The Food and Drug Administration (FDA) today stripped hydroxychloroquine, the malaria drug touted by President Trump, of its emergency use authorization for treating coronavirus patients.
Dr. Gary Brisbow, director of the Biomedical Advanced Research and Development Authority’s medical countermeasure programs, requested the FDA revoke the controversial drug’s status.
Already, the FDA had issued a warning about the use of the drug outside clinical trials or hospitals, due to its potential to cause dangerous heart side effects, and the National Institutes of Health (NIH) recommended its use be isolated to trials.
Earlier this month, a study linking the drug to a higher risk of death in COVID-19 patients was retracted from the medical journal The Lancet, reigniting debates over the drug and its safety.
But the FDA cites new data from a clinical trial as evidence that the drug does not help coronavirus patients recover, and may pose risks that outweigh its potential benefits.
Because hydroxychloroquine has long been approved for treating other conditions – malaria, lupus and rheumatoid arthritis – it could still be used ‘off-label’ and clinical trials may continue.
Still, the FDA’s decision to revoke its emergency approval status comes as a blow to Trump – who has been conspicuously quieter about the drug in recent weeks – and to at least one hope for a coronavirus treatment.
‘FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ [hydroxychloroquine] and CQ [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,’ wrote chief scientist, Dr Denise Hinton, in the Monday letter.
The FDA primarily pointed to the results of a clinical trial of hydroxychloroquine performed at Shanghai Jiao Tong University School of Medicine.
Results from the study of 150 patients, published in the BMJ, showed no signs that patients treated with hydroxychloroquine fared any better than those who did not get the drug at any point over the 28-day trial period.
Researchers stopped the study short as a result of its dismal results.
The study was the nail in the coffin for the FDA’s stance on hydroxychloroquine.
When the FDA issued its emergency use authorization (EUA) for hydroxychloroquine on March 28, the decision was met with excitement from Trump and skepticism from much of the medical community.
FDA officials pointed tepidly to limited evidence that the drug might help stem the replication of coronavirus and ease symptoms.
Since then, a flurry of studies have returned very mixed results, mostly based on small data samples.
Several of these studies were stopped short, either because the drug was showing little benefit, or due to high rates of cardiac complications in the patients.
Critics suspected that the FDA’s quick decision was in response to political pressure from the Trump administration, a claim that agency head Dr Stephen Hahn has vehemently denied.
It comes after three authors of a momentous study that claimed that hydroxychloroquine raised the risks of death for coronavirus patients treated with the controversial malaria drug have retracted their research.
The retraction was published in the Lancet on Thursday, and comes just two days after the medical journal posted an ‘expression of concern.’
Along with the publication, more than 120 prominent scientists raised questions about the data used in the study, which was sourced from a database run by a private company, Surgisphere.
On the heels of that research’s May publication, international trials of the drug were halted – but the World Health Organization (WHO) announced Wednesday it would restart the hydroxychloroquine arm of its international SOLIDARITY trial.
Trump took the drug he dubbed a ‘game-changer’ and a ‘gift from God.’