The National Medicines Safety Agency will take legal action after the publication of a controversial study, signed by the professor, accused of having “infringed” ethical rules.
Is it a “huge health scandal”as denounced by learned societies, or do these accusations come from “fools”, as asserted by the one they aim at? Anyway, Didier Raoult is again singled out, after the opening last July of a judicial investigation against the University Hospital Institute (IHU) Méditerranée Infection in Marseille.
The controversial professor is accused by doctors of conducting a clinical trial “savage” giant with hydroxychloroquine as a treatment for Covid-19, which he mentioned in a pre-published study last April. The National Medicines Safety Agency (ANSM) announced on Saturday June 3 that it was preparing to take legal action.
From this “pre-print” to the latest announcements from the Medicines Agency, franceinfo looks back on the main stages of this scientific controversy on the way to becoming a legal case.
1Didier Raoult signs a vast study
It is from there that the “scandal” emanates. In early April, Professor Didier Raoult, who left the management of the IHU last September, published with other members of his team a “pre-print”, that is to say a version not proofread by peers, of a study. The latter looks back on a trial carried out between March 2, 2020 and December 31, 2021, a period during which 30,423 Covid-19 positive people received hydroxychloroquine and other molecules from the IHU.
The document insists on the effectiveness of this treatment, while the National Medicines Safety Agency (ANSM) recalled in April that “the data published to date do not support a clinical benefit of hydroxychloroquine, whether or not associated with azithromycin, in the treatment of Covid-19, regardless of its context of use”.
2Doctors denounce a “wild” therapeutic trial
In a column published by The worldSunday, May 28, a dozen medical companies blame two things for this trial, which in their eyes represents a “huge health scandal”. First, they criticize the hydroxychloroquine treatment received by these thousands of patients for almost two years. “The systematic prescription to patients with Covid-19, whatever their age and symptoms, of drugs as varied as hydroxychloroquine, zinc, ivermectin or azithromycin, on pre-printed prescriptions, has first carried out without solid pharmacological bases, and in the absence of any proof of effectiveness”can we read in this forum.
In addition, the doctors believe that Didier Raoult and his team have “break the rules” by not asking for permission from theNational Medicines Safety Agency, yet mandatory to carry out a clinical trial. It is “probably the largest ‘wild’ therapeutic trial known to date”, denounce the scientists. They are therefore asking for sanctions from the authorities.
3Didier Raoult castigates a “stand of imbeciles”
Pointed out, Didier Raoult is quick to react to this forum. On franceinfo, the professor emeritus evokes a “stand of fools” and persists in saying that its protocol works against Covid-19 and that international studies have been “rigged”. He assures that his studies are “retrospective work” conducted after patients have been treated. “It’s just an observational study, (…) there has never been a therapeutic trial”he adds on BFMTV.
4The ANSM points to ethical breaches
The drug policeman returns on Tuesday May 30 to the process used by Didier Raoult for his study. For the ANSM, “in view of initial analyzes”the hydroxychloroquine study “could be qualified as RIPH”research involving the human person “category 1”. So she would have “had to have a favorable opinion from a committee for the protection of persons and authorization from the ANSM”. “The ANSM is continuing its analyzes and will, if necessary, take legal action again if the latter reveal breaches of the regulation of clinical trials”specifies the health agency to AFP.
5 The Minister of Health threatens sanctions
The day after the details of the ANSM, François Braun evokes potential sanctions against the signatories of this publication. “We will be required to take, with Sylvie Retailleau (the Minister of Higher Education and Research), all the necessary measures towards all the signatories”warns the Senate the Minister of Health, who speaks of a “an inadmissible new episode of this affair”. The same day, a search is carried out at the IHU, as part of an investigation by the Marseille public prosecutor’s office on suspicion of unauthorized clinical trials, but which does not concern at this stage the treatment of Covid-19.
6The management of the AP-HM requests the withdrawal of the study
The study by Didier Raoult and his colleagues is in trouble: Friday, June 2, the director of the Public Assistance-Hospitals of Marseille (AP-HM) asks the authors still working in his institution to withdraw this publication . “I think that the reputation of the Marseille IHU is seriously enough in question today for this paper to be withdrawn”explains François Crémieux, the director of Marseille hospitals.
In the aftermath, Professor Jean-Christophe Lagier, co-author and head of the infectious diseases department, “announces its withdrawal”as the AP-HM writes on Twitter.
7ANSM announces that it will take legal action
Based on its observations made a few days earlier, the ANSM announced on Saturday June 3 that it “prepares to take legal action” regarding the publication of this study. “This study should have received a favorable opinion from a committee for the protection of persons and authorization from the ANSM to be implemented”adds the agency to franceinfo.