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Haïti devient-elle un Laboratoire d’Essai pour le Coronavirus?

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Les Essais Recommandés avant la validation de la chloroquine

Vous n’êtes pas sans savoir que :

  • Le sujet du traitement du nouveau coronavirus par chloroquine a été évoqué à maintes reprises dans le monde.
  • l’OMS a appelé le monde à la prudence dans l’usage de ce médicament
  • Que selon Dr Marie Colette A. Jean-Pierre, une infectiologue locale, l’hydroxychloroquine, ne tiendrait pas encore la route.

Selon les informations collectées, de Dr Colette et des prescriptions de l’OMS, le traitement à la Chloroquine nécessite des essais plus rigoureux sur un échantillon plus vaste qui serait plus représentatif. Aussi, ces essais doivent impérativement prendre en compte les contre-indications et pouvoir révéler les éventuelles complications.

Lire aussi : L’OMS appelle à la prudence pour l’usage de la Chloroquine

les premières études sur l’administration du médicament n’ont pas été menées avec rigueur et le temps de latence de l’épidémie de 2003 n’a pas permis de définir tous les paramètres. Il y a d’autres paramètres à considérer. L’étude précédente n’a pas permis de révéler les potentielles complications et les cas dans lesquels ce médicament serait contre indiqué. L’échantillonage est faible et les études ne sont pas randomisées. Dautres études complémentaires, plus rigoureuses, doivent permettre de corroborer les premières.

Marie Colette A. Jean-Pierre , MD ID Care Specialist
La chloroquine comme traitement du Coronavirus 1

Maintenant ce que vous ne savez peut être pas est que:

Le protocole du Ministère de la Santé Publique et de la Population (MSPP) vient d’admettre la Chloroquine comme traitement dans son plan de lutte contre le Covid-19

De très tôt ce matin, nous avons reçu le document suivant, sous nom de “Algorithme de PEC du Covid 19” faisant mention de l’hydroxychloquine dans le traitement des malades atteints du Coronavirus.

Algortihme de PEC du Covid 19 MSPP
Capture d’écran du Document du MSPP

Des essais cliniques recommandés pour la validation de la chloroquine

Qu’est ce qu’un essai clinique?

Selon l’Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), un essai clinique est une recherche biomédicale organisée et pratiquée sur l’Homme en vue du développement des connaissances biologiques ou médicales.

Les essais cliniques portant sur les médicaments ont pour objectif, selon le cas, d’établir ou de vérifier certaines données pharmacocinétiques (modalités de l’absorption, de la distribution, du métabolisme et de l’excrétion du médicament), pharmacodynamiques (mécanisme d’action du médicament notamment) et thérapeutiques (efficacité et tolérance) d’un nouveau médicament ou d’une nouvelle façon d’utiliser un traitement connu.

L’essai peut se faire chez le volontaire malade ou le volontaire sain.

Les organismes généralement impliqués et les conditions

En France, pour débuter, l’essai doit avoir obtenu un avis favorable du Comité de protection des personnes (C.P.P.) et une autorisation de l’Agence nationale de sécurité du médicament et des produits de santé (ANSM).

Le CPP rend son avis sur les conditions de validité de la recherche, notamment au regard de :

  • la protection des personnes, notamment la protection des participants;
  • l’adéquation, l’exhaustivité et l’intelligibilité des informations écrites à fournir ainsi que la procédure à suivre pour obtenir le consentement éclairé, et la justification de la recherche sur des personnes incapables de donner leur consentement éclairé ;
  • la nécessité éventuelle d’un délai de réflexion ;
  • la nécessité éventuelle de prévoir, dans le protocole, une interdiction de participer simultanément à une autre recherche ou une période d’exclusion ;
  • la pertinence de la recherche, le caractère satisfaisant de l’évaluation des bénéfices et des risques attendus et le bien-fondé des conclusions ;
  • l’adéquation entre les objectifs poursuivis et les moyens mis en œuvre ;
  • la qualification du ou des investigateurs
  • les montants et les modalités d’indemnisation des participants ;
  • les modalités de recrutement des participants.
  • Pendant toute la durée de l’essai, l’ANSM est tenue informée des effets indésirables graves et inattendus pouvant être liés au médicament expérimental et de tout fait nouveau lié à la recherche susceptible de remettre en cause la sécurité des personnes se prêtant à la recherche ; elle peut prendre toute décision concernant ces essais (suspension, interdiction).

Ce que tout cela implique

Avant de valider un quelconque traitement pour une maladie, des essais cliniques sont recommandés. Ces essais sont faits sur un nombre défini de personnes volontaires et sous contrôle des instances accréditées.

L’objectif, les conditions de réalisation et de déroulement de l’essai, les modalités d’inclusion, d’information, de traitement et de surveillance des personnes participant à l’essai doivent être définies par les médecins ainsi que les investigateurs et les procédures de recueil des informations sur l’efficacité et la tolérance des médicaments dans un protocole préétabli.

Qu’en est-il de la Chloroquine?

D’un côté, il y’a ceux qui appellent à la prudence et à attendre de vastes essais cliniques menés selon la stricte orthodoxie scientifique pour valider ou non le traitement par chloroquine ; de l’autre, ceux qui veulent accélérer le processus et l’administrer très largement au nom de l’urgence sanitaire.

En France, plusieurs élus, dont Christian Estrosi, font monter la pression pour généraliser rapidement l’utilisation de la chloroquine.

Quant à Donald Trump, il en a vanté les mérites à plusieurs reprises, notamment dans ces tweets du 21 mars. ~AFP

D’où le rappel très ferme de l’Organisation mondiale de la Santé (OMS) lundi 23 mars, qui “condamne l’usage de médicaments sans preuve de leur efficacité“, mettant en garde contre les “faux espoirs“, dans une allusion à peine voilée à la publication de l’IHU. Cliquez ici

Serait-on devenu des souris de laboratoire ou transformés involontairement en volontaires pour des essais cliniques pour le bien de l’humanité?

Comme vous avez pu lire plus haut, l’essai peut se faire chez des volontaires malades ou des volontaires sains et L’objectif, les conditions de réalisation et de déroulement de l’essai, les modalités d’inclusion, d’information, de traitement et de surveillance des personnes participant à l’essai doivent être définies par les médecins ainsi que les investigateurs et les procédures de recueil des informations sur l’efficacité et la tolérance des médicaments dans un protocole préétabli.

On se demande donc si tout cela a été pris en compte et où on pourrait trouver les documents y relatifs.

Des questions donc se soulèvent:

  • La chloroquine sera-t-elle uniquement utilisée sur des gens volontaires?
  • Les protocles des essais cliniques pour l’utilisation de la chloroquine dans le traitement du coronavirus ont-ils été préalablement établis?
  • Qui est responsable pour veiller au respect des protocoles?
  • Sommes nous devenus des souris de laboratoire?
  • La décision d’appliquer la chloroquine est-elle une décision originale prise par les autorités sanitaires ou encore une fois juste un copi-coller des mesures prises ailleurs?
  • Que dit l’OMS dans cette décision?

Pensez à visiter notre COV-MAP pour les rapports sur l’évolution de l’épidémie dans le monde et à accepter de recevoir des notifications pour nos prochaines publications.

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