IN RESEARCH, WOMEN DON'T MATTER

...These were significant findings with obvious and important implications for the treatment of tens of thousands of hypertensive women...

...It's very unscientific...

...What if national publicity about the health risks of fat led women to reduce their fat intake by 5 or 10 or 15 per cent over the next five or ten years...

...I think it's malpractice to put a woman with a cholesterol level of 235 on drugs to lower it to 200...

...We see side effects all the time...

...We don't know a goddamn thing about women and cholesterol," she says...

...Researchers seldom recognize that women are different," says P. Ellen Parsons, a survey statistician at the National Center for Health Statistics...

...It was finally accepted by a small journal, the New York State Journal of Medicine, after review by twice the usual number of readers...

...I think the self-reported data were reflective of what the women were doing"—using less fat...

...We figured out that if women and men are different, we needed to double the number of people in our study to show results...

...The GAO report questions whether the policy is implemented even now...

...Whether sexism or legitimate concern drives the individual decisions about funding or designing a particular study, the consequences of not doing research on women touch everyone...

...In that closed session, the NCAB said it was rejecting the study for policy reasons, but the letter sent to the investigators cited "scientific problems...

...Why were major journals so reluctant to publish important clinical findings...

...Was Diet FIT rejected because of design problems or because of sexism...

...The answers to these questions come from studying thousands of patients," she says...

...I aggressively treat black women and black and white men...

...their self-reports were not questioned...

...She points out that women in their fifties with a cholesterol level of 290 are half as likely to have a heart attack as a man of the same age with a level of 230...

...She adds that the Center has no institutional plan for generating information on women...

...They would mention that it was easier to keep the kitchen clean, easier to wash pots and pans...

...At that point, the original investigators accused Schnall and his colleagues of illegally and immorally publishing their data...

...Schnall suggests that their article stepped on too many toes...

...If I have a patient with hypertension and I treat her and she gets a heart attack and then I see this article by Peter Schnall, I think, 'Oh no, this is why she got the heart attack.' But if I did not treat her, I'd think that was the reason she had the heart attack...

...In a rare cooperative gesture, the National Heart, Lung, and Blood Institute offered to help pay for the study—if NCI sponsored it...

...Ramey finds the lack of research on women and heart disease particularly appalling...

...To be perfectly honest, I still treat everybody, but with discomfort for white women...

...In general, the lack of research exploring whether men and women, blacks and whites, respond differently to the same treatment means that doctors in communities all over America don't have the information they need to treat their patients correctly...

...The Women's Health Trial collapsed...

...We don't know if treatment is helpful or harmful...

...The division's board of scientific counselors will review the idea at its October meeting...

...One test that was considered was serum cholesterol...

...We don't know what it can do, long-term...

...You can only tell by looking at large populations...

...In a telephone conversation, one editor said the article was too "hot" for them...

...However, researchers and women around the country are beginning to ask why...

...He has just added 100 women to his study of hypertension and workplace stress...

...There are signs of change...

...However, the National Cancer Advisory Board again turned it down in closed session...

...Ramey notes the large studies of men who were taught to cut down on saturated fats...

...There are always side effects," she continues...

...It got men to reduce their smoking, saturated fat intake, and blood pressure...

...For one thing, lack of previous research on women is seriously hindering new research on women...

...This new Diet FIT proposed to follow 24,000 women aged fifty-five to sixty-nine for five years...

...After further analysis of the HDFP data, Schnall and his colleagues wrote an article describing what they found...

...Perhaps the project's name was unfortunate...

...The medical profession will not accept criticism from people who do not have a reputation...

...And it was going to study women—only women...

...When the Diet FIT study was being reviewed, it was frequently referred to jokingly as Ms...

...sex, race, and severity of disease...

...At their July retreat, the division's branch directors approved an expenditure Barbara Berney is a Pew Fellow in Health Policy at Boston University...

...The New England Journal of Medicine, the Journal of the American Medical Association, and Lancet all rejected it without comment...

...Two thousand women in Houston, Cincinnati, and Seattle had signed up to participate...

...But he did more than that...

...It can be the difference between life and death...

...They say they ate something, that's what they ate...

...It questioned the wisdom of the NIH and the researchers of the Hypertension Detection and Treatment Project...

...It sounds like a lot...

...Representatives Patricia Schroeder, Democrat of Colorado, and Olympia Snowe, Republican of Maine, cochairs of the Congressional Caucus for Women's Issues, charged that women's health has been put at risk by medical-research practices that fail to include women in research studies...

...Large studies of women are uncommon...

...The general feeling is that no one could reduce fat intake that much and still have a palatable diet...

...Research left undone endangers women, in Ramey's outspoken view...

...The official reason was budgetary constraints, but the study was limited to men only...

...Is it linked to liver cancer or what...

...Many would say—in good faith—that these facts also make such studies less urgent...

...In June, U.S...

...Black women in the hypertension study benefited the most from the study's prescribed treatment...

...When the National Cancer Advisory Board rejected funding for the Women's Health Trial, it criticized the study design and suggested that the researchers look at more diseases than just breast cancer—although one in ten women can expect to develop breast cancer and 40,000 American women die of this illness every year...

...Men continue to study men," he says, "and it's not surprising that the women studying heart disease, such as Suzanne Haynes, study it in women...

...Or had it...

...A report and contract specifications are in the works now...

...Estelle Ramey is another researcher who worries about the consequences of the lack of research on women...

...Its goal was to reduce the incidence of the disease, but at the end of eight years, while the project was successful in reducing the three risk factors, the men who received the special intervention did not have a lower rate of death from coronary heart disease than those who did not...

...So six times as many women die of heart disease," she says...

...I stopped treating people with hydrochlorthiozide," he said...

...That is the attitude...

...More than 300 had already enrolled in a feasibility study and learned new ways to shop, cook, and eat...

...Schnall was shocked to see that white women with moderate and severe hypertension who received special treatment (called "stepped care") through the study had died at more than double the rate of those who had not...

...But the Congressional hearings seem to be having an effect...

...Peter Greenwald, director of the National Cancer Institute's Division of Cancer Prevention and Control, has not lost interest...

...It's a satisfying intellectual answer, but subject to accusation that you are sexist...

...They just lack knowledge about diet," she says...

...But to go from 30 to 20 per cent takes intensive education...

...However, according to a General Accounting Office study, guidance for implementation of the policy was not published until July 1989...

...I'm lucky because most of my patients are black...

...They refused to share the data...

...Yet the differences between men and women can be important to both patients and doctors...

...The study was controversial in part because it would have been the single most expensive randomized trial ever conducted by NCI...

...If you separate the results of research into its component parts, you're calling for doctors to change their approach to their patients, according to Schnall...

...What had happened...

...It reminded everyone in the health-research community of MRFIT (pronounced "Mr...

...Some reviewers and staffers were concerned that NIH might again fund an expensive trial and get negative results...

...it was reviewed again at the NCAB meeting in December, and turned down again...

...While waiting for the outcome of this promised research, women can cut down on fat in their diet...

...All the women dead in the cemetery would be surprised to hear that it's a man's disease...

...What is known about serum cholesterol comes from large heart-disease studies...

...On a cold January day in 1983, just after he'd taken a new job as assistant professor of medicine at Cornell Medical College in New York City, Schnall was standing at his colleague's desk looking over a paper...

...They have never been collected...

...More and more scientists will be women and minority-group members, as the president of the American Association for the Advancement of Science pointed out recently...

...This group had 168 per cent more deaths than the group of similar women in the control group, who did not receive treatment through the study but were, instead, referred to their own physicians...

...Board member Howard Temin threatened to resign if the project were not reconsidered...

...Serum-cholesterol changes in women in their fifties, and the changes are different from the changes that men experience...

...Anastos confirms this from her Brooklyn practice...

...Researchers often deliberately exclude women, and even female animals, from their studies...

...next were black men, then white men, and finally white women, who seemed to be harmed by it...

...They sent it to three prestigious journals that practicing physicians use to keep up with research that helps them treat patients...

...It's very difficult...

...He consulted with Michael Alderman, chair of the department of social medicine at Albert Einstein Medical College, and Rochelle Kern of Columbia University...

...We don't know anything about women and diet...

...In October 1986, the NIH announced a new policy that proposals including women and minorities in their study populations would receive more favorable consideration for funding than those that exclude them...

...In January 1988, funding for the full study was denied...

...of $10 million a year for dietary-intervention studies on middle-aged women...

...Turning down Diet FIT was a gross slap in the face to all women...

...Then Diet FIT might not pick up any difference between the women who were specially taught to reduce their fat intake and women who were not...

...The NIH Task Force on Women's Health Issues recently sent its report to the Institutes' acting director, recommending expansion of research on women, especially low-income women and women of color...

...Principal researcher Maureen Henderson and her colleagues went back to the drawing boards, changing the study's design to look at colon/rectal, ovarian, and uterine cancer, as well as breast cancer, and also added heart disease...

...But critics doubt that claim...

...It is easy to reduce fat intake from 40 per cent (close to the average for Americans) to 30 per cent...

...David Byar, the chief of NCI's Biometry Branch and a supporter of the Women's Health Trial, responds that its very concentration on women worked in the study's favor...

...In her testimony at hearings on the matter, Schroeder expressed outrage at NCI's refusal to fund Diet FIT...

...This is the in-crowd," says Schnall...

...One question raised about Diet FIT was that there was no good lab test to corroborate the amount of fat women reported eating...

...It was reviewed by scientists inside and outside the National Cancer Institute, and they scored it high enough to receive funding...

...The National Heart, Lung, and Blood Institute will probably contribute, as may other institutes of NIH...

...I cannot figure them out in my office...

...According to NCI's Byar, the division is looking for ways to include women in the trial...

...The study was to follow 6,000 women for ten years, looking for links between dietary fat and breast cancer...

...Stepped care" seemed to be killing white women aged thirty to sixty-nine who entered the treatment program with a diastolic blood pressure of 105 or more...

...Hypertension means high blood pressure...

...MRFIT was a large study of middle-aged white men with a high risk of coronary heart disease...

...Estelle Ramey, physiology researcher and women's health advocate, says NIH just didn't think you could trust women to tell you what they ate...

...It was entitled "Sex Hormones and GS Ratings...

...However, it grew to only 13.5 per cent of the NIH budget, though women are more than 50 per cent of the population...

...But in terms of serious complications, there is no way to tell their cause on a case-by-case basis...

...FIT (pronounced, of course, "misfit...

...But as Carolyn Clifford, the project officer at NCI, reports, "We just don't have data on serum cholesterol and diet in women...

...Heart disease has long been considered a man's disease, because men die of it at a much younger age than women do...

...She is seventy years old and going strong...

...If some dietary-intervention study like the Women's Health Trial or its newer version, Diet FIT, is not funded, we may not find out...

...You're calling for them to take an individualized approach to treatment...

...Senior NCI staffers have suggested that the Board had not read the study before voting on it and may not even have received the staff's review...

...Doctors change the drugs they prescribe because of what they read in the literature, Schnall says, but which patients they treat really depends on the recommendations of the Joint Commission on Hypertension...

...Reviewers also raised questions about whether women would really reduce their fat intake by half to only 20 per cent of calories, and whether researchers could tell if they had...

...The National Institutes of Health (NIH) Task Force on Women's Health Issues said the study was suspended because of problems with its methodology and competing hypotheses...

...A new version of the study, now called Diet FIT (short for Dietary Fat Intervention Trial), was voted down "for policy reasons" last December...

...But she does worry about the research left undone...

...It was one of many funding decisions made that day, but it was not ordinary...

...You have to cut fat and oils a lot, substitute jam or jelly for spreads like butter or margarine, substitute yogurt for sour cream and mayonnaise, and modify recipes to cut fat...

...When, for scientific reasons, they have to limit diversity, they choose to study themselves...

...White men control these things," she says...

...Kathy Anastos, an internist practicing in Brooklyn, New York, agrees...

...From 1986 to 1987, the proportion of the NIH budget devoted to research on "women's health issues," very broadly defined, grew by 8 per cent...

...Cholesterol seems much less dangerous in women than men...

...This is the power elite...

...Carolyn Clifford is the NCI project officer for the Women's Health Trial...

...Working in a cramped office near the NIH campus, she acknowledges that cutting fat to 20 per cent is difficult...

...I asked Schnall what he did when he saw those results...

...The debate over funding the Women's Health Trial raged within the scientific and women's health communities for months, and it is not yet over...

...Since women get heart disease later in life than men, and since their rate of heart disease is lower than men's, it is more difficult and expensive to study heart disease in women...

...There are no baseline data...

...But Dr...

...Anastos, on the other hand, believes the lack of research on women is "clearly and unequivocally sexism...

...The feasibility of the larger, long-term study had been demonstrated...

...So we studied men because that's where the results already are...

...I first met her ten years ago when she gave a lunch-hour talk about the nonphysio-logical basis for sex discrimination in the workplace...

...Then when they get the results, they apply them to everyone...

...Nevertheless, as Ramey points out, of 2,000 postmenopausal women, twenty will get serious heart disease and twelve will die from it...

...For example, cholesterol: "The new anticholesterol drugs are a mine field," she says...

...But Clifford says the feasibility study for the Women's Health Trial showed it could be done...

...Fit"), the Multiple Risk Factor Intervention Trial...

...I feel I have to adhere to the standard of practice...

...Amazing as it may seem, there are not even good incidence data on nonfatal cardiovascular disease in women...

...Tables at the end of the paper showed the results of treatment by...

...He contacted the authors of the paper and asked to look at their data so he could try to figure out why the women had died...

...Yes, there were methodological arguments about the Women's Health Trial and Diet FIT, but many women at the Institute felt the objections grew from the fact that the study concentrated only on women," says Suzanne Haynes, a longtime NIH researcher...

...Peter Greenwald recently halted a large screening study on prostate, lung, and colon/rectal cancer...

...Peter Schnall is a young-looking, soft-spoken internist whose professional passion is workplace stress and high blood pressure...

...Six of the same 2,000 will get breast cancer and two will die...

...And what are the consequences of not looking at existing studies to see how men and women differ...

...I asked her about the problem of drug side effects...

...It's Catch-22...

...The paper discussed the results of a large hypertension study—called "HDFP," for hypertension detection and follow-up program—which suggested that everyone with hypertension would benefit from systematic treatment...

...All the large heart trials have been done in men, and this is women," Clifford says...

...At the end of two years, the study's principal investigator, Maureen Henderson of the Hutcheson Cancer Center in Seattle, reported that study participants had cut their fat intake by half, to about 22 per cent of calories...

...When the scientists and advisers who decided to cancel the Women's Health Trial made their decision in a secluded meeting room on the sprawling NIH campus in Bethesda, Maryland, they affected women all over America—and possibly the world...

...They can push their physicians to look at them as individuals with individual risk patterns to take into account when deciding on treatment—especially important in preventive treatment, which involves risks taken to prevent a disease that may never occur...

...Studying colon/rectal cancer and excluding women finally raised a red flag...

...Ramey recently retired from a career in physiology research...

...Peter Schnall explains exclusion of women this way: "Researchers are following tradition...

...It also challenged the Joint National Commission on Hypertension, a group associated with NIH whose recommended treatment protocols establish what is "state of the art" medical care...

...Men never lie," Ramey says sarcastically...

...For white women with hypertension," she says, "we don't know what we are doing...

...We were upstarts...

...What was this fight really about...

...According to Brooklyn physician Anastos, lipids are thought to protect women from heart disease in a way that changes at menopause...

...We don't know if or how lipid metabolism changes at menopause," she says, "because the studies do not ask women about menopause, not even, 'Do you still have your period or do you get hot flashes?' They just use some arbitrary age...

...Vincent DeVita, who recently resigned as director of NCI, has called Diet FIT a big gamble...

...MRFIT was expensive: $ 130 million over eight years...

...It was titled, "Should Mild Hypertension Be Treated...

...And they go on to ask two other important questions: What are the consequences of not doing research on women...

...Furthermore, both the Women's Health Trial and Diet FIT deal with post-meno-pausal women...

...And women can join groups such as the National Women's Health Network and the Association for Women in Science that speak out and intervene on behalf of women in the research and health communities...

...Barbara Berney is a Pew Fellow in Health Policy at Boston University...