Mayhem for Raoult.
The National Medicines Safety Agency (ANSM) ordered an inspection and seized the Marseille prosecutor's office on the basis of article 40 of the code of criminal procedure for potentially fraudulent clinical trials carried out within the IHU Méditerranée Infection, led by microbiologist Didier Raoult, according to La Provence.
Information confirmed to the regional daily by the prosecutor of the Republic of Marseille, Dominique Laurens.
After reports made in May 2021, “on possible breaches of the IHU Méditerranée Infection in the regulation of clinical trials (…), we consider that certain studies should have been carried out in accordance with the legislation governing research involving humans.
This is not admissible, ”denounced the ANSM.
An investigation opened at the AP-HM
There was no question of “wild” trials carried out on tuberculosis patients by teams from the IHU Mediterranean, such as those revealed by Mediapart last week.
The Institute then prescribed a treatment based on four drugs to which the ANSM formally opposed for its potential toxicity.
Information confirmed by the management of the AP-HM this Wednesday evening, which opened an internal investigation last weekend, and will shortly submit its conclusions to the ANSM.
Investigation which, according to the press release, could go as far as a "request for the suspension of all research activity at the IHU as a precaution".
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"According to these elements, we could be brought to take additional measures in particular to ensure the safety of the patients treated in this context", one further explains to the ANSM which also announces to expedite an inspection within the IHU.
Lots of procedures out of the blue
A few weeks earlier, L'Express had reported that many other out of the box procedures had been carried out in recent years.
"At least four
(of them)
do not respect the law governing experiments on human beings," the weekly recounted.
Read alsoVaccination, hydroxychloroquine ... These strange studies shared by Didier Raoult
"This case is a French Senior Prevent", estimated Monday a scientist at the heart of the file with the Parisian, referring to the politico-health scandal that has agitated Brazil for several weeks.
The private hospital chain Prevent Senior is accused of having carried out, last year, an experimental study based on hydroxychloroquine on patients who had not given their consent.
Work whose results were notably shared on Twitter by a certain… Didier Raoult.
