{"id":4931,"date":"2021-11-02T09:11:56","date_gmt":"2021-11-02T08:11:56","guid":{"rendered":"https:\/\/sceaux-lagazette.fr\/?p=4931"},"modified":"2021-11-08T10:59:32","modified_gmt":"2021-11-08T09:59:32","slug":"la-deontologie-tres-relative-de-didier-raoult","status":"publish","type":"post","link":"https:\/\/sceaux-lagazette.fr\/index.php\/2021\/11\/02\/la-deontologie-tres-relative-de-didier-raoult\/","title":{"rendered":"La d\u00e9ontologie tr\u00e8s relative de Didier Raoult"},"content":{"rendered":"\n<p>Mercredi 27 octobre au soir&nbsp;: le journal \u00ab&nbsp;La Marseillaise&nbsp;\u00bb<a href=\"https:\/\/www.lamarseillaise.fr\/societe\/maj-ihu-mediterranee-les-soupcons-d-essais-illegaux-confirmes-par-une-enquete-interne-de-l-ap-hm-DK9408858\" target=\"_blank\" rel=\"noreferrer noopener\"> annonce<\/a>&nbsp;: \u00ab&nbsp;<em>IHU-M\u00e9diterran\u00e9e : les soup\u00e7ons d\u2019essais ill\u00e9gaux confirm\u00e9s par une enqu\u00eate interne de l\u2019AP-HM (<\/em>H\u00f4pital de Marseille La Timone, NDLR)<em>&nbsp;\u00bb<\/em>.<\/p>\n\n\n\n<p>Derri\u00e8re cette annonce du quotidien local, il y a un enjeu majeur pour le directeur de l\u2019\u00e9tablissement&nbsp;: selon le Code de la sant\u00e9 publique, enfreindre la l\u00e9gislation en mati\u00e8re d&rsquo;essais cliniques est passible d&rsquo;un an d&#8217;emprisonnement et de 15 000 euros d&rsquo;amende.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Un encadrement strict de tout essai<\/h2>\n\n\n\n<p>Des <a href=\"https:\/\/ansm.sante.fr\/vos-demarches\/chercheur#\" target=\"_blank\" rel=\"noreferrer noopener\">r<\/a><a href=\"https:\/\/ansm.sante.fr\/vos-demarches\/chercheur#https:\/\/www.inserm.fr\/dossier\/medicament-developpement\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u00e8gles strictes<\/a> ont \u00e9t\u00e9 mises en place progressivement pour les essais cliniques sur l\u2019homme. Tester un m\u00e9dicament ne peut se faire qu\u2019avec l\u2019autorisation de l\u2019<a href=\"https:\/\/ansm.sante.fr\/\" target=\"_blank\" rel=\"noreferrer noopener\">Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament<\/a> (ANSM),<a href=\"https:\/\/ansm.sante.fr\/vos-demarches\/chercheur#\" target=\"_blank\" rel=\"noreferrer noopener\"> charg\u00e9e de v\u00e9rifier<\/a> que les travaux pr\u00e9alables (phase pr\u00e9clinique) ont \u00e9t\u00e9 men\u00e9s et que l\u2019essai \u00e0 un int\u00e9r\u00eat (les travaux d\u00e9j\u00e0 men\u00e9s montrent qu\u2019il a un rapport b\u00e9n\u00e9fices\/risques sup\u00e9rieur aux traitements existants pour la maladie vis\u00e9e). L\u2019\u00e9valuation clinique comprend trois phases&nbsp;:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Une phase I d\u2019\u00e9valuation des effets sur l\u2019homme&nbsp;: son \u00e9volution dans l\u2019organisme (cin\u00e9tique) et sa toxicit\u00e9 gr\u00e2ce \u00e0 des examens de toutes sortes sur les volontaires.<\/li><li>Une phase II d\u2019\u00e9valuation des effets sur la maladie vis\u00e9e. Cette phase vise notamment \u00e0 d\u00e9terminer la dose efficace et les effets secondaires.<\/li><li>Une phase III sur une cohorte plus importante de malades pour mesurer l\u2019int\u00e9r\u00eat th\u00e9rapeutique du m\u00e9dicament.<\/li><\/ul>\n\n\n\n<p>Pour lancer cette \u00e9valuation clinique, il faut en pr\u00e9alable monter un dossier qui permettra \u00e0 l\u2019ANSM de donner, ou pas, son accord.<\/p>\n\n\n\n<p>Il faut aussi obtenir l\u2019avis favorable d\u2019un <a href=\"https:\/\/fr.wikipedia.org\/wiki\/Comit%C3%A9_de_protection_des_personnes\" target=\"_blank\" rel=\"noreferrer noopener\">comit\u00e9 de protection<\/a> des personnes (CPP), tir\u00e9 au sort parmi les 40 existants en France et compos\u00e9 de 14 membres (7 du monde m\u00e9dical et 7 de la soci\u00e9t\u00e9 civile).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Des essais r\u00e9alis\u00e9s sans autorisation<\/h2>\n\n\n\n<p>En mars 2020, quand l\u2019IHU-M avait publi\u00e9 une premi\u00e8re \u00e9tude sur les effets de la chloroquine, avec une vingtaine de patients, certains de ceux qui ont analys\u00e9 l\u2019\u00e9tude, s\u2019\u00e9taient \u00e9tonn\u00e9 de voir que l\u2019IHU-M n\u2019avait pas respect\u00e9 le cadre de l\u2019\u00e9tude dont il avait demand\u00e9 l\u2019autorisation, en incluant notamment des enfants, alors que le dossier de demande (et son autorisation donc) pr\u00e9voyait seulement un essai sur des adultes.<\/p>\n\n\n\n<p>Certaines personnes (probablement au sein m\u00eame de l\u2019IHU) ont alert\u00e9 sur le fait que l\u2019IHU menait des essais non autoris\u00e9s&nbsp;: d\u2019abord aupr\u00e8s de l\u2019ASNM (en mai) puis aupr\u00e8s de m\u00e9dias. Pendant que l\u2019ASNM menait son enqu\u00eate, l\u2019Express et M\u00e9diapart ont men\u00e9 la leur.<\/p>\n\n\n\n<p>Le 6 octobre, l\u2019Express publie <a href=\"https:\/\/www.lexpress.fr\/actualite\/sciences\/publication-d-etudes-comment-l-ihu-et-didier-raoult-font-fi-de-la-loi-et-l-ethique-scientifique_2159813.html\" target=\"_blank\" rel=\"noreferrer noopener\">un article<\/a> qui pointe un certain nombre d\u2019essais ill\u00e9gaux.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Le premier est une \u00e9tude r\u00e9alis\u00e9e en 2013 et ayant fait l\u2019objet d\u2019une publication en 2015. \u00ab&nbsp;<em>Ces travaux, sign\u00e9s notamment par le Pr. Didier Raoult, pr\u00e9sentent \u00ab\u00a0les r\u00e9sultats pr\u00e9liminaires avant\/apr\u00e8s d&rsquo;une \u00e9tude prospective comparant la mortalit\u00e9 de 61 patients \u00e2g\u00e9s de 84 ans en moyenne, dont 42 ont \u00e9t\u00e9 trait\u00e9s par antibiotiques et 19 par transplantation [f\u00e9cale, NDLR]&nbsp;\u00bb, <\/em>\u00e9crivent les auteurs. Aucune autorisation n\u2019appara\u00eet dans le document publi\u00e9.<\/li><li>Le second concerne une \u00e9tude r\u00e9alis\u00e9e en 2016\/2017, l\u00e0 aussi sans aucune autorisation.<\/li><li>La troisi\u00e8me a \u00e9t\u00e9 lanc\u00e9e en 2019 et porte sur des malades atteints de schizophr\u00e9nie, toujours sans autorisation.<\/li><li>247 (!) \u00e9tudes ont \u00e9t\u00e9 men\u00e9es entre 2011 et 2021 en s\u2019appuyant sur un seul num\u00e9ro d\u2019autorisation identique. 238 d\u2018entre elles portent la signature de Didier Raoult. Beaucoup portent la signature des professeurs Fournier et Lagier.<\/li><\/ul>\n\n\n\n<p>De son c\u00f4t\u00e9, M\u00e9diapart a <a rel=\"noreferrer noopener\" href=\"https:\/\/www.bfmtv.com\/sante\/tout-comprendre-les-accusations-d-essais-irreguliers-contre-l-ihu-mediterranee-de-didier-raoult_AN-202110240121.html\" target=\"_blank\">publi\u00e9<\/a> courant octobre une enqu\u00eate \u00e0 propos d\u2019<a href=\"https:\/\/www.francetvinfo.fr\/sante\/ce-que-l-on-sait-de-l-experimentation-non-autorisee-de-traitements-contre-la-tuberculose-a-l-ihu-de-marseille-dirige-par-didier-raoult_4824761.html\" target=\"_blank\" rel=\"noreferrer noopener\">une \u00e9tude clinique<\/a> sur la tuberculose, commenc\u00e9e en 2017 et poursuivie jusqu\u2019en mars 2021. L\u2019IHU a fait une demande d\u2019autorisation en 2019 (alors que l\u2019\u00e9tude \u00e9tait commenc\u00e9e depuis deux ans\u2026), demande qui n\u2019a pas \u00e9t\u00e9 accept\u00e9e. Des alertes ayant alors \u00e9t\u00e9 remont\u00e9es aupr\u00e8s de la Soci\u00e9t\u00e9 de pathologie infectieuse de langue fran\u00e7aise, laquelle a demand\u00e9 en novembre 2019 \u00e0 Didier Raoult de cesser ce protocole.<\/p>\n\n\n\n<p>Sur ce dossier, la r\u00e9ponse de Didier Raoult est que les traitements test\u00e9s b\u00e9n\u00e9ficient d\u2019une autorisation de mise sur le march\u00e9 (AMM) pour d\u2019autres infections. Il a d\u00e9j\u00e0 d\u00e9velopp\u00e9 ce type d\u2019argument concernant l\u2019hydroxychloroquine. On rappellera ici que le M\u00e9diator a \u00e9t\u00e9 utilis\u00e9 pour des pathologies que ne correspondaient pas \u00e0 son AMM.<\/p>\n\n\n\n<p>L\u2019AP-HM (dont d\u00e9pend l\u2019IHU) a men\u00e9 une enqu\u00eate interne \u00e0 la suite de cette publication de M\u00e9diapart. Le 27 octobre, elle a publi\u00e9 un communiqu\u00e9 de presse montrant que cette enqu\u00eate confirme les faits r\u00e9v\u00e9l\u00e9s par M\u00e9diapart, notamment le fait que certains des patients trait\u00e9s avaient eu des complications r\u00e9nales au point que l\u2019un d\u2019entre eux a d\u00fb \u00eatre op\u00e9r\u00e9.<\/p>\n\n\n\n<p>\u00c0 la suite de l\u2019enqu\u00eate qu\u2019elle a men\u00e9e depuis le mois de mai, l\u2019ASNM a <a href=\"https:\/\/www.lexpress.fr\/actualite\/societe\/sante\/essais-cliniques-a-l-ihu-de-didier-raoult-pourquoi-l-agence-du-medicament-saisit-la-justice_2161283.html\" target=\"_blank\" rel=\"noreferrer noopener\">saisi la justice<\/a> le 27 octobre.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Le point de vue de la communaut\u00e9 scientifique<\/h2>\n\n\n\n<p>Des scientifiques ont r\u00e9agi tr\u00e8s vite aux d\u00e9clarations fracassantes de Didier Raoult sur le Covid en d\u00e9but 2020, la Gazette<a href=\"https:\/\/sceaux-lagazette.fr\/index.php\/2020\/12\/05\/betisier-5-on-dispose-dun-traitement-efficace-quon-interdit-de-prescrire\/\" target=\"_blank\" rel=\"noreferrer noopener\"> l\u2019a rappel\u00e9<\/a>. Et ils ont fait \u00e0 leur mani\u00e8re&nbsp;: en analysant les \u00e9tudes publi\u00e9es par l\u2019IHU et en mettant le doigt sur les \u00e9normes biais qu\u2019on pouvait y trouver.<\/p>\n\n\n\n<p>Le comportement du directeur de l\u2019IHU a aussi \u00e9t\u00e9 point\u00e9 comme ne correspondant pas au fonctionnement normal de la communaut\u00e9 scientifique&nbsp;: d\u00e9clarations sur ses \u00ab&nbsp;d\u00e9couvertes&nbsp;\u00bb prioritairement adress\u00e9es aux m\u00e9dias, refus d\u2019\u00eatre confront\u00e9 \u00e0 ses pairs.<\/p>\n\n\n\n<p>Le 21 septembre, le comit\u00e9 d\u2019\u00e9thique du CNRS a publi\u00e9 un long avis (approuv\u00e9 dans sa s\u00e9ance du 25 juin 2021) sur \u00ab&nbsp;<em>les dimensions d\u00e9ontologiques et \u00e9thiques de la crise sanitaire<\/em>.&nbsp;\u00bb On peut lire dans le r\u00e9sum\u00e9 la phrase suivante&nbsp;: \u00ab&nbsp;<em>le COMETS d\u00e9plore le comportement irresponsable de certains chercheurs qui ignorent, ou veulent ignorer, les fondements de la d\u00e9marche scientifique que sont la rigueur, l\u2019honn\u00eatet\u00e9, la fiabilit\u00e9 et la transparence des m\u00e9thodes utilis\u00e9es et l\u2019\u00e9valuation critique des publications par les pairs<\/em>.&nbsp;\u00bb<\/p>\n\n\n\n<p>Dans le corps de l\u2019avis, on peut lire&nbsp;:<\/p>\n\n\n\n<p><em>\u00ab&nbsp;Face \u00e0 l\u2019urgence de trouver des solutions th\u00e9rapeutiques \u00e0 la COVID-19, des acteurs de la recherche et du monde m\u00e9dical ont soutenu que l\u2019intuition ou le \u00ab bon sens \u00bb m\u00e9dical seraient suffisants pour d\u00e9cider de l\u2019efficacit\u00e9 et de la s\u00e9curit\u00e9 d\u2019un traitement. Ils ont d\u00e9clar\u00e9 \u00eatre les tenants d\u2019une \u00ab \u00e9thique du traitement \u00bb qui serait oppos\u00e9e \u00e0 une \u00ab \u00e9thique de la recherche \u00bb. Ce discours a servi la promotion, par Didier Raoult et son \u00e9quipe de l\u2019IHU de Marseille, du traitement de la COVID-19 par un antipalud\u00e9en connu de longue date, l\u2019hydroxychloroquine (HCQ). Largement ouvert au public, dans des conditions peu respectueuses des r\u00e8gles de d\u00e9ontologie m\u00e9dicale, le traitement a fait l\u2019objet d\u2019un emballement m\u00e9diatique et politique alors m\u00eame que son efficacit\u00e9 sur la COVID-19 ne reposait que sur une \u00e9tude clinique contestable. &nbsp;<\/em><\/p>\n\n\n\n<p>Cela fait d\u00e9j\u00e0 plus d\u2019un an que les scientifiques, dans leur tr\u00e8s grande majorit\u00e9, se sont fait une opinion sur Didier Raoult, et le moins qu\u2019on puisse dire est qu\u2019il n\u2019est pas favorable. Beaucoup attendent qu\u2019il soit sanctionn\u00e9. On verra dans les mois qui suivent ce qu\u2019il en est&nbsp;!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mercredi 27 octobre au soir&nbsp;: le journal \u00ab&nbsp;La Marseillaise&nbsp;\u00bb annonce&nbsp;: \u00ab&nbsp;IHU-M\u00e9diterran\u00e9e : les soup\u00e7ons d\u2019essais ill\u00e9gaux confirm\u00e9s par une enqu\u00eate interne de l\u2019AP-HM (H\u00f4pital de Marseille La Timone, NDLR)&nbsp;\u00bb. Derri\u00e8re cette annonce du quotidien local, il y a un enjeu majeur pour le directeur de l\u2019\u00e9tablissement&nbsp;: selon le Code de&#8230;<\/p>\n","protected":false},"author":11,"featured_media":5028,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[53,60],"tags":[],"class_list":["post-4931","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-analyses","category-sante","entry","simple"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>La d\u00e9ontologie tr\u00e8s relative de Didier Raoult - La Gazette<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sceaux-lagazette.fr\/index.php\/2021\/11\/02\/la-deontologie-tres-relative-de-didier-raoult\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La d\u00e9ontologie tr\u00e8s relative de Didier Raoult - La Gazette\" \/>\n<meta property=\"og:description\" content=\"Mercredi 27 octobre au soir&nbsp;: le journal \u00ab&nbsp;La Marseillaise&nbsp;\u00bb annonce&nbsp;: \u00ab&nbsp;IHU-M\u00e9diterran\u00e9e : les soup\u00e7ons d\u2019essais ill\u00e9gaux confirm\u00e9s par une enqu\u00eate interne de l\u2019AP-HM (H\u00f4pital de Marseille La Timone, NDLR)&nbsp;\u00bb. 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