Raoult’s IHU has tested treatments refused by the French Medicines Authority – The HuffPost

CHRISTOPHE SIMON via AFP

MEDICAL RESEARCH – Confirmation comes directly from Public Assistance – Marseille Hospitals. This Wednesday, October 27, following an internal investigation, the hospital establishment assured that the University Hospital Institute (IHU) of Marseille led by the controversial professor Didier Raoult “continued to deliver” experimental treatments against turberculiasis “Despite the reservations made by the French Medicines Authority (ANSM)”.

On October 22, the information site Mediapart revealed that “since 2017, the IHU“ has been carrying out a wild experiment against tuberculosis, causing in several patients, including a minor, serious complications ”.

The ANSM had refused these tests

According to Mediapart, 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 humans, in particular clinical trials of drugs .

The AP-HM, which conducted a rapid internal investigation into the “potential seriousness of the reported facts”, indicated on Wednesday that a “research protocol on this combination of antibiotics had indeed been filed by the AP-HM ”. A spokesperson told AFP that this protocol had been filed in August 2019, but that it had been withdrawn a month later “given the reservations expressed by the ANSM”.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 IHU Méditerranée continued to deliver these treatments”, explained the spokesperson for the AP-HM.

The investigation carried out by the public establishment on which the IHU depends also confirms that “some” of the patients treated against tuberculosis with the combination of antibiotics in question were “suffering from renal complications, of which at least one of them. required surgery, ”wrote the AP-HM.

Justice has been seized

She explains that she will continue her investigations, in conjunction with the competent supervisory authorities, in particular the ANSM. The latter also let it be known that she was going to “conduct an inspection within” the IHU and that she had seized the public prosecutor about unapproved clinical trials.

The ANSM indicated that it was “alerted in May 2021 (…) on possible breaches of the IHU 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 humans (…). This is not admissible ”, indicated the authority.

“The latest ‘revelations’ are a storm in a glass of water,” the professor reacted on Twitter on Monday. Raoult. As a reminder, the IHU and its director had met a strong media response at the start of the pandemic of covid-19, in 2020, by advocating hydroxychloroquine as a treatment for the disease, despite the lack of proven effect. Since then, relations are particularly tense between the doctor and the APHM.

See also on the HuffPost: The contradictions of Didier Raoult during his hearing before the deputies