The Food and Drug Administration’s rush to greenlight unproven malaria medicines to fight the coronavirus may derail clinical trials of other potential cures for the deadly virus
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The Trump administration is also considering authorizing another unproven coronavirus treatment for emergency use. The drug, a Japanese flu medicine called Avigan, has been publicly endorsed by Japanese Prime Minister Shinzo Abe. But it is not approved by the FDA, and the agency has rejected it in the past over concerns about side effects.
Only by running randomized clinical trials of experimental treatments will scientists and doctors find a cure for the coronavirus, says Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania. Such trials are the gold standard for getting answers, because doctors cannot cherry-pick who gets a dose of the drug being studied or which results to share.
The FDA is working quickly with a range of pharmaceutical companies through its recently established coronavirus treatment acceleration program, Commissioner Stephen Hahn said in a statement provided to POLITICO. “We are also looking at pragmatic and expedited ways to make these products available to patients, while still ensuring the FDA’s standards are met,” Hahn said.
The Trump administration’s push to make experimental therapies widely available for use outside of clinical trials have earned swift criticism from patient groups accusing the FDA of folding to political pressure. In one case, the group Patients Over Pharma has publicly urged FDA Commissioner Stephen Hahn to act based on the best science rather than political calculus.
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