Reprioritizing Research Activity for the Post‐Antibiotic Era:Ethical, Legal, and Social Considerations

Abstract

Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research-including clinical trials and regulatory requirements-to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 21st Century Cures Act. Experts have also sought to advance antibiotic development by encouraging greater use of trials with noninferiority hypotheses, which are thought to be easier to conduct. The goal underlying these proposals is to stave off the post-antibiotic era by expanding the pharmaceutical armamentarium as quickly as possible. But although new antibiotic agents are necessary to combat the long-term threat of drug-resistant disease, we argue that these research policies, which effectively lower the bar for antibiotic approval, are ethically problematic. Rather, given broader public health considerations related to the full lifecycle of antibiotic use-including development of resistance-we should reject an overly permissive approach to new antibiotic approval and instead set the bar for regulatory approval at a point that will naturally direct research resources toward the most transformative chemical or social interventions.

Designing development programs for non-traditional antibacterial agents

“…Thus, despite their non-inferiority designs, these trials are not focused on current non-inferiority , but rather future superiority (Table 4). Although it may be important to take steps to reserve new interventions for use only in the future as a matter of stewardship, that is for regulators, prescribers, and payers to consider 42,43 ; it does not dictate whether the study itself evaluates a worthwhile clinical question.…”

Antimicrobial resistance and antibiotic consumption in Mexican hospitals

“…Controls should be established on the use, production, research and development of antibiotics, and they should even be considered a public good. 3 Antimicrobial resistance control requires the understanding of a global phenomenon, with multiple interrelated areas or activities: the environment, agricultural production, practice of medicine and food production. One of the main interventions is to achieve a safe and appropriate antibiotic use.…”

A School-Based Educational Intervention for School-Aged Children and Caregivers about Rational Use of Antibiotics in Urban Areas of Shaanxi Province: A Study Protocol for a Randomized Controlled Research

“…In 2010, the “Lancet” reported on “super bacteria” that can resist almost all antibiotics [ 11 ], and the 2011 theme of World Health Day was to Combat drug resistance—No action today, no cure tomorrow [ 12 ]. In 2014, a global antibiotic resistance monitoring report found that antibiotic resistance exists in all regions, revealing that at any time, the world will reach the “post-antibiotics” era [ 13 ], and in 2015, reports in China showed that the detection rate of methicillin-resistant Staphylococcus aureus (MRSA) was 35.8% and that the detection rate of erythromycin-resistant Streptococcus pneumoniae was 91.5% [ 14 ].…”