Farmagenere - English version

Farmagenere

Within the framework of Gender-Specific Medicine, which aims to adopt a perspective attentive to the concepts of sex and gender and to promote the development of personalized medicine in this sense, Gender Pharmacology is included. Gender-Specific Pharmacology focuses on the differences that exist in terms of efficacy and safety of different pharmacological treatments, based on the sex and gender of the individual receiving care. These differences, in fact, have a significant impact on the effectiveness of treatments and on the likelihood of developing potential side effects.

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The words

Sex: is generally assigned at birth and refers to an individual’s biological characteristics, such as genetic, gonadal, anatomical, and hormonal traits.

Gender: a social construct that depends on the historical period considered, as well as on the geographical area and the culture in question. This concept therefore changes over time, also depending on personal sensitivity, and is thus fluid by definition.

Gender binary: refers to the Western view of gender, which describes only two possible categories, namely male and female. A non-binary view of gender instead includes multiple nuances beyond male and female.

Cisgender: a person whose gender identity corresponds to the biological sex assigned at birth.

Transgender: a person whose gender identity does not correspond to the sex assigned at birth. It is an umbrella term that encompasses several different gender identities.

AFAB: Assigned Female At Birth, a person assigned female at birth.

AMAB: Assigned Male At Birth, a person assigned male at birth.

The objectives

Medicine should be guided by a principle of equity, according to which all people should be provided with the same opportunities, taking into account the differences that exist among them and thus ensuring social justice for every individual. Our research and our commitment to the Third Mission that characterizes us aim to increase awareness in this regard, striving to create a virtuous model and to promote the development of a medicine of the future that is as inclusive as possible. Through our work, we seek to explain that it is not diseases that should be treated, but rather people who should be treated and cared for.

The problem of clinical underrepresentation

The underrepresentation of cisgender women in clinical and preclinical research is a problem that remains highly relevant today. Despite the fact that in the United States, since 1993, a law has required NIH-funded clinical studies to include both men and women, there is no regulation mandating the inclusion of animals of both sexes in preclinical studies. As a result, the female population continues to be strongly underrepresented: women account for about 30% of trial participants, even though their life expectancy is longer (84.7 years compared to 80.1 years for men) and their period of illness-related disability is more prolonged, leading to more extensive use of medications.

Historically, until the twentieth century, the female body was considered not to differ from the male body except for the reproductive system, a view rooted in a patriarchal culture. Today, the exclusion of women from trials is also linked to economic reasons and to the desire to simplify studies: hormonal cyclicity and the different stages of life (pregnancy, breastfeeding, menopause), as well as the use of hormonal contraceptives, make women a complex population to analyze.

However, biological differences between the sexes profoundly influence the efficacy and safety profile of drugs. Women show significant differences in absorption, metabolism, and elimination (ADME), mainly due to hormones, lower body mass, higher percentage of body fat, and specific features of the gastrointestinal system. For example, in female individuals the higher proportion of adipose tissue favors the distribution of lipophilic drugs, whereas in men it favors that of hydrophilic drugs. Women also have slower gastric emptying, reduced intestinal motility, higher gastric acidity, and a lower renal filtration rate, which prolongs drug residence time in the body and increases the risk of toxicity.

Despite this, drug dosages continue to be based on the standard model of a 70-kg cisgender man, without adequately taking into account differences related to sex, gender, age, ethnicity, weight, and body composition. This lack of personalization may be among the causes of the increased incidence of side effects and adverse drug reactions in women.

Transgender people

Transgender people may choose whether to undertake a gender-affirming pathway (GAHT), mainly based on the use of estrogens or testosterone, depending on the desired gender expression. However, their presence in clinical studies is extremely limited: they are generally included only in research related to HIV, pre-exposure prophylaxis (PrEP), and sexually transmitted diseases. This stems from biases that have directed research toward these topics, leaving a significant gap in knowledge regarding the effects and possible interactions between gender-affirming hormone therapies and other medications.

In Italy, more than half a million transgender people have no representation in the models used to study drugs. For this reason, disaggregating data by sex and gender in clinical trials is not a theoretical exercise but a necessity: the lack of specific data increases side effects, risks, and inequalities. Sex- and gender-specific pharmacology aims precisely to bridge this gap by adapting therapies to the characteristics of each patient and promoting a personalized medicine that considers men, women, and transgender people on an equal footing.

The progress

In recent decades, enormous progress has been achieved:

1993, the Food and Drug Administration (FDA) requires the recruitment of both sexes in the phases of drug development
2005, the European Medicines Agency (EMA) mandates the use of representative samples of both sexes (Gender Consideration in the Conduct of Clinical Trials).
2016, the Italian Ministry of Health officially recognized Gender as a determinant of health (see PDF).
2019, the Ministry of Health prepared the Plan for the Application and Dissemination of Gender Medicine (see PDF).
July 24, 2023: implementation of the Plan for the Application and Dissemination of Gender Medicine adopted with Ministerial Decree 13/06/2019 – approval of the regional planning act entitled “Regional Plan for the Application and Dissemination of Gender Medicine (2023–2025)”.
The National Health Service (SSN), the World Health Organization (WHO), and the United Nations (UN) have also promoted this new approach to medicine, encouraging the adoption of new preventive, diagnostic, and therapeutic health strategies capable of taking into account differences between men and women, not only in biological and clinical terms but also cultural and socio-psychological ones (Gender as a determinant of health). This approach can allow the SSN to achieve savings, including economic ones, by limiting the use of drugs where ineffective on the one hand, and by reducing relapses and hospitalizations on the other, by targeting treatments and improving the health of users. Attention to sex and gender in the field of public health is therefore a winning and strategic choice.
Law 3/2018 on the application of Gender Medicine (Plan for the Application and Dissemination of Gender Medicine), from which the 2019 Plan was subsequently derived. The Plan affirms the need to guarantee prevention, diagnosis, and care to every person, with an approach that takes gender differences into account, at all stages of life and in all living and working environments.
Agenda 2030 (UN Italy, The new 2030 Agenda for Sustainable Development), goals 3 and 5 (Health and Well-being and Gender Equality), and Global Health 50/50 (Global Health 50/50), the supranational organization whose aim is to promote greater equity in health by encouraging the disaggregation of data by sex and gender.