There is a wide disparity in medical testing between men and women in the United States. This disparity can be assessed through a plurality of mediums. In this paper, I outline the gender disparity throughout American medical testing, which has disproportionately affected millions of American women nationwide, putting them at risk without their knowledge or informed consent. I begin by examining cardiovascular disease as a microcosm for gender disparity, eventually reviewing the historical and contemporary context of exclusion (and inclusion) policies, and I conclude with the social implications of exclusionary justifications.
For an understanding of the wage gap or the gap in leadership positions, one can look at the job market, examining the ways in which women are segregated to low-level positions with fewer opportunities of advancement, or the income gap between those of different genders that work the same or similar jobs. For an understanding of unequal access to adequate healthcare, bodily autonomy, or protections in the workplace, one can look towards politics, evaluating the male-dominated U.S. government body. The nature of and exact numbers included within these disparities are widely evaluated, discussed, and critiqued, often for the purpose of evolving previous dialogue and raising awareness about additional discrepancies that arise when controlling for variables such as race or social class. But what about the unbalanced aspects of society that are imperceptible to the population, unequally affecting American masses without widespread awareness? Such is the case within the pharmaceutical industry.
Although exact numbers are not known, females are largely underrepresented, if not explicitly excluded, in almost all clinical research. Perhaps surprisingly, this gender discrepancy is so pervasive that it is not only prevalent in human research, but also extends to animal testing. So, while male rodents are the ‘standard animal’ for animal testing, male humans are considered the ‘standard human’ for human testing. The standardization of men is inherently problematic, as it assumes that women-specific health concerns are ‘deviant’ or ‘additional’ because they do not fall within the standard male paradigm, thereby creating a research world that prioritizes a specific gender (DeBruin 127). If women were seen as different than men, and not inferior, men would not be taken as the human standard and it would not be assumed that only studying men would be sufficient research for conditions that may affect humans of both genders (DeBruin 127). Furthermore, when both sexes are included in research, sex-specific analyses, which examine, for example, whether the condition manifests differently based on sex, or whether the drug being tested has side effects that differ based on sex, are generally not conducted (DeBruin 129). So, even when research includes women participants, an overwhelming male majority of trial participants often results in findings that, while advertised as representing the general population, may not apply to women at all (Stefanick 54).
This disparity can be most easily seen through the microcosm of cardiovascular disease. In the United States, cardiovascular disease ranks as the number one cause of death for both women and men. Despite this statistic, studies into cardiovascular disease focus primarily on men. A 2003 analysis of cardiovascular treatment trials, for example, disclosed that women accounted for just 27 percent of all participants, and that only a third of the trials that incorporated both sexes differentiated data based on sex (Stefanick 54). In fact, women have been excluded altogether from a number of crucial studies into cardiovascular disease, including the Multiple Risk Factor Intervention Trial, which was conducted on 15,000 men, the Physicians Health Study of Aspirin’s Preventative Capabilities Against Heart Conditions, which was conducted on 22,071 men, and all extensive trials on cholesterol-lowering medication (DeBruin 119).
Even seemingly reliable sources, such as the American Heart Association’s Guidelines for Women, utilizes research that skews heavily male. In the randomized clinical trials used to create the gender-specific guidelines, women represented only 30% of patients, with 13% of trials explicitly excluding women all together, and only one-third of all trials reporting specific gender analyses. As recently as 2005, a survey from the American Heart Association found that 1 in 5 physicians were unaware that a greater number of women than men die from cardiovascular disease each year. The same study determined that women, who are at similar risk to cardiovascular disease when compared to men, are more likely to be considered at lower risk by physicians, and are even less likely to be referred for diagnostic testing (Jones, Daniel, and Mazure 11). Men are two to three times more likely than women to have an implantable defibrillator implanted to deter sudden cardiac death.
This gendered disparity has real consequences. A young woman hospitalized for a heart attack is twice as likely to die as a young man in the same situation (Stefanick 54). Among other factors, this female patient is less likely to be recognized for women-specific symptoms — which include less recognizable elements, such as irritation in the stomach, jaw, neck or back, shortness of breath, and nausea –, are less likely to be taken seriously by a physician, and are more likely to have added risk factors with medications that do not acknowledge or even study women-specific dangers (Jones, Daniel, and Mazure 3).
These conditions have only recently been challenged, with sparse amounts of progress being made nationally. In 1977, F.D.A. guidelines for drug research advised that non-pregnant women of childbearing potential, including those using effective methods of contraception and those that have had vasectomies, be excluded from all drug testing. This meant that only post-menopausal women could be utilized in drug trial research, leaving out a significant majority of the female population throughout the United States (DeBruin 130). Only since 1991, when the NIH adjusted its policy on the awarding of federal research grants, have researchers been required to include data on gender representation and analysis in study proposals and renewal requests (DeBruin 118). In 1993, after an increase in research regarding the importance of gender representation, the National Institute of Health Revitalization Act made it a legal requirement to include both women and men in trials, but only when there is a “known sex-related prevalence of the disease under investigation to provide appropriate data on the efficacy of treatments for both women and men” (Melloni et al. 142). Still, these policies often go unenforced, and gender biases remain rampant throughout the medical community. For example, the Code of Federal Regulations of the NIH Office of Protection from Research Risks maintains criteria for the Internal Review Board approval of research that has the provision: “when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included…” (Jones, Daniel, and Mazure 10). This provision, equating pregnant women to children and other disadvantaged groups, inferiorizes women while making parallels that are not backed by any sort of research.
These policies have a number of problematic social implications. First, excluding women from medical trials based on their pre-menopausal state due to the well-being of a possible or actual fetus assumes that women are incapable of responsibly and morally assessing potential health risks autonomously (DeBruin 131). Additionally, this practice conflates women’s health with women’s reproductive health, furthering the patriarch
al notion that women are only valuable with regard to biological functions (Jones, Daniel, and Mazure 10). Secondly, regulations which consider the impact of research solely on the individual women involved within the study, and their actual or potential fetuses, ignores the importance of the health of women as a group. Overall, the individual women being studied are not the only ones who can potentially gain from clinical research, as women in general benefit from knowledge obtained (DeBruin 131). Third, if there is legitimate moral interest in assuring fetal well-being, researchers should aim to find ways to keep potential or actual fetuses safe while conducting research, instead of settling on the exclusion of an entire sex. Additionally, because fetal well being is affected by agents to which both a potential mother and a potential father could be exposed to, researchers should not only be careful on the conduction of studies involving women, but should also be wary on the conduction of studies on men (DeBruin 131).
When asked about gender disparities within research, many researchers assert that including women in sufficient numbers and conducting sex based analyses increases budget costs. The Institute of Medicine, for example, noted in its 2001 report that the inclusion of women both “‘introduces additional variables (in the form of hormonal cycles) and decreases the homogeneity of the study population” (Stefanick 11). While these claims of additional expenses are truthful, justifying women’s exclusion by cost suggests that hormonal cycles are supplementary, and is therefore ‘different’ from the standardard of human the male, reinforcing the aforementioned standardization of men and further inferiorizing women as a group. In any pharmaceutical research, resources must be allocated, but excluding anyone based on group membership (such as sex, race, or sexual preference) is morally unacceptable, especially when there is considerable risk for excluded parties (DeBruin 128). The argument that hormonal fluctuation may ‘confuse’ results would only be appropriate if such consistent, uniform data best served the health care needs of all people. Excluding women from such studies may increase the homogeneity of data, but such data can not best serve the health needs of both men and women. And, when women’s physiology does not affect the uniformity of the data, the exclusion of women does not make the data more homogenous, and is still not justifiable (DeBruin 129). The Institute of Medicine concludes the aforementioned 2001 report by stating that “being male or female is an important human variable that should be considered when designing and analyzing studies in all area and at all levels of biomedical and health-related research” (Stefanick 11).
In conclusion, the underrepresentation of women in clinical trials has both concerning medical and social implications. American women, at large, are put at substantial health risks by biases and policies that frame a male-dominated pharmaceutical industry that does not work in the favor of all citizens. These risks are urgent and often fatal, and cannot be adequately justified through the popular arguments of cost or data homogeneity, which fail to acknowledge the equivalent value of the female sex to the male sex. Such arguments must be immediately dismantled in favor of ethical understandings that will ultimately work to uphold, sustain, and strengthen the female population of the United States. We can do better.