With the ongoing global pandemic, the world has come together playing different roles, to end the deadly virus. Many of them include several researchers, government employees issuing safety guidelines, healthcare workers, etc. Researchers are vigorously working day and night to come up with a cure or a vaccine for this contagious virus. Multiple studies are constantly conducted with ongoing human trials for many. Furthermore, some had also received authorization for use.
The U.S. Food and Drug Administration (FDA) had declared an emergency use authorization (EUA). However, it is now dismissed. The EUA was issued for 2 anti-malarial drugs; Chloroquine and Hydroxy-chloroquine.
These anti-malarial drugs have previously been used in treating chronic rheumatoid arthritis. Moreover, President Donald Trump had previously touted about how it is an effective treatment for COVID-19. However, their clinical proof was inconclusive. This further led to major concerns developing regarding the scientific authenticity of the early medical investigations, which concluded the effectiveness of the drug against the virus causing the global pandemic.
The research behind this
Different pieces of research had shown contradicting results that raised conflicts and further questions. One of the clinical studies had the team of researchers end parts of their study early, owing to the excess deaths.
In late March, the FDA issued the EUA for the use of chloroquine and hydroxy-chloroquine against the virus. This led to criticism from several researchers in the medical and pharmaceutical research community.
This was mostly due to the conflicting evidence which raised bars for both, potential efficacy, and risks. The deaths that followed in the clinical study, only raised further conflicts, and a declaration of an official statement of precaution regarding the use of the drug.
The FDA and EUAs
EUAs are granted only in very specific circumstances. It is essential for the advantages to outweigh the risks of an accelerated provincial authorization which would allow the use of therapies and devices that haven’t completed a thorough approval process or the drugs and equipment.
However, COVID-19 pandemic has its own demands. The world as never prepared for it, and many aspects of it are still uncertain. While many regulations have been improvised, so has the FDA. The FDA has issued several more EUAs compared to its typical approximate figure. This is especially as it is related to equipment testing for diagnostics of the SARS-CoV-19.
President Donald Trump, however, touted the exaggerated effects of chloroquine and hydroxy-chloroquine. At a time like this, the general public is relying on social media, public figures, and news, for the latest updates on the virus and to act accordingly. Any piece of misleading or false information can only be harmful during a time like this.
However, Trump later declared to be regularly taking this medication himself. He has claimed it to be a sort of precaution. However, he also added that it was a false belief that this precaution would prevent him from the infection completely.
The supply of the drug has been strained consistently due to the high demand after the issuance of the EUA. However, this potentially led to terrible consequences for individuals who had a legitimate need for the medications for their medical conditions that have been approved and clinically tested for the use. Such medical conditions could include lupus and chronic arthritis.
DA revoking EUAs for the drugs can be alarming due to the current ambiguity regarding medication, cure, and vaccine for the virus. However, clinical trials and human trials are currently underway globally, with several researchers working on different researches and giving predicted times of a successful vaccine. Hence, there is still hope for the end to this pandemic.