In a communicated released this Wednesday, the National Medicines Safety Agency (ANSM) denounces years of “serious shortcomings”, in the context of clinical trials at the Marseille institute led by Didier Raoult, the IHU, announcing to seize justice and demand a reorganization of the body.
“The ethical rules have not been systematically respected, not ensuring the protection of people at a sufficient level”, summarizes the ANSM, after an investigation carried out at the end of 2021 at the IHU in Marseille. after revelations from the express and Mediapart.
In this press release, the ANSM indicates “seize again the public prosecutor” for “the implementation of research in the absence of a prior favorable opinion from a committee for the protection of persons within the IHU and the AP-HM” on the one hand, and “the communication to the ANSM by the IHU prior to the inspection of a falsified document concerning an opinion of the internal ethics committee of the IHU”. Two “criminally reprehensible” facts, according to the ANSM.