New Haven Register (New Haven, CT)
Group seeks probe of animal lab practices
NEW HAVEN — An animal welfare group, citing alleged abuse and deaths of lab animals at Yale University, including one instance in which a confidential indepth investigation was conducted, has called for an investigation of the research program by Yale President Peter Salovey.
Michael Budkie, executive director of Ohio-based
Stop Animal Exploitation Now!, wrote to Salovey seeking the probe, including with it six reports sent by Yale’s Office of Research Administration to the National Institutes of Health’s Office of Laboratory Animal
Welfare. Yale spokeswoman Karen Peart confirmed the reports were genuine, said all animal complaints are investigated and cited the importance of animal research, and the university’s
compliance with animal care standards and federal and other regulations.
The most extensive report cited by Budkie, dated Oct. 30, 2020, cited “inadequate anesthesia,” “improper storage of controlled drugs,” “a rat succumbing to dehydration” and “contaminated sucrose solution,” among other alleged lapses.
While the five additional reports, also signed by Pamela S. Caudill, Yale senior associate provost for research administration, mostly involved mice that had died or were dehydrated for lack of water or food, one from Dec. 20, 2019, reported that a female mouse and a litter of seven 2-week-old pups were left without food and one of the baby mice had been cannibalized.
That Caudill letter stated that since the other mice were in “good body condition … it is unclear if a day without food would have precipitated cannibalism or if this is an expected occasional observation in large mouse breeding colonies.”
Another letter, also dated Dec. 20, 2019, reported that “an emaciated mouse with a severe malocclusion” — misalignment of the teeth — had been found dead. Budkie wrote that the deformity should have been seen before the mouse had become emaciated. Caudill wrote to OLAW that the incident was used “as a teachable moment for the research staff to enable them to identify malocclusions in the future.”
However, a four-page report by Yale dated Oct. 30, 2020, described an investigation that brought in the dean of the Yale School of Medicine and the university’s legal counsel. It began with a report from a lab employee on Aug. 6, 2020, followed up the same day by an email from the same employee to the principal investigator, the director of the Office of Animal Research Support and a person from Environmental Health and Safety. Other officials were brought in as well, the letter stated.
In her letter, Caudill wrote, “Because of the potentially serious implications not related to animals, the University decided to keep the investigation confidential until completed.”
According to her letter, most members of the lab were interviewed and compliance and post-approval monitoring records dating back to 2012 were reviewed. According to Peart, who answered questions through emails, the records were monitored back that far “to look at the lab’s historic compliance history, which was quite good. The focused investigation by
Yale was on activities in 2020.”
Caudill wrote, “Two lab members recalled difficulties in maintaining anesthesia . . . when rodents exhibited movement when they were supposed to be under full anesthesia . . . . Additionally, there was a third, relatively new, member of the lab who had been anesthetizing rodents for cranial implant surgeries with only ketamine,” when ketamine and xylazine are required.
Another point raised in Caudill’s letter was the practice of leaving a safe containing controlled drugs unlocked all day, which she called “not appropriate.”
She said there was “no evidence of unauthorized use of the controlled substances,” Peart confirmed, also through an email, that there was “no evidence” of any drugs being removed.
In his letter to Salovey, Budkie wrote, “As a result of the significant deviations from approved protocols — improper animal housing, excessive deprivation of water, anesthesia which was so severely botched that animals moved during procedures, and improper handling of controlled substances, this project must be immediately terminated and the staff involved in these abuses must be prohibited from future use of animals. It is simply heinous that all of these failures occurred within only one lab.”
Yale, in its resolution plan, cited in the Oct. 30 letter, had the principal investigator review animal housing, surgical procedures, post-operative care plans and more with “all animal users in the laboratory”; had laboratory members “using animals” review the rodent food and fluid policy and other care protocols; and modified the rat breeding protocol, the Cahill letter says.
Peart said Yale’s Institutional Animal Care and Use Committee, which reviews research proposals and is responsible for assessing and overseeing of the university’s animal care and use program, did not suspend the project.
Experiments
Budkie said the Animal Welfare Act, overseen by the U.S. Department of Agriculture, has “a very serious limitation” because “rats, mice, birds, coldblooded animals and animals that could be used in agricultural research are excluded.”
Yale reports the instances of improper care to the Office of Laboratory Animal Welfare because it receives grants from the National Institutes of Health. The medical school ranked fourth nationally in NIH grants in 2020, receiving $512 million from the governmental agency, according to the Blue Ridge Institute of Medical Research.
Budkie said while violations of the Animal Welfare Act may carry a fine of $10,000, when it comes to NIH, “there’s no one that goes in and does an inspection. There’s no one that issues a fine.”
In an interview, Budkie said, “If we can make the connection between these compliance issues and a specific laboratory and a specific publication, we contact the journal … and call on them to retract the article.” The problem, he said, is that another lab wanting to reproduce the experiment might not get the same results because the animals in Yale’s research were not treated according to the study protocol.
“Right now … science, and researchers in particular, are going through a crisis of reproducibility,” Budkie said. “What they’re finding is that they can do the same study in two different facilities with the same species and strain of animal and get different results.”
Peart said there was no concern about whether the experiments could be reproduced.
“Things like this are important, even if you don’t care about the animals,” Budkie said. “The vast majority of this experimentation is paid for with federal tax dollars,” totaling $16 billion a year. “At the same time, we’re trying to figure out how to pay for health care in this country.”
A Jan. 12 article published by Nature’s Scientific Reports estimated that 111.5 million mice and rats are used each year in research and criticized the lack of oversight by the Animal Welfare Act. The author wrote that the rodents comprise 99.3 percent of animals in research institutions and that, if the percentage of reports of “painful procedures” undergone by animals covered by the act were applied to rats and mice, then 44.5 million of those animals “underwent potentially painful experiments.”
An analysis in Science magazine, however, put the number at 10 million to 25 million.
In response to Stop Animal Exploitation Now!’s letter, Peart issued a statement saying, “To provide transparency and maintain compliance relating to our animal care and use program, the university promptly reports all animalrelated issues to OLAW. To encourage reporting of animal-related concerns, Yale operates a hotline and offers other avenues where animal-related concerns can easily (and confidentially) be reported. Those involved in animal research at Yale are committed to reporting any issues.”
She said “a thorough investigation is performed for all complaints, and appropriate corrective actions are put in place.”
Peart said the number of animals in Yale’s research labs is about 5 percent lower than before the COVID-19 pandemic, “primarily due to personnel occupancy restrictions in laboratories and animal facilities.”
“Yale takes seriously its responsibility for the appropriate care of animals. Our laboratories comply with or exceed all federal regulations and independent accreditation standards,”
Peart wrote.
“Animal research plays a central role in COVID-19 and many other diseases, providing hope for millions of patients and their families,” Peart wrote. “Accordingly, Yale scientists will sustain their commitment to the appropriate use of animals in research. Our faculty members use animals only when there are no appropriate alternative models for advancing their research.”