Another monkey at FDA lab dies

A rhesus monkey died at a toxicology lab near Pine Bluff last summer, seven months after the U.S. Food and Drug Administration permanently ended a nicotine-addiction study there after four squirrel monkeys died.

The 5-year-old male rhesus macaque, known as AR388, died Aug. 3 of “accidental strangulation,” according to a final report that William Slikker Jr., director of the National Center for Toxicological Research, sent Sept. 7 to Brent Morse, director of the Division of Compliance Oversight in the Office of Laboratory Animal Welfare in Bethesda, Md.

The monkey was in a “restraint chair” in the Operant Test Battery chamber to play a game on a computer screen, according to the report.

AR-388 was found with the “yoke of the restraint chair pushed all the way up touching the top of the chamber causing obstruction of the airways,” wrote Slikker.

Efforts were made to resuscitate the unresponsive monkey. His heart was beating erratically and his breathing was shallow and labored, according to the report. His brain had been deprived of oxygen, Slikker wrote.

“AR-388 was euthanized,” according to the report.

All restraint chairs in the chamber were checked for maintenance issues, according to the report.

“The chair in question did not malfunction,” wrote Slikker.

The Institutional Animal Care and Use Committee was informed of the death Aug. 6 and initiated an investigation, according to the report.

As a result, the committee recommended, and the lab “initiated” several changes, including installing live-feed cameras so the monkeys in the Operant Test Battery chambers can be monitored in real time.

“Indicators for intervention” were also being developed, Slikker wrote.

Morse responded to Slikker in a Sept. 12 letter writing, “The prompt consideration of this unfortunate incident by the National Center for Toxicological Research was consistent with the philosophy of institutional self-regulation. Similarly, the actions taken to resolve the issue and prevent recurrence were appropriate. We appreciate being informed of this matter and find no cause for further action by this office at this time.”

A group called Stop Animal Exploitation Now received the final report through an open-records request and furnished it to the White Coat Waste Project, a coalition that wants to stop “wasteful” government spending on unnecessary animal experiments.

“The fact that monkeys keep dying there reflects a systemic failure of oversight and accountability,” said Justin Goodman, vice president of advocacy and public policy for the White Coat Waste Project. “We’re continuing to see this problem with this same facility despite the commissioner trying to clean things up.”

Goodman was referring to FDA Commissioner Scott Gottlieb, who permanently ended the lab’s nicotine study in January 2018. Gottlieb had put the study on hold in September 2017.

GOODALL CALLED IT TORTURE

On Sept. 7, 2017, renowned primate researcher Jane Goodall wrote Gottlieb 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,” she wrote in a letter that didn’t mention the center by name. “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.”

Gottlieb replied to Goodall in a Sept. 25, 2017, 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.”

“Although the FDA commissioner received a letter from Dr. Jane Goodall related to care concerns with this study, this letter did not contain information about the four deaths, which was a key part of the concerns that led to the study’s hold and subsequent termination announced on Friday, Jan. 26, 2018,” Tara G. Rabin, a spokesman for the FDA, wrote in an email to a reporter three days later. “The FDA commissioner was made aware of the four deaths specifically during discussion among FDA leaders.”

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.

PROBE INTO RESEARCH

Gottlieb said he 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.

The monkeys from the Arkansas nicotine-addiction study were retired to a sanctuary in Florida.

But monkeys are used in other experiments at the Jefferson County center. A 2017 annual report indicated there were 158 non-human primates at the research facility.

On Feb. 8, 2018, Gottlieb toured the Arkansas lab and sent an email to all FDA staff the following day.

“As an agency, we always face challenges, and we’ve faced some significant ones over the last several months in relation to a research study that was being conducted at NCTR,” Gottlieb wrote. “Although the questions asked by this research were important, the findings from our assessment of the conduct of that study raised concerns that required our intervention. Those findings have called upon us to strengthen our animal research programs across the agency. …

“I want to be clear on one thing: The issues related to this study do not diminish my confidence in NCTR, nor lessen my strong commitment to their ongoing work and the studies that we’ll continue to solicit. My concerns were related to this one study. It also does not change my support for the critical public health role that NCTR plays. … The institution has been involved in many of the significant scientific findings of modern times, particularly work aimed at informing the safe use of products and exposing the risk of toxicological dangers.”

Located about 20 miles north of Pine Bluff, the National Center for Toxicological Research is the only FDA center outside the Washington, D.C., metropolitan area. It was once part of the U.S. Army’s Pine Bluff Arsenal.

“During the 1950s cold war era, the Army used the site, located in the northeast sector of the arsenal, for research into biological pathogens and the production of chemical warfare agents,” according to the Encyclopedia of Arkansas History and Culture.