2023-06-02 20:39:13
It is by a single tweet that the Marseille University Hospitals (AP-HM) announced on Friday June 2 that the controversial study of more than 30,000 patients with Covid-19, carried out by the teams of Professor Didier Raoult, was going to be withdrawn “at the request of several signatories”.
This manuscript, not peer-reviewed and not published by a scientific journal, was put online on April 4 (it is always available Friday evening) and widely disseminated on social networks by the former director of the University Hospital Institute (IHU) Méditerranée Infection, now retired, and several other researchers from the Marseille IHU. For its authors, including the brand new head of the infectious diseases division Jean-Christophe Lagier, the study made it possible to conclude on the effectiveness, in terms of reducing mortality, of the treatment combining hydroxychloroquine (HCQ) and azithromycin (AZ ), the famous “Raoult protocol”.
In a column published in The world on May 28, many medical organizations and learned societies denounced the conclusions but also the conditions under which this study was carried out, calling it “possibly the largest known ‘wild’ therapeutic trial”. For these doctors and scientists, the data collected by the IHU was in contradiction with the Jardé law, which in France regulates research involving the human person. “We ask that all the competent institutions (supervisory establishments, administrative and judicial authorities, High Authority for Health, National Consultative Ethics Committee, National Council of the Order of Physicians, etc.) become aware of the issues and assume their responsibilities. »they wrote in their forum.
After their appeal, the National Agency for the Safety of Medicines and Health Products (ANSM) raised other criticisms, considering “that the study should have received a favorable opinion from a committee for the protection of persons and authorization from the ANSM to be implemented”. The agency, within which a first report led to the opening of a judicial investigation in July 2022 into possible ethical breaches at the IHU, announced that it could go to court again if further analyzes revealed “breaches of the regulation of clinical trials”.
Contacted by The worldthe Ministry of Health also mentions “a new breach of ethical and deontological rules” and the upcoming summons of IHU officials by the minister, François Braun. The subject was even invited to the Senate, where, questioned by Bernard Jomier (PS) on Wednesday May 31, the minister qualified the study as « provocation ».
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