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Hydroxychloroquine safety study pulled on data integrity concern

A retraction by three of the study’s authors has been published by The Lancet

clinical trial

Medical journal The Lancet has withdrawn a study that raised a red flag over the safety of potential coronavirus treatment hydroxychloroquine as some authors can no longer “vouch for the veracity” of the data.

The widely-cited article – which linked use of the antimalarial to higher rates of ventricular arrhythmia and death in COVID-19 patients – led to the suspension of a World Health Organization study of hydroxychloroquine last month, which restarted this week.

The study prompted a media storm, particularly after President Donald Trump revealed at a press conference he was taking the drug prophylactically to ward off the coronavirus.

In a statement, The Lancet said it “takes issues of scientific integrity extremely seriously, and there are many outstanding questions about Surgisphere and the data that was allegedly included in this study”.

A retraction by three of the study’s authors has been published by The Lancet, which says the company behind the data – Surgisphere Corp – has refused to reveal their complete data set for independent audit.

The study looked at records of almost 15,000 patients treated with hydroxychloroquine or related drug chloroquine, and said it found an elevated risk of ventricular arrhythmias and ‘lower in-hospital survival’ when used in COVID-19 patients, and no evidence of a benefit against coronavirus.

Questions were immediately raised about the findings, with one researcher – Professor Peter Horby who is leading the University of Oxford’s large-scale 10,000-patient RECOVERY trial of coronavirus drugs – told the BBC that his team hadn’t seen that safety signal in the prospective trial.

“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic,” says the retraction by Harvard University researcher Mandeep Mehra, Frank Ruschitzka of University Hospital Zurich, and Amit Patel of the University of Utah.

“We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused,” they conclude.

Whether hydroxychloroquine is safe or not is a separate issue to its efficacy in thwarting COVID-19 of course, and on the latter the jury is still very much out.

This week, one study found that the drug had no benefit when used as post-exposure prophylaxis, although the results of ongoing studies like RECOVERY and the WHO’s SOLIDARITY trial will be needed to see if it can play a role in people already showing COVID-19 symptoms.

Article by
Phil Taylor

5th June 2020

From: Research, Regulatory



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