The Lancet journal has issued a statement of concern after over 100 scientists from across the world flagged discrepancies in its recent study linking the malaria drug hydroxychloroquine with increased death risk during COVID-19 treatment.
“We are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information,” the editors of the journal said.
The statement has come after more than 100 scientists from across the globe wrote an open letter to the editor of The Lancet, Richard Horton, questioning the validity of the study which assessed the safety and effectiveness of hydroxychloroquine (HCQ) in COVID-19 treatment.
The research, which was published on May 22, was an observational study of 96,032 hospitalised COVID-19 patients from six continents that reported substantially increased deaths, and incidences of heartbeat rhythm changes associated with the use of the drugs HCQ and closely related chloroquine.
Based on the study, the scientists had concluded that the drugs are “associated with decrease in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.”
Soon after the study was published, the World Health Organisation (WHO) paused recruitment of patients to the HCQ arm in their SOLIDARITY clinical trial, which they resumed on Wednesday after the scientists questioned the study.
The research was based on a database from a company based in Illinois, US called Surgisphere Corporation, which according to the study contains COVID-19 patient data from hundreds of hospitals around the world.
From this database, the study assessed data from 96,032 patients admitted to 671 hospitals across six continents by April 14, of whom, 10,698 had died in hospital by April 21, according to the research.
However, in the open letter, the researchers flagged several points of concern about the validity of this data, and the kind of analysis done in the study with it. Among the major issues cited in the Lancet study by the scientists, are concerns that there was no mention of the countries or hospitals that contributed to the data source and no acknowledgments of their contributions.
The data reported in the study from Australia, for instance, the open letter said, was not compatible with government reports from the country.
Data from Africa, for instance, indicated that nearly 25 per cent of all COVID-19 cases and 40 per cent of all deaths in the continent occurred in “Surgisphere-associated hospitals” which had patient monitoring facilities that could detect and record “nonsustained or sustained ventricular tachycardia or ventricular fibrillation”. “Both the numbers of cases and deaths, and the details provided, seem unlikely,” the scientists flagged in the open letter.