FDA Terminates Nicotine Study Involving Nonhuman Primates

[Michael Oberdorfer]

Speaking of Research reports the American Psychology Association, the American College of Neuropsychopharmacology, and the College on Problems of Drug Dependence continue to query the FDA why they suspended a research study last September. The aim of the project was to study the effects of nicotine dosing and addiction and involved squirrel monkeys. This study was extensively peer-reviewed including the selection of the animal model.

This action was taken by FDA commissioner, Scott Gottlieb, after he received a letter from Jane Goodall who called the study “cruel and unnecessary” and “shameful.” The White Coat Waste Project also communicated their objections to the study. The story was originally reported in The Washington Post.

Gottlieb responded to Goodall in a letter that he would review the project stating in part that “assays and computer models can, in certain circumstances, replicate and replace the need for animal-based and human studies, while still providing access to critical, reliable data.”

The APA now reports:
“There are indications that prior to completion of the FDA review and promised report, the agency has already taken multiple steps to effectively end the research program. Even if the reviews are positive, the research cannot be resumed with those animals, and the FDA is preparing to transfer the study animals to new locations, some of which may not ensure adequate protections. This process upends procedures of the National Center for Toxicological Research, which sponsors the research, and ultimately wastes public dollars since the study cannot be followed to its conclusion.”

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