July 2002
The Knowledge Gap In Women's Health

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© 2003

 

Bryn Mawr College
A quarterly newsletter on research, teaching, management, policy making and leadership in Science and Technology

The Knowledge Gap in Women’s Health
By Dorothy Wright

Until the early 1990s, women were underrepresented in clinical studies of diseases that affect both men and women, including major killers such as heart disease, cancer and stroke. Research supported by the National Institutes of Health (NIH) into women’s health typically focused on the reproductive system, especially during the childbearing years. Progress has been made over the last decade to close the knowledge gap in women’s health. Given the lag between the conception of a clinical study and the publication of results — often a decade or more — time will tell what significant findings may emerge as a result of expanded inclusion. Meanwhile, more remains to be done to scale the social, cultural and economic barriers to the enrollment of women and other minorities in clinical studies.

Women-Only Protocols

Donna L. Vogel ’71

Guidelines for the inclusion of women in clinical research have been in place at NIH since 1986. Yet in 1990, a U.S. General Accounting Office (GAO) report mandated by the Congressional Caucus on Women's Issues found that women routinely were excluded from NIH-supported medical research. "Women, especially those of reproductive age, were not involved in any meaningful way in studies of universal public health problems such as heart disease, lung cancer and substance abuse," says Donna L. Vogel ’71, director of the Fellowship Office at the National Cancer Institute. "Implementation was slow, it was not well communicated, gender analysis of the data was not being done and the impact of the policy could not be determined. Women subjects still were enrolled largely in women-only studies. There was an abundance of data on men in trials of diseases affecting both sexes, but it could not be generalized to women."

As a cardiologist, Elsa-Grace Giardina ’61 recalls those days. A professor of clinical medicine at Columbia College of Physicians and Surgeons and director of the Center for Women’s Health, she says, "I can actually remember — it’s so striking now — in the 1980s having written a proposal to the NIH to study a new modality for treating ventricular arrhythmias, and the reviewer responded to the effect of, ‘Why do you have so many women? This is a man’s disease.’"

Elsa-Grace Giardina ’61

From Guidelines to Law

Following the 1990 GAO report, NIH guidelines were strengthened to ensure inclusion of women and minorities in NIH clinical studies. In 1993 they were made law with passage of the NIH Revitalization Act, which requires that women and minorities be included in clinical research and that clinical trials be designed and carried out to determine whether the variables under study affect women and minorities differently from other subjects in the study. Exclusion is allowed if there is a substantial scientific rationale for doing so; cost is not an acceptable justification. Researchers must actively recruit women and minorities as study participants. NIH further clarified the guidelines in 2000 and 2001.

"I think the law has enormously impacted the way researchers write grants now," Giardina observes.

In fact, Vogel says, "Since the 1993 law, the number of female and male subjects in NIH-funded studies involving both sexes is about equal, excluding studies of single-sex/gender conditions," Vogel says. "We are now able to get meaningful data on diseases and conditions that affect both men and women, including sex/gender differences in incidence, severity, access to care and response to treatment."

The 1990 GAO report also prompted the establishment of the Office of Research on Women’s Health (ORWH) at NIH. ORWH has three major mandates: to strengthen, develop and increase research for women’s health in order to eliminate gaps in knowledge and determine the research agenda for women's health; to ensure that women are represented in NIH studies, especially clinical studies; and to increase the number of women in biomedical research careers.

Progress and Change

The Women's Health Initiative (WHI), which was announced by ORWH in April 1991, is one of the largest clinical studies ever conducted. The 15-year project will cost more than $635 million and involves more than 160,000 women ages 50 to 79 at 40 clinical centers around the country.

One component of this study is evaluating the effect of a low-fat diet in preventing heart disease and breast and colon cancer. Another is looking at the effect of long-term hormone replacement therapy (HRT) on heart disease and osteoporosis, and whether or not it increases the risk of breast cancer. A third is evaluating the effect of calcium and vitamin-D supplementation in preventing osteoporotic fractures and colon cancer.

Barbara V. Howard ’63

"The initiative is a major step forward," says Barbara V. Howard ’63, president of the MedStar Research Institute and a WHI principal investigator. "We have a very diverse cohort of women geographically, ethnically and in terms of prior health issues. The three clinical trials are the first to address these questions with a long-term, large cohort. Clinicians have been prescribing HRT for years on the basis of trials that went no more than a year or two."

Progress in closing the knowledge gap in women’s health will take time to appear. "Sometimes it takes a long time to begin to see changes," Giardina says. "It might take 10 years from the time you conceive of a study until the time you publish the article. There’s no question about it: the efforts made on a federal basis to enroll more women are beginning to pay off. I think it’s slow, but I think it’s beginning to pay off."

Minorities and the Poor

Other gaps remain in clinically based knowledge of disease and health risks. "By and large, clinical studies are still based on upper-class white populations," Howard says. "Despite the legislation requiring inclusion of minorities, there has been real difficulty in actually making it happen."

One reason is a pervasive mistrust of the medical community. "People do not want to be guinea pigs," says Terri L. Cornelison ’81, a program director in the National Cancer Institute’s Division of Cancer Prevention and an assistant professor of obstetrics and gynecology in the Division of Gynecologic Oncology at Johns Hopkins University School of Medicine. "There is a general mistrust of individuals involved in the medical profession. There is a feeling based on historic experience that minorities may receive a different quality of care and may be exploited. These barriers are hard to surmount."

Jo Anne Earp ’65

Jo Anne Earp ’65, chair of the Department of Health Behavior and Health Education, University of North Carolina School of Public Health, maintains that the gap between rich and poor is a societal problem that must be solved. "As a public-health researcher, I am much more worried about poor women and men than I am about limited opportunities for upper- or middle-class women," she says. "I think our priorities should first be to close the racial and economic gaps, although in many developing countries those socioeconomic differentials are also gender differences."

Poor women are coping with practical issues that make it difficult for them to participate in research. "I work at Columbia Presbyterian Medical Center in Washington Heights, which has a very high Hispanic population," Giardina explains. "If you sit in the cardiac clinic, you’ll see a lot of children. The children are there because our patients are babysitting for their grandchildren. To ensure their continued participation in clinical studies, we may need to provide transportation or cab fare, and offer a room where the kids can play while their grandmothers are seeing the doctor."

What can be done? "The first thing we need to do is help people understand the crucial importance of representation in a study," Cornelison says. "If their population is not represented, the knowledge gained may not benefit their health care."

Building Community Trust

Howard has conducted numerous studies over the years involving women, African Americans, Native Americans and other minority groups. She is chair of the steering committee and a principal investigator for the Strong Heart Study, a large longitudinal and family study of heart disease and diabetes in Native Americans, which began in 1988. "Ours is one of the few successful studies in this ethnic group," she asserts. "There’s an absolute, cardinal rule if you want to do studies in minority communities: you have to ask their advice and you have to take it.

"With the Strong Heart Study, we’ve worked very closely with the tribes to make this a community-led study. In our WHI trial, we’ve really worked hard to go into the African-American community to gain their confidence."

Earp also advocates this type of approach. Her team recently studied the effectiveness of a lay health adviser network in increasing mammography screening among African-American women ages 50-plus in rural North Carolina. The researchers trained local women to become health advocates encouraging their peers to seek mammograms. "These were the powerful women in those communities — the pastors in the churches, the movers and shakers," she explains.

Community-wide mammography use increased 6 percent, while low-income women in intervention counties showed an 11-percentage-point increase above that by low-income women in comparison counties.

Increased Representation

Ultimately, closing the knowledge gap in women’s health will also depend on increasing the representation of women and other minorities in the health professions. "We need to place more health care providers who look like the participants we are trying to study," Cornelison says.

Howard agrees: "There’s a real gap in the number of Ph.D.s and M.D.s coming out of most of the minority communities and going into research careers."

Can colleges such as Bryn Mawr help close this gap? "Without a doubt," Vogel asserts. "I found that being a science major at Bryn Mawr was a tremendous opportunity. Bryn Mawr gave everybody an opportunity to be heard, to participate and to be motivated to pursue careers in science and medicine."

The role of women’s colleges in increasing the number of women in leadership positions in science and technology careers was a major theme of a recent Bryn Mawr symposium on "Women in Science" (see Bryn Mawr S&T, January 2002). Toby M. Horn ’72, Office of Academic Services, District of Columbia Public Schools, said, "Women’s colleges and small liberal arts colleges have the best potential to encourage women to major in math, science and technology."

About Our Sources

Barbara Viventi Howard ’63, president of the MedStar Research Institute, Washington, D.C., majored in biology at Bryn Mawr and received a Ph.D. in microbiology at the University of Pennsylvania. She is a principal investigator for NIH’s Women’s Health Initiative and has conducted studies of health risks in women, African-Americans, Native Americans and other minority groups.

Donna L. Vogel ’71, director of the Fellowship Office at NCI, majored in chemistry at Bryn Mawr. She earned an M.D. and Ph.D. in developmental biology at the Albert Einstein College of Medicine. Vogel has conducted clinical and basic research in NIH’s intramural research program and has had leadership roles in training and career development, clinical research and minority/disability issues.

Elsa-Grace Giardina ’61, professor of clinical medicine at Columbia College of Physicians and Surgeons and director of its Center for Women’s Health, majored in history at Bryn Mawr. She earned an M.D. at New York Medical College. Giardina is the principal investigator on several grants that focus on the presentation of women with heart disease and the biological effects of medications and hormones on the heart. As director of the Center for Women’s Health, Giardina is responsible for sex/gender health education of medical students and house staff of the College of Physicians and Surgeons. She practices cardiology in Manhattan.

Terri Cornelison ’81 is a program director in the Breast and Gynecologic Research Group of the Division of Cancer Prevention at the National Cancer Institute, assistant professor of Obstetrics and Gynecology in the Division of Gynecologic Oncology at Johns Hopkins University School of Medicine, and a gynecologic oncologist practicing in the Washington, D.C. area. A chemistry major at Bryn Mawr, Cornelison received an M.D. at Yale and a Ph.D. in molecular and cellular oncology at George Washington University.

Jo Anne Earp ’65 is department chair and professor of health behavior and health education at the University of North Carolina School of Public Health. She is a medical sociologist whose research interests focus on the role of social and attitudinal factors in explaining variation in health behaviors, particularly early detection of cancer and other women’s health issues. Earp majored in English at Bryn Mawr and earned an Sc.D. in Behavioral Sciences at Johns Hopkins University School of Public Health.

About the Author

Dorothy Wright contributes news and feature articles on science, technology, engineering and general interest topics to a variety of publications, including Civil Engineering, Engineering News Record and Bryn Mawr Now.

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