Biennial Report of the Director, National Institutes of Health Fiscal Years 2006 & 2007

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	Statement of the Director, NIH

	NIH Overview

	Extramural and Intramural Research Programs

	Strategic Planning and Roadmap 1.5

	Other Crosscutting Activities and Policies


	Cancer

	Neuroscience and Disorders of the Nervous System

	Infectious Diseases and Biodefense

	Autoimmune Diseases

	Chronic Diseases and Organ Systems

	Life Stages, Human Development, and Rehabilitation

	Minority Health and Health Disparities

	Estimates of Funding for Various Diseases, Conditions, and Research Areas



	Fields and Approaches
	Epidemiological and Longitudinal Studies

	Genomics

	Molecular Biology and Basic Research

	Clinical and Translational Research
	Tools and Training
	Disease Registries, Databases, and Biomedical Information Systems

	Technology Development

	Research Training and Career Development
	Health Communication and Information

	Health Communication and Information Campaigns and Clearinghouses


	Introduction

	Alzheimer’s Disease Centers

	Claude D. Pepper Older Americans Independence Centers

	Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers

	National Center on Minority Health and Health Disparities Centers of Excellence Program

	Rare Diseases Clinical Research Network

	Autism Centers of Excellence

	Chapter 4 Appendix


	A. Pub. L. No. 109-482 (Relevant Provisions)

	B. Priorities and Plans of the Institutes and Centers and the Program Offices in the Office of the Director

	C. Common Fund Strategic Planning Report, FY 2008

	D. Research Training and Graduate Medical Education Data

	E. Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research (excerpt)

	F. Report of the Advisory Committee on Research on Women’s Health (excerpts)

Home > Biennial Report > Appendix F

Biennial Report of the Director, NIH, FY 2006 & 2007

Appendices

Appendix F:
Report of the Advisory Committee on Research on Women’s Health




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Office of Research on Women’s Health and NIH Support for Research on Women’s Health Issues
Fiscal Years 2005 & 2006

Following are excerpts of the report—the Introduction and Overview. The full report will be available at http://orwh.od.nih.gov/.

Introduction

When the National Institutes of Health announced that it was establishing an Office of Research on Women’s Health (ORWH) in September 1990, there were great expectations of what might result, but it is unlikely that, at that time, anyone expected the magnitude of programs and accomplishments related to women’s health research and careers that would flourish across the NIH in the years that would follow.

The ORWH became the first office within the Department of Health and Human Services to have the specific purpose of addressing women’s health issues, yet its initial intent was to abate the criticisms that NIH did not have a consistent or enforced policy that required the inclusion of women in the research that it funded, especially when that research was on conditions that were not female specific. Over the years that have followed, the NIH institutes and centers (ICs), often with ORWH’s collaborative support, have funded research that addresses specific gaps in knowledge about women. But they also have independently given increasing attention to ensuring research that allows comparisons of differences, or similarities, between men and women in responses to interventions being examined through clinical research. And, these concepts are beginning to penetrate the thinking at the basic laboratory research level, although without a specific NIH policy requirement. While the ORWH has specific goals to enhance women’s health research, develop programs to promote biomedical career advancement for women, and for both men and women to conduct women’s health research or studies that provide sex/gender aspects of health by comparing men and women in their responses to the interventions studied, the ORWH has continued its initial mission by leading trans-NIH efforts for consistent monitoring of the inclusion of women and minorities in clinical research.

This report is a comprehensive summary of all of the activities and programs of the ORWH, as well as an Executive Summary followed by more detailed information of highlights of women’s health research within the NIH ICs and OD Program Offices.

Many continue to attempt to evaluate progress on women’s health research by referring to budgetary expenditures on women’s health when compared to men’s health. This is not the most reliable way to assess progress, primarily because basic laboratory studies are at the foundation of progress about women’s health, and often such basic studies have the potential to increase knowledge about both men and women, or serve as the foundation for ensuing clinical research. Further, with the current concepts of women’s health extending beyond that of the reproductive system, and with the NIH policy of inclusion requiring that both men and women be included in clinical research on conditions that affect them – therefore, referring to research that is not female specific, both sexes are included in the studies. The result is that NIH research dollars must be summarized as that related to women’s health research, that related to men’s health research, and that related to, or including, both men and women. Consequently, the figures reported as specific for women’s health research must be considered to be less than the total spent to explore women’s health, with consideration of the additional amount listed under ’both’. A section included in this report, based upon figures provided by the ICs, provides specific amounts for FY 2005 and FY 2006 included in this report.

Approximately $ 3.5 billion was spent each year on sex/gender-specific research related to women’s health. In addition, over $ 22.5 billion was spent on research that benefits both women and men as either basic or laboratory research or clinical studies that included both women and men. Another way of reporting this data is that almost 13% of the NIH research budget was expended on research specific to women, almost 6%0 was expended on research specific to men, while the overwhelming majority (over 81%) of research funds were spent on research that either included both women and men, or was laboratory investigation that was important for exploring the health of both women and men.

In accordance with the NIH Revitalization Act of 1993^[1], the Office of Research on Women’s Health (ORWH) collaborated with NIH staff and members of the Coordinating Committee on Research on Women’s Health (CCRWH)^[2] to provide these programmatic summaries of NIH research and other efforts related to women’s health in FY 2005 and 2006. The ORWH also describes its role in catalyzing interdisciplinary career development and research centers on women’s health and sex/gender research. In addition, the Office develops programs to strengthen and foster women’s participation and advancement in biomedical careers and to promote careers for both men and women to conduct women ’s health or sex/gender based research. A complete listing of research, career development, and other projects supported by the ORWH during FY 2005 and 2006 is included in the appendices. The specific trans-NIH activities that monitor and track the inclusion of women and minorities in clinical research are also described. Highlights of women’s health and sex/gender research supported by the NIH institutes, centers, and offices are also included in this report. The NIH Institutes and Centers (ICs) with grant-making authority have reported progress in basic, clinical, and/or translational research that is benefiting girls and women, as well as serving to identify if and when sex/gender differences exist. The Offices within the Office of the NIH Director have also contributed to this research and this report.

A major ORWH research area relates to interdisciplinary programs. One of these programs is the Specialized Centers of Research on Sex and Gender Factors Affecting Women’s Health (SCOR). Eleven SCOR Centers have demonstrated exciting new developments from interdisciplinary research approaches to advancing studies on how sex and gender factors affect women’s health. Each SCOR promotes interdisciplinary collaborations and the development of research bridging basic and clinical sciences on sex and gender factors underlying a priority health issue. Research areas addressed by the centers include mental health, reproductive health, pain disorders, substance abuse, and urinary tract health. The SCOR program complements other federally supported programs addressing women’s health issues. Another major interdisciplinary program is the Building Interdisciplinary Research Careers in Women’s Health (BIRCWH). The BIRCWH program grants provide an opportunity for institutions to be involved in women’s health and sex/gender oriented research and to build a national supply of investigators by providing research training in conjunction with strong scientific and career mentoring that will enhance the career development of the women and men who are selected as scholars. This program has made impressive progress, with the 35 BIRCWH centers producing 287 scholars, most of whom have gone on to academic positions and received NIH grant awards. Other career development programs supported by the ORWH include the Women’s Reproductive Health Research Career Development Centers (WRHR) of the National Institute of Child Health and Human Development, and numerous other NIH RFAs and PAs.

The NIH ICs and Offices present a brief accounting of their scientific advances in the Executive Summary section of this report. More detailed discussions of these advances are included in the section on Reports of the Institutes, Centers, and Offices.

This report is prepared for, and reviewed by, the Advisory Committee on Research on Women’s Health, that has the responsibility for preparing a report on the activities related to women’s health at the NIH.

You are invited to read this in-depth report to become acquainted with the tremendous advancements that have taken place during this two-year period and the promise for even greater advancements in the future, representing the broad diversity and success of the ORWH, and the trans- NIH activities to advance the health of women and men, and career opportunities in biomedical sciences.

Vivian W. Pinn, M.D.
Associate Director for Research on Women’s Health
Director, Office of Research on Women’s Health

Executive Summary

Overview

The scope and expansion of women’s health research across the NIH has been remarkable over the past two years. This report is evidence of the progress that has been achieved. In this Overview, we describe the missions of the NIH Institutes and Centers (ICs), with a special focus on how they address women’s health issues. The Highlights of Institute and Center Activities section that follows provides a synopsis of their research agenda and accomplishments in women’s health that have been achieved in FY 2005 and 2006. Readers are encouraged to review the detailed reports of the individual NIH ICs that follow. These present important advances in understanding diseases and conditions that disproportionately affect women.

The Fogarty International Center (FIC) supports a range of research and research training programs, many of which include activities on women’s health. Research training programs working in low- and mid-income nations on topics, such as population and health, maternal and child health, AIDS, and stigma and global health, represent FIC’s efforts that include significant attention to women’s health issues. The ORWH supports many of these efforts, along with other NIH Institutes. In addition, the FIC and the ORWH have teamed up to explore issues facing women in science in developing countries and to consider gender and global health issues. These initiatives have informed the programmatic directions of the FIC and other NIH ICs.

Cancer continues to take a devastating toll on American women. However, important progress is being achieved in the fight against cancer overall as well as specific cancers differentially affecting women. These include cancer of the breast, cervix, ovaries, endometrium, colon and rectum, and lung as well as malignancies associated with acquired immunodeficiency syndrome (AIDS). In 2007, an estimated 678,060 women will be diagnosed with cancer, and approximately 270,100 women will die of the disease. Despite these grim statistics, the U.S. is making important progress against cancer. Incidence rates for cancer of all sites, sexes, and populations combined were stable from 1992 through 2003 after increases that started in 1975. Incidence rates for cancer overall for women were stable from 1975 through 1979 but then increased from 1979 through 2003. However, there was a 6 percent relative decline in breast cancer incidence among women between 2002 and 2003, including a 14 percent decrease in 50- to 60-year-olds who had been diagnosed with estrogen receptor (ER) positive breast cancer. The decrease in this age group may be due to the recent decline in use of hormone therapy (HT) by postmenopausal women. Mortality rates for all cancers have declined, but the annual decline in men is twice as large as that for women. While mortality has decreased for 10 of the top 15 cancers in women, lung cancer deaths in women continue to increase, although at a slower rate in more recent years. Survival rates for cancer patients show improvement overall, although the amount of improvement is slightly less for women than men. The National Cancer Institute (NCI) supports an extensive research program through their intramural and extramural programs, with a number of programs and activities focusing on women’s cancers, including the NCI Office of Women’s Health, located within the NCI Office of Science Planning and Assessment; the Breast and Gynecologic Cancer Research Group in the Division of Cancer Prevention; the Breast Cancer Surveillance Consortium (BCSC) and the International Breast Screening Network in the Division of Cancer Control and Population Sciences; the Gynecologic Oncology Group (GOG) and the Clinical Trials Cooperative Group in the Division of Cancer Treatment and Diagnosis; the intramural Breast and Gynecologic Malignancies Faculty and the trans-NCI Human Papillomavirus (HPV) Working Group. By working with partners from public, private, and academic settings and focusing investment in strategic areas with high potential, we hope to accelerate the pace of discovery and facilitate the translation of research knowledge into clinical applications.

The mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to explore complementary and alternative healing practices in the context of rigorous science, train CAM researchers, and disseminate authoritative information to the public and professionals. Complementary and alternative medicine (CAM) encompasses those health care and medical practices that are not currently an integral part of conventional medicine. The list of CAM practices and therapies changes as interventions proven to be safe and effective become accepted as mainstream health care practices. The NCCAM groups CAM practices within the following areas: (1) whole medical systems (i.e., traditional Chinese medicine, naturopathic medicine, Ayurveda); (2) mind-body medicine (i.e., meditation, yoga); (3) biologically based practices (i.e., herbal therapies, special diets); (4) manipulative and body-based practices (i.e., chiropractic, massage); and (5) energy medicine (i.e., Reiki, Qi gong). The NCCAM conducts and supports basic and applied (clinical) research and research training within these areas. CAM therapies are used to treat a broad range of health conditions by both men and women, including back and neck problems, allergies, fatigue, arthritis, headaches, diabetes, and CVD. CAM therapies for women treat a variety of conditions, such as menopausal symptoms, breast cancer, osteoporosis, pain associated with osteoarthritis and fibromyalgia, and reproductive issues. Thus, NCCAM’s research portfolio includes investigations focused on a variety of diseases, using a myriad of CAM therapeutic interventions.

The National Center for Research Resources (NCRR) provides laboratory scientists and clinical researchers with the environments and tools they need to understand, detect, treat, and prevent a wide range of diseases. This support enables discoveries that begin at a molecular and cellular level to move to animal-based studies and on to patient-oriented clinical research, resulting in cures and treatments for both common and rare diseases. The NCRR develops and supports a wide range of biomedical resources. Through its support of multidisciplinary research, the NCRR is uniquely positioned to provide funds directly for research or to act in partnership with other NIH components to address emerging clinical and basic research needs, including those addressing women’s health issues.

The National Center on Minority Health and Health Disparities (NCMHD) promotes minority health and leads, coordinates, and assesses the NIH effort to reduce and eliminate health disparities. To achieve its mission, the NCMHD employs a multifaceted strategy to conduct and support research in basic, clinical, social, and behavioral sciences; disseminate information, promote research infrastructure and training; foster emerging programs; and extend its reach to minority and other health disparity communities. Congress mandated the development of three principal programs within the NCMHD aimed at addressing health disparities: the Loan Repayment Program, the Centers of Excellence Program, and the Research Endowment Program. Additionally, the NCMHD supports the Research Infrastructure in Minority Institutions Program (RIMI) and the Minority Health and Health Disparities International Research Training Program (MHIRT). These combined efforts position the NCMHD to lead and coordinate the NIH health disparities activities for the benefit all affected populations, including women of diverse populations.

The mission of the National Eye Institute (NEI) is to conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of blind persons. The major causes of blindness (i.e., glaucoma, macular degeneration, diabetic retinopathy, uveitis, and cataract) affect both women and men. However, because women live longer on average than men, more women than men are affected by these age-related eye diseases in the U.S. Several eye conditions affect women significantly more frequently than men. These conditions are optic neuritis, a demyelinating disease of the optic nerve that may be a precursor of multiple sclerosis; dry eye, a common condition that is associated with decreased tear secretion and in most cases mild discomfort, but in more severe cases may result in corneal scarring and blindness; corneal endothelial dystrophy, a slowly progressive disease that occurs when endothelial cells deteriorate as a result of cell loss from age or trauma; keratoconus, a visually disabling thinning disorder of the central cornea that results in irregular astigmatism, progressive corneal distortion, and corneal scarring; and age-related macular degeneration, a deterioration of the region of the retina that is responsible for high-resolution vision.

The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for research, training, and education programs to promote the prevention and treatment of heart, lung, and blood diseases. The NHLBI stimulates basic discoveries about the causes of disease, speeds the translation of basic discoveries into clinical practice, fosters training and mentoring of emerging scientists and physicians, and communicates research advances to the public. The NHLBI creates and supports a collaborative research infrastructure in partnership with private and public organizations. The Institute also collaborates with patients, families, health care professionals, scientists, professional societies, patient-advocacy groups, community organizations, and the media to maximize the use of research results and resources to address the public health needs of the nation. The NHLBI places high priority on improving the cardiovascular health of women through its research programs, which have generated new knowledge about the influences of lifestyle, menopause, chest pain, hypertension, diabetes, and drug treatment (including hormone therapy) in women and also have led to improved diagnostic tests and treatment guidelines for women. The NHLBI has had responsibility for the NIH Women’s Heath Initiative since 1998 and provides support for the Women’s Ischemia Syndrome Evaluation as well as other important studies.

The National Human Genome Research Institute (NHGRI) led the NIH’s contribution to the International Human Genome Project (HGP). The finished sequence of the human genome was completed in April 2003, and has already begun to change the way we address research on women’s health. In October 2005, a different international consortium of scientists from six countries, led by the NHGRI, announced the production of a different map of the human genome, one that may prove even more powerful because of its medical applications. The result is the “HapMap. ” Like the earlier sequence, all of the data from the HapMap has been placed in the public domain. The HPG spelled out the letters of the DNA code that all human beings share. The HapMap provides detailed information about the variation in the genome. The HapMap investigates those spelling differences in the human instruction book that predispose some people to different types of cancer as well as other diseases. In December 2006, the NHGRI awarded a contract to continue the HapMap Project to make it an even more powerful tool to reveal the way in which genetic variation is organized into chromosomal neighborhoods. As this information unfolds, the NHGRI will continue to investigate diseases specific to women. In 1994, NHGRI investigators were among the first to report that women carrying the gene mutations called Breast Cancer 1 (BRCA1) or Breast Cancer 2 (BRCA2) have a higher risk of developing both breast and ovarian cancer than women without such mutations. The NHGRI continues to investigate the role of these genes in breast and ovarian cancer, and this research has led to better screening and treatment of those with a family history of breast cancer. In hopes of expanding the usefulness of this research, the NHGRI also supports research that explores the effect of educating women of different ages and ethnic group about benefits of genetic screening in evaluating their risk of inherited diseases.

The National Institute of Allergy and Infectious Diseases (NIAID) funds basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses that affect the health of women and girls. The NIAID involves women in many of its clinical studies on the treatment and prevention of autoimmune diseases, human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS), and sexually transmitted infections (STIs). The NIAID also collaborates with other organizations on research initiatives aimed at improving women’s health.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports basic, clinical, and epidemiologic research, research training, and information programs on many of the more debilitating diseases affecting Americans. The NIAMS supports research on a number of diseases that disproportionately affect women including osteoarthritis, osteoporosis, rheumatoid arthritis, temporomandibular joint and muscle disorders (TMJD), fibromyalgia, scleroderma, and systemic lupus erythematosus (lupus). Scleroderma and lupus are diseases in which health disparities have been clearly identified. The NIAMS is committed to uncovering the bases of these gender, racial, and ethnic disparities and to devising effective strategies to treat or prevent them.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB), which was established by law in December 2000, is the newest research institute within the NIH. This Institute serves as the hub within the NIH for the coordination of biomedical imaging and bioengineering efforts. The NIBIB: (1) fosters, conducts, supports, and administers research and research training programs in biomedical imaging and bioengineering by means of grants, contracts, and cooperative agreements; (2) provides coordination, integration, and review of progress and planning of biomedical imaging and bioengineering research; (3) formulates research goals and long-range plans with the guidance of the National Advisory Council for Biomedical Imaging and Bioengineering; and (4) sponsors scientific meetings and symposia, collaborates with industry and academia, and fosters international cooperation regarding biomedical imaging and bioengineering. The NIBIB recognizes the significant potential of improved imaging technologies in early disease detection. During FY 2005 and 2006, the NIBIB funded grants that were focused on women’s health research or technologies aimed at improving devices for female populations. These projects range from advanced imaging methodologies to new drug delivery systems designed specifically for women’s diseases, such as breast cancer, and disorders and conditions that predominate in women, such as osteoporosis. Researchers supported by the NIBIB plan to develop high resolution x-ray grids in mammography to detect breast cancer at its earliest stage, thereby greatly increasing patient survival rates. In addition, NIBIB-funded investigators are working on novel drug delivery treatments that will promote bone resorption for women suffering from osteoporosis. During the past two years, the NIBIB supported research on women’s health in the following disease areas: aging, autoimmune disease, breast cancer, cervical cancer, reproduction, diabetes-related research, obesity, epilepsy, HIV/AIDS, heart disease, osteoporosis, and TMJD.

The National Institute of Child Health and Human Development (NICHD) sponsors research that spans human growth and development, starting from before conception and continuing through infancy, childhood, and adolescence. This research covers all critical stages of development that provide the foundation for adult health. The Institute’s research aims to overcome many of the complex challenges that face women in addition to those faced by their children and families. The NICHD’s portfolio includes research on infertility, preterm birth, complications of childbirth, HIV infection in women, parenting, and many other scientific areas that are critical to improving the quality of life for women.

The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to promote the general health of the American people by improving craniofacial, oral, and dental health through research. As a central part of this mission, the NIDCR funds scientific research to prevent diseases and improve the quality of life for the millions of Americans who suffer from chronic and infectious diseases affecting the mouth and face. NIDCR-supported research spans areas as diverse as understanding the oral infections that lead to dental decay, periodontal diseases, and recurrent herpes lesions; oral manifestations of osteoporosis and other bone diseases; salivary gland dysfunction and disease; craniofacial birth defects and developmental disorders; and connective tissue diseases and disorders. The NIDCR has a long tradition of support and leadership in the field of pain research, including conditions where gender-based differences have been reported, such temporomandibular joint and muscle disorders (TMJD). The NIDCR’s commitment to the fundamental study of the body’s hard tissues, such as teeth, cartilage, and bone, has led to advances in biomaterials research and to the emerging field of tissue engineering and biomimetics, fields that use the body’s own cellular and molecular processes to repair and regenerate tissues and organs. Among the NIDCR’s efforts in this area are studies that are characterizing the TMJ disk at tissue and cellular levels, thus providing vital information that will one day allow for biological approaches to reconstruct or regenerate the temporomandibular joint. Recognizing the importance of gene-to-gene, gene-environment, and behavioral interactions, the Institute has long emphasized the importance of genetic, behavioral, social science, and epidemiological research. The research advances that affect women in particular are to be found within many of the Institute’s broad research categories.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports basic and clinical research on diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases. Within NIDDK’s research mission, diseases and health risks that disproportionately, predominantly, or solely affect women include gestational diabetes; obesity (especially in racial and ethnic minority populations); coronary artery disease; cardiovascular and end-stage renal disease associated with diabetes; eating disorders; irritable bowel syndrome (IBS) and other functional gastrointestinal disorders; osteoporosis; thyroid diseases (including Graves disease, goiter, and hypothyroidism); hyperparathyroidism; gallstones; primary biliary cirrhosis; painful bladder syndrome/interstitial cystitis (PBS/IC); urinary tract infections (UTIs); urinary NIDDK mission also may have an important impact on diseases that are primarily within the mission of other ICs, such as hormonal factors in breast cancer and the relationship of obesity to cardiovascular disease (CVD). The NIDDK supports research that directly addresses important women’s health issues, both through basic research directed to understanding underlying disease processes and through clinical research that translates this understanding into therapies and preventive interventions.

Because environmental agents are likely to play a role in a numbers of diseases that differentially affect females, the National Institute of Environmental Health Sciences (NIEHS) supports research on diseases such as breast cancer, osteoporosis, ovarian dysfunction, uterine fibroids,and autoimmune diseases. The Institute’s approach is to define the underlying susceptibilities to these diseases, to investigate the role of estrogenic and other endocrine-active compounds in their etiology, to identify important environmental triggers for their development and important nutritional factors that can reduce risk, and to determine the importance of the timing of exposure on disease risk. As results of these studies become available, women can better determine how to alter lifestyle factors leading to these diseases, and environmental health regulators can better define standards that protect women from environmental triggers of these diseases. The Institute has several groups that focus on women’s health, including the Laboratory of Reproductive and Developmental Toxicology, the Hormones and Cancer Group, the Chromatin and Gene Expression Group, and the Comparative Pathology Group. These research groups and others are conducting basic research on issues such as toxicology and reproductive and developmental health, hormone regulation of tumor development and growth in target organs, including the uterus and mammary gland, genetic regulation of cancer susceptibility, as well as epidemiologic research on women ’s health issues, such as fertility, early pregnancy, and uterine fibroids. By understanding the basic mechanisms of disease, new therapeutic interventions can be developed to prevent and treat these diseases.

The mission of the National Institute of General Medical Sciences (NIGMS) is to support research and research training for the basic biomedical sciences. For example, the NIGMS supports research on cell structure and function, from the outer plasma membrane to the activation of genes in the nucleus. This knowledge is necessary to understand the disease process. Most studies supported by the NIGMS do not target any particular disease or condition but rather encompass basic research in cellular and molecular biology, chemistry, biochemistry, molecular biophysics, and genetics. Often basic research supported by the Institute will result in findings pertinent to women’s health.

The National Institute of Mental Health (NIMH) supports research on a range of mental disorders, including those that affect women exclusively, such as perinatal depression, or are more prevalent in women, such as eating disorders. Through programs, such as the Women’s Mental Health Team, the NIMH has fostered interdisciplinary collaboration and research to improve diagnosis, treatment, services, and the prevention of mental disorders in women. Data on the epidemiology of mental disorders and associated disability highlight differences in both the prevalence and clinical course of mental disorders between men and women. Starting in childhood, girls have higher rates of anxiety disorders and eating disorders than boys, while boys are more likely to suffer from autism and attention deficit disorder. After puberty, women have higher rates than men of depression, eating disorders, and anxiety disorders, including posttraumatic stress disorder. The course and severity of mental disorders also differ between men and women. For example, men have an earlier average age of onset of schizophrenia, while women are more likely to suffer from the rapid cycling form of bipolar disorder. Within the female populations, some women are at increased risk of depression during certain times of reproductive change, such as the perinatal period. Through its research programs and related programmatic activities, the NIMH seeks to improve scientific understanding of the effects of sex and gender differences in mental health and mental illness.

The National Institute of Neurological Disorders and Stroke (NINDS) mission is to reduce the burden of neurological disease, a burden borne by every age group, every segment of society, and people all over the world. Most nervous system disorders affect men and women equally, but certain disorders are more prevalent in or are of special interest to women. Examples of such diseases include multiple sclerosis (MS), pain, stroke, epilepsy, and Rett syndrome. MS is a chronic autoimmune disease of the central nervous system that causes inflammation and the loss of myelin, a protective covering around nerve fibers. MS is one of the most common neurological disorders leading to disability in young adults. Hormonal factors may influence some forms of MS, making them more common in women. Strokes are caused by a rapid disruption in the blood supply to part of the brain as a result of blood vessel blockage (ischemic stroke) or blood vessel rupture (hemorrhagic stroke). A stroke can result in sudden numbness or weakness, confusion, trouble with vision, speech, or coordination, or a sudden severe headache. Stroke is the third leading cause of death in the U.S. and a major cause of disability in both women and men. In general, women have a lower risk of stroke than men, but because of their longer life expectancy, they account for 60 percent of stroke fatalities. Epilepsy is characterized by chronic, recurring seizures caused by abnormal electrical activity in the brain. Although anti-epileptic drugs (AEDs), brain stimulation, or surgery can help many patients control the disorder, for others, the seizures are resistant to therapy or the treatments cause unacceptable side effects. Women with epilepsy can face special problems, such as increased seizure frequency during phases of the menstrual cycle (called catemenial epilepsy). Female patients taking selected AEDs must consider changing medications if they wish to become pregnant since certain AEDs can cause higher-than-normal rates of birth defects. Rett syndrome is a childhood neurological impairment seen almost exclusively in females, causing severe cognitive impairment, autistic behavior, stereotypic movements, and frequently seizures. The NINDS supports basic, translational, and clinical research on these and other neurological disorders.

The mission of the National Institute of Nursing Research (NINR) is to support clinical and basic research that establishes a scientific basis for the care of individuals across the life span. NINR-supported research encompasses the health of individuals, their families, and their caregivers. It also focuses on the special needs of at-risk and underserved populations, with an emphasis on health disparities. The Institute’s research focus transcends many disciplines to promote health and improve patient and caregiver quality of life across a broad rangeof diseases and conditions. The NINR unites the disciplines of biological and behavioral sciences to elucidate the complex interactions between the physiological factors of health and disease and the behavior, decisions, and perceptions of the individual. In 2006, the NINR released its new five-year strategic plan, titled Changing Practice, Changing Lives. Developed in close consultation with representatives of the extramural community, this new plan details the NINR’s scientific priorities. The Institute will focus its research on health promotion and disease prevention; improving quality of life through self-management, symptom management, and caregiving; eliminating health disparities; and leading critical research on the end of life. The plan also highlights four cross-cutting strategies for advancing nursing science, including advancing the integration of biological and behavioral sciences, promoting the design and use of new patient care technologies, improving nursing science methods, and developing the next generation of investigators. The NINR’s mission and research goals are inherently suited to addressing the current challenges in women’s health research.

The National Institute on Aging (NIA) conducts and supports a diverse portfolio of research on older women’s health, including studies of Alzheimer’s disease and other dementias, menopause and hormone therapy, osteoporosis, physical disability, and other diseases and conditions. NIA-supported investigators continue to explore the reasons behind gender differences in disability, morbidity, and mortality at older ages. In addition, the NIA supports an extensive program of research pertaining to health disparities among special populations. The NIA has several on going research initiatives dealing specifically with women’s health, including the Study of Women’s Health Across the Nation (SWAN),the Women’s Health Initiative Study of Cognitive Aging (WHISCA), and Women’s Health and Aging Study (WHAS). These studies and others are providing valuable information about the menopausal transition in women of diverse racial and ethnic backgrounds; the effects of hormone therapy on memory and cognitive functions; disability among older women; and other health issues of importance to older women, who are more likely than men to live alone and in poverty and to be institutionalized at an earlier age.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports research on the behavioral and medical causes and consequences of alcohol use, abuse, and alcoholism, and on new ways to prevent and treat these significant public health problems. It is estimated that there are 18 million alcohol-abusing or alcohol-dependent individuals in the U.S., of which more than four million are women. Women drink less alcohol and have fewer alcohol-related problems and dependence symptoms than men, but among the heaviest drinkers, women equal or surpass men in the problems that occur because of their drinking. In contrast to young people who begin drinking at age 21, equal numbers of young men and women who begin drinking at age 13 are four times more likely to develop alcohol dependence sometime during their lifetime. The NIAAA continues to expand its research portfolio on the impact of alcohol and alcohol misuse on women’s health. Research related to women’ s health is found in each programmatic division of the institute. Because of the multidimensional and multidisciplinary nature of alcohol use disorders and their prevalence worldwide, collaborative research endeavors on a national and international scale are required for progress toward the goals of reducing alcohol abuse disorders and alcoholism among women. Significant scientific advances in understanding the causes, consequences, prevention, and treatment of alcohol use, abuse, and dependence among women have occurred in the past two fiscal years.

The National Institute on Deafness and Other Communication Disorders (NIDCD) conducts and supports research and research training on normal mechanisms as well as diseases and disorders of hearing, balance, smell, taste, voice, speech, and language. The Institute also conducts and supports research and research training that is related to disease prevention and health promotion. The research portfolio addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders. The Institute also supports efforts to create devices that substitute for lost and impaired sensory and communication functions. A number of diseases, disorders, or conditions within the mission of the NIDCD affect women disproportionately.

The National Institute on Drug Abuse (NIDA) addresses critical questions concerning drug abuse and addiction by monitoring emerging trends, identifying and studying underlying physiological and social factors, and determining how best to use this knowledge to develop, test, and implement prevention and treatment programs. An important focus in NIDA’s portfolio is research to investigate issues specific to women and to sex/gender differences in drug abuse and addiction. There is a complex relationship between drug use and biological vulnerability that may vary by sex or gender. Growing evidence suggests that drug abuse may begin and progress differently for men and women. These patterns of progression are characterized by different risk and protective factors and motivations and carry different consequences. In recognition of the important role that sex/gender plays in drug abuse, sex/gender research findings are being taken into account in the design, testing, and implementation of interventions to prevent and treat drug abuse and to provide services for both males and females. NIDA has established a Women and Gender Research Group to promote research on issues specific to women and substance abuse. This group has representation from all of NIDA’s divisions and offices, covering topics from genetics and basic biology to risk factors, prevention, consequences, and treatment of substance abuse. The major goal of this effort is to infuse the study of sex/gender differences and female-specific issues in all areas of drug abuse research and to disseminate research findings.

In addition to the involvement of the NIH ICs mentioned before, several of the Offices within the Office of the Director of NIH participate in activities related to women’s health and sex/gender issues. The Office of Dietary Supplements (ODS) supports research to expand the evaluation of the role of dietary supplements in disease prevention and risk reduction associated with diseases of interest to women, including breast cancer. In addition, ODS supports research to further scientific understanding of the biochemical and cellular effects of dietary supplements on biological systems and their physiological impact across the life cycle. The Office of Behavioral and Social Sciences Research (OBSSR) opened on July 1, 1995. Congress established OBSSR in recognition of the key role that behavioral and social factors play in illness and health. The OBSSR mission is to stimulate behavioral and social sciences research throughout the NIH and to integrate these areas of research more fully into other NIH health research enterprises, thereby improving the understanding, treatment, and prevention of diseases. Many of these diseases are related to women’s health, such as type two diabetes, coronary heart disease, obesity, addictive behaviors, and disorders of mood and affect. The Office of Rare Diseases (ORD) seeks to stimulate and coordinate research on rare diseases and to support research to respond to the needs of patients who have one of the approximately 7,000 rare diseases recognized today. Several of these rare diseases differentially affect women, including lymphangioleiomyomatosis, Rett syndrome, congenital adrenal hyperplasia, and preeclampsia. The ORD collaborates with the NIH ICs and Offices to stimulate research on rare diseases, to foster collaborations with other national and international entities, and to support a range of outreach activities related to rare diseases. The Office of AIDS Research (OAR) was established in 1988. Perhaps no other disease so thoroughly transcends every area of clinical medicine and basic scientific investigation, crossing the boundaries of nearly every NIH IC. The NIH supports a comprehensive program of basic, clinical, and behavioral research on HIV infection, its associated co-infections, opportunistic infections, malignancies, and other complications. This diverse basic, clinical, and behavioral research portfolio demands an unprecedented level of scientific coordination and management of research funds. The OAR coordinates the scientific, budgetary, and policy elements of NIH AIDS research. Through its unique, trans-NIH planning, budgeting, and portfolio assessment processes, the OAR ensures that research dollars are invested in the highest priority areas of scientific opportunity. As such, the OAR represents the roadmap for NIH AIDS research, allowing NIH to pursue a united research front against the pandemic. The trans-NIH strategic plan for AIDS research establishes an agenda in the following areas of emphasis: vaccines; therapeutics; etiology and pathogenesis; natural history and epidemiology; behavioral and social science; training, infrastructure, and capacity building; and information dissemination. Research relevant to the needs of women is addressed in all of these areas.

¹ Public Law 103-43, 107, stat, 22 (codified at 42 USC [sec.486 (A)]. See pages 17-20 for a list of the CCRWH members.
² See pages 17-20 for a list of the CCRWH members.

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Office of Research on Women’s Health and NIH Support for Research on Women’s Health Issues Fiscal Years 2005 & 2006

Overview

Office of Research on Women’s Health and NIH Support for Research on Women’s Health Issues
Fiscal Years 2005 & 2006