A Necessary Waiting Game
“A Necessary Waiting Game” was originally published at City Journal.
On March 28, the Food and Drug Administration approved the emergency use of the antimalarial drugs chloroquine phosphate and hydroxychloroquine sulfate for hospitalized Covid-19 patients. This decision was partly based on early, but limited, data on their effectiveness. The FDA, however, stipulated that emergency use is authorized only when clinical trials aren’t available or participation isn’t feasible. This stipulation highlights the importance of properly conducting well-designed clinical trials without interference. These trials demonstrate the safety of a novel therapy and then, through a randomized controlled trial (RCT), can prove that a novel therapy works. This reflects the standard process of authorization for emergency use of unapproved therapies.
Initially, clinical trials must show that medications are safe in healthy adults and then in affected patients. Malaria drugs are known to cause complications in some adults taking them for malaria or autoimmune diseases; these complications aren’t common to all patients. We don’t know what complications may arise from using these medications in Covid-19 patients, or for which patients. No published stories have appeared about these drugs causing harmful effects in Covid-19 patients, but it’s possible that too few patients have been treated to see such complications. The safety of these drugs, given the projected number of patients, needs further investigation.
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