They were born with an open back, with heart defects and brain damage, shortened or missing limbs, deformed intestines, bladders or genitals. The cause for the malformations, among which hundreds of Germans and Britons born between the beginning of the 1950s and the middle of the 1970s, still today as adults, is given to a former drug of the Berlin pharmacy company Schering.
Mothers had received a drug from their doctors at the beginning of their pregnancy to determine if they really expected a child : named Duogynon in Germany, Primodos in the UK. Their content, a combination based on the female sex hormones gestagen and estrogen, was the same ; it could be swallowed or injected and was able to cause a menstrual bleeding.
If menstruation did not take place despite the hormone shock, the woman was considered pregnant. Urine test strips had not yet prevailed.
For the first time, the serious suspicions that are on the preparations of the past could be systematically examined by independent experts and at the present state of science. Neil Vargesson, professor of biology at the Scottish University of Aberdeen, researched on embryonic malformations for many years. He has worked with a team of his faculty to reproduce the Duogynon, Primodos, active ingredient and has already been tested in the laboratory for zebrafish embryos for its fruit-damaging effects.
“We were able to demonstrate that Primodos actually damages fish embryos, depending on both the stage of embryonic development and its dosage.”
Vargesson told the taz.
The Missing Proof
So far there have been indications, but no evidence for a causal link between the intake of Duogynon and the malformations. On the one reason being that clinical studies from the 1950s – when Schering brought the drug on the market – were not carried out in a way from which evidence could be derived. Another reason being that Duogynon has not been produced anymore for almost 40 years. Schering was taken over by Bayer AG in 2006, and they categorically excludes Duogynon “as the cause of embryonic malformations“.
“The exact mechanism of action of Primodos / Duogynon on zebrafish is not yet known, but there are indications that the developmental stage of the blood vessels and the nerves play a key role in the nature and extent of embryonic damage”
said Vargesson.
“We could see enlarged hearts, open backs, damaged blood cells and damage to the nervous system. It is not just premature, but dubious, from these first results, to draw conclusions about possible damage to human embryos, I estimate that we will have to research at least three to five years in the lab and in very different animals”
said the scientist.
“Zebrafish, whose embryonic development is similar to those of higher vertebrate animals, and which develop completely and very quickly outside the mother’s body, are an important model organism for biologists. However, further experiments on rodents, fish and also sheep are essential in order to make assured statements. Research on pregnant women is prohibited for ethical reasons”
Vargesson said.
“You have to emphasize again and again that there is no such a thing as a natural malformation rate. Three per cent of all newborns are born with malformations, without apparent causes.”
added Vargesson.
New Hopes
The research approach of Neil Vargesson brings nevertheless new, great hope for the alleged Duogynon victims who have so far vainly struggled in the United Kingdom and in Germany as self-help groups for the recognition of their suffering by governments and parliaments and for a compensation fund based on the model of the foundation for contergan victims. Whether and how fast reliable results will be available, however, is also a matter of financing. The British parliament, which has been examining medical and scientific findings on Duogynon for one and a half years, has recently invited the Scottish biologists to a meeting. There were no concrete financial commitments so far.
“It’s also unusual to want to research a drug that is not there. My attention for Duogynon, came about by chance, almost as a by-product of my actual research interest.”
admited Vargesson.
Contergan was recommended to pregnant women in the 1960s against morning sickness and triggered one of the biggest drug scandal of the past century. The question of how the drug, can be used without harming unborns in the mother’s womb has been the focus for many years. Contergan is still of great therapeutic interest and use, said Vargesson, for the treatment of leprosy as well as certain types of cancer of the plasmatic cells.
Contergan Open Questions
Despite years of intensive research, it is still unclear as what exact building blocks of Contergan drug cause the malformations.
Vargesson does research on this, since he wants to know which molecules he has to forego completely, which he could change as well as which he should exchange, in order to make the medium safe and yet medically usable. Vargesson has recently patented several promising varieties of a slightly modified conteric.
Vargesson is optimistic:
“When I heard that another drug might also cause malformations in unborn babies, I had to look at the matter more closely.
Certain substances that were present in Duogynon are still found today in modified form in antibabies. There should be an interest in exploring possible undesirable side effects.
Whether it goes, and how, will depend above all on financial decisions.”
