Wake Forest University (WGHP)
WINSTON-SALEM, N.C. (WGHP) — Wake Forest University is paying after the alleged mistreatment of monkeys, cats, rabbits and sheep.
Between September 2021 and May 2024, members of Stop Animal Exploitation NOW!, a group that raises awareness about and seeks to end animal experimentation, sent four letters to the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service to file official complaints against the university, saying its caused injury or death to at least 25 animals since 2021.
Animal testing
Scientists at Wake Forest University School of Medicine tell FOX8 that it uses animals to study conditions and illnesses, as well as potential treatments.
The School of Medicine says that federal law requires animal testing before most human clinical trials can be conducted.
According to the Food and Drug Administration, testing of some kind is required before human trials, but there are not always suitable alternatives to animal testing. Before developers can test new medical products on humans, they have to show the FDA that their products are “reasonably likely to be safe” through “scientifically reliable and validated test methods.” While the FDA “encourages and accepts scientifically valid alternatives to animal testing,” it also says that there are not yet “validated alternatives to animal testing” for all medical products.
Allegations
Attached to SAEN’s letters were USDA inspection reports obtained by the group detailing unsanitary conditions of animal enclosures, mishandling of animals by WFU staff and improper drug administration. Michael Budkie, executive director of SAEN, sought the maximum fine of $12,722 per infraction/per animal.
On May 23, the USDA sent a settlement agreement to Wake Forest University, providing an overview of the reported violations of the Animal Welfare Act.
On Jan. 6, 2021, the university allegedly failed to communicate with the attending veterinarian regarding a macaque’s recovery after a four-hour anesthesia period. The animal vomited during recovery, which was not promptly reported to the attending veterinarian. The following morning, the attending veterinarian team found the animal unresponsive, and it was euthanized when its condition worsened.
On March 17, 2021, a staff member allegedly mishandled a rabbit while administering fluids under the skin. The rabbit died after administration of the fluids, and its cause of death was determined to be medical asphyxiation.
Between August 2020 and June 2021, staff were accused of lacking proper training and needing guidance in “humane methods of animal maintenance and experimentation including proper pre-procedural and post-procedural care of animals.”
Between July 2020 and July 2021, the research team supposedly failed to communicate five instances of cats not recovering as anticipated to the attending veterinarian team. The researcher said the cats were quiet, alert and responsive, but later during same-day evaluations, the attending veterinarian team found the cats were in pain, hypothermic or hyperthermic and in shock or in distress — conditions that required immediate attending veterinarian intervention.
In May 2021, five rabbits did not receive the protocol-approved drug following surgical procedures. USDA says the people responsible ran out of gabapentin, used to reduce stress and ease the handling of rabbits, and the attending veterinarian team was not notified about the lack of medication until the next day.
The Institutional Animal Care and Use Committee says animal “headwells” should be cleaned at least once per week and more often if needed.
An inspection on July 28, 2021, found the cleaning of cat enclosures was not on schedule. Between August 2020 and June 2021, one cat’s cage should have been cleaned a minimum of 42 times. It was only done nine times with the longest interval being 25 days between cleanings.
That same day, inspectors found 10 sheep in an area with no shade available except that provided by a three-sided, unventilated, run-down shed and ineffective shade cloth structure. Temperatures that day were recorded as high as 95 degrees.
On Nov. 2, 2021, inspectors saw a rhesus macaque improperly seated and restrained. That same day, two feed receptacles for pigs were coated in dark brown, dried grime.
In October/November 2022, an investigator was accused of failing to report an exposed vascular access port in a nonhuman primate for four days.
In April 2023, staff allegedly administered an off-protocol drug to a macaque, resulting in hypothermia for the animal. The attending veterinarian team was not promptly notified.
In May 2023, a macaque was injured when it was placed in an enclosure with another nonhuman primate.
Around January 2024, the IACUC accused WFU of giving anesthesia to five vervets and performing unapproved MRI procedures.
On April 22, 2024, a juvenile vervet was suspended by her collar on a section of a damaged chain link. She later died.
Settlement
The university was fined $12,850 as part of a settlement and was not required to make any kind of admission of guilt.
“If the USDA believes a noncompliant event is serious, it can issue warnings or fines,” Wake Forest University School of Medicine said in a statement. “Recently, the school and the USDA settled on a fine of $12,580 for self-identified alleged noncompliance that occurred between 2021 and the present. As part of the settlement, the school neither admits nor denies the allegations.”
Budkie, however, believes the fine should have been more than $300,000.
“While a penalty of any size is still an animal abuse conviction, a $12,850 fine has no punitive value for a facility as large as WFU whose 2023 research budget is over $150,000,000,” he said.
He added the fine was a “little more than a slap on the wrist.”
Wake Forest University’s School of Medicine emphasized that the program is in good standing with AAALAC International and that it remains “committed to full compliance with local, state and U.S. federal regulations and most importantly, the humane care of all animals in our program.”
Wake Forest University School of Medicine’s full statement
The animal research program at Wake Forest University and the School of Medicine has been in existence for more than 60 years. During that period, the program has remained in good standing with our accrediting body, AAALAC International, demonstrating confidence in the program’s overall effectiveness. While any program can include missteps, excellent programs self-identify and correct them.
In accordance with the Animal Welfare Act & Regulations (AWAR), the U.S. Department of Agriculture (USDA) inspects our facilities, and the university must report self-identified incidents of alleged noncompliance with AWAR. When a question about best practices or compliance is identified, it is resolved via oversight committee-approved corrective actions.
If the USDA believes a noncompliant event is serious, it can issue warnings or fines. Recently, the school and the USDA settled on a fine of $12,580 for self-identified alleged noncompliance that occurred between 2021 and the present. As part of the settlement, the school neither admits nor denies the allegations.
In the pursuit of new treatments for patients and a better understanding of medicine and biology, we remain committed to full compliance with local, state and U.S. federal regulations and most importantly, the humane care of all animals in our program.
Additional Background
As an academic learning health system, we are committed to improving health and advancing healing. With this mission in mind, scientists at Wake Forest University School of Medicine study animal models to identify the causes, diagnoses and treatments of conditions and illnesses that impact the people in communities we serve.
Federal law requires animal testing before most human clinical trials can be conducted, and nearly every major medical advance of the last century is the result of animal research studies. These discoveries include new treatments for cancer and diabetes, antibiotics, organ transplants and vaccines.
All research studies with animals require the review and approval of our Institutional Animal Care and Use Committee (IACUC), which is made up of veterinarians, scientists, lay persons and representatives from our local community. The IACUC ensures that animal use is necessary, the numbers are minimal, the detailed procedures meet current veterinary standards, and that appropriate steps are taken to prevent, minimize or eliminate risks to our animals.
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We are also regulated by and conform to strict requirements from the U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals, the National Research Council’s Guide for the Care and Use of Laboratory Animals, and the U.S. Department of Agriculture’s (USDA’s) Animal Welfare Act & Regulations. As part of our compliance with Animal Welfare Act Regulations, we are also subject to random, unannounced inspections by USDA veterinarians.
The Wake Forest University School of Medicine research program is fully accredited by AAALAC International, the preeminent accreditation organization for institutions conducting animal research. We were among the first organizations to receive this accreditation in the 1960s and have remained fully accredited continuously for more than half a century.
At Wake Forest, we are committed to only the highest standards of care that come with the privilege of working with animals. We strive to meet or exceed all federal regulatory standards and remain dedicated to state-of-the-art veterinary care to ensure all of our research animals are treated compassionately, ethically and humanely.
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