The History and Histrionics of Pain and Distress in Laboratory Animals

Christian E. Newcomer

Director, Division of Laboratory Animal Medicine

Professor, University of North Carolina, Chapel Hill, N.C.

I am pleased to have the opportunity to speak today. I would like to thank ILAR, for sponsoring this program, and my specialty group, the American College of Laboratory Animal Medicine, for asking me to represent some of the thinking of its constituency.

HISTORICAL PERSPECTIVE

I was concerned that there would be little left to say at the end of a day awash with the data, opinion, and histrionics that often accompany this subject. Rather than looking at the present or into the future, I thought I would begin by looking to our past in an effort to frame our progress in an historical perspective since the passage of the Animal Welfare Act (AWA) in 1966.

Congressional Remarks

I referred to the original congressional testimony on the AWA in an attempt to understand the intent of Congress regarding the alleviation of pain and distress and how these remarks translated into statutory law, regulations, and, later, policy implementation. Most of this testimony was rather uninformative and bland; however, the remarks of Congressman Claude Pepper (1965) were truly prescient. He suggested that we establish an office of Laboratory Animal Welfare in the Department of Health, Education, and Welfare; inspect and license facilities; create a process to ensure that investigators are qualified to do their work; and restrict all surgeries done for the purpose of student surgical training to terminal



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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 The History and Histrionics of Pain and Distress in Laboratory Animals Christian E. Newcomer Director, Division of Laboratory Animal Medicine Professor, University of North Carolina, Chapel Hill, N.C. I am pleased to have the opportunity to speak today. I would like to thank ILAR, for sponsoring this program, and my specialty group, the American College of Laboratory Animal Medicine, for asking me to represent some of the thinking of its constituency. HISTORICAL PERSPECTIVE I was concerned that there would be little left to say at the end of a day awash with the data, opinion, and histrionics that often accompany this subject. Rather than looking at the present or into the future, I thought I would begin by looking to our past in an effort to frame our progress in an historical perspective since the passage of the Animal Welfare Act (AWA) in 1966. Congressional Remarks I referred to the original congressional testimony on the AWA in an attempt to understand the intent of Congress regarding the alleviation of pain and distress and how these remarks translated into statutory law, regulations, and, later, policy implementation. Most of this testimony was rather uninformative and bland; however, the remarks of Congressman Claude Pepper (1965) were truly prescient. He suggested that we establish an office of Laboratory Animal Welfare in the Department of Health, Education, and Welfare; inspect and license facilities; create a process to ensure that investigators are qualified to do their work; and restrict all surgeries done for the purpose of student surgical training to terminal

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 procedures. He stressed the importance of appropriate anesthesia, pain relief, and postoperative care. “Three Rs” Remarkably, the congressman discussed the “Three Rs” in his remarks. He talked about refinement and statistical analysis as a method of eliminating excessive animal use. Furthermore, he expressed the belief that institutions should provide references to research publications as part of their reporting requirement, hinting at responsibility of the scientists to demonstrate publicly the prudence and productivity of their animal research efforts. Pepper was a visionary (and/or had extraordinary staffers), and most of his ideas were adopted 20 or more years later. Is this 20-year delay evidence for the effective stonewalling of sound regulatory advances by the scientific community as the animal protection/rights organizations have claimed? Or, alternatively, should we continue to be concerned that the advocacy for animal welfare in research has been translated into an advocacy for excessive, runaway regulation as claimed by the scientific community? The chasm between these perspectives has a pragmatic as well as a philosophical dimension: How much effort should we invest in bridging the gap between these perspectives; Does or should a cost benefit analysis prevail here as it does in virtually all other policy-making decisions; and most importantly, Have we really accomplished anything to benefit the animals? These points aside for now, Pepper and the Congress were clear in one issue: Some pain and distress may be justified and necessary. To quote Pepper, “If it is avoidable in the interest in promoting the health and protecting the lives and prolonging the lives of human beings, I am not here to oppose that.” Attention to Language Congress was also careful in wording the 1966 AWA. Note their selection of the word “afflict” as opposed to the word “affect,” with a more neutral connotation in the following statement: “The use of animals is instrumental . . . for diseases which afflict both humans and animals.” According to Webster's dictionary, “afflict” means to distress with mental or bodily pain and to trouble greatly or grievously. Thus, Congress too has openly registered its assent that some level of pain and distress may be necessary. Later language in the AWA importunes us to “minimize pain and distress in animals” but not eradicate it. I believe these nuances in language are especially important because they are a directive from Congress to the USDA-Animal Care that a cost benefit analysis in the hands of

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 reasonable people should prevail and that USDA-Animal Care should not attempt to embrace pure fantasy—the hyperbolic HSUS 2020 Initiative —through the development of further regulations. Acknowledged Contributions of IACUCs In the span of the last 20 to 30 years, the vast reduction in endemic infectious diseases in laboratory animal colonies across the United States has probably already eliminated 90 to 95% of the total pain and distress potentially experienced by ALL laboratory animals used in biomedical research. Although this process was perhaps accelerated by the advent of IACUCs in programs in which this kind of communal engagement was necessary, it was already moving forward under veterinary guidance before the 1985 AWA amendments. The research community has received few accolades for this astonishing effort. Through the IACUC in collaboration with institutional veterinarians, we now have a structure and mechanism to tackle the remaining 5 to 10% of thorny pain and distress issues and to make sound decisions about the level of attention and intervention appropriate for problem areas on a case-by-case basis. ANTICIPATED CHANGES Multidimensional Impact Even without AWA regulation or policy change, we have extended our stewardship to the laboratory rat and mouse used in research by conforming to the principles of humane care and “good science.” It is clear from the Animal Care Strategic Plan 2000 that the USDA-Animal Care anticipates expanding its authority in this area. This expansion could have a significant impact on the record-keeping requirements, on other dimensions of rodent care in research facilities, and on the cost of doing animal research (particularly where animal pain and distress may be involved). These potential effects give us reason to stress the need for caution and thoughtfulness in any revision of the USDA pain and distress categories or in the regulatory definition of the term “distress. ” In my view, the UDSA-Animal Care should rely on the NRC's Recognition and Alleviation of Pain and Distress in Laboratory Animals (NRC 1992) to define the term “distress” without being unduly prescriptive or trivial, and the autonomy and integrity of IACUC-scientist interactions should be preserved at the institutional level as indicated in the current AWA regulations. Inclusion of Rodents There are a number of other action verbs used in USDA-Animal Care Strategic Plan 2000, which indicates an aggressive agenda in the current year. I want to

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 comment on a couple of these. One initiative involves enhancing the statutory and regulatory authority of Animal Care, presumably in reference to the inclusion of rodents in the regulations. In addition, the addition of a definition for “distress” may warrant USDA-Animal Care to identify funding for studies on distress in laboratory animals through statutory law and congressional appropriations so that scientists, IACUCs, and USDA regulators can interact on the basis of facts and not futile opinion. Pursuit of Excellence Another Animal Care initiative involves encouraging excellence in animal care instead of (as traditionally) encouraging compliance. While this approach is superficially appealing, its ultimate impact depends on the criteria used to define excellence and whether it imposes a larger regulatory bureaucracy on everyone to assist a few floundering organizations that fail to function at a high level without external prompting. One final point in the Animal Care Strategic Plan 2000 expresses the USDA's intention to “empower, support and develop employees. ” Although the concept of this intention is noble, I believe the appropriate order of events should be first to develop, then to support, and finally to empower employees. Empowered renegade employees can be a problem in any organization, but the lasting ramifications for careers of those regulated, institutional integrity, and cynicism toward regulations and regulators brings added importance to rigorous criteria for employee development in this arena. In my opinion, these criteria should be developed by expert panels that involve ACLAM boardcertified veterinarians, other veterinary specialty groups, scientists with diverse expertise, and others who represent the regulated entities and the public. RECOMMENDED ALTERNATIVE LANGUAGE Finally, I want to offer some alternative language to improve the categorization of pain and distress in the annual reports filed by institutions concerning their use of laboratory animals. Let me preface these remarks by saying that improved categorization, per se, will contribute little or nothing to ameliorate the pain and distress experienced by laboratory animals used in scientific studies. Veterinarians and IACUCs already perform this function commendably. Categories C and D In my view, the language for USDA categories “C” and “D,” as they are described in the USDA instructions, is adequate; and I will make the assumption that you are all familiar with that language or know where to find it. No one today has broached a sensitive subject that has been talked about ever since the act was revised in 1985-1986 —the pain category designation for animals used in

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 terminal studies. It is my belief that those animals should be in USDA Category “C” if they are anesthetized according to acceptable veterinary standards. They should not be in Category “D.” If you look back at the language of the AWA, the importance of adequate veterinary care is obvious. Congress trusted that veterinarians would provide the proper care in the mid-1960s, and that trust was extended to veterinarians and IACUCs in the 1985 AWA amendments. Congress expects that veterinarians in research will meet the standards of contemporary veterinary practice. I believe the American public widely maintains that their animals do not suffer or experience pain during the process if they die under anesthesia in the care of a veterinarian. It may have been an anesthetic or a surgical accident, grievous for both the client and the veterinarian; but it would not usually raise the specter of animal pain, distress, or suffering. I therefore believe that if an animal is anesthetized using a method that meets veterinary standards and the approval of the IACUC then this subject should not be recorded in USDA Category “D.” Category E I propose that the reporting language could be improved by splitting Category “E.” The HSUS literature appropriately alludes to the problem in Category “E” in its discussion. Animals are sometimes denied analgesics, anesthetics, and tranquilizers, not because it would affect the science, but because those substances are not clearly clinically indicated in the treatment of the kind of pain or distress that animals would suffer under those kinds of conditions. Such an example might be an animal used in an infectious disease study involving malaise, mild abdominal cramping, low-grade fever, diarrhea, and dehydration. How many and what kinds of drugs would be necessary to relieve that constellation of symptoms, and would this treatment be completely successful? It is very possible that no appropriate drugs would fall into the drug categories specified under Column “E”: anesthetics, analgesics, or tranquilizers. My solution to the language problem is minimalistic and simple: split USDA Category “E” into two categories, “E1” and “E2,” and retain the original language for “E1.” For Category E2, fashion some language to express our need to include other types of vague pain, distress, and suffering, which are poorly characterized and for which the anesthetics, analgesics, sedatives, and tranquilizers may not be deemed appropriate. I offer the following language for the new Category “E2”: “Provide the common names and approximate numbers of animals used in applications that resulted in significant pain or distress but for which palliative efforts either were not undertaken or were deemed ineffective in the opinion of the IACUC and the attending veterinarian due to the type of pain or distress syndrome involved and the current status of applicable pharmacological and non-pharmacological therapeutic options.” The language recommendations above represent my attempt to create a

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 catchall, to put the discrimination for inclusion in this catchall with the IACUC and the attending veterinarian, where it truly belongs. I do not believe that an exhaustive revision of the current reporting requirement coupled with annual USDA-Animal Care inspections and protocol reviews will improve the ability of institutions to conduct science under humane conditions. Congress stood behind the IACUC in its statutory language, which reflects their belief that institutions are competent to proceed the right way. I believe the good faith principle should be extended to IACUCs and veterinarians because evidence exists that we have performed very well and have made significant progress. CONCLUSION I have always believed that complicated policy matters are best informed by the simplest and clearest expression of principle. I want to leave you with a guiding principle that is taken from The Little Prince, by Antoine de Saint-Exupéry (1943) during an exchange between the Little Prince and the king: “If I order the general to fly from one flower to another like a butterfly, or to write a tragic drama, or to change himself into a seabird, and if the general did not carry out the order that he had received, which one of us would be in the wrong,” the king demanded, “the general or myself?” “You,” said the little prince firmly. “Exactly. One must require from each one the duty which one can perform, ” the king went on. “Accepted authority rests first of all on reason.” (p. 38) REFERENCES de Saint-Exupéry A. 1943. The Little Prince. San Diego: Harcourt Brace. NRC [National Research Council]. 1992. Recognition and Alleviation of Pain and Distress in Laboratory Animals . Washington, D.C.: National Academy Press. Pepper C. Congressional Committee Report, September 30, 1965. Washington, D.C.: GPO.