Authors retract study which led the WHO to suspend a trial into hydroxychloroquine

The authors of a study that cast doubt on the controversial malaria treatment hydroxychloroquine have retracted their research paper over the “veracity” of the data they presented.

The retraction concerns a paper published in the Lancet at the end of May which concluded that the treatment had no benefit and may even put patients at risk of dying.

The findings led the World Health Organization to suspend its trial into the drug - although it said on Wednesday it would resume the study after concerns over the paper were first raised.

Researchers not involved in the Lancet study cast doubt on the methodology and transparency around the data, which was provided by the firm Surgisphere.

An investigation by the Guardian newspaper found that few of Surgisphere’s employees had a scientific or data background. One was a science fiction writer and another an adult-content model, the paper reported.

The authors of the Lancet paper launched a review into Surgisphere to “evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper”.

However the independent reviewers were unable to get hold of the data on which the paper was based.

The researchers said in a statement: “We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources.”

In a statement the Lancet said: “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 WHO's decision to suspend its trial prompted others to follow suit, including Sanofi. A Sanofi spokesman said the company would review available information and run consultations in the coming days to reassess its position.

Hydroxychloroquine has been the subject of much debate in recent weeks after a very small French study - since debunked - found it was effective in the treatment of coronavirus. US president Donald Trump has repeatedly championed the study against the advice of experts and last month admitted he was taking it as a preventive therapy.

The Lancet study looked at the records of 96,000 patients and concluded that treatment with hydroxychloroquine and chloroquine showed no benefit and even increased the likelihood of patients dying in hospital.

Martin Landray, professor of medicine and epidemiology at the University of Oxford and leader of a large-scale randomised control trial looking into hydroxychloroquine, said an observational study - such as the Lancet paper - was a “wholly inadequate method” of making decisions on the harms and benefits of drugs.

“The sooner we get answers from randomised controlled trials the better. If it turns out hydroxychloroquine is effective for Covid-19, then let’s use it; if not, let’s abandon it. But this is not a time for speculation and certainly not a time to hold up the very trials that will give us the knowledge we need.”

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