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Postal service updates: October - December

Bias in research – is women’s health being overlooked?

It’s no secret that our biological sex affects the way we develop, from hormones to physical appearance.  So when will medical research recognise these differences?

Gender bias is the prejudices against or favouritism towards one gender over another. So, could bias be present within medical research?  

Gender biological bias contributes to health inequity worldwide [1]. Historically, for conditions that affect both sexes, women, especially women of colour, have been underrepresented in clinical trials [2].  

Health research has heavily focused on men, with the results applied to women under the assumption that female bodies would react to drugs and medical therapies in the same way [3]. Yet, the reason for women not being included in these trials has ranged from inconsistencies in data due to their changing monthly cycle of hormones to safety precautions if a woman becomes pregnant. The underrepresentation of women in medical research has meant women’s diseases are sometimes missed, misdiagnosed, or remain a total mystery.  

Studies show that often women are less likely than men to receive more advanced diagnostic and therapeutic interventions [4]. Producing biased knowledge through research carried out on men, and then generalising the results has been criticised since the 1970s [5]. Without inclusive research that includes sex differences in study design and analysis, both men and women could be missing out on disease risk factors, diagnosis, and treatment. 

Why have women been underrepresented in clinical research?   

While there is no straight answer to this question, it’s thought that genetics and hormonal factors play a part.  

In 1977, following the thalidomide scandal, the US Food and Drug Administration (FDA) recommended that women of childbearing age should not be included in future clinical research [6]. Although these initial regulations were put in place to protect women, exclusion has led to gender misrepresentation in many different areas of research [7].  

Varying hormone levels during a woman’s menstrual cycle are thought to be a big reason why, historically, research has focused on men. Thankfully, today there is growing acknowledgement that understanding the interactions between female hormones and medications is very important.  

Which health conditions are affected by biological bias? 

1. Heart attacks 

Decades of research have positively changed the likely outcome for someone suffering a heart attack. Yet shockingly, women are 50% more likely than men to receive the wrong initial diagnosis for a heart attack. And following a heart attack, women are also less likely to be prescribed medications to help prevent a second [8].  

Women having a heart attack often delay seeking medical help longer than men because many do not recognise the symptoms. As heart disease research has mainly focused on men, it has caused many to automatically think of chest pain as the first sign of a heart attack – which is not always true.  

While chest pain is a well-known indicator of a heart attack, women may also experience dizziness, nausea, or vomiting [9].  

Symptoms of a heart attack women should look out for (as well as chest pain or discomfort): 

  • Shortness of breath 
  • Nausea/vomiting 
  • Back or jaw pain

2. Autoimmune disease 

Around 78% of people affected by an autoimmune disease are women [10]. Grave’s disease and Hashimoto’s thyroiditis are seven to ten times more common in women than men, and multiple sclerosis (MS) and rheumatoid arthritis (RA) are two to three times more common [11].  

Helping to answer the question of why this gender bias appears so strong is important to explain why more women than men are affected and find better ways to treat different conditions. Two possible reasons are the differences in hormone levels and the presence of two X chromosomes (and their associated genes). 

Read our blog on why are women more prone to thyroid conditions for more on this.  

3. Menopause  

Menopause can be a difficult time for many women. Symptoms can range from mood swings and fatigue to weight gain and hot flushes, affecting them emotionally, physically, and mentally. Despite this, many women feel there is not enough available support for their menopause journey and sometimes feel isolated when trying to find answers to their questions [12].  

A recent survey of over 4,000 menopausal and peri-menopausal women in the UK highlighted a lack of understanding and support for symptoms [13]. The findings, which feature in Channel 4 documentary Davina McCall: Sex, Mind and the Menopause, showed many feel ignored both in the workplace and by healthcare providers. 87% of people surveyed believe the NHS should send all women in their 40s or 50s a list of menopause symptoms to raise awareness.  

More research is needed to make sure menopausal women have the right information for managing symptoms, understanding therapies, and knowing how to access help instead of being expected to get on with it.  

4. Osteoporosis 

Osteoporosis is a condition that weakens bones, making them fragile and more likely to break. Women are more at risk of developing osteoporosis due to menopausal hormonal changes, which affect bone density. While osteoporosis is four times more common in women, the condition also affects men, with research suggesting men tend to have more osteoporosis-related complications [14].  

Compared to the other conditions mentioned above affected by a biological bias, in osteoporosis trials, men appear underrepresented. Because men are poorly studied concerning this condition, often they go underdiagnosed and inadequately treated as the side effects of anti-osteoporotic drugs in men are still poorly known [15]. 

While genetics have a part to play in osteoporosis development and complications, low vitamin D levels, calcium intake, and physical exercise are all also risk factors [16]. Efforts to better understand osteoporosis risk factors require further research which includes equal representation from both genders to create recommendations for population-based interventions. 

5. Drug research and gender bias  

Drug research and development are also affected by gender bias. A lack of female involvement in clinical trials means, historically, women have been at greater risk of adverse medication side effects, as dosages were often calculated based on male data [17]. 

Research published in the journal Biology of Sex Differences confirmed the drug dose gender gap and highlighted a disregard for the differences between male and female bodies [18].  

Including women earlier in the drug development process will increase representation, help reduce gender bias in clinical trials and lead to safer and more accurate recommended dosages [19]. 

What’s being done to reduce the gap?  

There has been a shift in attitudes and requirements for who must be included in clinical trials. And these changes are helping to positively influence research for the benefit of marginalised groups, including women.  

Scientists must now account for sex as a possible biological variable in animal and human studies. In 1993, the FDA lifted its ban on women participating in clinical research. The European Union’s Clinical Trials Directive also now expects that drug trials reflect the population to be treated once the medicine is on the market. 

Take control of your health 

Despite these changes being implemented to help address the gender divide, a lack of funding for women’s health remains a problem. For example, although one in three women may suffer from a reproductive or gynaecological health issue in their lifetime [20], it’s estimated that less than 2.5% of UK publicly funded research is dedicated to reproductive health [21].  

Take a look at our range of Women’s Health Checks and Men’s Health Checks, or visit the Test Finder to help find the test that’s right for you.


 References 

  1. Hamberg, K., 2008. Gender Bias in Medicine. Women's Health, 4(3), pp.237-243.
  2. Cotton, P., 1990. Examples Abound of Gaps in Medical Knowledge Because of Groups Excluded From Scientific Study. JAMA: The Journal of the American Medical Association, 263(8), p.1051. 
  3. National Women's Health Network |. 2022. Taking on Gender Bias in Clinical Trials | National Women's Health Network. [online] Available at: https://nwhn.org/taking-on-gender-bias-in-clinical-trials/ [Accessed 6 June 2022].  
  4. Council on Ethical and Judicial Affairs, AMA: Gender disparities in clinical decision making. JAMA 266, 559–562 (1991).  
  5. Ramasubbu K, Gurm H, Litaker D: Gender bias in clinical trials: do double standards still apply? J. Womens Health Gend. Based Med. 10, 757–764 (2001). 
  6. Liu, K. and DiPietro Mager, N., 2016. Women’s involvement in clinical trials: historical perspective and future implications. Pharmacy Practice, 14(1), pp.708-708. 
  7. The Pharmaceutical Journal. 2022. Why we need to talk about sex and clinical trials - The Pharmaceutical Journal. [online] Available at: <https://pharmaceutical-journal.com/article/feature/why-we-need-to-talk-about-sex-and-clinical-trials#fn_1> [Accessed 1 July 2022].
  8. British Heart Foundation. 2022. Bias and Biology. [online] Available at: <https://www.bhf.org.uk/informationsupport/heart-matters-magazine/medical/women-and-heart-disease/download-bias-and-biology-briefing> [Accessed 1 July 2022].  
  9. Harvard Health. 2022. Gender differences in cardiovascular disease: Women are less likely to be prescribed certain heart medications - Harvard Health. [online] Available at: <https://www.health.harvard.edu/blog/gender-differences-in-cardiovascular-disease-women-are-less-likely-to-be-prescribed-certain-heart-medications-2020071620553> [Accessed 1 July 2022].
  10. Fairweather, D. and Rose, N., 2004. Women and Autoimmune Diseases1. Emerging Infectious Diseases, 10(11), pp.2005-2011
  11. Im EO, Lee B, Chee W, Dormire S, Brown A. A national multiethnic online forum study on menopausal symptom experience. Nurs Res 2010; 59:26–33. 
  12. Primary Care Women's Health Forum. 2022. Research reveals 92% of women in the UK feel unprepared for menopause | Primary Care Women's Health Forum. [online] Available at: <https://pcwhf.co.uk/news/silence-isnt-golden-research-reveals-92-of-women-in-the-uk-feel-unprepared-for-the-menopause/> [Accessed 1 July 2022]. 
  13. Fawcettsociety.org.uk. 2022. [online] Available at: <https://www.fawcettsociety.org.uk/Handlers/Download.ashx?IDMF=9672cf45-5f13-4b69-8882-1e5e643ac8a6> [Accessed 1 July 2022]. 
  14. Feldstein, A., Elmer, P., Orwoll, E., Herson, M. and Hillier, T., 2003. Bone Mineral Density Measurement and Treatment for Osteoporosis in Older Individuals with Fractures. Archives of Internal Medicine, 163(18), p.2165. 
  15. Dy CJ, Lamont LE, Ton QV, Lane JM. Sex and gender considerations in male patients with osteoporosis. Clin Orthop Relat Res. 2011;469:1906–1912. 
  16. NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy, 2001. Osteoporosis Prevention, Diagnosis, and Therapy. JAMA: The Journal of the American Medical Association, 285(6), pp.785-795. 
  17. Science Connected Magazine. 2022. All of Us: A Lack of Diversity in Medicine. [online] Available at: <https://magazine.scienceconnected.org/2022/04/all-of-us-addresses-lack-of-diversity-in-medicine/> [Accessed 1 July 2022].
  18. Zucker, I. and Prendergast, B., 2020. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biology of Sex Differences, 11(1). 
  19. Liu, K. and DiPietro Mager, N., 2016. Women’s involvement in clinical trials: historical perspective and future implications. Pharmacy Practice, 14(1), pp.708-708. 
  20. GOV.UK. 2022. Survey reveals women experience severe reproductive health issues. [online] Available at: <https://www.gov.uk/government/news/survey-reveals-women-experience-severe-reproductive-health-issues> [Accessed 1 July 2022]. 
  21. Ukcrc.org. 2022. [online] Available at: <https://www.ukcrc.org/wp-content/uploads/2015/08/UKCRCHealthResearchAnalysis2014-WEB.pdf> [Accessed 1 July 2022].