Lhe French health authorities on Wednesday denounced years of “serious shortcomings” in the context of clinical trials at the Marseille institute led by Didier Raoult, the IHU, announcing to take legal action again and demand a restoration of order of the organization. “The ethical rules have not been systematically respected, not ensuring the protection of people at a sufficient level”, summarizes in a press release the National Agency for the Safety of Medicines (ANSM) after a investigation carried out at the end of 2021 at the IHU in Marseille after revelations from The Express and Mediapart.
This illegal research was, for many, undertaken before the Covid-19 pandemic, during which Didier Raoult acquired significant celebrity by multiplying widely discredited positions, in particular on the supposed effectiveness of treatments such as hydroxychloroquine. The incriminated trials therefore concern other pathologies. According to the ANSM, they were hired 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 from children with gastroenteritis. For dozens of them, parental consent is missing. Consequently, the ANSM announces two types of action. One, carried out by his own care, consists in having the trials started irregularly interrupted and in imposing “corrective and preventive actions” to put the research at the IHU back in good order.
Serious side effects in a high proportion of patients
However, these measures will not be immediate since the ANSM must go through a contradictory procedure with the IHU as well as the hospitals of Marseille (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 last fall when the Mediapart survey was published. She now accuses the IHU not only of having carried out unauthorized trials but also of having sent her a false document in order to justify the launch of one of the incriminated researches.
However, the ANSM refrains for the time being from initiating procedures on the most spectacular aspect of this file: the experimentation by the IHU of treatments supposed to fight against tuberculosis, carried out for several years. 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. However, the authorities intend to dig into the subject and do not rule out, in the long term, also taking legal action in this regard.
