For decades, the bedrock of medical knowledge has been laid on the foundation of research primarily conducted on male subjects. This is because the notion of the ‘average’ human being in medical research has traditionally been modelled after the male body. From physiology to pharmacology, the fundamental understanding of human biology has been skewed towards male patterns.
This historical bias has had profound implications for women's health, leading to misdiagnosis, ineffective treatments, and even harmful side effects.
Why Are Women Missing From Clinical Trials And Medical Research?
The National Institutes of Health revealed that a significant barrier to women's inclusion in clinical trials emerged from a 1977 Federal Drug Administration (FDA) policy excluding women of childbearing age from early phases of drug studies unless the research pertained to life-threatening illnesses.
While the FDA subsequently rescinded this policy around the time of the 1993 NIH Revitalisation Act, which mandated the inclusion of women and minorities in government-funded health research, challenges persist.
But the exclusion of women from medical research has deeper roots. Concerns about the complexities of female biology, reproductive health, and ethical considerations surrounding experimentation on women contributed to this bias. Additionally, the prevailing view of women as primarily caregivers rather than independent patients further marginalised their health needs.
Dosage and Metabolism
Women metabolise drugs differently than men due to variations in body composition and hormonal influences. This can result in either underdosing or overdosing, with potentially severe consequences.
According to an article titled ‘Inequality In Medicine’ published in the journal Nature:
- Data from the US Food and Drug Administration (US FDA) indicates a higher incidence of drug-related adverse events among women compared to men. Between 2004 and 2013, over two million such events were reported for women, surpassing the 1.3 million cases documented for men.
- A report by the US General Accounting Office revealed that of the ten drugs withdrawn from the US market between 1997 and 2000, a majority were removed due to side effects primarily affecting women.
- The initial research linking low-dose aspirin to a reduced risk of heart attack was exclusively conducted on male participants. Subsequent studies on women revealed that while aspirin decreased the incidence of strokes, it did not have a comparable effect on heart attack prevention.
- Women metabolise the sleep aid Ambien (zolpidem) at a slower rate than men. Despite numerous reports of incidents, such as women driving while almost asleep, the US FDA maintained its original dosing recommendations for over two decades. It wasn't until 2013 that the agency adjusted dosage guidelines to accommodate these gender-based metabolic variations.
Hormonal Differences
Women's hormonal fluctuations, influenced by menstrual cycles, pregnancy, and menopause, introduce complexities often overlooked in research. Drugs and treatments designed without considering these factors can be less effective or even harmful for women.
In the early 1960s, researchers observed lower heart disease rates in women compared to men until menopause, prompting investigations into hormone replacement therapy as a potential preventive measure. Notably, the initial trial involving 8,341 participants exclusively included male subjects.
Furthermore, an article titled ‘Justice and the Inclusion of Women in Clinical Studies,’ shared that the National Institutes of Health-funded pilot study from Rockefeller University examining the link between obesity and breast and uterine cancer entirely excluded women.
Disease Manifestations
Diseases often present differently in men and women. Heart attacks, for instance, exhibit distinct symptoms in women, frequently leading to delayed diagnosis and increased mortality rates.
An article titled ‘Males Still Dominate Animal Studies’ published in the Journal Nature states that research indicates a significant gender disparity in animal studies. For instance, less than half of animal studies focused on depression or anxiety involve female subjects.
Moreover, their review of leading journals in kidney disease found a striking imbalance: five studies exclusively using male subjects were published for every study including females. In some cases, this ratio escalated to as high as sixteen to one.
Also Read: Here's How Protein Contributes To Balancing Hormones In Women
Additionally, early research into coronary heart disease predominantly focused on male subjects, even though a significant proportion of women between the ages of 40 and 60 exhibit risk factors for CHD. This is particularly concerning given that CHD is a leading cause of death among women and often presents with different symptoms compared to men.
A Call for Change
Recognising the limitations of male-centric research, the scientific community and regulatory bodies are increasingly emphasising the importance of sex and gender considerations in research.
- Inclusion of Women in Trials: Efforts are underway to ensure that women are adequately represented in clinical trials across various medical fields.
- Sex-Specific Analysis: Researchers are analysing data to identify differences in how diseases affect men and women, leading to more targeted treatments.
- Funding for Women's Health Research: Increased investment in research focused on women's health is crucial to address the existing gaps.
Challenges and Opportunities
While progress is being made, challenges persist. Overcoming deeply ingrained biases, securing adequate funding, and designing complex studies that account for sex and gender differences require sustained effort. However, the potential benefits of addressing this gender gap are immense. By prioritising women's health research, we can develop more effective treatments, improve patient outcomes, and ultimately achieve better health for all.
The journey towards gender equity in medical research is ongoing. By acknowledging the historical bias and taking proactive steps to include women in research, we can create a future where healthcare is truly personalised and effective for all.