Sound scienceIn the Rush to Innovate for COVID-19 Drugs, Sound Science Is Still Essential
Hydroxychloroquine and chloroquine have been at the center of debate in recent weeks over which drugs should be used to treat COVID-19. Neither product has strong evidence to support use for this purpose, and small studies reported to date have either had significant flaws or failed to demonstrate effect. Nonetheless, the president can’t seem to stop pushing them, arguing that patients have nothing to lose. As physicians, bioethicists and drug law experts, we have a responsibility to inject caution here. As public officials and scientists rush to innovate, no one should overlook the critical role of strong regulatory protections in supporting our ability to actually figure out which drugs work against COVID-19. Weakening commitment to science and evidence during this crisis truly would be “a cure worse” than the disease.
Hydroxychloroquine and chloroquine have been at the center of debate in recent weeks over which drugs should be used to treat COVID-19. Neither product has strong evidence to support use for this purpose, and small studies reported to date have either had significant flaws or failed to demonstrate effect.
Nonetheless, the president can’t seem to stop pushing them, arguing that patients have nothing to lose. As physicians, bioethicists and drug law experts, we have a responsibility to inject caution here. As public officials and scientists rush to innovate, no one should overlook the critical role of strong regulatory protections in supporting our ability to actually figure out which drugs work against COVID-19. Weakening commitment to science and evidence during this crisis truly would be “a cure worse” than the disease.
FDA’s Emergency Use Authorization
There are no Food and Drug Administration-approved drugs to treat COVID-19, and no product has strong data to support its use against this disease. Nonetheless, on March 28, the FDA issued an emergency use authorization (EUA) for certain hydroxychloroquine sulfate and chloroquine phosphate products donated to the strategic national stockpile by various pharmaceutical companies. The EUA was granted exclusively to the Biomedical Advanced Research and Development Authority (BARDA), allowing it to distribute these stockpiled drugs to local public health authorities for the unapproved use of treating hospitalized COVID-19 patients unable to participate in clinical trials.
An EUA is not the same as the FDA’s traditional marketing approval. To be approved under normal rules, drugs must be shown safe and effective for their intended use. An EUA, in contrast, is a temporary authorization granted in the face of a public health emergency, based only on a determination that a product “may” be effective and that its likely benefits outweigh its likely risks. This EUA was supported only by “limited in-vitro and anecdotal clinical data in case series” – with no acknowledgment of contrary data or significant safety concerns. Overall, it’s sown even further confusion about the promise and uncertainties of these drugs.
Off-Label Use
An EUA is not the only way that COVID-19 patients may access hydroxychloroquine and chloroquine. A physician is generally free to prescribe approved drugs for unapproved uses as part of their authority to practice medicine. This is referred to as “off-label” use. Because several hydroxychloroquine and chloroquine products have been FDA-approved for malaria, lupus and rheumatoid arthritis, they’re eligible for off-label use against COVID-19.
