- A retraction was made by The Lancet after inconsistencies were found in published hydroxychloroquine research
- Findings caused clinical trials to be halted globally
- Hydroxychloroquine has been touted as a 'cure' for Covid-19 since early in the coronavirus outbreak
A study recently published in The Lancet, and widely reported on, pointed out that hydroxychloroquine, as well as a related medicine chloroquine, is not an effective treatment for Covid-19 and may, in fact, cause negative side-effects like serious heart rhythm disorders.
The findings from the study caused hydroxychloroquine clinical trials worldwide to be halted. But, when the UK publication The Guardian probed the research further, they found several inconsistencies in the data provided by the US company Surgisphere.
Dr Mandeep Mehra, executive director of the Center for Advanced Heart Disease at Brigham and Women's Hospital in Boston - and the study's lead author - asked The Lancet for a retraction because he could no longer vouch for the accuracy of the data, according to The Guardian.
According to Richard Horton, editor of The Lancet, these developments were “shocking” and were an example of research misconduct against the backdrop of a global health emergency.
The Guardian also launched a separate investigation into the company Surgisphere. As a result, a paper in the New England Medical Journal was also retracted as it was based on one of Surgisphere’s data sets.
What the study said
At the time of publication the authors of the study published in The Lancet declared this large-scale study – in a long line of existing studies – as the most definite proof that the drug is ineffective against Covid-19.
"This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with Covid-19," said lead author Dr Mehra.
According to the researchers, this observational study suggests that the use of these two drugs should be limited to clinical trials until there is proof from randomised trials.
In this study, data from nearly 15 000 hospitalised Covid-19 patients who were given hydroxychloroquine or chloroquine, and a control group of about 81 000 patients who didn’t take the drug, were analysed.
The death rate of those in the control group who didn’t take the drugs was 9.3%, while that of those who received chloroquine was 16.4%, and those who received hydroxychloroquine 18%, according to the now retracted paper.
According to the article in The Washington Post, the study had a major impact worldwide – resulting in several clinical trials being stopped, including one by the WHO. France also subsequently banned the use of hydroxychloroquine on Covid-19 patients.
In a statement, the authors of the study apologised to the editors and readers for any “embarrassment or inconvenience caused”.
Questions, concerns about quality of research
The Lancet editor Richard Horton is not the only one who is deeply concerned by this development. The retractions raised concerns from several members of the medical and scientific community about standards which allow the swift publication of Covid-19 related literature.
“I’m concerned that the usual standards, both at the level of the journals and at the level of authors and faculty rushing to get high-impact work published, has meant that our usual standards have fallen,” stated Steven Joffe, a medical ethicist at the University of Pennsylvania, in The Washington Post.
Is hydroxychloroquine getting a second chance?
While hydroxychloroquine is approved for the treatment of lupus and chloroquine for malaria, they have been touted as possible “game changers” against Covid-19, even though there was little evidence to back up this claim.
In March 2020, these drugs formed part of the World Health Organization’s (WHO) Solidarity Trial to test the efficacy of existing drugs against Covid-19. But as the pandemic progressed, prominent studies indicated that these drugs had no significant effect on Covid-19 and could even cause death when used incorrectly.
Despite the retraction, hydroxychloroquine should still be approached with caution as other studies are still sticking to their conclusions that the drug has little to no effect on Covid-19. Researchers from at the University of Minnesota Medical School, for example, suggested, based on a randomised, placebo-controlled study, that hydroxychloroquine was no more effective than a placebo.
Right now, it remains crucial that the drug goes through randomised clinical trials and that the public is educated on possible side-effects and dangers when the drug is used off-label and in different quantities than prescribed.
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