The Medicines Agency (ANSM) told AFP on Tuesday, July 20 to conduct
“investigations”
concerning possible
“breaches of the regulation of clinical trials”
during studies on Covid-19 conducted at the IHU in Marseille, led by Didier Raoult, confirming information from
L'Express
.
To read also: Pr Didier Raoult: "I do not regret anything"
"The ANSM was recently alerted, as part of its system for whistleblowers, on possible breaches of the IHU of Marseille in the regulation of clinical trials on certain studies that the Institute has conducted"
, the drug gendarme explained to AFP. The health authority
"is currently carrying out the necessary investigations and verifications"
and
"if the investigations reveal any breaches of the regulation of clinical trials"
it
"will take health measures to guarantee the safety of the participants and, if necessary, will take action. new justice ”
, she assured.
In France, all studies meeting the definition of research involving human beings, in particular clinical trials of medicinal products, must obtain prior authorization from the personal protection committee, or even from the ANSM itself.
At the start of the Covid-19 pandemic, several scientists familiar with medical articles were alarmed at the conditions for carrying out two studies signed by Prof. Raoult, director of the Institut hospitalo-universitaire (IHU) Méditerranée Infection, on the efficacy of hydroxychloroquine to treat Covid-19.
The first, published on March 20, 2020, had been authorized by the ANSM, but it included two minors and also tested another drug, azithromycin, which was not provided for in the authorized protocol.
Read also: Covid-19: hydroxychloroquine does not reduce mortality, admits Didier Raoult
The second, published on April 11, 2020, was presented by the IHU as an observational study that does not need the same authorizations although it was indeed, according to many specialists, an interventional study since it concerned the administration of a drug in another strength and for an indication other than in current medical practice - hydroxychloroquine being marketed in France for the treatment of autoimmune diseases such as lupus and rheumatoid arthritis.
A report of these facts by
"a health professional"
was closed in November 2020 by the Marseille prosecutor who considered the offenses denounced as
"insufficiently characterized"
, according to its press release.
However, new elements have since emerged, such as a fix to the first study, published in January in the International Journal of Antimicrobial Agents.
But to relaunch the investigation, it would be necessary either for the prosecution to seize it ex officio or for the ANSM to make a new report, specifies the weekly, which emphasizes that the IHU
"did not follow up"
to its questions. .
Read also: Is hydroxychloroquine widely used around the world, as Didier Raoult asserts?
"These breaches" of
the rules governing medical research appear to be common practice within the IHU, says
L'Express,
which cites numerous studies by students or researchers from the institute in recent years which have, according to him, been , freed from the rules governing experiments involving human beings, even before the Covid epidemic.
