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In the retraction notice, Elsevier mentioned that its integrity and publishing ethics team, as well as the journal’s co-owner, the International Society of Antimicrobial Chemotherapy, found multiple issues with the study
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A controversial study which promoted the use of hydroxychloroquine drug as a treatment for COVID-19 was officially withdrawn from an academic journal. On Tuesday, Elsevier, a Dutch academic publishing company which owns the International Journal of Antimicrobial Agents, issued a retraction of a study which was conducted in March 2020.
The company said that “concerns have been raised regarding this article, the substance of which relate to the articles’ adherence to Elsevier’s publishing ethics policies and the appropriate conduct of research involving human participants.” Elsevier further stated that the concerns had also been raised by “three of the authors themselves regarding the article’s methodology and conclusions.”
In the retraction notice, Elsevier mentioned that its integrity and publishing ethics team, as well as the journal’s co-owner, the International Society of Antimicrobial Chemotherapy, found multiple issues with the study. Among those issues was the fact that the journal wasn’t able to confirm whether any of the patients involved in the study were acquired before ethical approval had been obtained.
The journal was also unable to establish whether there was equipoise between the study patients and the control patients. As per the Association of Healthcare Journalists, equipoise refers to the “genuine uncertainty within the expert medical community – not necessarily on the part of the individual investigator – about the preferred treatment.”
The authors of the study disassociate from the article
The retraction notice also mentioned that the journal was not able to establish whether the subjects in this study should have provided informed consent to receive azithromycin as part of the study. Since the publication of the journal, even the authors of the study Johan Courjon, Valérie Giordanengo and Stéphane Honoré, have contacted the journal to express their concerns “regarding the presentation and interpretation of results.” They stated that they “no longer wish to see their names associated with the article”.
The original study noted that the effectiveness of hydroxychloroquine to treat COVID-19 would increase if used with azithromycin, which is an antibiotic. It went on to mention that at the time of the study, azithromycin was not considered standard care.
After the retraction statement was issued, several other authors disagreed with the move and disputed the grounds for it. What makes the matter concerning is the fact that the controversial study is the highest-cited paper on COVID-19 to be retracted, Nature reported. It was the second most cited paper on the virus overall.
In the light of the study, in March 2020, the US Food and Drug Administration issued an emergency use authorization that allowed for the stockpiling of hydroxychloroquine as well as its distribution and use in certain hospitals with patients who were suffering from COVID-19.
Then US President Donald Trump also touted hydroxychloroquine as a “miracle drug” for Covid-19, at one point claiming that he was taking the drug prophylactically. After the retraction, the French Society of Pharmacology and Therapeutics issued a statement condemning the study.
The body said that the “study constitutes a clear example of scientific misconduct, marked by data manipulation and bias in the interpretation of results, aimed at falsely presenting hydroxychloroquine as effective.”
“This highly controversial study was the cornerstone of a global scandal. The promotion of its results led to the overprescription of hydroxychloroquine to millions of patients, resulting in unnecessary risk-taking for millions of people and potentially thousands of avoidable deaths … One of the fundamental principles of medicine – primum non nocere (‘first, do no harm’) – has been sacrificed here, with dramatic consequences,” it added.