The Marseille IHU accused of “serious breaches” by the ANSM, which takes legal action

The Mediterranean University Hospital Institute (IHU) in Marseille, whose director is Professor Didier Raoult, is once again in the sights of the health authorities. The National Agency for the Safety of Medicines and Health Products (ANSM) takes legal action after noting “serious breaches and non-compliance with the regulations for research involving humans (RIPH)“within the institution.

An inspection at the end of 2021

For the ANSM, which carried out an inspection at the end of 2021 on clinical trials dating from before the pandemic at the IHU, “the ethical rules were not systematically respected” and “not allowing to ensure the protection of people at a sufficient level”.

Indeed, according to the health authority, trials were carried out without obtaining patient consent or the opinion of an independent protection committee. The ANSM cites for example the case of rectal samples taken from children affected by gastroenteritis, in the early 2010s and for which many consents are missing. “A research authorized in 2009 by the management of the AP-HM in the service of Pr. Jouve, current president of the CME, even before the IHU Méditerranée Infection existed “ as Professor Raoult explains in a press release.

Another point underlined by the ANSM: the “falsification of an internal ethics committee document”bearing the mention “favourable opinion” for the launch of a study.

Two “reprehensible” facts according to the ANSM

The ANSM qualifies these facts as being “criminally reprehensible” and announces that it is initiating a contradictory procedure with the IHU as well as the hospitals of Marseille (AP-HM) to stop the trials concerned. For her, “failure to comply with the regulations on your part has led to repeated and repeated bad practices for several years” and “lead to questioning, even calling into question the capacity of [la] structure to carry out RIPH in compliance with the applicable legislation”.

No penalties for TB trials

Regarding the trials on treatments against tuberculosis, which have created side effects in some patients, the ANSM is refraining for the time being from initiating procedures.

But its investigations are continuing, in conjunction with the General Inspectorate of Social Affairs (IGAS). “Indeed, if we have not, at this stage of our investigations, identified elements proving the implementation of an unauthorized clinical trial on the treatment of multi-resistant tuberculosis of patients treated during the year 2019, we nevertheless highlighted the use of combinations of antibiotics different from international recommendations and potentially dangerous for patients. The frequency of serious adverse events over the 2019 period appears high” indicates the instance.

However, Professor Didier Raoult expresses his satisfaction to see that “the ANSM notes that there has never been the slightest therapeutic trial on tuberculosis carried out within the IHU Méditerranée Infection, contrary to the allegations contained in the internal investigation of the AP-HM and in the articles of Mediapart “.