Mrs. Trull graciously consented to conduct an interview
with SAOVA to discuss the benefits of animal research, the function of NABR,
and federal legislation that would expand the scope of the Animal Welfare Act.
Q: How does the focus of NABR differ
from that of its sister organization, the Foundation for Biomedical Research?
A: Whereas
the Foundation is a public education charity that focuses on informing and educating
the public about the importance of animals in biomedical research, NABR is an
institutional membership association
with the mission of ensuring sound public policy for the humane use of animals
in biomedical research. NABR spends a great deal of time educating law makers
and executive branch officials, and when necessary engages the courts in
support of its mission. NABR’s membership is comprised of 340 institutions,
both public and private, in all 50 states and Puerto Rico.
Q: This month PETA posted a job listing
online for an Undercover Investigator. In the job description, the Position Objective is “to use a variety of undercover
investigative methods to conduct field investigations in PETA's focus areas,
including the use of animals for food, clothing, experimentation, and
entertainment.” How does the
research community prepare itself for intrusions of this nature into their
daily routines?
A: The threat of an animal rights
activist infiltrating a biomedical research facility is very real and has
occurred multiple times in the past. With more than three decades of
experience, NABR advises facilities on best practices for both preventing and managing
the consequences of infiltrations. We also provide each of our members with a
comprehensive Crisis Management Guide which walks them through the process of
protecting their facilities and employees and developing and maintaining a
crisis management team.
Q: The Animal Welfare Act (AWA) excludes
coverage of rats, mice and birds used for research. In December 2012, the Animal Legal Defense Fund
(ALDF) introduced legislation that would rescind these exemptions, claiming it
restores the original intent of Congress.
As NABR was instrumental in obtaining the statutory exemptions and
amendments, has your position changed over the years regarding regulatory
intent of the AWA?
A: NABR is
currently in the process of surveying its membership to determine how many rats
and mice are in use at research facilities across the U.S. Although rats and
mice make up more than 95% of all animals in biomedical research, the
institutional responses to the survey will help NABR determine more precisely
how such legislation may affect both the regulated community and those
institutions that have never before been regulated by the USDA. For example,
many small biotechnology companies only use rats and mice, meaning they would
likely be subject to the same regulations as much larger institutions. This
could potentially be very costly, time consuming, and could present a threat to
struggling small businesses -- especially when one considers the Secretary of
Agriculture has the legal authority to levy fines against a research facility
up to $10,000 per animal, per day. The costs could be astronomical.
Furthermore, because of the large number of rodents used in research it is
unclear whether the USDA would have the resources to regulate the species. With
the fiscal constraints Congress has been facing, it seems unlikely they would
appropriate additional funds for these purposes.
Q: In their white paper, ALDF claims
that withholding federal protection from these animals means that researchers
need not consider alternatives to animal research and are under no obligation
to minimize an animal’s pain, provide a minimum standard of care, or implement
proper euthanasia techniques. Aren’t
research animals already highly regulated? Are there industry standards and
protocols to address any gaps in external regulations?
A: If an
institution receives federal funding from any branch of the Public Health
Service, including NIH, it must file an animal welfare assurance
document with the agency which requires it to adhere to the recommendations
contained in the Guide for the Care and Use of Laboratory Animals. The Guide
serves as the basis for welfare for all vertebrate biomedical research animals,
and addresses all of the aforementioned concerns. Furthermore, many institutions
and companies using animals in biomedical research are accredited by the Association
for Assessment and Accreditation of Laboratory Animal Care International (AAALAC),
which uses the Guide as the basis for its accreditation process. FDA and EPA
regulated companies must comply with Good Laboratory Practices. Finally, and most importantly, it's in the
best interests of a research program to insure animals are treated well and
without pain because stressed animals skew research results.
Q: According to ALDF, this legislation
will provide sweeping animal welfare benefits at little cost. Has NABR completed any estimates of the cost
burden should this additional regulation should become law?
A: When this
subject was under debate in 2001, NABR estimated that regulating rats, mice and
birds under the Animal Welfare Act would cost USDA registered research
facilities an additional $84 million annually, in mostly administrative
compliance costs. Facilities that would have been required to register
with USDA for the first time might have spent $80 to $200 million to comply
with all statutory requirements. The USDA APHIS budget would also be impacted –
inspectors’ workload would double or even triple.
Q: There are many steps being taken by
animal rights lawyers to lay the groundwork in courts that test current
requirements for legal standing and push the courts to give animals limited
rights. How would even small changes in
property status affect use of animals in research?
A: The
ultimate goal of many animal rights lawyers is to obtain legal standing for
animals. Changing the property status of animals is the first step in a
long term process aimed at enabling well-funded animal rights organizations to
bring expensive and time-consuming legal actions that would entail potentially
enormous costs. Lawyers filing lawsuits on behalf of animals could
challenge their use in research programs, as pets, in animal sports, in agriculture
and in a multitude of other contexts. While some changes are being pushed for
in the courts, animal rights organizations are simultaneously pursuing legal
rights for animals through federal and state legislation, ballot initiatives
and other means. In fact, just this year a bill was introduced in Massachusetts
that would permit any person to bring a legal action "for the protection
and humane treatment of animals."
Q: The recent panel study report to the
National Institutes of Health (NIH) recommends downsizing chimpanzee
facilities. Will the remaining colony of chimpanzees kept for research fill the
needs for future studies? At one time, weren't chimpanzees the only good model
for certain human HIV research? How did that change? With emerging diseases and resistant
infections, how might the loss of future research animals via regulation impact
the prospect for advances in medical research to alleviate human suffering?
A: Science
is constantly evolving, so animal models change as well. The Institute of Medicine
and an NIH working group have determined that the chimpanzee model is not
necessary for some types of research. It is unclear whether the NIH director
will simply accept the working group’s recommendations or will elaborate on the
future of federal research chimps. Much
was learned about HIV from chimps, but the virus does not make them sick in the
same way as it does people, so they did not prove to be the optimal model. Should there be a disease as devastating as
AIDS in the future, the chimp may prove pivotal to treating and curing the
disease, so it would seem prudent and in the best interest of the public health
to maintain a breeding colony.
Q: Last month SAOVA reported to our
readers that the ALDF website lists the formation of 171 U.S. Student Animal
Legal Defense Chapters. In addition there
are State Bar Animal Law Sections and Committees in 24 states plus the American
Bar Association. Animal Law Courses are
now taught in 144 schools, up from just 9 in 2000. Realistically, the field of animal law
exists for the purpose of changing how animals are viewed in the legal
system. How concerned is the research
community about this rapidly growing field and its potential impact?
A: As the
field of animal law has grown, so have the legal departments and pro bono
networks of sophisticated, well-financed animal rights organizations. It is clear that many animal rights
organizations and animal rights lawyers believe research with animals should be
severely restricted or prohibited. Through
academic scholarship in five animal law journals and law reviews, lawyers and
law students within the animal rights movement have begun to lay the groundwork
and develop new legal theories to grant additional legal protections to
animals, including research animals. Ultimately,
these efforts have the potential to seriously impact life-saving medical and
scientific research. NABR has been
monitoring these developments for some time and has developed an Animal Law
website that provides information tracking law courses, lawsuits, court
decisions as well as the laws and regulations in place to ensure the humane use
of animals in biomedical research. www.nabranimallaw.org/
Q:
We read headlines almost every
day about breakthroughs in research.
Most medical advancements have been dependent upon animal research. What species are most commonly used and why
are these species so useful in biomedical research?
A: Rodents
are, by far, the most common animal model in biomedical research and safety
testing. And these are not your garden
variety rodents. For example, mice
specially bred with specific genetic characteristics are designed for the
disease under study, whether its diabetes, birth defects or obesity. This has
revolutionized medical research and opened many doors to finding new cures for
disease, especially cancer.
Research with dogs, cats, and non-human primates is
necessary to study certain diseases. However, as biomedical research changes
and evolves, the number of these animals used in research has dropped
dramatically over the last several decades.
In fact, these animals account for less than .05 percent of the total
number of lab animals used in research. Several additional species are proving
to be increasingly important animal models, including zebrafish, C. Elegans
(worms) and fruit flies
Q: Human health has obviously benefited
from animal research but animals benefit too through development of vaccines,
cancer treatments, and surgical procedures. What are some of the most exciting
areas of current research?
A: Dr. James
Cook, a researcher at University of Missouri, is developing biological joint
replacements for both people and animals.
Cook has created new cartilage in animals using a biological “scaffold” in
the animals’ joints. This research could do away with metal and plastic joints,
and instead, regenerate a fully functional biologic joint for anyone who needs
one.
Another exciting example of animal research is happening now
at the Masonic Cancer Center at the University of Minnesota. Doctors have
developed a vaccine for a deadly brain cancer that affects both people and
dogs. Doctors recruit pet owners to enroll their dogs with brain cancer
into a study. After removing the tumor
from a dog’s brain during surgery, the doctors create a cancer vaccine using
that dog’s unique tumor cells. They inject the dog with several rounds of
vaccination and eventually the dog builds up immunity to the cancer. The dog’s
immune cells act like an army to kill the foreign invader, the brain
tumor. This vaccine is extending dogs’ lives dramatically and many dogs
become tumor-free. What the scientists are gleaning from this cancer research
helps not only man’s best friend, but also may help human brain cancer patients
facing a grim prognosis.
Q: Animal Rights Activists who oppose use
of animals in medical testing claim that various testing procedures exist, such
as in vitro cell culture testing and computer simulations, as well as expanded
use of human volunteers for micro dose drug testing, which make the use of
animals in medical research obsolete. What role does the in vivo animal model
fulfill in medical research that cannot be substituted through these other
non-animal protocols?
A: To date,
there is no comprehensive substitute for animal models in research. In certain
areas of study, like toxicology, the number of animals required has dropped
dramatically and been replaced with cell cultures, tissue cultures,
mathematical and other models. These
non-animal methodologies are often much less expensive and faster than animal
models. But for basic and biomedical research, there is a need for a whole,
living system and an animal substitute does not exist.
In order to study something with a computer model you have
to know enough about the disease to put it into a computer. There are so many diseases scientists are
still learning about, particularly diseases of the brain like Alzheimer’s
disease, Parkinson’s disease and autism.
Understanding the underlying mechanisms of the brain must be studied in
a brain. A computer model simply can't
substitute.
It would, of course, be preferable not to use animals for research study, but
simplistic claims that animal research should be obsolete ignores the
complexity of the research process. One
only has to go to a children's cancer ward or a trauma center or have a parent
with Alzheimer's disease to realize medical research has a lot of work to do to
alleviate pain and suffering, and animal models remain our best bet to discover
how to cure disease. When additional non-animal alternatives are developed,
science will naturally reduce the need and use of animal models. This
progression will only happen when viable alternatives exist and are
scientifically validated.
Q: Blum v. Holder is a federal lawsuit
challenging the Animal Enterprise Terrorism Act (AETA) as an unconstitutional
infringement on free speech. How is
NABR’s involved in this case?
A: NABR,
joined by eleven other organizations, filed an amicus brief in this lawsuit on
March 12, 2012, explaining the specific Rules of Construction in the law which
expressly exempts constitutionally-protected free speech from the AETA and urging
the U.S. District Court in the District of Massachusetts to find the AETA
constitutional. NABR filed the brief to
ensure the court is aware of the AETA’s importance to the biomedical research
community and make certain that the strongest possible defense is
presented. The brief argues the law is a
measured and important response to threats, intimidation, and economic harm
committed by animal rights extremists against research facilities and
scientists who conduct life-saving research with laboratory animals. During an
August 29, 2012 hearing on the government’s motion to dismiss the case, several
of the points raised by NABR’s brief were argued. NABR, along with many others, is awaiting the
court’s decision.