What is hydroxychloroquine and why is it controversial?

WHO said it had temporarily suspended clinical trials of hydroxychloroquine
AFP via Getty Images

Hydroxychloroquine is a controversial anti-malaria drug which has been thrown into the spotlight in recent months by US President Donald Trump, who says he has tried it as a potential defence against coronavirus.

Several studies have shown that the drug has no effect on Covid-19 patients, could be harmful and has the potential to cause heart problems.

The French Government banned the use of the drug as a treatment for coronavirus, while the US Food and Drug Administration also withdrew its authorisation and cautioned against the use of hydroxychloroquine use with coronavirus patients.

But researchers behind a global study into hydroxychloroquine led by Oxford University have warned against dismissing the dug prematurely, saying it could still save lives.

The study, known as Copcov, aims to enrol 40,000 healthcare workers from across the world to determine whether the drug is effective at fighting Covid-19.

Donald Trump revealed he was taking the drug
AP

One of the trial’s lead investigators, Dr Will Schilling, said: “We really don’t know if hydroxychloroquine works or not in prevention or very early treatment. That question remains unanswered."

Professor Nick Day, director of the Mahidol Oxford Tropical Medicine Research Unit, also leading the study, added: “By the time patients are admitted to hospital virus multiplication is well past its peak and inflammation in the lungs and other complications may prove lethal.

“At this stage the steroid dexamethasone, which reduces inflammation, saves lives but the antivirals hydroxychloroquine and chloroquine do not.

“However, that does not rule out that they could be effective much earlier in the illness. Prevention is much easier than cure.

"The Copcov study will find out if these drugs can prevent Covid-19 or not.”

“The benefits found in small post-exposure treatment trials, although modest, could be very valuable if they were confirmed.”

Candlelit vigil for coronavirus victims and NHS - In pictures

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Meanhwile one hydroxychloroquine study found that the drug helped hospital patients survive coronavirus. Researchers at Henry Ford Health System in the US found that 13 per cent of people given hydroxychloroquine died, compared to 26 per cent of those who weren't given the drug.

Dr Marcus Zervos, head of infectious diseases at Henry Ford, told a press conference: "Our results do differ from some other studies. What we think was important in ours ... is that patients were treated early.

"For hydroxychloroquine to have a benefit, it needs to begin before the patients begin to suffer some of the severe immune reactions that patients can have with Covid."

But other researchers not involved in the trial, the results of which were published in the International Journal of Infectious Diseases, remain sceptical.

Dr. Todd Lee of the Royal Victoria Hospital in Montreal wrote: "As the Henry Ford Health System became more experienced in treating patients with Covid-19, survival may have improved, regardless of the use of specific therapies."

Mr Trump raised eyebrows when he said he takes hydroxychloroquine, despite warnings from his own government's health experts. He told reporters that he takes a hydroxychloroquine pill “every day”, combined with zinc.

Brazilian President Jair Bolsonaro is another champion of the drug and recently said he'd taken it when he became infected with coronavirus.

Mr Bolsonaro tested positive for Covid-19 after months of playing down the virus' severity while deaths mounted rapidly inside his country.

The drug is controversial
AFP via Getty Images

What is hydroxychloroquine and is it safe?

Hydroxychloroquine is a drug used to treat acute malaria, lupus, and some types of arthritis.

It is a derivative of chloroquine, which is also used to treat malaria.

It is widely used to treat rheumatic diseases as it can reduce inflammation, pain, and swelling.

The drug is on the World Health Organisation's List of Essential Medicines, the safest and most effective medicines needed in a system.

However, it is not free of risk: common side effects of taking it include vomiting, headache, changes in vision, and muscle weakness, while severe side effects can include allergic reactions, vision problems, and heart problems.

What has Trump said about taking the drug?

Mr Trump said he took the drug daily with zinc, "because I think it's good. I've heard a lot of good stories."

"You'd be surprised at how many people are taking it, especially the front-line workers, before you catch it," he added. "The front-line workers – many, many are taking it. I happen to be taking it.

"I'm taking it, hydroxychloroquine, right now, yeah. A couple of weeks ago, I started taking it.”

Mr Trump said his use of the medicine was approved by the White House physician, Sean Conley, but said that it was he, not his doctor, who took the first step.

Trump: I started taking it because I think it's good... I've heard a lot of good stories
AP

"I asked him, 'what do you think?' He said, 'if you'd like it.' I said 'yeah, I'd like it.'"

Trump said he has received many "positive calls" from people telling him about the malaria drug. He said he had received a letter from an unidentified New York doctor, who said he had given the drug to hundreds of patients and "I haven't lost one."

"It seems to have an impact, and maybe it does, maybe it doesn't but if it doesn't, you're not going to get sick or die," Trump added. "I take a pill every day. At some point I'll stop."

He told reporters he showed "zero symptoms” of Covid-19.

A new trial has suggested hydroxychloroquine could help coronavirus patients 
AFP via Getty Images

"Every couple days they want to test me, you know, for obvious reasons,” he said. “I mean I am the president, so they want to test me. I don't want to be tested but they want to test me," he said. "I've shown always negative."

Mr Trump has also retweeted claims America’s leading infectious disease expert, Dr Anthony Fauci, misled the US on hydroxychloroquine by refusing to endorse the use of the anti-malaria drug in combating Covid-19.

Commenting on Mr Trump's remarks regarding the drug, Dr Stephen Griffin, associate professor in the School of Medicine, University of Leeds, said they were “a staggering, irresponsible act that could very well also amount to self-harm”.

He warned that hydroxychloroquine is prescribed and monitored carefully because of its potential side effects. He said people following Mr Trump’s example could “endanger themselves”.

Former Government chief scientific adviser Sir David King said of Mr Trump: “Every word he says should be ignored in terms of advice”.

He added: “I’m sorry but this is not the pronouncements of a person who is listening to the scientists. He is making it up as he goes along.”

What's the official advice about taking hydroxychloroquine?

The US Food and Drug Administration (FDA) issued an advisory warning that hydroxychloroquine has "not been shown to be safe and effective".

It cited reports that the drug can cause serious heart rhythm problems in coronavirus patients.

The FDA has withdrawn its authorisation for hydroxychloroquine use with coronavirus patients.

The Centers for Disease Control (CDC) says there are no approved drugs or therapeutics to prevent or treat Covid-19.

​The UK Government has said that chloroquine and hydroxychloroquine are not licensed to prevent Covid-19 or treat symptoms.

Dr June Raine, chief executive of the UK's medical products regulator, said in June: "We have told those conducting clinical trials using hydroxychloroquine to treat or prevent COVID-19 to suspend recruitment into their trials.

"Neither hydroxychloroquine nor chloroquine are licensed to treat COVID-19 related symptoms or to prevent infection.

"It is important to note that patients taking hydroxychloroquine and chloroquine to treat other health conditions can continue to do so, as advised by their healthcare professional, as the balance of benefits and risks remains favourable in the licensed uses."

Several clinical trials have shown that hydroxychloroquine has no positive effect on coronavirus patients.

Some trials have suggested the drug could cause heart problems 
AFP via Getty Images

But a major UK trial is set to resume after it was paused because of concerns about side-effects, raised in studies that have since been retracted.

The COPCOV trial will give chloroquine, hydroxychloroquine or a placebo to more than 40,000 healthcare workers from Europe, Africa, Asia and South America.

One of the lead researchers, Professor Sir Nicholas White from the University of Oxford said: "Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomised controlled trial."

Prof Martin Llewelyn, of the Brighton and Sussex Medical School, said: "Although rates of coronavirus are low just now in the UK, healthcare workers are still being affected across the NHS and a second wave of infection this winter is widely expected.

One small uncontrolled study in France on the use of hydroxychloroquine in combination with another drug, azithromycin, found some reduction in patients’ viral load.

However, another study from France, published in the BMJ medical journal, found that hydroxychloroquine did not help significantly reduce admission to intensive care or death rates of people hospitalised with pneumonia due to coronavirus.

Staff in a hospital in the UK 
POOL/AFP via Getty Images

A randomised clinical trial carried out in China, also published in the BMJ, also concluded that taking hydroxychloroquine did not speed up recovery for hospitalised patients with mild to moderate persistent Covid-19.

The study also found that those taking hydroxychloroquine were more likely to have “adverse events”.

The Centre for Evidence-Based Medicine (CEBM) said in May it was aware of 218 trials involving chloroquine and hydroxychloroquine.

There have been more than 16.4 million confirmed cases of coronavirus throughout the world, with around 650,000 deaths.

Additional reporting by PA

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