French drugs authority investigating Raoult's Covid hydroxychloroquine trials

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France’s drug safety authority is investigating clinical trials at the infectious disease department of the Marseille university hospital, including two conducted by its director Didier Raoult on the use of hydroxychloroquine to treat Covid-19.

The Agence Nationale de Sécurité du Medicament, or ANSM, says it is looking into alleged procedural violations in some of the IHU Marseille's clinical trials, which in France must be authorised by one of 39 ethics committees and sometimes even the ANSM itself.

An investigation published in the weekly L'Express found that several trials conducted at the IHU Marseille had not received authorisation or had changed their protocols afterwards, notably two of director Didier Raoult’s Covid hydroxychloroquine studies.

The ANSM says it is investigating problems raised in alerts it received recently through its whistleblower mechanism.

Concerns about Raoult's studies

Early in the Covid epidemic, Raoult, a prominent virologist, pushed for the use of hydroxychloroquine as a low-cost Covid-19 treatment. The drug is based on the chloroquine molecule used to treat malaria and authorised in France to treat auto-immune diseases like lupus.

Hydroxychloroquine was endorsed by then-US President Donald Trump, but has since been been banned in France for treating Covid-19.

Raoult backed up his claims with two small studies conducted at the institute in March and April 2020, the first of which received ANSM authorisation for testing the drug on 36 Covid patients, including two 12-years-olds.

Published on 20 March 2020 in the International Journal of Antimicrobial Agents, which is edited by Jean-Marc Rolain, a colleague of Raoult's at the institute, the trial ultimately included two 10-year-old children who were not indicated in the initial authorisation request, and it added another drug, azithromycin, which had also not been authorised.

The ANSM did not authorise a second trial of hydroxychloroquine and azinthormycin on 80 patients, but it was conducted anyway as an observational study. But other scientists say that it involved administering medication to people, and therefore should have been subject to authorisation.

Legal action

In April 2020, a healthcare worker filed a complaint about the two studies with the Marseille prosecutor's office, which looked into the case and decided not to press charges.

The prosecutor said the two 10-year-olds in the first study had not been exposed to risks because they received placebos, and the second study did not need authorisation because hydroxychloroquine could be considered a standard treatment.

The case can be reopened at the request of the ANSM, which says that if its current investigation shows problems with the clinical trials “we will take health measures to guarantee the safety of participants, and if needed, take legal action.”

Questioning science

While the science and effectiveness of the use of hydroxychloroquine to treat Covid has been questioned, these are procedural and administrative issues about patient safety and consent.

But they raise questions in the eyes of the general public about how much to trust scientists.

"I think the combination of a pandemic with social media and people deliberately putting out misinformation, that gets a lot of people thinking that all science is fraudulent, which it is not," the scientific integrity consultant Elisabeth Bik told the AFP news agency.

She has scanned thousands of scientific papers for errors and fraud, and has found problems with over 60 studies conducted in recent years at the IHU Marseille.

Raoult has sued her for harassment after she pointed to anomalies in dozens of his studies, including the ones looking at hydroxychloroquine, and she has been subject to online harassment.

A member of Raoult’s team doxxed her, publishing her private information online.

“Scientists have always trusted each other's work. I think I'm here to say that we maybe should not all blindly trust each other's work,” she said.

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