Is there a lack of clinical trials related to women’s health? Unfortunately, the answer seems to be a ‘yes’. There is no dispute that most medical research has been done on male biology, be it humans or animals, mostly by male doctors and scientists, leaving women with a healthcare system that, according to Dr. Kate Young from Monash University, has been “made by men for men”.
A research published in July 2019 by the Allen Institute of Artificial Intelligence studied the participation of women in medical research over 25 years, by looking at 43,000 research studies and 13,000 clinical trials across conditions including hepatitis, HIV/AIDS, chronic kidney diseases, digestive diseases and cardiovascular disease (often called the “man’s disease”, even though it is the number one killer of women).
The result showed a much lower percentage of female participants in comparison to that of real-world patients. Worse, a pilot study from Rockefeller University, supported by the National Institutes of Health (NIH), on how obesity affects breast and uterine cancer didn’t enlist any women at all. In these cases, the numbers are minuscule: the alcohol safety test of a female Viagra drug called “Addyi” was done on 23 men and two premenopausal women.
Operating under the general assumption and misconception in early research that men and women were the same, treatments administered to women were the same as used on men. One of the first studies to disprove this assumption was a 2005 study on women’s health titled “A Randomized Trial of Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women” that shows that the effect of aspirin on women as a preventive medication for heart failure was not the same as men.
The 10-year-long study showed that women taking aspirin every other day were just as likely to suffer from a heart attack as women who were taking placebos. The drug did, however, prevent the risk of a stroke in women, an outcome that was not seen in men. Even though more women in the U.S. have been included in medical trials since the 1990s, due to the FDA and NIH’s policies, there is still a bias when it comes to the results. While women may now be included in the trials as a result of these guidelines, researchers have not always analysed their results.
This under-representation of women is leading to improper treatment and drug discovery. In 1938, a drug to prevent miscarriages in women was found to have harmful effects on the daughters of roughly 400,000 women on the drug 30 years later. In 2018, a research paper titled “Cancer immunotherapy efficacy and patients’ sex: a systematic review and meta-analysis” showed how after the analysis of multiple databases for randomised controlled trials of immune checkpoint inhibitors, that cancer immunotherapy is much more beneficial for men and men’s survival rate from spontaneous cancer.
With women being underrepresented in clinical trials, the understanding of women’s health has been limited, resulting in women being provided with ineffective treatment and medication. We also need a greater study of women’s health if we want to understand how diseases present themselves differently in women.
For example, women show unique symptoms when it comes to a stoke than men. Women often report symptoms such as nausea, fatigue, hiccups and seizures when having a stroke; symptoms that are very different from the ones in men. Due to this difference in symptoms between men and women, it often takes a longer time to realise that the woman is suffering from a stroke. Further, sexually transmitted diseases presented themselves differently in men and women, with women less likely to have symptoms of common STDs as compared to men.
If we want to improve health outcomes for women, we not only need a better understanding of how diseases present themselves, but also how treatments work in their bodies. We must change the protocols around research studies and clinical trials, and pay more attention to how women describe their conditions and reactions to treatment – this requires both empathy and an acceptance that women’s bodies function differently.