The Food and Drug Administration (FDA) on Monday, 15 June, announced to withdraw the emergency use authorisation for chloroquine and hydroxychloroquine (HCQ) as treatment for severe COVID-19 patients, IANS reported.
The decision on the 'wonder drug' - as touted by the US President Donald Trump - is taken in the wake of recent clinical trials that showed that the antimalarial drugs were not effective against the coronavirus.
"In light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits" of hydroxychloroquine no longer outweigh those risks, the FDA wrote on its website.
Politics or Science: What Led to the Authorisation?
On March 28, the US FDA issued an emergency use authorisation for chloroquine and hydroxychloroquine for the treatment of COVID-19. By April 24, however, the FDA issued a drug safety communication warning regarding hydroxychloroquine and heart rhythm disturbances that can lead to sudden cardiac death.
The drugs are traditionally used to treat malaria and certain autoimmune conditions, including lupus and rheumatoid arthritis. These can be taken to treat those conditions, but should not be taken to treat COVID-19 anymore.
The FDA noted that doctors could still use the medicines “off label” to treat coronavirus patients, and clinical trials examining their use against COVID-19 can continue since it has been approved for other illnesses.
According to a Politco report, health agencies and experts have always been critical of the decision, which was presumably taken by the FDA under political pressure and was based on insufficient evidence. Apart from not showing any real benefit to coronavirus patients, evidence for harm has been found from the drug use, recent trials have shown.
The Politco report reads, “The administration’s focus on the malaria medicines in the early months of the pandemic deepened a divide between the White House and its health agencies. Several administration officials told POLITICO they felt the drugs got outsized attention while FDA scrambled for solutions in March. Other current and former Health and Human Services officials later said that the emergency authorities and White House demands cast a shadow on FDA as it struggled to remain independent.”
The request for emergency authorisation as well as the recent withdrawal of the drugs came from an agency within the Department of Health and Human Services called the Biomedical Advanced Research and Development Authority (BARDA). Notably, Gary Disbrow, the current acting director of the agency replaced Rick Bright, who had accused officials of removing him from the position because he had raised health concerns about the use of HCQ.
“Drugmakers donated millions of the pill to the government’s strategic national stockpile after Bright wrote to the FDA requesting for emergency use, a move he now says he was pressured to make,” according to Politico.
(With inputs from IANS)
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