The end of the line for hydroxychloroquine for COVID-19.

Today, the FDA removed the Emergency Use Authorization supporting the use of hydroxychloroquine treatment or prophylaxis for COVID-19 infection. None of the multiple clinical studies involving the drug has shown any efficacy in treating or preventing COVID-19. While cardiac toxicity was a concern, no study suggested that was the defining issue. The most important thing appeared to be the lack of efficacy. 

The timing of this announcement is a bit surprising since it comes soon after one of the major studies calling hydroxychloroquine into question was withdrawn from the Journal Lancet. In addition, several studies of the drug that were stopped by the WHO were restarted after the withdrawal of the Lancet article. Despite this, there was no real evidence that the drug worked and therefore should be allowed to continue to be approved for COVID-19.

There was more political squabbling surrounding this drug than scientific discourse. The initial data was tenuous at best, and most physicians were never convinced of its value. It is better to move on and find something that truly will help people.

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

2 thoughts on “The end of the line for hydroxychloroquine for COVID-19.

  1. HI Jim, Regarding your comment about hydroxychloroquine: There was a valid scientific question behind taking chloroquine to clinical trials for treatment of Covid. The scientific question came about from a study done by a prominent French scientist (I believe Didier Raoult is his name). Furthermore, a putative mechanism of action exists, potentially involving an anti-inflammatory effect mediated through the TFEB/autophagy/mTOR pathway. Furthermore, there were many questions in regards to the dosing of the drug and its relationship to QT prolongation and atrial fibrillation, vs. the virus having effects on these pathways. Even more importantly, there are 60 or more clinical trials right now, testing one or another thing about hydroxychloroquine. I am not a “believer” in hydroxychloroquine, but I do stand for giving it a fair chance -hydroxychloroquine could well have beneficial effects if dosed properly and scientists should have been able to find out. I am not sure what prompted the FDA’s announcement, but these clinical trials are now compromised by the FDA’s announcement -as if science was not hard enough to do.


    1. French study was garbage and claimed an antiviral effect, not anti-inflammatory. Also, dose required for anti-inflammation is too high to achieve in humans. Trials will continue; just not the open label use of the drug.


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