Doubt looms over hydroxychloroquine study that halted global trials - Ars Technica

The Lancet medical journal on Tuesday issued an “expression of concern” over the validity of a recent study suggesting that the anti-malarial drugs chloroquine and hydroxychloroquine raise the risk of death and heart complications in hospitalized COVID-19 patients.

More than a hundred outside experts have raised questions and skepticism about the data and analysis, even as researchers halted clinical trials in light of the study's findings.

The limited evidence for use against COVID-19 and the known risks led the Food and Drug Administration to issue a safety warning that the drugs "should be limited to clinical trial settings or for treating certain hospitalized patients.".

The researchers claimed to do so using the largest set of data to date, involving more than 96,000 hospitalized COVID-19 patients from six continents.

According to the authors, a thorough hashing of the data indicated that those taking either hydroxychloroquine or chloroquine had significantly higher risks of death and heart complications compared with COVID-19 patients who did not take either of the drugs.

At the heart of the problem is that the data used for the study was from a data analytics company called Surgisphere, based in Illinois.

Further, before Desai and Surgisphere focused on data analytics, their most public-facing activity was selling medical textbooks.

In response to criticism and skepticism over the COVID-19 data, Surgisphere issued a statement saying, in part, that it will submit to an independent audit of its data.

Nevertheless, on Tuesday, The Lancet issued an expression of concern over the study, saying that “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.

Two other COVID-19-related studies involving Surgisphere data have also been called into question.

Researchers have also questioned a pre-print study (one that has not yet been published or peer reviewed) looking at the anti-parasitic drug Ivermectin for COVID-19