A 2014 report from George Washington University found women are underrepresented in clinical trials. The study claims that women not only make up 1/3 of subjects in cardiovascular studies, but only 1/3 of studies that include women at all even report how findings differ by sex. The same issue was found in lung cancer studies, even though lung cancer kills more women than sex-specific variants such as ovarian or uterine cancer. Women are also uncommon in studies concerning psychological illnesses like Alzheimer’s and depression, despite those diseases affecting twice as many women as men. This issue also affects drug testing.
In early 2013, the Food and Drug Administration lowered the recommended dose for the sleeping pill Ambien, specifically for women. Several studies had shown that the normal dose for drugs containing the ingredient zolpidem would keep female users drowsy into the morning, which could impair their ability to drive and potentially cause crashes. According to Dr. Ellis Unger, a director for FDA’s Office of Drug Evaluation, “We don’t understand why yet, but women are more susceptible to next-morning impairment.” The current recommended dose for Ambien is 10 milligrams for men, but only 5 milligrams for women. How could medical trials miss such a major side effect in a drug that had been in medical use for 21 years prior? Unfortunately, there is a long history of short-sightedness in medical research that affects clinical trials to this day.
Men are seen as the “default body”
Reshma Jagsi, M.D., director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, says that there are old traditions in the medical field that keep women from being considered key inclusions in relevant studies. According to her, “there is a deeply rooted idea that the 70kg white male is ‘normal'” and that women’s bodies are deviations from the baseline model. Researchers will work with men assuming that their results will also apply to women, without having to deal with female hormones, which they mistakenly believe would make testing more difficult.
This explains why women are underrepresented in studies regarding lung cancer or heart disease; researchers assume “everyone has a heart and lungs, so the results we get from men will apply to everyone.” This idea doesn’t hold water in practice. For example, heart attack symptoms in women are much more subtle than those in men: the dramatic image of a pain suddenly shooting down your arm doesn’t really occur for women. Instead, women will experience things like shortness of breath, nausea, and exhaustion, which doctors often attribute to other diseases. Women also metabolize drugs differently than men, which was demonstrated when the FDA had to lower the dose for Ambien.
New Policies Sometimes Fail to Get Women into Medical Trials
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, has implemented several policies over the years in attempts to make sure more women were included in medical trials. In 1977, an FDA policy excluded “women of childbearing potential”, which bizarrely included women on birth control, single women, or women with husbands with vasectomies. Backlash against policies like this heightened in the 1980’s when activists protested the exclusion of women from HIV drug trials. The NIH created an internal policy encouraging the inclusion of more women in studies, which was turned into law in 1993 via the NIH Revitalization Act. This act required that women be included in all trials, that the trials specifically note with the sex of the participants had an effect on the results, that cost was not a valid reason for excluding women, and that the NIH create programs to recruit more women as volunteers.
These policies have done some demonstrable good: In 1991, Dr. Bernadine Healy, the first female NIH Director, launched an initiative that enrolled over 150,000 women in clinical trials. These women helped NIH researchers study hormone therapy, diet modification, the effects of calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer for the following 15 years. However, investigation into the NIH has shown less than perfect results from the inclusion policies.
Before the NIH Revitalization act, the Government Accountability Office found that the NIH did not consistently find women for clinical trials, and did little to ensure researchers included gender as a variable in their studies. The ratification of those polices into government law was supposed to fix these issues, but a study published by Academic Medicine found that “NIH policies have not resulted in significant increases in reporting results by sex, race, or ethnicity.”
How to Get More Women in Clinical Trials
Nancy Pire-Smerkanich is an assistant professor at the School of Pharmacy at the University of Southern California who has previously interviewed on the subject of diversity and inclusion in clinical trials.
Pire-Smerkanich says that many women would like to participate in clinical trials, but need to be informed of the risks involved in order to feel comfortable. “Women need to be studied earlier in the drug development process and throughout the life cycle, and I think researchers are interested in doing this. Whether they are always supported in these efforts is another unknown.” The current lack of knowledge on the unique effects of drugs on women makes it much more difficult to get women into medical trials because the risks are unknown. This can be a tricky Catch 22 to get over, particularly for pregnant women, who are understandably cautious. If clinical researchers put in more work to inform and recruit female subjects, they will eventually fill that lack of knowledge, and will hopefully recruit many more women for trials in the future.
