DRUG EVALUATION DURING COVID -19 PANDEMIC

 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. Though this unprecedented emergency provides a compelling reason for the FDA to act as efficiently as possible, the agency and the medical community can still maintain the highest scientific standards while acting expeditiously.

At least 25 drugs are under investigation for use in Covid-19, with 10 in active clinical trials. The first published major randomized, controlled trial of an antiviral drug combination (lopinavir–ritonavir) began enrolling patients in China just a week after the virus had been identified. Contrary to expectations, its results were negative, providing important clinical guidance.

Rigorous premarketing evaluation of drugs’ safety and effectiveness in randomized, controlled trials remains our primary tool for protecting the public from drugs that are ineffective, unsafe, or both. It is a false dichotomy to suggest that we must choose between rapid deployment of treatments and adequate scientific scrutiny.

Though the pandemic will inevitably leave considerable morbidity, mortality, and loss in its wake. Damage to the country’s medication-assessment process — and the public’s respect for it — should not be part of its legacy. 

THIS SHALL TOO PASS , LET THE EARTH INVIGORATE!