WHO says it did not see Surgisphere data that halted virus drug trial

The World Health Organisation’s chief scientist has said it did not see data collected by a US company called Surgisphere that is at the heart of controversy over coronavirus drug trials halted by the WHO.

The WHO said this week it would resume trials of hydroxychloroquine, an antimalarial drug, after pausing them in the wake of a study in The Lancet, a medical journal, which showed it had no benefit for virus patients and suggested it could be linked to increased mortality.

Soumya Swaminathan, the WHO’s chief scientist, told the Financial Times on Thursday: “In hindsight, you can say maybe we should have asked for the database, we should have examined [it], but that’s not normal, especially when it’s published in The Lancet.”

The Lancet study was compiled using a database administered by Surgisphere, a little known Chicago-based healthcare analytics company that provides data to medical researchers and others.

Experts have raised doubts over how Surgisphere, whose founder Sapan Desai was a co-author of the study, obtained data from hospitals across the world. They have also drawn attention to inconsistencies with government-reported figures.

Ms Swaminathan said that “in hindsight, one could criticise” the failure to examine the database, “but the decision was based on an expert group considering all evidence and making an informed decision with a view to protecting patients”.

The Lancet has published a so-called “expression of concern” on the Surgisphere-linked study, saying the data that underpinned it was faulty. When the study was published it led to multiple governments and entities around the world pausing hydroxychloroquine trials.

The drug has been touted as a coronavirus treatment by fans including US president Donald Trump, who says he is taking it for preventative purposes.

Surgisphere did not reply to a request for comment. It has previously said, responding to criticism, that it made one error that was later on rectified, and that it was committed to demonstrating the robustness of its work.

Ms Swaminathan said that authors, especially during this pandemic, had a “responsibility to put out information that is credible, that is really based on strong data, and not things that are speculative or outright false . . . We’ve seen how damaging that can be.”

She said: “We are happy that The Lancet has asked the authors to relook at their data and put out that cautionary note and we look forward to seeing the results of that external independent audit.”

A WHO spokeswoman said it relies on data from reputable scientific journals and member states. “We cannot risk endangering patients if even the smallest safety concern is raised [particularly during a pandemic] so we decided to pause the trial until we could actually look at data from our own trial and from an observational study in the UK,” she said.

“As soon as we verified the safety data and the Lancet study was found flawed, we immediately resumed the trial,” she added.

Ms Swaminathan said: “When you’re doing a trial, you have to follow scientific and ethical principles regardless of the political or other implications.”

The Lancet did not immediately respond to a request for comment.

A study published in the New England Journal of Medicine on Wednesday found no benefit for the prophylactic use of hydroxychloroquine.

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