Media Coverage About SAEN Stop Animal Exploitation Now

University of Florida suspends research study that resulted in dogs' deaths

 

From Alan Festo, The Gainesville Sun, May 23, 2023

Newly released documents uncovered by a watchdog group show that the University of Florida suspended a research study after the death of two animals.

The group is now asking for the university and its president to terminate the program entirely.

The temporary halt comes after university officials found that a study's principal investigator failed to follow through on "corrective actions" required by UF's Institutional Animal Care and Use Committee (IACUC) during research that resulted in the death of two dogs, documents obtained by Stop Animal Exploitation Now! (SAEN) show.

The dogs were part of a Duchenne muscular dystrophy study in mid-2023, and each received an adeno-associated virus vector — a form of gene therapy — administrated directly into the heart.

David Norton, UF's vice president for research, notified Axel Wolff, director of the Division of Compliance Oversight for the Office of Laboratory Animal Welfare — part of the National Institutes of Health — of the suspension in a letter dated Oct. 19, 2022.

“Due to the lack of principal investigator response to the above corrective actions and concerns over animal welfare and overall protocol adherence, the IACUC voted to suspend the protocol involved in the adverse event effective immediately,"

Among the corrective actions required were that the lab and veterinarians with UF's Animal Care Services division develop a standard operating procedure for UF's Small Animal Hospital so that the dogs receive better care. The committee also has required modification to the IACUC protocol to better outline human endpoints.

Officials for SAEN said the suspension doesn't go far enough at that the study should be permanently shut down.

“Given the fact that this project has already had violations of federal regulations sufficient to cause death of two research subjects, and that the behavior of the Principal Investigator has given rise to 'concerns over animal welfare and overall protocol adherence,' and that this is experimentation is in an area wherein significant toxicity to humans has already been demonstrated, this protocol should be permanently terminated,” wrote SAEN's co-founder Michael A. Budkie in a letter to the UF President Ben Sasse.

The suspension follows a report written by Norton to the Office of Laboratory Animal Welfare that outlined events that ultimately led to the dogs' deaths. It noted that “the procedure went smoothly and the dogs recovered well.”

On Aug. 20, however, one of the dogs began to show "abnormal respiratory signs" after receiving an injection a day earlier. According to UF's report, the dog was taken to UF's Small Animal Hospital where its condition "rapidly deteriorated" and it ultimately stopped breathing.

On Sept. 3, another dog involved in the June 24 study suffered an "episode of regurgitation." Over the following days, the dog developed intermitted inappetence, fever and abnormal palpitation. The dog was admitted to the Small Animal Hospital on Sept. 7 for imaging and supportive care. A hiatal hernia and evidence of pneumonia were discovered during testing. After receiving treatment, the dog's appetite and fever returned to normal and it was discharged on Sept. 12.

But just three days later, the dog's fever returned, and suffered from "respiratory distress." The dog was taken back to the hospital where a decision was made on Sept. 18 to euthanize the animal.

The university's Institutional Animal Care and Use Committee (IACUC) voted on Oct. 4 to classify the causes of death as adverse events to the treatment.

A complaint by SAEN in February alleges that the dog died on Aug. 20 due to not being treated timely, and that the animal was not adequately observed. The complaint insists on a full investigation of UF's muscular dystrophy research and, upon its conclusion, UF be issued the maximum allowable fine of $12,722 per infraction per animal.

In an emailed response to The Sun regarding the complaint in February, a UF spokesman said it "is committed to the ethical use of animals in its pursuit of medical advances that benefit both humans and animals"

"Almost every drug, treatment, medical device, diagnostic tool or cure we have today was developed with the help of laboratory animals," the statement continued. "Animal research at UF is governed by a federally mandated Institutional Animal Care and Use Committee that reviews all requests for approval to use vertebrate animals and inspects all areas where animals are housed and used."

University officials say that its Animal Care and Use Program has received full and continued accreditation from AAALAC International, a nonprofit that promotes the humane treatment of animals in science.

"Full accreditation serves as a testament to our program’s commitment to quality and humane animal care, rigorous research practices, and continuous improvement," UF's statement said.

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