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Journal admits 'serious scientific questions' over coronavirus treatment study

Hydroxychloroquine has been much touted by US president Donald Trump - George Frey/Reuters
Hydroxychloroquine has been much touted by US president Donald Trump - George Frey/Reuters
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The World Health Organization is to resume a trial into a controversial coronavirus treatment after suspending it over safety concerns flagged in a paper published in the Lancet medical journal.

The WHO announced it would resume a trial into hydroxychloroquine after the Lancet admitted there were  “serious scientific questions” surrounding the data in a paper it published on the treatment.

The Lancet paper said the treatments had no benefits and may even put patients at risk of dying, leading the WHO to suspend its trial into the treatments last month. The leaders of a UK-based trial vowed to continue, saying they were confident their study was safe.

The WHO's director-general, Tedros Adhanom Ghebreyesus, said its experts had advised the continuation of all trials including hydroxychloroquine.

"The executive group will communicate with the principal investigators in the trial about resuming the hydroxychloroquine arm of the trial," Dr Tedros said.

The WHO's decision to suspend its trial prompted others to follow suit, including Sanofi. A Sanofi spokesman said the company would review available information and run consultations in the coming days to reassess its position following the WHO's latest decision on Wednesday.

In a statement, the Lancet acknowledged "important" questions over the research, after dozens of scientists issued an open letter last week raising concerns about the methodology and transparency around the data, which was provided by the firm Surgisphere.

"Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention," the Lancet said in a statement.

An expression of concern is not as serious as a retraction but it does mean that there are serious questions over its findings.

An investigation by the Guardian newspaper found that few of Surgisphere’s employees had a scientific or data background. One was a science fiction writer and another an adult-content model, the paper reported.

The malaria drugs have been the subject of much debate after a very small French study - since debunked - found they were effective in the treatment of coronavirus. US president Donald Trump has repeatedly championed hydroxychloroquine against the advice of his advisors and last month admitted he was taking it as a preventive therapy.

The Lancet study looked at the records of 96,000 patients and concluded that treatment with hydroxychloroquine and chloroquine showed no benefit and even increased the likelihood of patients dying in hospital.

It led to the WHO suspending the hydroxychloroquine arm of its Solidarity trial. However, the leaders of the Recovery trial, which is testing a range of treatments including hydroxychloroquine on patients in 176 NHS hospitals, said they would continue.

Martin Landray, professor of medicine and epidemiology at the University of Oxford and leader of the Recovery trial, said an observational study - such as the Lancet paper - was a “wholly inadequate method” of making decisions on the harms and benefits of drugs.

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“The sooner we get answers from randomised controlled trials [such as the Recovery trial] the better. If it turns out hydroxychloroquine is effective for Covid-19, then let’s use it; if not, let’s abandon it. But this is not a time for speculation and certainly not a time to hold up the very trials that will give us the knowledge we need.”

Peter Horby, professor of emerging infectious diseases and global health at the University of Oxford, said: “The Lancet publication ... has had major adverse impacts, resulting in the suspension of numerous well-designed clinical trials. This is completely unjustified. Even if the results were correct, observational data such as this, with its inherent weaknesses, should not be used to stop trials which will provide definitive and actionable answers.”

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