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.