The National Agency for the Safety of Medicines and Health Products (ANSM) has decided to implement, this Monday, June 13a series of particularly severe sanctions against the Mediterranean Infection University Hospital Institute (IHU), directed by Didier Raoult, and to a lesser extent against the University Hospitals of Marseille (AP-HM), guardianship of the IHU.
On April 27, the ANSM released an unprecedented 293-page report. In this document, the agency sharply denounced the practices in force within the two establishments and announced that it had seized the criminal justice system. It also warned the IHU and the AP-HM that it was going to put in place the most severe sanctions at its disposal, unless the two establishments took the necessary measures. If the AP-HM had immediately made amends, in particular by suspending two illegal trials in progress, the content of the press release published by Didier Raoult at the time suggested that the IHU would ignore these requests. And indeed, since the ANSM announces this Monday, June 13 that it has implemented the sanctions provided for due to the inaction of the IHU.
The study pinned by L’Express is well suspended
In its press release, the ANSM indicates in the first place that it puts in place a health policy in order to suspend research involving the human person (RIPH) called “Pathologies associated with travel and acquisition of pathogens and multidrug-resistant bacteria in medical students doing a practical internship outside France”. This is a study in which the IHU asked its own students – people who are by definition dependent on the IHU, because under its authority – to carry out vaginal and rectal self-sampling before and after having stayed at the foreign. But as revealed by an investigation by L’Express published in July 2021, this research did not obtain the authorization of a Committee for the Protection of Persons, which is illegal under the law governing the RIPH, and “an absolute scandal in terms of ethics”, recalls Pr. Mathieu Molimard, specialist in clinical pharmacology at the Bordeaux University Hospital, who has followed this case closely. The ANSM indicates that it is suspending this research and prohibits any new inclusion of participants or the collection of their data as well as their use, which suggests that the IHU had not interrupted it, despite the ongoing investigations.
The ANSM adds that the scientific journals in which the studies relating to this research have been published will be informed of the health policy decision. Logically, these publications should therefore be retracted. However, there is still doubt about the review Travel Medicine and Infectious Disease since Philippe Gautret, doctor at the IHU, is still one of the editors.
The IHU temporarily placed under the supervision of the ANSM
The French health agency has also implemented two injunctions. The first obliges the IHU and the AP-HM to implement a staff training program in compliance with the law governing the RIPH. This program must be provided by an external organization, include Good Clinical Practices (GCP) – a training that is nevertheless elementary – and be finalized “by the end of 2022 at the latest”, warns the ANSM. The agency thus confirms its judgment of last April, namely that the personnel concerned, including Didier Raoult, are not competent in the matter, whereas they are supposed to be the representatives of the center of excellence of French research, as the director of the IHU often reminds us.
The second injunction is even more severe since it temporarily places the IHU under guardianship. Indeed, the Marseille establishment will no longer be able to “set up a new research project if it is not correctly qualified with regard to the public health code”. In other words, the IHU will have to justify, before starting any new research involving human beings, that it has consulted a Committee for the Protection of Persons, or even the ANSM, and obtained their authorizations if necessary, this “with the aim of to ensure the protection of people who lend themselves to research”, writes the ANSM.
Above all, the IHU will “must systematically provide the ANSM, within one month, with exhaustive reports on the referenced publications and the prospective and retrospective research in progress”. The health agency requires that the IHU send it a full review of the research in progress, as well as that which has been the subject of publications for the past five years. Finally, the ANSM has decided to show complete transparency since it has published all of its exchanges with the IHU and the ANSM between its report last April and today. They testify in particular to the weakness of the arguments brought forward by the IHU.
The IHU targeted by multiple investigations
The ANSM investigation was triggered after being warned by whistleblowers, then numerous investigations published in L’Express, but also in Mediapart, which show that the IHU did not respect ethics and scientific integrity, nor the law that governs the RIPH, since he has conducted trials on multiple occasions without obtaining the mandatory opinion of a CPP or, sometimes, the consent of all the patients examined.
And this investigation is not over. The ANSM confirms that it is still looking into “several other research”, in collaboration with the General Inspectorate of Social Affairs and the General Inspectorate of Education, Sport and Research (IGAS / IGESR), which conducts its own investigations. The ANSM should in particular decide on the administration of unrecognized treatments against tuberculosis.
In its April report, the ANSM indicated that it was not yet able to conclude on this subject since it could not establish that these were random clinical trials, as Mediapart claimed. However, the ANSM did not agree with the IHU and pointed out that the institute had prescribed “combinations of antibiotics distinct from national or international recommendations”. She was also concerned about a lack of information for patients – therefore an infringement of their rights – since no document proves that they were correctly informed to take treatment “outside a validated framework”, as well as the risks involved. The ANSM therefore opens the way to a prosecution for dangerous use of a drug outside its marketing authorization.
Didier Raoult’s institute is also targeted by a investigation by the Health, Safety and Working Conditions Committees (CHSCT) of the various supervision of the IHU, triggered after the revelations of L’Express reporting a cluster of Covid-19 on the floor of Didier Raoult as well as the deleterious atmosphere reigning within the Institute. The Marseille institute is also in the sights of criminal justice, since the Marseille prosecutor’s office was seized by the ANSM. Finally, Didier Raoult is directly concerned by the National Council of the Order of Physicians (CNOM), which appealed “at least” the blame imposed for having promoted hydroxychloroquine as a treatment for Covid-19, when he did not could not prove its effectiveness. The CNOM requests the aggravation of the sanction, or that it remains at least the same.
Victor Garcia