What it takes to validate behavioral toxicology tests: a belated commentary on the Collaborative Behavioral Teratology Study.

"Design Considerations in Screening for Behavioral Teratogens: Results of the Collaborative Behavioral Teratology Study" (CBTS) was an important conference whose proceedings were published in entirety in Neurobehavioral Toxicology and Teratology (7:532-822; 1985). The proceedings advocate that mandatory "behavioral teratology" testing be made part of regulations governing approval of new drugs and chemicals. This conclusion is unjustified either by the CBTS proceedings or by the present status of "behavioral teratology." First, there is little basis for accepting the validity of testing in developmental psychopharmacology, since so few agents acknowledged to lack the presumed toxic effects are explicitly identified and systematically tested. Second, findings from the CBTS itself can be construed as having indicated poor reliability: Amphetamine, the only drug examined in the CBTS, was selected for study expressly because of prior positive data, yet the study found it to be inactive. Third, the presumed "sensitivity" of behavioral measures is shown to be irrelevant. Fourth, and perhaps most important, the CBTS does not consider the public health risks of mandating nonvalid procedures within regulations. Drugs that are crucial both in therapy as scientific tools may not have been developed had regulations now advocated been in place at the time of their development.