About 10 days after the Indian Council of Medical Research (ICMR) approved the use of hydroxychloroquine for prophylaxis by healthcare workers attending to suspected or confirmed COVID-19 cases and asymptomatic household contacts of confirmed cases, the publisher of an international journal — that published a study on the drug’s purported efficacy — has expressed “concerns” about the paper. The paper was published on March 17 in the International Journal of Antimicrobial Agents.
Also read: Hydroxychloroquine shows potential to treat COVID-19, a preprint claims
ICMR’s approval was based on the recommendation of the National Taskforce for 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”.
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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.”
Also read: India revokes ban on export of hydroxychloroquine, drug used in treatment for COVID-19
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 more than half the number of patients at the end of six days of therapy. The paper, which did not include the data of six patients who were lost to follow-up and with one person dying, was published based on data of the 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 was Editor-in-Chief of the journal.
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Concerns about the paper were first raised by 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. Dr. Bik 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 their expression of concern about the study, ISAC, however, observed: “The Editor-in-Chief of the journal, Jean-Marc Rolain, had no involvement in the peer review of the manuscript”.
Soon after the U.S. President Donald Trump championed hydroxychloroquine as a treatment for COVID-19, Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, said during a White House press briefing on March 20 that there was “no evidence” that the drug could be used as a prophylactic or as a 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.”
Solidarity trial
Meanwhile, India is all set to join the World Health Organization’s multi-country “Solidarity trial” aimed at testing four drug combinations including chloroquine to treat COVID-19. Late last month, the U.S. Food and Drug Administration issued an emergency use authorisation for hydroxychloroquine and chloroquine for COVID-19 treatment.
Soon after Mr. Trump backed hydroxychloroquine as a treatment, two Nigerians are reported to have overdosed on the drug. Also, a man in Arizona, U.S., died and his wife was hospitalised after they reportedly self-medicated with hydroxychloroquine. And a doctor in India died after taking two doses of the drug.