WASHINGTON, DC—Breast cancer and cervical cancer are two of the three main diseases where research on women's health over the last 20 years has paid off in marked progress, according to a new report from the Institute of Medicine (IOM) released at a news briefing here. The third area of progress cited is cardiovascular disease.
The report notes, however, that progress has not been consistent across all racial and ethnic groups, and that advances have stalled on lung, ovarian, endometrial, and colorectal cancers, as well as on unintended pregnancy, autoimmune disease, and addiction disorders.
The committee made seven recommendations to move women's health research forward (see box).
The report, “Women's Health Research: Progress, Pitfalls, and Promise,” notes that for many decades medical research neglected the health of women apart from reproductive issues. But, said the chair of the committee that wrote the report, Nancy E. Adler, PhD, Professor of Medical Psychology and Director of the Center for Health and Community at the University of California, San Francisco, “one of our key findings is how much women's health research has changed in the last 20 years.
“One of the game-changers 20 years ago was the requirement to include women in clinical trials....All research should be designed from the get-go to include women.” Still, it is no use including women if the data on them are not analyzed separately, she added.
In 1993 the National Institutes of Health Revitalization Act mandated the inclusion of women and minorities in clinical research. The IOM report notes that one of the major contributions to women's health research was the reported 2002 finding from the large NIH-sponsored Women's Health Initiative (WHI) study that combination (estrogen plus progestin) postmenopausal “hormone-replacement therapy” (HRT) increased the risk of breast cancer.
The WHI is a $625-milllion dollar prospective clinical study of more than 16,000 women coordinated by NIH's National Heart, Lung, and Blood Institute. Since July 2002, notes the report, there has been a precipitous decline in the number of hormone prescriptions filled and a decreased incidence in invasive estrogen-positive breast cancer.
A Canadian study published online in the Sept. 23, 2010 issue of the Journal of the National Cancer Institute found that the nearly 10% drop in invasive breast cancer rates coincided with the decline in use of hormone-replacement therapy reported among Canadian women aged 50-69 years.
Like the WHI, the Million Women Study in the United Kingdom also showed that breast cancer risk increased with the use of combined postmenopausal HRT.
Progress If Something Harmful Is Stopped?
Asked by OT whether the nation's investment in women's health research has served to end unproven medical practices such as use of HRT, the committee members said yes. Dr. Adler said the committee talked a lot about whether it was progress if a harmful medical practice is stopped: “We decided that it was,” she said.
“We're moving more toward evidence-based medicine,” added Marietta Anthony, PhD, a committee member and Associate Director of Women's Health Programs at the Arizona Center for Education and Research on Therapeutics, and Director of Women's Health for the Critical Path Institute.
The WHI “demonstrated the worth of these studies,” said another committee member, Alina Salganicoff, PhD, Vice President and Director of Women's Health Policy and KaiserEDU.org at the Kaiser Family Foundation. “They're very expensive, but they're worth it,” she said.
Mammography, Breast Cancer Biology
Research advances have also been made in understanding the value of mammography for women over age 50 and in understanding the biology of breast cancer, the committee noted, including the importance of gene mutations such as BRCA1 and BRCA2 and over-expression of HER2.
“The technology associated with mammography has improved substantially since the first studies of its efficacy,” states the report, and the ability to identify women at high risk of breast cancer has also improved.
On the downside, though, the report states that “the reasons for the higher mortality in black women need to be better understood and addressed,” and that “the ability to differentiate between tumors that will progress and metastasize from those that will not is needed.”
Progress against cervical cancer has been dramatic due to the proven efficacy of a prophylactic vaccine against human papillomavirus (HPV) types 6/11/16/18, which are associated with cervical cancer, states the report.
Dr. Anthony called the vaccine “a brilliant technological breakthrough,” and said that its use has the ability to “change the incidence of cervical cancer all over the world.”
Still, the report says, despite cytology-based screening, cervical cancer continues to be an important problem for US women, especially among certain racial and ethnic groups: “The biggest limitation of cervical cytology is its poor sensitivity, and liquid-based cytology has not improved sensitivity.”
The report was sponsored by the US Department of Health and Human Services. Asked if she is pleased with the report, HHS Acting Director of the Office on Women's Health Frances E. Ashe-Goins, RN, MPH, said yes: “I'm really excited that this report was released on the same day the Patient Protection and Affordable Care Act [health reform legislation] is being discussed,” she said.
President Obama was speaking out about the benefits of health reform to the American people—including broader access to preventive services such as mammography—on the six-month anniversary of his signing the health reform legislation into law. “The report points out what successes we've had, and the successes show us which way we need to go,” Ms. Ashe-Goins added.
“I'm very pleased with this report; the bottom line is that all of our work in women's health has made a difference,” Vivian W. Pinn, MD, Director of the NIH Office of Women's Health Research and NIH Associate Director for Women's Health Research, told OT.
Shortly after the IOM released its report, the Office celebrated its 20th anniversary with a day-long symposium at NIH. The national, nonprofit Society for Women's Health Research played a key role in establishing the Office on Women's Health Research, lobbying the Congressional Caucus on Women's Issues to establish it at NIH.
Seven Key Recommendations on Women's Health
To fill gaps and advance scientific knowledge, the Institute of Medicine committee made the following recommendations:
1. US government agencies and other relevant organizations should sustain and strengthen their focus on women's health across the whole spectrum of research.
2. The NIH, the Agency for Healthcare Research and Quality (AHRQ), and the Centers for Disease Control and Prevention (CDC) should develop targeted initiatives to increase research on female populations with the highest risks and burdens of disease.
3. Research on diseases and conditions in women that have high morbidity and affect quality of life—such as lung, ovarian, and endometrial cancers—should be increased.
4. The NIH Office on Women's Health Research should increase research collaborations with the Office of Behavioral and Social Sciences Research to better understand the behavioral determinants of women's health.
5. Government and other funding agencies should ensure adequate participation of women, analysis of data by sex, and reporting of sex-stratified analyses in health research; the US Food and Drug Administration should enforce requirements for sex-stratified analyses in regulatory decision-making. Similarly, medical journals should adopt a guideline that all papers reporting the outcome of clinical trials report on men and women separately (unless the disease or condition affects only one sex, such as prostate cancer).
6. Research should be conducted on how to translate scientific findings on women's health into clinical practice rapidly, since there is often a 15 to 20 year gap between a research finding and a change in medical practice.
7. HHS should appoint a task force to develop evidence-based strategies to communicate and market research-based health messages to women, since “the public is confused by conflicting findings and opposing recommendations that emerge from health research, including women's health research.”
The IOM report on women's health is available at http://national-academies.org