Medicines and Side Effects: Risks are more often seen in women

What has changed today?
“Recently there has been an awareness on the part of the regulatory authorities, first in the United States then in Europe and finally also in Italy where in the 2018 entered into force on Lorenzin decreewhich also obligatorily introduces the experimentation of drugs on women before being placed on the market. Today, therefore, for all new drugs, testing on women is also mandatory. However, the problem exists for all the drugs that were put on the market before these new rules ”.

Why have preclinical tests been conducted only on men for a long time?
«The reason has often been given that one woman of childbearing age could be pregnant and therefore the real and legal risk of inducing malformations in the fetus during drug trials involved serious problems. The main reason, however, is linked to savings, in terms of costs but also of time. In fact, it must be emphasized that before a drug reaches the market, it undergoes a study phase of about 10 years with very high costs. Furthermore, bringing men and women together in the experimentation is not possible because it would risk having a confounding effect, even at the dosage level. The tests must therefore be conducted separately. Added to this is the fact that the women represent a more heterogeneous category than men: one account, for example, is a woman of childbearing age, who takes contraceptives, one account is a menopausal woman who takes hormone replacement therapy. These are subgroups that should be analyzed, for many drugs, specifically, with costs and times that consequently multiply.

Could gender differences, and therefore attributable to environmental and cultural factors, also explain the increased risk of side effects in women?
“In part, yes. The classic example is that the women are more inclined to take supplements or natural medicines and these can interfere very heavily with the effects of drugs, making them not very effective but in some cases even potentially toxic ».

There was talk of a different reaction by men and women to the anti-Covid vaccine as well. In this case, how can the phenomenon be explained?
“It should be immediately clarified that in the case of the anti-Covid vaccine, before being placed on the market, the experimentation was carried out on an equal number of subjects, both men and women. Although the data on side effects have not all been analyzed by separating the gender, we can say that it tends to be women exhibited a better immune response which doesn’t necessarily mean better protection. Rather it means that by evaluating the number of antibodies in the bloodon average it is greater in women than in men. In women we then found some more cases of allergic side effectswhich are however – it should be reiterated – very few and more side effects related to thrombotic phenomenathis is because blood coagulation is one of those physiological processes for which there is a certain difference in man compared to woman who is more exposed to the risk of venous thrombosis. Again though these are very rare episodes ».

Source: Vanity Fair

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