Draft:StalinonTest
Comment: Period and comma before not after <ref>...</ref>. Use straight apostrophe (') not curly (’). —Anomalocaris (talk) 01:37, 31 July 2026 (UTC)
The Stalinon is an ancient medicine against infections staphylococci, based on diiododiethyltin, withdrawn from the market when its toxicity was noticed.
History
[edit]Design and distribution
[edit]Stalinon was designed in the early 1950s as a treatment for furunculosis. Stannomaltine, a pharmaceutical specialty 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 pharmacist from Saint-mandéGeorges Feuillet then decided to create a drug based on diiododiethyltin, the experimental effectiveness of which 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 to evoke linoleic acid extracted from flax), and argues its marketing by presenting it as a derivative of Stannomaltine, although it differs significantly.[5]
THEauthorization 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 (capsules) transparent, but 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 mai 1954.[6] 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.[7] 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 — conséquences d'un œdème cérébral.[8] The cases ofintoxication then accumulate, until the now undeniable toxicity of Stalinon is made public in juin 1954. Delivery of the product is suspended in juillet 1954[9]. The Stalinon then caused several hundred victims, 102 of whom died, many others suffering serious after-effects: loss of visual acuity, headaches chronic, motor disorders up to paralysis of the lower limbs.[10][11]
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;[12]
- 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 décembre 1957sentences 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 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 février 1959 after several years of debate to ensure greater control.[13]
It is undoubtedly partly due to the Stalinon scandal that the marketing authorization of thalidomide, marketed from octobre 1957 in Germany, was pushed back to France[1][11].
Culture
[edit]The Stalinon affair inspired the novel Market withdrawal, by Clement Caliari.[14]
References
[edit]- 1 2 3 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: 123–151. doi:10.3917/rfas.073.0123.
- 1 2 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.
- 1 2 Jean-Pierre Anger (2001). "L'étain et les organoétains dans l'environnement" (PDF). Annales de toxicologie analytique.
- 1 2 3 British Medical Journal Publishing Group (1958-03-01). ""Stalinon": a Therapeutic Disaster". Br Med J. 1 (5069): 515–515. doi:10.1136/bmj.1.5069.515. ISSN 0007-1447. Retrieved 2018-11-21.
{{cite journal}}: Unknown parameter|issn2=ignored (help) - ↑ Marc Cramer (1959). "L'affaire du Stalinon et le contrôle des médicaments en Suisse". La Croix-Rouge suisse.
- ↑ Christian Bonah (15 September 2007). "L'affaire du Stalinon et ses conséquences réglementaires, 1954-1959" (PDF). La revue du praticien.
- ↑ B. Poirot-Delpech (8 November 1957). "" M. Feuillet n'est pas un imprudent, c'est un criminel " plaide Me Floriot, avocat des victimes". Le Monde.
- ↑ 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.
- ↑ "La délivrance du médicament "Stalinon" est suspendue". Le Monde. 6 July 1954.
- ↑ Bertrand Poirot-Delpech (9 November 1957). "La plupart des victimes sont des enfants". Le Monde.
- 1 2 Soline Roy (29 July 2026). "Une fabrication «abracadabrantesque» : Georges Feuillet, le pharmacien qui a tué 102 personnes en soignant leurs furoncles". Le Figaro.
- ↑ "Pourquoi certaines molécules sont-elles retirées du marché ?". sante.lefigaro.fr (in French). 2010-11-14. Retrieved 2018-11-25.
- ↑ Laure-Marine Chemin (2014). "L'évolution du rôle du pharmacien d'officine français en tant qu'acteur de santé".
- ↑ Anne Crignon (23 May 2011). "Un scandale sanitaire". Bibliobs (in French). Retrieved 2018-11-21.
Screen Shot of Wikipedia GUI editor apparently ready to save the content of this - translated fr Stalinon page - notice that the References section looks relatively good (though I think it would be better if some parts the refs had been left untranslated.)
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