Sex doctor blames: the man should no longer be the benchmark in research

The hormones, the weight, the susceptibility to certain diseases – men and women are different. Organic anyway. Yet drug research often assumes that both can use the same drugs and the same dose. The man is the benchmark under investigation.

A motion of the National Council wants to change that. Research into complaints and diseases that specifically affect women needs to be stepped up considerably. While the Federal Council recognizes the need, it rejects a national research program. That is unacceptable for gender doctor Vera Regitz-Zagrosek of the Charité in Berlin.

Where are women neglected in drug research?
Vera Regitz-Zagrosek: The gender category is often overlooked. New drugs are being discovered on animals – and 80 percent of experiments are being conducted on males. As a result, drugs that work mainly in women can not be detected at all. And you can’t tell if they can have a different effect depending on the cycle. In addition, more men will be included in clinical drug trials later on. This has particular implications for the early phases of research, where dosages are being determined. All this means that drugs are less well adapted to women.

The predominantly male research is often justified by the fact that women can always be pregnant undetected and that participation in a study does not want to endanger the life of the unborn child. Legitimate sorting out women?
Absolutely not. Our women should be worth the effort we put into drug trials. Many are performed on older people, at least in the cardiovascular field. We don’t have the problem with the pregnancies. But for studies in younger age groups, we need to test these drugs in women. Pregnancies can now be proven with certainty.

The Federal Council recognizes the need for more women-specific research in medicine, but rejects a national research program on this – is Germany doing more in this regard?
I don’t understand the arguments the Federal Council should use to reject a national gender medicine research program. It’s pretty clear that we don’t have any data on women and don’t know how best to treat heart attacks, strokes, and diabetes in women. Knowing all these shortcomings, a national research program would be highly desirable. In Germany there is actually more movement. The coalition agreement of the new cabinet stipulates that gender medicine must continue to be given priority.

Where should the research most urgently begin?
There is an urgent need for research into risk factors specific to women. For example, when we talk about risk factors for cardiovascular problems, women-specific factors such as hormones, pregnancy or depression do not appear in the list of important risk factors. In addition, the drug industry should be required to investigate whether women and men really need the same drugs in the same dosage. There is strong evidence that women often require lower doses.

Studies assume that women have an increased risk of side effects. What medication is it?
We see that some sleep aids break down more slowly in women and still have a hangover the next morning. It is also known that some tumor drugs and anti-inflammatory drugs are less well tolerated by women than by men. The problem is that no extensive research has been done on this. In the case of cardiovascular drugs, side effects are published separately for each gender in only about 12 percent of studies. It is much more expensive to treat side effects of drugs later than to avoid them sooner.

Heart attacks are an example where women are often at a disadvantage in diagnosis because their symptoms are different. What other topics are there?
We rarely talk about stress-related diseases and rheumatic autoimmune diseases, which affect about 80 percent of women. Also that the mechanisms for some sex-specific manifestations of liver disease are not well understood and that we know too little about drug treatment during pregnancy. There could be many more examples.

Should women talk about it with their GP?
It is very important that women ask their GP whether their medicines or treatment methods have been sufficiently tested on women, whether there are dose determination studies for women and men and whether it is known with certainty that the medicines do not have different side effects. in different genders.

In medical examinations, is it often the case that symptoms of the disease are incorrectly attributed to a woman’s menstruation or mental state?
There is a lot of research that indicates that women are taken less seriously as patients. That, for example, heart disease is overlooked in them because the symptoms are rated as “mental.”

How can women judge for themselves whether, for example, abdominal pain can mean something serious or is normal?
Women cannot judge that for themselves. Patients can never really do that. This is also a difficult problem for doctors to know how to assess the pain. It requires attention, listening and careful diagnosis.

What change in clinical research would you like to see as a woman?
I want all studies to investigate differences between women and men. And that in all drug tests it is made clear which dose a woman and which a man needs and which side effects are typical and avoidable for the sex in question.

Do you approach research differently from your male colleagues?
Indeed, women sometimes have different strategies and other things are more important to them. I think women are more interested in so-called soft endpoints, such as quality of life and life satisfaction. In studies, they sometimes take this into account more than men.

How long do you think it will be before there is gender equality in clinical research?
If there is political support and there is a real recognition that gender-specific aspects also need to be explored, we can certainly make great progress in five years’ time.