The cross : Women have long been underrepresented in clinical trials. Why ?
Antoinette Pechere-Bertschi : Research needs to study homogeneous collectives to draw conclusions. We therefore favored the Caucasian man, 1 meter 80 for 70 kg – I’m barely caricaturing. Women were excluded because they introduced complexity, due to the different variations to which they are subjected throughout their lives – menstruation, pregnancy, menopause.
Excluding them was therefore an easy choice, but also a way, a little paternalistic in my opinion, of protecting them and their fetus in the event that a pregnancy should occur during the trial. Obviously, the exposure of pregnant women to certain molecules can wreak havoc on babies, as we saw in the 1960s with thalidomide. However, it seems to me that this argument no longer holds, as women are more than capable of taking birth control correctly if they wish to participate in trials.
Are they better taken into account today?
A. P.-B. : The desire to achieve parity in an ethical concern is there, and has been for twenty years already, but we are still far from it. In 2015, I was very struck to note that the American Sprint study, which defines the levels of arterial hypertension from which it is necessary to institute medical treatment, included only 36% of female subjects. However, it is on this work that the authorities have based themselves to establish the current recommendations across the Atlantic, it is not nothing!
More recently, I participated in a large study on a new drug to protect the kidneys of diabetic patients and again, there were only 30% female subjects. This imbalance also applies to animal research: rats are favored over female rats. How can we be sure that we are not putting women at risk with such a percentage?
What are the consequences of this imbalance?
A. P.-B. : This may have an impact on the efficacy and tolerance of certain treatments. We now know that the way drugs are distributed and metabolized in the body is different in women, in particular because the enzymatic mechanisms are not the same. However, the doses are defined for the needs of men.
More broadly, the low inclusion of women has resulted in an asymmetry of medical knowledge. The gap with men is nevertheless tending to close, and above all, the field of research is widening. A few years ago, women were reduced to what is called the “bikini syndrome”: most of the studies concerning them focused on their reproductive and nourishing systems, in particular on substitution treatments for menopause. This is no longer the case today.