South Dakota officials said Friday they will continue to make a malaria drug available to treat COVID-19, even as the U.S. Food and Drug Administration warned against its use outside of hospital and research settings.
So many things about the coronavirus pandemic seems like we're sailing into uncharted waters, and this is another one. We're not aware of South Dakota or any other state previously getting involved in clinical trials for drugs.
Clinical trials for either new drugs, or for existing drugs used for new purposes, are highly regulated. There is a lengthy process involving documented past research, current objectives of the trial, and assurances of safety.
Some people believe that the emergency nature of COVID-19 is reason for suspending or skipping some of the protocols for a clinical trial. We're very skeptical about making that connection.
In this case, hydroxychloroquine is an established drug with approved uses for malaria and lupus. President Trump has suggested the drug could be used in the fight against COVID-19, and that we don't have time to put it through the regular channels. Regrettably, some Americans have purchased the drug and started self-administering it based on the suggestion.
The FDA flagged reports of serious side effects and death among patients taking hydroxychloroquine and the related drug chloroquine.
The state of South Dakota is partially funding a hydroxychloroquine trial in partnership with Sanford Health. The state received 1.2 million doses of the drug from the Strategic National Stockpile.
Officials say participation in the trial is voluntary, perhaps as a bit of a waiver in case things go wrong. Susan Hoover, an infectious disease physician at Sanford Health, said its physicians are aware of the potential of both hydroxychloroquine and azithromycin, an antibiotic sometimes administered with the malaria medication, to disrupt heart rhythms. They are closely monitoring patients who receive the drugs.
We understand how eager everyone is to find both a vaccine and a cure for COVID-19, but we also don't believe we should compromise the integrity of trials by skipping important protocols.
-- Jon M. Hunter