“Wild experimentation” against tuberculosis at the IHU in Marseille: an internal investigation confirms that the trial was not approved – Le Monde

The Marseille University Hospital Institute (IHU Méditerranée Infection), headed by the controversial professor Didier Raoult, has “Continued to deliver” tuberculosis treatments “Despite the reservations made by the French drug authority”, confirmed, Wednesday, October 27, the Public Assistance-Hospitals of Marseille (AP-HM).

Based on article 40 of the code of criminal procedure, the National Agency for the Safety of Medicines and Health Products (ANSM) seized the public prosecutor, considering “That some studies carried out by the IHU did not comply with the legislation governing research involving human beings”, report Wednesday Mediapart, according to whom the ANSM also “Diligent[é] an inspection within the IHU “.

October 22, Mediapart revealed that, “Since at least 2017 and until March 2021, the IHU” had conducted a wild experiment against tuberculosis, causing in several patients, including a minor, serious complications.

According to Mediapart, this experiment used a combination of four drugs whose joint effectiveness had never been evaluated. An experiment carried out despite the refusal of the National Agency for the Safety of Medicines and Health Products (ANSM), which must give its approval to research involving human beings, in particular clinical trials of medicinal products.

Other investigations

The AP-HM, which conducted a rapid internal investigation into the “Potential seriousness of the reported facts”, reported on Wednesday that a “Research protocol on this combination of antibiotics had indeed been submitted by the AP-HM”.

A spokesperson told Agence France-Presse that this protocol was filed in August 2019, but was withdrawn a month later “Taking into account the reservations expressed by the ANSM”. Gold, “In the absence of an open trial and despite the reservations expressed by the ANSM, the IHU Méditerranée continued to deliver these treatments”, explained the spokesperson for the AP-HM.

The investigation carried out by the body responsible for the IHU also confirms that ” some “ of patients treated for tuberculosis with the implicated combination of antibiotics have been “With kidney complications, at least one of which required surgery”, wrote the AP-HM.

She explains that she will continue her investigations, in conjunction with the competent supervisory authorities, in particular the ANSM. ” The last “Revelations” are a storm in a glass of water “, had tweeted Professor Raoult on Monday.

Regarding the treatment of tuberculosis: The infectious and tropical diseases pole will communicate soon … https://t.co/8Pw2XW9JGW

– raoult_didier (@Didier Raoult)