It appears that Scippone has misinterpreted the citation. Madela cited Best Pharmaceuticals for a lack of justification for use of cynomolgus monkeys. This is not a citation for using the wrong species altogether. The USDA may not tell a pharmaceutical company what species should be used. The Animal Welfare Regulations1 specifically address the need for a proposal to contain a rationale for the appropriateness of the species to be used in a study. Because testing prospective drugs on animals is necessary for safety assessment according to the Food and Drug Administration, regulations are often cited as to the appropriateness of the non-rodent species. These regulations do not actually define which specific species are to be used. The IACUC proposal should specify why the monkey is the appropriate animal model rather than simply confirming that a non-rodent species must be used. A different species may be a better model for toxicological testing of an anti-hypertensive drug. The decision to use a particular species should be based on species anatomy, pharmacology and physiology and on the biochemistry of the drug being developed.
Russell and Birch developed the 3Rs2, which are often used as the basis for decisions on animal use and welfare issues. Included in these principles is the use of a phylogenic perspective to choose an appropriate animal model for a study. Nonhuman primates are placed at the top of that phylogenic tree; therefore, special scientific justification should be expected when the use of this animal is proposed in a study. Whenever a species of lower phylogeny might be used, it should be. The Food and Drug Administration requires the use of a non-rodent species, often the dog or monkey because of similarities to specific human biochemical pathways.
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