A database by the Chicago company Surgisphere Corp. was used in an observational study of almost 100,000 patients published on May 22 in the Lancet that tied the malaria drugs hydroxychloroquine and chloroquine to a higher risk of death in hospitalized patients with the virus.
"After publication of our Lancet article, several concerns were raised with respect to the veracity of the data and analysis conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication", authors Mandeep Mehra, Frank Ruschitzka and Amit Patel said in a statement published by The Lancet, Thursday.
"We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused", they conclude.
About 26 per cent of patients in the trial getting the drug died, compared with about 24 per cent receiving standard care.
Experts say the growth rate of newly reported infections in the United States may be accelerating because, over the past few weeks, many states have reopened nonessential businesses and loosened social distancing measures meant to slow the new coronavirus' spread.
Though the firm claimed to have gathered their data from thousands of patients at hundreds of hospitals worldwide, an independent investigation has questioned the accuracy of their research.
A pharmacy tech pours out pills of hydroxychloroquine at Rock Canyon Pharmacy in Provo Utah
Professor Horby said: "The independent Data Monitoring Committee has reviewed the emerging data about every two weeks to determine if there is evidence that would be strong enough to affect national and global treatment of COVID-19".
While some studies have shown COVID-19 patients having heart issues when taking hydroxychloroquine or chloroquine, the drugs were approved decades ago and have been used by hundreds of thousands of people with little concern.
Ghebreyesus, said the Agency's board reviewed the data concerning heart risks and found "no reasons to modify the trial".
Independent monitors met Thursday night to review results so far and recommended ending the hydroxychloroquine part of the study because results from 80% of participants suggested continuing was futile.
No questions have been raised about the integrity of the other two papers. But the report from The Lancet and The New England Journal of Medicine showed that the drug that taken either alone or with an antibiotic to treat patients with COVID-19 was of no benefit and increased a patient's risk of cardiac death. Both studies also involved three of the same researchers. World Health Organization then resumed their trial this week when the researchers admitted the data on which the Lancet study was based were flawed.
"Because all the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor, we are unable to validate the primary data sources underlying our article", Mehra and colleagues wrote.
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