Invisible Women: Exposing Data Bias in a World Designed for Men

we account for the benefits to women in doing resistance training to counteract osteopenia and osteoporosis, both of which they are at high risk for post-menopause.

Other male-biased advice includes the recommendation for diabetics to do high-intensity interval training; it doesn’t really help female diabetics⁹³ (we don’t really know why, but this is possibly because women burn fat more than carbs during exercise⁹⁴). We know very little about how women respond to concussions,⁹⁵ ‘even though women suffer from concussions at higher rates than men and take longer to recover in comparable sports’.⁹⁶ Isometric exercises fatigue women less (which is relevant for post-injury rehabilitation) because men and women have different ratios of types of muscle fibre, but we have ‘a limited understanding of the differences’ because there are ‘an inadequate number of published studies’.⁹⁷

When even something as simple as ice-pack application is sex-sensitive, it’s clear that women should be included in sports-medicine research at the same rates as men.⁹⁸ But they aren’t.⁹⁹ And researchers continue to research men and act as if their findings apply to women. In 2017, a Loughborough University study¹⁰⁰ was hailed around the UK news media as proving that a hot bath has anti-inflammatory and blood-sugar response benefits similar to exercise.¹⁰¹ Published in the journal Temperature with the sub heading ‘A possible treatment for metabolic diseases?’ the study included no women at all.

We know that men and women have different metabolic systems. We know that diabetes, one of the diseases particularly singled out as being relevant to this discovery, also affects men and women differently,¹⁰² and that it is a greater risk factor for cardiovascular disease in women than in men.¹⁰³ But despite all this, the paper’s authors consistently failed to acknowledge any relevance of sex differences to their research. They cited animal studies that had similarly been conducted in all male populations, and perhaps most shockingly of all, in a section specifically looking at ‘limitations with the present investigation’ they completely failed to mention the fact that the study was all-male as a potential drawback, only referring to their ‘relatively small sample size’.

There have been some attempts to force researchers to properly represent females in medical research. Since 1993, when the US passed the National Institute of Health Revitalization Act, it has been illegal not to include women in federally funded clinical trials. Australia’s main funding body made similar rules for the research it funds,¹⁰⁴ as has the EU, which in fact went even further, also requiring both sexes to be studied in pre-clinical animal studies. This requirement did not come into effect in the US until January 2016,¹⁰⁵ which is also when the NIH introduced the requirement that the data in trials it funded be disaggregated and analysed by sex (unless there is a compelling reason not to).¹⁰⁶

Other positive developments include the German Society of Epidemiology which has for more than a decade required researchers to justify including only one sex in any study where the results could potentially affect both sexes;¹⁰⁷ and the introduction of the same by the Canadian Institutes of Health in 2012, as well as mandatory questions about the consideration of sex and gender in the study design. Some academic journals also now insist that papers submitted for publication should provide information about the gender of participants in clinical trials, for example.¹⁰⁸

Trailing behind everyone is the UK, whose main funders ‘make no substantive reference to, or requirements regarding, the consideration of gender in research design and analysis’,¹⁰⁹ and despite the at-risk population of women suffering more morbidity and mortality,¹¹⁰ UK research funding for coronary artery disease in men is far greater than for women. Indeed, such is the dearth of gender-based clinical research from within the UK, that Anita Holdcroft, emeritus professor at Imperial College London, has written that for cardiovascular treatment, ‘it is pertinent to use studies from North America and Europe where these issues have been investigated’.¹¹¹

Still, while the situation in the UK is dire, significant problems remain elsewhere. For a start, the evidence we’ve just seen on the representation of women in trials suggests that these policies are not being rigorously enforced. And, indeed, this is what analyses of the NIH have found. Four years after the NIH announced their first policy calling for the inclusion of women in medical trials, a report was released by the GAO which criticised the NIH for having ‘no readily accessible source of data on the demographics of NIH study populations’, making it impossible to determine if the NIH was enforcing its own recommendations.¹¹² By 2015 the GAO was still reporting that the NIH ‘does a poor job of enforcing rules requiring that clinical trials include both sexes’.¹¹³

There also remain plenty of loopholes for US drug manufacturers who don’t want the cost and complication of including unharmonious females with their messy hormones in their neat clinical trials, because the rules only apply to NIH-funded trials; independent drug manufacturers can do whatever they want. And the evidence suggests that many of them do: a 2016 paper found that ‘a quarter of the drug manufacturers in an industry survey did not deliberately recruit representative numbers of women as participants in drug trials.’¹¹⁴ When it comes to generic drugs, the FDA only specifies ‘guidelines’ rather than rules and, as we’ve seen, these guidelines are being roundly ignored. And the NIH policy on including female subjects in clinical trials doesn’t apply to cell studies.

Then of course there’s the issue of legacy drugs. Two million women per year take Valium for conditions ranging from anxiety to epilepsy, and it was aggressively marketed towards women for decades.¹¹⁵ And yet, a 2003 paper points out,¹¹⁶ this ‘mother’s little helper’ was never tested in randomised clinical trials with female subjects. A 1992 survey by the US General Accounting Office (the Congressional watchdog) found that less than half of publicly available prescription drugs had been analysed for sex differences.¹¹⁷ A 2015 Dutch paper baldly states that ‘The specific effect on women of a huge number of existing medications is simply unknown.’¹¹⁸

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