Single-sided research can be harmful to the well-being of women.
Nowadays, women continue to face challenges due to the fact that pharmaceutical research primarily focuses on men. Consequently, they often experience late diagnoses, misprescribed medications, and undiagnosed diseases that are wrongly identified as depression. Isabella Erb-Herrmann, the managing director of AOK, sheds light on this issue, questioning whether we have a gender-biased medicine.
Dating back to ancient times, Aristotle established the male body as the standard and considered women as a "deviation" from this norm, a belief system that has shaped both knowledge and practices for centuries. Unfortunately, the majority of medications are still developed by testing on men weighing 80 kilograms, resulting in significant negative consequences for women's health.
So, what are the effects of this discriminatory approach?
Women are disproportionately affected by misdiagnoses and ignored metabolic and hormonal imbalances. They experience medication side effects more frequently than men. Moreover, medication packaging is inappropriately sized, leading to considerable waste, and subsequently, high costs for health insurance companies and policyholders. This situation is both unsustainable and detrimental to women's health.
Has there been any change in the conduct of clinical studies lately?
Since January 31, 2022, pharmaceutical companies in the EU are required to conduct clinical studies with a balanced gender and age distribution. Although this change may offer the potential for a safe and equal supply of medications, it is likely to take several years from the initial stage of research to the market launch of a drug. Therefore, the impact of the regulation will only be felt in approximately five years. In another relevant aspect, gender-adjusted regulations do not seem to have been introduced thus far regarding preclinical studies, where male animals are frequently used prior to clinical studies. One should note that women respond differently to active substances.
How can the taboo surrounding pregnancy, endometriosis, and menopause in research be overcome?
Medication manufacturers assess the medical value added before investing in new medicines and therapies, which is a prerequisite for approval. To quantify the added value, data are necessary. However, since women have traditionally ignored health issues relating to pregnancy, endometriosis, and menopause, these areas lack relevant data. Consequently, we must address these gaps now, as the advancement of AI and algorithms will likely amplify existing disparities in healthcare and their results base on existing data. Politics also needs to address the issue more proactively, recognizing women's health as an investment in society. Similar measures have been initiated in France with a national endometriosis strategy.
As a major insurance provider, how can improvements be achieved and stimuli be generated?
Health insurance companies can primarily shed light on the issue. For example, AOK is planning a women's health campaign next year to raise awareness. Women are also becoming more vocal, politically active, and their voices are being heard. There are organizations like the Female Network for Health, Healthcare Women, and the German Association of Female Doctors, in addition to the Midwives Association.
I had a conversation with Isabella Erb-Herrmann regarding this topic.
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AOK, as a prominent player in the health insurance industry, is planning a women's health campaign to raise awareness about gender disparities in medicine and pharmacology. Despite the EU's mandatory gender-balanced clinical studies, healthcare disparities persist due to the lack of preclinical studies inclusivity and insufficient data on women's health issues, such as pregnancy, endometriosis, and menopause.
