There is a long-standing assumption that medicine, and the research underpinning medical interventions, is gender neutral. However, a growing body of evidence is demonstrating that this is not the case, with harmful consequences. Today’s analysis, from Dr Amy Vassallo (@amyjvassallo), Dr Cheryl Carcel (@cheryl_carcel), Prof Louise Chappell (@chappell_louise), Prof Robyn Norton (@RobynNorton8), Dr Janani Shanthosh (@janshanthosh), Prof Mark Woodward and Dr Zoe Wainer (@dr_zoe_wainer) of The George Institute for Global health (@GeorgeInstitute) provide an overview of current research, policy and practice gaps in Australian medical research. This analysis is drawn from their article, recently published in The Medical Journal of Australia.

Sex and gender-based bias and blindness in medicine

You may be surprised to learn that only in 1993 did it became mandatory in the United States for women and ethnic minority groups to be included in clinical trials. And perhaps even more surprising, only in 2016 did the US National Institutes of Health implement a policy requiring researchers to consider “sex as a biological variable”. No equivalent policies exist in Australia. Therefore many “knowns” in medicine have been founded on research conducted with male cells, male animals and clinical trials involving only or predominantly men (with many assumptions underpinning how sex or gender is determined for all of these). While it is always problematic to assume the findings of research conducted with one group will automatically apply to others, this weighting towards these subjects clearly reveals a sex and gender-based bias, as well as assumptions about what sex and gender are, how they are determined, and how these concepts are relevant to medical research. This bias and blindness spans communicable and noncommunicable diseases, and affects prevention, diagnosis and treatment, with potentially significant consequences.

Stuck in time? Conceptions of gender and gender identity have a profound impact on health, which is yet to be fully acknowledged and accounted for in medical research. Photo by CDC on Unsplash

For example, heart disease is a leading cause of illness and death for Australian women, yet it continues to be primarily known as a “man’s disease”. Despite this substantial disease burden in women, diagnosis of heart disease and models of clinical care draw heavily on previous research conducted only with men. As a result, women’s symptoms are often mis- and under-diagnosed.

Conversely, osteoporosis is viewed as primarily a postmenopausal women’s disease, yet men account for nearly a third of osteoporosis-related hip fractures. Data show that men are rarely evaluated or treated for osteoporosis, and tend to have a higher mortality rate than women from complications of this condition.

The gendered impacts of the COVID-19 pandemic also cannot be ignored. A global call for sex-disaggregated data shows that while there appear be equal numbers of cases between men and women, sex differences are emerging at the global level with men experiencing more hospitalisations, ICU admissions and deaths and women experiencing greater social and secondary impacts. Routine data on incidence and outcomes for trans and gender diverse people is critical, but lacking. Despite known differences, clinical trials of COVID-19 treatments or vaccines are not separately analysing their safety and efficacy data by sex or gender, and certain groups, such as pregnant and breastfeeding women, are excluded from research studies altogether. This is not a new issue; pregnant and breastfeeding women are routinely excluded from clinical trials.

Addressing the data gap through policy

One important way of addressing the sex and gender-based evidence gap in medicine is to have policies in place requiring medical researchers to not limit studies to one sex or gender (without adequate justification) and undertake sex and/or gender-based analysis. Our research has shown that these policies are especially important at three critical points in the research pipeline – when applying for/gaining competitive funding, when publishing research findings, and when translating that evidence into clinical practice.

A growing number of countries around the world, including the US, Canada, Ireland and Germany, are introducing policies and practices to ensure sex and gender are incorporated into medical research, and that research data are disaggregated to enable analysis of biological and/or sociocultural factors.

Our research has demonstrated that Australia is lagging behind in implementing this approach. Through a web-based search we found that only two of the top 10 medical research funders had a policy relating to consideration of sex and gender. For journals publishing medical research, four of the top 10 did not have a policy in place for collection, analysis and reporting of sex and gender data. The remaining six stated they follow general reporting guidelines which include sex and gender, rather than addressing the issue directly. Lack of awareness, as well as the cost of funding sex and gender-specific research, were perceived as barriers to change in policy and practice. Larger organisations leading by example were identified as a future facilitator for change. Most key informants were positive about creating specific policies into the future.

This work demonstrates that current Australian medical research frameworks do not routinely consider the potential – and complex – role of sex or gender in research, and how these can impact burden of diseases, appropriateness of treatments and outcomes. As softer approaches to remedying this have not been effective, a systematic and mandatory approach to collecting, analysing and reporting sex and gender data is critical to address this knowledge gap.

Where to from here?

Our investigation found that stakeholders have an appetite for change. A series of recommendations have been proposed for critical groups working throughout the medical research sector, which we are pursuing as the next phase of this work. Questions also need to be asked about how sex and gender is determined, given the emerging science on the biological and social complexity of these concepts.

While these “gatekeepers” of research practice are critical influencers of the conduct and culture of medical research, community members, researchers and clinicians have an important role to play as well:

As a health care consumer, express your support for research that analyses and reports study results by sex and/or gender and ask questions when you participate in research about how information about your sex and/or gender is being collected, used and reported.
As a researcher, incorporate sex and gender into your research – consult the Australian Bureau of Statistics Standard for information on best practice in collecting and reporting sex, gender, and variations of sex characteristics variables, and consult the SAGER guidelines and a tutorial for analysis sex differences as additional valuable resources.
As a clinician, seek out and translate sex and gender-specific research findings into your everyday clinical practice.

Recognise that health and wellbeing is impacted by complex intersections of many biological, environmental and social factors. These factors, biases and status hierarchies are essential to investigate along with sex and gender in order to fully understand and support health outcomes for all people.

Incorporating these policy and practice recommendations across the medical research sector will lead to better science, more reliable and reproducible research findings, better care, and contribute to achieving true gender equity in health outcomes into the future.

This post is part of the Women's Policy Action Tank initiative to analyse government policy using a gendered lens. View our other policy analysis pieces here.

Posted by @SusanMaury

The gender-based data gap in Australian medical research is a problem for everybody