French health officials on Wednesday denounced several years of “serious deficiencies” in the context of clinical trials at the IHU’s Didier Rault-led agency. They again announced that they would take legal action and seek to restructure the system.
“The ethical rules are not properly respected and do not adequately ensure the safety of the public,” the National Institute for the Safety of Drugs (ANSM) summed up in a press release following an investigation into late 2021. IHU in Marseille after the revelations of Express and Mediabart.
This illegal research was carried out on many people before the Govt-19 epidemic, during which Mr. Rowlatt gained considerable popularity, especially when it came to the effectiveness of treatments such as hydroxy chloroquine, which multiplied widely discredited positions.
So the alleged trials are about other symptoms. According to the ANSM, they were recruited without the mandatory consent of an independent panel or, in some cases, without the consent of all patients examined.
This is an example of a rectal sample taken in children with gastroenteritis in the early 2010s. For dozens, there was no parental consent.
Two types of actions
As a result, ANSM declares two types of actions. One, carried out by his own care, involves the irregular interruption of tests and the imposition of “appropriate and preventive measures” to keep research back in good condition at the IHU.
However, these measures will not be immediate because ANSM will have to pursue a conflict of interest with IHU and Marseille hospitals, whose responsibility is also being questioned.
At the same time, when the Mediabart survey was released, ANSM announced that it was taking legal action already taken last fall. He now alleges that the IHU not only conducted unauthorized tests, but also provided him with a false document to justify initiating one of the alleged investigations.
Fight against tuberculosis
However, ANSM currently excludes starting procedures on the most exciting aspect of this file: IHU’s anti-tuberculosis treatments that have been carried out for many years.
In a large number of patients, these procedures cause severe side effects. But ANSM considers that they have not developed a clinical trial and therefore does not consider itself in a position to intervene directly in this matter. However, the authorities want to dig into the matter and have not long ruled out taking legal action in this regard.