Investigations conducted by the ANSM and Marseille hospitals confirm, following the revelations of “express” and “mediapart”, the drifts of the IHU, always led by Didier Raoult.
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For years, the Hospital-University Institute (IHU) of Marseille has freedom with respect to the rules that govern human research. An “not eligible” drift, publicly responded to the National Medicine Safety Agency and Health Products (ANSM), Wednesday, October 27, announcing to justice and diligent an inspection within the IHU. The institution responsible for sanitary police decisions, it is true, was under pressure. Five days earlier, Mediapart revealed a new transgression from this Marseille institution, led by the highly disputed Didier Raoult. The microbiologist had made known by defending the interest of hydroxychloroquine against CIVID-19, without ever being able to prove it.
The IHU, explained Mediapart, led a wild trial to evaluate a cocktail of four antibiotics in patients with multidrug-resistant tuberculosis – in these patients, the tuberculosis bacillus no longer meets the standard treatments of this disease. Now, among the four antibiotics used by the IHU, two do not appear in the long list of WHO recommended treatments to treat these tuberculosis. Administering these treatments without supervision is therefore “a possible loss of luck for patients, the effectiveness of this therapeutic regime is not known,” says Professor Nicolas Véziris, head of the National Center for References on Mycobacteria At Saint-Antoine Hospital (AP-HP) in Paris. A loss of luck, but also a risk: if many anti-tuberculosis are known for their potential toxicity, one of the two molecules prescribed by the IHU has been particularly toxic to the kidney in at least three patients.
The revelation of this last offense was the drop of water too much. It is added, indeed, to the Disclosure by Express , on July 20, a series of failures to the rules Legal and ethical framing clinical trials. The IHU of Marseille conducted research in persons, including children, without prior authorization from the two competent authorities, the ANSM, on the one hand, and a committee for the protection of persons, on the other.
Unrealized Studies
Faced with the outcry, the ANSM stated that it has launched an investigation after “alerted in May 2021, as part of its reporting collection device from warning launchers”. “On the basis of our first investigations, the ANSM seized the prosecutor of the Republic [from Marseille] on the basis of Article 40 of the Code of Criminal Procedure,” announces the establishment. “Some studies should have been carried out in accordance with the legislation governing the research involving the human person [Articles L. 1121-1 et seq. Of the Public Health Code].” A way of saying, by antiphrase, that they do not have not been.
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