Share:
Are women less considered in drug testing?
Although women take significantly more tablets than men in many phases of their lives, before they are approved, active ingredients are mostly tested on male subjects. Something has to change in this situation, experts say.
Women take more medication than men
Women usually need more medication than men. Be it the daily anti-baby pill, thyroid hormone or, in later years, anti-osteoporosis medication. But they do not just swallow typical remedies for women. Even independently of such tablets, women are on average prescribed significantly more drugs than men. In studies on the approval of drugs, however, the relationship is usually the other way around. In a message from the dpa news agency, pharmacologist Karin Nieber of the University of Leipzig criticized: "Women are not well represented in studies on how diseases occur in the population."
Women are not well represented in drug trials. (Image: kasto / fotolia.com) Slower drug degradation
Men and women, however, differ - from the distribution of fat on the body to the hormone system. On the occasion of two congresses on gender research in medicine in Berlin, Nieber explained that some enzymes also work in different ways and that this has an effect on the breakdown of active ingredients in the body. Like other colleagues, she therefore misses evaluations of studies for safe doses for women. The pharmacologist referred to the case of the sleeping drug zolpidem. It is said that women in particular break down the active ingredient more slowly, which could lead to limited reactivity in the morning after ingestion. "Women were later advised to reduce the dose by 50 percent," says Nieber. However, such adjustments are absolute individual cases. However, subsequent warnings are very well pronounced. For example, some health experts generally advise against using drugs such as zolpidem. Such hypnotics increase the risk of death and cancer, as scientists around Dr. med. Daniel F. Kripke from the Scripps Clinic Viterbi Family Sleep Center in California (USA) found in a study.
Women excluded from testing
Women did not play a role in clinical trials for a long time either. Under the influence of the thalidomide scandal, the US FDA in 1977 ordered companies to exclude women of childbearing age from testing - as a protection against consequences for fertility, especially in the case of an unexpected pregnancy. Numerous studies have shown that such drugs can increase the risk of miscarriage or can even lead to malformations in the womb. A rethinking started in 1993.
Patients are started on smaller doses
Controversial is whether the cans always fit. On the basis of her experience, the physician Verena Stangl, (Cardiology, Charité Berlin) explained that female patients are sometimes started on side effects such as hypertension with lower doses, which are then increased. "It would take more studies that explicitly examine women," said the doctor. But the manufacturers judge the "statistical differences" as the concentration of active ingredients and their retention in the blood as small. Drugs are also designed to work within a certain window, not just an exact target dose. The well-known differences therefore usually have no consequences for the regulations, according to a position paper of the Association of Research-Based Pharmaceutical Companies (Vfa)..
Tests on women make admission more expensive
Vfa expert Rolf Hömke emphasized that drugs that are to be approved for men and women, must be tested on both sexes. Women are involved in the mostly three-stage studies, albeit only in relatively late stages. However, in the first stage, the so-called Phase I, the vast majority of healthy men tested - "under conditions as simple as possible," said Hömke. Karin Nieber sees this as a mere cost issue: since women's hormonal levels fluctuate during the cycle, it takes them longer to detect statistically significant effects of an active ingredient. This makes the registration more expensive.
Women do not want to be test persons
Pharmaceutical producers still point to the risk of pregnancy when it comes to early study phases: study participants would have to use hormone-based in addition to the test drug - an unwelcome influence. In phase I, one wants to basically examine, for example, how active substances are distributed and degraded again. From the Vfa, the proportion of women in the later phase - depending on the clinical picture - roughly estimated at 30 to 80 percent. There is no requirement that the same number of men and women participate. It is important, according to Vfa, "that a sufficiently large number of treatments can be evaluated by each sex; and that is the case ". Another reason for the dilemma is that women do not want to be subject. "It's not that there are many women who have to cancel because all seats are taken," said Hömke. This is especially true for women of fertile age. The pharmacologist Nieber wonders why not in the first animal experiments female rats or mice are included. In their opinion, women should be involved in Phase I, especially in the case of diseases that primarily affect women. (Ad)