The National Medicines Safety Agency (ANSM) has decided. The Marseille IHU (IHUm) and its ex-director Didier Raoult conducted a wild clinical trial. The agency thus confirms the position taken by 16 French learned societies in a column published on Sunday 28 but in The world. These institutions criticized the IHUm teams for the systematic prescription, to patients with Covid-19, of drugs such as hydroxychloroquine, zinc, ivermectin or azitrhomycin, without a pharmacological basis and in the absence of any evidence. of efficiency.
A practice that was similar to the largest wild clinical trial in history, they denounced, since these prescriptions were also used for the publication, last March, of a preprint – a study published on the Internet but not re-read or verified. by peers – involving more than 30,000 Covid-19 patients. “We believe that these systematic prescriptions have been carried out outside any marketing authorization, but also outside any ethical or legal framework”, indicated the signatories, calling on the authorities to take strong decisions.
“The ANSM has taken note of the preprint”Early Treatment with Hydroxychloroquine and Azithromycin: A ‘Real-Life’ Monocentric Retrospective Cohort Study of 30,423 COVID-19 Patients (M. Million, D. Raoult et al). After analysis, we confirm that this study can be qualified as Research on the human person (RIPH) of category 1, indicates the agency to L’Express. It should therefore have received a favorable opinion from a committee for the protection of persons (CPP) and authorization from the ANSM to be implemented. The ANSM is preparing to take legal action again.”
In France, the performance of clinical trials is strictly regulated by the Jardé law of 2012. The latter classifies these trials into three categories. The first concerns the most sensitive trials which must be authorized by a CPP and the ANSM. However, the IHU conducted this trial without any authorization. Beyond the fact that this test was carried out without legal authorization, it also contravenes the scientific foundations, since these prescriptions were continued “for more than a year after the formal demonstration of their ineffectiveness”, write the learned societies.
The authorities must therefore take “measures adapted to the faults committed”, in the name of “patient safety” and the “credibility of French medical research”, they concluded. The call was therefore received five out of five by the ANSM.
If the reaction of the drug agency is already welcomed by the experts, the latter nevertheless regret that it did not intervene earlier, before so many patients had received these prescriptions “without benefit, and even at risk”, indicates in particular the coordinator of the forum, Mathieu Molimard, specialist in pharmacology.