Executive Summary
Both laypersons and scientists alike are uncomfortable with animal research when it causes animals to suffer. The Humane Society of the United States has launched our Pain and Distress Campaign to work with the scientific community to eliminate significant laboratory animal suffering by the year 2020. This goal is consistent with public opinion on animal research and with laws, regulations, and guidelines governing the conduct of animal research. While eliminating significant animal suffering in the laboratory is an ambitious target, what is needed along the way is a focused, urgent effort to recognize, alleviate, and prevent such suffering, so that science can progress without causing pain and distress to animals.
Polls have begun to document the influence of animal suffering on people's views toward animal research. For example, a recent poll (Aldous, Coghlan, and Copley, 1999) found that the British public's support for research on mice or monkeys declines 16% to 35% (depending on the species and field of research) when the animals are subjected to pain, illness, or surgery (factors associated with suffering). Similarly, American psychologists' and psychology students' support of animal research declines 43% to 50% (depending on the species) when asked to compare research involving caging or confinement and research involving pain and death (Plous 1996a, 1996b). The contrast between the media's (and public's) responses to two high profile cases of research in the 1980s (Baby Fae and the University of Pennsylvania Head Trauma lab) also illustrates the importance of the perceived level of animal suffering.
Public concern for research animal suffering has led to passage of two laws regulating animal research. Both laws, the Animal Welfare Act (AWA) and the Health Research Extension Act (HREA), seek to reduce any likely pain and distress experienced by research animals. Both seek to do so primarily through the establishment of Institutional Animal Care and Use Committees (IACUCs), which review in-house research proposals and periodically assess their facility's animal care and use program. Under the AWA, IACUCs are also required to ensure that researchers have searched for alternatives if their proposed animal research is likely to cause pain and distress, even if anesthetics and analgesics are used to prevent suffering. Despite its regulatory emphasis on alleviating pain and distress, the USDA provides little explicit guidance on the topic or on the potential impact of specific experimental procedures, such as infecting animals with pathogenic organisms, on animal well being.
The USDA issues annual reports that summarize data on the number of animals of regulated species used in research, testing, and education. This information is grouped under column headings that correspond to the USDA's pain and distress categories:
Procedures involving little or no pain or distress (Column C)
Pain or distress alleviated with drugs (Column D)
Pain or distress not alleviated because pain-relieving drugs would have interfered with the research (Column E)
Nationwide, about 55% of the over one million regulated animals used in research are typically reported in Column C, 35% in Column D, and 10% in Column E. In their annual reports to the USDA, research institutions are asked to describe any Column E procedures (unalleviated pain and distress) and explain why pain relieving-drugs were withheld.
The USDA's pain classification system has been criticized on several grounds. The current categories are confusing and there is no category for procedures causing pain and distress that were partially but not fully alleviated with drugs. The categories do not adequately address the issue of levels of pain and distress (the current categories boil down to a yes/no dichotomy). There is no definition for "distress" although the USDA is now working to produce one. There is no specific guidance to institutions on how to complete the annual report forms, nor is there effective USDA oversight of institutional decisions on categorization of actual experiments. It is not surprising, then, that an HSUS analysis of the annual statistics on animal use for recent reporting years reveals enormous (and unexplained) variation from state to state in the reporting of animals used in painful procedures without the administration of pain-relieving drugs.
Several foreign countries have pain classification systems that are more straightforward and meaningful than the U.S. system. Many of these systems report levels of pain and distress as minor, moderate, or severe, or some variation thereof. Recent statistics from The Netherlands, Switzerland, and Canada indicate that approximately 30% to 45% of research animals experience significant pain and distress, whereas the comparable U.S. numbers (Column E) average only about 10%. Similarly, the Canadians report that 13% of the animals used in the category of basic research experience moderate to severe pain. By contrast, the top fifty National Institutes of Health (NIH) funded non-profit research institutions in the U.S. reported less than 1% of animals experiencing pain and distress in 1996 and 1997. These discrepancies appear to be largely the result of the shortcomings of the U.S. reporting system, rather than on differences in the alleviation of pain and distress or the lack of figures on non-regulated species in the United States (lab-bred mice and rats, as well as birds, reptiles, amphibians, and fish).
Pain and distress caused by specific research models and techniques raise serious concerns for those in the animal welfare community as well as in the scientific community. Yet good estimates of how much animal pain and/or animal distress is caused by particular techniques or methods are not yet available. The HSUS has compiled a preliminary list of research models and techniques that cause pain and distress. Analyses by the USDA and HSUS indicate that the majority of the animals reported in Column E are used in various testing procedures, with vaccine testing prominent among them. More data are needed to discriminate amongst research models and specific techniques in terms of the pain and distress they typically induce. Pain and distress may be specific to a particular research model, species, or gender and may affect the extent of suffering caused in that particular animal model. Such information is critical to informed decision-making by researchers, IACUCs, and others.
Despite the regulatory emphasis on alleviating pain and distress, The HSUS recognizes that the systematic reduction of animal pain and distress in the research laboratory is not a trivial task, for several reasons. First, there is much conceptual confusion in the use of terms such as pain, distress and suffering, and how they relate to one another. Most of the relevant literature concentrates on pain, not distress or suffering. Second, animal use in the laboratory is quite varied; refinements developed for any one specific procedure do not necessarily translate to other procedures. Third, animal pain, distress and suffering are not easy to recognize or measure unambiguously and there is considerable opportunity for legitimate disagreement among scientists. Sensitive, practical measures to gauge levels of distress in common laboratory animal species do not presently exist. For the most part, animal care staff rely on ad hoc observations or on relatively insensitive measures such as weight loss, to ascertain whether animals are experiencing pain and/or distress. Fourth, there is limited published information about animals' experience of pain, distress, and suffering caused by typical laboratory procedures. Fifth, lab personnel may develop "distancing mechanisms" that help them cope with causing harm to animals but which can also lead to people ignoring or overlooking pain or distress that, with more attention, could be alleviated or avoided altogether.
If principal investigators, lab personnel, and IACUCs do not currently have the tools to document distress objectively, or do not recognize distress caused by disease, toxic agents or psychological factors, then it is unlikely that they will take action to alleviate such distress when it occurs. It is therefore essential to promote a discussion on when distress occurs and to achieve some consensus on those procedures that cause either pain or distress. It is not beyond the scope and responsibility of the scientific community to determine underlying principles of pain and distress alleviation in animals which can then be applied to the varied models and methods.
To help encourage a more systematic approach to pain and distress management, The HSUS has launched the Pain and Distress Campaign, which seeks to eliminate all significant pain and distress in animal research by the year 2020. The campaign has four main components:
The HSUS has convened a group of experts on pain and distress to draft a comprehensive report that addresses key issues, such as the levels of pain and distress caused by common research models and techniques.
The HSUS is actively seeking the collaboration of IACUCs and the broader scientific community. Through mass mailings to IACUCs, we have begun facilitating an exchange of information and policies so that new ideas and initiatives, including "best practices" and "humane endpoints," can be disseminated quickly.
The HSUS is encouraging the USDA to adopt a new classification system that divides pain and distress into none/minor, moderate, and severe categories. Until the current USDA classification system is revised, The HSUS will seek to foster more consistency and accuracy in how pain and distress are reported.
The HSUS plans to urge both private and government entities to fund studies aimed at developing more sensitive and practical measures of animal distress and methods by which such distress can be alleviated.
As part of our efforts to raise the profile of pain and distress issues with IACUCs, The HSUS will focus on specific research areas, practices and techniques where relatively little attention has been given to animal suffering. Our aim is to seek out new approaches to recognizing, measuring, and alleviating animal distress. Also, The HSUS will encourage the NIH to issue "best practice" guidelines covering specific techniques.
The HSUS urges the USDA to adopt new pain and distress categories recommended by a committee of representatives of animal research and animal protection organizations. Until a new system is in place, The HSUS recommends a number of improvements in the current system, including providing IACUCs with clear definitions and examples of levels of suffering, pain, distress, stress, and anxiety. The HSUS also recommends that:
Funding institutions provide support for refinement research
The USDA expand regulatory coverage to birds and lab-bred mice and rats, to not only formally provide protection to these animals under the AWA, but also to gather statistics on pain and distress in these animals
The NIH issue "best practice" and "humane endpoint" guidelines to facilitate the pace of innovation in laboratory animal welfare
The public's support for animal use in biomedical research has declined in recent years. The decrease in support is even more evident when the public is questioned about the experimental use of animals involving pain and/or distress. Given the public's concern for the humane treatment of animals in research and our ethical obligation to the animals themselves, there should be greater attention provided to refining techniques, to publicizing best practices, and to eliminating animal pain and distress. The HSUS Pain and Distress Campaign seeks to encourage these developments, with the goal of eliminating all significant animal pain and distress in research by the year 2020. The HSUS commends the USDA for initiating its own analysis of pain and distress reporting, and creating a proposed set of solutions for reducing animal pain and distress in a recent unpublished report.
In the past few years, fortunately, there has been an increase in attention to pain and distress issues within science and academe. These activities will lead to improvements for both animals and the humans that rely on them. In the end, better animal welfare will lead to better science, as pain and distress are eliminated and no longer have the opportunity to confound scientific data.
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