Clinical research at the Marseille IHU: “In the absence of a reaction from the institutions, the serious shortcomings observed could become the norm”

Ihe demonstration of the therapeutic effects of drugs in humans meets ethical and scientific standards built up over decades, to guarantee the relevance, quality and reliability of clinical studies, while respecting the rights and safety of people participating in the research. This implies in particular the informed consent of the participants, the prior obtaining of authorizations by the committees for the protection of persons and the National Agency for the Safety of Medicines, the transparency of the methods and the collection of data, the validation of the results independently and taking into account the benefit-risk balance of treatments before validating their indication.

We, the signatories of this forum, consider that these elementary rules have been widely violated, in particular by certain biologists and clinicians from the University Hospital Institute (IHU) Méditerranée Infection, in particular during the health crisis. The systematic prescription to patients with Covid-19, whatever their age and symptoms, of drugs as varied as hydroxychloroquine, zinc, ivermectin or azithromycin, on preprinted prescriptions, has first carried out without solid pharmacological bases, and in the absence of any proof of efficacy.

These systematic prescriptions were continued, which is more serious, for more than a year after the formal demonstration of their ineffectiveness. We believe that these requirements
systematic studies have also been carried out outside of any marketing authorization, but also outside of any ethical or legal framework, relying largely on methods of monitoring and evaluating patients by repeated PCR, without justification medical. These practices have led to the recent availability in “preprint” data from more than 30,000 patients, thus probably constituting the largest “wild” therapeutic trial known to date.

Fueled mistrust

The uncritical media coverage, in a favorable light, of these bad practices has largely contributed to fueling the distrust of some of our fellow citizens towards science, clinical research, health authorities and experts in general. In the particularly anxiety-provoking context of this health crisis, the peremptory statements proclaiming the effectiveness of these treatments have, unfortunately, met with great success among the public.

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