In response to the COVID-19 pandemic, states have funneled exceptional amounts of public funding into research and development of diagnostics, treatments and vaccines to help fight the virus. In th...

The COVID-19 pandemic has created a unique set of challenges for national governments regarding how to deal with a major international pandemic of almost unprecedented scope. As the pandemic consti...

The COVID-19 pandemic has resulted in widespread disruption of the typical way of doing things. In nearly every industry, responses to the pandemic have brought about departures from standard opera...

In their paper, “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?” Holly Fernandez Lynch and colleagues have present...

The target article by Lynch et al. offers approaches for improving trial availability and Expanded Access for non-pandemic diseases based on the analysis of the COVID-19 experience in the US...

Lynch et al.’ s work “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?” is an essential c...

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

We agree with Lynch et al. that patients with chronic diseases and Band-Aid treatments are unlikely to benefit from a version of Operation Warp Speed or by deprioritizing standards of scientific ev...

Years after the publication of “Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Disease?” I hope it continues to animate and...

In this issue, Lynch and colleagues discuss lessons learned from the “Operation Warp Speed” response to the COVID-19 pandemic in the United States—both about what to do and what not to do fo...

Lynch and colleagues describe positive and cautionary lessons learned from recent extraordinary research efforts to develop COVID-19 vaccines and therapeutics and consider whether some of th...