Despite being touted by some as a reason to reinstate hydroxychloroquine's emergency use authorization, many clinical experts are pointing out the flaws in a recent study suggesting the drug as an effective COVID-19 treatment.
The study, which came from Detroit-based Henry Ford Health System and was published July 2 in the International Journal of Infectious Diseases, purported that COVID-19 patients who received hydroxychloroquine early in their hospital stays had a better chance of survival.
Experts are drawing attention to the fact that the study was not randomized. A closer look reveals patients who received hydroxychloroquine were also more likely to get steroids, which improves a patient's chances for recovery, the experts said.
Henry Ford has asked the FDA to re-issue the emergency use authorization for hydroxychloroquine that the agency instated March 28 and rescinded June 15. Peter Navarro, President Donald Trump's trade advisor, has publicly supported the health system's push to continue using the drug as a COVID-19 treatment and has called EUA rescindment "tremendously negative", according to STAT.
However, many experts are arguing that another change of heart on hydroxychloroquine would be detrimental to the FDA's credibility and the public's trust in the agency. They are suggesting the FDA focus on evidence from trials only conducted on sufficiently randomized participants.
Despite being touted by some as a reason to reinstate hydroxychloroquine's emergency use authorization, many clinical experts are pointing out the flaws in a recent study suggesting the drug as an effective COVID-19 treatment.
The study, which came from Detroit-based Henry Ford Health System and was published July 2 in the International Journal of Infectious Diseases, purported that COVID-19 patients who received hydroxychloroquine early in their hospital stays had a better chance of survival.
Experts are drawing attention to the fact that the study was not randomized. A closer look reveals patients who received hydroxychloroquine were also more likely to get steroids, which improves a patient's chances for recovery, the experts said.
Henry Ford has asked the FDA to re-issue the emergency use authorization for hydroxychloroquine that the agency instated March 28 and rescinded June 15. Peter Navarro, President Donald Trump's trade advisor, has publicly supported the health system's push to continue using the drug as a COVID-19 treatment and has called EUA rescindment "tremendously negative", according to STAT.
However, many experts are arguing that another change of heart on hydroxychloroquine would be detrimental to the FDA's credibility and the public's trust in the agency. They are suggesting the FDA focus on evidence from trials only conducted on sufficiently randomized participants.