A study that prompted hope for a COVID-19 treatment in the early days of the pandemic has now been formally retracted by the scientific journal that published it.
Hydroxychloroquine, an antimalarial drug also approved for use in some autoimmune diseases, was first introduced to the world as a potential cure through a March 2020 study of 36 patients with COVID in the International Journal of Antimicrobial Agents. Elsevier, which owns the journal, issued its formal retraction on Tuesday.
"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, as well as concerns raised by three of the authors themselves regarding the article's methodology and conclusions," the lengthy retraction statement noted, in part.
It is the most highest-cited paper on COVID-19 to be retracted, and the second-most-cited retracted paper of any kind, according to the journal Nature.
The study's initial publication set off a frenzy of excitement over the drug's potential. The U.S. Food and Drug Administration issued an Emergency Use Authorization to allow it to be stockpiled and distributed to certain patients hospitalized with COVID. President Donald Trump announced that he was taking it prophylactically, and prescriptions for the drug increased from 1,143 in February 2020 to 75,569 in March 2020, according to the Centers for Disease Control and Prevention.
Yale School of Public Health professor of epidemiology Harvey Risch said in July 2020 he believed that by not approving the drug for COVID use, "tens of thousands of patients with COVID-19 are dying unnecessarily."
And Robert F. Kennedy Jr., Trump's pick to head the Department of Health and Human Services, suggested hydroxychloroquine's use for COVID was being "censored and politicized" in a July 2020 story on his Children's Health Defense website. "For the biopharma companies poised to profit from new drugs and Covid-19 vaccines—including the alarming Moderna vaccine co-developed by NIAID—it is not an attractive option to keep older drugs that have outlived their patent terms in the running," the story noted.
The study's retraction puts an end to a long line of criticism that started almost immediately after its publication, including over its unusually short peer-review time and small sample size.
Elsevier said that other problems with the data included that six patients with results that would've changed the study's positive conclusions were eliminated from the study after it began—something pointed out at the time by Dutch microbiologist Elisabeth Bik, who posted on X on Tuesday that the study was "finally" retracted. Elsevier also could not establish whether the patients had given fully informed consent to be treated with the antibiotic azithromycin, which was part of the study.
Lead author Didier Raoult, a French virologist who founded and directed the research hospital known as the Institut Hospitalo-Universitaire Méditerranée Infection, or IHU, was a controversial figure; 28 of his co-authored studies have now been retracted, according to Science. He faced a disciplinary hearing over recommending hydroxychloroquine for COVID, and was forced to step down from the IHU. He has also been dismissive of climate change, fear of epidemics, and Darwinian evolution.
Hydroxychloroquine has also been linked to serious side effects, including cardiac arrest, heart rhythm issues, liver failure, and kidney disorders, as noted by a 2020 FDA warning about the drug's use for COVID treatment outside of a hospital setting.
"A dark page in COVID-19 research finally turned," noted a statement issued this week by the French Society of Pharmacology and Therapeutics. "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. It also resulted in a massive waste of resources and the proliferation of hundreds of useless studies, to the detriment of research into truly effective treatments."
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