

That of thalidomide is a tragic story that is not over yet. This antiemetic drug, which was given to pregnant women in the late XNUMXs and early XNUMXs, gave birth to thousands of babies with congenital limb malformations. Twenty thousand malformed births around the world. In Italy it is not known exactly how many, because there are no official data. Moreover. There are some thalidomide victims who are still not recognized because they have “only” unilateral damage – to an upper or lower limb.
On the thalidomide scandal, Tuesday 2 May at 21, the Academy of Medicine of Turin will hold a scientific meeting, both in presence and in modality webinar, by title "Thalidomide congenital malformations: a never ending story”. (1) Speakers will be Benedetto Terracini, Professor of Human Tumor Epidemiology and member emeritus of the Academy of Medicine, and Luisa Guerrini, Associate Professor of Molecular Biology, Department of Biosciences - University of Milan.
'I don't know how much public opinion in Italy knows what thalidomide was. Was a drug widely used to treat and prevent vomiting in pregnant women, very popular around 1960. Worldwide there were 20 malformed babies. In addition to a certain number of conceived children who did not become newborns because they suffered from serious malformations of the limbs and internal organs. Italy was a heavily affected country. Just think that of the 34 pharmaceutical products circulating at the time, 10 were produced in Italy. Only that we don't have any data for Italy. Never bothered to count what thalidomide victims were', Benedetto Terracini explains in a video abstract. (2)
Luisa Guerrini for years she has been studying the teratogenic effects of thalidomide and has contributed to defining what happens during pregnancy in women who have taken this drug. You have shown that thalidomide causes the degradation of the p63 protein. Using the Zebra fish as a model system, Guerrini demonstrated that thalidomide acts only at the p63 protein level and not at the DNA level. And this is in agreement with the evidence that the children of thalidomides do not have any malformations transmitted to them by the parent. Finally, as happened in humans, Zebrafish also have unilateral developmental defects induced by thalidomide. (3)
On all the victims of thalidomide, recognized with a law approved belatedly in 2016, more than fifty years later, many genetic tests have been carried out which have not been conclusive, he says in video abstract. The cases collected in the 60s were also based on the 'most malformed' children, therefore there was a bias selection process on how to consider people, whether or not they are victims of thalidomide.
'We try to give voice and right to Italian victims of thalidomide not yet recognized by the Ministry, especially people affected by unilateral damage, with a missing upper or lower limb'.
The other topic more difficult to deal with scientifically, Terracini anticipates, is to document how drugs were registered in Italy in the 1958s. Indeed, the Ministry of Health was created in XNUMX and drug registration mechanisms were not as stringent as they are today.
The scientific meeting will therefore start from the fact that, around 1960, malformed live births due to maternal intake of the antiemetic thalidomide were around 2000. Over the years, attention to the victims by academia and health authorities has been scarce and a today the main reasons for scientific bewilderment are the ministerial exclusion of a cause-effect relationship (and therefore of compensation) for those born on a date deemed incompatible and for subjects affected 'only' by unilateral damage to the limbs. The tragedy didn't involve the United States, thanks to FDA Pharmacology Frances Oldham Kelsey's denial of approval of the drug. (4)
It is teratogenic a compound, substance or condition capable of inducing alterations in the normal development of the fetus during pregnancy and causing spontaneous abortion or congenital malformations, or after birth, which cause permanent damage to health (ISS Salute). (5)
In the early sixties with thalidomide there was the first major case investigated by the scientific community - and a scandal of worldwide proportions - linked to malformations caused by drugs during pregnancy, with the discovery of the connection between the use of this drug in the first two months of pregnancy and appearance of very serious malformations in the limbs of newborns. (6)
The disaster began when it was discovered that the drug had an antiemetic effect: it was therefore prescribed to pregnant women but without having been tested on pregnant animals. Estimates and numbers on congenital malformations caused by thalidomide are probably underestimated because they do not consider perinatal deaths and abortions. The case has shaken public opinion and highlighted the need for research into the possible teratogenic effects of drugs.
Sabrina Bergamini
(1) The meeting can be followed both by accessing the Aula Magna of the Turin Academy of Medicine (via Po 18, Turin), and by connecting remotely to the site https://www.accademiadimedicina.unito.it/attivita/sedute-scientifiche/prossime-sedute.html.
(2) Video abstract al link https://www.youtube.com/watch?v=L44kDN-h9JI
(3) Teratogenic drugs: the Thalidomide scandal. Microbiology Italy. https://www.microbiologiaitalia.it/farmacologia/farmaci-teratogeni-lo-scandalo-del-talidomide/
Thalidomide, discovered to cause malformations in the fetus. Corriere della Sera. 7.10.19 https://www.corriere.it/salute/malattie-rare/19_ottobre_07/talidomide-scoperto-come-causa-malformazioni-feto-dd4b9570-e924-11e9-a351-0f862d63c352.shtml
(4)Emanuela Pasqua. Scientist who opposed thalidomide dies at 101. Corriere della Sera. 8.10.15 https://www.corriere.it/salute/pediatria/15_agosto_08/muore-101-anni-scienziata-che-si-oppose-talidomide-699b2928-3de4-11e5-be68-18b96553415a.shtml
(5) Iss health https://www.issalute.it/index.php/la-salute-dalla-a-alla-z-menu/t/teratogenesi#farmaci-e-rischio-teratogeno
(6) Morena Pinto. Pharmakon, the thalidomide tragedy. The podcast born in the classrooms of SISSA. Trieste news. 5.10.22 https://www.triesteallnews.it/2022/09/pharmakon-la-tragedia-del-talidomide-il-podcast-nato-nelle-aule-della-sissa/