The US Food and Drug Administration (FDA) has this week revoked permission for hydroxychloroquine to be distributed to treat coronavirus patients, meaning that the federal government has been left with over 60 million doses that it cannot use.
President Donald Trump gave high praise to the efficacy of hydroxychloroquine at the end of March, calling it ‘very powerful’ and ‘a game changer’. This prompted the government to start stockpiling the drug but on Monday the FDA made the decision to revoke its emergency use authorization that allowed the drug to be used to treat Covid-19.
“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,” FDA chief scientist Denise Hinton wrote in an open letter to Biomedical Advanced Research’s Gary Disbrow and Development Authority (BARDA) last week.
“Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19,” Hinton continued. “As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19.”
The FDA had already warned against the use of both hydroxychloroquine and chloroquine outside hospitals to treat Covid-19, due to the drugs’ links with serious cardiac event and rhythm issues. Other common side effects include headaches, vomiting, weight loss and mood changes.
According to Carol Danko, a spokesperson for the US Department of Health and Human Services, the Strategic National Stockpile is now left with 63 million doses of hydroxychloroquine and another 2 million doses of chloroquine, which is a similar drug that was donated by German pharmaceutical company Bayer AG.
The news has sparked criticism from many expert health officials, who claim that the federal government acted too rashly and made their decisions for the wrong reasons and without significant scientific data that supported the effectiveness of the aforementioned drugs.
“Nationally, we put a great emphasis on one drug, hydroxychloroquine,” said David Holtgrave, the dean of the School of Public Health at the University at Albany, who co-authored a study of the drug as a treatment for coronavirus. “I worry that history will judge this as having over-invested in one treatment pathway as opposed to looking more broadly at a larger number of treatment candidates.”
President Trump has also been the target of criticism as his comments in late March sparked a shortage in hydroxychloroquine for patients that need it to treat lupus, rheumatoid arthritis and malaria, which the drug has historically been used for.
Initially, Trump tweeted a link to a French study that suggested hydroxychloroquine paired with the antibiotic azithromycin ‘had a real chance to be one of the biggest game changers in the history of medicine’ and could be used to treat Covid-19. Trump continued to champion the drug for months after and claimed that he even took it himself when worried about being exposed to the virus.
However, it was soon found that the study was not completed properly or to any sort of professional standard and the society that published it actually ended up distancing themselves from the study. In fact, the study did not even conclude that the drug indeed worked for Covid-19 patients. Instead, they simply stated that it decreased the amount of the virus that could be found in the nose and throat of patients.
Additionally, only 20 patients took part in the study and those that took hydroxychloroquine and died or ended up in the intensive care unit were omitted from the study completely. The International Study of Antimicrobial Chemotherapy received a number of complaints after publishing the study in its medical journal and eventually concluded that it ‘did not meet the Society’s expected standard’ and so removed all association.
Two large studies have since found that hydroxychloroquine and chloroquine are ineffective against Covid-19. One such study, published in the Journal of the American Medical Association, went one step further and showed that COVID-19 patients who took hydroxychloroquine or chloroquine where more than twice as likely to suffer a heart attack.
“This decision was based on evaluation of the EUA criteria and the scientific evidence available at that time. We continue to look at the data on hydroxychloroquine and chloroquine and we will make future determinations on these products based on available evidence including ongoing clinical studies,” FDA commissioner Dr. Stephen Hahn said in an open letter published last month, defending the agency’s decision to authorize emergency use of the drug.
“We also knew it was important to help ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand.”