September 12, 2021
When the male model dominates, even on health!
Medicine, theorized for centuries by men and men, still tends to equate women to men today. There is talk of neutral medicine or indifferent medicine, but when it comes to symptoms, diagnosis and effectiveness of the treatments the differences are all right!
The dosage of drugs, as well as the development and use of medical arranges (except for some particular needs), are generally studied on a model of young man, of about 70kg.
The woman is therefore considered as a variation of the male model, but the morphological and physiological differences determine a considerable difference in the body's response, as well as in the way the drug is absorbed, distributed and metabolized.
Due to the reduced number of representatives of the female gender in clinical trials, but also of the lack of statistical analysis that take into account gender differences, women are more exposed to adverse reactions to drugs due to overdose, a reduction in effectiveness and ad major or more serious side effects than men.
Although this awareness has matured and national and international regulatory bodies have created special programs to monitor women's health and their participation in clinical trials, and despite the fact that we are starting to talk about gender pharmacology, the experimentation protocols not They have changed and most of the studies do not provide for a difference between males and females at the time of arruping and data analysis.
Lack of time, mainly due to the difficulty of cutting time between work and domestic-family commitment, and poor attention of recruiters to female practical and psychological needs.
The Italian bioethical committee states that the lack of specific studies on women, especially in the early stages of research, does not allow to measure the real effectiveness of drugs on the female body as well as limiting the identification of drugs specially designed for women.
A stratified analysis by sex can provide useful indications on which is the best therapeutic choice for each individual and give information that allow you to deepen the study of diseases that affect both men and women, allowing you to better understand if there may be differences in the incidence or /and in the course ascribable to sex.
The dosage of drugs, as well as the development and use of medical arranges (except for some particular needs), are generally studied on a model of young man, of about 70kg.
The sub -representation of the female gender in the medical system has deep roots. Almost all of the medical school programs continues to argue that male and female bodies are generally the same with the exception of the sexual organs, a conviction known as "bikini-medicine". In vitro studies frequently do not take into account whether the cells contain the XX or XY chromosomes. When you pass in vivo, on animal models, the use of male animals is preferred to minimize the differences caused by hormonal fluctuations. In clinical trial women are often excluded from the I and II phases, necessary to determine dosage, side effects and safety of a drug and enter the experimentation directly in phase III, the one in which the effectiveness of the drug is established on a large slice of population.
The woman is therefore considered as a variation of the male model, but the morphological and physiological differences determine a considerable difference in the body's response, as well as in the way the drug is absorbed, distributed and metabolized.
Although this awareness has matured and national and international regulatory bodies have created special programs to monitor women's health and their participation in clinical trials, and despite the fact that we are starting to talk about gender pharmacology, the experimentation protocols not They have changed and most of the studies do not provide for a difference between males and females at the time of arruping and data analysis.
The numerical inferiority of female participation in experimental studies is attributable to numerous and different reasons. Economic reasons in the first place: to stratify data based on sex it is necessary to enroll men and women, doubled participation in research with the consequent increase in times and costs of experimentation. Biological reasons: women are considered "difficult" subjects for clinical experimentation, due to both cyclical and non -cyclical fluctuations (menstrual cycle, pregnancy, breastfeeding and menopause). This variability creates the need to have a large number of participants in experimentation in order to evaluate significant effects, and it is not said that this happens. In addition, very often in case of participation in a clinical trial by a fertile woman, to prevent the drug under examination from potentially having negative effects on the fetus the pharmaceutical house requires the use of hormonal contraceptives.
Lack of time, mainly due to the difficulty of cutting time between work and domestic-family commitment, and poor attention of recruiters to female practical and psychological needs.
The Italian bioethical committee states that the lack of specific studies on women, especially in the early stages of research, does not allow to measure the real effectiveness of drugs on the female body as well as limiting the identification of drugs specially designed for women.
A stratified analysis by sex can provide useful indications on which is the best therapeutic choice for each individual and give information that allow you to deepen the study of diseases that affect both men and women, allowing you to better understand if there may be differences in the incidence or /and in the course ascribable to sex.
An aspect that could help reverse this trend and push towards the widespread use of gender pharmacology could be the presence of a greater number of women engaged in research and clinical practice. Their presence, in the teams that design and manage their studies and within the regulatory committees would contribute to increasing attention towards the need to guarantee an equal female and male representation within the experiments.
The reduced female presence in the world of research, medical but not only - we think of areas such as engineering, mathematics, computer science - in which science is made by men, who live and perceive the world in their image, in which women are only one Variation on the theme has helped to create and feed a company based on a patriarchal model full of stereotypes and machist attitudes, which has come for the time to overcome.
Beatrice equal