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"the Academy" also pointed out that exclusion of children from drug studies was more unethical than clinical testing, and could lead to devastating results.

The antibiotic chloramphenicol was released in the 1950s without adequate testing in infants and children. As use of the drug became more common, reports of a serious and often fatal reaction called the Grey Baby Syndrome surfaced. This reaction was related to slow clearance of the drug in infants as compared to adults, due to deficiency in hepatic glucuronyl transferase in infants. Similarly, though less devastating, widespread use of tetracycline in children was subsequently shown to be associated with dental dysplasia.