Hydroxychloroquine status revoked for security reasons (Representation)
Washington:
The United States on Monday withdrew emergency use authorizations for two antimalarials favored by President Donald Trump to treat the new coronavirus, closing the door on politically charged treatments.
Hydroxychloroquine (HCQ) and chloroquine (CQ) were approved in March after discovering that they inactivate the virus in test tubes, and early small studies seem to show that they also work well in humans.
Since then, however, larger and better controlled experiments have shown that both drugs are ineffective in treating COVID-19 or preventing infection in people who have been exposed to the virus.
Meanwhile, safety concerns have been raised around their use – in particular the risk of causing an irregular heartbeat in some patients.
“It is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in the treatment of COVID-19,” wrote Denise Hinton, chief scientist of the Food and Drug Administration (FDA) in a letter.
“Nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.
“As a result, the FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19.”
The emergency approvals paved the way for donating drugs from a national stock to hospitals to fight COVID-19, and were seen as an intermediate step before full regulatory approval.
Both drugs are approved for use against malaria, as well as autoimmune conditions of rheumatoid arthritis and lupus.
Doctors will therefore still be able to prescribe them “off-label” against COVID-19, although this is strongly discouraged by the American health authorities.
Despite everything, the end of the authorizations dealt a blow to Trump, who personally supported HCQ on numerous occasions, calling him a potential “game changer” based on his intestinal feelings.
He also said he used the drug to prevent infection – but a recent clinical trial also found it to be ineffective.
HCQ also received ringtones from the right-wing media, notably Fox News, and from Brazilian President Jair Bolsonaro, as well as in France from supporters of scientist Didier Raoult, who conducted one of the first experiments which has given favorable results.
Overall, he pitted politicians against the scientific establishment.
In May, Rick Bright, a prominent government scientist, told Congress that he had been removed from his role in vaccine development because he had raised concerns about the HCQ and resisted its widespread use.
This month, two major clinical trials, one in the UK and one in the United States and Canada, have highlighted the ineffectiveness of the drugs.
But HCQ was also at the center of an academic scandal when the prestigious newspaper The Lancet withdrew a study which claimed that the drug increased the risk of death.
The document was withdrawn after most of its authors said they could no longer guarantee the authenticity of a data set provided by a small Chicago-based healthcare company.
Despite the case, the scientific consensus seems to have hardened against the use of HCQ for COVID-19.
(With the exception of the title, this story was not edited by GalacticGaming staff and is published from a syndicated feed.)
