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!
Audit prompts federal investigation at UTMB
By Harvey Rice, HoustonChronicle.com, August 23, 2015
Inquiry ahead after allegations of painful deaths for 12 monkeys
Allegations of mistreatment of Macaque monkeys infected with Marburg prompted the investigation of UTMB's National Laboratory.
GALVESTON - The University of Texas Medical Branch's National Laboratory, where some of the world's most dangerous diseases are researched, is under federal investigation following a scathing audit that accuses researchers of using shoddy practices, including allowing a dozen monkeys to suffer painful deaths after being infected with a lethal virus.
The National Institute of Health's Office of Laboratory Animal Welfare said Saturday in an email that it has launched an investigation into allegations of mistreatment of Macaque monkeys infected with Marburg, a lethal virus similar to Ebola. Penalties for a violation of federal policy on the humane care and use of laboratory animals could range from increased training requirements to UTMB losing funding from federal health agencies, including the National Institutes of Health and the Food and Drug Administration.
UTMB officials said Sunday that they have not received formal notification of the investigation.
In interviews and a forceful letter to federal officials, UTMB officials contested allegations made in a February audit report by the National Institute of Allergy and Infectious Diseases. The audit became public when a whistle-blower informed the animal rights group Stop Animal Exploitation NOW! of its existence. The group filed an animal welfare complaint to the U.S. Department of Agriculture, which enforces animal welfare laws and is required to investigate any complaint.
The audit examined the National Laboratory's performance on a contract with the National Institute of Allergy and Infectious Diseases to develop a strain of Marburg virus that could be used in experiments on monkeys to find a cure. The audit found 11 critical research problems that "would affect the validity or integrity of a study and/or the acceptability of a contract research organization," and 59 major problems that showed a departure from standard operating procedures and good laboratory practices "that could jeopardize the acceptability of a research organization."
Toby Boenig, UTMB vice president and chief compliance officer, said three USDA investigators visited the National Laboratory in July and that UTMB officials were awaiting the outcome.
The animal rights group has asked Chancellor Bill McRaven for an independent investigation by the University of Texas System.
Ray Greenberg, UT system executive vice chancellor for health affairs, said in an email, "We believe that UTMB has responded appropriately and is taking the necessary steps to reach resolution with the federal agencies."
As a result of the problems discovered with the Marburg study, auditors examined two previous studies. Six of the critical and six of the major problems were in one of those studies.
UTMB officials contested the allegations and are scheduled to meet Sept. 30 with National Institute of Allergy and Infectious Diseases officials to discuss the criticisms in the audit.
The National Institute did not respond to a request for comment.
UTMB officials said the audit criticisms are unfair because they were measured by higher standards than called for in the research contract with the National Institute. UTMB argues that the audit used the Good Laboratory Practices standard even though the contract with the National Institute did not specify use of the high standard. "By using that larger yardstick, it looked like we were not doing some of the things required by the study," said Dave Niesel, UTMB chief research officer.
The four-story Galveston National Laboratory, which cost $174 million and opened in 2008, is at the forefront of research on cures for Ebola and other lethal diseases. The National Laboratory is rated Level 4, meaning it is equipped to research the deadliest biological agents known because of its sophisticated safeguards. The top floor of the 186,000- square-foot building houses the Level 4 lab, where researchers must don thick protective garments and headgear that look like spacesuits when entering the most secure area where viruses are kept along with test animals.
Last year the laboratory received $6 million from the National Institutes of Health and the U.S. Department of Defense to develop cures for Ebola and the equally deadly Marburg virus, an agreement separate from the contract audited by the National Institute of Allergy and Infectious Diseases.
The laboratory's efforts to develop a stable strain of Marburg under the audited National Institute contract have been temporarily halted, but National Laboratory chief veterinarian Curtis Klages said the pause was unrelated to the audit and merely a chance to review the research. "It is a very frequent event in research," Klages said.
The audit report criticized the National Lab for leaving 12 Macaque monkeys infected with Marburg unattended for 15-18 hours. Eight of the monkeys were found dead in their cages. "It is unknown how long these animals might have suffered before dying," the audit report said. "It is unacceptable to leave animals that are expected to die unattended during the time frame death is expected."
A letter specifically addressing the accusations about the treatment of the monkeys says, "UTMB respectfully but strongly disagrees with the speculative observations made regarding UTMB's animal welfare program under this study ...."
Klages said that researchers did not want to disturb the monkeys at night, when most of them died, because it would disrupt their sleep patterns and affect the study. "The welfare of the animals is always our concern, but we have to look at it in light of the science," Klages said. "A very small number of animals have to go through this."
The whistleblower who revealed the existence of the audit disagreed with Klages. The whistleblower, who asked that his name be withheld because he feared retaliation from UTMB, said that sleep pattern disturbance only applies to breeding and that there is no evidence that it affects infectious disease research.
He also accused researchers of failing to report the monkey deaths to UTMB's Institutional Animal Care and Use Committee, which investigates unexpected animal deaths. Klages said that only unexpected deaths are reported and that death was the expected outcome of the experiment. The whistleblower disagreed, saying that the expectation was that the monkeys would be euthanized to spare them painful deaths. "It's shameful to not look in on an animal that needs to be euthanized," he said.
Niesel said that work is not normally done at night at the National Laboratory because the team that would respond in case of an accident is unavailable. "It's a very unique environment and a very hazardous environment," he said. "We are more than happy to proceed like that in the future, but the problem is that it increases the cost."
'That's a smokescreen'
The whistleblower said, "That's a smokescreen to say there is a reason we are not doing this." He conceded, however, that if a researcher was accidentally exposed to a virus at night, the response team would be unavailable.
He alleged that monkeys in other experiments had also died before being
euthanized, but said the alleged practice was confined to the National
Laboratory. Other departments doing animal experiments at UTMB rigorously
applied rules ensuring humane treatment, he said.
The whistleblower alleged lax supervision of animal welfare at the National Laboratory because of the research money it brings. "The investigators want to do it their way and they don't want anybody to say that this animal needs to be euthanized," he said. "They want complete and total control."
Klages said the allegation was false. "That's a goofy statement," Klages said.
UTMB said in a statement, "UTMB believes that our researchers followed the agreed upon protocols for animal care .... We continue to strive to provide the most humane treatment to animals involved in our research studies and we expect our staff to adhere to the highest ethical, legal and scientific standards."
The audit said that the failure of researchers to observe the monkeys in the period before their deaths resulted in a loss of data for the study, a theme that runs throughout the audit.
Although the National Institute of Allergy and Infectious Diseases ultimately accepted that some of the UTMB practices criticized by the audit met the terms of the contract, others appeared to go beyond mere procedure. For example, the audit found that at least three mathematics calculations were incorrect and resulted in potentially unreliable data. Boenig said that the mistakes were corrected and that measures were taken to make sure they would not be repeated.
"Nobody wants to have even a minute calculation error and certainly we would not argue against that," Boenig said.
The audit also criticized researchers for inconsistent and conflicting data entry, vague or nonexistent standard operating procedures and missing documentation.
'The data is good'
Niesel said that despite the audit criticism, the science is good. "I think this is something that would pass peer reviews," Niesel said. "The data is good and the data allows us to move on."
Michael Budkie, spokesman for Stop Animal Exploitation NOW!, said his
review of the audit led to a different conclusion. "We were just as
disturbed at the seeming level of incompetence involved in the research at
UTMB," Budkie said. "They couldn't even get the dates and times correct."
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