Didier Raoult again in the sights of the health authorities. The National Medicines Safety Agency (ANSM) denounced this Wednesday, April 27, “serious shortcomings” linked to clinical trials carried out at the IHU in Marseille under the direction of the professor, announcing a reorganization of the service and a new referral to justice.
After announcing last Wednesday during a press conference a series of criminal complaints to defend his “honor”, Didier Raoult was implicated by the ANSM on Wednesday for his management of the university hospital institute.
“The ethical rules have not been systematically respected, not ensuring the protection of people at a sufficient level”, explained the ANSM in a press release this Wednesday, after an investigation carried out at the end of 2021 within the IHU of Marseille (Bouches-du-Rhône).
The ANSM has incriminated trials carried out in the IHU without having first obtained the mandatory opinion of an independent committee, or sometimes the consent of all the patients examined. She notably cited the case of rectal samples taken in the early 2010s from children with gastroenteritis, whose parental consent had not been obtained for dozens of them.
An organizational and judicial response
The first action proposed by the ANSM was to have the trials started irregularly interrupted and to impose “corrective and preventive actions” to put the research at the IHU back in good order. Before its implementation, a contradictory procedure with the IHU and the hospitals of Marseille (AP-HM), also implicated in the case, will have to be established by the ANSM.
The ANSM’s second response was to take legal action, as it had already done last fall. Beyond the tests carried out without authorization, the ANSM criticized the IHU for having provided it with a false document to justify the launch of one of the offending researches.
No procedure on the tuberculosis file
Criticized for a few years, the file on the experimentation by the IHU of treatments supposed to fight against tuberculosis, which would have caused serious side effects, was not included in the procedures initiated.
The ANSM considered that this experiment did not represent a clinical trial as such and therefore did not consider it appropriate to intervene on this subject.
Didier Raoult defends himself
In a press release published on Wednesday, the Marseille professor questioned two accusations made by the ANSM. The first study pointed out had been “authorized in 2009 by the management of the AP-HM in the service of Pr. Jouve”, according to Didier Raoult. The latter also detailed a point underlined by the ANSM on “a study concerning self-sampling swabs” by giving concrete elements.
Press release.https://t.co/n980PrtcSc pic.twitter.com/ZlbvaV29aR
— Didier Raoult (@raoult_didier) April 27, 2022
The director of the Marseille IHU also welcomed the decision of the ANSM not to pursue the procedures concerning the case of tuberculosis, widely publicized after the internal investigation of the AP-HM and Médiapart few months ago. Didier Raoult finally concluded his writing by indicating that “these reproaches do not seem to us to justify a questioning of the IHU project as a whole”.
As a reminder, Didier Raoult has announced that he will leave his post as director of the Marseille IHU next September.