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Without a Pink Stamp

Investigation on why drugs are not tested on women

In recent years the realization has emerged that in the sphere of clinical trials women are considered “vulnerable subjects" as they are not adequately treated in regards to their specific needs. If drug trials on female-only diseases are excluded (for example gynaecological trials), the percentage of women enrolled in trials is still low. There is talk about under-representation of women in pharmaceutical trials. It is not easy to provide data on this subject, as  pre-clinical experimentation (animal trials) and clinical (human trials) are not stratified according to sex. An article published in "Nature" ( Putting Gender on the Agenda , June10, 2010) criticizes the fact that "medicine currently applied to women has less evidence than that applied to men".

The lack of experimental studies that take into account the differences between the sexes in a pharmaceutical environment is even more problematic due to the recent changes in health and diseases of women when put into the context of the general change in the status of women (at least in Western societies): one thinks of the increase in female education, participation in the world of work as well as in political-social development, yet their still persistent marginalization.

Some of the diseases considered masculine (such as heart disease or lung cancer) today tend to be more frequent in women (due to stress at work and an increase in smoking), but the drugs for their treatment are not tested specifically on them.

This is particularly disadvantageous for women who according to statistics are consumers of drugs to a greater extent than men, thus having more frequent and severe side effects. In particular, there is attention in the field of cardiovascular disease, which reveals that the percentage of women in the trials is not proportional to the percentage of women suffering from diseases for which drugs or medical devices are studied (this is the case, among others, of pacemakers ) .

A recent study devoted to heart disease (which appeared in 2010 in the "Journal of the American Heart Association ") shows that, though we see a slight increase, women are hardly represented: of twenty studies, only one  expects the enrollment of women. Although the data may vary from disease to disease ( it ranges from 18 percent in 1970 to 34 percent in 2006 of women’s participation in diseases related to hypertension and diabetes), and even though recruitment has increased over time, it remains low in relation to the general representation of the diseased population . If you consider oncology the same problem emerges: in the United States, 58 percent of patients who suffer from the disease are men, 42 percent are women, but only 32 percent are women in the trials .

It follows that the parameter measuring the dispensing of drugs refers to men (males) and the woman is considered a "variation" of this model, but the physical, morphological and physiological difference between men and women, causes a considerable diversity in the pharmacokinetics (ie in different absorption, distribution and metabolism of the drug) and pharmacodynamics (ie in different concentration of drug in the blood and tissues).

The international awareness of the problem has been highlighted, since the nineties of the twentieth century, in the guidelines of international organizations (among which the Food and Drug Administration) which are beginning to recommend the analysis of sex-differentiated data in clinical trials, auguring the inclusion of women in trial protocols in order to ensure an equal representation and equal opportunities in health.

But why is the number of women in the trials so low? There are several reasons .

There are biological reasons, since women are considered "difficult" subjects for biological, physiological, enzymatic and hormonal diversity, due to variations between child-bearing and non-fertile age. There are social reasons attributable to the difficulty of women entering clinical trials due to lack of time (caused by work and domestic commitments) or because of low income (due to unemployment or low paid work). Psychological reasons, therefore, such as lack of attention to the practical necessities and needs of women. And, moreover, economic reasons since it is not convenient for the drug companies to fund trials that require an increase in recruitment, with the inevitable increase in time and costs. Finally, a reason for the exclusion of women is the possible pregnancy in childbearing age, with the risk of foetal malformations: this is the reason why the drug companies either exclude women from the trials, or require the use of contraceptives.

On this point the bioethics literature is divided. In particular, in the context of feminist libertarian thought it is argued that women of childbearing age should be included in the testing as an overriding ethical requirement for the potential benefits, considering secondary the possible damage to the foetus viewed not yet to have dignity in the strong sense (and legitimizing the abortion in case of damage and malformations). This is a position challenged by those who recognize - on religious and/or philosophical grounds - the inherent dignity of unborn life: since the clinical trial may endanger the life or health of the foetus it is essential that the woman commits herself from the outset of the trial not to procreate. She should not be forced by the experimenters to take contraceptives, the commitment to abstain from sexual intercourse and the willingness to undergo regular testing to confirm a pregnancy being considered sufficient. This would eliminate any risk while respecting the moral conscience.

How to foster a pharmacology that is respectful of  sexual affiliation? One could, for example, indicate on the labels of the drugs whether specific experimentation on women has or has not occurred (a sort of "pink dot"). One could ensure a greater presence of women as experimenters and members of ethics committees, in order to ensure a specific focus on the feminine dimension . One could promote health training attentive to differences, including sexual ones. But above all, one could increase international cooperation and awareness among health authorities and pharmaceutical companies to support an experimentation separated by gender, even if this may not be very profitable, encouraging research on the subject and promoting the participation of women in clinical trials by appropriate information on the social importance of experimentation on women .

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Aug. 20, 2019

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