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US News After the clinical trials against tuberculosis, the drug agency wants an inspection at the IHU of Marseille

15:25  28 october  2021
15:25  28 october  2021 Source:   nouvelobs.com

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  Après les essais cliniques contre la tuberculose, l’agence du médicament veut une inspection à l’IHU de Marseille © Copyright 2021, the Obs

the drug agency (ANSM) announced Wednesday 27 October that it was going "Diligently inspection" of the Hospital-University Institute (IHU) of Marseille, led by the Controversy Professor Didier Raoult, who "continued to issue" treatment against tuberculosis, without his authorization.

The ANSM also indicated to the AFP that it had seized the Prosecutor of the Republic for these confirmed facts Wednesday by the public assistance-hospitals of Marseille (AP-HM).

On October 22, Mediapart revealed that "since 2017, the IHU" has been conducting a wild experimentation against tuberculosis, causing several patients, including a minor, serious complications.

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According to the information site, this experimentation used a combination of four drugs whose joint effectiveness had never been evaluated and was conducted despite the ANSM's refusal, which must give its downstream research involving human beings, In particular the clinical trials of drugs.

"Potential serious gravity"

The ANSM has indicated that it has been "alerted in May 2021 [...] on possible shortcomings of the IHU of Marseille" as to the regulation of these tests.

"Under our first investigations, we consider that some studies should have been carried out in accordance with the legislation governing the research involving the human person. [...]. This is not eligible, "the authority said.

The AP-HM, which conducted a quick internal investigation in the face of "potential serious gravity of the facts," said Wednesday as a "research protocol on this combination of antibiotics had been filed."

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A spokesman clarified the AFP that this protocol had been filed in August 2019, but that he had been withdrawn a month later "taking into account the reserves issued by the ANSM".

Now, "In the absence of an open trial and despite the reserves issued by the ANSM, the IHU Mediterranean continued to issue these treatments," explained the spokesman for the AP-HM.

"A storm in a glass of water" for Raoulet

The survey conducted by the body, on which depends on the IHU, also confirms that "some" patients treated against tuberculosis with the combination of antibiotics. have been "reinforced with renal complications, at least one of them required surgery," wrote the AP-HM. It explains that it will continue its investigations, in connection with the authorities of competent guardianship, including the ANSM.

"The last" revelations "are a storm in a glass of water," had tweeted Monday Professor Raoult.

The IHU and Didier Raoult met with a strong media echo at the beginning of the pandemic of Covid-19, in 2020, by advocating hydroxychloroquine as the treatment of the disease, despite the lack of proven effect.


Also on MSN - Ihu de Marseille: illegal tests?

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