WHO restarts drug trial as doubts grow over clinical data

Via Financial Times

The World Health Organisation will resume coronavirus trials of the contentious drug hydroxychloroquine after doubts emerged over the validity of a study that led to them being put on hold.

WHO officials said on Wednesday that the decision to resume was made after considering data from a number of studies. “We are now fairly confident, not having seen any differences in mortality . . . that the trial can continue,” said Soumya Swaminathan, the WHO’s chief scientist.

The case has fanned concerns about the reliability of the data and analysis used to make decisions about virus treatments as companies, researchers and doctors are under intense pressure to find ways to tackle the pandemic.

A high-profile study in the medical journal The Lancet last month said hydroxychloroquine, an antimalarial drug touted as a coronavirus treatment by Donald Trump, the US president, showed no benefit and could provoke adverse effects, including heart problems and death.

But in a surprise move on Tuesday, The Lancet published a formal “expression of concern” saying the data that underpinned that study was flawed. “Important scientific questions have been raised about data reported in the paper,” the medical journal said.

Experts have questioned how Surgisphere, a Chicago-based company whose founder Sapan Desai was a co-author of the paper, obtained health data from hospitals across the world. They have also drawn attention to inconsistencies with government-reported figures.

Three of the four authors of the study who were not affiliated with Surgisphere have commissioned an independent audit of the origin of the data.

The study analysed data on the condition of Covid-19 patients in hospital who had been given the drug but were not part of clinical trials. It said it drew its conclusions from data on over 96,000 patients in 671 hospitals on six continents. 

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The results from the Lancet study were cited as a reason to pause the WHO trial. It provided evidence to scientists, many of whom were already worried about the side effects of the drug hailed by Mr Trump, that it was not beneficial.

Surgisphere, in a response to the criticism, said it had made one error by adding an Asian hospital to its Australasia group, which has now been reclassified. “There was no error in analysis, and none of the results of the paper are affected,” it said. 

“It is also vitally important that our scientific colleagues around the world understand the validity of our database . . . We are committed to demonstrating the high standards we hold at Surgisphere, and the robustness of the work that has been completed.”

Surgisphere and Mr Desai did not respond to requests for comment from the Financial Times.

WHO officials said the hydroxychloroquine arm of its large-scale Solidarity trial would resume after being paused last month. Ms Swaminathan noted that no drug had yet been proved to be effective in reducing deaths from Covid-19.

Also on Wednesday, a trial from the University of Minnesota found that taking hydroxychloroquine does not prevent people from developing Covid-19. Mr Trump had previously said he was taking it as a prophylactic.

Peter Horby, professor of emerging infectious diseases at Oxford university and an investigator on Recovery, a UK study on hydroxychloroquine that was not stopped after the Lancet paper, said: “The Lancet publication . . . has had major adverse impacts, resulting in the suspension of numerous well-designed clinical trials. This is completely unjustified.” 

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He added: “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.”