Watchdog group requires investigation of remedy of rodents in Yale labs

NEW HAVEN – An animal welfare group leading alleged abuse and death of laboratory animals at Yale University, including a case where a confidential in-depth investigation was conducted, has requested an investigation into the research program by Yale President Peter Salovey.

Michael Budkie, Managing Director of Stop Animal Exploitation Now! In Ohio, wrote to Salovey looking for the probe, including six reports the Yale Research Administration Office sent to the National Institutes of Health’s Laboratory Animal Welfare Office. Yale spokeswoman Karen Peart confirmed the reports were genuine, said all animal complaints would be investigated, and cited the importance of animal research and the university’s compliance with animal care standards, federal and other regulations.

The largest report cited by Budkie, dated October 30, 2020, cited “inadequate anesthesia”, “improper storage of controlled drugs”, “a rat that succumbs to dehydration” and “contaminated sucrose solution”.

While the five additional reports, also signed by Pamela S. Caudill, Senior Associate Provost for Research Administration at Yale, mainly concerned mice that had died or were dehydrated from lack of water or food, one reported on December 20, 2019, that a female mouse and a litter of seven 2 week old puppies were left without food and one of the baby mice had been cannibalized.

This Caudill letter states that since the other mice are in “good physical condition … it is unclear whether a day without food would have triggered cannibalism or whether this is an expected occasional observation in large mouse breeding colonies.”

Another letter dated December 20, 2019 reported that “an emaciated mouse with a serious fallacy” – a misalignment of the teeth – had been found dead. Budkie wrote that the deformity should have been seen before the mouse was emaciated. Caudill wrote to OLAW that the incident “was used as a teachable moment for the research staff so that they can identify false conclusions in the future”.

However, a four-page report from Yale dated October 30, 2020 described an investigation involving the dean of the Yale School of Medicine and the university’s legal counsel. It started with a report from a lab worker on Aug 6, 2020, followed by an email from the same worker to the investigator, the director of the Animal Research Support Office, and a person from Environmental Health and Safety. Other officials were also called in, the letter said.

In her letter, Caudill wrote: “Because of the potentially serious non-animal-related consequences, the university has decided to keep the investigation confidential until it is complete.”

According to their letter, most of the members of the laboratory have been interviewed and the regulatory compliance and post-approval post-approval records reviewed. According to Peart, who answered questions via email, the records up to this point were monitored “to look at the laboratory’s historical compliance history, which was quite good. Yale’s targeted investigation focused on activities in 2020. “

Caudill wrote: “Two laboratory members recalled difficulties in maintaining anesthesia. . . when rodents showed movement when they should be under general anesthesia. . . . In addition, there was a third, relatively new member of the laboratory who only anesthetized rodents with ketamine for cranial implant surgery “when ketamine and xylazine are needed.

Another point raised in Caudill’s letter was the practice of leaving a controlled drug safe unlocked all day, which she said was “inappropriate.” She said there was “no evidence of unauthorized use of the controlled substances,” and Peart also confirmed via email that there was “no evidence” of drug removal.

In his letter to Salovey, Budkie wrote, “Due to the significant deviations from the approved protocols – improper animal husbandry, excessive water shortages, anesthesia botched so badly that the animals moved during the procedure, and improper handling of controlled substances The project must have must be stopped immediately and employees involved in these abuses must be prohibited from future use of animals. It’s just hideous that all of these errors should have occurred in just one laboratory. “

Yale, in its resolution plan cited in its October 30 letter, had the principal investigator review animal housing, surgical procedures, post-operative care plans, and more with “all animal users in the laboratory.” Have laboratory members who use animals review rodent feed and hydration policies and other care protocols. and modified the rat breeding protocol, says the Cahill letter.

Peart said Yale’s Institutional Animal Care and Use Committee, which reviews research proposals and is responsible for evaluating and overseeing the university’s animal care and use program, has not suspended the project.

Experiments

Budkie said the animal welfare act, which is overseen by the US Department of Agriculture, has “a very serious limitation” because it “excludes rats, mice, birds, cold-blooded animals and animals that could be used in agricultural research.”

Yale reports the cases of improper care to the Office of Laboratory Animal Welfare as it receives grants from the National Institutes of Health. According to the Blue Ridge Institute of Medical Research, the medical school ranked fourth nationwide in 2020 in NIH grants and received $ 512 million from the government agency.

Budkie said that while animal welfare violations can result in a $ 10,000 fine when it comes to NIH, “There’s no one to come in and do an inspection. There is no one to be fined. “

In an interview, Budkie said, “If we can make the connection between these compliance issues and a particular laboratory and publication, we will reach out to the journal … and ask them to withdraw the article.” The problem, he said, be that another laboratory trying to reproduce the experiment may 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 in a reproducibility crisis,” said Budkie. “They find that they can do the same study in two different facilities with the same species and strain and get different results.”

Peart said there was no concern that the experiments could be reproduced.

“Such things are important even when you don’t take care of the animals,” said Budkie. “The vast majority of these experiments are paid for in federal tax dollars,” a total of $ 16 billion a year. “At the same time we are trying to find out how we can pay for health care in this country.”

A Jan. 12 article in Nature’s Scientific Reports estimated that 111.5 million mice and rats are used in research every year and criticized the lack of control of the Animal Welfare Act. The author wrote that the rodents made up 99.3 percent of the animals in research facilities and that when the percentage of “painful interventions” reports from animals covered by the law were applied to rats and mice, 44.5 million of those Animals “potentially have been subjected to painful experiments. “

However, an analysis in the journal Science revealed a number of 10 to 25 million.

In response to the letter from Stop Animal Exploitation Now! Peart made a statement: “To ensure transparency and compliance with our animal care and use program, the university reports all animal-related issues to OLAW immediately. To encourage the reporting of animal-related concerns, Yale operates a hotline and other means through which animal-related concerns can be reported easily (and confidentially). Those involved in animal research at Yale are required to report any problems. “

She said, “a thorough investigation will be carried out on all complaints and appropriate corrective action will be taken.”

Peart said the number of animals in Yale’s research laboratories is about 5 percent lower than it was before the COVID-19 pandemic, “mainly due to staff restrictions in laboratories and animal facilities.”

“Yale takes its responsibility for the appropriate care of its animals seriously. Our laboratories meet or exceed all federal regulations and independent accreditation standards, ”Peart wrote.

“Animal research is central to COVID-19 and many other diseases and gives hope to millions of patients and their families,” Peart wrote. “Accordingly, Yale scientists will continue their commitment to the appropriate use of animals in research. Our faculty members only use animals when there are no suitable alternative models to advance their research. “

edward.stannard@hearstmediact.com; 203-680-9382