The Historical Exclusion of Women in Clinical Trials

For decades, medical research and clinical trials predominantly relied on data from a “standard” subject: a 70-kilogram white male. This practice, while seemingly pragmatic at the time, has resulted in a meaningful gap in our understanding of how diseases manifest and how treatments affect women differently.The consequences of this exclusion are far-reaching,impacting diagnosis,treatment efficacy,and overall health outcomes for women.

Until very recently, clinical trials were based on tests with a 70 kilos white man, although we know that women, from head to toe, are essential and biologically different.

Even animal models used in experiments were frequently enough male, driven by a desire to avoid perceived “confusion factors” associated with female physiology. This approach is now recognized as fundamentally flawed, as it fails to account for the inherent biological differences between sexes that can substantially influence research outcomes.

Beyond Gynecology: Recognizing the Breadth of Women’s Health

A significant shift in perspective is needed to recognise that women’s health extends far beyond reproductive health. Conditions like autoimmune diseases, which disproportionately affect women (approximately 80% of cases), have frequently enough been overlooked as specific women’s health issues. Understanding the unique ways these pathologies manifest in women is crucial for accurate diagnosis and effective treatment.

For example, systemic lupus erythematosus (SLE), an autoimmune disease, affects women nine times more often than men, typically appearing during childbearing years. This disparity highlights the need for targeted research and specialized care for women with autoimmune conditions.

The Dismissal of Women’s Symptoms: A Dangerous Legacy

Historically, women presenting with unexplained symptoms have frequently enough been dismissed as “tired” or “nervous.” This dismissal has had dire consequences, particularly in emergency situations. Studies have revealed numerous cases where women exhibiting symptoms of a heart attack were misdiagnosed with “neurotic angina,” leading to delayed treatment and,tragically,preventable deaths.

When a woman with chest pain arrived, they called her neurotic angina, that is, she was in her head. And these women died and still dying today in the emergency rooms.

This pattern of dismissal extends to other conditions as well. Women with autoimmune or rheumatological diseases may have their symptoms attributed to stress, lack of exercise, or poor diet, rather than an underlying medical issue. This can delay diagnosis and treatment, leading to a worsening of their condition and a diminished quality of life.

COVID-19 Vaccine and Menstrual Irregularities: A Missed Prospect

The development and rollout of COVID-19 vaccines highlighted another area where women’s health concerns were not adequately addressed. Many women reported changes in their menstrual cycles following vaccination, yet this was not systematically studied or taken into account during initial trials. This oversight underscores the need for more inclusive and comprehensive research protocols that consider the potential impact of medical interventions on women’s reproductive health.

Toward a More Equitable Future: Progress and Ongoing Challenges

Despite the historical biases, there is growing momentum toward a more equitable approach to women’s health. Government programs, such as those launched in the United States, are focusing on understanding the female body from biological, genetic, and pharmaceutical perspectives. Scientific journals and funding agencies are increasingly demanding parity in the study of drugs and medical interventions.

However, challenges remain. The long-term impact of political shifts on these initiatives is uncertain, and continued advocacy is needed to ensure that women’s health remains a priority. Moreover, it is indeed crucial for women to actively engage in their healthcare by asking questions about whether medications have been tested on women and what the appropriate dosage is.

The Importance of Sex-Specific Research: Immunotherapy as an Example

The benefits of sex-specific research are becoming increasingly evident. For example, studies have shown that immunotherapy, a type of cancer treatment, can have different toxicities and side effects in women compared to men. By taking these differences into account, healthcare providers can tailor treatment plans to minimize adverse effects and improve outcomes for women with cancer.

Call to Action: Demanding Parity in Medical Research

The path toward equitable healthcare for women requires a concerted effort from researchers, healthcare providers, and policymakers.It is indeed essential to demand that pharmaceutical companies prioritize the inclusion of women in clinical trials and conduct sex-specific analyses of drug efficacy and safety. By advocating for these changes, we can ensure that women receive the evidence-based care they deserve.