Covid-19: Lancet retracts paper that halted hydroxychloroquine trials

COVID-19: WHO resumes study on Hydroxychloroquine

Hydroxychloroquine safety study pulled on data integrity concern

This is the latest installment in the long-running hydroxychloroquine saga - a drug that gained worldwide notoriety after USA president Donald Trump touted it as a "game changer" and then admitted to taking it as a preventive treatment.

"As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process after severe criticism for the quality of its data", The Lancet said in its retraction statement.

Lead author Mandeep Mehra, MD, of Brigham and Women's Hospital in Boston, and two colleagues said they had called for an independent, third-party review in an attempt to replicate the analyses presented in the paper, to confirm the database's completeness, and evaluate origination of the database elements.

"As a result, they have concluded that they 'can no longer vouch for the veracity of the primary data sources, '" the Lancet explained, adding, "The Lancet takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that were allegedly included in this study".

The World Health Organization immediately suspended the hydroxycholoroquine arm of its worldwide Solidarity trial pending a safety review.

COVID-19: WHO resumes study on Hydroxychloroquine

The study retrospectively analysed some 96,000 patient records, finding that 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 current study involved 19 patients with a confirmed COVID-19 diagnosis that required hospitalisation, as well as with low blood-oxygen levels and evidence of inflammation.

"The executive group received this recommendation and endorsed the continuation of all arms of solidarity trial, including hydroxychloroquine".

A separate clinical trial on Wednesday in the U.S. and Canada found that taking hydroxychloroquine shortly after being exposed to COVID-19 does not work to prevent infection significantly better than a placebo.

In a statement, the authors of the study apologised to the editors and readers for any "embarrassment or inconvenience caused".

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Days after the article earned worldwide circulation on May 22, the World Health Organization announced on May 25 that it was suspending clinical trials for chloroquine in the treatment of coronavirus patients.

It had published a study involving almost 15,000 patients, from hundreds of hospitals, given hydroxycholoroquine or the similar drug chloroquine.

"It doesn't work", Martin Landray, an Oxford University professor who is co-leading the RECOVERY trial, told reporters.

The study was then retracted on Thursday after its authors said they were unsure about its data.

An independent audit company was asked to examine a database provided for the research by the United States company, Surgisphere, to ensure it had the data from more than 96,000 Covid-19 patients in 671 hospitals worldwide, that it was obtained properly and was accurate. Many scientists were angry that they had been stopped on the basis of a trial that was observational and not a "gold standard" RCT.

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Results showed no significant difference in death rates after 28 days, in length of stay in hospital or in other outcomes, the researchers said.

The findings come in the wake of deep concern in academic publishing that led to an article being retracted in the Lancet - one of the world's most prestigious medical journals.

At the height of the pandemic in March, Swiss hospitals all had their own policies with regard to administration of the drug, according to data gathered by Swiss television RTS.

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