By: Adaora Ntukogu
For a moment, imagine someone having a heart attack. If your mind has illustrated a middle-aged man grasping his chest in intense pain, you should not be surprised. In fact, if you Google the phrase “heart attack”, you are bound to see several pages of men clutching their chests in agony.
Heart disease refers to several kinds of heart conditions like congenital heart disease, cardiac arrest, stroke, and heart attack. Historically, heart disease has been delineated as a “man’s disease” in health care. One explanation is at younger ages, men have a greater risk of heart disease than women. On average, a first heart attack strikes men at age 65, and women at age 72. However, heart disease remains the leading cause of death in women in the United States. Why is it that heart disease in women is not given the same urgency as it is in men?
Although there is recognition today of the need to adequately include women in clinical trials, in previous decades the inclusion of men overshadowed women in clinical research design and conduct.
Historically, women have been largely excluded from scientific and medical research. It was not until 1994 that the National Institutes of Health (NIH) demanded the inclusion of women in clinical research. In March 1994, the NIH issued “NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research”.
The policy had several aims:
- NIH must ensure that women and minorities and their subpopulations be included in all clinical research
- Women and minorities and their subpopulations be included in Phase III clinical trials in numbers sufficient enough to allow for valid analyses of the differences in the effect of interventions
- Cost is not allowed as a valid reason for the exclusion of these groups
- NIH must create programs and support outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies
The result of this legislature was that the NIH would not fund any grant or project that did not comply with this policy.
Although there is recognition today of the need to adequately include women in clinical trials, in previous decades the inclusion of men overshadowed women in clinical research design and conduct. This was clearly observed when studying diseases prevalent in both sexes, wherein white males were considered to be the standard study population.
The reasoning behind the neglect of women as study participants can be summed up into three main points: women were excluded from medical research due to concern about exposure to experimental risk during childbearing years, a belief that women’s menstrual and hormone cycle would bring unnecessary complications to the scientific design of experiments, and a misperception that treatment is the same across sex and gender.
By excluding female participants of “childbearing age,” research has excluded a large portion of women. Also, the assertion ignores that some women may have no plans of pregnancy. The over-emphasis on “childbearing” equates women’s health with reproductive health and this is problematic because there are many other facets of women’s health. Also, although there are fluctuations in women’s hormones over time, leading up to menstruation and after menopause, this is not a sufficient reason to leave women out of research. Men also have hormonal changes over time, with the reduction of their testosterone levels as they age.
The misperception that treatments are universal and that men (typically white men) are the norm is dangerous. We now know that the display and treatment of illnesses in women and men can be very different. Differences in the prevalence and severity of a broad range of diseases, disorders, and conditions exist between them. This phenomenon can be examined when we look at heart disease in men and women.
Men typically start experiencing heart disease symptoms at an earlier age than women. One reason for this is that in women, heart disease risk appears to rise after menopause; it is believed that in younger women, naturally occurring hormones may play a protective role. Some studies suggest that during a heart attack, women are more likely to have unusual symptoms, such as nausea, dizziness, and fatigue. However, men and women do share many of the same symptoms: squeezing chest pain or pressure, shortness of breath, sweating, tightness in chest, pain spreading to shoulders, neck, arm, or jaw, feeling of heartburn or indigestion with or without nausea and vomiting, and sudden dizziness or brief loss of consciousness.
Women tend to overlook the classic heart attack symptoms. They also tend to minimize their symptoms and avoid seeking treatment. These occurrences may explain the heart disease disparities among men and women. Even after accounting for age, within a year of a first heart attack, survival rates are lower in women than in men. The Harvard Heart Letter discusses a recent study of about 50,000 people ages 65 or older who were hospitalized for heart disease. The researchers collected data about the advice and treatment people received in the hospital and they discovered that compared with men, women were less likely to receive prospectively beneficial medications like aspirin or even to receive advice about quitting smoking. The negligence is a result of the historical association of heart disease as a “man’s disease” and the decades of exclusion of women in clinical trials.
There are many potential areas for research in women’s health and special considerations need to be taken to recognize and reduce health disparities between men and women. There should be continued investigations in the areas of sex-based biology and differences in healthcare needs between men and women. Scientific journals should be more critical when examining the research they publish to ensure that there is adequate representation of women and minorities as research subjects. Researchers need to utilize the available tools to facilitate enrollment of women in clinical trials. A diverse research staff is needed to ensure the advocacy for women’s health research and all staff should be educated on the distinct needs of women in clinical trials. There should also be more heart disease awareness interventions targeted towards women so that they can be educated on the signs and symptoms and how they may be presented differently.
In hopes to raise awareness of heart disease and stroke as one of the major causes of death for women, the American Heart Association created Go Red For Women, an international organization designed to empower women to be proactive in fighting heart disease. With social initiatives highlighting women’s cardiovascular health becoming prominent, there is hope in reducing the disparities in heart disease between men and women.
- Wizemann T, Pardue M. Exploring the biological contributions to human health: does sex matter? Washington DC: National Academies Press; 2001.
- Liu, K. A., & Mager, N. A. (2016). Women’s involvement in clinical trials: historical perspective and future implications. Pharmacy practice, 14(1), 708. doi:10.18549/PharmPract.2016.01.708