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PHARMACOLOGICAL EXPERIMENTATION ON WOMEN

abstract


Starting with the analysis of the data on clinical experimentation on women, this
document shows their under-representation in enrolment and the poor differentiated
processing of the results. It shows how the experimentation on women is carried out only
for specifically female pathologies (even though there are a number of shortcomings even in
this) and is not, on the other hand, carried out for the pathologies which, traditionally male,
are increasingly becoming female as a result of the historical-social changes in the female
condition. It clearly shows that, although women are the greatest consumers of drugs, the
experimentation tends not to sufficiently consider their specific nature and the change in the
conditions of women’s health, with a consequent increase in side-effects, which are more
frequent and more serious with respect to men. The document analyses the main reasons for
this shortcoming (at a social, environmental, economic and biological level), discusses the
ethical problems arising from it (with particular reference to women of child-bearing age
and the question related to the use of contraceptives) and analyses the international and
national provisions on the issue.
The Italian Bioethics Committee proposes bioethical lines for an equal consideration
of women in experimentation, highlighting the need for a differentiation, showing the
dangers of a “neutral” pharmacology, indifferent to sexual differences. Women cannot be
assimilated to men, like a mere variable, but have a specificity that experimentation must
take into consideration in order to foster medicine that adequately recognises the equal
opportunities between men and women.
In order to increase pharmacological experimentation that is differentiated by sex, the
Italian Bioethics Committee suggests raising awareness in health authorities and
pharmaceutical companies to support separate experimentation for each sex, even though
not very profitable, encouraging research programmes on the subject; to promote the
participation of women in clinical trials with adequate information on the social importance
of the experimentation on women; to guarantee a greater number of women as
experimenters and members of ethical committees; to foster healthcare training that pays
greater attention to the female dimension in pharmacological experimentation, as well as
research and treatment; to increment international as well as national and local cooperation,
with special emphasis on the female condition in clinical experimentation.

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