FDA REVOKES emergency approval for hydroxychloroquine to treat coronavirus after the malaria drug touted by Trump failed to help 75 patients in a Chinese clinical trial
- On Monday, the Food and Drug Administration said hydroxychloroquine no longer has emergency use authorization for treating COVID-19
- The results of several large clinical trials of the drug touted by Trump suggest it is 'unlikely' to have antiviral effects
- It comes after the retraction of a study that suggested that the malaria and lupus drug might raise the risks of death for coronavirus patients
- WHO resumed its international trials of the controversial drug, but a more recent large clinical trial suggests no benefit to the drug
- Hydroxychloroquine is known to cause dangerous heart arrhythmias as a side
On Monday, the US Food and Drug Administration (FDA) stripped hydroxychloroquine, the malaria drug touted by Trump, of its emergency use authorization for treating coronavirus patients.
It comes after 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Earlier this month, a study linking the drug to a higher risk of death in COVID-19 patients was retracted from the medical journal The Lancet, reigniting debates over the drug and its safety.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 President Trump - who has been conspicuously quieter about the drug in recent weeks - and to at least one hope for a coronavirus treatment.
FDA officials have stripped hydroxychloroquine of its emergency approval status for treating coronavirus after reviewing new evidence from a Chinese study that suggests the drug is unlikely to have antiviral effects or ease symptoms
'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 President 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.
President Trump promoted the use of hydroxychloroquine for treating coronavirus and took it himself in the hopes it would prevent infection, but has grown quiet about the drug in recent weeks (file)
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.
And President Donald Trump himself continued to take the drug he dubbed a 'game-changer' in the hopes it would prevent infection.
The research, led by Dr Mandeep Mehra of Harvard Medical School, Dr Amit Patel of the University of Utah and Dr Frank Ruschitzka of the University Hospital Zurich, has been under outside review.
But Surgisphere - founded by study co-author, Dr Sapan Desai, whose name was conspicuously absent from the retraction letter - refused to transfer its data to the auditors, citing patient privacy. As a result, the review was cut short and the study was retracted.
'We can no longer vouch for the veracity of the primary data sources,' the three authors wrote to The Lancet in their retraction.
Even before the study was retracted from The Lancet, hydroxychloroquine was a controversial subject, politicized in part by President Donald Trump's references to the drug as a 'game-changer' and a 'gift from God.'
The study's lead author, Dr Mehra, is a cardiovascular surgeon and registered Republican.
Dr Mehra said in a personal statement shared with DailyMail.com that he found Surgisphere through a co-author and personally reviewed the company's data, but admitted that in hindsight, his review was perhaps not thorough enough.
The study authors published a retraction of their research on June 4, less than a month after the original article was published. They revealed that their data could not be reviewed and apologized for any 'embarrassment or inconvenience that this may have caused'
'I did not do enough to ensure that the data source was appropriate for this use. For that, and for all the disruptions—both directly and indirectly—I am truly sorry,' he said in the statement.
Results from Vote With Me suggest that Dr Patel, an adjunct professor of biomedical engineering at the University of Utah may be a registered Democrat.
Editors at the NEJM published an 'expression of concern' Tuesday that echoed that written by the editors of the Lancet. The NEJM, too, was suspicious of the data from Surgisphere.
More than 120 top scientists and doctors had criticized the study in an open letter to the journal, flagging 10 major flaws.
The Lancet then admitted there are 'serious questions' that need to be answered about the data - but did not reveal what those question were - in a public statement.
But scientists say the move was too late and that the 'harm was already done', as the race for a cure to halt the virus that has ravaged the world continues.
However, the World Health Organization announced Wednesday that the hydroxychloroquine arms of its international SOLIDARITY trial of potential coronavirus treatments would resume.
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