Contract research organization Inotiv is neglecting animals at an Indiana research facility that conducts toxicity testing of experimental drugs, the Humane Society of the United States (HSUS) claimed last month. The company has been in the spotlight in recent months for serious animal welfare violations at its Virginia beagle breeding facility, prompting a crackdown from lawmakers in that state and an investigation by the U.S. Department of Health. Agriculture (USDA).
Inotiv, a major supplier of large laboratory animals, said in a statement that it takes “all allegations seriously,” but rejects HSUS’ claim. Research at the Indiana facilities “is conducted under the highest ethical standards” and complies with all animal welfare regulations, a company representative said.
HSUS reported that an undercover investigator who worked at the facility for 7 months, until March, observed seriously ill beagles and monkeys, some groaning in pain, who were not promptly assessed or treated by the facility’s only veterinarian. The investigator also reported that minipigs whose limbs may have been broken by negligent workers were not assessed or treated because they had to be euthanized within a maximum of 6 days, and that beagles had received doses of experimental drugs while vomiting, shaking, feverish and working to breathe from previous doses. The investigator also said that two monkeys accidentally hanged themselves in restraint chairs.
HSUS says the staff were insufficient for the needs of thousands of animals at the site, including rodents. “So many toxicology projects were undertaken at Inotiv that there were not enough staff to handle the most mundane of herding tasks, like clipping dogs’ nails so they wouldn’t be caught and torn in chain-link kennels,” says its report, which was released in late April.
The group says it has filed a complaint against the facility with the USDA, which is responsible for enforcing the Animal Welfare Act (AWA). “We hope that sharing the fate of these animals will accelerate [Food and Drug Administration (FDA)] and changes in the pharmaceutical industry to replace outdated animal testing with superior modern technologies,” said Kitty Block, president and CEO of HSUS, in a statement. Press release.
“We believe the HSUS investigation raises important questions about animal welfare and good laboratory practices at Inotiv,” says Eric Kleiman, a researcher at the Animal Welfare Institute, an animal advocacy group. “USDA and FDA should investigate.”
In its statement, a representative from Inotiv said the company is “committed to providing the best care possible in accordance with the Animal Welfare Act and other applicable regulations and guidelines. If there is a problem, we investigate and put quickly implement corrective actions.
Inotiv said the Mount Vernon, Indiana facility has been involved in the development of drugs “that have cured or relieved more than 44 diseases over the past 30 years.” The company declined to provide examples, citing customer confidentiality.
The company has not responded to HSUS’ claims regarding specific incidents with beagles and monkeys. He declined to provide the staff-to-animal ratio at the seven-building facility, which houses about 1,386 macaques, beagles and pigs according to its 2021 USDA annual report. Inotiv claimed the ratio “is optimal for providing the best possible care under the auspices of the Animal Welfare Act.”
During an investor call on May 12, Inotiv CEO Robert Leasure said the company was making improvements to several of its facilities “to improve animal welfare,” including investing in systems water supply, air quality, electrical upgrades, improved sewage systems and veterinary care.
The USDA declined to comment, citing an “ongoing investigation,” which was prompted by violations at the Virginia beagle breeding facility. A USDA investigation is the first step in a process that may ultimately lead to the revocation of a company’s breeding license or cancellation of its research registration. During annual on-site assessments of the Indiana research facility, most recent in August 2021 and dating back to 2014, USDA inspectors found no violations of the AWA.
The HSUS allegations come as Inotiv, which has about 2,000 employees at 16 sites in the United States and six sites in Europe, has aggressively expanded its business as a supplier of large laboratory animals to American researchers. Over the past year, he has acquired several companies, including major supplier Envigo, which owned thousands of beagles, rabbits, non-human primates such as macaques and other animals. Inotiv now owns more than 61,000 animals, according to the latest USDA reports. By comparison, the large contract research organization Charles River Laboratories has about 71,000 animals recorded in its USDA filings. (These numbers exclude mice and rats, which are not regulated by the AWA.)