In a column published Sunday in The world, organizations involved in medical research denounce the method used by scientists at the IHU Méditerranée Infection in Marseille to carry out a “wild” therapeutic trial with hydroxychloroquine. Carried out between 2020 and 2021, it led to a study pre-published in April.
• What does the study co-signed by Didier Raoult say?
The authors of the study are categorical: hydroxychloroquine, “prescribed early or late, partially protects against deaths linked to COVID-19.” In a cheep Published May 24, Didier Raoult, co-author of the study and director of the IHU at the time of its completion, wrote that this work, “monitored by a bailiff,” “reports a 70% reduction in deaths among patients treated early “. and 40% of the 30,000 hospitalized patients between 2020 and 2021, that is, between 800 and 1,000 deaths prevented in Marseille”.
This study is a “preprint,” meaning it has not been peer-reviewed or published in a scientific journal. It refers to “all adults” positive for Covid-19 who were treated at the Institut hospitalo-universitaire Méditerranée Infections “between March 2, 2020 and December 31, 2021 and who did not reject the use of their data”.
• Why are the results of this study disputed?
To reach these conclusions, the scientists administered, as a reference treatment against Covid-19, a combination of hydroxychloroquine (HCQ), used in particular against arthritis or lupus, and azithromycin (AZ), an antibiotic used in particular against bronchial infections. .
However, “AZ was used alone (AZ-alone group) for patients who could not be prescribed HCQ for irreversible contraindications, at the discretion of the physician, or in case of patient refusal,” the study reports. These contraindications, heart problems for example, also make these patients more at risk of Covid-19: the epidemiologist Mahmoud Zureik therefore sees a “bias” in the study.
“No statistical method can make these groups comparable, there is nothing to be done about it…”, he told the World.
in a review published At the beginning of April, the National Agency for Medicines Safety (ANSM) also recalled that “the data published to date do not support a clinical benefit of hydroxychloroquine, associated or not with azithromycin in the treatment of Covid-19, regardless of its context of use”.
• What criticize the scientific signatories of the forum?
In a column published Sunday in The world, and signed by 16 organizations involved in medical research, it is above all the framework of the study that its authors are reproached for. The signatories consider that the “systematic prescriptions” of hydroxychloroquine and azithromycin at the IHU of Marseille were “made outside of any marketing authorization, but also outside of any ethical or legal framework, depending to a large extent on repeated methods of monitoring and evaluation of patients with PCR, without medical justification’.
Mathieu Molimard, professor of pharmacology at the Bordeaux University Hospital and signatory to the forum denounced on BFMTV the administration of the HCQ-AZ combination “long after the formal demonstration of the ineffectiveness of this treatment, provided during the summer of 2020”. The World Health Organization, a UN agency, ended the hydroxychloroquine component of its Solidaridad clinical trial on June 17, 2020.
The signatories, including Alain Fischer, president of the Academy of Sciences, believe it is “probably” the “largest known ‘wild’ therapeutic trial to date.”
“What worries us today is that the authorities, although they were overwhelmed during the pandemic, and we all were (…), should have assumed their responsibilities,” general practitioner Amélie Boissier-Descombes, also a general practitioner, said on BFMTV on Monday. President of the Association of Victims of Unauthorized Medical Trials, signatory to the platform.
This text requires a reaction from all the competent institutions in this file: “control establishments, administrative and judicial authorities, High Health Authority, National Ethics Consultative Committee, National Council of the Order of Physicians…”
• How does Didier Raoult react?
Didier Raoult lashed out at Franceinfo for a “tribune of imbeciles”. “Let the health authorities come to investigate hydroxychloroquine,” he also said, judging that the international studies were “rigged.”
Responding to those who consider his trial “illegal”, he also said in a May 24 tweet that inspectors who issued an administrative report in August 2022 on the management of the IHU had not “observed” such flaws.
However, this report had indicated that the protocol put in place at the IHU during the pandemic was to prescribe hydroxychloroquine to patients with Covid-19, and this “despite the prohibition” established by the decree of May 26, 2020.
“These facts are likely to have a criminal classification,” stressed the Igas and Igesr, the administrative services at the origin of this inspection.
The document had highlighted “widespread deviant medical and scientific practices within the IHU.” He denounced “serious shortcomings that are largely based on a distance shown until a very recent period (late 2021-early 2022) with rules considered binding” for clinical research.
With the World, the ANSM indicated that according to its “initial analyzes”, the study “should have received the favorable opinion of a committee for the protection of people (CPP) and the authorization of the ANSM to be implemented.” He indicated that he would take further legal action (the IHU is under judicial investigation) if necessary.
Source: BFM TV
