A missive to say the least astonishing. Under investigation by the French Medicines Agency (ANSM), the University Hospital Institute of Marseille (IHU), directed by Didier Raoult, sent him a 13-page letter. Its content, amazing in many respects, was fully published on the France Soir blog, fierce – even violent – defender of the IHU, but also of conspiracy theories.
Triggered following investigations by L’Express and Mediapart, the ANSM inspection aims to determine whether the IHU has respected ethics and especially the law governing research involving the human person (RIPH), and in particular if he has obtained the mandatory authorizations from the Committee for the Protection of Persons (CPP) and/or the ANSM before starting certain sensitive clinical trials. The preliminary report of the health constable, released by Mediapart last February, suggests the opposite. The document, overwhelming, points to many dysfunctions of the Marseille institute, which Didier Raoult, author of the letter he co-signs with Pr. Philippe Brouqui, fiercely disputes.
The IHU AP-HM war is in full swing
The first part of the document takes the form of heavy fire against the AP-HM – the parent institute of the IHU – which is “in a state of disrepair that I have not seen in Africa”, tackle Didier Raoult, and against its managing director, François Crémieux. The main argument consists in throwing the responsibility on the AP-HM, which is the promoter (the one who assumes the responsibility) of the targeted research, whereas the IHU is only the investigator (responsible for directing and monitoring ). But a few lines further, Didier Raoult indicates that the administrative slowness of the AP-HM forced him to “find alternative solutions” consisting in replacing his guardianship by taking on the role of promoter. “The slowness of the DRS [NDLR : la Direction de la recherche santé de l’AP-HM] left no choice but to promote certain studies through the IMF [NDLR : Fondation Méditerranée infection]“, he writes.
Screenshot of Didier Raoult’s letter to ANSM (page 5)
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The line of defense consisting of blaming the promoter while explaining that he took on this role is surprising. Especially since even considering that the IHU would be in its right to replace the AP-HM, this would not authorize it to launch clinical trials without having first obtained the favorable opinions of a CPP or ANSM, as required by law.
Pirouette and acts of contortionist
But the most interesting point of Didier Raoult’s letter is undoubtedly his response to questions about two clinical trials conducted on students and pinned by L’Express last July. The first study took place between June and August 2018 and focused on the prevalence of respiratory, gastrointestinal and vaginal bacteria in 134 interns at the Aix-Marseille Faculty of Medicine. The students were asked to collect nasopharyngeal, fecal and vaginal samples themselves one week before leaving on vacation and the week of their return to France. The results were published in 2019 in a scientific journal. The second, carried out in 2019, involves the same samples, but this time concerns a larger cohort of students (382). Its results were not published in a journal, but published online on September 24, 2020. In both cases, the authors (including Didier Raoult) indicate that the study protocol “has been authorized” by the committee of the IHU… Which cannot replace a CPP. “The protocol of these studies classifies them in the category of RIPH, they should therefore benefit from the favorable opinion of a CPP, then explained to L’Express Pr Mathieu Molimard, specialist in clinical pharmacology at the Bordeaux University Hospital, who confides having read the letter from the IHU “with amazement”.
In his letter to the ANSM, Didier Raoult indicates that after “having waited for two years to get the green light from Public Assistance [NDLR : AP-HM]”, the IHU decided “that this was a study based on routine care for which there is no need for a sponsor”. He asserts that vaginal and rectal self-sampling does not would not be interventional, but only observational, and that they therefore did not require authorization from a CPP or the ANSM.However, Didier Raoult recognizes a few lines above that rectal samples – taken from babies in a another study referred to by the ANSM – are indeed interventional acts. But more importantly, the law leaves no room for interpretation. Vaginal and rectal self-samplings in the context of a clinical trial are not observational: they require authorization from a CPP, as the four research law specialists interviewed by L’Express confirmed.
Screenshot (page 11/12) of Didier Raoult’s letter to ANSM in which he acknowledges that considering that this study is part of routine care is “inappropriate” today, but affirms that it was not the case 5 years ago, while the law has not changed since.
L’Express
A few lines later, Didier Raoult states this time that the authors already considered in 2017 that “this work was a matter of routine care” and had therefore sought the opinion of the IHU Ethics Committee that year. Unfortunately, this request “seems to have been misplaced,” he said. Didier Raoult therefore acknowledges that he decided to carry out this work without the consent of his guardianship, without the favorable opinion of his own ethics committee and, above all, without the mandatory authorization of a CPP.
And the contortionist number doesn’t stop there. Didier Raoult states that in order to publish the results of this work in scientific journals, he (re) sought the opinion of his ethics committee in 2019, which rightly replied that he agreed to give a opinion in favor of the condition that the test obtain the prior authorization of a CPP, which “no longer made sense since the study was completed,” acknowledges Didier Raoult. The icing on the cake, the director of the IHU still decides to submit his studies to the journals and indicates that he has obtained the favorable opinion of his ethics committee … Who had explicitly stated otherwise and who could not, in any case, replace a CPP. It is also surprising that one of the studies was published in the journal Travel Medicine and Infectious Disease – one of the editors of which is Philippe Gautret, doctor at the IHU – when she should have checked that the authorization put forward by the IHU was in conformity.
Screenshot of Didier Raoult’s letter to ANSM (page 13).
L’Express
It should also be remembered that in its preliminary report, the ANSM suspects the IHU of having produced false documents. Indeed, initially questioned about these studies, Didier Raoult had sent the drug agency a note from its internal ethics committee, dated August 2019 and bearing the mention “favorable opinion”. However, during their check, the inspectors discovered that the signatory disputed this document. The original indicated that the ethics committee did not give a favorable opinion but ordered the IHU to submit the trial to a committee for the protection of persons (CPP) to which it conditioned its decision, reports Mediapart. In his letter, Didier Raoult does not respond directly to the suspicion of having provided false documents, but he acknowledges that his ethics committee had indeed conditioned its opinion on that of a CPP.
“The IHU does not do research on tuberculosis”, “Tuberculosis is a major element of research inside the IHU”
Other strangenesses or inconsistencies appear in the missive, in particular when Didier Raoult defends himself within the framework of the “Tuberculosis” section. As Mediapart revealed last October, the IHU launched a trial on this infectious disease even though the ANSM had refused to give it its authorization. The work had, moreover, resulted in a deplorable result: 9 patients out of 20 experienced serious medical complications caused by the treatment of the IHU. Here again, Didier Raoult’s argument is surprising. If he had declared six days after the publication of the Mediapart article that “the IHU does not carry out research on tuberculosis”, he indicates in his letter that “tuberculosis is a major element of research within of the IHU”.
Screenshot of Didier Raoult’s letter to ANSM (page 14).
L’Express
The director of the IHU, on the other hand, is “satisfied” with the conclusions of the ANSM according to which “No element has been identified signing an approach that could characterize the implementation of an RIPH not authorized by the ANSM”. At the end of their check, the ANSM inspectors had indeed indicated that the prescriptions of the IHU against tuberculosis, which they considered “dangerous”, had not been made as part of a clinical trial. not authorized since the methods of patient follow-up do not correspond to those of a clinical trial. We will have to wait for the publication of the final report to know the reasons which led the ANSM to conclude in this direction. The drug agency could nevertheless find itself in a delicate position on this point, since it did not intervene when the IHU decided to carry out its experiments on tuberculosis without authorization.
The conclusions delivered in the coming weeks
Questions also remain. For example, Didier Raoult does not respond to the many other trials pinned by L’Express, including three experiments on fecal transplants involving in particular patients with schizophrenia. These tests, which normally require a double agreement from a CPP and the ANSM, do not mention any authorization. The absence of a response from the IHU could mean that the ANSM did not question it on this point – which would be surprising -, or that the Marseilles institute proved that these tests were carried out in accordance with the law.
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Anyway, the ball is now in the camp of the health constable – he should submit his final report in the coming weeks, according to a source familiar with the matter -, but also in the camp of the General Inspectorate of Social Affairs, which is carrying out a parallel investigation. As for the legal aspect, “the investigation is still ongoing”, confirmed the Marseille prosecutor’s office to L’Express.
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