We are so proud to have over 800 members across 32 countries in the Women’s Health Research Cluster. Our Vision is to achieve sex and gender health equity, and we strive for a future where women and girls live equitably health lives across their lifespans. We, at the Cluster, understand the importance of including girls and women, and studying unique and shared variables across and within sex and gender that influence our health. The integration of sex and gender-related variables into research is critical for advancing knowledge and care. One of the most powerful nations in our world is directing their government employees to retract submitted research that mentions sex or gender. The National Institutes of Health (NIH), one of the largest funders of health research in the world, has been impacted by executive orders curbing “DEI” initiatives, which appears to include initiatives such as sex as a biological variable (SABV).
In 1993, the NIH led the world in mandating that women and minorities needed to be included in NIH-funded clinical trials. This was partly in response to the fact that 90% of human females will experience side effects of new treatments brought to market, due to the lack of inclusion of females and analyses with sex as a factor. Unfortunately, even with these mandates to include sex and gender, in randomised control trials published in 2021, only 43% analysed with sex as a covariate. However, this is a statistical method to remove the effects of sex, or ‘erase’ sex if you will. It is important to analyse data with sex as a factor because otherwise, we miss discoveries and possible treatments – and we miss them not just for women, but for men too.
In 2016, the NIH expanded the inclusion of females into biomedical research (SABV), though again, only 5% of research in neuroscience and psychiatry were found to analyse with sex as a factor. If we want to make progress in our health, across the world, we cannot afford to ignore sex as a factor. Why not? Not only is valuable information lost, but ignoring sex as a variable prevents effective therapeutics coming to market. A prime example of this is lazaroids, a promising candidate for stroke recovery in men, which failed Phase 3 clinical trials, and as a consequence, did not make it to market. This happened because the analyses did not include sex as a factor (when a treatment or intervention works well in one sex but not in the other, the effects counter each other and generally results in “non-significance”). Thus, the failure to account and analyse with sex as a factor is a blatant barrier to medical discovery. It hurts men’s health. It hurts women’s health.
We have all likely experienced the fallacy of “one size fits all” in clothing. Why on earth would we think “one size” would work for medications? Any sex difference that occurs in disease prevalence, medication benefits, or symptom manifestation, suggests that either chromosomes (XX, XY) or “sex” hormones (estrogens, androgens, progestrogens), or some combination of both, are involved. In terms of our health, our genes AND our environment matter. Our environment includes not only social and stressful experiences, but also our hormones and hormonal experiences. We are still so far behind in our knowledge and understanding of how treatments may work differently depending on age, sex, and hormone history. New therapeutics are continuously being approved, yet – with the exception of the sleep aid Ambien – there are no official guidelines on dose based on body weight. Given the average woman weighs 15-19% less than the average man in North America, this will have repercussions on dose. Indeed, dose based on weight is rarely considered in over the counter medications, nevermind that there are sex differences in the ways that drugs, including anti-cancer medications, metabolise. Last year, a new therapeutic was approved by the FDA to combat memory decline in Alzheimer’s disease. However, on closer inspection of the results, the drug worked in males but not in females to slow cognitive decline. It also worked more favorably in white, but not black, individuals, and in people without the greatest genetic risk factor for late onset Alzheimer’s disease. These details matter. If we do not examine how sex and hormonal experiences influence health factors, we will fail to realise the promise of personalised medicine. Now more than ever, we need to band together in a united front to combat disinformation and support each other in our endeavours to promote women’s health research. This is not “woke” science – this is science. We ignore it at our own peril.
