A news, theIHU Méditerranée of Pr Didier Raoult is accused of “serious malfunctions” by a new report, which prompted the government to take legal action. Published this Monday, September 5, it highlights “several elements likely to constitute offenses or serious breaches of health or research regulations”said ministers François Braun and Sylvie Retailleau in a joint statement.
The report denounces in particular “widespread inappropriate medical and scientific practices”others”not complying with the regulations and which may generate a health risk for patients, in particular during research protocols”of the “deviations in management practices, which can generate harassment and ill-being at work” and “excesses in governance, which does not strictly respect the rules governing the foundations of scientific cooperation”.
Several “worrying” reports since 2021
On June 13, the National Medicines Agency (ANSM) had already taken measures against the health establishment, in particular the suspension of research involving a human person. “Following the inspection that we conducted at the IHU-MI and the AP-HM, we are today taking administrative measures aimed at forcing them to implement certain actions in order to comply with the regulations governing research. involving the human person“, indicated the ANSM in a communicated.
In November 2021, ANSM launched a inspection within the IHU-Méditerranée Infection and at the AP-HM after revelations from The Express and of Mediapart on trials conducted before the Covid-19 pandemic. The Agency issued its final report on Wednesday April 27 and highlighted “serious breaches and non-compliances with the regulations of research involving humans (RIPH)“.
The tests targeted were as follows:
- A trial looking for the bacterium tropheryma whipplei (causing gastroenteritis) in young children;
- Another aimed at researching pathologies associated with travel and the acquisition of multi-resistant bacteria in medical students doing a practical internship outside France.
This last trial has therefore been suspended by the ANSM and the administrative measures taken prevent “any new inclusion of participants in the research as well as the collection of data from participants and their use“, indicates the press release. The agency also imposes on the establishments concerned a staff training program, which must be carried out by the end of 2022. Indeed the conditions for collecting and using samples from participants to clinical trials, as well as the procedures for obtaining consent and informing participants, had not always been respected by staff. “Ethical rules were not systematically respected, making it impossible to ensure the protection of people at a sufficient level and as permitted by the regulations.“, indicated a communicated from the ANSM.
The IHU falsified a document to launch an unauthorized trial
The ANSM also accused the IHU ofhaving falsified a document with the mention “favourable opinion” in order to be able to launch one of the searches in question.
On this subject, the ANSM’s investigations continue, in particular on the treatment of patients suffering from infectious tuberculosis. “Indeed, if we have not, at this stage of our investigations, identified elements proving the implementation of an unauthorized clinical trial on the treatment of multi-resistant tuberculosis of patients treated during the year 2019, we nevertheless highlighted the use of combinations of antibiotics different from international recommendations and potentially dangerous for patients. The frequency of serious adverse events over the 2019 period appears high“, ends the press release.
Sources:
- IHU Méditerranée infection controlGeneral Inspectorate of Social Affairs
- Serious dysfunctions within the Institut Hospitalo-Universitaire Méditerranée Infection: the Minister of Higher Education and Research and the Minister of Health and Prevention convene the management and the founding establishments and ask them to implement a proactive action plan, September 5, 2022
- Inspection at the IHU-Méditerranée Infection and the AP-HM: the ANSM takes administrative measures, ANSM, June 13, 2022
- Inspection at the IHU-Méditerranée Infection and the AP-HM: the ANSM takes legal action again and initiates administrative proceedings, ANSM, 27 April 2022
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- Didier Raoult falsify his results on hydroxychloroquine?
