Lancet retracts article that linked hydroxychloroquine to higher death risks

The Lancet has retracted an influential study that showed that COVID-19 patients who took hydroxychloroquine had a higher mortality rate and increased heart problem, citing concerns about the quality of the data behind it.

The results of the study, which claimed to have analysed data from nearly 96,000 patients on six continents, led several governments to ban the use of the anti-malarial drug for coronavirus patients due to safety concerns.

The retraction came at the request of the authors of the studies, published last month, who were not directly involved with the data collection and sources, the British medical journal said.

The drug has been controversial in part due to support from US President Donald Trump, as well as implications of the study.

An investigation by The Guardian newspaper found that employees at Surgisphere, the company that The Lancet relied on for its data, had little to no data science or scientific background.

The study's authors said Surgisphere would not transfer the full dataset for an independent review and that they "can no longer vouch for the veracity of the primary data sources", according to Reuters news agency.

The Lancet in a statement said "there are many outstanding questions about Surgisphere and the data that were allegedly included in this study."

The Guardian on Wednesday reported the World Health Organisation and a number of governments had changed their COVID-19 policies and treatments on the basis of flawed data from the little-known US healthcare analytics company.

The development also called into question the integrity of key studies published in some of the world’s most prestigious medical journals.

A Guardian investigation revealed Surgisphere’s handful of employees appeared to include a science fiction writer and an adult-content model.

It has provided data for multiple studies on COVID-19 co-authored by its Chief Executive Sapan Desai but has so far failed to adequately explain its data or methodology.

A group of scientists who raised questions last week about the study in The Lancet about the use of the anti-malarial drugs in coronavirus patients have objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry, according to The New York Times.

Moments after their open letter was posted online Tuesday morning, the editors of the NEJM posted an “expression of concern” about the paper, and said they had asked the paper’s authors to provide evidence that the data are reliable, The Times reported.

In their letter to the NEJM, critics of the work pointed out “major inconsistencies” between the number of coronavirus cases recorded in some countries during the study period and the number of patient outcomes reported by the researchers over the same period.

The Surgisphere data from the United Kingdom reported on 706 patients hospitalised with confirmed COVID-19 in just seven of the UK’s 1,257 National Health Service hospitals.

But even no London borough or hospital had more than 100 confirmed cases by Mar 16, the critics said.

The study reported 346 patients with confirmed cases in three Turkish hospitals by Mar 15, but Istanbul University Hospital, one of the largest hospitals in the city, admitted its first COVID-19 patient on Mar 16, The New York Times reported citing the critics’ letter to NEJM.

The Guardian said a search of publicly available material suggests several of Surgisphere’s employees have “little or no data or scientific background”.

An employee listed as a science editor appears to be a science fiction author and fantasy artist. Another employee listed as a marketing executive is an adult model and events hostess, the Guardian found.

The company’s LinkedIn page last week listed “just” six employees. This was changed to three employees as of Wednesday.

Despite its claims to be “one of the largest and fastest” hospital databases in the world, Surgisphere has “almost no online presence”, according to the Guardian report.

Its Twitter handle has no posts between October 2017 and March 2020.

Until Monday, the “get in touch” link on Surgisphere’s homepage redirected to a WordPress template for a cryptocurrency website, raising questions about how hospitals could easily contact the company to join its database.

Desai has been named in three medical malpractice suits, unrelated to the Surgisphere database.

In 2008, Desai launched a crowdfunding campaign on the website Indiegogo promoting a wearable device that “can help you achieve what you never thought was possible”. The device never came to fruition.

Desai’s Wikipedia page has been deleted following questions about Surgisphere and his history, first raised in 2010.