Antimalarial drug touted by President Trump is linked to increased risk of death in coronavirus patients, study says

An analysis of 96,000 patients shows those treated with hydroxychloroquine Antimalarial drug were also more likely to suffer irregular heart rhythms.

A study of 96,000 hospitalized coronavirus patients on six continents found that those who received an antimalarial drug promoted by President Trump as a “game changer” in the fight against the virus had a significantly higher risk of death compared with those who did not.

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 Friday in the medical journal Lancet is the largest analysis to date of the risks and benefits of treating covid-19 patients with antimalarial drugs. Like earlier smaller studies, it delivered disappointing news to a world eager for promising treatments for the novel coronavirus as the global death toll grows to more than 300,000. While doctors have refined how they treat the disease, they have yet to discover a magic bullet against a pathogen for which humans have no known immunity.AD

“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 that “these findings provide absolutely no reason for optimism that these drugs might be useful in the prevention or treatment of covid-19.”

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President Trump stunned many doctors earlier this week when he said he was taking hydroxychloroquine “every day” — despite FDA warnings that the use of the drug should be limited to those in a hospital setting or in clinical trials. He has since said he is close to finishing his course of treatment and would stop taking the medication in “a day or two.”AD

At a White House press briefing Friday, Deborah Birx, who is coordinating the government’s coronavirus response, deflected a question about the president’s use of the drug, and added the Food and Drug Administration “has been very clear on their website about their concerns about hydroxychloroquine.”

The Lancet analysis — by Mandeep Mehra, a Harvard Medical School professor and physician at Brigham and Women’s Hospital, and colleagues at other institutions — included patients with a positive laboratory test for covid-19 who were hospitalized between Dec. 20, 2019, and April 14, 2020, at 671 medical centers worldwide. The mean age was 54 years, and 53 percent were men. Those who were on mechanical ventilators or who received remdesivir, an antiviral drug made by Gilead Sciences that has shown promise in decreasing recovery times, were excluded.

Mehra said in an interview that the widespread use of antimalarials for covid-19 patients was based on the idea of “a desperate disease demands desperate measures,” but that we have learned a hard lesson from the experience about the importance of first doing no harm.AD

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In retrospect, Mehra said, using the drugs without systematic testing was “unwise.”

“I wish we had had this information at the outset, as there has potentially been harm to patients,” he said.

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 or clarithromycin, within 48 hours of their diagnosis. The study is a retrospective analysis of their medical records, rather than a controlled study in which patients are divided randomly into treatment groups — the method considered the gold standard of medicine. But the sheer size of the study was convincing to some scientists.

And the difference between those who received the antimalarials and those who did not was striking.AD

For those given hydroxychloroquine, there was a 34 percent increase in risk of mortality and a 137 percent increased risk of a serious heart arrhythmias. For those receiving hydroxychloroquine and an antibiotic — the cocktail endorsed by Trump — there was a 45 percent increased risk of death and a 411 percent increased risk of serious heart arrhythmias.

Those given chloroquine had a 37 percent increased risk of death and a 256 percent increased risk of serious heart arrhythmias. For those taking chloroquine and an antibiotic, there was a 37 percent increased risk of death and a 301 percent increased risk of serious heart Antimalarial drug arrhythmias.Hydroxychloroquine’s false hope: How an obscure drug became a coronavirus ‘cure’ | The Fact CheckerClaims about hydroxychloroquine to treat covid-19 have gained traction despite a lack of scientific evidence. How did this happen? (Elyse Samuels, Meg Kelly, Sarah Cahlan/The Washington Post)

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Cardiologist Steven Nissen of the Cleveland Clinic said the new data, combined with data from smaller previous studies, suggests that the drug “is maybe harmful and that no one should be taking it outside of a clinical trial.”AD

Jesse Goodman, a former FDA chief scientist who is now a Georgetown University professor, called the report “very concerning.” He noted, however, that it is an observational study, rather than a randomized controlled trial, so it shows correlation between the drugs and certain outcomes, rather than a clear cause and effect.

Peter Lurie, a former top FDA official who now heads the Center for Science in the Public Interest, called the report “another nail in the coffin for hydroxychloroquine Antimalarial drug — this time from the largest study ever.”

He said it was time to revoke the emergency use authorization issued by the FDA, which approved the drug for seriously ill patients who were hospitalized or for whom a clinical trial was not available.

FDA spokesman Michael Felberbaum said Friday the agency generally “does not comment on third-party research” but that an emergency use authorization may be revised or revoked under certain circumstances, such as when there are linked or suspected adverse events, new data about effectiveness, or changes in the risk-benefit assessment of the drug. Last month, the agency warned against the use of the drug outside hospital settings or clinical trials citing reports of “serious heart rhythm problems.”

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