The National Medicines Safety Agency criticizes the institute in particular for not having respected the procedures supposed to protect the patients included in the trials.
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The report is not linked to Covid-19 or hydroxychloroquine, but it damages the image of Didier Raoult and the IHU Méditerranée. L’National Medicines Safety Agency (ANSM) says it has found of “serious shortcomings” in the context of clinical trials carried out in this Marseille institute, in a press release published on Wednesday April 27. She announces to seize justice.
The ANSM inspection, launched at the end of 2021 after revelations from The Express and Mediapart, relates to trials launched before the pandemic. “The ethical rules were not systematically respected, making it impossible to ensure the protection of people at a sufficient level”summarizes the ANSM.
According to the ANSM, the trials were 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 missing.
The agency, which had already taken legal action in 2021 after the Mediapart revelations, announces a new referral. She accuses the IHU of having sent her a false document in order to justify the launch of one of the incriminated researches.
In addition, it is initiating a contradictory procedure with the IHU as well as the Marseille hospitals (AP-HM) to stop the trials concerned and restore order to the institute’s research.
However, the ANSM is refraining for the time being from initiating proceedings on 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 did not constitute a clinical trial as such and therefore does not consider itself in a position to intervene directly on the subject.