Wanted Single, White Male for Medical Research

Abstract

In June 1990, congressional investigators issued a startling report. The General Accounting Office revealed that despite a 1986 federal policy to the contrary, women continued to be seriously underrepresented in biomedical research study populations. According to the National Institutes of Health, this practice resulted in significant gaps in [our] knowledge of diseases that affect both men and women. [1] In short, many of the important health data generated by the modern biomedical research revolution are data about men. The failure to include women in research populations is ubiquitous. An NIH-sponsored study showing that heart attacks were reduced when subjects took one aspirin every other day was conducted on men, and the relationship between low cholesterol diets and cardiovascular disease has been almost exclusively studied in men. Yet coronary heart disease is the leading cause of death in women. Similarly, the first twenty years of a major federal study on health and aging included only men. Yet two-thirds of the elderly population are women. The recent announcement that aspirin can help prevent migraine headaches is based on data from males only, even though women suffer from migraines up to three times as often as men. [2] The list goes on: studies on AIDS treatment frequently omit women, the fastest growing infected population. An investigation of the possible relationship between caffeine and heart disease involved 45,589 male research subjects. Most amazing is the pilot project on the impact of obesity on breast and uterine cancer conducted--you guessed it--solely on men. Moreover, the customary research subject not only is male, but is a white male. African-Americans, Latinos, and other racial and ethnic groups have typically been excluded from studies, again in spite of a formal NIH guideline encouraging the inclusion of such groups in study populations. Children and elderly persons also have received short shrift, particularly in the testing of new drugs. And in basic research, even female rats are frequently excluded as research subjects! [3] The physiology of women and men differs in ways that can affect how disease and treatment manifest themselves. Beyond the obviously sex-linked diseases such as uterine and prostate cancer, there is evidence that heart disease, AIDS, depression, and numerous other ostensibly general-neutral conditions are expressed differently in women and men. A similar situation exists among different racial and ethnic groups. Lupus, for example, reportedly affects one in 750 women generally, but its incidence is one in 245 among African-American women and one in 500 among Latinas. [4] Such differences make it inappropriate simply to generalize findings based on one gender or racial group to all beings. As a result of the past over-representation of white men in research populations, physicians now frequently lack adequate evidence on whether women and people of color will be helped, harmed, or not affected at all by numerous therapies now endorsed as promoting human health. NIH officials have admitted that the agency's policy on expanding study populations was inadequately publicized as well as substantively feeble, simply recommending that investigators proposing studies consider the inclusion of women and minority groups. In the four years that elapsed between the policy's announcement and the GAO report, NIH continued to review numerous proposals that either gave no information on the gender of their study populations, or proposed all-male studies without a rationale for doing so. The GAO report also notes that the NIH itself had no policy to ensure the inclusion of women in its intramural research program. Indeed, according to Science correspondent Joseph Palca, Acting Director William Raub said that a small group of NIH staff still had disdain for the policy encouraging inclusion. After the GAO report was released, NIH officials did attempt to mend fences. …