Femmes dans les essais cliniques

Femmes dans les essais cliniques : Un thème controversé abordé dans mon livre.

Pourquoi les femmes sont généralement exclues des tests de médicaments ? Les conséquences sur les patientes ? Un article très intéressant du Journal of Clinical Investigation  à lire ICI

Quelques phrases à retenir:

Until 1988, clinical trials of new drugs by the US Food and Drug Administration (FDA) were routinely conducted predominantly on men (8), even though women consume approximately 80% of pharmaceuticals in the US. The results of male-only clinical trials have led to the development of diagnoses, preventive measures, and treatments that are commonly extrapolated to women, yet the reverse is rare.

A consequence of extrapolating the results of male-only clinical data to female consumers is that women were (and still are) typically prescribed dosages devised for men’s average weights and metabolisms.

The administration of drugs to women at dosages designed for men can place women at risk for overdose. Furthermore, while little is known about the effects of aspirin on heart disease in women, postmenopausal women, like men, have been encouraged to take aspirin daily. The effects of other widely used drugs, such as Valium, were never tested in randomized clinical trials with female subjects, although 2 million women per year consume this drug to control conditions such as anxiety, epilepsy, muscle spasms, and alcohol addiction.

Investigators have defended their choice of males as research subjects on the grounds that men are cheaper and easier to study.

The net effect of gender bias in medical research is that women are at risk for adverse drug reactions and may suffer unnecessarily and die. Such adverse reactions occur approximately twice as often in women as in men. For example, some antithrombotic agents used to break up blood clots immediately after a heart attack, while beneficial to many men, may cause significant bleeding problems in women (12)


A lire également :

TEN WAYS GENDER DIFFERENCES CAN AFFECT HEALTH