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Introducing Jonathan Freedhoff, M.D.


November 1, 2000
The "Problem of Women": Clinical Trial Bias in Women's Health Care
By Leah Shafer

Illustration: Carrie Cox

No one would guess by looking at Marguerite Behn that she is a medical pioneer of sorts. The trim 78-year-old grandmother lives in a North Carolina retirement home, and she likes to swim three times a week. Retired 14 years now, this schoolteacher takes her husband for long walks every day; he has been confined to a wheelchair since having two major strokes and developing Alzheimer's disease. Come mealtime, she makes her way to the community dining hall, takes a food tray to her table, and makes history.

Behn is participating in the Women's Health Initiative (WHI) -- an expansive, $635-million, 15-year, multifaceted study of postmenopausal women. It's the first of its kind. With every meal she eats as part of her study, Behn is contributing to knowledge about how diet and nutrition affect health. In fact, she is part of a first wave of women participating in a nationwide medical study specifically about women.

Ten years ago, a government study on women's health shocked Americans and catapulted many people into action -- it was a sort of "shot heard 'round the world." This study revealed that the very medical research used to understand illnesses and develop remedies for them was virtually ignoring women on all levels. The medical community as a whole was not even considering women in clinical trials and research. Landmark studies on estrogen and heart attacks; aspirin and mortality; vitamins; cancer; and cholesterol were done on men only. This male-only clinical trials bias made no sense, given that both sexes are killed by many of the same diseases, especially heart disease, cancer, and stroke.

Behn, through her daily participation in the WHI study, represents the increasing participation of women in clinical trials of all sorts. This is a step in the right direction, but there's still a long way to go. After all, the point of all this is not just to give women proportional representation, but also to analyze the results of clinical trials for gender-specific differences. Some researchers are simply not doing that, and until they do, scientific understanding will remain precariously perched on a point between two paradigms: women's health as solely the maternal condition or women's health as a miniature version of men's. Neither one will pave the way to a healthy future for women.

Very real differences

So what of this "problem of women," as Sigmund Freud put it? Can women and men really be that different?

The answer is a resounding "yes," says Marianne Legato, M.D., professor of clinical medicine at Columbia University of Physicians and Surgeons and a charter member of the Advisory Committee on Research on Women's Health at the National Institutes of Health.

"Sex-based biological differences affect all the systems we've looked at so far and the way they react to disease," Dr. Legato says. "We are in a tremendous time warp; we are just beginning to understand the differences between men and women."

These differences are often quite fundamental: Women's bodies and men's bodies respond differently to both illness and remedy. But this situation is couched in a certain irony; historically, women's health has meant one thing only -- maternal health. To the medical community, women were essentially considered "walking wombs." So on the one hand, doctors wanted to make the ability to bear children the most important part of being female. On the other hand, however, they wanted to ignore all bodily implications and reactions to the very hormones that make childbearing and menstruating possible. Those hormone cycles make women systemically different from men and affect everything from the prevalence of certain diseases, such as osteoporosis, to the way drugs are absorbed and metabolized by the body.

Changing this historical inequity has been a very slow process. But the process sped up ten years ago in America and involved the cooperation of America's powerhouse of federal medical research, the National Institutes of Health (NIH).

A quick look in the rearview mirror

The NIH named its first female director in 1990, Bernadine Healy, M.D., and she took up the issue with gusto. A tremendous amount of action in the past decade has moved women's health research from virtual obscurity to national prominence. Dr. Healy created the Office for Research on Women's Health, which serves as a focal point for women's health research at the NIH, and as a whole the NIH has spent millions of dollars trying to bridge the knowledge gap. Because the NIH funds more than 90 percent of basic biomedical research done in the United States with its $11 billion annual budget, this attention is critical. The NIH revitalization act of 1993, created and passed by Congress, made it illegal to exclude or ignore women in medical research.

But the NIH isn't the only government institution involved in women's health research. The U.S. Food and Drug Administration (FDA) has funded more than 100 scientific projects through its Office of Women's Health; these projects include research into women and HIV, breast implant safety, women and autoimmune disease, and breast and ovarian cancers.

When we speak of major studies, we naturally return to the Women's Health Initiative and Marguerite Behn. The WHI is so special because it aims to answer questions about hormone replacement therapy after menopause and about the effects of calcium and vitamin D supplements and diet on heart disease, cancer, osteoporosis, and other disease processes. It's the first major study to look at socioeconomic, cultural, ethnic, and racial factors in relation to the kinds of diseases women get and the way they respond to treatments for those diseases.

The final results from the studies won't be available until 2005 or later, but several notable things have already come from the WHI, including an April 2000 report showing that a small number of women taking hormone replacement therapy have an increased risk of heart attacks, strokes, or blood clots during the first two years of use.

Behn is not in the hormone replacement therapy study, but is instead in one looking at the effects of diet on disease and mortality. This involves eating a structured diet that is rich in vegetables, fruits, and grains and is limited to 24 grams of fat a day, about the amount in a 4-ounce hamburger patty. She's been doing this for five years and has no intention of stopping. "I'm motivated because I feel that I'm doing something that's good for myself and for other people because I've invested this much time already," she says. "Also, all my life I've made some sort of contribution."

Getting the numbers to count

Undoubtedly, we have the science and the funding to narrow the significant knowledge gap on women's health issues. The United States commits $25 billion to $30 billion of private and public money to medical research annually, the largest amount in the history of the world. But amidst this plentiful bounty, one of the biggest barriers is getting women -- especially premenopausal and minority women -- to participate in research studies and clinical trials. Many women don't know much about medical research and may be wary or wholly unaware of it.

"Since women have traditionally not been included in trials, they need to be educated about them," said Phyllis Greenberger, executive director of the Society for Women's Health Research. "Women want and need different things than men in these trials ... for example, child care, hours of participation that are convenient, and sometimes transportation."

A future system modeled on today's successes

Creating studies for women begs the question: Will women volunteer their time and energy? They must, or the scientists working with this first wave of women will find their efforts blocked by a seawall.

The medicine of the future is based on the wisdom of today and the research of the past, so it will take longer than a single decade of studies to change centuries of thinking about women's health. We need to understand the mechanisms of disease in both men and women so we can treat everyone, Dr. Legato says. Scientists must continue to produce research that proves that women and men are different creatures with unique medical needs and that women's health means more than maternal health, so we don't subscribe to the old physician's adage of the nineteenth century: "Almighty, in creating the female sex, [has] taken the uterus and built up a woman around it."

Another area to keep an eye on is the inclusion of minority groups, specifically female minorities, in these same clinical studies. As the medical community lifts its gaze from 18- to 65-year-old white men as the standard subject for research studies and medical treatment, it becomes easier to answer questions about our biology as humans and create greater health care for everyone.

Related links:

Outside link: Office of Research on Women's Health at the National Institutes of Health

Outside link: Cancer Trials, a service from the National Cancer Institute

Outside link: Women's Health Initiative