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Irregular clinical trials: the drug agency wants an inspection at the IHU, led by Didier Raoult

2021-10-28T05:14:10.150Z


“The latest 'revelations' are a storm in a glass of water,” for his part replied the director of the IHU.


The Medicines Agency (ANSM) announced on Wednesday October 28 that it was going to "

conduct an inspection within

" the University Hospital Institute (IHU) of Marseille, headed by the controversial professor Didier Raoult, who "

continued to to deliver

»treatments against turberculosis, without his authorization.

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The ANSM also told AFP 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, Mediapart revealed that since 2017, the IHU "has been

conducting savage experimentation against tuberculosis, causing serious complications in several patients, including a minor

".

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 to have been "

alerted in May 2021 (...) on possible breaches of the IHU of Marseille

" as regards 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,

”said the authority.

Kidney complications

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 A spokesperson told AFP that this protocol had been filed in August 2019, but that it had been withdrawn a month later "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 organization, 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. them required surgery,

”wrote the AP-HM.

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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 IHU 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.

Source: lefigaro

All life articles on 2021-10-28

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