SAEN LogoUTMB fights fed report of study on monkeys
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Please LEVY a MAXIMUM FINE against University of Texas, Medical Branch for their blatant disregard of the Animal Welfare Act (AWA) when they failed to provide veterinary care for monkeys who suffered unnecessarily and died from Marburg virus. This must NOT be tolerated and MUST be punished to the fullest extent of the law. The time is NOW to send a clear message with stiff penalties to these renegade, negligent facilities that these behaviors will NOT be tolerated!

 

UTMB fights fed report of study on monkeys
By Laura Elder, GalvNews.com, October 24, 2015

University of Texas Medical Branch officials will meet next month with representatives of a federal agency in hopes of resolving disagreements over a scathing report essentially accusing researchers at the Galveston National Laboratory of disregarding the suffering of nonhuman primates infected with a deadly virus.

In that report, researchers also were cited for deficiencies in record keeping and data processing in their study of the infectivity and lethality of Marburg virus, which is related to Ebola and causes hemorrhagic fevers marked by severe bleeding, organ failure and, in many cases, death.

All protocols followed

But the medical branch, which conducts research to develop vaccines and treatments for diseases, said it followed every agreed upon protocol and treated nonhuman primates in the study with respect and care. Medical branch officials also say they were graded by a set of standards different from those agreed upon in its contract with the National Institute of Allergy and Infectious Diseases, which conducted the audit.

“UTMB believes that our researchers followed the agreed-upon protocols for animal care; however, we are working closely with NIAID to address concerns that they expressed related to this nonhuman primate protocol,” officials said.

Medical branch officials also say they are confident the $2.4 million federal contract won’t be jeopardized once their responses to the report are considered. Medical branch officials said they were working to set the record straight with federal officials.

89 audit ‘observations’

In all, the confidential audit report listed 11 “critical observations,” any one of which could “affect the validity or integrity of a study and/or the acceptability of a contract research organization,” according to audit documents.

One critical audit observation was about how long nonhuman primates, in this case monkeys known as cynomolgus macaques, suffered from effects of Marburg before being euthanized by medical branch researchers.

The report also listed 58 “major” and 20 “minor” observations.   

The uncharacteristically harsh federal report likely would have remained private were it not for a whistleblower who tipped off a national research watchdog group Stop Animal Exploitation Now.

Speculative and harmful

“The statements made in the audit report indicating anything short of the appropriate care and treatment of the animals under this study by UTMB is speculative and, we believe, harmful to the reputation of the institution and its individual investigators,” David W. Niesel, vice president and dean of the Graduate School of Biomedical Sciences and chief research officer at the medical branch, wrote in a March 13 letter to the Office of Regulatory Affairs at the National Institute of Allergy and Infectious Diseases.

 “UTMB is committed to providing the appropriate care and treatment of all its animals, especially nonhuman primates involved in biomedical research on UTMB’s campus while, at the same time, ensuring the safety and well being of its employees ... .”

Almost human?

While the morality of using animals for research has long sparked debate, the use of nonhuman primates, which include monkeys and apes, is particularly controversial and highly regulated. The brains of nonhuman primates share structural and functional features with human brains, scientists say. It’s that similarity that makes it scientifically advantageous to use them in research that could benefit humans. But it’s that very similarity that raises questions about whether primates experience pain and suffering in ways that are similar to humans.

The American Society of Primatologists puts it this way: Nonhuman primates are research subjects because they are so similar to humans, and the principal reason for this similarity is simple: humans are primates.

Macaques are genetically very similar to humans. They especially share analogous neurological, reproductive and immunological systems with humans, according to literature about the animals.

Fighting deadly filoviruses

The purpose of the medical branch study, funded by the National Institute of Allergy and Infectious Diseases, is to develop a “challenge virus” that other laboratories could use in efforts to develop vaccines and treatments to fight the deadly diseases caused by so-called filoviruses, which include Marburg and Ebola. The National Institute of Allergy and Infectious Diseases’ contract with the medical branch specified the use of nonhuman primates.

Agreed protocols

Before the study, the medical branch and the institute agreed on specific protocols about the monitoring of infected primates and the point at which the primates would be euthanasized, medical branch officials say. The medical branch conducted the study in accordance with approved study protocol, officials said.

According to the report, most of the animals — eight to 12 — were found dead between days eight and 10 of the challenge.

“Since approximately 15-18 hours had elapsed between the last observations, when the animals were still alive, and when the animals were found dead the next morning, it is unknown how long these animals might have suffered before dying,” according to the report. The report went on to say that observations were to increase in number as clinical signs warranted or when symptoms reached a score of five or more.

But none of the examples listed in the report exhibited a clinical observation score greater than five, medical branch officials said in written response to the federal agency.

Medical branch officials, in an interview with The Daily News, said that when the clinical signs in an animal reached the score of nine, protocols called for euthanizing the animal. But an animal couldn’t be euthanized before that point; doing so would bias study results, said Jason Comer, study director of Regulated Studies for the Institutional Office of Regulated Nonclinical Studies at the medical branch.

At the end of normal business hours, if an animal had a score of four, but was likely to die later in the night, staff could not hasten its death. It would be against protocol and would skew the study results.

No after hours

Researchers and veterinarians involved in the Marburg study met this week with The Daily News to discuss their responses to the report.

Because of safety practices at the laboratory, personnel aren’t allowed to enter after normal business hours to monitor the animals. There also are safety issues when it comes to a researcher monitoring an animal without other staff on hand to assist. There were no provisions in the contract for overnight monitoring of the animals, medical branch officials said.

And there’s also a matter of animal welfare, Comer said. Constantly turning on the lights and interrupting the monkeys would disturb their sleep patterns and cause them stress, which is an animal welfare issue. But it also could affect outcomes of the study, Comer said. When medical branch officials meet with federal officials next month, they hope to discuss how to control for after-hour monitoring without skewing study results.

The medical branch, in its response to the federal agency, also said it was investigating the feasibility of implantable data loggers to potentially capture body temperatures and respiration rates of animals.

“This would allow for additional data collection during nonbusiness hours,” officials said.

Wrong measures used

The medical branch also takes issue with the standards by which it was measured. Authors of the report acknowledge the studies were not intended to be conducted in

compliance with the U.S. Food and Drug Administration Good Laboratory Practices, which require extremely strict record keeping. Yet, that same agency graded the medical branch under those standards.

“This was a non-GLP study,” Curtis Klages, the attending biocontainment veterinarian at the Galveston National Laboratory, said. “It’s like we were told it was a history test and prepared for a history test and then were given a math test.”

In its response to the federal agency, the medical branch said it disagreed with observations by auditors who applied Good Laboratory Practices to a non-GLP study and made conclusory findings related to study data and animal welfare.

According to the audit report, “incomplete and/or inaccurate documentation and lack of a timely review compromises data integrity as well as study integrity.”

All for nothing?

Michael A. Budkie, executive director of Stop Animal Exploitation Now, said he found it most disturbing that animals might have suffered for research that might be unusable because of lax documentation.

“It makes it look like junk science paid for with federal tax dollars and animal lives are being spent to do this junk science,” Budkie said.

Comer said all of the data from the study is usable and nothing has been compromised.

Raul Reyes, a medical branch spokesman, took issue with Budkie’s assertion that it was “junk science.”

“It’s not junk science when you’re trying to save people’s lives,” Reyes said.

“We remain committed to conducting potentially lifesaving research and are proud of our accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International, a symbol of the highest commitment to animal care,” the medical branch said in a statement.

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