Rapid Benefit-Risk Assessments: No Escape from Expert Judgments in Risk Management


* Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Pl., HFV-102, Rockville, MD 20855, USA; tel: 301-827-4354; fax: 301-827-6661; hclaycam@cvm.fda.gov.


The “human health impacts assessment” described by Cox and Popken (this issue) is intended to be a benefit-risk tool that avoids pitfalls of using expert judgments for policy analysis or during strict application of the precautionary principle in risk management. The proposed benefit-risk calculation uses numerous assumptions and suppositions to calculate a ratio of quality-adjusted life years (QALYs) lost for the number of human illness days prevented by the use of a food-animal antimicrobial drug, to the number of human illness days caused by the use of the antimicrobial drug. Assumptions about data—e.g., expert judgments on the representativeness of parameter estimates—are commonly used in risk assessment and risk management, including Cox and Popken's method. Cox and Popken apply the technique to specific examples of enrofloxacin and macrolides antimicrobial drugs, sometimes used in broiler chickens for human food. Although enthusiastically portrayed as a straightforward calculation of QALYs lost for two decision alternatives, Cox and Popken were silent on the pivotal expert judgment subsumed in their method: quality weights for illnesses caused by antimicrobial-resistant and antimicrobial-sensitive microbes are tacitly assumed to be equal. Yet, the costs in terms of prolonged illness, additional medications, repeat medical visits, and dread of more serious sequelae are expected to differ substantially for antimicrobial-resistant versus antimicrobial-sensitive illnesses. Despite their enthusiasm to the contrary, the “human health impacts assessment” by Cox and Popken is not immune from expert judgments in risk management.