When most people think of pregnancy, they think of a cradled baby bump with that black and white ultrasound picture of the tiny button nose or food cravings. When I recall my pregnancy, the sound of rattling pill bottles comes to mind. A pill for esophagus eroding heartburn or a pill to replace the low level of thyroid hormones to keep my fetus from developing heart defects. The jangle of pill bottles continued well into my postpartum recovery, where after a rough delivery I was sent home with multiple prescriptions to help me heal and recover. During all of this, it was difficult to find information to decide if the medications prescribed were safe for my developing fetus or while breastfeeding. In the end, I decided to bear the relentless pain for months and forgo the medication to breastfeed as there was little information on how the medications would affect my newborn son. It was an experience that leaves one with the realization that nobody truly knows how to properly and safely care for women health issues as the published research and clinical trials simply do not exist.
This is not a new scenario for women. The root of this issue can be traced back to the drug Thalidomide that was prescribed in the 1960’s as a cure all for morning sickness during pregnancy. It was a wonder drug that left babies born without arms or legs, and as the multitude of birth defects caused by this drug piled up, pharmaceutical companies decided to take swift action to ensure this situation never happened again. Their solution? To eliminate all pregnant women and child-bearing females from clinical studies and research trials. During the 61 years since, we find ourselves in the middle of a pandemic and women have not stopped becoming pregnant and bearing children and not all women choose to have children or are of childbearing age.
The Heart and Stroke foundation recognizes the molecular and hormonal difference between men and women. The fact is, over the last 10 years, pharmaceutical research that included females declined from 33% to 29%. The current issue that is revealing this glaringly obvious lack of research is should pregnant and breastfeeding women receive the COVID-19 vaccination? Pregnant and breastfeeding women and females of childbearing age are strongly encouraged to receive the vaccine and to consider the risks and benefits of the vaccines. But how can you make an educated decision impacting your health and the health of another with little to no available research? There are limited short term studies involving these women and no long-term trials. Many of these women compare this situation to feeling like a scurrying lab mouse in a maze looking for the cheese, only to realize there’s none to be had.
Women are strongly continuing to protest and fight gender inequalities and gender wage gaps, but now the underground issue of gender related health disparities is rising during a life-threatening pandemic. Regardless of sex, we need to rise to the occasion as a community and demand inclusion and equality for the health and wellness of our grandmothers, mothers, daughters, wives and sisters. The Federal government must mandate policies for including women in health studies and clinical trials and obligate the reporting of the sex differences in these trials. Society must demand from their primary caregiver and local member of parliament to utilize only the research that recognizes and includes the outcomes for both sexes. Pharmaceutical companies must be issued mandated policies that demand the review of previous research to investigate the findings among men and women and report these findings separately and accordingly. Lastly the Canadian research ethics board must be held accountable for ensuring the reporting of findings based on sex during clinical trials and following up with these studies to ensure an ethical and safe documentation and presentation of these findings.
Brittany Burian is a registered nurse, wife, mother, sister, and daughter who is passionate about women’s health and equality.
References
E. C. J., Cooney, E., About the Author Reprints Elizabeth Cooney General Assignment Reporter Liz focuses on cancer, & Elizabeth Cooney General Assignment Reporter Liz focuses on cancer. (2020, June 10). Females still routinely left out of biomedical research - and in analyses. https://www.statnews.com/2020/06/09/females-are-still-routinely-left-out-of-biomedical-research-and-ignored-in-analyses-of-data/.
Heart and Stroke Foundation of Canada. (2020). https://www.heartandstroke.ca/?utm_campaign=W21_Prism_EN&utm_medium=SEM&utm_source=Google&utm_content=Masterbrand_Brand_EN&utm_term=theheartandstrokefoundation&gclid=EAIaIQobChMI06-2qp7Y7wIVFKGzCh0HCgICEAAYASAAEgIBevD_BwE&gclsrc=aw.ds.
Lippman, A. (2006, March). The Inclusion of Women in Clinical Trials: Are We Asking the Right Questions? Toronto; Women and Health Protection.
Sugimoto, C. R., Ahn, Y. Y., Smith, E., Macaluso, B., & Lariviere, V. (2019). Factors affecting sex-related reporting in medical research: A cross-disciplinary bibliometric analysis. The Lancet, 393, 550-559. https://doi.org/10.1016/S0140-6736(18)32995-7
Tannenbaum, C., Clow, B., Haworth-Brockman, M., & Voss, P. (2017). Sex and gender considerations in Canadian clinical practice guidelines: A systemic review, CMAJ, 5(1), E66 – E73. https://doi.org/10.9778/cmajo.20160051
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