If you (or your mother) were recently saved by a doctor who correctly diagnosed what you thought was indigestion as, in fact, a heart attack, you can thank the small band of mostly female M.D.’s who found a way to make medical gender bias politically sexy. Through backstage maneuvering, they got the members of Congress to look at two massive, federally funded studies of heart disease in 1990 and say, basically, What do you mean, you only looked at men? No women? Heart disease was – still is – the leading killer of both sexes. But as doctors now know, it manifests itself differently in men and women.
In 1993, the exclusion of women from any relevant federally funded research was banned by law. Soon after, the Food and Drug Administration began monitoring clinical trials to ensure the inclusion of women. So began the second flowering of the women’s-health movement, a kind of hard-science follow-up to the assertiveness training of Our Bodies, Our Selves.
It is now a movement of such scope that the flag is waved by everyone from survivors lobbying for more breast-cancer research to the pharmaceutical giants racing to produce more perfect designer estrogens. Biotech companies, medical-school faculty, senators in tough campaigns – everyone’s paying attention.
But some of those same, mostly female physicians have pushed on toward a next research frontier. Getting women into clinical trials was the easy part, they say. “The fact is that now you have to think about the differences between men and women – and that’s a much bigger problem. How do you design your experiments to include gender differences?” says Dr. Florence Haseltine of the National Institute for Child Health and Human Development (and founder of the influential Washington-based Society for the Advancement of Women’s Health Research).
The goal of advocacy groups like the SAWHR has subtly moved beyond getting scientists to give up their reliance on “the male model,” steering them toward a more thorough exploration of the basic biological differences between men and women in every organ, system, and function of the body. Gender-specific biology, as this emerging field is called, posits that every medicine you take, every treatment you receive, can have a different effect based on whether you’re female or male – and that those potentially critical differences have barely been explored.
Consider, for instance, differences that researches have found in just the past decade: that women are more likely than men to die within the first year following a heart attack; that women awaken more quickly from anesthesia; that woman smokers get lung cancer more frequently than men who smoke as much; that women are twice as likely to get a sexually transmitted disease and ten times as likely to contract HIV through unprotected sex with an infected partner. Why those things are true is less well known; still, that knowledge informs the way doctors advise and treat patients.
Considerations of gender ought to be integrated into medical research “on such a fundamental level that it really gets embedded in the system,” Haseltine says. Not coincidentally, this research shift has a political shading. Budget battles driven by advocacy groups can look like ugly gender wars: Why does breast cancer get more funding than prostate cancer? Research that looks at gender differences in disease, advocates argue, could improve care for both men and women, while filling in knowledge gaps resulting from the exclusion of women in research for so long. “This is not a one-way street,” says Phyllis Greenberger, executive director of the SAWHR. “Why are women living longer and getting their heart attacks later? Those are interesting questions. Maybe we can learn from women how to have men live longer and get their heart attacks later.”
A critical next step is to excite greater interest among the best medical theorists, whoever they are, the team behind SAWHR believes. “You want both males and females involved,” says Haseltine, “because you get more interesting thinking that way, and because you don’t want the field to be marginalized.”
Haseltine has the kind of mind that spins off more ideas in an hour than most people’s do in a year. This partially explains how she can run the Center for Population Research at the National Institutes of Health (NIH), plot research strategy with Greenberger, and run up to Yale (where she taught gynecology) to interview residents and find out how women’s health ranked in their medical-school curricula.
There’s certainly evidence that the subtle shift from thinking about women to thinking about gender differences has spread beyond Washington. Two years ago, a second front in the movement opened up in Washington Heights. At the Columbia University College of Physicians and Surgeons, professor of clinical medicine Marianne Legato has joined four major corporate sponsors in a partnership devoted to studying gender-based biology. The concept of gender-specific medicine was too new at the time to get it into the organization’s name, Legato says, so it was called the Partnership for Women’s Health. But she has just published issue 3 of the Journal of Gender Specific Medicine.
A cardiac specialist, Legato was not even thinking about gender differences, she says, until a medical writer approached her to collaborate on a book about women and heart disease in 1991. Describing her pre-1991 self as a “dyed-in-the-wool, conventional, conservative NIH baby,” she says the inquiry “opened my eyes to the notion that maybe women were not just small men, and maybe there was something to gender that was not fully explored.”
She wrote another book for practicing physicians highlighting some of the significant research so far in the field, and secured $1 million from Procter & Gamble, among others, to create an international database study of gender differences throughout the medical subspecialties. Legato is estimating that it will cost a half-million P&G dollars to do the first search, in the field of bone metabolism. The W.K. Kellogg Institute for Food and Nutrition Research – the cereal family – is backing a similar search in the field of nutrition.
Legato – a tall, deep-voiced woman of imposing poise who enjoys making mildly shocking remarks about the skepticism she’s faced within her own medical school – has a less-than-modest goal. It is to make the field of women’s health obsolete. “Instead,” she says, “there will be gender-specific medicine.”
Enthusiasm for this research template extends to researchers at prominent universities who are on the verge of new insights into the interplay of sex hormones and the immune system in autoimmune diseases, like multiple sclerosis, that predominate in women; into the function and metabolism of neurotransmitters in men and women; into the basic biological differences that make it harder for women than men to stop smoking. “Gender differences really turn people on once they try to think about them,” says Georgetown University Medical Center pharmacology chairman Raymond Woosley.
But the enthusiasm is not universal. Some scientists argue that age, ethnicity, and economic status are all better predictors of a person’s health status than gender. Others question how much of the way men and women experience disease differently is biologically determined and how much is social and cultural.
And how well does the science translate into more effective treatment? It’s been established that women metabolize food, alcohol, and atmospheric toxins differently from men and have greater sensitivities to many commonly prescribed drugs. It’s been established that pain is both experienced and relieved differently. The NIH has embarked on a major research effort aimed at targeting pain relief more precisely to males and females, and convened scientists for two days last April to discuss what’s known about the gender differences. There is also strong evidence that women metabolize drugs differently according to their age and where they are in their menstrual cycle.
But drug developers argue that it’s hard enough to get people to comply with their doctors’ orders and faithfully take their medicines. What happens when a woman is supposed to take the blue pill during one week of her cycle, the red pill the next week? “That’s an issue in the real world,” Carol Braun Trapnell, director of medical affairs for the pharmaceutical firm GloboMax LLC, noted at a recent SAWHR update on gender-specific biology.
Woosley notes, “There’s been a lot of gender research for gender’s sake,” and while much of it has been of high quality, “frankly a lot of it was too simplistic.” This remains a problem in legitimizing the field and breaking down institutional resistance within such citadels of conservatism as the nation’s medical schools. “It’s a lot harder to change basic scientific research than you might think,” Haseltine says, understating.
“Senior people tend to be very set in their ways, and this is a brand-new idea,” says John Bilezikian, chief of the Division of Endocrinology at Columbia-Presbyterian Hospital. “I just don’t think it’s part of anyone’s mind-set to think there are huge differences between men and women biologically,” aside from the perfectly obvious ones.
On the other hand, Bilezikian says, there are plenty of senior doctors and researchers who are simply going forward with the science. His laboratory, for example, is looking at osteoporosis both in women – who get 80 percent of the cases – and in men. Bilezikian’s team hopes to improve understanding of how male and female hormones, to cite one instance, affect bone health.
Woosley has yet to get the major NIH grant he’s sought for his work, although he has used pilot funds from the NIH and the FDA to establish through his laboratory that there are more than twenty drugs that, when taken by women, could trigger potentially fatal arrhythmias, including one – tamoxifen – recently identified as a possible breast-cancer preventative. “There are probably another twenty or more,” he says, “that haven’t been studied yet that could affect the heart.”
Woosley believes that differences among women and men in drug reactions continue to be under-studied, mostly because the clinical research is so difficult to do. That’s where popular pressure applied to scientific committees – which sometimes favor basic research over clinical studies – can make a difference. Last year, Congress directed the federal Department of Health and Human Services to fund a report, to be done through the Institute of Medicine, that would set an agenda for gender-specific medical research.
“What we’re trying to do,” says Haseltine, who conceptualized the report, “is to get people who review the grants to know that this is a legitimate question, because the young men and women really want to look into this, but the old guys don’t think it’s of any interest.”
Columbia’s Marianne Legato believes that in the future we’ll see doctors who advertise themselves as gender-specific specialists in their fields. “I think we could set up cardiovascular clinics and treat hypertension and cardiac disease differently in men and women,” she says. “We could do it in headache and probably anxiety and depression. But we still have an infant science in most other disciplines.” Legato wants to end the ongoing “ghettoization” of women “in centers with mauve walls and flowered trellises, talking about their reproductive systems.”
Legato’s partnership is almost wholly financed by private industry. One concern among scientists like Haseltine is that if government doesn’t underwrite gender-specific studies, private industry will dash ahead outside the careful peer-review structure. Legato is fond of telling how, when she approached P&G for funding, she piqued the curiosity of company executives by noting the differences in flow rates and glucose concentrations in the saliva of men and women. There might be room in the marketplace, she noted, for male and female toothpastes. She says, “We believe, and I think we’ve proven already, that an understanding of gender-based medicine is an economic bonanza for companies.”
But drug developers argue that it’s hard enough to get people to comply with their doctors’ orders and faithfully take their medicines. What happens when a woman is supposed to take the blue pill during one week of her cycle, the red pill the next week? “That’s an issue in the real world,” Carol Braun Trapnell, director of medical affairs for the pharmaceutical firm GloboMax LLC, noted at a recent SAWHR update on gender-specific biology.
Woosley notes, “There’s been a lot of gender research for gender’s sake,” and while much of it has been of high quality, “frankly a lot of it was too simplistic.” This remains a problem in legitimizing the field and breaking down institutional resistance within such citadels of conservatism as the nation’s medical schools. “It’s a lot harder to change basic scientific research than you might think,” Haseltine says, understating.
“Senior people tend to be very set in their ways, and this is a brand-new idea,” says John Bilezikian, chief of the Division of Endocrinology at Columbia-Presbyterian Hospital. “I just don’t think it’s part of anyone’s mind-set to think there are huge differences between men and women biologically,” aside from the perfectly obvious ones.
On the other hand, Bilezikian says, there are plenty of senior doctors and researchers who are simply going forward with the science. His laboratory, for example, is looking at osteoporosis both in women – who get 80 percent of the cases – and in men. Bilezikian’s team hopes to improve understanding of how male and female hormones, to cite one instance, affect bone health.
Woosley has yet to get the major NIH grant he’s sought for his work, although he has used pilot funds from the NIH and the FDA to establish through his laboratory that there are more than twenty drugs that, when taken by women, could trigger potentially fatal arrhythmias, including one – tamoxifen – recently identified as a possible breast-cancer preventative. “There are probably another twenty or more,” he says, “that haven’t been studied yet that could affect the heart.”
Woosley believes that differences among women and men in drug reactions continue to be under-studied, mostly because the clinical research is so difficult to do. That’s where popular pressure applied to scientific committees – which sometimes favor basic research over clinical studies – can make a difference. Last year, Congress directed the federal Department of Health and Human Services to fund a report, to be done through the Institute of Medicine, that would set an agenda for gender-specific medical research.
“What we’re trying to do,” says Haseltine, who conceptualized the report, “is to get people who review the grants to know that this is a legitimate question, because the young men and women really want to look into this, but the old guys don’t think it’s of any interest.”
Columbia’s Marianne Legato believes that in the future we’ll see doctors who advertise themselves as gender-specific specialists in their fields. “I think we could set up cardiovascular clinics and treat hypertension and cardiac disease differently in men and women,” she says. “We could do it in headache and probably anxiety and depression. But we still have an infant science in most other disciplines.” Legato wants to end the ongoing “ghettoization” of women “in centers with mauve walls and flowered trellises, talking about their reproductive systems.”
Legato’s partnership is almost wholly financed by private industry. One concern among scientists like Haseltine is that if government doesn’t underwrite gender-specific studies, private industry will dash ahead outside the careful peer-review structure. Legato is fond of telling how, when she approached P&G for funding, she piqued the curiosity of company executives by noting the differences in flow rates and glucose concentrations in the saliva of men and women. There might be room in the marketplace, she noted, for male and female toothpastes. She says, “We believe, and I think we’ve proven already, that an understanding of gender-based medicine is an economic bonanza for companies.”
The question still on the table: How long will it take for gender-based research to translate as productively to the physician’s office as it does to the corporate world?