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A box of Plaquenil (hydroxychloroquine) is seen at a drugstore in Paris. Xinhua News Agency/PA Images
Surgisphere

Hydroxychloroquine study in Lancet pulled after authors couldn't verify data

The now-retracted study found that hydroxychloroquine showed no benefit against the coronavirus – and even increased the risk of dying in hospital.

THREE OF THE four authors behind a large-scale study in The Lancet that raised safety fears over the use of common anti-malarial drugs to treat Covid-19 have retracted their paper, blaming a company that supplied the data set.

The study retrospectively analysed some 96,000 patient records used in a study that found hydroxychloroquine and chloroquine showed no benefit against the coronavirus – and even increased the risk of dying in hospital, with heart arrhythmia a particular concern.

The finding led the World Health Organization to suspend clinical trials into the medicines, but it was soon followed by widespread concern among scientists over a lack of information about the countries and hospitals that contributed data.

Mandeep Mehra, a professor at Harvard University who led the work, along with Frank Ruschitzka of the University Hospital Zurich and Amit Patel of the University of Utah, said in a statement they had tried to launch a third-party peer review into the data.

But Surgisphere, a little-known healthcare analytics firm based in Chicago that supplied the records, refused to cooperate with the peer reviewers, who had been asked to verify the records and replicate the study’s findings.

Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements.

“Based on this development, we can no longer vouch for the veracity of the primary data sources,” the three authors said.

Due to this unfortunate development, the authors request that the paper be retracted.

They stressed that they had worked “in good faith and at a time of great need” during the Covid-19 pandemic.

We deeply apologize to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused.

Sapan Desai, a vascular surgeon and Surgisphere’s chief executive, did not join the retraction. The public relations firm that represents him told AFP he would not be making a comment at this time.

This story was first highlighted in an exclusive by The Guardian, which raised concerns about the data provided by, and scientific qualifications of employees at Surgisphere.

This lead the Lancet and New England Journal of Medicine to issue expressions of concern, and also lead to the WHO to resume its hydroxychloroquine trials.

The trials had been suspended after this seemingly large-scale study published last month cast doubt over its effectiveness and safety.

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