While still under federal investigation for research practices and the deaths of macaque monkeys, the Galveston National Laboratory in a February report was cited for other animal deaths and deficiencies.
A routine inspection by the U.S. Department of Agriculture’s Animal Care Division in February revealed that 19 guinea pigs were found dead in their cage instead of having been properly euthanized during Ebola research, according to the inspection report.
The report further noted a sheep had been euthanized after sustaining a front leg fracture while being returned to its cage after getting weighed.
The report also said the University of Texas Medical Branch, the laboratory’s organizational parent, had failed to correctly document observations and did not report the animal deaths to its attending veterinarian in a timely manner.
The medical branch was still developing and implementing new protocols to address the problems when the guinea pigs were found dead in November and December, officials said.
The new protocols aim to correct procedures a federal audit published early last year noted as problematic in disease research performed on animals at the Galveston National Laboratory, where scientists study some of the world’s most lethal pathogens.
The medical branch has since implemented new policies requiring more frequent monitoring of animals infected with pathogens, said David Niesel, vice president and dean of the Graduate School of Biomedical Sciences and chief research officer at the medical branch.
The U.S. Department of Agriculture, which enforces the Animal Welfare Act, is still investigating the medical branch.
After the audit and two investigations, the medical branch is also now submitting quarterly reports to the federal Office of Laboratory Animal Welfare, Niesel said.
The latest document stems from a routine inspection of Ebola research performed at the national lab. In two separate studies, scientists seeking to develop vaccines injected about 50 guinea pigs with the virus.
In the cases where the guinea pigs were found dead in their cages, it happened five to seven days after being infected, Niesel said.
The guinea pigs were observed as frequently as the protocol required, but researchers did not properly document their observations, Niesel said. The inspection report also noted the guinea pigs should have been euthanized and not allowed to die of Ebola infection.
“We erred in the documentation,” he said. “We’ve talked to our personnel, and they indicated they made the observations, but it wasn’t documented on the form that was required.”
The report cited the medical branch for not reporting or communicating the deaths to its attending veterinarian immediately.
“This information is critical for the maintenance and refinement of an appropriate and adequate program of veterinary care,” the report said.
The medical branch acknowledged the failure in communication and noted the research facility has attempted to improve communication among the veterinary staff. The communication failures were highlighted in the earlier audit and a whistle blower lawsuit filed last month by a former attending veterinarian at the laboratory.
Medical branch officials disputed the notion that the problem was systemic, however.
“It wasn’t a systematic failure,” Niesel said. “In this case, there was clearly a communication problem and when we heard about it, we self-reported” the problem to appropriate agencies.
Despite the deficiencies, medical branch officials said the problems did not affect the integrity of the research.
“These animals were destined to die,” Niesel said. “We would have liked to have euthanized them at the end phase before they died, but that they died does not impact the validity of the study.”
After the release of the report, Stop Animal Exploitation Now, a Cincinnati-based animal rights group, filed a complaint to the U.S. Department of Agriculture asking it to launch another investigation. In the complaint, the group detailed areas of the Animal Welfare Act violated by the guinea pig deaths.
“In combination with the other violations in this inspection report, and when this report is placed into the context of the ongoing investigation regarding primate issues at UTMB, it becomes painfully obvious that this facility has not made any meaningful changes,” Executive Director Michael Budkie wrote.
“It is also eminently clear that their failure to abide by the Animal Welfare Act is systemwide and not limited to a specific species, or a specific project.”
The concerns extend beyond animal welfare, Budkie said.
“Even if you don’t care about animals, the fact that this kind of negligence is happening at a national lab should be concerning,” Budkie said in an interview.
While acknowledging communication and reporting deficiencies, medical branch officials have denied accusations that research is not being handled properly.
The research done at the Galveston National Lab is for the benefit of public health and scientists are working to find answers to some of the most complex diseases, officials said.
Changes to policy
A scathing audit conducted by agencies of the National Institutes of Health reported to observe “serious animal welfare issues” in research performed by the laboratory in its study of the Marburg virus, which is related to Ebola and causes hemorrhagic fevers marked by severe bleeding, organ failure and, in many cases, death. It was published in Feb. 2015.
The confidential audit report listed 11 “critical observations,” any one of which could “affect the validity or integrity of a study and/or the acceptability of a contract research organization,” according to audit documents.
The report also listed 58 “major” and 20 “minor” observations.
The audit panned the Galveston National Laboratory for leaving 12 macaque monkeys unattended for up to 18 hours while infected with the deadly disease. Eight of the monkeys were found dead, the audit said.
The agriculture department launched an investigation following the audit, and federal regulators have met with medical branch officials about suggested practices.
“The audit caused us to take a very serious look at what we were doing,” said Tobin Boenig, the vice president and chief compliance officer at the medical branch.
Medical branch officials said that under the former protocols animals did at times die inadvertently. The research facility is in the process of modifying those protocols and has not has not had a nonhuman primate die since the first changes took effect.
“We deal with the most deadly diseases,” Niesel said. “Our intention in research is to intervene before an animal dies.
“But every once in a while, even with an increased frequency of observation, some are going to fall through the cracks.”
Since the audit, the medical branch has spent time going through each protocol and making adjustments to suit each type of animal and each type of disease or agent, Niesel said.
“What we do is we try to align our observation frequency with that particular animal and that particular disease,” he said.
The laboratory prioritized implementation of its protocols, Boenig said.
The laboratory first made changes to protocols for studies using nonhuman primates. It has since made changes to protocols for guinea pigs and rabbits, although those were not in place at the time of the Ebola study. Protocols for small rodents, such as mice and rats, are still being developed.
The medical branch has made provisions to allow nighttime monitoring of infected animals. For example, researchers are now monitoring animals involved in anthrax studies every four hours.
“We’ve added nighttime observations during peak periods,” meaning when the disease is escalating, Niesel said.
The laboratory is working with federal granting agencies to get more money for the changes, he said.
“We can do additional things, but they are going to consume more resources,” Niesel said.