Is there a continued need for behavioral pharmacology in the discovery and development of medicines?

Since their introduction in the 1950s by Peter Dews, behavioral pharmacology laboratories have collected experimental data for discovery, approval, and regulation of many new and improved therapeutic agents across a host of therapeutic domains. The ethical use of animals in research requires evaluation of the value of animal data to justify their use. The present commentary provides a discussion of the risk-benefit analysis of the use of behavioral methods in drug discovery and drug development using antidepressants as an example. It is concluded that there are some misconceptions both within and outside drug discovery organizations as to the value of behavioral methods. We argue that there are no fully functional disease models of psychiatric disorders. The methods used in behavioral pharmacology are best viewed as whole-animal biological readouts of the actions of drugs. Behavioral pharmacology data, placed in the context of other pharmacological findings, enable the construction of confidence levels regarding the hypothesis that a new chemical entity will provide therapeutic benefit at tolerable and safe dose levels. The exclusion of behavioral pharmacology would diminish the ability of the drug discovery data set to provide needed levels of assurance that the efficacy and safety of the new chemical entity will translate into patients. New methodologies for the discovery of medicines are being developed (eg, tissue on chips and artificial intelligence paradigms). However, until nonbehavioral procedures are validated, the absence of behavioral pharmacology in drug discovery research shifts the risk of making new medicines onto the health of patients. SIGNIFICANCE STATEMENT: The pros and cons of using behavioral pharmacology in the discovery and development of new medicines are discussed.