Hydroxychloroquine questions escalate as journal says study on drugs “did not meet expected standards”

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Anthony Fauci Donald Trump hydroxychloroquine coronavirus COVID-19
APRIL 01: Dr. Anthony Fauci (L) director of the National Institute of Allergy and Infectious Diseases, listens to US President Donald Trump speak from the press conference room with members of the House Coronavirus task force Blanche on April 1, 2020 in Washington, DC. Fauci and the president disagree on the effectiveness of the drug hydroxychloroquine in the treatment of COVID-19.
Winning McNamee / Getty

At press conference on Monday, President Trump would not allow his medical expert, Dr. Anthony Fauci, to answer a question about hydroxychloroquine, an antimalarial drug, which has recently received attention as a treatment COVID-19 possible.

This particular question, asked by a CNN reporter, is particularly relevant: “What is the medical evidence? “

Three days before, on April 3, the publisher of the scientific article that brought the drug to the attention of public health experts – and President Trump – had questioned the reliability of the original research.

“The article does not respond to [publisher’s] expected standard, “said the International Journal of Antimicrobial Agents in a statement. The newspaper, which published “Hydroxychloroquine and azithromycin as a treatment for Covid-19: results of an open-label, non-randomized clinical trial” on March 20 after accelerated peer review, has stopped withdrawing the article.

Criticism will almost certainly exacerbate tensions in the White House. Trump’s repeated comments on hydroxychloroquine put him at odds with Fauci and other experts, who emphasize the importance of conducting randomized controlled trials of the drug – the gold standard of scientific research – before recommend its use for COVID-19.

Although hydroxychloroquine is approved by the Food and Drug Administration as a treatment for malaria, it has not yet officially approved the use of the drug on COVID-19. Last week, the FDA granted “emergency use authorization” in part to allow the federal government to start stockpiling the drug.

The IJAA opinion was reported by Retraction Watch, a blog founded by journalists Dr. Ivan Oransky and Adam Marcus. “Of course, the horse left the proverbial barn on this one,” they wrote. “Countless patients have received hydroxychloroquine, as well as chloroquine, for Covid-19 infection, thanks in large part to President Trump’s cheerleaders for drugs. “

In the study, the scientists recruited 42 COVID-19 patients in the south of France. They put 16 in a control group who received only conventional treatment. Among the others, some were treated with hydroxychloroquine only and the others were treated with hydroxychloroquine in combination with an antibiotic. On day 6, when the scientists tested all the patients for the presence of the COVID-19 virus, the results were encouraging. Most of the patients who received no medication were still infected. But only half of the patients treated with hydroxychloroquine tested positive for the virus, and none of the patients who received the two drugs tested positive.

On March 16, the authors published the document on a medical researcher’s website as a “preprint,” meaning that the work had not yet been critically reviewed by independent scientists, a standard for publication in scientific journals. On March 17, the authors submitted it to the International Journal of Antimicrobial Agents, which accepted it the next day and published it online on March 20. “This suggests that the peer review was done in 24 hours, an incredibly fast time,” wrote Elisabeth Bik. , Dutch microbiologist, in the medical blog Science Integrity Digest.

Shortly after publication, scientists who read the document began to report research gaps that cast doubt on the study. On March 24, Bik published a long list. There were inconsistencies in the way the authors collected and reported the data – they say, for example, that the document was conducted over 14 days but only provides six days of data. She reviewed the timeline of the study itself and wondered if the authors had started their research before obtaining approval from the National Medicines Safety Agency, which would be an ethical flaw. She also said that the composition of the control group did not closely match the composition of the groups who received the drugs – differences that could potentially skew the results.

She also noted that one of the authors of the article is also the editor of the IJAA. The newspaper denied a conflict of interest. “Given his role as editor of this review, Jean-Marc Rolain had no involvement in the peer review of the manuscript and does not have access to information regarding his peer review. Full responsibility for the manuscript peer review process has been delegated to an Associate Editor. “

The editors, the International Society for Antimicrobial Chemotherapy, apologized for the slow peer review process. Under normal circumstances, peer review is expected to reveal flaws before publication, which the authors are then asked to remedy. But with thousands of people dying from COVID-19, medical publishers are under pressure to quickly disseminate the results. “Although the ICCS recognizes the importance of helping the scientific community by rapidly publishing new data, this cannot be done at the expense of scientific review and best practice,” wrote the President of the Company, Andreas Voss.

New questions about the study are unlikely to have any immediate effect on treatment with COVID-19. With an expected shortage of hospital beds and ventilators, many doctors are open to prescribing medications that could alleviate the worst symptoms, much less lead to a cure.

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