A medical burden of proof: Towards a new ethic

Abstract

In current medical practice, innovators, drug and device companies often debut new interventions before they have shown benefit in robust clinical trials. Practitioners readily use these new therapies, in many cases because the practice is financially rewarding and the intervention makes sense within practitioners’ scientific worldview. Oftentimes, years after a practice was introduced, the medical community puts it to the test in large, well done randomized trials. Empirical evidence suggests that when this happens, nearly half of those practices are contradicted. We call this phenomenon ‘medical reversal’. What are the implications of reversal on our current system of hasty adoption and widespread use of new therapies? Here, we outline the concept of burden of proof in medicine. In the era of evidence-based medicine, who has the burden of proof to show that a therapy works? Currently in clinical practice, innovators and manufacturers are not carrying the burden. Instead, third parties and brave researchers are often required to challenge medical standards years after their introduction. Here, we argue that such a system is untenable. The burden of proof to show that an intervention works must be held by those who develop a new therapy, and by practitioners who profit from the therapy before it is introduced. Here, we promote this as a new physician ethic.