Prestigious medical journal The Lancet has issued an “expression of concern” on the hydroxychloroquine study that prompted the WHO to temporarily pause the HCQ arm of its multi-centre, multi-drug Solidarity trial.
The Lancet had published the large observational study on the use of hydroxychloroquine and chloroquine with or without an antibiotic. The study, an analysis of hospital registry data from 671 hospitals from across six continents, found no benefit from the drugs in treatment of COVID-19 patients, and instead found increase in deaths and frequency of irregular heartbeats.
“Important scientific questions have been raised about data reported in the paper by Mandeep Mehra et al...published in The Lancet on May 22. Although an independent audit of the provenance and validity of the data has been commissioned by the authors not affiliated with Surgisphere [referring to the Chicago-based company that provided the hospital database] 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. We will update this as soon as we have further information,” the journal said in a statement published online.
Similar concerns have been raised by the New England Journal of Medicine, too, that published a study on the effect of blood pressure medication on COVID-19 patients by the same group of authors.
The criticism of the Lancet study has implications for India, too, where the drug regimen (HCQ and azithromycin) is part of treatment protocol for COVID-19 patients in the country.
Hydroxychloroquine, used as an anti-malarial drug, and for treatment in rheumatoid arthritis and lupus, is also being prescribed for prevention of infection for frontline workers in the country. India is also participating in the WHO’s Solidarity trial.
Last week, top Indian scientists also questioned the Lancet study. In a letter to WHO chief scientist Dr Soumya Swaminathan, the scientists pointed out the study’s faulty methodology and called the global health body’s decision to stop the trial as “knee-jerk”.
The Lancet study has been widely criticised for its lack of transparency around the hospital data that it used. An investigation by The Guardian found that employees of the company Surgisphere, headed by Sapan Desai—also co-author of the study—had no scientific background, and included a science fiction author and a marketing executive.
