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A study says a certain dosing of hydroxychloroquine and azithromycin “improves survival by nearly 200%” among hospitalized COVID-19 patients who received invasive mechanical ventilation.
The study is posted on a website that publishes “preprints” — studies that “have not been finalized by authors, might contain errors and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.”
Experts called the study poorly designed and caution against drawing conclusions about cause and effect.
When President Donald Trump released a statement listing things he said "I was right about," the top item listed was "Hydroxychloroquine works."
As president, Trump controversially touted hydroxychloroquine, starting in the early stages of the coronavirus pandemic, despite a lack of evidence on whether it was safe or effective for use against COVID-19. But days before he released his June 12 statement on his website, news of a study surfaced that triggered more claims about the drug.
"Study: hydroxychloroquine can boost COVID-19 survival chances by nearly 200%," read the headline of a widely shared post on Instagram.
The post was from One America News, the conservative cable network that Trump has often praised. It was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.)
The post exaggerates the significance of the study, which promotes hydroxychloroquine as helping only certain COVID-19 patients.
The study says a combination of hydroxychloroquine and azithromycin was effective in certain hospitalized COVID-19 patients, but the study has not been fully vetted. It was posted on a website that publishes "preprints" — studies the website says are not yet peer reviewed by other scholars and that "should not be used to guide clinical practice."
Experts told PolitiFact the study is poorly designed and cautioned against using it to draw conclusions.
Hydroxychloroquine, which is an immunosuppressive and anti-parasitic drug used to treat autoimmune diseases such as lupus and rheumatoid arthritis, in addition to malaria, carries a particular risk for people with heart problems, plus other possible side effects.
Interest in the drug emerged early in the pandemic, in early 2020, from two small trials, including one that used hydroxychloroquine along with the antibiotic azithromycin (brand name Zithromax) and reported that the virus was essentially gone in five days. The research society that published that article later renounced it, saying it didn’t meet its standards.
In March 2020, as Trump touted hydroxychloroquine, the U.S. Food and Drug Administration authorized emergency use of hydroxychloroquine for certain hospitalized COVID-19 patients. But the FDA revoked its authorization less than three months later, after determining "it is no longer reasonable" to believe that it may be effective in treating COVID-19, "nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks."
The study cited by OAN was done by three researchers from the Smith Center for Infectious Diseases & Urban Health in East Orange, N.J., and one from the Saint Barnabas Medical Center in Livingston, N.J. The study says the researchers reviewed the medical records of 255 COVID-19 patients at Saint Barnabas who required invasive mechanical ventilation during the first two months of the U.S. pandemic. Its conclusion: Dosing of hydroxychloroquine and azithromycin above a certain level "improves survival by nearly 200% in this population."
The study was posted May 31 on medRxiv, a website that publishes studies that have not been fully vetted. This note is posted with the study: "This article is a preprint and has not been peer-reviewed. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice."
The website also says about its "preprint" or "unrefereed" articles: "Before formal publication in a scholarly journal, scientific and medical articles are traditionally certified by ‘peer review.’ In this process, the journal’s editors take advice from various experts — called ‘referees’ — who have assessed the paper and may identify weaknesses in its assumptions, methods and conclusions … Readers should therefore be aware that articles on medRxiv have not been finalized by authors, might contain errors, and report information that has not yet been accepted or endorsed in any way by the scientific or medical community."
Three experts who spoke to PolitiFact were critical of the study.
Joel Farley, a University of Minnesota College of Pharmacy professor, noted that the study was designed not to test the effectiveness of the two drugs, but rather as an observational study that basically looks at survival and then models what things might have predicted survival.
"The concern is that this poorly designed study might influence" prescribing of the two drugs "when the overwhelming body of evidence has shown it has no benefit for treating COVID," Farley said.
Dr. Neil Schluger, chairman of the Department of Medicine at New York Medical College, said that to conclude cause-and-effect "is an obvious error," calling the study very small with little hard data. "It’s likely that patients who died rapidly received less total (of the two drugs) because they were dead; one can’t conclude from these data that they died because they got fewer doses. It’s also likely that if they received lower doses on a daily basis, it’s because they were sicker to begin with," he said.
Ally Dering-Anderson, a professor at the University of Nebraska College of Pharmacy, said pairing hydroxychloroquine with azithromycin to treat a virus raises serious questions because azithromycin is a traditional antibacterial drug that doesn’t treat viruses and hydroxychloroquine has no known benefit in treating the SARS-CoV-2 virus. "There is no pharmacologically sound reason to believe that combining two drugs that don’t work will suddenly result in therapy that does work," she said.
Hydroxychloroquine is not approved in the U.S. for COVID-19. The FDA recommends against the use of hydroxychloroquine with or without azithromycin for treating COVID-19 patients. The World Health Organization recommends against using hydroxychloroquine to prevent or to treat COVID-19 infection.
A widely shared social media post stated: "Study: hydroxychloroquine can boost COVID-19 survival chances by nearly 200%."
A study says a certain dosing of hydroxychloroquine and azithromycin "improves survival by nearly 200%" among hospitalized COVID-19 patients who received invasive mechanical ventilation, but the post exaggerates the finding’s significance.
The study is posted on a website that publishes studies that "have not been finalized by authors, might contain errors and report information that has not yet been accepted or endorsed in any way by the scientific or medical community." Experts told PolitiFact the study is poorly designed and that no conclusion about cause and effect should be drawn from it.
For a statement that contains only an element of truth, our rating is Mostly False.
Instagram, post, June 9, 2021
Lead Stories, "Fact Check: Draft Research About Hydroxychloroquine As COVID-19 Drug Does NOT Yet Warrant Calling It A Cure," June 10, 2021
medRxiv, "What is an unrefereed preprint?", accessed June 11, 2021
International Journal of Antimicrobial Agents, "Chloroquine and hydroxychloroquine in coronavirus disease 2019 (COVID-19). Facts, fiction and the hype: a critical appraisal," July 17, 2020
PolitiFact, "Hydroxychloroquine and coronavirus: what you need to know," April 8, 2020
PolitiFact, "No proof that drugs not approved in US for COVID-19 caused drop in cases in India," May 21, 2021
U.S. Food and Drug Administration, "Chloroquine or Hydroxychloroquine With or Without Azithromycin," Oct. 9, 2020
World Health Organization, "WHO Living guideline: Drugs to prevent COVID-19," March 2, 2021
World Health Organization, "Therapeutics and COVID-19: living guideline," March 31, 2021
Email, Dr. Neil Schluger, chairman of the Department of Medicine at New York Medical College, June 14, 2021
Email, Ally Dering-Anderson, clinical associate professor at the University of Nebraska College of Pharmacy, June 14, 2021
Email Joel Farley, associate head of the department of pharmaceutical care and health systems at the University of Minnesota College of Pharmacy, June 14, 2021
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