‘Game-changer’ drug hailed by Trump is ‘more likely to kill’
A STUDY of 96,000 hospitalised coronavirus patients on six continents found those who received an antimalarial drug promoted by President Donald Trump as a “gamechanger” in the fight against the virus had a significantly higher risk of death.
People treated with hydroxychloroquine, or the closely related drug chloroquine, were also more likely to develop a type of irregular heart rhythm, or arrhythmia, that can lead to sudden cardiac death, it concluded.
The study, published yesterday in the medical journal ‘The Lancet’, is the largest analysis to date of the risks and benefits of treating Covid19 patients with antimalarial drugs.
It is based on a retrospective analysis of medical records, not a controlled study in which patients are divided randomly into treatment groups – a method considered the gold standard of medicine. But the sheer size of the study was convincing to some scientists.
“It’s one thing not to have benefit, but this shows distinct harm,” said Eric Topol, a cardiologist and director of the Scripps Research Translational Institute. “If there was ever hope for this drug, this is the death of it.”
David Maron, director of preventive cardiology at the Stanford University School of Medicine, said “these findings provide absolutely no reason for optimism that these drugs might be useful in the prevention or treatment of Covid-19”.
Past studies also found scant or no evidence of hydroxychloroquine’s benefit in treating sick patients, while reports mounted of dangerous heart problems associated with its use.
As a result, the Food and Drug Administration (FDA) last month warned against the use of the drug outside hospital settings or clinical trials.
The new analysis – by Mandeep Mehra, a Harvard Medical School professor, and colleagues at other institutions – included patients with a positive laboratory test for Covid-19 who were hospitalised between December 20, 2019, and April 14, 2020, at 671 medical centres worldwide.
Nearly 15,000 of the 96,000 patients in the analysis were treated with hydroxychloroquine or chloroquine alone or in combination with a type of antibiotics known as a macrolide, such as azithromycin, within 48 hours of their diagnosis.
The difference between patients who received the antimalarials and those who did not was striking.
For those given hydroxychloroquine, there was a 34pc increase in risk of mortality and a 137pc increased risk of a serious heart arrhythmias.
For those receiving hydroxychloroquine and an antibiotic – the cocktail endorsed by Mr Trump – there was a 45pc increased risk of death and a 411pc increased risk of serious
‘It’s one thing not to have benefit, but this shows distinct harm’
heart arrhythmias.
Those given chloroquine had a 37pc increased risk of death and a 256pc increased risk of serious heart arrhythmias.
For those taking chloroquine and an antibiotic, there was a 37pc increased risk of death and a 301pc increased risk of serious heart arrhythmias.
Cardiologist Steven Nissen of the Cleveland Clinic said the new data, combined with data from smaller previous studies, suggests the drug “is maybe harmful and that no one should be taking it outside of a clinical trial”.
Peter Lurie, a former top FDA official who now heads the Centre for Science in the Public Interest, called the report “another nail in the coffin for hydroxychloroquine – this time from the largest study ever”.
He said it was time to revoke the emergency use authorisation issued by the FDA, which approved the drug for seriously ill patients who were hospitalised or for whom a clinical trial was not available.
The new study’s findings cannot necessarily be extrapolated to people with mild illness at home or those, like Mr Trump, who are taking the antimalarials as a prophylactic.
The president stunned many doctors earlier this week when he said he was taking a pill “every day” – despite FDA warnings that the use of the drug should be limited to those in a hospital setting or in clinical trials.
Mr Trump has since said he is close to finishing his course of treatment and would stop taking the medication in “a day or two”.