The French government said Wednesday that doctors should no longer prescribe hydroxychloroquine for COVID-19 patients, an unproven and potentially harmful treatment for the disease nonetheless promoted by US President Donald Trump.
The move came after two French advisory bodies and the World Health Organization (WHO) warned this week that the drug, a treatment for rheumatoid arthritis and lupus, had been shown to be dangerous in several studies.
Europe's Discovery programme of hydroxychloroquine trials in several countries to gauge its effectiveness in the coronavirus fight have also been suspended since Sunday, France's Inserm research institute said.
The urgency of the coronavirus outbreak prompted some doctors to prescribe the drug despite a lack of research to demonstrate its effectiveness against the new coronavirus. A French infectious disease specialist in particular insists he has successfully treated some 4,000 patients by using hydroxychloroquine with the antibiotic azithromycin.
The doctor, Didier Raoult, has caught the ear of Trump, who stunned his own administration last week by revealing he was taking hydroxychloroquine as a preventive measure against COVID-19. Raoult has already rejected a comprehensive study published last week in The Lancet medical journal, which found that administering hydroxychloroquine or its related compound chloroquine actually increased the risk of dying for many patients.
Under the new French rules, the drug should be used only in clinical trials. Its use is not prohibited outright, and doctors working in hospitals would still be able to prescribe it off-label as a coronavirus treatment.
"In fact, it means that you're not allowed to recommend it, but I have never recommended it -- I have said what I was going to do," Raoult told Sud Radio of the government intervention Wednesday. "I don't think this changes anything much, especially since there are not that many COVID-19 cases left," he said.
His clinic, meanwhile, told AFP it would "continue treating patients with the most appropriate treatment."
It was not the first provocative statement from Raoult, whose defiant stance has made him a mainstay in the French media, about a disease that has caused more than 28,000 deaths in France in a matter of months.
In April, health officials denounced his claim that the outbreak was easing, which according to Raoult proved that "it's a fairly commonplace" respiratory disease.
'Good stories'
Hydroxychloroquine, also used to treat malaria, is sold under the brand name Plaquenil by French pharma giant Sanofi, which promised to offer governments millions of doses if studies proved it could be safely used in the coronavirus fight.
It has long been known to produce serious side effects, including heart arrhythmia, in some people. The French government changed the rules in March to let doctors prescribe it for coronavirus infection, hoping to find a treatment quickly since a vaccine is not expected until next year at the earliest.
President Emmanuel Macron even travelled to Marseille to meet Raoult, a move critics warned could be interpreted as endorsement of a treatment that has sharply divided medical experts. A few weeks later, France's ANSM drugs agency warned of a sharp rise in reports of hydroxychloroquine side effects since the outbreak began.
On Tuesday, the agency said it would suspend clinical trials with the drug for COVID-19, in line with a move by the WHO to pause trials for a safety review. France's HCSP health advisory council also advised Tuesday against using the drug as a coronavirus treatment. US regulators have also advised against taking the drug because of health risks, but that has not deterred Trump, who said last week that "I've heard a lot of good stories" about its potential in the coronavirus fight.
Brazil's President Jair Bolsonaro is also promoting hydroxychloroquine, and the country's health ministry said Monday that it would keep recommending it despite the WHO suspending trials. More than 350,000 people have died from the virus worldwide since it first appeared in China last December, according to a tally of official sources by AFP.