An FDA Breakthrough on Treatment The agency finally approves anti-malarial drugs for Covid-19.
https://www.wsj.com/articles/an-fda-breakthrough-on-treatment-11585609832?mod=opinion_lead_pos2
The Food and Drug Administration on Sunday green-lighted two malaria medicines that have shown some promise treating the novel coronavirus, and the emergency approvals couldn’t come soon enough. Expanding their use could bring quicker relief to patients and hospitals while allowing scientists to better assess their efficacy.
The malaria drugs hydroxychloroquine (HC) and chloroquine have been around for more than five decades, so their safety is well documented. New evidence suggests that they could also help fight the novel coronavirus, as op-eds by Dr. Jeff Colyer on these pages have reported. Both chloroquine and HC in vitro block the replication of RNA viruses like the novel coronavirus.
Hydroxychloroquine nowadays is often prescribed for the autoimmune conditions lupus and rheumatoid arthritis that result from the body’s immune system attacking its own cells. Scientists have also documented an overreactive immune response in severely ill coronavirus patients.
Notably, a study in France of 80 coronavirus patients given HC and azithromycin, an antibiotic for upper respiratory infections, documented “a clinical improvement in all but one 86 year-old patient who died, and one 74 year-old patient still in intensive care unit.” Doctors have also reported anecdotal evidence of the malaria drugs’ efficacy.
More study is needed, and a clinical trial of the two drugs involving 1,100 patients started last week in New York. But the FDA’s emergency authorization will let more doctors prescribe the drug outside of clinical trials, and hospitals will be required to maintain data on drug dispensation and patient outcomes. This will allow a larger review than possible in a controlled clinical trial.
Production of the drugs will need to increase so patients with autoimmune conditions can maintain their treatments, and the emergency approval covers only drugs supplied by the National Strategic Stockpile. The Department of Health and Human Services reported Sunday that Novartis has donated 30 million doses of HC, and Bayer has contributed one million doses of chloroquine to the federal government, which can distribute the drugs to areas with the highest need.
Some are attacking President Trump for giving patients “false hope” by encouraging the emergency drug approvals. They quibble that the French study lacked a control group, but are flogging a smaller Chinese study that found no statistical benefit from HC. That study’s control group received other antiviral drugs.
Effective drug treatments would reduce the strain on hospitals and in the long term will be more important and less costly than government quarantines in defeating the pandemic.
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