Notre Dame reports 75 lab mice died after dose doubled in drug research. Feds alerted.

A total of 75 mice died in a research lab at the University of Notre Dame after research staff mistakenly doubled the dose of an experimental drug last fall, the university recently self-reported to federal regulators.

Staff didn’t follow the protocols approved by an in-house committee to oversee animal care, the report states. As a result, 52 mice were found dead from the research interventions, the report states. Another 23 were euthanized because of the stress they were experiencing.

The animal rights watchdog group Stop Animal Exploitation Now obtained the university’s report and provided it to local news media after doing one of many records requests that it routinely files on facilities nationwide each year with the National Institutes for Health.

Research institutions, like Notre Dame, are required to self report any violations of federal policies that govern the humane care of lab animals, which includes the Animal Welfare Act. They also must include corrective actions to prevent further violations.

Those reports go to NIH’s Office of Laboratory Animal Welfare, or OLAW. They are part of the “assurance of animal welfare” contracts that institutions must negotiate with the NIH so they can continue to do research with animals and still receive NIH funding, according to the NIH’s Office of Extramural Research.

“The University of Notre Dame is committed to protecting the welfare of animals used in research, and we take this responsibility very seriously,” Sue Ryan, the university’s executive director of media relations, said in a written statement. "We have commissioned an outside review to ensure that our protocols and practices adhere to all relevant regulations."

When asked who or what sort of entity or person is doing the outside review, she replied, “We have nothing more to add at this time.”

In filing the report, Jeffrey Rhoads, Notre Dame’s vice president for research, described how research staff in the Galvin Life Sciences Center made the decision to double the experimental drug’s dosage with a mistaken understanding of the dosage that had been approved by the university’s Institutional Animal Care and Use Committee.

Staff also didn’t seek the committee’s approval to change the dosage — that is, to change the protocol — as they should have, Rhoads wrote.

SAEN Executive Director Michael Budkie, based in Ohio, wrote March 26 to Notre Dame’s president, the Rev. John Jenkins, and called on the firing of the university lab staff whose actions led to mice deaths. Budkie said SAEN commonly requests staff be fired at institutions that have violations.

“They (Notre Dame staff) didn’t know what the dosage was supposed to be,” Budkie said in a phone interview, calling it incompetence. “This doesn’t sound like a well-performed scientific experiment, does it?”

Because the research is about potential medicine that could get into human use, he added, “This is not solely about what happens to animals.”

Most scientific journals, he said, require a statement that researchers adhered to all of the required protocols before publishing their research.

In 2020, SAEN similarly pointed out self-reported violations at a Notre Dame lab for mice that had been injected with breast cancer cells to study tumors: two mice had missing limbs, two had “bowels exteriorized” after surgery and 10 had tumors that were larger than the approved protocol. All were euthanized. Also, the university reported that someone in the lab intentionally “struck” a live mouse against a table.

May 2020: Notre Dame lab working with mice last year violated federal animal guidelines, records show

According to a story in The Tribune in 2020, Notre Dame responded by removing a person from the specific lab work and by forming new protocols to better train lab personnel and to keep an accurate account of procedures.

An NIH spokesman told The Tribune, when asked, that the agency doesn’t comment on individual institutions or violations.

“NIH has an ethical and legal obligation to ensure the welfare of, and minimize risks for, humans and other animals who are involved in NIH-funded research,” he released in a written statement from the NIH Office of Extramural Research. “We take very seriously the humane care and use of laboratory animals used in NIH-funded research.”

Skeptically, Budkie said NIH typically just requires an institution to do additional reporting.

But the NIH emphasizes a collaborative approach where institutions help to guard against violations. It opened 870 cases of potential violations in 2020, which grew to 1,111 by 2022, which the agency attributes to both the lifting of pandemic restrictions and more allegations filed by interest groups.

In an NIH blog about its policies to protect animal welfare, NIH officials state: “The purpose of self-reporting and OLAW oversight is to improve procedures and practices at institutions to ensure animal welfare and ultimately the quality of science. While we understand that an institution may be cautious when sharing compliance information, it shows transparency and a willingness to quickly and effectively correct any issues. When taken together, this goes a long way to strengthening public trust and assures the community that potential animal welfare concerns are evaluated.”

South Bend Tribune reporter Joseph Dits can be reached at 574-235-6158 or jdits@sbtinfo.com.

This article originally appeared on South Bend Tribune: Notre Dame alerts NIH about lab mice deaths after mistakes in dosage