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An almost retracted study on hydroxychloroquine exposes perils of hasty trials

globalresearchsyndicate by globalresearchsyndicate
June 4, 2020
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An almost retracted study on hydroxychloroquine exposes perils of hasty trials
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Mumbai: In the last one week the hydroxychloroquine (HCQ) trial studies for treatment of Covid-19 has seen a series of retraction and resumptions with medical journals and the World Health Organisation (WHO) caught in the crossfire of this debate. The WHO last week stopped one arm of the Covid-19 Solidarity trial of HCQ, only to resume it again this week. Its decision to stop the trial was based on a study published in medical journal Lancet, by professor Mandeep Mehra of Harvard and the Brigham and Women’s hospital, who used data from 96 thousand patients across four continents to conclude that the drug caused higher mortality in its trial patients.

However, a day after its publication over 50 clinicians from across the world raised questions about the trial method and authenticity of the data that the researchers used to conclude about the dangers of the drug.

Several countries including India who were doing the HCQ trial were in a spot after this study came out, but continued with their trial. The chief investigators of the Recovery Trial in the United Kingdom, Peter Hornby and Martin Landray who have data on 10,000 patients of HCQ also went ahead with their trial of the drug. “We saw no cogent reason to suspend recruitment for safety reasons,” said Peter Sandercock, chairman of the Recovery Trial. He said the hazard ratio for 28-day mortality in the trial’s current data, the trial’s primary outcome, varied significantly from that in the non-randomized assessment reported in The Lancet.

Some of the objections to the Lancet study were that the authors did not adhere to standard practices in the machine learning and statistics community, they did not release their code or data and quoted implausible ratios of chloroquine to hydroxychloroquine use in some continents. For example, the study said in Australia 49 received chloroquine and 50 received hydroxychloroquine, but clinicians pointed out that chloroquine is not readily available in Australia and administration requires authorization from the Therapeutic Goods Administration to do so. Following this open letter Lancet had to issue a clarification short of retraction, which also questioned the role of the firm Surgisphere, which provided the data for the trial.

“Important scientific questions have been raised about data reported in the paper by Mandeep Mehra et al—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis—published in The Lancet on May 22, 2020”, wrote Lancet editors.

As the race for Covid-19 treatment rages on, researchers have been striving to get that magic bullet that is easily available and affordable to patients.

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