What has happened at the IHU Méditerranée Infection, directed by Didier Raoult, in recent years?
While the French microbiologist, who acquired media fame with the Covid-19 pandemic, has long been discredited by his peers, the National Medicines Safety Agency (ANSM) on Wednesday delivered an unprecedented charge against the practices that he has supervised for years.
The finding is damning: within the IHU, "the rules of ethics have not been systematically respected, not making it possible to ensure the protection of people at a sufficient level and as required by the regulations", writes the ANSM.
What exactly does the report say?
What are these consequences for Didier Raoult and his team?
We take stock.
Why was a report conducted?
In October 2021, Mediapart revealed the existence of a "wild experiment" on tuberculosis within the IHU.
Since at least 2017 and until March 2021, the institute prescribed a treatment based on four drugs, while the ANSM had opposed it, this assembly could prove to be toxic rather than effective, judged the agency .
A few weeks earlier, L'Express had indicated that at least four other procedures had been carried out out of the ordinary in recent years at the IHU.
Its director Didier Raoult then brushed off the accusations, speaking of "a storm in a glass of water".
Internal reports have also reached the ANSM as part of its “whistleblower system”.
In the wake of these accusations, the ANSM seized the public prosecutor of Marseille and launched an inspection at the end of the year to verify the conditions under which certain clinical trials are carried out at the IHU.
These are the conclusions of this investigation which were made public on Wednesday.
In what conditions ?
The ANSM investigation was carried out at the end of November 2021 under what seem to be difficult conditions.
The drug agency reports in particular on the “climate of hostility and mistrust in which the inspection opening meeting was held on November 18, 2021 on the premises of the IHU”, as well as “the verbal aggression likely to undermine the respect due to the function of the inspectors that occurred during the visit to the premises of the IHU”.
What does the report say?
The ANSM investigation identified 15 deviations, eight of which are deemed "totally unacceptable" and liable to administrative sanctions or criminal prosecution.
The inspectors claim that on many occasions trials have been undertaken without obtaining the mandatory opinion of an independent committee, nor, 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 report also mentions a falsified document that the IHU gave to the ANSM.
The text, dated August 7, 2019, told the drug agency that the institute's ethics committee had given a "favorable opinion" to a trial.
However, during their investigation, the ANSM inspectors discovered that the original document did not bear this mention.
On the contrary, the ethics committee asked the IHU to submit this trial to a committee for the protection of persons, whose consultation is mandatory in this case.
What are the lawsuits?
As a result, the ANSM announced two types of actions.
One, of an administrative nature and carried out by its own care, consists in requesting the interruption of trials started irregularly and imposing “corrective and preventive actions” to put the research at the IHU in good order.
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.
On the criminal side, the ANSM has announced that it will take legal action again – it had already done so in the fall when the Mediapart investigation was published.
As at the time, she accuses the IHU of having conducted irregular trials.
This "lack of knowledge or consideration of regulatory obligations", specify the inspectors, represents a transgression of the Public Health Code, punishable by one year's imprisonment and a fine of 15,000 euros.
The ANSM adds another charge: having communicated to it a false document to justify the launch of one of the incriminated researches.
The Marseille prosecutor's office told AFP that it had "taken note of the communication" from the ANSM and "will decide on the criminal action to be taken after analysis of the elements brought to light within the framework of the administrative investigation". .
In addition, the ANSM is refraining, for the time being, from initiating proceedings on the most spectacular aspect of the case: the experimentation by the IHU of treatments supposed to fight against tuberculosis.
In a high proportion of patients, these practices have caused serious side effects.
But the ANSM considers that they do not as such constitute a clinical trial and therefore does not consider itself in a position to intervene directly on the subject.
However, the authority intends to continue its investigation and does not rule out, in the long term, also taking legal action in this regard.
What do Raoult and his team answer?
Didier Raoult, who is also already pushed out by his supervisory authority AP-HM and blamed by the Order of Physicians, believes that the reproaches of the drug agency "do not seem to justify a questioning of the IHU project as a whole".
He focuses his answer on experimenting with treatments that are supposed to fight against tuberculosis.
“We are satisfied that the ANSM notes that there has never been the slightest therapeutic trial on tuberculosis carried out within the IHU Méditerranée Infection, contrary to the allegations contained in the internal investigation of the AP-HM and in Mediapart articles,” he wrote.
His lawyer Brice Grazzini denounces him as "relentless".
“We are told about the IHU, it is not just Professor Didier Raoult at the IHU,” he told France Bleu Provence.
To the accusations of lack of consent, Me Grazzini insists on the conditional - "he would miss" - and underlines that "only justice can say whether or not there has been a breach".
In a press release, the AP-HM affirmed that it was implementing "all the recommendations with immediate effect", including the suspension of research carried out without the opinion of a committee, and being "at the disposal of the ANSM and justice for all subsequent investigations”.
