NEJM 2020 – Drug Evaluation during the Covid-19 Pandemic
Drug Evaluation during the Covid-19 Pandemic
List of authors.
April 14, 2020
The search for a treatment for Covid-19 is testing our country’s ability to quickly develop, test, and deploy medications, presenting both opportunities and challenges to our drug-assessment apparatus. Several aspects of the U.S. response raise serious concerns, highlighting how the processes for evaluating and approving drugs can go awry during a public health crisis.
The global pandemic has put pressure on clinicians and the Food and Drug Administration (FDA) to act swiftly to make medications available to patients. When very limited observational and anecdotal evidence raised the possibility that the antimalarial drugs chloroquine and hydroxychloroquine may have activity against SARS-CoV-2, President Donald Trump quickly began celebrating the promise of their widespread use, stating on national television that he had a “hunch” that such therapy was effective and that the drugs could be a “game changer” in addressing the pandemic. More recently, he openly encouraged patients to take the drugs and suggested he might do so himself, despite having tested negative for the virus.