Investigation of the IHU: Didier Raoult’s surprising line of defense

After more than two and a half years of controversy, the excesses of the Institut hospitalo-universitaire Méditerranée infection” (IHUm) could come to an end. Monday, September 5, the government published the result of a vast joint investigation by the General Inspectorate for Social Affairs (IGAS) and the General Inspectorate for Education, Sport and Research (IGESR). The document (559 pages divided into three volumes), overwhelming, draws up an endless list of “deviant medical and scientific practices” at the IHUm, but also serious managerial and financial abuses. “Several elements” of this report are “likely to constitute offenses or serious breaches of the regulations in terms of health or research”, sum up François Braun Minister of Health and Sylvie Retailleau, Minister of Higher Education and Research, who seized the public prosecutor under article 40 of the criminal procedure code and summoned the new management to present a plan that must follow the recommendations of the IGAS/IGESR report to the letter”, under penalty of having its funding cut off.

The final document hardly differs from the preliminary report, revealed in part by the press last July. Some surprising details nevertheless appear, such as the testimony of a hospital agent who confides that he was the victim of a “computer throw” by a member of the management of the IHUm (p. 77), when another deplores that an IHUm professor advises first-year medical students to freeze their sperm before getting vaccinated, arguing that the messenger RNA would integrate into the nucleus of human chromosomes (p. 60), false information repeatedly denied.

Volume 3 nevertheless details a new element, the “contradictory phase”, which took place this summer. During this period, the representatives of the targeted institutes – Aix Marseille University, the Mediterranean Infection Foundation (MI), the AP-HM and the IHUm – had the opportunity to provide documents and arguments likely to alleviate potential penalties. Only Yolande Obadia, president of the MI foundation and Didier Raoult, former director of the IHUm, disputed the initial conclusions of the investigators. The arguments of Pr. Raoult, particularly edifying, were systematically swept away by the investigators, who took the trouble to explain why they do not hold water.

“You are asked to de-anonymize these testimonials or delete them”

During their investigation, IGAS/IGESR interviewed nearly 300 people. Faced with the inspectors, many witnesses requested anonymity, for fear of reprisals. These testimonies particularly displeased Pr. Raoult, who asked to “de-anonymize” them (p. 48, 72 and 74, volume 3) in order to “ensure [leur] veracity” or, failing that, to delete them. He also demanded that favorable remarks be included, which he said would have been hidden. The inspectors rejected these requests, retorting that “people who had a positive or neutral speech were minority, even though the mission had relayed to the various employer structures a very broad call for testimony”. The IGAS/IGESR, which does not have judicial power, but only an investigation, also that it “will belong to justice […] if it deems it relevant, to request non-anonymized testimonies”.

These requests for anonymity are hardly surprising when we know the virulence of Didier Raoult with regard to his detractors. The professor filed a complaint against microbiologist Elisabeth Bik, a specialist in the detection of fraud and scientific manipulation, who revealed numerous abuses of the IHUm. He also relayed on his Twitter account (nearly a million subscribers) an article from France Soir accusing his detractors of being stalkers for whom the “Widow (a reference to the guillotine) is getting impatient”. The day after the publication of an article in L’Express revealing a climate of fear at the IHU, he published a video in which he compared newspapers investigating his institute to I’m everywherea Nazi collaborationist newspaper. His own daughter, critical of her father, filed a complaint for harassment against the virulent Pr. Eric Chabrièreformer right-hand man of Pr. Raoult.

Researchers pushed to falsify their results

The hundreds of hearings conducted by the IGAS/IGESR investigators as well as the documents, scientific publications and opinions of the reference centers collected have made it possible to highlight legal and ethical problems (page 82) at the IHUm. Among them, “unusual pressure” from the management team of the IHUm towards researchers so that they produce as many scientific studies as possible – putting quality aside, as detailed in a previous survey by L’Express -, but also by “voluntarily watering down the results and the data”, or even by “deleting” the results which are not suitable.

In response, Pr. Raoult explained why the IHUm’s strategy in terms of research and care is excellent, since the Marseilles institute would be, according to him, “certainly, for 30 years, the center in which been made the most discoveries in the field of infectious diseases” and that in terms of care, it is better than its parent body, the AP-HM.

The response of the investigators, scathing, explains that the argument of Pr. Raoult is irrelevant. “Paragraph 36 is not about strategy,” they write, but about the pressure researchers are under to change their scientific results to satisfy management. As the former director did not provide any evidence to invalidate the suspicions of manipulation and pressure, the IGAS/IGESR therefore did not change its conclusions on this point.

Tuberculosis experiment: the defense does not hold water

The adversarial phase also allowed Pr. Raoult to come back to the serious dysfunctions concerning the treatment of patients with tuberculosis. The IHU notably tested two molecules (sulfadiazine and minocycline), which are “not even referenced” in the scientific literature (p. 92) denounces the report. These prescriptions have also caused serious adverse effects in several patients. “Health risks have been taken, the loss of opportunity for some patients arises. These facts are likely to fall under a criminal qualification”, write the investigators.

This time, Didier Raoult defends himself on several pages and cites numerous scientific works. But the inspectors, who have carefully studied the advanced studies, explain that it presents “experimental work”, “in vitro data” or hypotheses of comparisons between leprosy and tuberculosis. None of these arguments therefore provides a sufficient level of proof to justify the use of these molecules. To obtain a sufficient level of proof, it would have been necessary to carry out a clinical trial in accordance with the law – which aims to protect the health of patients -, which the IHU did not do.

A patient who is neither French nor English speaking, signs a consent form in French

The report details (p. 103) other “facts likely to fall within the scope of a criminal qualification”. These are “serious breaches” that occurred during the “Mycobac” protocol, which consisted of collecting human samples from tuberculosis patients. The IHU researchers did not collect all the consents of the patients, included minors when it was not authorized and had non-French-speaking patients sign consent sheets (written in French).

In his response, Prof. Raoult acknowledges that samples were taken from a minor, “which is unfortunately an isolated error”, he writes. He then explains that it is common for the IHU to take samples from foreigners since it is customary to have interpreters in the departments caring for patients suspected of tuberculosis”. He further adds that “three types of interpreters have been used in recent years “including professionals, but also… Google translation. Finally, he specifies that members of the IHU speak Arabic or Russian.

An answer that did not convince the inspectors, especially since the documents sent by the IHU to support its argument contained personal medical data that was supposed to remain secret. Above all, the IGAS/IGESR notes that no concrete proof of the presence of an interpreter during the signing of the consent sheet has been provided. Similarly, no version translated into other languages ​​(thanks to Google translation, for example) was presented. They emphasize, again, that a foreign patient signed a consent sheet the day of his consultation even though the professor of the IHU who took care of him indicated that it was impossible to communicate with him.

In general, the answers of Prof. Raoult are particularly virulent with regard to the investigators. For example, he denounces “the absence of distance from the mission, which is more akin to a commando mission than to an inspection in the service of the French State” (p. 128). He believes that the inspectors do not have “scientific” or medical skills (p. 47) and questions their ability to issue an opinion on the IHU. He accuses them of carrying out “misinterpretations” (p. 83) and of proposing “extravagant” recommendations (p. 124). He even asks them to review and modify “a certain number of methodological elements” of their report and threatens: “if not, we could have to appeal to the administrative court” (p. 51). He scratches, in passing, the other French IHU, Inserm (p. 61) or even the AP-HM, while praising the superiority of his institute and recognizing no error, or almost.

IHU studies under investigation for “scientific misconduct”

Tuesday, September 6, the Marseille prosecutor’s office announced that it had opened a judicial investigation last July following reports from the Medicines Agency (ANSM). The French agency had also published a vitriolic report last April noting very many abuses, including research on the human person carried out without legal authorization, or even forgery in writing and use of forgery. She had seized the prosecutor in October 2021 and May 2022. The file, now in the hands of the investigating judges, should logically thicken with the report of the IGAS, even with the investigations of the CHSCT.

In the meantime, the scientific journal Journal of Clinical Microbiology, published, on Wednesday September 7, “expressions of concern” targeting four scientific studies of the IHU co-signed by Didier Raoult, but also the new director of the IHU, Pierre-Edouard Fournier. These notices indicate that these works are likely to contain errors or be untrustworthy. The journals American Society for Microbiology and AAFC did the same for two other studies co-signed by the former director. This procedure was triggered following an investigation for “scientific misconduct” conducted by Aix Marseille University. Hundreds of articles could be affected by these investigations.