A controversial examine that promoted hydroxychloroquine, an antimalarial drug, as a therapy for Covid-19 has formally been withdrawn.
On Tuesday, Elsevier, a Dutch educational publishing firm which owns the Worldwide Journal of Antimicrobial Brokers, issued the retraction of the March 2020 examine, saying “issues have been raised concerning this text, the substance of which relate to the articles’ adherence to Elsevier’s publishing ethics insurance policies and the suitable conduct of analysis involving human members”.
Elsevier added that issues had additionally been raised by “three of the authors themselves concerning the article’s methodology and conclusions”.
An investigation by Elsevier’s analysis integrity and publishing ethics workforce, in addition to the journal’s co-owner, the Worldwide Society of Antimicrobial Chemotherapy, discovered a number of points inside the examine, in response to a prolonged retraction discover.
Amongst these embody the journal being unable to verify whether or not any of the sufferers concerned within the examine had been acquired earlier than moral approval had been obtained. The journal has additionally not been capable of set up whether or not there was equipoise between the examine sufferers and the management sufferers. In keeping with the Affiliation of Healthcare Journalists, equipoise is the “real uncertainty inside the knowledgeable medical group – not essentially on the a part of the person investigator – about the popular therapy.”
The retraction discover additionally mentioned that the journal has not been capable of set up whether or not the topics on this examine ought to have supplied knowledgeable consent to obtain azithromycin as a part of the examine. In keeping with the unique examine, the effectiveness of hydroxychloroquine to deal with Covid would improve if used with azithromycin, an antibiotic. It went on so as to add that there’s “cheap trigger to conclude that azithromycin was not thought-about normal care on the time of the examine”.
Because the examine’s publication, three of its authors, Johan Courjon, Valérie Giordanengo and Stéphane Honoré, have contacted the journal to specific their issues “concerning the presentation and interpretation of outcomes” and said that they “not want to see their names related to the article”. In the meantime, a number of different authors disagree with the retraction and dispute the grounds for it, the retraction discover mentioned.
In keeping with Nature, the examine is the highest-cited paper on Covid-19 to be retracted, in addition to the second-most-cited retracted paper general.
In March 2020, the US Meals and Drug Administration issued an emergency use authorization that allowed for the stockpiling of hydroxychloroquine, in addition to its distribution and use for sure hospitalized sufferers with Covid-19.
Then US president Donald Trump additionally touted hydroxychloroquine as a miracle drug for Covid-19, at one level claiming that he was taking the drug prophylactically. Earlier this 12 months, a examine revealed within the peer-reviewed Biomedicine & Pharmacotherapy journal discovered that individuals who took hydroxychloroquine had been 11% extra more likely to die from Covid.
Following the examine’s retraction, the French Society of Pharmacology and Therapeutics issued an announcement, saying that the examine “constitutes a transparent instance of scientific misconduct, marked by information manipulation and bias within the interpretation of outcomes, aimed toward falsely presenting hydroxychloroquine as efficient”.
“This extremely controversial examine was the cornerstone of a worldwide scandal. The promotion of its outcomes led to the overprescription of hydroxychloroquine to tens of millions of sufferers, leading to pointless risk-taking for tens of millions of individuals and probably 1000’s of avoidable deaths … One of many elementary ideas of drugs – primum non nocere (‘first, do no hurt’) – has been sacrificed right here, with dramatic penalties,” it added.