Research animals mistreated by leading supplier, animal welfare group alleges | Science

The contract research organization Inotiv is neglecting animals at a research facility in Indiana that conducts toxicity testing of experimental drugs, the Humane Society of the United States (HSUS) alleged 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 by lawmakers in that state and an investigation by the U.S. Department of Agriculture (USDA).

Inotiv, a major supplier of large laboratory animals, said in a statement that it takes “all allegations seriously,” but rejects the HSUS claim. Research at the Indiana facility “is conducted to 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 severely sick beagles and monkeys, some wailing in pain, that were not promptly assessed or treated by the facility’s lone veterinarian. The investigator also reported minipigs with limbs possibly broken by careless workers were not assessed or treated because they were due to be euthanized in up to 6 days, and that beagles were dosed with experimental medicines while they were vomiting, shaking, feverish, and laboring to breathe from previous doses. The investigator also said two monkeys accidentally hanged themselves in restraint chairs.

HSUS asserts that staffing was inadequate for the needs of thousands of animals at the site, including rodents. “So many toxicology projects were taken on at Inotiv that there was not enough staff to attend to even the most mundane of husbandry tasks, such as trimming dogs’ toenails so they wouldn’t get caught and torn in chain-link kennels,” says its report, which was released in late April.

The group says it has filed a complaint about the facility with USDA, which is responsible for enforcing the Animal Welfare Act (AWA). “It is our hope that sharing the plight of these animals will accelerate [Food and Drug Administration (FDA)] and pharmaceutical industry changes to replace outdated animal tests with superior modern technologies,” Kitty Block, president and CEO of HSUS, said in a press release.

“We believe that the HSUS investigation raises significant questions about animal welfare and good laboratory practice at Inotiv,” says Eric Kleiman, a researcher at the Animal Welfare Institute, an animal advocacy group. “Both the USDA and FDA should investigate.”

In its statement, an Inotiv representative said the company is “dedicated to providing the best care possible in accordance with the Animal Welfare Act and other applicable regulations and guidelines. When any concerns are raised, we investigate and implement corrective actions quickly.”

Inotiv said the facility in Mount Vernon, Indiana, has been involved in developing drugs “that cured or alleviated more than 44 diseases over the last 30 years.” The company declined to provide examples, citing client confidentiality.

The company did not respond to HSUS’s allegations about specific incidents with beagles and monkeys. It declined to provide the ratio of staff to animals at the seven-building facility, which houses approximately 1386 macaques, beagles, and pigs according to its 2021 USDA annual report. Inotiv asserted that the ratio “is optimal to provide the best care possible within the auspices of the Animal Welfare Act.”

In an investor call on 12 May, Inotiv CEO Robert Leasure said the company is making improvements at several of its facilities “to enhance animal welfare” including investing in water systems, air quality, electrical upgrades, improved sewer systems, and veterinary care.

USDA declined comment, citing an “ongoing investigation,” which was triggered by violations at the Virginia beagle breeding facility. A USDA investigation is the first step in a process that can ultimately lead to the revocation of a company’s breeding license or cancellation of its research registration. In annual on-site assessments of the Indiana research facility, most recently in August 2021 and dating back to 2014, USDA inspectors have found no AWA violations.

The HSUS allegations come as Inotiv, which has about 2000 employees at 16 sites in the United States and six sites in Europe, has been aggressively building its business as a supplier of large laboratory animals to U.S. researchers. Over the past year it has acquired several companies, including the large supplier Envigo, that owned thousands of beagles, rabbits, nonhuman primates such as macaques, and other animals. Inotiv now owns more than 61,000 animals, according to the most recent USDA reports. By comparison, the prominent contract research organization Charles River Laboratories has about 71,000 animals recorded in its filings with USDA. (These numbers exclude mice and rats, which are not regulated under the AWA.)

The contract research organization Inotiv is neglecting animals at a research facility in Indiana that conducts toxicity testing of experimental drugs, the Humane Society of the United States (HSUS) alleged 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 by lawmakers in that state and an investigation by the U.S. Department of Agriculture (USDA).

Inotiv, a major supplier of large laboratory animals, said in a statement that it takes “all allegations seriously,” but rejects the HSUS claim. Research at the Indiana facility “is conducted to 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 severely sick beagles and monkeys, some wailing in pain, that were not promptly assessed or treated by the facility’s lone veterinarian. The investigator also reported minipigs with limbs possibly broken by careless workers were not assessed or treated because they were due to be euthanized in up to 6 days, and that beagles were dosed with experimental medicines while they were vomiting, shaking, feverish, and laboring to breathe from previous doses. The investigator also said two monkeys accidentally hanged themselves in restraint chairs.

HSUS asserts that staffing was inadequate for the needs of thousands of animals at the site, including rodents. “So many toxicology projects were taken on at Inotiv that there was not enough staff to attend to even the most mundane of husbandry tasks, such as trimming dogs’ toenails so they wouldn’t get caught and torn in chain-link kennels,” says its report, which was released in late April.

The group says it has filed a complaint about the facility with USDA, which is responsible for enforcing the Animal Welfare Act (AWA). “It is our hope that sharing the plight of these animals will accelerate [Food and Drug Administration (FDA)] and pharmaceutical industry changes to replace outdated animal tests with superior modern technologies,” Kitty Block, president and CEO of HSUS, said in a press release.

“We believe that the HSUS investigation raises significant questions about animal welfare and good laboratory practice at Inotiv,” says Eric Kleiman, a researcher at the Animal Welfare Institute, an animal advocacy group. “Both the USDA and FDA should investigate.”

In its statement, an Inotiv representative said the company is “dedicated to providing the best care possible in accordance with the Animal Welfare Act and other applicable regulations and guidelines. When any concerns are raised, we investigate and implement corrective actions quickly.”

Inotiv said the facility in Mount Vernon, Indiana, has been involved in developing drugs “that cured or alleviated more than 44 diseases over the last 30 years.” The company declined to provide examples, citing client confidentiality.

The company did not respond to HSUS’s allegations about specific incidents with beagles and monkeys. It declined to provide the ratio of staff to animals at the seven-building facility, which houses approximately 1386 macaques, beagles, and pigs according to its 2021 USDA annual report. Inotiv asserted that the ratio “is optimal to provide the best care possible within the auspices of the Animal Welfare Act.”

In an investor call on 12 May, Inotiv CEO Robert Leasure said the company is making improvements at several of its facilities “to enhance animal welfare” including investing in water systems, air quality, electrical upgrades, improved sewer systems, and veterinary care.

USDA declined comment, citing an “ongoing investigation,” which was triggered by violations at the Virginia beagle breeding facility. A USDA investigation is the first step in a process that can ultimately lead to the revocation of a company’s breeding license or cancellation of its research registration. In annual on-site assessments of the Indiana research facility, most recently in August 2021 and dating back to 2014, USDA inspectors have found no AWA violations.

The HSUS allegations come as Inotiv, which has about 2000 employees at 16 sites in the United States and six sites in Europe, has been aggressively building its business as a supplier of large laboratory animals to U.S. researchers. Over the past year it has acquired several companies, including the large supplier Envigo, that owned thousands of beagles, rabbits, nonhuman primates such as macaques, and other animals. Inotiv now owns more than 61,000 animals, according to the most recent USDA reports. By comparison, the prominent contract research organization Charles River Laboratories has about 71,000 animals recorded in its filings with USDA. (These numbers exclude mice and rats, which are not regulated under the AWA.)