HCQ clinical trials will resume: WHO

HCQ clinical trials will resume: WHO

The Lancet says it has concerns about article on use of drug in COVID-19 patients

04/06/2020, AGENCE FRANCE-PRESSE, REUTERS,GENEVA/NEW YORK

Hydroxychloroquine has anti-inflammatory and antiviral properties .REUTERS

The World Health Organisation said on Wednesday that clinical trials of the drug hydroxychloroquine will resume, after having been suspended pending a safety review in the search for coronavirus treatments.

“On the basis of the available mortality data... the executive group will communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm,” WHO chief Tedros Adhanom Ghebreyesus told a virtual news briefing.

Concerns about data

British medical journal The Lancet said on Tuesday that it had concerns about data behind an influential article that found that HCQ increased the risk of death in COVID-19 patients, a conclusion that undercut scientific interest in the medicine championed by U.S. President Donald Trump.

Hydroxychloroquine — which has anti-inflammatory and antiviral properties — inhibited the coronavirus in laboratory experiments, but has not been proven effective in humans, particularly in placebo-controlled, randomised clinical trials considered the gold standard for data. The debate has become highly politicised, and many scientists have voiced concern.

Open letter

Nearly 150 doctors signed an open letter to The Lancet last week calling the article’s conclusions into question and asking to make public the peer review comments that preceded publication.

“This is not some sideshow or minor issue,” said Walid Gellad, a Professor at University of Pittsburgh’s medical school, who was not a signatory of the letter but has been critical of the study. “We’re in an unprecedented pandemic. We’ve organised these enormous clinical trials to figure out if something works. And this study stopped or paused a couple of those trials, and changed the narrative around a drug that no one knows if it works or not,” he said.

The study, using data provided by healthcare data analytics firm Surgisphere, was not a traditional clinical trial that would have compared hydroxychloroquine to a placebo or other medicine.

The Lancet’s editors said in a note that serious scientific questions about the study were brought to their attention and an independent audit of the data has already been commissioned.