After the Didier Raoult controversy, the Medicines Agency eases restrictions on clinical trials at the IHU in Marseille

The IHU Méditerranée Infection remains under surveillance, but in a moderate manner. The National Medicines Safety Agency (ANSM) will ease the restrictions imposed on clinical trials at the IHU in Marseille, formerly headed by Didier Raoult, without lifting them entirely given the attitude still “unsatisfactory” of the institute. “Research involving humans (RIPH) may resume, but under certain conditions”, announced the ANSM in a press release on Friday October 27. Clearly, the agency requires the IHU to transmit a quarterly report of clinical trial projects, as well as prescriptions for treatments outside of marketing authorization.

Under the direction of Professor Didier Raoult, who was dismissed last year, the IHU of Marseille (under the supervision of Assistance publique-Hôpitaux de Marseille, or AP-HM) was the setting for multiple clinical trials which did not respect the ethical rules in force, for example on patient consent. In the wake of the health crisis, the ANSM has conducted an investigation into the practices of the IHU in recent years. These investigations led it to restrict the conditions of clinical trials at the institute at the end of 2022, leading it to suspend all trials in force.

Now headed by Professor Pierre-Edouard Fournier, long close to Didier Raoult, the IHU has implemented the requested actions, according to the ANSM, which therefore lifts its “injunctions” in force. But the Agency is not entirely satisfied: it judges, in a report sent alongside its press release, that the IHU does not seem “not having fully understood the existing regulatory frameworks in terms of patient care”. In particular, the publication online in the spring of a new study on the effects of hydroxychloroquine, co-signed by Didier Raoult. The teacher insisted that she was only“observational” and therefore did not constitute a clinical trial, but this interpretation is open to question.