"Expressions of concern": The Lancet casts doubt over hydroxychloroquine study

Henrietta Brewer
June 3, 2020

The same database by the Chicago company Surgisphere Corp., was used in an observational study of almost 100,000 patients published in Lancet that tied the malaria drugs hydroxychloroquine and chloroquine to a higher risk of death in hospitalized patients with the virus.

Several clinical trials were put on hold after the study was published.

A third COVID-19 study using Surgisphere data has also raised eyebrows - in a preprint posted in early April, Surgisphere founder and CEO Sapan Desai concluded ivermectin, an antiparasitic drug, dramatically reduced mortality in COVID-19 patients.

Within days of publication, large randomized trials of the drugs, meant to prove or disprove the study's analysis, were halted, and the World Health Organization and several national governments changed Covid-19 policies and treatments accordingly.

US President Donald Trump has also announced he is taking hydroxychloroquine as a COVID-19 preventive measure, contrary to medical warnings.

An worldwide trial using hydroxychloroquine to treat Covid-19 patients will be restarted after questions arose about a study linking the antimalarial drug to increased death and heart risks.

The Lancet's editors said: "Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere and is ongoing, with results expected very shortly, we are issuing an expression of concern to alert readers to the fact that serious scientific questions have been brought to our attention".

The study, using data provided by healthcare data analytics firm Surgisphere, was not a traditional clinical trial that would have compared hydroxychloroquine to a placebo or other medicine. "We will update this notice as soon as we have further information".

Hydroxychloroquine and its older form, chloroquine, are widely used in India for treatment of malaria, which prompted the Indian Council of Medical Research to defend its use amid safety concern.

"We also clearly outlined the limitations of an observational study that can not fully control for unobservable confounding measures, and we concluded that off-label use of the drug regimens outside of the context of a clinical trial should not be recommended".

The study analysed data from nearly 15,000 patients with Covid-19 receiving the drugs and 81,000 people who did not. Lately, its role is being investigated in the treatment and prevention of Covid-19.

Other treatments in the trial, including the experimental drug remdesivir and an HIV combination therapy, are still being tested.

"In many ways, the harm has already been done".

Tedros said that to date, more than 3,500 people have been recruited into the trial in 35 countries.

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