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Paradigm shifts in the approach to women’s health care

Eileen M. Van Dyke, MPS, PA-C; Deborah A. Gerbert, PA-C; Lawrence M. Herman, MPA, PA-C; Lyle W. Larson, PhD, PA-C; Marie-Michèle Léger, MPH, PA-C; Robert McNellis, MPH, PA-C; Daniel L. O’Donoghue, PhD, PA-C; Cynthia Ulshafer, PA-C

The authors are members and staff of the Clinical and Scientific Affairs Council (CSAC) of the AAPA. This article was written by Eileen M. Van Dyke, MPS, PA-C, and edited by Sarah Zarbock, PA-C.

Women’s health care has traditionally focused on the screening, diagnosis, and treatment of conditions unique to women. However, the recent recognition of significant differences in risk factors, disease manifestations, and responses to treatments in women also affects the best evidence-based management options to optimize treatment outcomes for many conditions not unique to women. As with all patients, ethnicity, culture, education, social and economic status, and access to medical care are important determinants of overall health. These health-related issues are especially important for women for several reasons, including, among others, their lower earning power, their higher incidence of chronic disease, and their lower likelihood of seeking health care when needed.¹ Thus, gender-based women’s health care not only incorporates the roles and expectations of the culture and society specific to one woman at a given point in her life but also necessarily includes awareness of biological and physiologic differences between females and males.

This report focuses on a shift in the approach to gender-based medicine using results from recent research and evidence-based recommendations regarding evaluation and treatment of women that are specifically different from those for men. Physician assistants can and should be learning new information about gender-based differences in diseases and conditions in order to provide the highest possible level of expertise and the most appropriate health care for women of all ages.

Research, past and present

Although women represent approximately half of the adult population,² they spend a greater share of health care dollars. According to one study, the total mean annual charges per capita expenditure was $7,104 for women and $5,050 for men. These charges included primary care visits, specialty care, emergency department care, hospitalizations, and diagnostic services.³

Yet not until 1993 did the National Institutes of Health (NIH) Revitalization Act require that both women and minorities be included in all NIH-supported clinical research studies.⁴ That same year, the FDA published the Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs that lifted the restriction against including women of childbearing age in clinicaltrials.⁵ This exclusion of women had been justified based on the premise that hormonal changes could interfere with research results or because of the possibility that the subject might become pregnant during a study, putting the fetus at risk.

“Gender-neutral” research—in reality, research that ignored or was developed to assess potential differences between the sexes—had become the de facto norm, perpetuating disparities in many aspects of health care for women. Gender-based studies now hold an important place on national research agendas, as evidenced by the creation of the FY 2006 NIH Research Priorities for Women’s Health.⁶ Furthermore, the results of research focused on women’s health, such as the Women’s Health Initiative study and others, have gained national attention.^7,8

It can no longer be assumed that any given disease will manifest similarly or follow the same course in women and men or that women and men respond to treatments identically. Continued research is needed to explain differences and determine their level of medical significance.⁹

Health care delivery and access

Although factors such as career choice, education, income, and health insurance coverage create gender influences on health care outcomes, these environmental factors cannot fully explain the many differences between men and women with respect to disease etiology and pathophysiology, treatment responses, and outcomes.¹⁰ If the quality of health care for women is to improve, other disparities, including access to care, cost of care, and allocation and utilization of resources, must be recognized and dealt with by policy makers and providers alike.¹¹ However, the approach to the treatment of women must have a fundamental paradigm shift to fully accomplish this very complicated task.

Pharmacology issues

A primary focus of gender-based medicine is examining differences in pharmacodynamics and pharmacokinetics between women and men. The FDA’s 1993 Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs required analysis of data for sex-related variations in response to drug treatment.¹² This guideline advised that when the clinical characteristics of a drug are studied, the influence of menstrual and menopausal status and of estrogen treatment or systemic contraceptives on pharmacokinetics should be considered.¹³ Further recommendations emphasized that assessments of differences in drug action due to sex-specific variations, ethnicity, age, body size, hepatic and renal function, disease state, or enzyme activity be included in research studies.¹² Only some of these had been traditionally included in clinical trials.

There are male-female differences in response to pharmacologic agents that go well beyond the normal and expected variation seen from patient to patient. For example, the incidence of adverse events was statistically higher for women than for men in clinical trials of numerous drugs—especially agents that are potent inducers or inhibitors of the cytochrome P450 pathway.^13,14 Male-female differences in metabolic pathways and oxidative metabolism of certain drugs by the liver results in the clearance of many benzodiazepines more rapidly in men than in women.^13,14 Physiologic differences can affect male and female response to the same drug, and this dissimilarity becomes especially important for drugs with a narrow therapeutic range.^13,14 Women are more likely to develop drug-induced QT prolongation and torsades de pointes, for instance.^13-15 Women appear to have a greater response than men to selective serotonin reuptake inhibitors.¹⁴ They appear to have more adverse events with antihypertensive medications, as well as more bleeding events when taking warfarin.^13,14

Women and cardiovascular disease

Many women do not recognize that heart disease is the leading cause of death for women in the United States. In fact, the American Heart Association (AHA) reported that approximately 500,000 American women die each year from cardiovascular disease (CVD)—more than die from the next seven causes of death combined.^16,17 It is a common misconception, not only among the lay population but among clinicians as well, that breast cancer is the biggest killer of women.

Women present with coronary heart disease (CHD) at older ages than men. Women often do not have typical (or even atypical) chest pain or chest pain equivalents; instead, their presenting symptoms commonly include fatigue and shortness of breath.^18,19 Risk factor control is especially important for African-American women, who have the highest incidence among women of CHD as well as the highest incidence of uncontrolled hypertension, obesity, physical inactivity, and dyslipidemia.²⁰

The diagnosis of heart disease is a greater challenge in women than men; interestingly, nearly two thirds of women who die suddenly from a cardiac cause did not have previous cardiac symptoms that were recognized.^16,17 In persons older than 65 years, low levels of HDL cholesterol are a stronger predictor of death from heart disease in women than in men. High levels of triglycerides may be a more important risk factor in women, especially in elderly women.¹⁷ Women are less likely than men to receive diagnostic or therapeutic procedures and rehabilitation after their first MI.^18,21,22 Finally, women are more likely than men to die after their second MI.²¹

The majority of women are not aware of the risk factors for CHD in women or of differences in presenting symptoms, jeopardizing their chances for aggressive screening and risk factor control (see Table 1).^16,17 While awareness has grown since 2000, there is still a knowledge gap, especially for women who are younger than 45 years or in a minority group. According to a 1997 AHA survey, only 30% of women listed heart disease as the leading cause of death for women. By 2004, 46% acknowledged CHD as the number one cause of death.^16,17 Recent efforts to promote awareness of CHD in women through programs developed by the AHA and the NIH, such as the “Red Dress” campaign, seem to have been effective.

Diabetes in women

Recent studies show that type 2 diabetes mellitus may be a stronger risk factor for heart disease in women than in men.¹⁷ Diabetic women have a higher risk for stroke and MI than do diabetic men.²³ In comparing data from the National Health and Nutrition Examination Survey (NHANES) III 1988-1994 and NHANES 1999-2000, Ford and colleagues noted an increased prevalence of metabolic syndrome in women compared to men.²⁴ Studies have found that obese postmenopausal women develop reduced insulin sensitivity to a greater degree than premenopausal women do, which in turn increases their risk for development of metabolic syndrome as they age. This outcome may be due to obese women’s increased abdominal fat and high levels of triglycerides.²⁵

There also appears to be a difference between men and women in terms of the preferred time to measure blood glucose levels. A recent study shows that for women, blood glucose levels after meals are better predictors for development of heart and blood vessel disease; thus, it is important for women with diabetes to closely monitor themselves using after-meal glucose levels.²⁶ Women with gestational diabetes have a 20% to 50% chance of developing diabetes in the next 5 to 10 years.²³ The children of women who had gestational diabetes have a higher risk of obesity later in life. However, recent studies have shown increasing evidence that breast-feeding has a protective effect against obesity in adulthood.²⁷

Conclusion

Clinicians have the ability and responsibility to ease the burden of disease and improve quality of life for women. They can achieve these goals by remaining vigilant to gender differences in how diseases develop, manifest themselves, and are treated and by tailoring treatment strategies to improve outcomes. PAs should be aware of gender differences when caring for women and develop preventive strategies to decrease the risks of CVD and diabetes, among other conditions. To be most effective, these efforts should begin as early as adolescence.

The teaching and practice of women’s health care can no longer concentrate on contraception, pregnancy, and menopause to the exclusion of other concerns. Future research must consider differences in men’s and women’s roles and responsibilities, information about access to and use of resources, and the best ways to address inequalities between men and women’s health care. It is crucial that culturally competent providers and researchers strive to develop and provide appropriate services that respond to the health care needs of all women of all ages.

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