Gender-sensitive medicine can save lives

From the 1970s to the 1990s, women were largely excluded from drug trials. Regardless, however, drugs were administered in equal doses for both sexes. Often to the detriment of women, because not only are their anatomical structures different but so are metabolism and distribution of the drugs – with sometimes fatal consequences.

Background

In 1977, the U.S. Food and Drug Administration (FDA) issued a directive to exclude childbearing women from early clinical trials of most drugs. This was done in response to the thalidomide disaster, primarily to eliminate negative consequences on fertility and in the event of pregnancy. Researchers also feared that cycle-related hormonal fluctuations could distort study results. As a result, women were excluded from drug studies and study results obtained from men were simply transferred to women. This instruction was revised in 1993 with the “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” in America. In the late 1990s, several drugs were finally withdrawn from the market because of many side effects, some of them disastrous. The affected individuals were predominantly women. Investigations revealed that these drugs had not been tested on female cells, nor on female study participants. In Germany, it is only since 2004 that drug researchers have been legally recommended to test and evaluate drugs prescribed to both sexes. Since 2011, drug manufacturers have been required to submit a gender-specific evaluation of their pivotal studies. However, drugs that came on the market before 2004 were most likely tested only on men, including aspirin and acetaminophen.

Differences in drug effects

Research has shown that diseases that can occur in both sexes often manifest and progress differently in women and men. For example, a woman has a different ratio of fat to muscle mass and a different water content, which is even more cycle-dependent. The different enzymatic profile in women can lead to drugs being overdosed very quickly and also to increased side effects. While estrogens have a protective effect and strengthen the immune defense, the male hormone testosterone, in contrast, inhibits the immune defense. This is why a flu vaccination in women is actually effective from half the dose. Also, the intestines work more slowly in women, so drugs stay in the body for longer. In addition, enzymes in the liver work differently in women, so they can break down alcohol and medications half as slowly as men.

Stereotypical diseases?

For a long time, medicine was only interested in certain organs and their diseases in a gender-specific way, for example, prostate and breast cancer. For a long time, heart attacks were considered a male disease and a “manager’s disease” that did not affect women. Yet more women die of heart attacks in Germany than men! The regular intake of aspirin is considered (for both sexes) to be an effective medicine against a heart attack, but a study from 2005 (The New England Journal of Medicine, online publication on 7. 3. 2005) showed that it does not affect women. Taking a low dose of acetylsalicylic acid (ASA) does not appear to reduce the risk of myocardial infarction in healthy women, but it does reduce the risk of stroke. Cardioprotective effects were only detectable for women over 65 years of age.

Heart attack in women underestimated

Women have different disease symptoms than men, which are not well known to the general public. Therefore cardiologists assume that the average woman does not recognize a heart attack because she is only familiar with the classic “men’s symptoms” such as shortness of breath, pressure and a twinge in the chest. In contrast, however, women’s jaws, shoulders and back ache and they may feel nauseous. Women are generally thought to be late to the doctor’s office for heart attacks. Once there, they are often not taken seriously with their pain. It is rather often suggested to them that they are imagining their pain. Women also describe their complaints in greater detail and more extensively than men. This also leads to the fact that their symptoms are often classified by doctors as exaggerated. As a result, men are still treated more quickly in the emergency room than women! Women are also referred to psychologists or psychiatrists more often than men for unclear diagnoses, but depression and other mental illnesses are, in contrast, still considered a stereotypical female condition. Depression in men is therefore often not recognized, because they are often diagnosed purely in terms of their bodies. In psychiatry, men are the underserved gender.

Gender medicine in research and teaching

Osteoporosis or depression in men, heart attacks in women – for numerous diseases, women and men show different symptoms and react differently to medical therapies. Assuming that men’s and women’s bodies differ only in the areas of gynecology and obstetrics, however, current medical knowledge has so far been based mainly on findings about the male organism. As a result, diseases may be diagnosed incorrectly, side effects of drugs may be misjudged, or appropriate therapies may not be initiated. Gender medicine is still too rarely included in the curricula of medical faculties, and medically relevant differences between men and women are often not taught. However, gender-specific characteristics urgently need to be implemented in modern medicine in prevention, diagnostics, therapy and rehabilitation. It’s best to specifically ask your doctor about any differences in medication effects and dosage and let him or her advise you on this.

The Leipzig-based medical technology company VivoSensMedical continues to advance research in women’s health and focuses its research on the indication areas of women’s health, female chronobiology and autoimmune diseases in women. To this end, the company is conducting numerous studies with women, based on the biomarker core body temperature. The vision: to bring about a paradigm shift in medical diagnostics and to create gender-sensitive, individual diagnostics for better therapies.

References

Jahn, I., Gansefort, D., Kindler-Röhrborn, A. et al. (2014) Gender-sensitive research in epidemiology and medicine: how can it 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. 1993 Jul 22;58(139):39406-16.

Knopf D. (2005) ASA protects women only to a limited extent. In: Pharmazeutische Zeitung; Issue 13. https://www.pharmazeutische-zeitung.de/index.php?id=pharm1_13_2005, Accessed 1 Nov. 2019.

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

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

https://gender.charite.de/ Accessed 11/1/2019.

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