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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
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.’"
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.
"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."
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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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