Europe 1 with AFP / Photo credits: Nicolas TUCAT / AFP 18:37 pm, May 30, 2023

"There has never been a therapeutic trial," defended Tuesday Professor Didier Raoult, former boss of the IHU of Marseille, following a forum of doctors accusing him of having conducted "the largest 'wild' therapeutic trial known" on hydroxychloroquine.

"The largest known 'wild' therapeutic trial" or a simple "observational study"? After the publication of an inflammatory forum against a study on hydroxychloroquine, the former boss of the IHU of Marseille Didier Raoult counter-attacks and the government ensures compliance with the law. 16 learned societies denounced Sunday in Le Monde a study co-signed by the Marseille infectiologist, involving more than 30,000 patients treated at the IHU (University Hospital Institute) Méditerranée Infection for two years.

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This study shows efficacy of hydroxychloroquine to Covid patients

This study – not yet published in a scientific journal or peer-reviewed, but simply posted online in April – concludes that administering hydroxychloroquine to Covid patients reduced their mortality. According to the doctors who signed the tribune of Le Monde, including Professor Mathieu Molimard of the French Society of Pharmacology, this prescription was made "in the absence of any evidence of efficacy" and, more seriously, continued "for more than a year after the formal demonstration of (its) ineffectiveness".

"There has never been a therapeutic trial", "it is just an observational study", claimed Didier Raoult Tuesday on BFMTV, two days after denouncing "a tribune of fools". Asked about the administration of this protocol to Covid patients for several months after unfavorable opinions from the health authorities on the use of hydroxychloroquine, Didier Raoult replied: "I had every right, myself, but also others, to prescribe hydroxychloroquine", a drug used in the treatment of malaria in particular.

Patient Safety

The infectiologist discredited by his peers since the Covid-19 health crisis even says that "thousands of people who could have been treated have not been treated" because of the choices on hydroxychloroquine. The doctors who signed the tribune call on the authorities to take "measures adapted to the mistakes committed", in the name of "patient safety" and the "credibility of French medical research". For the National Agency for the Safety of Medicines, "in view of initial analyses", the study on hydroxychloroquine "could be qualified as a category 1 RIPH (editor's note: research involving humans) and should therefore "have benefited from a favorable opinion of a committee for the protection of persons and an authorization from the ANSM".

"The ANSM continues its analyzes and will, if necessary, again seize the justice if they highlight breaches of the regulation of clinical trials," says the health agency to AFP. After a scathing report and largely confirming revelations by L'Express and Mediapart, the Medicines Agency had already taken legal action in spring 2022. And, in September, after another damning report (IGESR/Igas) on the medical, scientific and managerial excesses of the IHU in the Raoult era, François Braun (Health) and Sylvie Retailleau (Research) had also announced prosecutions and the summoning of the leaders.

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Rehear the leadership

Questioned by AFP, the office of the Minister of Health recalled this referral to the Marseille prosecutor's office "on the unacceptable practices of the IHU". Since the convening of the founders of the IHU in October, "inappropriate and dangerous prescriptions have ceased", it was stressed. But given "the seriousness of these new elements, the two ministries will have to hear again the founding institutions and the management of the IHU-MI quickly". The Marseille prosecutor's office opened a judicial investigation in July 2022, after the referral to the ANSM. At this stage, there has been no indictment, the prosecutor's office told AFP at the end of May.

At the end of the Council of Ministers, the spokesman of the government, Olivier Véran, former Minister of Health, replied on the continuation of the soap opera Raoult: "a certainty is that hydroxychloroquine has never worked against the coronavirus". Retired since the summer of 2021 from his position as university professor-hospital practitioner, Didier Raoult was replaced a year later at the head of the IHU by Pierre-Edouard Fournier. Now professor emeritus, he comes to the IHU "from time to time", according to a spokesman for the institution. Within the IHU, all clinical trials involving humans have been suspended since September.