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Rubrik: Mittwochs-Kolumnen |
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Male and/or female test persons? |
Von Katharina von Salis As an occasional consumer of medicines, I have often wondered how the drug I was perscribed had been tested. It came as something of a surprise some years ago, when I learned that most medicines were solely or mainly tested on young men. I had always assumed that medicinal products were tested both on male and female subjects - how else could the pharamceutical industry evaluate their effect on both men and women? I inquired as to why this was the case and was told that it would be too expensive to test every new medical drug both on men and women. Men are an easier test subject since they do not have a monthly hormonal cycle which confuses the observation of a "normal" reaction to a medicine. The (young) male person was the norm, even if men are, strictly speaking, a minority. As a natural scientist, this "reasoning" was totally at odds with my thinking. Surely, the fact that most women do have a 1 monthly hormonal cycle and several other fundamental physiological differences from the seemingly male "norm", means that it is impossible to assume that a particular drug will affect men and women in the same way. Then, a couple of years ago, I read an article about investigations around the sleeping problems of postmenopausal women. Again the tests also were performed on young men, even though, in this case, the researchers could not argue that the hormonal cycle of the women would blur the results! Is it perhaps pure habit to think of young men when thinking of test persons for medical problems and drugs? Regularly one finds small advertisments in ETHintern or flyers pinned on one of the many bulletin boards around ETH appealing for test persons for all kinds of medical experiments at ETH and other institutes. Some years ago I started to complain to those authors of such advertisments that were looking only for male testers. After learning that, in the USA, the Food and Drug Administration stated since 1993 that women must be included in all phases of the testing of new medical drugs, I have added this information to such complaints. In addition, the US National Institute of Health does not fund research and development of drugs which do not include both men and women as test subjects. Swiss Intercantonal Drug Control on the other hand stipulates that medical drugs be tested on all patient groups that may be assumed to use them. However, this only applies for new medicines and therefore excludes many more traditional painkillers and antibiotics.
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What are the rules, if any, for all the new "functional food", including special sportsdrinks and foods that are appearing on the market? And what about small and larger research projects being carried out at ETH? Do they all comply with the request for full and representative testing - even including not so young men? Who knows? Who wants to know?
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