Are women less considered in drug testing?

Are women less considered in drug testing?



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Investigations of active ingredients: too many men in drug tests?
Although women take significantly more tablets than men in many phases of life, active substances are predominantly tested on male subjects before they are approved. Experts say that something has to change in this situation.

Women take more medication than men
Women usually have to take more medication than men. Be it the daily contraceptive pill, thyroid hormones or, in later years, remedies for osteoporosis. But they don't just swallow typical remedies for women. Regardless of such tablets, women are prescribed significantly more medication on average than men. However, the ratio is usually the other way around in drug approval studies. In a message from the dpa news agency, pharmacologist Karin Nieber from the University of Leipzig criticized: "Women are not represented in studies to the extent that diseases occur in the population."

Slower degradation of active ingredients
But men and women 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 affects the breakdown of active substances in the body. Like other colleagues, she therefore misses evaluations of studies with a view to safe doses for women. The pharmacologist referred to the case of the sleeping pill Zolpidem. It is said that women in particular break down the active ingredient more slowly, which could lead to limited responsiveness in the morning after ingestion. "Women were subsequently advised to reduce the dose by 50 percent," said Nieber. However, such adjustments are absolute individual cases. However, subsequent warnings are very well given. For example, some health experts generally advise against drugs such as zolpidem. Such sleeping pills increase the risk of death and cancer, as scientists led by Dr. Daniel F. Kripke of the Scripps Clinic Viterbi Family Sleep Center in California (USA) found in a study.

Women excluded from tests
Women also played no role in clinical studies for a long time. In 1977, under the influence of the thalidomide scandal, the American approval agency, the FDA, instructed companies to exclude women of childbearing potential from tests - as 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 miscarriages or lead to birth defects in the womb. A rethink only started in 1993.

Smaller doses are started in patients
It is controversial whether the cans always fit. Based on her experience, the medical doctor Verena Stangl, (Cardiology, Charité Berlin) explained that female patients start with lower doses, which are then increased, partly because of side effects such as high blood pressure. "It would need more studies that explicitly examine women," said the doctor. However, the manufacturers assess the “statistical differences” as small, for example in the concentration of the active substances and their length of stay in the blood. Medicines are also designed to work within a certain window, and not just at an exact target dose. The known differences therefore usually have no consequences for the regulations, according to a position paper by the Association of Researching Pharmaceutical Manufacturers (Vfa).

Tests on women make admission more expensive
Vfa specialist Rolf Hömke emphasized that drugs that are to be approved for men and women must also be tested on both genders. Women are usually involved in the mostly three-stage studies, albeit only at relatively late stages. However, the majority of healthy men are tested in the first stage, the so-called Phase I - “under conditions as simple as possible,” says Hömke. Karin Nieber sees this as a question of costs: Since the hormone level fluctuates in women during the cycle, it takes them longer until statistically significant effects of an active ingredient can be demonstrated. That makes the approval more expensive overall.

Women don't want to be a subject at all
Pharmaceutical producers still refer to the risk of pregnancy when it comes to early study phases: study participants would have to use hormonal contraception in addition to the test drug - an unpleasant influence. In phase I you want to basically check how active ingredients are distributed and how they are broken down. Vfa roughly estimates the proportion of women at 30 to 80 percent in the later phase, depending on the clinical picture. It is not mandatory that as many men and women have to participate. According to the Vfa, it is important that “a sufficiently large number of treatments can be evaluated by each gender; and that is the case ". Another reason for the dilemma is that women do not want to be a subject at all. "It is not the case that there are many women who have to be canceled because all the seats are taken," said Hömke. This is especially true for women of fertile age. Pharmacologist Nieber wonders why female rats or mice are not included in the first animal experiments. In her opinion, women should be involved in phase I, especially in the case of diseases that particularly afflict women. (ad)

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