Coronavirus: WHO re-starts hydroxychloroquine trials amid controversy over published research

Concerns should lead to ‘serious reflection on whether the quality of editorial and peer review during the pandemic has been adequate’

Clinical trials of the drug hydroxychloroquine to treat coronavirus are to re-start the World Health Organisation has said amid concerns over research into its effects that have been published in leading medical journals.

The controversy over the malaria drug, hailed by President Donald Trump, and studies published in The Lancet and New England Medical Journal has led to warnings from scientists over the effect the pandemic has had on the quality of research being published during the crisis.

On Wednesday The Lancet revealed it had published an "expression of concern" about a study into hydroxychloroquine using data provided by US company Surgisphere. The Lancet said there were "important scientific questions" that had been raised.

The study said neither hydroxychloroquine or chloroquine should be used to treat Covid-19 patients due to high numbers of deaths, prompting the WHO to suspend tests until the safety data was reviewed.

Concerns about the data were initially raised on blog posts and then on the website PubPeer, which allows users to discuss and review scientific research.

Among the criticisms were the seemingly high mortality rates linked to drugs that have been routinely prescribed since the 1950s.

Peter Horby, professor of emerging infectious diseases at the University of Oxford, said the concerns were very serious “and ought to bring about serious reflection on whether the quality of editorial and peer review during the pandemic has been adequate. Scientific publication must above all be rigorous and honest. In an emergency, these values are needed more than ever.”

Dr Stephen Griffin, associate professor in the school of medicine at the University of Leeds, said: “The withdrawal of these drugs from various clinical settings based upon what may be dubious mortality data could deprive Covid-19 patients of a potentially effective therapy. Lastly, we must ask is it feasible, or indeed fair, for individual peer reviewers to assess such studies, as they necessarily depend upon intrinsic trust and cannot logistically validate such enormous data sets.”

The Lancet said an independent audit of the data was now underway and results were expected soon.

The Guardian reported Surgisphere has only a handful of employees with little or no data or scientific background.

In a statement the company said: "In our hydroxychloroquine analysis, we studied a very specific group of hospitalised patients with Covid-19 and have clearly stated that the results of our analyses should not be over-interpreted to those that have yet to develop such disease or those that have not been hospitalised.

"We also clearly outlined the limitations of an observational study that cannot fully control for unobservable confounding measures, and we concluded that off-label use of the drug regimens outside of the context of a clinical trial should not be recommended.

"Our Covid-19 research was not funded by any drug company, private or public donor, or political organisation.

"Our research collaborators on the piece for The Lancet devoted their time through personal funds and resources because they saw the urgent humanitarian need and opportunity to inform rapidly evolving pandemic responses."