Didier Raoult seeks to counterattack on Tuesday May 30 after the publication of a scathing column in Le Monde by doctors. They believe that he conducted a “wild therapeutic trial” in the context of the Covid-19 pandemic. He is charged with offenses punishable by imprisonment.
[Updated May 30 at 11:30 a.m.] Didier Raoult responded on BFM TV to the publication of a column published in Le Monde on Sunday May 28. Medical organizations denounce the actions of the IHU Méditerranée Infection in Marseille following the publication of a study on a “wild” therapeutic trial on hydroxychloroquine against the 2019 coronavirus.
“There has never been a therapeutic trial” at the IHU in Marseille according to Didier Raoult. The doctor specifies that this is an “observational study”, according to him. Here he defends the method used in a pre-published study (it’s a preprint: an unreviewed study) at the end of April. Several medical organizations have denounced him for not respecting the legal regulatory and ethical framework.
During this study, conducted between 2020 and 2021, Didier Raoult was then director of the IHU and he also co-signed this work. According to his figures, 30,000 patients have been prescribed treatment with hydroxychloroquine and azithromycin. The day after the publication of this article, the ANSM (National Agency for the Safety of Medicines and Health Products) recalled “that hydroxychloroquine, azithromycin and ivermectin do not constitute treatments for Covid-19. “
“A tribune of fools! Let the health authorities come and investigate hydroxychloroquine” counterattacks the Marseille doctor on franceinfo. He risks up to “three years in prison, a ban on practicing and a fine of 15,000 euros” according to the Public Health Code if the fact of carrying out or having carried out research involving the human person without authorization is proven .
The professor assures that his protocol is operational and that the international studies “have been rigged”. The ANSM indicates that “the use of such treatment exposes patients to potential adverse effects which can be serious. Finally, no other health authority within the European Union, nor the World Health Organization , does not recommend using these treatments in these indications.”
For Mathieu Molimard, professor in charge of the pharmacology department at the Bordeaux University Hospital, quoted by franceinfo: “We are clearly not in care, we are clearly not in the direct interest of the patient. On the other hand, it there is an interest in publishing. The interest in publishing is that it brings in money.” The health professional explains that the Sigaps system (Query, management and analysis system for scientific publications) can “bring money back to their institutions” thanks to its operation.
The summary of the report points in particular to “deviant medical and scientific practices widespread within the IHU.” It is thus highlighted several medical malfunctions, several of which can be the subject of a criminal qualification according to the persons in charge of the mission. Concretely, on the medical level, the hospital is accused of:
Professor Didier Raoult, particularly publicized at the heart of the Covid-19 crisis, is the subject of a report to the public prosecutor of Marseille, launched by two ministers, that of Health, François Braun, and that of Higher Education and Research, Sylvie Retailleau. A legal action following the submission of a report, published Monday, September 5, 2022, conclusion of an eight-month mission led by the General Inspectorate for Education, Sport and Research (IGESR) and the General Inspectorate of Social Affairs (IGAS). The document “highlights serious dysfunctions of the IHU concerning the quality of its research and care activities”, announced the two ministers in a joint press release.
To all these statements, Didier Raoult responded, as required by procedure. The now ex-director of the IHU regrets “a dependent mission only attempting a very small part of the 3,000 documents that the mission asked us to send to him”, questioning the methodology and in particular the comments mentioned in the report. , from anonymized interviews.
Regarding the administration of hydroxychloroquine, Didier Raoult first claims not to have treated all patients affected by Covid-19 with this process and claims to be covered by the freedom of prescription which the Director General of health. Moreover, the Council of the Order also found no fault against him in this regard. Finally, he specifies that certain doctors, even without contraindications, did not wish to prescribe it to certain patients.
Against tuberculosis, Didier Raoult assures that the treatments proposed were for experimentation in particular to “evaluate to allow the reduction of the duration of treatment”, one of which, with clofazimine, was “evaluated favorably” before to be “invalidated by the ANSM without explanation.”
On the subject of consent in clinical research, the professor refutes the shortcomings described, and evokes, regarding the minor object of a study, ‘an “isolated error.” He also claims that interpreters were used to seek consent from foreign patients and that Google Translate was even used by practitioners and nurses.
He also defends the prescription guide for anti-infectives, believing that “expert recommendations are by definition not a scientific truth, this being illustrated by the fact that treatment recommendations are different in almost each of the European countries and across the Atlantic.”
In October 2021, an investigation by Mediapart and L’Express revealed that several clinical trials, carried out at the Marseille IHU under the authority of Professor Didier Raoult, “flouted” scientific regulations. According to the investigation, from 2017 until March 2021, the IHU had prescribed a treatment based on four drugs that the National Agency for Medicines and Health Products (ANSM) had yet opposite because this cocktail was toxic rather than effective. “The latest revelations are a storm in a glass of water” reacted Didier Raoult on October 25.
Two days later, the National Medicines Safety Agency (ANSM) had ordered an inspection and seized the Marseille public prosecutor’s office on the basis of article 40 of the code of criminal procedure, as confirmed by the public prosecutor of Marseilles, Dominique Laurens. “After reports made in May 2021, on possible breaches by 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 the human person. This is not admissible“explained the ANSM. But in June 2022, the inspection report published by the ANSM cleared Didier Raoult, not highlighting any research involving the unauthorized human person.