Nicotine Addiction Study Shut Down By FDA Over Animal Subject Concerns

Federal regulators abruptly ended an animal study designed to examine the effects of nicotine, after four chimpanzees died, the agency announced last week. 

FDA Commissioner Scott Gottlieb indicated that the study was cancelled in a statement issued on January 26, noting that the agency plans to launch a new program to help review further studies for potential animal mistreatment.

Gottlieb said he plans to strengthen the agency’s commitment to “humane and judicious animal research.”

The FDA cancelled the study after it received complaints involving the treatment of squirrel monkeys, as researchers investigated the effects of exposure to nicotine at various levels, the onset of addiction, and how it relates to adolescence and young adults. Four of the monkeys died.

Once investigators learned of the deaths, the study was shut down, and the animals were placed in a sanctuary home. Then the FDA’s Principal Deputy Commissioner was directed to form an agency review team focusing on the safety and well being of animals involved in the study and assess the circumstances surrounding deaths.

The FDA also called in primate veterinarians and animal care professionals to conduct site visits to the FDA’s National Center for Toxicological Research (NCTR) in Arkansas, where the squirrel monkeys were housed, to ensure they received proper care. Roughly 20 animals involved in the study were transferred to the sanctuary.

Investigators eventually determined the study was not consistent with the agencies animal welfare standards. There were also repeated reported deficiencies made under a third party welfare contractor which were not reviewed.

While the study was halted and an investigation occurred, the deaths also raised concerns regarding lack of adequate oversight for animal studies in general, which could lead to similar deaths.

In response, the agency commissioned a third party independent investigation of the animal research program and has established the Animal Welfare Council to provide centralized oversight of animal research activities and facilities.

The agency is also considering new technologies which may reduce the need for animal testing. However, it emphasized animal testing may still be necessary in some areas, as it has always provided essential research and insight into treating and preventing many life threatening diseases.