Published on in Vaccine Update for Healthcare Providers
On Dec. 1, 2020, Wesley Self and co-workers from Vanderbilt University Medical Center published results of a 34-center, placebo-controlled trial on the effectiveness of hydroxychloroquine for the treatment of patients with COVID-19 (Self W, et al. Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020;324(21):2165-2176).
Researchers studied hospitalized adults with a median of five days of symptoms prior to randomization. They found that clinical status at 14 days into illness did not differ between those who did or didn’t receive hydroxychloroquine; none of the primary or secondary clinical outcomes differed between the two groups. Twenty-five of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group died from their infection. The authors concluded, “Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized patients.”
The results of this study were not surprising. Indeed, two in vitro studies had previously shown that hydroxychloroquine did not have anti-viral activity against SARS-CoV-2, and randomized trials in both the United Kingdom and Brazil showed no clinical benefit. Nonetheless, on March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) for hydroxychloroquine to treat adults hospitalized with COVID-19; in the wake of studies showing lack of benefit, the FDA revoked its EUA authorization on June 15, 2020. But not before about 10% of those who had received hydroxychloroquine developed cardiac arrhythmias, some severe.
Why did the FDA issue an EUA for hydroxychloroquine? On March 16, 2020, a small, open-label, non-randomized trial on the use of hydroxychloroquine in patients with SARS-CoV-2 was “published” on YouTube. The trial purportedly showed “a rapid and effective speeding up of the healing process.” The findings of possible benefit, clinicians’ desperation for something — anything — to treat this virus, and President Trump’s promotion of the drug based on “gut instinct” by ordering the government to stockpile 29 million pills no doubt influenced the FDA’s decision.
An accompanying editorial to the Vanderbilt study makes clear the lesson that should be learned from the hydroxychloroquine disaster (Saag MS. Misguided Use of Hydroxychloroquine for COVID-19: The Infusion of Politics Into Science. JAMA. 2020;324(21):2161-2162.) “The clear, unambiguous, and compelling lesson from the hydroxychloroquine story for the medical community and the public is that science and politics do not mix ... For other potential therapies or interventions for COVID-19 (or any other diseases), this should never happen again.”
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