In Her Own Right The Institute of Medicine's Guide to Women's Health Issues (1997) / Chapter Skim
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9 Research on Womnen, Women in Research
9 Research on Womnen, Women in Research
Pages 179-206
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From page 179... ...
But society has moved beyond attitudes that sanction genderbased exclusions and inviolate medical authority. Following the lead of AIDS activists, formerly excluded groups now assert the right to partici 179
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From page 180... ...
Together, these demands have triggered far-reaching reexamination of who participates in research, both as subjects and as scientists. "For the nation's research agenda to be just, it must ensure that medical research promotes the health and well-being of both men and women," states IOM's Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, which was appointed to examine the policies and practices that govern who gets to participate in and who gets to perform the clinical research that provides so much of our new medical knowledge.1 But its extensive study revealed a number of extrascientific factors that also shape research.
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From page 181... ...
Thus, any group -- such as women or racial minorities -- that is systematically underrepresented in clinical studies runs the risk of receiving treatments tested on people unlike themselves and thus potentially less effective or even harmful. So has biomedical research in fact slighted women?
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From page 182... ...
Thus, the committee could only conclude that "the available evidence is insufficient to determine whether women have participated in the whole of clinical studies to the same extent as men and whether women have been disadvantaged by policies and practices regarding their participation or a failure to focus on their health interest in the conduct of research."4 The committee did find two major -- and life-threatening -- exceptions. Though unable to "establish that gender inequity existed in the whole of past clinical research," it did find "evidence relevant to this issue in two areas of disease research: AIDS and heart disease."5 Important research projects of these two major killers of females "either exclude women altogether or include them in numbers too small to yield meaningful information about their treatment.
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From page 183... ...
The major risk factors -- high blood pressure, cigarette smoking, and obesity -- hold for both genders, but certain of the familiar male early warning signs do not. In a man, coronary heart disease usually first shows up as a myocardial infarction, but in a woman as the chest pain called angina pectoris.
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From page 184... ...
"Finally," notes the inclusion committee, "in clinical trials of AIDS drugs, which often may provide significant sources of first-rate medical care and access to experimental treatments for persons with AIDS, the numbers of women participating lags behind expectations for a disease that is increasing the most rapidly among women."15 Another life-threatening area where research lags is women's addictions. "The classical studies that have informed our thinking about 184
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From page 185... ...
Is a drug, surgery, or other treatment proven useful for one gender equally suitable for the other? If studies do not include adequate numbers of both men and women, these questions go unanswered -- and usually even unasked.
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From page 186... ...
. since in each case the drug will be titrated by the clinician to the appropriate dose or concentration." And even in wide therapeutic index drugs, "there should be few health consequences for large gender differences .
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From page 187... ...
And this century has a sordid history of human experimentation. "Public outcry and tragedy have driven policy development in the area of research on human subjects," note ethicist Tracy Johnson, M.A., of the Bass & Howes consulting firm and historian Elizabeth Fee, Ph.D., professor of history and health policy at Johns Hopkins School of Hygiene and Public Health.26 In 1938, after a drug called Elixir Sulfanilamide killed 107 people, Congress required, in the Food, Drug and Cosmetics Act of 1938, that manufacturers prove medications safe before bringing them to market.
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From page 188... ...
Though the tragedies involving thalidomide and DES did not involve research subjects, they drastically heightened fears of drug effects during pregnancy. Together they alerted scientists and terrified the public about the perils of exposing pregnant or even potentially pregnant women to unproved drugs.
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From page 189... ...
Still, although this country missed the disaster's main brunt, some "investigating" doctors got it from the manufacturer and distributed it here. Despite the small number of cases on this side of the Atlantic, Americans, like people around the world, experienced "a powerful emotional impact that created an aversion to involving pregnant women and women of childbearing age in drug research," the inclusion committee notes.28 Then, as if to underline the point, a second drug-related disaster, this time involving large numbers of American families, came to light less than a decade later.
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From page 190... ...
And beyond official requirements, drug companies established exclusionary policies of their own. Stunned by the huge liabilities of previous disasters involving pregnant women, they eschewed research subjects who could expose them to any similar catastrophe in the future.
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From page 191... ...
They represented not healthy people seeking to avoid unnecessary injury but desperately ill people seeking relief from an incurable and inexorably fatal disease. They wanted to try new drugs, and they wanted them fast, so they willingly tolerated risks unacceptable to ordinary people.
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Now this gigantic, highly self-aware age group, which since babyhood had wrenched the nation's attention to whatever issues it was currently facing, began coming to grips with how much science had yet to learn about female aging. Their dawning awareness, combined with the general growth of health advocacy in the wake of AIDS, changed women's place in research from a bureaucratic footnote to a major political issue.
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From page 193... ...
to foster the increased enrollment of women in biomedical research -- especially in pivotal decisionmaking roles within clinical medicine and the research environment."34 The NIH Revitalization Act of 1993 made ORWH a permanent entity and called for increased research funding for reproductive cancers, osteoporosis, contraception, and fertility. Though vetoed by President Bush in June 1992 over the issue of fetal tissue research, it was reintroduced, passed, and signed by President Clinton, who opposed the ban on fetal research, in 1993.
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From page 194... ...
Others argued that it would be wrong and harmful to women's health to spend $625 million and find after 14 years that little in the way of useful information had been learned. It would not help women's health and women's health research to publicly announce and then misuse an enormous amount of money."37 Struggling to consider only "the merits of the science," the committee called the side issues "important" but declined to comment on them further.
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From page 195... ...
"As in all scientific endeavors," notes the inclusion committee, "clinical studies seek to achieve results that are unbiased by the preconceptions of preferences of investigators, staff or study participants. This does not mean that the conduct of science is necessarily objective."40 Like all human beings, scientists see their experience -- including their professional work -- through "lenses" provided by their culture.
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From page 196... ...
"The fields of sports medicine, psychiatry and occupational medicine would focus on different issues if women's recreational and nonrecreational activities and stresses dominated," the committee suggests. "Indeed, the specialties themselves might have developed differently, focusing on leisure activities instead of ‘sports,' or on the hazards of domestic activities instead of the workplace."45 Had women's rather than men's concerns prevailed, questions that engage gynecological researchers might also have evolved differently.
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From page 197... ...
Organizers of the Physician's Health Study, for example, found that 90% of the appropriately aged medicos were male; the profession included too few middle-aged females to provide the desired statistical power. "The investigators' reservations regarding the ability to perform such an analysis were sound," the committee found, but a more imaginative approach to including women could have produced useful results.
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From page 198... ...
Clinical trials should include both genders, but requiring scientists to enroll sufficient numbers to ensure the statistical power to detect unsuspected and implausible gender differences would produce little additional information at greatly increased cost."53 Instead of raising the cost and complexity of each and every study, "mechanisms are needed at the national level to ensure that more attention is paid to questions of justice and gender in the setting of re 198
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From page 199... ...
How can sexually transmitted diseases and reproductive cancers best be controlled? What is the best way to deal with menopause and premenstrual syndrome?
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From page 200... ...
"The ethos of a discipline determines its direction," the committee believes, and much of OB/GYN has traditionally lacked leaders convinced that "research within the discipline is a high priority." Only a dozen or fewer departments "can be counted as serious research centers"; almost two score receive no federal research funding at all.59 These facts add up to "cause for concern about the current and future state" of OB/ 200
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From page 201... ...
But females have traditionally tended much less often than males to become researchers, a fact "likely to increase the shortage of research personnel unless special efforts are made to encourage research careers for women and to meet their particular needs."62 And those needs are substantial, because women face "special obstacles in choosing the laboratory over clinical practice," Polan notes. The dilemmas of joining the rigid race for tenure with one's "biological clock" ticking in the background, of doing the grueling work that leads to a secure academic position while raising small children, and of finding one's way in a male-dominated research culture all discourage would-be investigators.
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From page 202... ...
The Dalkon Shield disaster hit contraceptive research like an atomic bomb, leveling much of the corporate landscape and contaminating what remained with long-lasting legal and regulatory fallout. Liability insurance, already becoming increasingly difficult to obtain, rose drastically in cost in the wake of the billions of dollars of claims against Robins' defective product.
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From page 203... ...
In other countries with other regulatory and insurance arrangements, progress has continued apace, however. In the United States, manufacturers must present convincing evidence that contraceptives are safe before they can obtain FDA approval.
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NOTES 1. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Trials, Vol.
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From page 205... ...
40. Women and Health Research, Vol.
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