A Case Study of Statistics in the Regulatory Process: The FD&C Red No. 40 Experiment2

1981 Journal of the National Cancer Institute  
Unexpected findings in a mouse study in which the safety of FD&C Red No. 40 (Red 40) was examined led to additional experimentation and to new statistical analyses and models. The possibility of acceleration of tumors raised questions about an operational definition of acceleration and of appropriate statistical methods for assessing acceleration. especially in the face of data dredging. The evaluation of Red 40 was further complicated by cage and litter effects and the multigenerational
more » ... generational design. In this report the investigations of these studies are reviewed and are used to illustrate how new scientific work can emerge through the regulatory process. A number of issues in animal experimentation that need to be examined are indicated. -JNCI 1981; 66:197-212.
doi:10.1093/jnci/66.1.197 fatcat:xgpqwgh2frh5bdc5knfxzbmizm