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Dr. Nicole Woitowich is the Associate Director for the Women’s Health Research Institute at Northwestern University, with a specific focus on the influences of sex and gender on women’s health. She just published a study looking at the impact of relatively new and hard fought-for rules and regulations at the NIH to include sex and gender as biological markers, and for women and females to be included in all NIH funded research. In an interview she did with The WAM Weekly, Dr. Woitowich explains how the results were dramatic, disappointing, and why we may need yet another overhaul of the regulations to ensure women get equity when it comes to medical research.

WAM: You just released a report that took many people in the women’s health research field aback. Can you summarize those findings and tell us why they are important? 

Dr. Woitowich: My colleagues and I compared the number of research studies which included both male and female subjects between 2009 and 2019. We found that while the number of studies which included both males and females has increased significantly since 2009, from 29% to 48%, there was no corresponding increase in the number of studies that analyzed data by sex. This is worrisome, because we know that sex plays a large role in health and disease and sex-based analyses can help us determine if and how drugs and therapies work differently in men and women.

In addition, we found that even though some studies claimed to include both sexes, close to 1/3 failed to report the exact number of males and females subjects.To me, this poor scientific reporting should be unacceptable.By failing to report and analyze data by sex, it makes it difficult for scientists to repeat studies and build on prior knowledge. Scientists may need to make assumptions based on the missing information, which requires additional time, resources, and tax-payer funded research dollars.

WAM: Is it not legally required by the NIH of research grant recipients to include women and females in their studies?

Woitowich: NIH-funded clinical trials are legally required to include women following the 1993 NIH Revitalization Act.Yet, for many years there was no such guidance for basic science research which relied heavily on male cells and animals.

In 2016, the NIH sought to address this gap in the basic sciences by introducing a policy which requires researchers to consider sex as a biological variable in their studies.It does not mandate or require that both sexes be included. In fact, when we surveyed NIH study section members, the individuals tasked with reviewing grants, some felt that the policy was ‘‘[a] waste of time,” and that the policy was “not usually a score-driving consideration.”

While I think this policy is a great start, it is only one piece of the puzzle. We need to encourage academic publishers, funders, and research institutions – other gatekeepers in science – to require sex-based analyses and reporting.

WAM: What are the implications of your findings on women’s health?

Woitowich: It is encouraging that more studies are including both sexes, but disheartening to know that there has not been an improvement in the number of studies to analyze data by sex over the past decade.These analyses are critical for us to determine if and how sex influences diseases and disorders, and unfortunately due to years of male-bias, this has led to key gaps in our understanding of women’s health and the development of sex-specific treatments and therapies.

WAM: You also discovered that neuroscience in particular was slow in responding to the call for data on women in research. What were the results there?

Woitowich: The field of neuroscience was one of the worst offenders in 2009 – 41% of studies used only male subjects. By 2019, the number of male-only studies dropped to 28%, and the number of studies which included both males and females increased from 29% to 63% between 2009 and 2019.

At first glance, these data seem encouraging. However, more than half (52%) of all neuroscience studies to include both sexes in 2019 failed to report the exact number of male and female subjects. As I mentioned above, this is a huge problem for the rigor and reproducibility of science and indicates to me there is still much more work to be done in this field. 

WAM: Is there any indication that there are other groups harmed by not having this kind of research analysis?

Woitowich: My work has focused on basic science research – primarily looking at the sex of research subjects, be it cells, animals, or humans. Yet, human clinical research studies need to consider other factors such as gender, race, ethnicity, sexual orientation, and socioeconomic status (just to name a few). This is because social determinants also impact health outcomes and access to care.

If our goal is to achieve truly personalized medicine and reduce health disparities, then we need to take a holistic approach to analyzing health data. That includes considering both biological and social variables that contribute to health and disease and ensuring that minoritized individuals and groups are represented as key stakeholders and partners in research.

WAM: How do we fix this problem – and can we do it quickly?

Woitowich: We need a major shift in biomedical research practices and policies, which will require buy-in from multiple groups: scientists, publishers, funders, educators, policymakers, patients, and advocates. Sex-inclusive science is not a disease-specific issue. It truly impacts the health and well-being of all people, and I think that message can be hard to distill. We need advocates and allies who will demand that science change and funding for research that explores these critical intersections. While we might not be able to fix this overnight, I think the impetus for change is here and now.