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Adding to section on gender bias affecting diagnosis/medical care to Gender disparities in health

In the lead after footnote 3: Females are underrepresented in clinical trials and subjected to physician bias in diagnosis and treatment.

Gender Bias in Clinical Trials
Gender bias is prevalent in medical research and diagnosis. Historically, women were excluded from clinical trials, which affects research and diagnosis. Throughout clinical trials, Caucasian males were the normal test subjects and findings were then generalized to other populations. Women were considered more expensive and complicated clinical trial subjects because of variable hormone levels that differ significantly from men’s. Specifically, pregnant women were considered an at-risk population and thus barred from participation in any clinical trials.

In 1993, the U.S. Food and Drug Administration (FDA) published “Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” overwriting the 1977 decision to bar all pregnant women from clinical trials. Through this, they recommended that women be included in clinical trials to explore differences in the sexes, specifying that the population included in clinical trials should be indicative of the population to whom the drug would be prescribed. This mandated the inclusion of female participants in clinical trials sponsored by the National Institutes of Health (NIH). The FDA's 1998 “Presentation of Safety and Effectiveness Data for Certain Subgroups of the Population in Investigational New Drug Application Reports and New Drug Applications” regulations mandated that drug trials prove safety and efficacy in both sexes in order to gain FDA approval and led to drugs being taken off the market due to adverse affects on women that had not been appropriately studied during clinical trials. Several more recent studies determined in hindsight that many federally funded studies from 2009 included a higher percentage of female participants but did not include findings specified between males and females.

In 1994, the FDA established an Office of Women's Health, which promotes that sex as a biological variable should be explicitly considered in research studies. The FDA and NIH have several ongoing formal efforts to improve the study of sex differences in clinical trials, including the Critical Path Initiative, which uses biomarkers, advanced technologies, and new trial designs to better analyze subgroups. Another initiative, Drug Trial Snapshots, offers transparency to subgroup analysis via a consumer-focused website. However, despite such work, women are less likely to be aware of or to participate in clinical trials.

Although inclusion of women in clinical trials is now mandated, there is no such mandate for use of female animal models in non-human research. Typically, male models are used in non-human research and results are generalized to females. This can complicate diagnosis. A 2011 review article examined sex bias in biomedical research and found that while sex bias has decreased in human clinical trials, particularly since the US National Institute of Health Revitalization Act of 1993, sex bias has increased in non-human studies. Additionally, studies often fail to analyze results by sex specifically. Another example of this is the thalidomide epidemic. In the late 1950s thalidomide was prescribed to pregnant women to treat morning sickness. Its use unexpectedly resulted in severe birth defects in over 10,000 children. However, proper studies were not conducted to determine adverse effects in women, specifically those who are pregnant and it was determined that mice, the animal model used to test thalidomide, were less sensitive to it than humans.

Gender Bias in Diagnosis
Bias in diagnosis can also stem from physician bias. For example, a 2018 study of patients presenting with chest pain at an ambulatory clinic in Switzerland showed that men with chest pain were two to three times more likely to be referred to a cardiologist than women experiencing the same symptoms. Another study from 2019 examined the effects of physicians' gender bias on diagnosis of nonspecific, functional, and somatoform (NFS) syndromes. NFS is an "umbrella term" that encompasses symptoms without a medical explanation and is more likely to be given as a diagnosis to females than males presenting with identical complaints of back pain. Additionally, females are diagnosed with anxiety disorders two and a quarter times more often than males, per a 2011 study. Despite this, the majority of animal studies of drugs to treat anxiety disorders were focused on male rats as test subjects.

Studies have also explored the impact of a physician’s gender on diagnostic gender bias. A 2018 study of myocardial infarction patients in Florida hospitals determined a higher mortality rate for female patients treated by a male physician. These researchers also found that the mortality rate for female patients treated by male physicians decreases with the number of female patients a male physician treats. This may be attributed to female patients not seeking treatment as early as male patients and differing presentation in symptoms of acute myocardial infarction in males and females.

A 2018 literature review of 77 medical articles found gender bias in the patient-provider encounter as it related to pain. Their findings confirmed a pattern of expectations and treatment differences between men and women, “not embedded in biological differences but gendered norms.”  For example, women with pain were viewed as “hysterical, emotional, complaining, not wanting to get better, malingerers, and fabricating the pain, as if it is all in her head.” Women suffering with chronic pain are often erroneously attributed psychological rather than somatic causes for their pain by physicians. And in searching for the effect on pain medication given to men and women, studies determined that women received less effective pain relief, less opioid pain medication, more antidepressants, and more psychiatric referrals.