The health authorities formalized, Monday, June 13, a series of measures targeting the IHU of Marseille (Bouches-du-Rhône) directed by Didier Raoult. “A corrective and preventive action plan must be put in place”said the National Medicines Safety Agency (ANSM) in a letter sent on June 7 to the IHU and made public on Monday.
These measures, the content of which the ANSM had already widely announced, are taken in the wake of a report published at the end of April by the agency. She had delivered an unprecedented charge against the establishment. The agency had also seized criminal justice.
Didier Raoult, still at the head of the IHU for a few months, acquired significant media celebrity by holding positions, now discredited, on the Covid-19. In particular, he defended the supposed effectiveness of treatments such as hydroxychloroquine. However, the ANSM’s indictment did not concern Covid-19 and went back much earlier. The authority accuses the IHU of having freed itself for years from multiple rules to conduct research on patients. On many occasions, trials have thus been undertaken without obtaining the mandatory opinion of an independent committee or, sometimes, the consent of all the patients examined.
The ANSM will therefore suspend one of these trials, which was still in progress and involved taking samples from themselves from medical students of different nationalities. This is one of the measures confirmed on Monday.
At the same time, the agency requires that the IHU send it a full review of the research currently in progress, as well as that which has been the subject of publications over the past five years. Finally, it asks that the IHU provide training for its teams in the regulation of clinical trials, specifying that these courses should be given by personalities independent of the institution.
The authorities also sent an injunction to the supervisory authority of the IHU, the Marseille hospitals (AP-HM), asking it to guarantee the implementation of such a training program. The health authorities also recall that they are continuing their investigation into the practices in progress at the IHU. These include the administration of unrecognized treatments for tuberculosis. In its April report, the ANSM had refrained from concluding on the subject, not being able to establish that these are clinical trials in good and due form, but had warned that it would continue its investigations.