The World Health Organization’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 following 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.
The Lancet study was retracted on Thursday by three of its authors, but not by the founder of Surgisphere, Sepan Desai, a co-author whose company provided data on which it was based.
Before the retraction, Soumya Swaminathan, the WHO’s chief scientist, told the Financial Times: “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 had been compiled using a database administered by Surgisphere, a little known Chicago-based healthcare analytics company that provides data to medical researchers and others.
The Lancet said institutional reviews of Surgisphere’s research collaborations were “urgently needed”.
Experts had already raised doubts over how Surgisphere obtained data from hospitals across the world. They had 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 had published an “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 three authors who retracted the study said: “Our independent peer reviewers informed us that Surgisphere would not transfer the full data set, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements,” they said. “As such, our reviewers were not able to conduct an independent and private peer review.”
The drug has been touted as a coronavirus treatment by fans including US president Donald Trump, who said he is taking it for preventive 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 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.”
WHO 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.”
A study published in the New England Journal of Medicine on Wednesday found no benefit for the prophylactic use of hydroxychloroquine.