‘Largest study ever’ shows that hydroxychloroquine raises risk of coronavirus death
One of the largest studies to date on the antimalarial drug President Donald Trump said he’s been taking to prevent coronavirus infection shows that confirmed-positive patients who received it had a higher risk of death than those who did not, and a significantly higher risk of heart arrhythmia.
The paper published Friday in the peer-reviewed journal the Lancet offers a more comprehensive review of the drug compared to other studies after observing medical records of about 96,000 coronavirus patients in six continents.
It’s what one former U.S. Food and Drug Administration official called “another nail in the coffin for hydroxychloroquine — this time from the largest study ever,” Peter Lurie, head of the nonprofit called Center for Science in the Public Interest, told The Washington Post.
Another expert told the outlet: “It’s one thing not to have benefit, but this shows distinct harm. If there was ever hope for this drug, this is the death of it,” said Eric Topol, a cardiologist and director of the Scripps Research Translational Institute.
A team of cardiologists analyzed the medical records of 96,032 lab-confirmed coronavirus patients hospitalized between Dec. 20 and April 14, the study said.
The records came from 671 hospitals around the world. A nearly equal amount of men and women were studied who averaged 54 years old, according to the study.
“Patients for whom one of the treatments of interest was initiated more than 48 hours after diagnosis or while they were on mechanical ventilation, as well as patients who received remdesivir, were excluded,” the study said.
Nearly 15,000 of the total patient samples studied were given hydroxychloroquine, chloroquine with an antibiotic called macrolide, hydroxychloroquine with a macrolide, or just chloroquine alone.
Individuals receiving the hydroxychloroquine had about a 34% higher chance of dying compared to controls, and about a 137% increased risk of heart arrhythmias, or irregular heart beats, according to the study.
Patients who received hydroxychloroquine and macrolide saw about a 45% increased risk of mortality, with about a 411% higher chance of serious heart abnormalities.
The study is one of at least a dozen on the drug used to treat or prevent malaria, as well as treat autoimmune conditions such as lupus and rheumatoid arthritis, according to the FDA.
In April, the agency approved an “emergency use authorization” for hydroxychloroquine despite a proper understanding of its risks and benefits in coronavirus patients.
The FDA issued a warning at the end of the same month reminding health care workers and the general public that using the drug outside of a hospital setting is dangerous because heart abnormalities can occur without immediate care.
“The EUA was based upon limited evidence that the medicines may provide benefit, and for this reason, we authorized their use only in hospitalized patients under careful heart monitoring,” the agency said.
But Janet Woodcock, head of the FDA Center for Drug Evaluation and Research, said the EUA is not an “FDA approval in any shape or form,” after the agency received backlash for the decision, according to Stat.
“We simply said it’s possible from the in vitro data this may have a beneficial effect and the benefits may outweigh the risks,” Woodcock told the outlet. “... Given the circumstances, I would say we did the best we could.”
During a press briefing Monday, Trump announced he has been taking hydroxychloroquine for “a couple weeks,” McClatchy News previously reported.
His doctor Sean Conley and press secretary Kayleigh McEnany confirmed Trump’s claims in a White House statement and press conference, respectively.
“After numerous discussions he and I had regarding the evidence for and against the use of hydroxychloroquine, we concluded the potential benefit from treatment outweighed the relevant risks,” Conley said in the statement.
About a month prior, Trump called one U.S. study that claimed hydroxychloroquine did not prove effective for treating coronavirus a “Trump enemy statement,” The Guardian reported.
Other studies on hydroxychloroquine
A doctor from France sparked the craze over hydroxychloroquine when he reported that the drug, combined with the antibiotic azithromycin, appeared to help coronavirus patients recover.
Two weeks later, the journal that published the paper discredited the study, saying it “does not meet the [International Society of Antimicrobial Chemotherapy’s] expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.”
About a dozen other studies, both peer-reviewed and non peer-reviewed, have analyzed the malaria drugs since then, however many had small sample sizes and studied specific groups of people, leading some to believe the studies weren’t as comprehensive as the pandemic crises required.
One non-peer reviewed preprint published in mid-April claimed the drugs had no benefits and were linked to higher death rates in coronavirus patients, but it only studied 368 male Veteran’s Affairs patients, McClatchy News previously reported.
Since then, doctors have learned more about the pathogen, including its ability to attack the heart and other organs such as the kidney and liver, according to McClatchy News.
The extra knowledge poses extra risks for patients given hydroxychloroquine because the drugs are known to cause abnormal heart rhythms, and those who already suffer from heart and kidney disease have higher chances of suffering from these potential abnormalities, according to the FDA.
This story was originally published May 22, 2020 at 10:41 AM with the headline "‘Largest study ever’ shows that hydroxychloroquine raises risk of coronavirus death."
