 235, 330, 343, 345 

fellowships, 86 

female 

fertile, 82, 344 

fertility, 83, 138-140, 173, 177, 180-183, 191, 

193, 194, 200, 209, 226, 234, 235, 319, 

325-327, 329, 330, 332, 342-346, 349, 

436 

fetus, 62, 82, 192, 224, 316, 317, 326, 391, 421 

fibromyalgia, 5, 35-38, 351 

fibrosis, 15 

foundations, 95, 298 

functional gastrointestinal disorders, 5, 29, 

30 

gastroenterology, 10, 33, 213, 266, 349, 364 

gender 

equity, 236, 237 

gender-related, 117 

gendered, 211 

genders, 34, 49, 189, 417, 427 

gene 

therapy, 429 

genetic 

genitalia, 169, 170, 297, 377 

genitourinary, 67 

genomics, 420 

gestation, 82, 284, 348 

gestational diabetes, 62, 64, 83, 202, 312, 

339 

global health, 151, 152, 165, 208, 211, 214 

government-funded, 332 

governmental, 21, 175, 178, 236, 333, 373 

gynecologic cancer(s), 280 

gynecology, 26, 28, 34, 43-45, 62, 64, 71, 

81, 90, 129, 137, 197, 201, 206, 207, 225, 

230, 243, 266, 271, 277-279, 281, 310, 311, 

337, 349, 351, 352, 364, 371, 395, 396, 

434, 436 

hands, 26, 53, 100, 195, 196, 232, 234, 430 

harassment, 226 

hard-of-hearing, 379, 380, 383 

hazard, 127, 430 

hazards, 126, 127, 129, 133 

HDL, 424 

headache, 40, 53 

health 

behavior(s), 180, 221, 289, 305 

care, 1-3, 19, 26, 29, 46-48, 57-59, 66, 86, 

102-105, 115, 119, 123, 124, 128, 133, 135, 

136, 141, 146, 154, 162, 164, 167, 169, 171, 

172, 174, 178-180, 193, 194, 203, 211, 

215-217, 221-223, 225, 230, 236, 237, 

245, 257, 269, 278, 283, 287, 288, 297, 

303-305, 313, 315, 339, 340, 365, 368, 

370, 372, 373, 375, 376, 381-383, 388-

390, 400, 402, 420, 422, 424 

careers, 238, 380, 382 

disparities, 48, 153, 166, 174, 175, 178, 179, 

185, 203, 205, 210, 218, 236, 237, 258, 

269, 283, 289, 297, 302-304, 366-368, 

373, 374, 376, 378, 380, 381, 399, 402, 

415 

literacy, 202, 205, 287, 288, 366, 368, 

381, 425 

promotion, 19, 20, 25, 114, 115, 211, 255, 

287, 365, 366, 418 

statistics, 19, 114, 115, 193, 235, 270, 271, 

346 

hearings, 2, 194, 365 

heart 

attack(s), 12, 54, 87, 296, 403, 404, 438, 

439 

448
disease, 16, 54, 57, 61, 66, 80, 81, 93, 96, 

112, 117, 152, 165, 171, 192, 224, 226, 239, 

256, 286, 287, 315, 332, 354, 356, 381, 

391, 399, 402, 403, 405, 406, 412, 413, 

415, 417, 420-424, 427, 434, 436-439 

hematology, 10 

hemorrhage, 135 

hepatitis, 11, 14, 76, 77, 217, 220, 222, 265, 

363, 389 

hernia, 353 

herpes simplex virus, 67 

Hispanic, 10, 40, 203, 209, 252, 273, 287, 

289, 306, 344, 345, 351, 368 

HIV/AIDS, 98-100, 108, 155, 167, 197, 215, 219, 

221-223, 242, 243, 287, 296, 297 

holistic, 79, 208, 295, 377 

homelessness, 214-218, 220 

homicide, 366 

homosexual, 378 

hormone 

replacement therapy, 61, 75, 261, 308, 

319, 320, 360, 364, 436 

therapy, 61, 92, 93, 95, 96, 170, 261, 308, 

319, 320, 360, 364, 394, 399, 400, 

402, 432, 435, 436, 439 

hormones, 12, 23, 54, 55, 83, 92-96, 116, 140, 

171, 232, 243, 256, 261, 262, 320, 324, 

326, 359, 360, 399-402, 406-408, 432, 

435 

hospitalization(s), 135, 137 

hotline, 242 

human 

hurricane, 105 

hypercholesterolemia, 417 

hyperglycemia, 90 

hyperplasia, 201 

hypertension, 5, 49-51, 96, 108, 188-191, 226, 

227, 318, 394, 412, 415, 417, 419, 421, 426-

429, 433 

hypertrophy, 415 

hypnosis, 267 

hypothalamus, 101 

hysterectomy, 28, 191, 206, 349, 351, 370 

imaging, 36, 58, 80, 88, 90, 199, 292, 386, 

416, 420, 422 

immigration, 289, 302, 303, 373 

immune 

function, 83, 243 

response, 82, 83, 244, 410 

immunization, 337, 348 

implant, 379, 380 

impoverished, 215, 216, 218, 219 

Indian(s), 16, 111, 203, 209, 367 

induction, 45, 135, 267, 336, 364 

inequality, 219, 224 

inequity, 302 

infancy, 192, 197, 254 

infectious disease, 68, 90, 91, 102, 207, 219, 

248 

infertility, 23, 27, 47, 84, 87, 134, 137, 139-141, 

152, 166, 181, 192, 199, 233, 259, 262, 263, 

318, 325, 326, 329, 330, 332, 342-346, 

357, 361, 434, 436 

information technology, 172, 179, 180, 198 

insomnia, 104, 122, 184, 349 

institutionalization, 31, 32 

insulin 

resistance, 433 

interstitial cystitis, 35, 40, 44, 122, 306, 351 

intolerance, 15 

intramural, 38, 323 

ischemic 

heart disease, 152, 165 

Japanese, 92 

labor and delivery, 91, 92, 136, 267 

lactation, 63, 72, 259, 262, 333-337, 357, 360 

laparoscopy, 23 

Latina(s), 48, 99, 135, 215, 218, 238, 252, 

287-289, 302-305, 355, 367, 372, 373 

449
Latino(s), 173, 182, 183, 236, 287-289, 302-

304, 367, 372 

LDL, 424 

legislation, 19, 114, 178-180, 293, 383 

leptin, 417 

lesbian, 16, 18, 108, 111, 113, 119, 174-176, 225-

230, 365, 366, 372, 377, 389, 390, 395, 

396 

leukemia, 10, 257, 333 

life span, 1, 24, 26, 50, 54, 58, 117, 152, 165, 

190, 207, 208, 233, 266, 269, 270, 288, 

305, 319, 322, 334, 339, 365, 366, 388, 

399, 402, 419, 428, 433, 434, 436, 439 

lifestyle factors, 287, 299, 416 

liver disease, 49, 189, 332, 427 

longevity, 134, 395 

low 

birth weight, 192, 194, 209, 210, 326 

literacy, 288 

low-grade squamous intraepithelial lesion 

(LSIL), 272 

lung cancer, 16-18, 20, 56, 75, 112, 113, 115, 

209-211, 213, 228, 387 

lupus nephritis, 263, 264, 266, 361, 362, 364 

lymphangioleiomyomatosis, 34 

macular degeneration, 391, 392 

magnetic resonance 

imaging (MRI), 416 

mammogram(s), 199, 373, 388, 394 

mapping, 368 

marijuana, 77 

married women, 210 

massage therapy, 349 

mast cells, 41 

Medicaid, 46, 47, 257, 258, 303, 370, 388, 

437 

Medicare, 105, 135, 196, 257, 370, 388, 437 

memory, 100, 101, 394 

menarche, 40, 191, 231, 325, 331 

menopause, 12, 21, 55, 92-96, 139, 140, 170, 

200, 202, 209, 226, 255, 261, 312, 326, 

355, 359, 393-395, 399-402, 407, 434, 

436 

menstrual cycle, 23, 117, 256, 356, 398, 399, 

401, 402 

menstruation, 21, 23, 140, 256, 307, 398-402 

mental health, 34, 66, 69, 71-73, 123, 124, 

142, 144, 145, 147, 149, 150, 173, 175, 184, 

185, 216, 222, 227, 228, 268, 339-341, 

365-367, 372, 373, 392, 396 

mentoring, 61, 73, 80, 87, 89, 237, 240, 314, 

423 

metabolic syndrome, 334, 337, 417, 424, 433 

metabolism, 64, 89, 90, 232, 235, 322 

metals, 13, 126, 176, 260, 317, 318, 328, 358 

metastasis, 82 

Methadone, 77 

microbicides, 100 

microchimerism, 347, 348, 364 

migraine, 12, 40, 310 

migration, 347 

minority, 18, 19, 43, 71, 103, 113, 114, 119, 174, 

175, 218, 222, 226, 229, 236, 237, 259, 

263, 264, 268, 287, 289, 291, 303, 305, 

335, 353, 357, 361, 362, 369, 385, 390, 

415 

misdiagnosis, 14, 23, 38, 40, 265, 305, 363 

mobility, 239, 240 

mood disorder(s), 69, 120, 122, 184, 340 

motherhood, 22, 72, 340 

motility, 30, 193 

multidisciplinary, 41, 65, 90, 168, 178, 185, 

234, 263, 268, 280, 281, 319, 339, 349, 

352, 353, 361, 374, 408, 409, 420, 421 

multigenerational, 177, 327 

multinational, 187 

450
multiple sclerosis, 11, 14, 15, 30, 55, 247, 259, 

260, 264-266, 357, 358, 362-364 

murine models, 263, 361 

myasthenia gravis, 11, 14, 265, 363 

myeloma, 105 

Native American, 10, 335, 344 

nerves, 50, 190, 428 

neurobiological, 121 

neurodevelopment, 231 

neuropeptides, 116, 117 

neuroscience, 436 

neurosurgery, 265 

neurotoxins, 235 

newborn, 177, 201, 285 

nicotine, 17, 112, 117, 118, 210, 213 

non-Hodgkin lymphoma, 10 

norethindrone, 93 

nuclear, 88 

nurse-midwives, 252 

nurse-researchers, 107 

nutrition, 63, 64, 89, 156-158, 160, 173, 175, 

224, 231, 256, 287, 288, 335, 337, 351, 

365, 391-393, 419 

obesity, 55, 62-64, 66, 80, 81, 83, 89, 96, 

104, 121, 160, 174, 193, 287, 301, 318, 319, 

333, 335, 349, 354, 390, 417, 424, 434 

obstetrics, 34, 43-45, 62-64, 71, 81, 90, 96, 

129, 135-137, 197, 201, 206, 207, 225, 230, 

243, 266, 271, 277-279, 281, 310, 311, 337, 

339, 341, 351, 352, 364, 371, 398, 434, 

436 

oophorectomy, 206 

oral 

contraceptives, 43, 85, 209, 269, 295, 

401, 402, 426 

health, 163, 255-258, 312, 313 

orphans, 28 

orthopedic, 246 

osteoarthritis, 36, 57 

osteoporosis, 87, 89, 90, 312, 365, 397, 434 

ovarian 

cancer, 139, 228, 238, 318, 334 

failure, 178, 325 

function, 434 

overweight, 62, 63, 81, 121, 130, 156-158, 160, 

287, 390, 417 

ovulation, 400 

ovulatory, 432 

pain threshold, 43 

pap test, 276 

papilloma, 387 

papillomavirus, 48, 198, 243, 272, 277-280, 

437 

Parkinson’s disease, 55, 317 

pathogenesis, 243, 259, 357 

Pathologist, 28, 292, 386 

pathophysiology, 41, 122, 171, 264, 353, 362, 

421 

patient-centered, 58, 403, 405, 424, 437 

pelvic floor disorders, 300, 368, 370 

perimenopause, 399, 423, 424 

perinatology, 235, 269 

periodontal disease, 256 

periodontitis, 256, 312 

Personalized Medicine, 264, 348, 362, 387 

pharmacists, 92, 93, 125, 127, 129, 197, 303 

pharmacogenomics, 89 

pharmacology, 72, 298 

pharmacotherapy, 17, 112 

phenotyping, 90 

phthalates, 126, 192, 235, 241, 317, 321, 324, 

327, 330 

physical 

abuse, 76, 106, 217, 226 

activity, 97, 98, 130, 156-158, 160, 239, 

320, 365, 389, 416, 425 

phytoestrogens, 176 

placenta, 82, 118, 126, 326 

451
pollutants, 140, 141, 176, 240, 318-328, 331 

pollution, 138, 192, 193, 317, 319, 320, 322, 

325, 329, 331 

polymorphisms, 41, 92 

positron emission tomography, 88, 90 

postmenopausal women, 75, 93, 95, 119, 130, 

171, 308, 393, 394, 409, 435 

postpartum depression, 66, 70-73, 185, 271, 

334, 341, 367 

posttraumatic stress disorder, 120, 122, 153, 

268, 269, 296, 366 

preeclampsia, 62, 82, 83, 320 

pregnancy, 12, 16, 27, 47-49, 62-64, 66, 67, 

69-72, 78, 82, 83, 85, 87, 89, 92, 97, 100, 

110, 112, 118, 128, 137-140, 142, 146, 151, 152, 

166, 173, 179, 180, 185, 189, 191-193, 201, 

202, 208, 209, 226, 228, 231, 255, 256, 

259, 261-263, 266, 268, 269, 271, 273, 

279, 282, 283, 286, 292-295, 302, 310-

312, 316, 318, 321, 326, 330, 338, 339, 

341-345, 348, 357, 359-361, 364, 366, 

374, 376, 391-393, 397, 398, 421, 426, 427, 

433, 439 

premature ovarian failure, 178 

prematurity, 92, 192, 285 

prenatal, 71, 138, 177, 181, 219, 235, 262, 267, 

269, 271, 285, 324, 339, 360 

prescription drugs, 122, 124, 348, 366 

prescriptions, 104 

preterm birth, 87, 208, 235, 267, 271, 282, 

283, 285, 312 

progesterone, 27, 75, 82, 83, 92-95, 141, 394, 

436 

progestin, 95, 96, 399, 400, 402, 434 

proteomics, 233 

psychiatric disorders, 71, 76, 120 

psychiatrist, 248, 249 

psychologist, 246 

psychosocial 

stress, 268 

puberty, 9, 116, 140, 177, 181, 182, 191, 194, 231, 

235, 255, 256, 261, 312, 319, 326, 330, 426 

public 

health, 2, 5, 16, 17, 19, 20, 24, 69, 71, 83, 

85, 91, 111-119, 123, 125, 127, 129, 130, 

132, 135, 156, 158, 159, 163, 164, 168, 

174-176, 183, 185-188, 193, 197, 202, 207, 

208, 211-213, 215, 217, 218, 220, 221, 

223, 224, 242, 252, 254, 255, 258, 275, 

288, 292, 293, 297, 299, 301, 302, 304, 

316, 319, 321, 322, 328, 331, 333, 338, 

339, 346, 354, 355, 377, 395, 396, 401, 

413-415, 418, 419 

policy, 2, 48, 59, 99, 174, 176, 178, 281, 

301, 313, 314, 316, 365, 374, 399 

pulmonary disease, 49, 75, 188, 209, 228, 

427 

quality of 

care, 136 

life, 30, 31, 34-36, 38, 42, 43, 49, 75, 102, 

156, 161, 171, 189, 205, 216, 226, 227, 

230, 248, 256, 257, 259, 287, 295, 296, 

298, 310, 349-351, 357, 365, 369, 370, 

393, 397, 403, 405, 406, 409, 418, 

423-425, 427, 429, 432 

racial and ethnic groups, 129, 365, 367 

radiation, 13, 261, 359, 397, 422 

radiology, 398 

raloxifene, 436 

regenerative medicine, 236 

rehabilitation, 356, 388, 397, 398, 422 

relaxation, 170, 341 

religion, 148 

reproduction, 82, 102, 119, 179, 199, 200, 202, 

209, 230, 263, 266, 325, 326, 332, 345, 

361, 439 

reproductive 

age, 134, 143, 148, 306, 336, 346 

cancer, 18, 114, 139 

function, 179, 231 

452
health, 24, 46, 47, 83, 107, 108, 124-129, 

133, 134, 137, 138, 140-142, 144, 147, 149, 

152, 166, 172, 173, 176-183, 191-193, 206-

208, 224, 230-232, 234, 235, 241, 252, 

259, 281-283, 287, 302-305, 316, 325, 

326, 328-330, 332, 346, 355, 374-376, 

399 

resiliency, 118, 145, 151, 174 

retirement, 237 

rheumatism, 35, 265, 337, 364 

rheumatoid arthritis, 11, 14, 36, 55, 75, 261, 

262, 265, 334, 337, 360, 363, 364 

rheumatology, 10, 35, 36, 53, 265, 363, 364, 

398 

risk factors, 13, 32, 39, 40, 42, 43, 57, 68, 99, 

117, 152, 155, 165, 179, 215, 218, 239, 254, 

260, 285, 287, 297, 308-310, 325, 335-

337, 358, 371, 392, 395, 413, 415, 416, 418, 

421, 432, 433 

Salaries, 382 

Salary, 64, 65, 87, 104, 382 

schizophrenia, 193 

scholars, 24, 65, 80, 86-91, 168, 180, 206, 

224, 238, 374, 419 

scholarship, 237, 338, 372, 398 

school-based, 17, 112 

science-based, 231, 288, 392 

scleroderma, 6, 11, 14, 49, 51-53, 108, 188, 

194-196, 265, 348, 363, 412, 427, 430-432 

sclerosis, 11, 14, 15, 30, 55, 247, 259, 260, 

264-266, 357, 358, 362-364 

secondhand smoke, 16, 18, 112, 114, 210 

sedentary, 239, 287 

self-care, 98, 125, 238, 289, 327, 328 

self-management, 156 

sepsis, 285 

sex 

and gender differences, 54, 55 

bias, 12, 261, 359 

hormones, 116, 261, 359, 399, 402, 406-

408, 432 

sexual 

abuse, 76, 122, 217, 226, 296, 297 

assault, 217, 303 

behavior, 44, 216, 294, 295, 311, 374, 377, 

396 

orientation, 120, 175, 227, 228, 373, 377, 

378, 390, 396 

sexually transmitted 

diseases (STDs), 46, 47, 77, 86, 118, 153, 

166, 219, 221, 222, 345, 374, 389, 390 

infections (STIs), 47, 48, 67-69, 152, 166, 

173, 207, 217, 218, 226, 228, 276, 283, 

297, 302, 365, 376, 378 

shortness, 49, 189, 195, 427 

siblings, 347 

single 

Sjögren's syndrome, 11, 14, 265, 363 

sleep 

disturbances, 37, 423 

smoker, 17, 112, 212 

smoking, 16-20, 56, 75, 111-115, 156, 157, 198, 

209-214, 226, 228, 257, 269, 285, 287, 

335, 388, 390, 413, 416, 417, 424 

spirituality, 226 

statin(s), 404 

stem cells, 179, 232, 236, 429, 432 

steroid hormones, 55, 83, 93 

stress, 27, 68, 70, 97, 104, 116, 117, 119-122, 141, 

153, 210, 222, 223, 226, 268, 296, 300, 

301, 318, 325, 353, 354, 366, 369, 371, 

373, 394, 416, 417 

stroke, 12, 38, 55, 57, 61, 170, 256, 315, 400, 

405, 413, 415, 417, 420, 439 

substance abuse, 76, 77, 117, 120, 123, 124, 

152, 165, 174, 222, 226, 227, 269, 365, 378, 

395 

sudden infant death syndrome (SIDS), 333 

suicide, 28, 69, 71, 153, 166, 174, 184, 209, 

228, 366, 390, 395, 422 

supplement, 229, 305, 396 

453
surgeon(s), 18-20, 27, 28, 113-115, 144, 149, 

168, 211, 213, 258, 290, 312, 347, 370, 384, 

409 

systemic lupus erythematosus, 11, 260, 265, 

358, 360, 364 

T cell, 348 

tamoxifen, 407 

temporomandibular joint and muscle 

disorders, 40, 41 

testosterone, 93, 169-171, 192, 261, 359 

therapist(s), 28, 104, 239, 240, 264, 362, 397 

tobacco 

cessation, 17, 112 

control, 16, 17, 111-113, 211-214 

products, 17, 18, 113, 114, 211 

tomography, 88, 90, 416 

toxin(s), 125, 131, 134, 140, 141, 179, 182, 235, 

254, 298, 299 

transgender, 16, 18, 111, 113, 174, 176, 225, 365, 

367, 372, 377, 378, 389, 390, 395, 396 

transgenerational, 233, 330 

translational research, 80, 237, 405, 438 

transplant, 49, 189, 196, 347, 348, 427, 428 

twins, 13, 184, 260, 358 

underinsured, 413, 422 

unpaid, 154, 167 

unplanned, 118, 173, 302, 343 

urethral, 351 

urinary 

incontinence, 30-33, 97, 300, 301, 368, 

369, 371 

tract infection(s), 21, 73, 74, 87, 90, 91, 

300, 307 

urine, 21, 22, 27, 31, 94, 97, 170, 291, 292, 332, 

385, 386, 416 

uterine cancer, 30, 171, 209 

uveitis, 14, 265, 363 

vaccine(s), 48, 100, 188, 198, 201, 242, 245, 

246, 250, 274-276, 278-280, 287, 348, 

389 

vaginitis, 67, 262, 360 

ventricular hypertrophy, 415 

vertigo, 379 

victimization, 76, 153, 166, 214, 217, 221, 222 

victims, 11, 38, 153, 154, 221, 227, 228, 303, 

373 

violence, 76-78, 99, 121, 151-155, 164-168, 174, 

180, 197, 198, 200, 201, 203, 215, 217, 218, 

221, 222, 224, 226-228, 287, 288, 302, 

303, 365, 366, 368, 372, 373, 395 

virology, 264, 362, 437 

vocabulary, 143, 148 

vulvodynia, 5, 38-45, 253, 305-311, 351 

weight 

control, 388 

gain, 62-64, 122, 210, 286, 335, 349, 423 

loss, 122, 256, 301, 369 

WISEWOMAN, 413, 414 

Women’s Health Initiative (WHI), 61, 93, 170, 

315, 399 

454
NIH Publication No. 10-7606-C