In the mad scramble to find safe and effective drugs to treat patients suffering from COVID-19, the winners and losers amongst the litany of candidates are starting to emerge, with a previously-strong contender—hydroxychloroquine—falling from favor with the FDA, and another commonly-used drug seeing success in a major clinical trial.

The U.S. Food and Drug Administration has revoked the emergency use authorization (EUA) for the otherwise well-established malaria drugs chloroquine and hydroxychloroquine, due to the conclusion made by the Biomedical Advanced Research and Development Authority (BARDA) that the drug “may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” according to the FDA’s chief scientist, RADM Denise M. Hinton.

Heavily politicized due to its endorsement by President Donald Trump, hydroxychloroquine has seen mixed results from its use as a treatment for COVID-19 patients following the drug’s emergency use authorization status granted by the FDA, allowing health-care workers to administer it as a treatment for those with severe symptoms caused by the coronavirus. But with no appreciable benefit available for COVID-19 patients from the drugs, their use could prove to be dangerous for those suffering from the disease, as chloroquine and hydroxychloroquine are known to cause abnormal heart rhythms, such as a prolonged QT interval, a side effect that could exacerbate the cardiac damage that the SARS-CoV-2 virus is known to cause.

To date, COVID-19 has infected more than 8.1 million people and killed at least 440,000 worldwide. In the U.S. alone, over 2.1 million have tested positive for the virus, with over 116,800—more than the total number of American casualties in World War I—dying from the illness.

“We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence,” the FDA’s Anand Shah said in a statement.

But despite this setback, a commonly-used corticosteroid called dexamethasone has been shown to dramatically reduce the chances of death for COVID-19 patients. The subject of an Oxford University-led randomized trial called RECOVERY, dexamethasone has been shown to reduce the chances for critically ill patients on ventilators from dying by roughly one-third. Cases that were less severe but still required oxygen masks saw a 20 percent better chance of recovery, although there was no effect for those with only mild symptoms. First approved for use in 1961, dexamethasone is an inexpensive drug used to treat a wide variety of conditions.

“Finding effective treatments like this will transform the impact of the COVID-19 pandemic on lives and economies across the world,” according to Nick Cammack, head of the COVID-19 Therapeutics Accelerator at Wellcome, a UK biomedical research charity in London. “While this study suggests dexamethasone only benefits severe cases, countless lives will be saved globally.”

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7 Comments

  3. The FDA is nothing more than an extension of Big Pharma. Clearly, it favours the use of drug medication as the “accepted” means to combat disease while downplaying the side effects that many medications create within the user. After decades of use to combat malaria, suddenly the FDA has determined that hydroxychloroquine is considered “dangerous” to those who take it to combat the effects of COVID-19. But they don’t get overly concerned about the 100k+ deaths that occur annually by those who take prescription drugs. Their hypocrisy is quite evident! RM

    1. As a matter of fact, hydroxychloroquine is outright dangerous to COVID-19 patients with severe symptoms, considering a well-known adverse effect of the drug is irregular cardiac rhythms; combine this with a virus known to attack the cardiovascular system, and HCQ could very well be downright lethal in far too many circumstances. While at first there was hope that the potential benefits the drug could provide might outweigh the risks, those benefits don’t appear to have panned out, so there’s far more risk involved than reward, in terms of treatment.

      This wasn’t just a matter of the FDA making some sort of arbitrary dismissal of HCQ: Oxford University (of whom presumably doesn’t control the FDA) also found that HCQ wasn’t effective in improving survival rates, showing only a 9% improvement, compared to dexamethasone’s 36%–a fourfold improvement.

      Dexamethasone has been in circulation for about as long as HCQ, and the two drugs, being similar in price, are also dirt cheap, so Big Pharma doesn’t care if HCQ (already a money-maker before the pandemic) gets kicked to the curb in this circumstance.

  4. Matthew, agreed on the FDA’s correctly identifying the unjustifiable risk of hydroxychloroquine in any medical treatment plan for COVID-19. The FDA is far from perfect, but they got it right on that one.

    On Twitter, I saw a mortality statistic this morning: COVID-19 is 50 to 100 times as lethal to people, when compared with the influenza death rate.

    Also on Twitter today, the first science-based forecast I have seen for the beginning of a 2nd wave of COVID-19:
    https://flutrackers.com/forum/forum/-2019-ncov-new-coronavirus/south-korea-2019-ncov/823386-south-korea-2019-ncov-cases-12-438-cases-280-deaths/page24#post872010

    Last week my family and I drove to a San Fernando valley mortuary for what is called a viewing of our dead family member. I stayed in the car, because the viewing was of course indoors. The bereaved parent was then able to show me his cellphone photo that he had just taken of the dead person, who fortunately was still recognizable. (Sometimes morticians apply makeup, etc., to the deceased person.) So the son still looked like himself, and yet at peace. Both parent and deceased child were trained musicians, and in the last few days, the parent has often been reminded of the theme to Dvorzak’s New World Symphony … sweet.

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