The authors claimed that hydroxychloroquine significantly reduced SARS-CoV-2 viral load
Highly dubious claim by French researcher Didier Raoult and colleagues that hydroxychloroquine monotherapy and the combination of hydroxychloroquine and azithromycin are “significantly associated with reduction/disappearance of viral load in patients with COVID-19” It has been over four and a half years since the “research”. ‘ was published on March 20, 2020, but the paper was finally retracted on December 17 of this year. The paper published in International Journal of Antimicrobial Agents The study was withdrawn due to concerns about ethical approval of the study. The paper submitted to the journal on March 16, 2020 was accepted for publication the following day.
Three days after the paper was published, the ICMR approved the use of hydroxychloroquine as a prophylactic measure by healthcare workers and those caring for COVID-19 patients. Emergency use authorization for this drug was also obtained from the US FDA on March 28, 2020, but it was revoked about half a month later. The publication of this paper and FDA approval garnered significant attention worldwide and contributed to the demand for this drug despite adequate evidence of its benefits. The drug was also strongly supported by then-US President Donald Trump.
On April 3, two weeks after the paper was published, the journal’s publisher, the International Society of Antimicrobial Chemotherapy (ISAC), which co-owns the journal with Elsevier, issued a statement saying, “The paper does not meet the standards expected by the society.” expressed concern. . An independent peer review commissioned by the journal also concluded that the trial had “several major methodological issues, including its design, outcome measures, and statistical analysis.” However, the journal did not retract the paper until a few days ago.
ISAC’s statement cited concerns about the peer review process, stating that despite being the journal’s editor-in-chief and author of the paper, “Jean-Marc Rolland was not involved in the peer review of the manuscript and was not provided with any information regarding the review. cannot be accessed.”
The paper was revealed to have come under scrutiny again several months ago when three authors contacted the journal saying they had “concerns about the presentation and interpretation of the results” and no longer wanted to be associated with the paper. It became. retraction watch. Currently being supported retraction watcha spokesperson for the magazine said, “At the request of the authors, the magazine is restarting a previously closed investigation.”
Ethical approval for the study was granted on March 6, and follow-up of participants was to last 14 days, according to the paper. But “with the submission date now March 16, the schedule has become seemingly impossible,” independent research integrity researcher Elizabeth M. Bick wrote on PubPeer in March 2020. In its retraction notice, the magazine addressed these concerns: It was not possible to confirm whether all patients were able to enter the study in time for the data to be analyzed and incorporated into the manuscript prior to submission on March 20, 2020. Whether all patients were enrolled in the study at the time of admission, rather than having been hospitalized for some time before starting the treatment described in the paper. ”
According to details available in the EU Clinical Trials Registry, the study’s secondary objectives were to determine “the clinical efficacy of on-time treatment until fever-free, normalization of respiratory rate, average length of hospital stay and mortality.” It was to evaluate. Results for secondary objectives are not available in the paper. While the primary objective of the study was to reduce the duration of viral carriage and therefore infection, the secondary endpoint was to reduce the risk of transmitting the virus to others, as well as ensuring that patients received clinical benefit. “This is very important in determining whether the .
issued – December 21, 2024 9:33 PM IST
