What risks Didier Raoult, pinned by doctors for a "wild" therapeutic trial?

His opponents want to see him condemned, by the courts and by his peers. On Sunday, in a forum published in Le Monde, several medical authorities denounced the organization by the controversial Professor Didier Raoult of a "wild" therapeutic trial, on patients with Covid-19 at the IHU of Marseille, between 2020 and 2021. Reproaches, if proven, punishable by one or even three years in prison, as well as a ban on practising, in case of aggravated breaches.

The concerns of the medical bodies that signed the forum come from a "preprint" (an unreviewed study) published last March, and signed by the teams of Professor Didier Raoult. The document states, in its conclusions, that hydroxychloroquine would "partially" reduce the risk of mortality related to Covid-19, a claim already disputed several times by health authorities.

"We pave the way for a return to nineteenth-century medicine"

In this study, 30,000 Covid patients were administered "drugs as varied as hydroxychloroquine, zinc, ivermectin or azithromycin (...) without solid pharmacological bases, and in the absence of any evidence of efficacy, "denounces the tribune, launched at the initiative of Professor Mathieu Molimard, head of the pharmacology department at the University Hospital of Bordeaux.

Read alsoHydroxychloroquine, effectiveness of vaccines against Covid... Has Didier Raoult really changed his mind?

These prescriptions were continued "for more than a year after the formal demonstration of their ineffectiveness". For the health professionals who signed the text, this study is proof that a "wild" therapeutic trial has been conducted within the IHU.

As a result, "we demand action, at the criminal level, ordinal, on the side of the High Authority of Health, the National Ethics Committee. Otherwise, we open the way to a return to nineteenth-century medicine, where a doctor could administer, according to his intuition, any drug to his patients, "says Mathieu Molimard to Le Monde.

Up to three years in prison

Conducting wild therapeutic trials is clearly condemned by law. The fact of carrying out or having carried out "research involving the human person" without the authorization of a committee for the protection of persons or a competent authority, without assessment of the benefits-risks, without basis on the latest state of scientific knowledge is punishable by "one year of imprisonment and a fine of 15,000 euros", specifies the Public Health Code.

This sentence can be increased to three years in prison and a fine of 45,000 euros, and is accompanied by a ban on civil, civil and family rights, as well as a ban on practicing for five years, if the leaders of the study have not obtained the free and informed consent of patients. Had the IHU obtained the necessary authorizations and patient consent for this hydroxychloroquine study? Asked about this by Le Monde, Professor Didier Raoult did not wish to answer.

In addition to justice, physicians who coordinated a wild study may be subject to disciplinary measures by the College of Physicians. "In case of conviction, the sanction can be a warning, a reprimand, a ban on practice with or without suspension of medicine for up to three years. The strongest sanction being the removal from the Roll of the Order, "says the Order of Physicians in an explanatory sheet.

Serial suspicions at the IHU

In December 2021, Didier Raoult had already received a reprimand for having communicated "information that was not based on any confirmed data", by promoting hydroxychloroquine as a treatment against Covid-19.

This is not the first time that the IHU, directed by Professor Didier Raoult from 2011 to 2022, has been singled out for trials suspected of being irregular. A judicial investigation is already opened after a scathing report from the ANSM, for "forgery in writing", "use of forgery in writing" and "interventional research involving a human person not justified by his usual care".

Another inspection report had also pointed out the medical, scientific and managerial excesses of the IHU under the leadership of Didier Raoult. The government had also announced to take legal action on this subject on September 5. On this aspect, the Marseille prosecutor's office is still in the analysis phase.

For his part, Didier Raoult, replaced at the end of August at the head of the IHU by Pierre-Édouard Fournier, denies the accusations against him. Within the institute, all clinical trials involving humans have been suspended since the change of management. The institute said it was waiting for a future return from the ANSM on this subject.