In the days of many pointlessly gendered products from yoghurt for men to Sellotape for girls, you would have thought that medicine would also be specific to men and women. Surely one of the few times ‘gendering’ makes sense? But this isn’t the case. Instead, half of the population are systematically excluded from clinical trials…
Clinical trials determine whether a drug is safe and effective at treating what it is supposed to. They provide the evidence for drugs being put on the market and prescribed by doctors. But not just any human will do for this important work of swallowing tablets – usually only healthy young men are eligible for such trials.
We know that men and women have biological differences governed by our sex. From hormones to organs, height and body mass – men and women are built differently. And that is ok. One is not better than the other; they are just not the same. Surely it would make sense that clinical trials took such difference into consideration and enrolled both men and women to test whether drugs are safe and effective for their particular sex?
In the world of clinical medicine, men are the standard. Their bodies are viewed as stable, solid, and able to withstand the tests they are exposed to. In contrast, women’s bodies are viewed as weaker, inherently vulnerable, high risk, and their hormones considered ‘confounders’ to the test – yeah because men don’t have hormones too?
This means that results from clinical studies involving only men are commonly generalized to women, whereas the reverse is nearly never true.
There are some good reasons that women are sometimes excluded from clinical trials.
One legitimate concern is whether some medicines may have a detrimental impact on pregnant women and their babies. Historical issues with medicines such as thalidomide have shown us the devastating effect of giving medicines to pregnant women without knowing the effects.
There are also worries about fertility. Women have a limited egg supply, so any drug which could damage fertility may have an effect which would last a lifetime for a woman. This is generally not the case with men as they are able to produce sperm throughout their life (case in point Mick Jagger – still upset at the suggestion of the snip).
Yet pregnant and fertile women still get ill. They need medication too. The common advice in pregnancy is ‘it’s not worth the risk’ – this is the case for alcohol, particular foods (including lots of good stuff like soft cheese), and caffeine. Basically, anything that makes life worth living.
This is also the attitude for medicine.
Lots of pregnant women require regular medication, just get sick or experience pain (labour bloody hurts!). Current advice is that women should take ‘safe’ medications such as paracetamol only when they really need it (because we all know women take painkillers mostly for fun rather than headaches). And they should not be taken ‘at the slightest ache or pain’ because of the potential risk. But surely we need better knowledge about what pregnant women can safely take, rather than a ‘suck it up buttercup’ attitude.
Even if we accept that pregnant and fertile women may be too risky for some studies.
Why are women who do not want to have children, are on effective contraception, are celibate, are not having sex with men, or have reached menopause also excluded?
A big reason is that women are not always seen as reliable when it comes to them determining their future plans for children. Women are treated as ‘walking wombs’ – risky because of their potential for children, and not trusted to be willing, or able, to control their own fertility.
But, apart from fairness, is there actually a problem with excluding women from research?
Yes. Lots of them.
The bodies of men and women react to drugs differently. Women are at double the risk of adverse drug reactions because drugs developed and tested solely on men may be dangerous for women. Conversely, drugs that could benefit women may be eliminated in early phases of testing as there may be no benefits to men.
Even if a drug is safe for both men and women, it is important to determine dosage. For many drugs, women need lower doses due to their lower body mass. Currently, scientists work out what’s right for men and then just twiddle the numbers a little to determine the female dose.
Differences are not just due to body mass either.
It is now known that paracetamol is eliminated by women’s bodies at approximately 60% the rate of elimination documented in men.
One approach to reducing the gender bias in medical research has been to get more women into medicine and research. Whilst this in itself is great – women too make excellent doctors. It’s not enough.
Assuming that by having female doctors and researchers the problem is resolved oversimplifies the issue. It is the construction of women and how this impacts the culture of medical research which needs attention.
So each time you reach for an aspirin for that killer headache after a classic night at the Outback, you can thank amazing research for being able to reduce your hangover to manageable levels, but how much more amazing could that research be if it was properly representative of us all. Male, female, young, old, and even pregnant.