The questions posed by Pr Raoult's experiment on chloroquine

• In Marseille, all people feeling "feverish" can, if they wish, be screened by the teams of Pr Didier Raoult.
• Convinced of the efficacy of chloroquine against Covid-19, the Marseilles infectiologist decided to launch a large campaign of massive screening and prescription of chloroquine for patients infected with the coronavirus.
• But his process, which does not obey the strict rules of a clinical trial, raises doubts and questions within the scientific community, which does not give up the hope aroused by this treatment.

A long queue. Hundreds of people, some wearing protective masks, others covering their noses with their scarves or face in the wind. Among the crowd braving confinement in Marseille, people suffering from coughs or fever. All responded to the call made by Professor Didier Raoult, eminent infectious disease specialist and director of the Institut hospitalo-universitaire (IHU) Méditerranée Infection in Marseille, which is launching a vast campaign of screening and prescribing chloroquine as part of work of the Marseille scientist to find a treatment for Covid-19.

While there is currently no treatment and the epidemic continues to progress, chloroquine is on everyone's lips. But is Pr Raoult's approach reliable or is the process fanciful? Many voices call for caution and respect for the strict rules surrounding any clinical trial.

Screen everyone and widely prescribe chloroquine

"We have decided, for all the febrile patients who come to consult us, to practice the tests for the diagnosis of infection with Covid-19", indicates the IHU in a press release published on Sunday. This is a step backwards from the national guidelines, which favor screening limited to the most fragile or those with the most severe symptoms. In a press release, the Regional Health Agency thus recalls that "in an epidemic phase, the principle is to no longer systematically test".

So why these massive screenings in Marseille? Since the appearance of the coronavirus, Professor Raoult has defended the use of chloroquine against the disease. However, many specialists believe that the tests carried out by the infectious disease specialist in a sample of 24 patients do not meet the criteria necessary for a proper clinical trial. Prof. Raoult therefore decided to go to the next level by testing the all-rounder, and to prescribe chloroquine to those who are diagnosed with Covid-19.

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Beware of "false hopes"

“The work led by Professor Raoult raises questions. The results that he puts forward are very attractive, and he is a reference in what relates to the use of chloroquine, comments Dr François Braun, president of Samu - Urgences France, head of the emergency department of CHR de Metz and author of a thesis on acute chloroquine poisoning. The doses he prescribed to his patients as part of his trial - 600 mg per day for ten days - are far below the toxicity thresholds for this molecule. But you have to look at this carefully, and keep in mind that apart from official clinical trials, there is currently no recommendation to prescribe chloroquine to all patients infected with Covid-19 . So, maybe it lowers the viral load of infected patients who receive it, but such work requires well-defined management and framework. In addition, it is not trivial and not without risk to allow so many people - potentially infected - to move in this way despite the confinement ”.

Asked about the use of chloroquine by Professor Raoult, Dr. Karine Lacombe, head of the infectious diseases department at Saint-Antoine Hospital, in Paris, did not hide her dissatisfaction. "I am absolutely disgusted by what is happening, on the basis of a scientifically questionable essay and which shows absolutely nothing," she said on France 2 on Monday. People are exposed to a false hope of healing, for a disease which we know that in 80% of cases, after a few days, there is no more virus and that we cure spontaneously. What is happening in Marseille is absolutely scandalous: using a drug outside of marketing authorization [marketing authorization] by exposing people who take it to complications, without having verified the basic conditions of use of chloroquine, it is really outside of any scientific approach. You can't give it to just anyone, under any conditions. ”

The World Health Organization (WHO) has also condemned the administration of drugs to patients infected with Covid-19 before the scientific community has agreed on their effectiveness, warning against the "false hopes" that they might arouse.

Caution and strictly framed protocol

Voices therefore call for caution, insisting on the need to wait for large clinical trials conducted according to strict scientific orthodoxy. "Small, non-randomized studies, based on observations, will not give us the answers we need," said WHO director-general Tedros Adhanom Ghebreyesus during a virtual press conference. from Geneva. A message that seems directly addressed to Professor Raoult, whose trial on a small sample of patients has raised as many doubts as his approach to screening and prescribing massive chloroquine started on Monday.

Thus, "the High Council for Public Health recommends not to use this treatment in the absence of a recommendation, with the exception of severe, hospital forms, on the collegial decision of doctors and under strict supervision", said Monday evening on Minister of Health Olivier Véran, before emphasizing that the Scientific Committee "excludes any prescription in the general population or for forms not severe at this stage, in the absence of any convincing data". For its part, the AP-HP, which brings together the 39 hospitals in the Paris region, warned in turn against "a disorderly use of multiple molecules without control and above all without the possibility of drawing valid conclusions".

For now, a European clinical trial, Discovery, was launched Sunday in at least seven European countries, including France, to test four experimental treatments against the coronavirus, including hydroxychloroquine. It will include a total of 3,200 patients, including at least 800 French. In its opinion, the High Council of Public Health "encourages doctors to include as many patients as possible in the various therapeutic trials underway in our country, because it is the surest way to quickly determine whether a treatment is effective or not, ”said Olivier Véran. The French trials are supervised by Inserm, and five French hospitals will participate, but the IHU led by Pr Raoult is not one of them to date, according to Inserm.

"We have to make sure there is no danger"

Some of the molecules tested as part of the European clinical trial, including hydroxychloroquine, "are not freely available," said Prof Bruno Lina, virologist and member of the Scientific Council, who warns the government of the action to be taken with coronavirus. If they are prescribed, it is without marketing authorization ”. For the virologist, the combination of hydroxychloroquine and azithromycin [an antibiotic], the treatment prescribed by Pr Raoult in Marseille, must be the subject of the greatest vigilance: "We must be careful about the combination of these products. It is possible that there is toxicity from this association. This is why we must make sure of the absence of danger before proposing this combination ", comments Pr Lina, adding that" the treatment with hydroxychloroquine tested within the framework of Discovery will be it without association with the antibiotic "also prescribed by Pr Raoult.

This Tuesday, while a publication announces that "Professor Didier Raoult slams the door of the scientific council of Macron", his entourage denies: "Didier Raoult has not resigned from the Scientific Council, assures a collaborator of the doctor at 20 Minutes . Busy with the management of the IHU Méditerranée Infection, he will not participate in the next meetings ”. In a video published on Tuesday on Twitter, the Marseille doctor returned to the situation, without fully clarifying it completely. He declares: "I am in contact with the ministry and the President of the Republic to tell them what I think. I am in direct contact with them because the advice is not what I think should be strategic advice. ”

"I am in contact with the Ministry and with the President of the Republic to tell them what I think. I stay in contact with them directly, because the council does not correspond to what I think should be a strategic council." # Coronavirushttps: //t.co/hQFUhq687H

At the same time, the Elysée Palace announced the creation of Care, a scientific committee made up of 12 researchers and doctors, whose mission will be to advise the government in support of the Scientific Council.

Regarding the results of European clinical trials conducted on chloroquine, it will take several weeks. But the Minister of Health pledged on Monday evening to communicate "including the intermediate data making it possible to envisage an evolution of the regulatory framework for prescriptions for medicines (...) so as to make them accessible".

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