The journal that published a paper claiming that hydroxychloroquine had “significant” success in treating COVID-19 patients now has an expression of “concerns” published by its publisher. On March 23, ICMR approved the use of drug as a prophylaxis by healthcare workers and those caring for COVID-19 patients.
Aabout 10 days after the Indian Council of Medical Research (ICMR) approved the use of hydroxychloroquine as prophylaxis by healthcare workers taking care of suspected or confirmed COVID-19 cases and asymptomatic household contacts of confirmed cases, the publisher of the journal has expressed “concerns” about the paper. The paper was published on March 17 in the International Journal of Anti-Microbial Agents.
ICMR’s approval was based on the recommendation of the Task Force for coronavirus disease (COVID-19). On March 31, the Health Ministry approved the use of hydroxychloroquine in combination with azithromycin for “patients with severe disease and requiring ICU management”.
On April 3, a fortnight after the journal published the paper, the journal’s publisher the International Society of Antimicrobial Chemotherapy said: “ISAC shares the concerns regarding the above article published recently in the International Journal of Antimicrobial Agents (IJAA). The ISAC Board believes the article does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.”
Researchers led by Didier Raoult of the University of Marseille who carried out a trial on 26 COVID-19 patients found “significant” reduction in viral load in over half the number of patients at end of six days of therapy. The paper did not include the data of six patients, who were lost to follow-up and death of one person, was published based on data of first six days of a 14-day trial. The paper was published a day after it was submitted to the journal, and one of the authors is the Editor-in-Chief of the journal.
Concerns about the paper were first raised by Dr. Elisabeth Bik, a Dutch microbiologist, in the medical blog Science Integrity Digest and on PubPeer, a website that allows independent scientists to publish post-publication review of scientific papers. She wrote that the “peer review was done in 24 hours, an incredibly fast time.” She also pointed out that one of the authors is the Editor-in-Chief of the journal.
In the expression of concern, the publisher also said the “Editor-in-Chief of the journal, Jean-Marc Rolain had no involvement in the peer review of the manuscript”. The IJAA notice was reported by Retraction Watch blog on April 6.
Soon after the U.S. President Donald Trump championed for hydroxychloroquine as a treatment for COVID-19, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases said during a White House press briefing on March 20 that there is “no evidence” that the drug can be used as a prophylactic or as treatment for COVID-19 patients. He also said: “It was not done in a controlled clinical trial. So you really can’t make any definitive statement about it.”
Meanwhile, India is all set to join World Health Organization’s multi-country “Solidarity trial” aimed at testing four drug combinations including chloroquine to treat COVID-19. On March 29, the Food and Drug Administration issued an emergency use authorisation for hydroxychloroquine and chloroquine for COVID-19 treatment.
Soon after the U.S. President Donald Trump backed hydroxychloroquine as a treatment for COVID-19, two Nigerians are reported to have over-dosed on the drug. A man in Arizona, U.S., died and his wife were hospitalised after they self-medicated with a home remedy of hydroxychloroquine. And a doctor in India died after taking two doses of the drug.