Following 4 Deaths, FDA Shuts Down Monkey Experiment

After becoming aware that 4 animals had died during a study investigating nicotine exposure in squirrel monkeys, the FDA stepped in and shut the study down.

Conducted at the National Center for Toxicological Research (NCTR), the study was intended to demonstrate the effect of exposure to various levels of nicotine on the onset of addiction in adolescents and young adults.

Following the deaths—3 of which occurred during anesthesia administration and 1 due to gastric dilataion—the FDA placed the study on hold and conducted a full review to “determine the safety and well-being of the animals involved in the study, assess the circumstances surrounding the animal deaths, and gather information regarding the conduct of the study.”

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The remaining monkeys are being placed in a permanent sanctuary home.

After 2 site visits to the NCTR and an extensive review of the study’s procedures and processes, concerns were raised, including:

• A generalized lack of adequate oversight that could lead to similar issues in other studies
• Several repeated reported deficiencies that occurred under the third-party animal welfare contractor used during the study
• Inconsistencies with the agency’s high animal welfare standards

FDA Commissioner Scott Gottlieb, MD, has vowed to strengthen the FDA’s commitment to humane and judicious animal research to ensure that animal welfare concerns such as these are always addressed. He also laid out several additional actions the FDA will take to ensure study standards are always in line with the agency’s standards:

• An independent, third-party investigation will look into the FDA’s animal research programs. These investigations will start with the NCTR to help identify any future issues.
• The newly established Animal Welfare Council will have oversight of all FDA animal research activities and facilities.
• The “3 R's”—replacing, reducing, and/or refining animal studies—will become a priority for the FDA. Specific groups have already been formed, such as the Toxicology Working Group and the Interagency Coordinating Committee on the Validation of Alternative Methods, to strengthen the agency’s commitment to these 3 R's.

“When these [animal] studies are necessary, the animals involved in research must be cared for under strict, humane guidelines,” Gottlieb said. “I am committed to ensuring an effective, humane, and judicious animal research program at the FDA and I will continue to communicate with our stakeholders on our efforts.”