There's often a fine line between the effect and overdose of a medication. We explain how the pharmaceutical industry tries to achieve this balancing act, why dosages are not (yet) more tailored to the individual and what counts besides gender.
Developing a new medicine is a long process. Once pharmaceutical scientists have found substances with the potential to treat a disease, they test them on animals and cell cultures for effect and tolerability. When does the substance begin to show a positive impact, and at what point do undesirable side effects or even dangerous consequences occur? These are the leading questions in research.
If an active substance has proved successful in this test phase, initial studies are conducted on healthy adults. The findings flow into further studies – also conducted on patients – until as much comparative data as possible has been collected on the effect, dosage and side effects of a new medicine. Out of 5,000 to 10,000 substances studied, only about one makes it to market. In other words, it takes a lot of work before a medication is ready for approval.
In the past, data was mainly collected from male study participants. The reasons why women are less likely to be recruited as study participants include hormonal fluctuations and fertility. In the meantime, laws have been introduced that require studies to include equal numbers of women and men. This success can be accredited to the still young discipline of gender medicine. The laws ensure that the biological characteristics of women are given equal weighting in research as those of men.
It’s known that men and women metabolise a medicine in the body at different rates. However, researchers have generally judged the differences to be too small to effectively adjust the doses. As a result, most medications have a uniform dosage for all.
However, there are also cases of medications in which the gender differences are so significant that the dosage has to be adjusted. For example, if someone has a deficiency of growth hormones, the active ingredient somapacitan (growth hormone medication) is administered in higher doses for women, while minoxidil, a medication for hair loss, requires a lower dose for women.
Apart from biological differences, other physical conditions have a large influence on the effect of a medication. Weight, fat and muscle content as well as kidney and liver health determine how the body metabolises the medicine. In other words: whether someone is fit or obese, or suffers from renal insufficiency is more important than gender per se.
There is a general move today towards the tailoring of dosages. Gender is now included in the factors taken into account when setting and combining active substances. Doctors check the effective impact on the body with “effect level” measurements, enabling them to determine the optimal dose with substantial precision.
The risk of side effects is indeed greater for women than men. Experts believe this is due to the tendency of women’s bodies to metabolise active substances more slowly – which actually means that medication is overdosed for women. At the same time, older women in particular are more likely to take several medicines at the same time, which can lead to unwanted interactions.
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