NEW DELHI: The Lancet Journal late on Thursday retracted the controversial study on hydroxychloroquine which said the repurposed anti-malaria drug increased the risk of mortality in covid-19 patients as the company that collated the data, Surgisphere, did not cooperate with the review.
“Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process after severe criticism for the quality of its data," The Lancet said in its retraction statement.
The study, published last month, faced severe criticism after it was revealed that there were discrepancies in the data, most prominent of which was about deaths in hospitals in Australia being higher than the reported government numbers and another dataset from a hospital in Asia being accounted for in the Australasian region.
The Lancet had earlier this week issued an ‘expression of concern’ about an observational study that showed risk from the anti-malaria drug in treating covid-19 patients.
Lancet's ‘expression of concern’, which is a means to alert readers about the integrity of a paper, followed several scientific questions being raised about the data for 96,000 patients that was reported in the paper by its author Mandeep Mehra.
The study was the reason the World Health Organization (WHO) last week halted the hydroxychloroquine arm of the Solidarity Trial.
Hours after the ‘expression of concern’, the WHO said clinical trials of the repurposed anti-malaria drug hydroxychloroquine for treatment of covid-19 will resume, after a committee reviewed the available data for the drug. So far, more than 3,500 patients have been recruited for the mega trial in 35 countries
The journal apologised for the inconvenience it caused various stakeholders.
"We all entered this collaboration to contribute in good faith and at a time of great need during the covid-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused," The Lancet said.
Hydroxychloroquine and its older form, chloroquine, are widely used in India for treatment of malaria, which had prompted the Indian Council of Medical Research to defend its use amid safety concern. The ICMR has been providing a weekly dose of hydroxychloroquine to healthcare workers as prophylaxis, meaning use of the drug to prevent an infection rather than cure it.
Indian pharmaceutical companies, especially Ipca Laboratories and Zydus Cadila Ltd, are two of the world’s largest manufacturers of hydroxychloroquine, and the hype surrounding the repurposed anti-malaria drug had led the two companies to scale up production to allow for sufficient inventories for domestic market and exports.