FDA shuts down nicotine research study, overlooking concerns of scientific organizations

American Psychological Association Science Alert

Background In September 2017, the American Psychological Association, the American College of Neuropsychopharmacology, and the College on Problems of Drug Dependence wrote to Food and Drug Administration Commissioner Scott Gottlieb, MD, following the FDA announcement that it was suspending a program of nicotine research with nonhuman primates on the advice of Dr. Jane Goodall and the White Coat Waste Project, an organization that is fundamentally opposed to all research with non-human animals. Dr. Gottlieb announced that FDA would conduct an independent review of the research program and release a report. The scientific organizations asked that FDA provide public information about the review including naming members of the review committee and explaining its timeline and rationale. The FDA has not responded.

Update — 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.

Conclusion  FDA appears to be ignoring the concerns of established scientists and scientific organizations, while placing nonhuman animals at potential risk and failing to fund research in the public interest.

Note: The full text of the letter to FDA Commissioner Scott Gottlieb, MD, is available here. It references a letter opposing the claims of White Coat Waste and Dr. Goodall, signed by 46 researchers and endorsed by 78 additional scientists, including well-known experts in substance use disorders, and an article in the Washington Post that detailed the original FDA decision.