Lancet study: HCQ may harm patients

Joanna Estrada
May 23, 2020

A new study published Friday says COVID-19 patients who were treated using chloroquine or hydroxychloroquine - a drug touted by President Donald Trump as a cure for the coronavirus - were more likely to die than those who did not take the drug.

On April 24, the Food and Drug Administration cautioned against the use of hydroxychloroquine "outside of the hospital setting or a clinical trial due to risk of heart rhythm problems".

Mehra's group analyzed some 96,000 patients from 671 hospitals on six continents with COVID-19 infection, from December 20 to April 14, all of whom had either died or been discharged from the hospital by April 21.

The study looked at the records of 15,000 people who had been treated with the antimalarials and one of two antibiotics that have sometimes been paired with them. But the problem is that, while researchers can control for risk factors that they know about, they can't rule out that patients getting chloroquine and hydroxychloroquine are dying for reasons they don't understand that have nothing to do with the drugs.

However, the new research, published May 22 in The Lancet, is the latest in a long line of studies suggesting that the drug is useless against the new coronavirus and COVID-19. "In the meantime, we suggest these drugs should not be used as treatments for COVID-19 outside of clinical trials".

The difficulty with observational (sometimes called "real-world") studies is that, often, the patients whom doctors choose to treat with a drug are different - in this case, probably sicker - than those who go untreated.

The research, which was paid for by grants from the National Institutes of Health and the University of Virginia, evaluated data from 368 COVID-19 patients and found that about 28 percent who were given the drug in addition to the usual care died, versus 11 percent of those who only received routine care.

The antimalarial drugs have been surrounded by controversy after enthusiastic remarks by US President Donald Trump earlier this year that left some epidemiologists uneasy given the well-known risks of the drugs particularly for people with heart conditions. There was also a control group of patients not given these treatments.

Hydroxychloroquine and chloroquine were linked with an increased risk of mortality in hospitals, researchers said.

In all, 1,868 took chloroquine alone, 3,783 took that plus an antibiotic, 3,016 took hydroxychloroquine alone and 6,221 took that plus an antibiotic.

"It is clear that high-profile endorsements for taking these drugs without clinical oversight is both misguided and irresponsible".

"Randomized clinical trials are essential to confirm any harms or benefits associated with these agents", Mehra said.

Researchers are searching through available options to treat the coronavirus, which has killed more than 330,000 people, including drugs like the antimalarials that are also already approved to treat lupus and rheumatoid arthritis. Former FDA official Peter Lurie added that the study is "another nail in the coffin for hydroxychloroquine, this time from the largest study ever conducted".

Lead author Mandeep Mehra, a Harvard Medical School professor and doctor at Brigham and Women's Hospital, told the Post in retrospect it was unwise to put the drugs into widespread use without systematic testing, but "a desperate disease demands desperate measures".

Other reports by Click Lancashire

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