For years, the University Hospital Institute (IHU) of Marseille has taken liberties with regard to the rules governing research carried out on humans. Drift “Not eligible”, publicly reacted the National Agency for the Safety of Medicines and Health Products (ANSM), Wednesday, October 27, by announcing that it had taken legal action and carried out an inspection within the IHU. The establishment responsible for health policy decisions, it is true, was under pressure. Five days earlier, Mediapart revealed a new transgression of this Marseille institution, headed by the much disputed Didier Raoult. The microbiologist had made himself known by defending the interest of hydroxychloroquine against Covid-19, without ever having been able to prove it.
The IHU, explained Mediapart, conducted a wild-type trial to evaluate a cocktail of four antibiotics in patients with multidrug-resistant tuberculosis – in these patients, the tuberculosis bacillus no longer responds to standard treatments for this disease. However, among the four antibiotics used by the IHU, two do not appear in the long list of treatments recommended by the WHO to treat these tuberculosis. Administering these treatments without supervision therefore constitutes “A possible loss of opportunity for patients, the effectiveness of this therapeutic regimen not being known”, estimates Professor Nicolas Véziris, head of the branch of the National Reference Center on Mycobacteria at Saint-Antoine Hospital (AP-HP), in Paris. A loss of luck, but also a risk: although many anti-tuberculosis drugs are known for their potential toxicity, one of the two molecules prescribed by the IHU has been shown to be particularly toxic to the kidney in at least three patients.
The disclosure of this latest offense was the last straw. It is added, in fact, to the disclosure by L’Express, on July 20, of a series of breaches of legal and ethical rules governing clinical trials. The Marseille IHU in particular carried out research on people, including children, without prior authorization from the two competent authorities, the ANSM, on the one hand, and a personal protection committee, on the other.
Studies not conducted
Faced with the outcry, the ANSM said it had launched an investigation after having “Was alerted in May 2021, as part of its system for collecting reports from whistleblowers”. “On the basis of our first investigations, the ANSM seized the public prosecutor [de Marseille] on the basis of Article 40 of the Code of Criminal Procedure ”, announces the establishment. “Certain studies should have been carried out in accordance with the legislation governing research involving humans [articles L. 1121-1 et suivants du code de la santé publique]. » A way of saying, by antiphrasis, that they were not.
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Conduct by the IHU of Marseille of unauthorized trials on patients: the courts seized