By Chris Ezeh – Publisher EuroAfricaNews Magazine
For nearly 25 years, regulators have championed the need for equal representation of men and women in health research. Yet, despite these efforts, women continue to face disproportionate risks from medications and treatments. The lack of gender balance in drug testing and clinical trials not only endangers women’s lives but also undermines the effectiveness of therapies worldwide. This article explores the critical gaps in drug research and the urgent need to address them to ensure safer, more effective healthcare for women everywhere.
For nearly a quarter of a century, regulators have advocated for equal inclusion of men and women in health research. Despite this, women remain significantly underrepresented, a gap that has severe consequences. The disparity in how drugs affect men and women is not just a minor oversight; it is a systemic issue that endangers women’s lives and compromises the effectiveness of medical treatments. Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality. Reports on differences in reporting patterns between women and men exist nationally..
The Stark Reality of Gender Disparity in Drug Safety
Between 2004 and 2013, over 2 million women in the United States experienced drug-related adverse events, compared to 1.3 million men. This alarming statistic from the US Food and Drug Administration (FDA) underscores the heightened risk women face when taking medications.
Even more troubling, a report by the US General Accounting Office revealed that, of the ten drugs removed from the US market between 1997 and 2000, eight were withdrawn due to side effects that predominantly affected women. These included widely used drugs like the antihistamine Seldane and the anti-heartburn medication Propulsid, both of which caused heart disturbances, often fatal, primarily in women.
The Root Cause: Under-representation in Research
One of the primary reasons women suffer more adverse effects from drugs is their under-representation in studies of disease mechanisms and treatments. When researchers overlook women, they miss critical differences in how the female body responds to therapies, leaving doctors with insufficient guidance on prescribing drugs based on sex. Despite efforts from researchers and policymakers to address this issue, progress has been slow. The resistance often stems from the perception that including women in studies is inconvenient or unnecessary. However, experts argue that this is a short-sighted view. As Cara Tannenbaum, the scientific director of the Institute of Gender and Health at the Canadian Institutes of Health Research (CIHR), asserts, “You could miss important discoveries if you don’t include both sexes.”
The Glaring Gaps in Clinical Trials
The under-representation of women is not just a relic of past research; it persists today. In cardiovascular clinical trials, for example, only one-third of participants are women; of those trials, just 31% report results by sex. The problem is particularly acute in the early phases of clinical trials, where researchers identify safe and effective doses. These early trials often exclude women, which means that by the time women are included in more extensive phase III trials, they may be receiving doses that are ineffective or even harmful.
This exclusion dates to a 1977 FDA decision that barred women of reproductive age from participating in early-phase studies unless the research involved life-threatening illnesses. However, the FDA reversed this ban in the 1990s, the legacy of male-biased research persists, with significant implications for drug safety and efficacy in women.
Preclinical Research: A Male-Dominated Field
The bias against women extends beyond human clinical trials. Preclinical animal studies, which lay the groundwork for human trials, also predominantly use male subjects. For instance, less than 45% of animal studies on depression or anxiety include females. This male-centric approach skews the entire drug development pipeline, leading to treatments that are optimized for male physiology. Without including female animals in preclinical research, scientists lack the necessary data to justify testing a drug on women. As Tannenbaum aptly puts it, “I don’t even know if it’s ethical to tell women, ‘Yes, you should be in this trial to test this new drug, but actually, we’ve never tested it in a female vertebrate.'”
The Path Forward: Inclusion and Accountability
Including women in research is not just a matter of fairness; it is essential for advancing scientific knowledge and improving public health. Since 2016, the US National Institutes of Health (NIH) has required grant proposals in vertebrate research to include both sexes and analyse results by sex. Yet, challenges remain, particularly for researchers breaking new ground by studying female subjects without a robust knowledge background.
Overcoming these challenges requires a shift in mindset and better education for researchers and medical professionals. Many researchers mistakenly believe that including females in their studies would require doubling the sample size. However, experts like Marcia Stefanick from Stanford University clarify that only a small increase in sample size is needed to detect sex-specific adverse events.
The Role of Journals and Funding Agencies
Journal editors and reviewers play a crucial role in enforcing standards for sex-specific reporting in research. As Tannenbaum suggests, journals should require that studies include sex-disaggregated data as a condition for publication. Such measures would ensure that researchers are accountable for including both sexes in their studies, ultimately leading to better science and safer treatments.
Including women in health research is not a luxury but a necessity. By recognizing and addressing the unique ways women respond to therapies, we can move toward a future where medical treatments are safe, effective, and equitable for everyone. As Gillian Einstein, a neuroscientist at the University of Toronto, states, “Fundamentally, it’s an issue of better science.” The time for change is now.