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Its name is now known to everyone: hydroxychloroquine. The miracle remedy put forward by Professor Raoult, supposed to have a beneficial effect on patients with coronavirus. Since the Marseille epidemiologist has praised its merits, studies contradict each other without being able to define if the drug can indeed cure these patients. A doubt which, for Professor Mathieu Molimard, head of the medical pharmacology service at the Bordeaux University Hospital, is enough to put an end to all research on it. "For the moment, I do not have the beginning of the beginning of proof that it is effective," he assures.
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Guest of Patrick Cohen Sunday, who is also a member of the board of directors of the French Society of Pharmacology and Therapeutics returns to all the elements that argue against the use of hydroxychloroquine.
No effects noted from the first test phases
"When we develop a drug, we must first look at what we know about this drug. Regarding hydroxychloroquine, we know that it works in vitro for many viruses such as the flu, chikungunya, SARS. -COV-1, crazy, HIV ... ", begins the neurologist. "In vitro" means that these are laboratory tests, under artificial conditions created for the purposes of these tests.
But when it comes to the step in vivo, that is to say to test on an organism, a problem arises: "It never worked", explains Mathieu Molimard. Worse, "it worsened the condition of the patients, especially those suffering from chikungunya and HIV. It increased the growth of the virus."
With regard to the coronavirus, "during the first phase (devoted to in vitro observation) we obtained an orange light. In phase 2, the drug is given to patients and placebos to others , then we observe a particular criterion ". In this case, "the decay of the virus in the nose". And there, "the fire turned red," says the specialist.
In other words, two studies, one on 30 patients and the other on 150, gave negative results. "There is no different decrease between the group which received by drawing the hydroxychloroquine and the group which did not receive it," says Mathieu Molimard. "In this case, normally we stop" , he continues. "We don't have to do 150 studies as we are currently doing. It costs millions of euros and we are wasting time.
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The lack of a comparative test with placebo
Finally, Mathieu Molimard points out another deviation from the protocol to be respected in order to verify the effectiveness of a drug on a pathology: the absence of phase 3. This corresponds, once again, to the medication being taken by a group and placebo by another. "We then look if the drug will change relevant criteria. The only thing that interests us at the end is whether it will reduce hospitalizations, resuscitation, deaths," details the specialist. "If it is positive, we will be able to treat all the patients, we will have convinced the scientific community. But if it is negative, we stop the costs, because we have already gone too far."
In the case of hydroxychloroquine, "this phase 3 has not been done," deplores Mathieu Molimard. However, this would have made it possible to establish a month earlier if this treatment worked, according to him. In the context of studies conducted by Professor Didier Raoult, the absence of a group of "control" patients, the group that receives placebos, has been pointed out.
Other drugs may be effective
Not to mention that hydroxychloroquine is not the only option considered by scientists. When developing a drug, you have to know how to sort it out, but above all "don't waste time", explains Mathieu Molimard. "We work by 'go or no go' (you have to go or not go). You have to know how to stop as quickly as possible, because we have dozens of drugs that can be given and that can potentially be effective against Covid-19. If you push a drug that doesn't work further, you've wasted money, energy, resources and put patients at risk, "he added, pointing those who strive to demonstrate the effectiveness of chloroquine.
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An unfavorable risk-benefit ratio
Another anomaly highlighted by the pharmacologist: hydroxychloroquine is a drug that enters the body very slowly. This characteristic explains its effectiveness in the case of lupus (autoimmune disease), which is treatable over the long term, but questions any beneficial effect in the case of the coronavirus, which must be treated quickly. Especially since, "if we gave a very high dose in a few days to a patient, we would kill him," adds Mathieu Molimard.
According to him, to say that hydroxychloroquine poses no risk because it is a drug administered for other conditions that Covid-19 does not make sense. The benefit-risk balance of a treatment is not evaluated in absolute terms, but according to a specific disease. "The risk-benefit of hydroxychloroquine in the case of the coronavirus is rather unfavorable," concludes the specialist.
Careless administration
Even without these essential results, chloroquine was administered. "We have broken down the basic safety steps," says Mathieu Molimard, who regrets that the ban could have been circumvented, the drug being already on the market for another indication. And it is not without consequence. Unlike Professor Raoult who said that hydroxychloroquine and azithromycin (anti-inflammatory also recommended by some against the coronavirus) were "the two least dangerous drugs in the world", the pulmonologist warns: "I do not not the least dangerous drug in the world because everyone has risks. "