I think Madela was justified in her concerns and in citing Best Pharmaceuticals. It does not appear that the company did an adequate job of justifying their use of cynomolgus macaques for this research protocol. The company seems to have provided a single reference, which would not be enough rationalization for the use of this species rather than rabbits or dogs in the toxicity studies.
Extensive justification and an exhaustive literature search should be required before using nonhuman primates (NHPs) in a toxicology testing protocol. In the past, there have been many instances of discordances in the data, where results from NHP studies do not match up with results in humans. For example, several drugs have been reported to cause deaths in humans after studies with NHPs gave no indication that such a result could be expected1.
The IACUC should have been more proactive in its review of the researcher's protocol before approving it. Previous approvals from the FDA for a toxicology study utilizing NHPs do not necessarily mean that this study would have been appropriate as well. I also found that Scippone's comments to Madela seemed vague, and it appeared that he hadn't taken a hands-on stance himself in assuring that the cynomolgus macaques were an appropriate species for these studies.
The Guide for the Care and Use of Laboratory Animals2 (The Guide) is very specific about the IACUC's responsibility to ensure that the proper species and numbers of animals are used for any research protocol. The Animal Welfare Act3 also makes it clear that valid rationalization for any species being used must be documented and that any IACUC inspection results must be provided to USDA inspectors for review so that they can report deficiencies or deviations and cite those not in compliance.
Best Pharmaceuticals should have a policy requiring the use of more than one reference to justify animal use. This would alleviate further confusion and disagreements pertaining to use of animal species and future citations caused by lack of due diligence on the part of the IACUC and the researchers involved.
References
Bailey, J. Nonhuman primates in medical research and drug development: a critical review. Biogenic Amines 19, 235–255 (2005).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals (National Academies Press, Washington, DC, 1996).
Animal Welfare Act as Amended (7 USC, 2131-2156).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Arrington, H. Response to Protocol Review Scenario: More references required. Lab Anim 37, 293 (2008). https://doi.org/10.1038/laban0708-293b
Issue Date:
DOI: https://doi.org/10.1038/laban0708-293b
