The claim that individuals legitimately differ with respect to their values seems to be uncontroversial among bioethicists, yet many bioethicists nevertheless oppose right-to-try laws. This seems to be due in part to a failure to recognize that such laws are intended primarily to be political, not legal, instruments. The right-to-try movement seeks to build political support for increasing access to newly developed drugs outside of clinical trials. Opponents of right-to-try laws claim that increasing access outside of clinical trials would undermine (...) evidence-based medicine. They seek to maximize overall gains to patients by protecting them from adverse drug reactions and ensuring that drugs are more effective on average. In contrast, right-to-try activists have a point that regulatory judgments of drug safety and effectiveness impose one set of trade-offs on all individuals, regardless of their different values. That might be acceptable if determinations of safety and effectiveness were black and white, but that does not seem to be the case. This article argues that judgments of safety and effectiveness are in an important respect normative and reflect the perceived value of those ends relative to others. Such judgments, when universally imposed, harm patients who would readily make do with less knowledge of drug safety and effectiveness in exchange for more time and self-determination. The relevant moral principle is that of respect for individual autonomy. Just as that principle should lead one to substitute collective decisions for individual ones to regulate a natural monopoly, the same principle should lead one to substitute individual decisions for collective ones to avoid a government monopoly on access to newly developed drugs. It is argued that reforms should increase the number of treatment options available to patients outside of clinical trials. The final section of the article discusses ways in which current regulations might be reformed so as to provide more treatment options outside of clinical trials, without undermining evidence-based medicine. (shrink)

Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients, either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, we suggest (...) using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan–Do–Study–Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research—even during a pandemic. (shrink)

Statements of the core ethical and professional responsibilities of medical professionals are incomplete in ways that threaten fundamental goals of medicine. First, in the absence of explicit guida...

Volume 20, Issue 9, September 2020, Page 41-44.

Few would disagree with the notion that it would be a wonderful thing if we could more quickly learn how to treat, or better yet cure, diseases afflicting millions of people. Alex John London argue...