Greg Miller, PhD
The Centers for Disease Control and Prevention estimates that in the United States, more than two million people are sickened every year with antibiotic-resistant infections, with at least 23,000 dying as a result. Antimicrobial resistance to existing antibiotic agents is one of the top public health concerns in the world today. CLSI has maintained the global leadership position in the area of antimicrobial susceptibility testing (AST) for humans and animals for the past 30 years. Our AST work is core to CLSI’s mission, as our standards, guidelines, and annual M100 supplement are major weapons in the war on antibiotic-resistant infections.
CLSI regularly reviews and refines its consensus process to ensure our standards and guidelines are of the highest quality and will continue to be well accepted by the laboratory medicine community. Importantly, managing potential conflicts of interest is challenging and has received increased scrutiny in health care in recent years. The Board of Directors has carefully considered how perceived conflicts of interest may influence CLSI standards and guidelines, and has made a policy change that volunteers from pharmaceutical companies and allied stakeholders will no longer be permitted to be voting members on AST standards, guidelines, and supplements. The AST breakpoint-setting process is unique within CLSI standards development activities because during AST document development meetings, decisions are made that affect the use of specifically named products in the marketplace. The potential for conflict of interest is clear when individuals vote to set breakpoints that directly affect the use of specifically named products from their own or from competitors’ companies. This new policy is closely aligned with US Food and Drug Administration (FDA) practices related to their advisory committees and other guidelines.
This policy was put into effect as of January 1, 2015 for the Subcommittee on AST and will be put into effect January 1, 2016 for the Subcommittee on Antifungal Susceptibility Testing and the Subcommittee on Veterinary AST. The delay for the latter groups was needed to allow appropriate realignment of voting members without disrupting the work of those committees.
CLSI continues to welcome and strongly encourage input and participation from all stakeholders in the AST breakpoint-setting process. Representatives from pharmaceutical companies or those contracted by pharmaceutical companies may be present and can provide input as nonvoting members (advisors and/or technical advisors and reviewers) of a breakpoint-setting consensus committee, subcommittee, or working group. Representatives from industry that do not benefit from the sales of antibacterial products and services will continue to participate as voting members—consistent with the practice of the FDA to invite industry representation at advisory committees.
I would like to emphasize that CLSI is not altering its core principles of inclusiveness, openness, and transparency. The policy change regarding potential conflict of interest will allow CLSI to continue to meet its mission—to develop clinical and laboratory practices and promote their use worldwide—by developing and revising our annual M100 supplement and other AST documents with strong input from all stakeholders for the benefit of public health. I, along with the CLSI leadership, greatly value the contributions from all of our volunteers who give generously of their time and talent for the benefit of patient care. Thank you very much for your service.