The year 2010 marks a special anniversary in the study of women’s health. Twenty years ago, the National Institutes of Health (NIH) established the Office of Research on Women’s Health (ORWH) to correct a historical imbalance in clinical research.
“Up until this time, due to an erroneous assumption that what was tested in men could be applied to women, many important clinical trials excluded women as subjects, which resulted in a fundamental lack of knowledge about women’s health,” explains Nancy Milliken, MD, vice dean of the UCSF School of Medicine and director of the National Center of Excellence in Women’s Health (CoE). “Spearheaded by women in Congress, new regulations began to require that clinical trials funded by NIH include female subjects. Fortunately, our understanding of women’s health is accelerating.”
Ovarian blood vessel. Colored scanning electron micrograph (SEM) of a section through a blood vessel in an ovary.
UCSF has been on the front lines of this historic shift through ongoing research that has focused specifically on advancing women’s health, and today UCSF continues to have a leadership role.
“For the last four years, the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences has been No. 1 in NIH research funding in comparison to its peers,” notes Linda C. Giudice, MD, PhD, chair of the department. Giudice serves on ORWH’s advisory committee for women’s health research, and is recognized nationally for her contributions to basic science research in reproductive medicine and her pioneering work on the impact of environmental contaminants on fertility.
UCSF researchers consistently make headlines for their discoveries in women’s health, and none have been more significant than findings by researchers in the Women’s Health Clinical Research Center over the past decade regarding hormone therapy prescribed to postmenopausal women.
Deborah Grady, MD, MPH, founding director of the center, and her colleagues have done extensive studies on the use of hormone supplements, which were among the most widely consumed pharmaceuticals in the country as recently as 2000. Their discoveries on associated risks contributed to a decrease in hormone therapy use by about half.
Through the Heart and Estrogen/Progestin Replacement Study (HERS), a clinical trial of 2,800 women with known coronary disease, Grady and others – in conjunction with the randomized trials conducted by the Women’s Health Initiative – found that while hormone therapy can be useful in treating menopausal symptoms such as hot flashes, there is an increased risk of breast cancer, stroke and dementia.
“In the assessment of the overall risks and benefits, in terms of actual clinical outcomes, it is clear that the clinical risks outweigh the benefits,” says Grady. “These findings have changed thinking enormously from a widely used drug for prevention of osteoporosis and coronary disease to use only for treatment of symptoms and not for prevention.”
Following these pivotal trials, analyses of available literature suggested the “timing hypothesis” – whether the point when hormones are started, relative to the menopause, has a significant impact on risk and benefit. To address this, Marcelle I. Cedars, MD, director of the UCSF Center for Reproductive Health, is leading UCSF’s participation in a multicenter trial to evaluate the use of hormone therapy in newly menopausal women. Researchers at UCSF continue to investigate how best to care for the growing number of women in the perimenopausal and postmenopausal age group.
Left: Claire Brindis, DrPH, MPH; Right: Tracey Woodruff, PhD, MPH
Grady was among the first researchers to show that the risk for breast cancer increased by about 30 percent with five or more years of postmenopausal hormone therapy. Subsequent studies have confirmed that a precipitous drop in breast cancer rates among postmenopausal women paralleled a decrease in the use of hormone therapy.
Specialized Research Centers
The UCSF women’s health enterprise includes several research centers that focus on specific health issues and represent collaboration across the UCSF professional schools. They include:
- UCSF Women’s Continence Center: The center studies the underlying causes of and potential treatments for incontinence, a problem afflicting millions of American women. Under the leadership of Jeanette Brown, MD, the center focuses on high-risk groups such as women with diabetes or those who are obese, and recent study findings showed that weight loss can reduce incontinence.
The center is one of 10 Specialized Centers of Research supported by the NIH and ORWH nationwide, and its bench-to-bedside collaborative research program facilitates direct translation of scientific results to improved patient care.
- Lesbian Health & Research Center: One of the few lesbian-focused groups at an academic health sciences institution, the center has active training and education programs. To better prepare clinicians to treat and support their lesbian patients, the founding co-directors of the center, Suzanne Dibble, RN, DNSc, professor emerita in the UCSF School of Nursing Institute for Health & Aging, and Patricia Robertson, MD, professor of obstetrics, gynecology and reproductive sciences, recently published Lesbian Health 101: A Clinician’s Guide, the first clinical text devoted to the topic.
- The center also has undertaken a program to disseminate information on the somewhat increased risk of breast, ovarian and endometrial cancer, obesity, smoking-related disease and mental health issues among lesbian, bisexual and transgender people – a group less likely to seek assistance for symptoms.
- Women’s Interagency HIV Study: Women with HIV were an understudied and neglected population until 1993, when Ruth Greenblatt, MD, a women’s health and infectious diseases specialist who now is a professor in the UCSF School of Pharmacy, led a multidisciplinary team in conducting research in this population. Greenblatt and her team currently lead a comprehensive, longitudinal investigation into HIV infection and treatments in women that involves 4,000 participants nationwide. The research has produced more than 450 publications, expanded understanding of HIV/AIDS, and improved the survival and lives of thousands of women and their children.
- Center for Reproductive Sciences: The center brings together a multidisciplinary group of basic researchers and physician-scientists. Their work focuses on conducting high-quality, cutting-edge research in the field of reproductive sciences, transferring concepts developed in the laboratory to clinical applications and providing a training program for future leaders in the field of reproductive sciences.
- UCSF Bixby Center for Global Reproductive Health: The center was formed in 1999 to address the health, social and economic consequences of sex and reproduction through research and training in contraception, family planning and sexually transmitted infections. The center strives to develop preventive solutions to the most pressing domestic and international reproductive health problems. Co-directors are Philip Darney, MD, MSc, Claire Brindis, DrPH, MPH, and J. Joseph Speidel, MD, MPH.
- Program on Reproductive Health and the Environment: Launched in 2007, the program investigates the links between exposure to widely dispersed chemicals and problems with infertility, miscarriage, abnormal fetal development and disease.
“One of our unique strengths is that we intersect clinical, public and environmental health sciences,” says Tracey Woodruff, PhD, MPH, program director. “This allows us to enhance our understanding of the science, to translate that science to key leaders from government and nongovernmental organizations and health-affected and environmental groups, and to actively improve public policies and care that impact our health.”
- ATHENA Breast Health Network: In 2009, the University of California launched an unprecedented, statewide collaboration with the goal of advancing the understanding of breast cancer and radically improving the course of patient care by designing and testing new approaches to research, technology and health care delivery. Under the leadership of Laura Esserman, MD, MBA, director of the UCSF Carol Franc Buck Breast Care Center, the project will include 150,000 women throughout California who will be screened for breast cancer and followed for decades through the five UC Cancer Centers. “Our goal is to improve survival and reduce suffering from breast cancer, to accelerate research and compress the time to implement innovations in clinical practice,” says Esserman. “ATHENA is an example of a bold vision for improving one area of women’s health and a model for accelerated progress in advancing human health,” adds Milliken. “It is exciting that UCSF researchers are engaged in collaborations to improve our understanding of women’s health at many levels – in basic science laboratories, clinical trials, demonstration projects and population studies – all key indicators for a brighter future.”