The push for more women in medical research
There are two assumptions that can be made in the medical and medical research communities that may affect the health of both women and men. The first assumption is that factors in health are similar in men and women when they are not and the second is, conversely, assuming there are differences when similarities exist. Research in clinical trials have historically used the assumption of similarities between men and women, also called gender blindness, to justify the exclusion of women from medical studies and clinical trials. This exclusion has led to a gap in knowledge that continues to affect women today.
Prior to 1977 there were two widely prescribed drugs that were found to cause devastating effects in pregnant women and their children. With risks that include increased incidence of cancer, fetal abnormalities, developmental issues, and miscarriage, the uses of thalidomide and diethylstilbestrol (DES) resulted in such significant tragedies that the Food and Drug Administration (FDA) recommended that all women of childbearing age be excluded from clinical trials. The new guidelines were based on concerns for: risk to fetus during pregnancy, hormonal complications from menstrual cycle, hormonal complications from use of hormones for birth control or hormone replacement therapy, difficulty recruiting women, and their higher dropout rates. Women could be included in the later stages of trials, after drug toxicity was established, but were usually not included then either. The data gathered from men was used with the expectation that drugs would have a similar physiological effect on women, even though many of the reasons listed above for exclusion were sex-based physiological differences. With this, the FDA essentially banned women’s participation as subjects in clinical research from 1977-1993, losing the possibility of knowledge on how the drugs studied might affect women differently than they affected the participating men.
Throughout this time period, concerns of underrepresentation of women in clinical trials came from multiple agencies connected to the federal health system. In 1993, after years of encouragement from the National Institute of Health (NIH), the FDA released a new recommendation that women be included in the early stages of clinical trials again, but with close monitoring of possibility of pregnancy, and that those trials should show differences in how the drugs worked for men and women. In 1998, the FDA came out with an updated version of this called: “Presentation of Safety and Effectiveness Data for Certain Subgroups of the Population in Investigational New Drug Application Reports and New Drug Applications”. The newer guideline gave more specific requirements for NIH funded New Drug Applications (NDA) to show safety and efficacy data for distinct populations of people, including sex, age, and racial subgroups.
Out of 10 prescription drugs removed from the market between 1997-2001, eight were found to have more health risks for women.
Even with the new regulations, the effects of the exclusion of women from clinical trials has reverberated for many years after their reinstatement in 1993. Out of 10 prescription drugs removed from the market between 1997-2001, eight were found to have more health risks for women. Adverse drug reactions show up to 1.5-1.7 times more often in women than in men. Women are still underrepresented in studies compared to their proportion of the general population and many of those studies continue to group both genders together in findings.
The good news is, that when women are included on research teams there is more equity of enrollment when it comes to gender and more sex-specific analysis of results. With women’s participation in STEM fields on the rise, especially in the life sciences where medical research is categorized, we’re slowly moving toward a more comprehensive knowledge of how drugs and other treatments affect women and men specifically, instead of relying on assumptions of similarities when there might be differences.