Blogs / Sex and Gender

Sex, drugs and clinical trials

IMG_8358Looking back through history you can find oh-too-many instances of women being viewed as deficient or defective versions of the ‘archetypal human being’ that is Man.

From the father of biology, Aristotle, who described women as ‘lesser’, ‘infertile’ and irrational in comparison to man, right through to the infamously misogynistic 19th century philosopher, Nietzsche, who dubbed women ‘weak’, ‘superficial’, and ‘untrainable’ creatures with an ‘instinct for a secondary role’, the derogation of women has crossed centuries and disciplines,

Unfortunately, this view of women is by no means restricted to the annals of history when it comes to academia, as a recent Scientific American Mind article revealed.

According to the magazine, until as recently as the 1990s women of childbearing age were banned from participating in clinical trials in the US, which was largely for fear they might unexpectedly become pregnant, and they have since continued to be excluded from many trials because their “different hormones” are considered to be a “confounding variable” in such studies. This is despite the discovery that numerous medications have different impacts on women than men – particularly at so-called ‘standard’ doses – and that eight out of the ten drugs pulled from the market by the FDA between 1997 and 2001 posed greater health risks to women than their male counterparts.

The first thing to take issue with here is the apparent assumption that prior to 1993 women could not be trusted to take the appropriate steps to avoid becoming pregnant. The second is the notion that a woman’s hormones are in some sense “different”. Ultimately this word suggests something is other than it should be, but as women – pesky hormones and all –  account for over 50 percent of the population, I am curious to know what scientists are contrasting them with to warrant such a categorisation. Once again, we seem to find a tacit assumption that man is the biological prototype of humanity and woman a distortion, abnormality or, to use the field’s own terminology, a ‘confounding’ variation.

And this assumption has specific, harmful consequences in the world of pharmaceuticals, where it seems decisions have long been made on which drugs are safe for women, and what doses are appropriate, without any testing for side effects or efficacy on women themselves. As a result, research into sex-specific medication guidelines  – a relatively recent development – has already revealed diverse reactions among women to recommended doses of a number of commonly used drugs, including painkillers and sleeping tablets.

For instance, studies have found that women respond better to SSRI antidepressants than men, but their less acidic stomachs might allow the drug to be absorbed more quickly –  increasing their toxicity – while the higher proportion of body fat in women may trap antidepressants in the body for longer. The same factors could also make anti-anxiety medication more potent and toxic to women in standard doses.

Research also suggests that women take longer to metabolise sleep aids, while liver enzymes that are especially active in young women could render drugs such as anticonvulsants less effective and hormonal changes during pregnancy mean women with bipolar disorder require higher doses of the drug Lamictal to control their depression whilst pregnant.

This is pretty shocking stuff when you consider the faith that the public puts in the pharmaceutical industry and relevant regulatory bodies to thoroughly vet products before they are made available to the public. It also raises some worrying questions about the extent to which this kind of gender bias is present in medical and biological research, as well as the possibility that important corners are being cut in order to get drugs on the market more quickly.

The magazine reports that the FDA has recently pledged to step up its efforts to account for sex differences in clinical trials (about bloody time!) but I would be very curious to get a more in depth picture of the current state of affairs in the US, and to find out whether such a bias is extant in European pharmaceutical studies.

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