A drug former President Donald Trump repeatedly endorsed as a COVID-19 prevention and treatment method despite scientific objections has been linked to nearly 17,000 deaths in a new study.
During the first wave of the pandemic, hydroxychloroquine, an anti-malaria drug also used to treat lupus and rheumatoid arthritis, began being prescribed off-label to hospitalized patients, despite there being no evidence proving its efficacy or safety for treatment of the virus.
At the time, French infectious disease specialist Didier Raoult released a now widely-debated study claiming the drug had a 100% cure rate against COVID-19. Trump soon started touting the drug as a "game changer," saying once, "if things don't go as planned, it's not going to kill anybody."
HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).....— Donald J. Trump (@realDonaldTrump) March 21, 2020
But French researchers claim the use of hydroxychloroquine from March to July 2020 was associated with an 11% increase in COVID patients' mortality rate and an estimated 16,990 deaths across six countries as a result.
The U.S. Food and Drug Administration initially approved the emergency use of hydroxychloroquine for hospitalized COVID patients in March 2020, but months later — and following a clinical trial — the federal agency revoked authorization, partially in light of adverse cardiac events. By the end of June, the NIH also ended its clinical trials into hydroxychloroquine after finding it was highly unlikely to benefit hospitalized COVID patients, and other studies and health experts came to the same conclusion.
Still, Trump doubled down on his support of the drug's use, saying in August 2020 that the drug actually had "tremendous support" and that statements of its inefficacy were being used as a political tactic against him.
Months later, a study published in the National Library of Medicine found a correlation between Trump's public advocacy of the drug and the amount of online searches and purchases of it.
In this recent study, published in the February issue of Biomedicine & Pharmacotherapy, researchers said hydroxychloroquine-involved deaths were highest in U.S. patients with 12,739. Spain saw 1,895 deaths, Italy 1,822, Belgium 240, France 199 and Turkey 95 — though the latter three are stated to be imprecise estimates due to scarce data. Also for this reason, the study states the death rate is likely underestimated due to other gaps in data reporting.
The study states the toxicity of hydroxychloroquine in COVID-19 patients is partially due to its cardiac side effects, but it also says hydroxychloroquine-related deaths are likely directly related to the promotion of its prescription and the misinterpretation of the FDA's emergency use authorization versus its actual approval.
As a result of their findings, the researchers point to the "hazard of drug repurposing with low-level evidence for the management of future pandemics." Most importantly, they say their study illustrates the importance of limiting off-label use of treatments until accurate data and evidence is produced.