Citing Deaths of Lab Monkeys, FDA Ends an Addiction Study

The deaths of four squirrel monkeys used as subjects in a nicotine addiction study have prompted the Food and Drug Administration to shut down the research permanently and to establish a council to oversee all animal studies under the agency’s purview.

“It is clear the study was not consistent with the agency’s high animal welfare standards,” Dr. Scott Gottlieb, the agency’s commissioner, said in a statement Friday. “These findings indicate that FDA’s animal program may need to be strengthened in some important areas.”

Gottlieb has called in an independent investigator to examine the agency’s animal research programs, starting with those at the National Center for Toxicological Research, in Arkansas, where the squirrel monkeys were housed. The 20 or so study animals will be transferred to a sanctuary, the commissioner said.

Federally funded medical research that relies on animals has been contentious for years. The National Institutes for Health has banned the use of chimpanzees in biomedical research and has retired hundreds of lab chimps, some of which have been moved to sanctuaries. The NIH continues to finance research on other nonhuman primates for studies of neurobiology, metabolic illness and other ailments.

FDA researchers are continuing other primate studies, the agency said, although Gottlieb said he wanted to reduce reliance on them.

The suspended study, begun in 2014, was designed to inform agency officials who have expanded oversight of tobacco products, regulation of e-cigarettes and alternative nicotine delivery devices.

The research was supposed to measure the effects of nicotine on addiction, mostly on young squirrel monkeys although it also included some adults. Researchers taught the squirrel monkeys to press a bar to get a dose of nicotine. After they became addicted, the scientists lowered the doses and observed the effects.

They started with a group of 24 monkeys, but by the end of last summer four had died — three from anesthesia given while catheters were put in, and one from a type of gastric bloat.

Patsie, another squirrel monkey in the study, nearly died while under anesthesia on July 20 of last year. Patsie stopped breathing, but veterinarians were able to revive him.

The mishaps drew the attention of many animal welfare activists, including the celebrated primate expert Jane Goodall. In a September letter to Gottlieb, Goodall accused the researchers of performing cruel and unnecessary nicotine addiction experiments on the squirrel monkeys.

In September, the FDA suspended the studies and started investigating treatment of the animals. They found numerous deficiencies, although the agency has not released an inspection report with details.

Anthony Bellotti, president of the White Coat Waste Project, which had enlisted Goodall’s help, praised the agency’s action. “We applaud the FDA for ending these wasteful baby monkey nicotine tests and for retiring the primates,” he said.

Jack Henningfield, professor of behavioral biology at Johns Hopkins School of Medicine, disagreed with the decision to stop the study.

“These studies are done to address really serious questions about the nature of tobacco addiction,” Henningfield said. “This is research in serious service to humanity. If there was an accident leading to the death of someone working in global warming research, you’d correct that situation, not stop doing global warming research. You’d say, ‘We are going to do it better, with more safety and even more care.'”