Gender-sensitive medicine can save lives

From the 1970s through the 1990s, women were largely excluded from drug trials. Despite this, medications were administered in the same doses to both genders. This often worked to the detriment of women, as not only are their anatomical structures different, but so are the metabolism and distribution of the drugs—sometimes with fatal consequences.

Background

In 1977, the U.S. Food and Drug Administration (FDA) issued a directive to exclude women of childbearing age from early clinical trials of most drugs. This was done in response to the thalidomide disaster, primarily with regard to potential adverse effects on fertility and during pregnancy. Researchers also feared that cycle-related hormonal fluctuations could skew study results. The result: women were excluded from drug trials, and the study results obtained from men were simply extrapolated to women. This directive was revised in 1993 with the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” in the United States. In the late 1990s, several drugs were ultimately withdrawn from the market due to numerous side effects, some of which were fatal. The individuals affected were predominantly women. Investigations revealed that these drugs had not been tested on female cells or on female study participants. In Germany, it has only been legally recommended since 2004 that drug researchers also test and evaluate medications prescribed to both genders on women. Since 2011, drug manufacturers have been required to submit a gender-specific analysis of their clinical trials. However, drugs that entered the market before 2004 were most likely tested only on men, including aspirin and acetaminophen.

Differences in the effects of medications

Research has shown that diseases that can affect anyone often manifest differently in women and men and also progress differently. For example, a woman has a different ratio of fat to muscle mass and a different water content, which is also cycle-dependent. The different enzymatic profile in women can lead to rapid drug overdose and an increased incidence of side effects. While estrogens have a protective effect and strengthen the immune system, the male hormone testosterone, in contrast, suppresses the immune system. That is why a flu vaccine is actually effective in women even at half the dose. Additionally, the digestive system works more slowly in women, so medications remain in the body longer. Furthermore, enzymes in the liver function differently in women, meaning they break down alcohol and medications about half as fast as men do.

Stereotypical illnesses?

For a long time, the medical community focused its gender-specific research solely on certain organs and their diseases, such as prostate and breast cancer. Heart attacks were long considered a “men’s disease” and a “manager’s disease” that did not affect women. Yet in Germany, more women die from heart attacks than men! Regular aspirin use is prescribed (for both genders) as an effective preventive measure against heart attacks; however, a 2005 study (The New England Journal of Medicine, published online on March 7, 2005) found that it has no effect whatsoever in women. Taking a low dose of acetylsalicylic acid (ASA) does not appear to reduce the risk of a heart attack in healthy women, but it does lower the risk of stroke. Cardioprotective effects were only detectable in women over 65 years of age.

Heart attacks in women are underestimated

Women experience different symptoms of illness than men, and these are not widely known to the general public. Female cardiologists therefore believe that the average woman does not recognize a heart attack because she is only familiar with the classic “male symptoms,” such as shortness of breath, chest pressure, and chest pain. In contrast, however, women often experience pain in their jaw, shoulder, and back, and may feel nauseous. It is generally assumed that women wait too long to see a doctor when they have a heart attack. Once there, their pain is often not taken seriously; instead, they are frequently led to believe that they are merely imagining their pain. Women also describe their symptoms in greater detail and with more precision than men. This, too, leads doctors to often dismiss their symptoms as exaggerated. The result: men are still treated faster than women in the emergency room! When diagnoses are unclear, women are also more frequently referred to a psychologist or psychiatrist than men; in contrast, however, depression and other mental illnesses are still considered stereotypical women’s ailments. Depression in men is therefore often not recognized, so that they are frequently given a purely physical diagnosis. In psychiatry, men are the underserved gender.

Gender Medicine in Research and Teaching

Osteoporosis or depression in men, heart attacks in women—for numerous conditions, women and men exhibit different symptoms and respond differently to medical treatments. Based on the assumption that male and female bodies differ only in the fields of gynecology and obstetrics, current medical knowledge has thus far relied primarily on findings regarding the male body. The result can be that diseases are misdiagnosed, side effects of medications are misjudged, or appropriate treatments are not initiated. Gender medicine is still too rarely included in medical school curricula, and medically relevant differences between men and women are often not taught. However, gender-specific considerations must be urgently integrated into modern medicine in the areas of prevention, diagnosis, treatment, and rehabilitation. It is best to specifically ask your doctor about any differences in drug effects and dosages and seek their advice on the matter.

The Leipzig-based medical technology company VivoSensMedical is driving the Research on Women’s Health The company is making steady progress and focuses its research on women’s health, female chronobiology, and autoimmune diseases in women. To this end, the company is conducting numerous studies involving women based on the biomarker of core body temperature. The vision: to bring about a paradigm shift in medical diagnostics and to develop gender-sensitive, personalized diagnostics to improve treatment outcomes.

References

Jahn, I., Gansefort, D., Kindler-Röhrborn, A., et al. (2014) Gender-sensitive research in epidemiology and medicine: How can this be achieved? Bundesgesundheitsbl. 57: 1038. https://doi.org/10.1007/s00103-014-2010-8

Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Fed Regist. July 22, 1993;58(139):39406-16.

Knopf, D. (2005) “The contraceptive pill offers women only limited protection.” In: Pharmazeutische Zeitung; Issue 13. https://www.pharmazeutische-zeitung.de/index.php?id=pharm1_13_2005, Accessed: November 1, 2019

The New England Journal of Medicine, published online on March 7, 2005. http://content.nejm.org/cgi/reprint/NEJMoa050613v1.pdf

https://nachgefragt-podcast.de/tag/geschlechtersensible-medizin/ Accessed: November 1, 2019

https://gender.charite.de/ Accessed: November 1, 2019

https://www.vfa.de/embed/positionspapier-beruecksichtigung-von-frauen-und-maennern-bei-der-arzneimittelforschung.pdf-1 Accessed: November 1, 2019