Hyped coronavirus drug study mired in controversy over data reliability

Serious concerns have been raised about data used in a recent hydroxychloroquine study showing the drug causes increased mortality.

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Serious questions are being raised over a study reporting negative effects of controversial coronavirus treatment hydroxychloroquine.

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The story of hydroxychloroquine, the anti-malarial drug touted by the likes of US President Donald Trump as a game-changing COVID-19 treatment, has taken another unexpected turn. On Tuesday, The Lancet, one of the world's leading medical journals, issued an "expression of concern" stating "serious scientific questions" have been raised about a recent observational study purportedly linking the drug to a higher incidence of heart problems and increased mortality rate in COVID-19 patients.

The study, originally published in The Lancet on May 22, looked at over 96,000 patients, with nearly 15,000 patients in the cohort having received chloroquine or hydroxychloroquine. The research prompted the WHO to implement a "temporary pause" on its hydroxychloroquine clinical trial so it could review safety data it had gathered.

But shortly after the pause, on May 28, over 180 researchers signed an open letter to Richard Horton, the editor of The Lancet, raising concerns about the study. The collaboration raised a number of concerns over the validity of the data and the ethical standards of the study and a Guardian Australia report showed inconsistencies in the statistics. The report has since been amended but concerns remain. 

The data in The Lancet paper was provided by a Chicago-based company known as Surgisphere, a health care analytics company that claims to have used electronic health records from 1,200 hospitals across the world to inform its analysis. One of the chief executives of Surgisphere, Sapan Desai, is a co-author on The Lancet study. Scientists have called for the dataset that informed the study to be made publicly available. But the company said in a statement that its "data use agreements" prevent sharing of patient level data.

An additional paper using Surgisphere data from 169 hospitals and published in the New England Journal of Medicine has also received similar criticism. The paper discusses the harmful effects of ACE inhibitors and AR blockers, medications for high blood pressure. On Tuesday, the New England Journal of Medicine issued its own expression of concern, asking the authors of the piece to "provide evidence that the data are reliable."

Surgisphere didn't immediately respond to a request for comment.

While the controversy has thrown into question the validity of The Lancet's hydroxychloroquine study, the concerns by no means suggest hydroxychloroquine is safe or effective as a COVID-19 treatment option. There are no clear indications the drug benefits people with COVID-19 and a handful of studies have demonstrated negative side effects. Hydroxychloroquine has received an emergency use authorization by the FDA, but in April it highlighted serious concerns about its use outside of a hospital setting.

Researchers are still looking to understand how hydroxychloroquine might benefit patients with COVID-19, including in combination with the antibiotic azithromycin and zinc. There are more than 150 hydroxychloroquine trials ongoing, with the majority assessing the effects of the drug in battling COVID-19 infection, according to the National Institutes of Health's clinical trial website.

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