The health authorities formalized on Monday June 13 a series of measures targeting the IHU led by Didier Raoult, a few weeks after denouncing the practices in force within the Marseille establishment in terms of clinical trials.
"
A corrective and preventive action plan must be put in place
," said the National Medicines Safety Agency (ANSM) in a letter sent to the IHU on June 7 and made public on Monday.
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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, which had delivered an unprecedented charge against the IHU led by Didier Raoult.
The agency had also seized criminal justice.
The latter, still at the head of the IHU for a few months, has acquired an important media celebrity for two years by taking positions, today discredited, on the Covid-19, in particular the supposed effectiveness of treatments like the 'hydroxychloroquine.
Facts from before the Covid
However, the ANSM's indictment did not concern the Covid 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.
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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 must 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.
Contacted by AFP, the AP-HM indicated that it "
as of the end of April and the publication of the report (...) implemented all the recommendations with immediate effect
".
It mentions in particular “
the suspension of all research carried out without requesting an opinion from a committee for the protection of the necessary persons
” and “
the bringing into compliance with the regulations of research involving the human person
”.
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.