August 4, 2021

ANSM announces “investigations” on possible “regulatory breaches”

The Medicines Agency (ANSM) announced Tuesday, July 21, to conduct « investigations » concerning possible “Breaches of the regulation of clinical trials” during studies on Covid-19 conducted at the Institut hospitalo-universitaire (IHU) in Marseille, directed by Didier Raoult, confirming information from L’Express.

“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”, said the drug gendarme. The health authority “Is currently carrying out the necessary investigations and verifications”. “If the investigations reveal breaches of the regulation of clinical trials”, the ANSM assured that it “Will take sanitary measures to guarantee the safety of the participants and, if necessary, will take legal action again”.

Reportage : At the heart of the IHU, the fortress of Didier Raoult

Two studies criticized

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 committees, or even from the ANSM itself.

At the start of the Covid-19 pandemic, several scientists familiar with medical articles were alarmed about the conditions for carrying out two studies signed by Professor Raoult, director of the IHU Méditerranée Infection, on the effectiveness 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.

The second, dated April 11, 2020, was presented by the IHU as an observational study that does not need the same authorizations. However, according to many specialists, this was indeed an interventional study since it concerned the administration of a drug in a different strength and for a different indication than in current medical practice. Hydroxychloroquine is well marketed in France, but only for the treatment of autoimmune diseases such as lupus and rheumatoid arthritis.

Practices prior to the Covid-19 pandemic

A report of these facts by “A health professional” had been closed in November 2020 by the Marseille prosecutor’s office, which considered the offenses denounced as “Insufficiently characterized”, according to its press release. Since then, new elements have appeared, including a fix to the first study, published in January in the journal International Journal of Antimicrobial Agents.

However, to relaunch the investigation, it would be necessary for the prosecution to seize it ex officio, or for the ANSM to make a new report, specifies L’Express. The daily stresses that the IHU “Did not follow up” to his questions.

“These shortcomings” to the rules governing medical research “Appear as a common practice within the IHU”, affirms L’Express. The author cites numerous studies by the institute in recent years which, according to him, have broken free from the rules governing experiments involving human beings, even before the Covid-19 epidemic.

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The World with AFP