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Beyond the 'Bikini View'
Scientists Urged to Expand Gender-Specific Research Portfolios

By Carla Garnett

On the Front Page...

Sex matters. It's that simple — and that complicated, according to an Oct. 21 lecture sponsored by the Office of Research on Women's Health to kick off NIH's new intramural research agenda on women's health.

Continued...

"I think it's highly appropriate that — after having made sure that the way we do research and the way we support activities in the extramural program correctly address women — we finally come around to the intramural program," said NIH deputy director Dr. Ruth Kirschstein, in opening remarks. The first director of NIH's Office of Research on Women's Health, Kirschstein introduced the keynote speaker for the first in a series of lectures that also launched the women's health scientific interest group at NIH.

In a lecture titled "Women's Health in the 21st Century: Morphing into Sex-Based Biology/Gender-Specific Medicine," keynote speaker Dr. Marianne Legato, a cardiologist who founded and directs the Partnership for Gender-Specific Medicine at Columbia University's College of Physicians and Surgeons, challenged her colleagues to answer a fundamental question: Is women's health relevant to the general health of everybody or should it be isolated emotionally, scientifically and geographically in women's health centers, in offices of women's health or in pockets of interest in women's health?

As Legato proceeded to outline, the query wasn't necessarily a criticism of women's health efforts to date, nor was it strictly rhetorical. Examine the emphasis placed on women's health in the past two decades, she urged, and determine whether much of the focus may have been put on a still-too-limited view of female biology.

"What does women's health really mean?" Legato asked the Wilson Hall audience. "Does it go beyond the 'bikini view,' that is, breast health and reproductive biology? [I know] many physicians in the real world outside of this academic campus and my own academic island. I can tell you that the bikini view is the view most practicing physicians have of women."

Legato began by stressing the difference between the terms sex and gender. "Imprinting and hormonal factors determine the developmental sequence and characteristics of biological systems, or sex, of the individual," she said. "Gender is the result of implanting an individual into a culture or society, which assigns them relative value and gives them specific roles to play by virtue of their biological sex. These factors are important determinants of health that affect the quality and function of biological systems."

That culture and society have played nearly as vital a role as science and medicine in carving out a niche for women's health may be evidenced by the proliferation of so-called bikini-view medical centers around the nation, she said.

"I can tell you that women's health centers are one of the most powerful marketing tools of the last decade of the 20th century and the early part of the 21st century," Legato pointed out. "Whether women's health is a scientific imperative is another and different question."

Citing a 2001 Institute of Medicine (IOM) monograph that concluded, "Sex does matter. It matters in ways that we did not expect. Undoubtedly, it also matters in ways that we have not begun to imagine," Legato said gender-specific research – "not a synonym for women's health research," she stressed — has revealed as yet only the tip of a very large iceberg.

"We never imagined the scope and significance of the differences between men and women in all the systems of the body," she noted. "The IOM monograph illustrates so nicely why being male or female is not simply a question of hormones and begins before hormonal impact is even felt."

Legato then pointed out a number of critical differences or potential differences between male and female biology that deserve further study. Beginning with genetics, for example, she noted that Y-chromosome-linked DNA contains genes involved in basic cellular functions and that in the female, one of the two X chromosomes is randomly silenced in a process called lyonization. (Two of the 46 human chromosomes — the X and the Y chromosome — determine sex. Females have two X chromosomes and males have one X and one Y chromosome.)

Bones also vary between the sexes in possibly important ways, according to Legato. Distinct age-peaking for bone mass in women — usually by the early 20s &150; can be documented; in men, maximum bone density is achieved much more gradually and plateaus later, by age 30. A period of accelerated bone loss occurs in women at menopause and continues for about 5 years afterwards. "What is not clear is whether the bone loss is related only to estrogen deficiency," Legato said, explaining yet another indication for gender-specific research. "Counseling therefore could differ [for men and women] on how and when to adjust lifestyle to achieve and preserve maximum bone density."

In addition, the cardiovascular system — from the size, shape and electrical system of the heart to the protein channels and receptors of the cardiac cell membrane — is different in some respects in the sexes. Women have faster heart rates than men. These differences may prove to be crucial considerations for preventing, diagnosing and treating heart disease, the nation's top killer of both sexes, she said.

Legato also offered brief highlights on the roots of research on women's health. In 1900 the average life expectancy for a woman was 48. Menopause and diseases of aging were not a priority. "As you can imagine," she said, "the focus was on maternal survival in childbirth, survival of infants and small children, infectious disease and conditions that arose from poor public sanitation."

Legato said it was "inevitable that the parallel phenomena of feminism and the explosion of American science and technology would both grow out of World War II. The rumblings certainly began after WWII, but the preeminence of women's health has only been accomplished since 1985 — the date of the Public Health Service's first formal statement that we knew nothing about women's health directly. It's a short history, a powerful history and a very recent history."

Legato said she includes the history lesson in her lectures for those "who think that women haven't been studied directly simply because men have all the power and they don't like or care about women. That's simply nonsense. The current concern about women's participation in clinical studies arises from two very well-entrenched — and diametrically opposed — public policy positions: protectionism of women and access to the benefits of participation in clinical investigation."

Protectionism, she explained, was a reaction to the atrocities to vulnerable populations such as prisoners, women and children that were uncovered at the Nuremberg trial in 1947. More than 30 years later, the Belmont report of 1979 advocated justice in clinical investigation. A statement of basic principles by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addressed the ethical problems surrounding the conduct of research with human subjects. The report said that if women were to reap the benefits of research, then as a matter of justice they would have to take the risks of participating as subjects in clinical investigation.

A 1994 IOM monograph, Women and Health Research: Legal and Ethical Issues of Including Women in Clinical Studies concurred "that women and men should have the opportunity to participate equally in the benefits and burdens of research."

Legato said the IOM document was pivotal, and its conclusions perhaps somewhat humbling for biomedical scientists. "There is no question that this was the first thoughtful reflection on the possibility that men and women might experience disease differently," she explained. "It also acknowledged the very important point that scientists had made the assumption — without confirmatory testing — that what we learn from studying men could be extrapolated to women without modification. I still find that — as an NIH-supported, traditionally trained investigator — the most mind-boggling part of our approach to women's health. We never questioned the fact that every one of us was selecting males at all levels — from tissue culture to humans — to do medical investigation and making the leap that the data could be extrapolated to women without modification."

Acknowledging the host of unanswered questions that would be prompted by increasing gender-specific studies, Legato urged discourse instead of dismissal: "This is something that I think needs significant debate at the NIH and in a public forum right now. There are still very important ethical, moral and economic issues in studying the premenopausal woman and we haven't even debated these in a formal way, much less developed any solutions for them."

Legato said the IOM monograph forecast in a blunt assessment where a limited view of the field could lead: "Our moral analysis of our practices considering the inclusion of women in clinical research will fail to capture all that it should, if we restrict our focus to the charge of exclusion and underrepresentation."

Legato concluded that for many in the science community — even among some women's health advocates — the sea change for gender-specific research must begin with a much broader attitude, a multidisciplinary approach and a look at women across their entire lifespan. "We have to move from 'We don't want to be victims anymore' to 'We have an irresistible offer to make to the general public: to study us is to reap a rich harvest indeed,'" she said. "Outcome studies are essential if we are to justify and maximize a continuing interest and investment in women's health. Women have to be studied firsthand if we're really going to have reliable information."


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