Health authorities finally tackle Didier Raoult's IHU

The Marseille IHU was the setting for "serious breaches and non-compliance with the regulations for research involving the human person", summarized in a press release the National Medicines Safety Agency (ANSM), which publishes the conclusions. of a survey conducted at the end of 2021.

Didier Raoult, who still heads the IHU for a few months, has acquired significant media celebrity for two years by taking positions, now discredited, on Covid-19, in particular the supposed effectiveness of treatments like hydroxychloroquine.

This is the first time that the health authorities have also explicitly attacked Professor Raoult.

He has already been pushed out by his supervisory authority, the Marseille hospitals, and blamed by the Order of Physicians.

The ANSM's indictment, which largely confirms revelations from L'Express and Mediapart, does not concern the Covid and goes back much earlier.

The authority accuses the IHU of having freed itself for years from multiple rules to conduct research on patients.

"The ethical rules have not been systematically respected, not ensuring the protection of people at a sufficient level", indicates the ANSM in its press release which accompanies a more detailed report.

Justice seized

On many occasions, trials have thus been undertaken without obtaining the mandatory opinion of an independent committee or, sometimes, the consent of all the patients examined.

This is for example the case of rectal samples taken in the early 2010s on children with gastroenteritis.

For dozens of them, parental consent is absent.

The IHU Mediterranean Infection Institute in Marseille, February 26, 2020 GERARD JULIEN AFP / Archives

Consequently, the ANSM announces two types of action.

One, carried out by his own care, consists in requesting the interruption of the trials started irregularly and imposing "corrective and preventive actions" to put the research at the IHU in good order.

However, these measures will not be immediate, since the ANSM must go through a contradictory procedure with the IHU as well as the AP-HM, whose responsibility is also questioned.

At the same time, the ANSM announces that it is taking legal action, which it had already done in the fall when the Mediapart survey was published.

As at the time, she accuses the IHU of having conducted irregular trials, but she now adds another charge: having communicated to her a false document to justify the launch of one of the incriminated researches.

On the other hand, the health authorities are waiting to learn more about the most spectacular part of the accusations brought against the IHU: for years, its teams have been experimenting with treatments supposed to fight against tuberculosis despite their lack of effectiveness.

The investigation continues

While the other breaches are essentially ethical, these practices have had dramatic consequences.

In many tuberculosis patients, serious side effects have been recorded, in one case going so far as to require surgery.

But the ANSM considers that they did not constitute a clinical trial as such and does not consider itself in a position to intervene directly on the subject because it exceeds its field of competence as a regulatory authority.

However, Mr. Raoult's line of defense focuses on this aspect.

The researcher denies any research on tuberculosis in his institute and, during a press conference last week, promised to sue Mediapart for having mentioned "wild trials".

"There have been no illegal therapeutic trials," he said.

However, even assuming the absence of research strictly speaking, the ANSM report is far from clearing the IHU, attacking a choice of treatments which "does not appear justified".

The authority therefore intends to continue its investigation and does not rule out, in the long term, also taking legal action in this regard.

“We are not justice, we took health decisions where we could take them”, explained a source within the ANSM.

And to recall that another investigation is being carried out by the General Inspectorate of Social Affairs (IGAS), this time on the way in which the IHU is managed.

© 2022 AFP