A controversial study that promoted hydroxychloroquine, an antimalarial drug, as a treatment for Covid-19 has officially been withdrawn.
On Tuesday, Elsevier, a Dutch academic publishing company which owns the International Journal of Antimicrobial Agents, issued the retraction of the March 2020 study, saying “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 added that concerns had also been raised by “three of the authors themselves regarding the article’s methodology and conclusions”.
An investigation by Elsevier’s research integrity and publishing ethics team, as well as the journal’s co-owner, the International Society of Antimicrobial Chemotherapy, found multiple issues within the study, according to a lengthy retraction notice.
Among those include the journal being unable to confirm whether any of the patients involved in the study were acquired before ethical approval had been obtained. The journal has also not been able to establish whether there was equipoise between the study patients and the control patients. According to the Association of Healthcare Journalists, equipoise is the “genuine uncertainty within the expert medical community – not necessarily on the part of the individual investigator – about the preferred treatment.”
The retraction notice also said that the journal has not been able to establish whether the subjects in this study should have provided informed consent to receive azithromycin as part of the study. According to the original study, the effectiveness of hydroxychloroquine to treat Covid would increase if used with azithromycin, an antibiotic. It went on to add that there is “reasonable cause to conclude that azithromycin was not considered standard care at the time of the study”.
Since the study’s publication, three of its authors, Johan Courjon, Valérie Giordanengo and Stéphane Honoré, have contacted the journal to express their concerns “regarding the presentation and interpretation of results” and stated that they “no longer wish to see their names associated with the article”. Meanwhile, several other authors disagree with the retraction and dispute the grounds for it, the retraction notice said.
According to Nature, the study is the highest-cited paper on Covid-19 to be retracted, as well as the second-most-cited retracted paper overall.
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 for certain hospitalized patients with 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. Earlier this year, a study published in the peer-reviewed Biomedicine & Pharmacotherapy journal found that people who took hydroxychloroquine were 11% more likely to die from Covid.
Following the study’s retraction, the French Society of Pharmacology and Therapeutics issued a statement, saying 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.
