(Marseille) The French Medicines Agency (ANSM) announced on Wednesday that it would conduct an inspection within the University Hospital Institute (IHU) in Marseille, headed by the controversial professor Didier Raoult, who issued treatments against turberculosis, without its authorization.
The Medicines Agency (ANSM) also indicated that it had seized the public prosecutor for these facts confirmed on Wednesday by the Public Assistance of Marseille Hospitals (AP-HM).
On October 22, the French news site Mediapart revealed that “since 2017, the University Hospital Institute of Marseille” has been carrying out a wild experiment against tuberculosis, causing in several patients, including a minor, serious complications “.
According to the news site, this experiment used a combination of four drugs whose joint efficacy had never been evaluated and was carried out despite the refusal of the ANSM, which must give its approval to research involving human beings, in especially clinical trials of drugs.
The ANSM indicated that it was “alerted in May 2021 […] on possible breaches ”of the University Hospital Institute of Marseille regarding the regulation of these tests.
“According to our initial investigations, we consider that certain studies should have been carried out in accordance with the legislation governing research involving human beings. […]. This is not admissible, ”said the authority.
The AP-HM, which conducted a rapid internal investigation into the “potential seriousness of the reported facts”, said Wednesday that a “research protocol on this combination of antibiotics had been filed”.
A spokesperson told AFP that this protocol had been filed in August 2019, but that it was withdrawn a month later “given the reservations expressed by the ANSM”.
However, “in the absence of an open trial and despite the reservations expressed by the ANSM”, the Marseille University Hospital Institute “continued to deliver these treatments”, explained the spokesperson for the AP- HM.
One of the patients had to be operated
The investigation carried out by the organization, on which the Marseille University Hospital Institute depends, also confirms that “some” of the patients treated against tuberculosis with the combination of antibiotics in question were “suffering from renal complications, including at least one of them 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 latest ‘revelations’ are a storm in a glass of water,” Professor Raoult tweeted Monday.
The Marseille University Hospital Institute and Mr. Raoult met with strong media coverage at the start of the COVID-19 pandemic, in 2020, by advocating hydroxychloroquine as a treatment for the disease, despite the lack of proven effect .