Best Pharmaceuticals had been developing anti-hypertensive drug S-3842, tentatively named Lovartin, and it was now at the stage of toxicological testing in laboratory animals. The researcher completing the IACUC protocol form for the testing procedure wrote that he would be using cynomolgus monkeys as one of the test species because they are considered a standard non-rodent species used in certain toxicological studies, such as the current one. He even provided a literature reference (a standard requirement at Best) to back up the claim. The IACUC diligently reviewed the protocol and eventually approved it.
Dr. Shana Madela, the USDA veterinary officer assigned to inspect Best Pharmaceuticals, was performing a routine inspection and looked through the Lovartin IACUC application. It contained the statement that monkeys were used because they are “a standard non-rodent species used in toxicological studies and there is a large amount of historical data to support their use.” It also included the reference confirming that statement. Madela understood that monkeys could be used, but she was not convinced that they should be used. She asked John Scippone, the Attending Veterinarian, if dogs or rabbits could be used as a non-rodent species, rather than monkeys. Scippone responded that the investigator and his team felt that for the needs of the Lovartin study, monkeys were the most appropriate species and that this had been discussed and approved by the IACUC. Nevertheless, Madela was not satisfied that an adequate justification had been provided for using monkeys instead of other non-rodent species, and she cited Best Pharmaceuticals for the oversight.
As expected, the company and its IACUC were infuriated. They felt that it was not within Madela's authority to question the approval given by the IACUC for the use of monkeys, particularly when the Food and Drug Administration (FDA) had previously accepted their monkey toxicological studies. “Do you know what this means?” said Scippone. “She thinks she has the authority to tell us what species we should use to get approval for a drug. Maybe she should tell that to the FDA. We'll see how far she gets with that!”
Do you think that Madela was within her authority to cite Best for having what she considered to be inadequate justification for using monkeys? Do you think that the justification provided to the IACUC was sufficient?
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Silverman, J. Deciding which animals to use. Lab Anim 37, 293 (2008). https://doi.org/10.1038/laban0708-293a
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DOI: https://doi.org/10.1038/laban0708-293a
