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The Lancet study was retracted on Thursday by three of its authors, but not by the founder of Surgisphere, Sepan Desai, a co-author whose company provided data on which it was based.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 medical journal said institutional reviews of Surgisphere’s research collaborations were “urgently needed”.
Later on Thursday, a study published in The New England Journal of Medicine on heart drugs and coronavirus was also retracted by all of its authors, including Mr Desai.
Mandeep Mehra, a Harvard University doctor who was a co-author on that study, said: “It is now clear to me that in my hope to contribute this research during a time of great need, I did not do enough to ensure that the data source was appropriate for this use. For that, and for all the disruptions — both directly and indirectly — I am truly sorry.”
Experts have raised doubts over how Surgisphere obtained data from hospitals across the world for both studies. 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 supporting the Lancet study, “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 study led to multiple governments and entities around the world pausing hydroxychloroquine trials. The journal published an “expression of concern” earlier this week, saying the data that underpinned it was faulty. The NEJM had published a similar notice.
The three authors who retracted the study published in the Lancet 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. As such, our reviewers were not able to conduct an independent and private peer review.”
Hydroxychloroquine 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.
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,” a spokesperson said.
“As soon as we verified the safety data and the Lancet study was found flawed, we immediately resumed the trial.”
Ms Swaminathan added that scientific 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.”
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June 05, 2020 at 04:33AM
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WHO says it did not see Surgisphere data that halted virus drug trial - Financial Times
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