Draft:Stalinon
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| Contributor note: Machine translation from page on French 'pedia I'l refine to proper English. Update: I thought the citations copied over; didn't. Ugh. Glitch or are would-be translators being actively prevented from starting with a machine translation? If intentional, makes me want to abandon the effort. If the references (which I see will need fixing) can be moved over, I want to proceed. How? Don't understand why they didn't make it. Tried restart, using Wikipedia:Translation, but it's been crippled. ([[1]]) I see there's a CS1 translator module but I guess it's broken? It's stated " all you need to do is copy the citation from the source and paste it into the en-wiki article, preview, fix any errors, and publish " - by this it's meant it has to be done citation by citation? Please reply on talk. |
Stalinon is an medicine against staph infections, based on diiododiethyltin, improperly placed on the market, and withdrawn when its severe toxicity was noticed.
History
[edit]Design and distribution
[edit]Stalinon was designed in the early 1950s as a treatment for boils (furunculosis). Stannomaltine, a pharmaceutical based on tin and tin oxide[1], then fell into disuse, but the effectiveness of tin in the treatment of conditions staphylococci has been known for a long time[2]. A French pharmacist, Georges Feuillet, then decided to create a drug based on diiododiethyltin, whose experimental effectiveness against staphylococcus had been demonstrated a few years earlier[3], and oflinoleic acid[4] (" vitamin F ", known to be good for the skin). He calls it " Stalinon " (of stannum, the Latin name fortin, and" -linon " for linoleic acid extracted from flax), and argues its marketing by presenting it as a derivative of Stannomaltine, although it differs significantly.
The authorization was granted in 1953, it was put on the market in November of the same year, sold without prescription. Anomalies appear quickly : the medicine is sold in the form of pearls which were supposed to be clear, but which are ultimately tinted to hide the appearance of a precipitated which the distributor does not worry about, nor does it take into account the alerts it receives from doctors and pharmacists from May 1954. Faced with doctors' alerts, Feuillet wants to be reassuring, responding to them :
Nos laboratoires contrôlent rigoureusement la fabrication, et les essais du laboratoire national des médicaments ne relèvent aucune toxicité
and limits himself to ordering, discreetly, to reduce the quantity of diiododiethyltin in future preparations. The victims are suffering from disorders neurological :
céphalées intolérables, vomissements, vertiges, troubles urinaires, douleurs abdominales, température très basse, vision double et fatigue à la lumière
, as well as serious psychological disorders (consequences of cerebral edema[5]). The cases ofpoisonings then accumulate, until the now undeniable toxicity of Stalinon is made public in June 1954. Delivery of the product is suspended in July 1954. The Stalinon then caused several hundred victims, 102 of whom died, many others suffering serious after-effects. In the long term, survivors experience loss of visual acuity[5], of headaches chronic, motor disorders up to paralysis of the lower limbs.
Trial
[edit]The ensuing trial highlights several serious flaws in the marketing procedure[4] :
- the authorization was based on a modification of the formula of Stannomaltine, even though the two drugs have almost nothing in common ;
- toxicity tests were carried out by mistake with capsules containing 3 mg instead of 50 mg of active ingredient (the marketed version being supposedly dosed at 15 mg per capsule) ;
- the toxicity of organic tin compounds can manifest slowly - the tests used were therefore insufficient to demonstrate this toxicity ;
- due to verification defects on the part of the manufacturer and distributor, the medicine placed on the market was contaminated with triethyltin iodide[3], more toxic ;
- the tin compounds were able to react with degradation products of linoleic acid[4].
The trial which ends in December 1957 sentences the responsible pharmacist to two years in prison and a heavy fine.
Repercussions
[edit]Regulation
[edit]The investigation which took place during the Stalinon trial ended in the spring of 1957[1], at the same time is signed thebirth certificate of the European Union. This birth translates into a need for France to show that its laws meet international challenges : the Stalinon affair becomes an opportunity to be exemplary through a reassuring reform[2]. The regulation of medicines in France is amended in February 1959 after several years of debate to ensure greater control.
Culture
[edit]It is undoubtedly partly due to the Stalinon scandal that the marketing authorization of Thalidomide, marketed from October 1957 in Germany, it took so long to be granted[1] in France and was withdrawn just as quickly, limiting the number of cases taking place in France.
The story of the Stalinon inspired the novel Retrait de marché, published under the pen name Clement Caliari.[6]
References
[edit]- ^ a b c Bonah Christian; Gaudillière Jean-Paul (2007). "Faute, accident ou risque iatrogène ? La régulation des événements indésirables du médicament à l'aune des affaires Stalinon et Distilbène". Revue française des affaires sociales (in French): 123–151.
- ^ a b Lalo, Corinne; Solal, Patrick (2011-11-10). Le livre noir du médicament (in French). Place des éditeurs. ISBN 978-2-259-21646-3. Retrieved 2018-11-21.
- ^ a b Jean-Pierre Anger (2001). "L'étain et les organoétains dans l'environnement" (PDF). Annales de toxicologie analytique (in French).
- ^ a b c ""Stalinon": a Therapeutic Disaster". Br Med J. 1 (5069): 515–515. 1958-03-01. doi:10.1136/bmj.1.5069.515. eISSN 1468-5833. ISSN 0007-1447. Retrieved 2018-11-21.
- ^ a b Bertrand Poirot-Delpech (30 October 1957). "L'inventeur du produit ne contrôlait pas les livraisons de ses fournisseurs. Les médecins-experts sont d'accord sur les méfaits de la drogue". Le Monde..
- ^ "Clément Caliari". Le Nouvel Obs (in French). 2011-04-21. Retrieved 2026-07-11.