FDA axes study at Arkansas lab; nicotine addiction research led to deaths of 4 monkeys

Posted: January 30, 2018 at 4:30 a.m.

Squirrel monkeys, on Monkey Island, a man-made oasis in the middle of a marsh with hollowed-out, artificial oak trunks that are heated to provide year-round shelter, at the Bronx Zoo in New York, May 26, 2015. The monkeys are some of the new stars of the Children’s Zoo, a section of the Bronx Zoo that reopens on Saturday after a $4 million renovation that took more than a year. (Chang W. Lee/The New York Times)

The U.S. Food and Drug Administration has permanently ended a nicotine addiction study at an Arkansas laboratory after four squirrel monkeys died there.

An investigation of the FDA's National Center for Toxicological Research near Pine Bluff found that the remaining 20 or so squirrel monkeys there were "safe and being well cared for," but there was a "a generalized lack of adequate oversight" that could lead to future problems, said Scott Gottlieb, the agency's commissioner.

Gottlieb said there were also reports of repeated "deficiencies that occurred under the third-party animal welfare contractor" used during the study.

In a statement issued Friday, and posted online at www.fda.gov, Gottlieb said he immediately put the study on hold when he learned in September that four monkeys had died at the Arkansas lab. Gottlieb then asked for an FDA team to be formed to investigate.

"Based on this team's findings, it is clear the study was not consistent with the agency's high animal welfare standards," Friday's statement from Gottlieb says. "These findings indicate that FDA's animal program may need to be strengthened in some important areas."

Gottlieb said he has called for an independent, third-party investigation of all the agency's animal research programs, starting with those conducted at the Arkansas lab.

He has also established a new Animal Welfare Council to provide centralized oversight of all animal research activities and facilities under the agency's purview.

Three of the monkeys died because of complications from anesthesia and one death was related to bloat, the cause of which is often unclear, said Tara Rabin, a spokesman for the FDA. Rabin said she didn't know when the monkeys died.

According to documents posted on www.fda.gov, the nicotine addition study began in 2014 with 24 male monkeys -- 12 adults and 12 adolescents. Research needed to be done on adolescent monkeys because tobacco use by humans often begins in adolescence, according to one of the documents.

Squirrel monkeys live in the tropical forests of Central and South America, according to animalcorner.co.uk. Their range extends from Costa Rica through central Brazil and Bolivia.

Squirrel monkeys grow to be 10 to 14 inches long, plus a 14- to 17-inch tail. Their brain to body-mass ratio is 1:17, which means they have the largest brain, proportionately, of all the primates, according to the website.

Gottlieb said the remaining monkeys at the Arkansas facility will be placed in a new permanent sanctuary home, "which will provide them with appropriate long-term care."

Renowned primate researcher Jane Goodall wrote to Gottlieb on Sept. 7, saying the treatment of the monkeys was "tantamount to taxpayer-funded torture."

"I was disturbed -- and quite honestly shocked -- to learn that the U.S. FDA is still, in 2017, performing cruel and unnecessary nicotine addiction experiments on monkeys," wrote Goodall in a letter that didn't mention the center by name.

Goodall wrote that devices were placed in young squirrel monkeys to deliver nicotine directly into their bloodstreams. Then the monkeys were put in restraint devices and trained to press levers to receive doses of nicotine.

"This apparently enables them to determine at what point the monkeys become addicted," wrote Goodall.

Each monkey is locked alone in a cage for nearly three years, she wrote.

"To continue performing nicotine experiments on monkeys when the results of smoking are well-known in humans -- whose smoking habits can be studied directly -- is shameful," she wrote.

Goodall was enlisted in the fight by White Coat Waste Project, which is a coalition that believes "taxpayers shouldn't be forced to pay over $15 billion every year for wasteful experiments on dogs, cats, monkeys and other animals that are irrelevant, slow, expensive and hinder life-saving medical advancements," according to whitecoatwaste.org.

Gottlieb replied to Goodall in a Sept. 25 letter: "After learning of concerns related to the study you referenced, I directed the agency to place a hold on the research study earlier this month. Accordingly, at this time, all experimentation involving the monkeys in the study you referenced has been halted."

Rabin said a key part of Gottlieb's decision concerned the deaths of the four monkeys, which wasn't mentioned in Goodall's letter to Gottlieb.

"The FDA commissioner was made aware of the four deaths specifically during discussion among FDA leaders," Rabin said.

In his statement Friday, Gottlieb said the review team made site visits to the Arkansas lab.

"In addition to conducting two visits to the study site, the team reviewed extensive documentation of procedures and processes related to the study," he said.

According to Gottlieb's statement, new technologies have allowed the agency to reduce animal testing, but "there are still many areas where animal research is important and necessary."

"Without animal research, it would be impossible to gain some of the important knowledge needed to prevent human and animal suffering for many life-threatening diseases," Gottlieb said. "In the past, animal research has played a critical role in vital health advancements such as preventing polio, eradicating smallpox and identifying new cancer treatments.

"Further, there are still some areas for which non-animal testing is not yet a scientifically valid or available option. For example, animal research with primates continues to be an essential part of the safe and effective development of certain critical childhood vaccines."

Metro on 01/30/2018