ACTION ALERT:
Contact USDA to DEMAND MAX FINE against UTMB
Dr. Robert Gibbens, Director, Western Region, USDA
(970) 494-7478
[email protected]
[email protected]
SAMPLE MESSAGE:
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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