COVID-19 Records

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Gates Package, p.991 · gates:exh:00401

Page text: p.991 · original PDF

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attachment · document
Topics
Therapeutics and treatmentsVaccinesWHO and international investigation
3 but in early June a Unfortunately, that's not what happened. Safe, effective COVID vaccines were available within the year--a historic feat that will get its due in the next chapter--but treatments that could keep large numbers of people out of the hospital were surprisingly slow out of the gate. It wasn't for lack of trying. Doctors began prescribing a drug called hydroxychloroquine off-label--that is, for something other than its approved purpose--almost from Day 1. Early reports suggested that it could be effective against COVID, and the FDA gave the provisional green light known as emergency-use authorization. The early evidence for hydroxychloroquine came from lab studies of its effect on cells taken from the kidneys of the African green monkey. These cells are often used to screen potential antiviral drugs because viruses replicate very quickly in them, and in fact the method did surface some promising treatments, including the antiviral drug remdesivir. In early studies, hydroxychloroquine was able to block one pathway by which the COVID virus entered the monkey cells, suggesting that it might do the same in humans. Hundreds of clinical studies tried to replicate these promising results,3 but in early June a definitive randomized study in the U.K. found that the drug provided no benefit for patients who'd been hospitalized with COVID. Ten days later, the FDA revoked the emergency-use authorization, and two days after that the WHO dropped hydroxychloroquine from a trial it was running. The problem, it turns out, was that human cells have a different pathway from the one that the drug blocked in monkey cells--so the promising results didn't translate from animals to people. As far as treating COVID goes, the drug was a dead end. Meanwhile, the hydroxychloroquine craze caused a run on the drug, and many patients who needed it to treat lupus and other chronic conditions couldn't get it.