The U.S. Food and Drug Administration's toxicology lab in Arkansas didn't report the deaths of four squirrel monkeys to a laboratory animal-welfare office because it wasn't required to do so, according to the FDA.
But a taxpayer-watchdog group said it appears the National Center for Toxicological Research near Pine Bluff tried to skirt the federal Freedom of Information Act and keep the monkey deaths a secret.
"I think most people would find it absurd that the FDA would report a paperwork error on the monkey experiments (as they did in July 2016), or a fire in the monkey lab that didn't harm any animals (as they did in August 2017), but decide not to report monkeys repeatedly dying unexpectedly in the same experiments," Justin Goodman, vice president of advocacy and public policy for the White Coat Waste Project, said in an email.
The FDA maintains no policies or guidelines were violated when the four monkeys died at the Arkansas lab, so the deaths weren't reported to the Office of Laboratory Animal Welfare in Bethesda, Md., which oversees animal welfare at FDA facilities.
"The FDA takes very seriously its obligation to use responsible and humane animal testing methods when animal testing is needed to fulfill the agency's public health mission," the agency said. "In reviewing the facts and circumstances surrounding the deaths of squirrel monkeys in an FDA study, the FDA's National Center for Toxicology Research, which was then conducting the study on behalf of the FDA's Center for Tobacco Products, determined that the deaths were not reportable to OLAW. This determination is consistent with guidance OLAW has published on the subject."
The White Coat Waste Project sued the FDA in August after trying for eight months to obtain information about a nicotine addition study involving monkeys at the Arkansas facility.
On Sept. 25, The Washington Post published a story citing anonymous sources saying four monkeys had died at the Arkansas lab. That prompted the White Coat Waste Project to file an open-records request Oct. 3 with the Office of Laboratory Animal Welfare. Among other things, the project requested information about "animal welfare noncompliance incident reports" at the Arkansas lab.
The office produced documents 10 days later, but none of them mentioned any monkey deaths at the Arkansas facility, Goodman said.
In November, lawyers for the FDA and the White Coat Waste Project reached a court-ordered agreement, and the lawsuit was dismissed. In January, the FDA produced 2,064 pages of documents and 44 videos that had been requested by the project.
The new cache of documents listed the following monkey deaths at the Arkansas facility:
• August 2015: One-year-old squirrel monkey died from anesthetic complications during a brain scan.
• March 2016: Squirrel monkey died during surgery to address "acute gastric dilation."
• May 2017: Squirrel monkey euthanized after being found near death.
• July 2017: Squirrel monkey died due to "laryngeal and tracheal obstruction."
"Without our FOIA lawsuit and campaign, no one would have known about the problems," Goodman said.
A Sept. 15 email obtained in January indicates the monkey deaths and the open-records law were both discussed in a telephone conversation between someone at the Arkansas lab and the animal welfare office in Maryland, Goodman said.
"I have spoked (sic) to OLAW," according to the Sept. 15 email. "They agree it is not a non-compliance and does not require an official report. I updated them in case of a FOIA. At this time, they have not received any FOIA."
The names of the sender and recipient of the email are redacted. Goodman said either the sender, recipient or both were on the staff of the Arkansas lab, based on the project's open-records request to the FDA. Goodman said it appears the issue was discussed by telephone to avoid leaving a paper trail of emails.
Tara G. Rabin, a spokesman for the FDA, said it's not unusual for people at the agency to talk on the telephone with someone at the Office of Laboratory Animal Welfare.
"Engaging directly with OLAW by phone is often the most effective way to obtain guidance on reportable situations," she said.
Rabin wouldn't say who at the Arkansas facility made the decision that the monkey deaths weren't "reportable" to the Office of Laboratory Animal Welfare. Bill Slikker is director of the National Center for Toxicological Research.
"We meant that the institution, NCTR, made the decision based on its collective expertise," Rabin said in an email.
The animal welfare office acknowledges that some monkeys may die during the normal course of experiments. According to the office's "guidance," examples of situations "not normally required to be reported" include:
• Animal death from "spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic and therapeutic procedures were in place and followed" and
• Animal death "related to manipulations that fall within parameters" described in protocol approved by the Institutional Animal Care and Use Committees.
The Office of Laboratory Animal Welfare is under the National Institutes of Health.
When asked about the Sept. 15 email, David Kosub, a spokesman for the institutes, replied via email, "NIH takes very seriously all allegations of non-compliance and investigates every allegation. That said, NIH does not discuss whether an investigation is taking place, and NIH does not comment on ongoing investigations if such investigations are underway."
The White Coat Waste Project is a watchdog group dedicated to exposing and eliminating the federal government's taxpayer-funded animal experimentation budget, which the group says costs more than $15 billion a year.
Scott Gottlieb, FDA commissioner, announced Jan. 26 that the nicotine addiction study at the National Center for Toxicological Research had permanently ended and he called for an independent, third-party investigation of all the agency's animal research programs, starting with those conducted at the Arkansas lab. Rabin said that investigation is still underway.
Gottlieb's announcement came the same day that documents from the lawsuit were released to the White Coat Waste Project, Goodman said.
Gottlieb had suspended the nicotine addiction study in September after receiving a letter from renowned primate researcher Jane Goodall, who described the treatment of monkeys at the Pine Bluff lab as "tantamount to taxpayer-funded torture."
The remaining squirrel monkeys at the Arkansas lab were "safe and being well cared for," but there was "a generalized lack of adequate oversight" that could lead to future problems, Gottlieb said Jan. 26. There were also reports of repeated "deficiencies that occurred under the third-party animal welfare contractor" used during the study, he said.
Goodman said the 30 remaining monkeys at the Arkansas lab will be retired out of the facility.
Gottlieb was sworn in as commissioner May 11.
On Feb. 8, he 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.
After President Richard Nixon signed an executive order in 1969 banning such research and production at federal facilities, the Army subsequently transferred operation of the site to the Food and Drug Administration, according to the encyclopedia entry. In 1971, the FDA started a new research facility at the site, researching the effects of toxic chemicals on people and the environment.
A Section on 03/13/2018