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Questioning the validity of the 4+/5+ binge or heavy drinking criterion in college and clinical populations.

BACKGROUND AND AIMS
The terms 'binge drinking' and 'heavy drinking' are both operationalized typically as 4+/5+ standard drinks per occasion for women/men, and are used commonly as a proxy for non-problematic (<4/<5) versus problematic (4+/5+) drinking in multiple research contexts. The Food and Drug Administration in the United States recently proposed the 4+/5+ criterion as a primary efficacy end-point in their guidance for trials examining new medications for alcohol use disorders (AUDs). Internationally, similar cut-offs have been proposed, with the European Medicines Agency having identified reductions in the number of heavy drinking days (defined as 40/60 g pure alcohol in women/men) as a primary end-point for efficacy trials with a harm reduction goal.


ANALYSIS AND EVIDENCE
We question the validity of the 4+/5+ cut-off (and other similar cut-offs) on multiple accounts. The 4+/5+ cut-off has not been shown to have unique predictive validity or clinical utility. The cut-off has been created based on retrospective self-reports and its use demonstrates ecological bias. Given strong evidence that the relationship between alcohol consumption and problems related to drinking is at least monotonic, if not linear, there is little existing evidence to support the 4+/5+ cut-off as a valid marker of problematic alcohol use.


CONCLUSIONS
There is little empirical evidence for the 4+/5+ standard drinks per occasion threshold for 'binge' or 'heavy' drinking in indexing treatment efficacy. Further consideration of an appropriate threshold seems to be warranted.