‘Failure at every level’: How science sleuths exposed massive ethics violations at a famed French institute

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‘Failure at every level’: How science sleuths exposed massive ethics violations at a famed French institute
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A group of agitators has spent years pushing for action against Didier Raoult and his collaborators. Now they’re wondering whether anyone will be fully held to account

Didier Raoult and his institute found fame during the pandemic. Then, a group of dogged critics exposed major ethical failingsWith six studies published in the 2010s, French microbiologist Didier Raoult added to his already vast publication record. He and his colleagues conducted a wide range of investigations into infectious diseases and their treatments. They took stool samples from patients on long-term antibiotic treatment, looking for alterations in their gut microbiome.

But the ethical failings are “not disputed” within the scientific community, says Philippe Amiel, a lawyer who specializes in human experimentation. The authorities have known about problems at the IHU for years, adds Karine Lacombe, an infectious disease specialist at Sorbonne University. If they had acted earlier, she says, “the picture of the pandemic in France would have been totally different.

In videos posted online by the IHU, Raoult is often seated in an office, wearing a lab coat, long gray hair and beard slightly unkempt. He speaks soberly and quietly, frowning slightly while delivering reassuring pronouncements: The new coronavirus has a mortality rate not too different from widespread respiratory infections; a treatment will be coming soon.

Besançon, too, was curious. He looked into the paper, which had been submitted to the journal on 16 March and accepted the next day, and noticed that one of the authors was also editor-in-chief at the journal. “So you have a very short reviewing time and editorial conflict of interest,” he says. “I just find this potentially a big red flag. But I thought, it’s just one paper.”

But Amiel says the studies describe samples taken for research purposes and not just as part of standard care, and that this type of study should “undoubtedly” be authorized by a CPP. And many of the 248 studies relied not on feces, but on other material, including vaginal samples, urine, blood, and even breast milk. Any change in research protocol should prompt a new application for ethical approval, Amiel says.

investigation, journalist Victor Garcia finds multiple IHU studies did not have proper ethical approval. Raoult says the studies relying on material other than stool samples had “supplemental favorable advice” from the local ethical committee, but that his team did not report this in its papers. The only country for which his team did not have ethical approval was Niger, he adds, which did not have an ethical approval process until 2016. He says he and his colleagues have submitted a reply to Frank’s paper, and they have asked Springer Nature— the journal’s publisher—to retract it.

The inspectors reported that INSERM, which had helped found and run the IHU, withdrew from the institute in 2018. An INSERM spokesperson says it had found that several research projects did not meet its scientific standards. CNRS withdrew in 2016 and has had “no connection” with the IHU since 2019, according to a spokesperson. The reports did not specifically blame Raoult for these failings.

The fight has taken its toll on the critics. They have faced not just abuse from his supporters on social media and complaints to their employers, but also the threat of legal action from Raoult, who has had multiple legal complaints bankrolled by the IHU. Raoult’s lawyer saidagainst Bik in April 2021 for harassment and blackmail. He has also filed legal complaints against other critics, including Lacombe; Raoult lost his case against her in November 2022.

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