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Women’s health neglected due to gender bias in clinical trials

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A recent study shows that gender biases in the design of clinical trials affect women’s medication use. This is because these are more prone to unwanted side effects.

Clinical trials conducted mainly on men

Women would suffer about twice as much as men side effects from taking medication. Indeed, a recent American study dating from last June was published in Biology of Sex Differences. The main reason would be due to the fact that clinical trials are mostly conducted on men.

Historically, women were generally excluded from pharmaceutical clinical trials because they presented risks in being people of childbearing age. A popular belief that is now well discredited has also contributed to this oversight, that a study of men is valid without modifications to women.

These side effects after taking medication include “nausea, headache, drowsiness, depression, excessive weight gain, cognitive deficits, seizures, hallucinations, agitation and heart abnormalities”, this list is not exhaustive.

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Medicines not suitable for women

The main problem is that most drugs are prescribed at the same dose, with no difference, for men and women. So, a large majority of drugs currently on the market have been approved following clinical trials in men.

The study seeks to know whether the gender difference in the pharmacokinetics medication, that is, the study of the drug’s fate in the body, is linked to the appearance of side effects. Indeed, it is this factor that influences the appearance of side effects, rather than weight or body size for example.

Of the 86 drugs evaluated, and approved by the Food and Drugs Administration, 76 had higher pharmacokinetic values ​​in women. Indeed, high blood concentrations were observed in women, as well as longer elimination times. These observations are intimately linked to the differences between the sexes in the appearance of side effects.

A source of danger?

This situation is very widespread: “ Neglect of women is widespread, even in cell and animal studies where subjects have been predominantly male », Explains Irving Zucker, director of this study. Medicines designed on the principle of single dosage, effective on men, thus harms women.

This practice of the same dose thus becomes problematic insofar as the difference between the sexes is neglected, whether in terms of pharmacokinetics or dismorphism in body weight. The risk is then over-medication and the appearance of side effects and adverse reactions “on women specifically”.

To counter this bias, the researchers recommend a dose reduction based on scientific evidence.

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