November 29, 2021

The Marseille IHU implicated in irregular clinical trials against tuberculosis

This is a new element in the already heavy file of the University Hospital Institute (IHU) of Marseille. For several years, the IHU has been carrying out, under the direction of the controversial professor Didier Raoult, irregular clinical trials on treatments for tuberculosis, writes Mediapart, Friday October 22.

“Since 2017”, l’IHU “Leads a wild experiment against tuberculosis, causing in several patients, including a minor of 17 years, serious complications”, explains the newspaper, which quotes several employees of the institute on condition of anonymity. This experiment was “Initiated by its director, Didier Raoult, and his deputy, Michel Drancourt”, precise Mediapart.

According to the site, which is also based on e-mail exchanges and hospitalization reports, IHU teams tested a combination of four drugs whose joint effectiveness had never been evaluated.

These trials were carried out despite the refusal of the National Medicines Safety Agency, the ANSM, which must give its approval to research requiring experiments on human beings, in particular clinical trials of drugs.

Several studies conducted in a way “Not eligible”

Asked by Agence France-Presse, the Marseille IHU did not immediately respond. The ANSM, without mentioning these trials in particular, acknowledged that several studies had been carried out in a manner “Not eligible” by the organization, and said they have initiated “Adequate suites”, without further details.

Read also Clinical trials at the IHU of Didier Raoult: the ANSM announces “investigations” on possible “breaches of the regulations”

Information from Mediapart come in addition to revelations published during the summer by L’Express, according to which many studies carried out at the IHU for years broke free from the rules governing experiments carried out on human beings.

Marseille hospitals, one of the six founding members of the IHU, for their part estimated in a press statement that if these “Breaches” were confirmed, they “Would be of real gravity by their supposed scale, by the time during which they would have lasted, by the possible implication of several professionals and if necessary their full conscience and their repeated desire to register outside the regulatory framework”.

The AP-HM has promised to tie up with “All stakeholders as soon as possible in order to analyze the follow-up to be given to this alert and to initiate, if necessary, all useful investigations [pour] know the reality of the facts ”, reserving the possibility also to seize the parquet floor of Marseilles.

The IHU and Mr. Raoult encountered a strong media aura at the start of the Covid-19 pandemic, in 2020, by promoting hydroxychloroquine as a treatment for the disease, despite the lack of proven effect. Several studies have been carried out by the IHU to confirm the interest of this treatment, but they have been criticized by many scientists as to their methodology and their conditions.

More recently, Mr. Raoult has been criticized for advertising a Brazilian study defending a treatment with hydroxycholoroquine, when these trials then caused a wide scandal for having been carried out on patients without their consent, and for giving rise to the publication of truncated results.

Didier Raoult will leave the head of the IHU at the end of June at the latest, the founding members of the institute having wished to launch a succession process. He retired this summer as a university professor-hospital practitioner.

Explanations: Article reserved for our subscribers Didier Raoult pushed to exit by the partners of the Marseille University Hospital Institute

The World with AFP