It’s almost the end of October and all are eagerly waiting for 31st December as if COVID expires by then. I know it’s not hilarious, but hoping against hope is what this pandemic taught us all about. Who thought this little virus could change our perspective about everything around us. Suddenly OCD is the new normal, use of sanitizers and masks aren’t restricted to healthcare worker, eating healthy and physical activity is the need of the hour. And the irony is, the whole world was locked down just because of a notorious virus that wants to roam across the territories. It has mocked the health care system, most powerful nations, politics, racism, migrant and magical healers. But in the midst of this terror it offers us a chance to rethink how we were leading our lives. And was that important for the benefit of our society?
As we are still fighting against this pandemic, there are thoroughly scrutinizing drugs that are approved for other indications. And these drugs are being studied in clinical trials for the treatment of COVID-19 and associated complications. Several institutions continue to review the most recent clinical data to provide up-to-date treatment recommendations for clinicians who are treating COVID-19 patients. And between all this chaos came up a drug named hydroxychloroquine which is an anti-malarial drug used for treating malaria. So the first time it came into the news was in March 2020 when US president eulogized it as a rock star. But soon many responses from the scientists came lamenting over the insane publicity of the drug as a remedy for COVID 19. How every on June 2020 WHO announced that the Solidarity Trial to find the effectiveness of hydroxychloroquine for COVID-19 treatment was being stopped(1) . As it didn’t reduce the mortality rate among the hospitalized COVID-19 patients. And also on July 1st ,2020 the FDA came up with a review which concluded that there were serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure(2). And eventually many others catcall it, saying off-label drug.
So what are OFF-Label Drugs? These are licensed medications for indication that have not been approved by national medical regulatory authority. Then is it ethical to use off-label drug for treating a patient with COVID-19 for which it’s not proven yet? Is a randomized control trial necessary to prove the efficacy of hydroxychloroquine in the context of this pandemic? Or is it the government’s right to decide the treatment protocol and what should the physicians do? However, the clinical use of such drugs should adhere to the basic principles of medical ethics which are autonomy, beneficence, non-maleficence, and justice(3). Compromising these principles is a threat to humanity. This has also put the physician in the dilemma to choose between the treatment protocol and its veracity. Hence, this reflects the need for a proper guideline for using off-label drugs in emergency situation like this. And it was rightly said by Hippocrates –“Wherever the art of Medicine is loved, there is also a love of Humanity. ”
Reference:
1. Solidarity” clinical trial for COVID-19 treatments [Internet]. Who.int. 2020 [cited 24 October 2020]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments.
2. FDA cautions use of hydroxychloroquine/chloroquine for COVID-19 [Internet]. U.S. Food and Drug Administration. 2020 [cited 24 October 2020]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or
3.Collier R. WHO guidelines on ethical public health surveillance. Canadian Medical Association Journal. 2017;189(29):E977-E977.
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