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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 A View from the Trenches B. Taylor Bennett University of Illinois, Chicago, Ill. I have divided my remarks into four sections. First I would like to let you know who I am and what I believe qualifies me to be here making these remarks. Next I will explain how it is that I came to be standing here today. I will then explain why I cannot support efforts to introduce new language to the current definition of pain, the addition of a definition for distress, or changes in the current annual reporting process by revising the current Animal Welfare Policies. I will close by telling you why I think that any expenditure of fiscal or human resources to develop new paper definitions is not the best use of those resources. WHO I AM I have spent more than 30 years as a laboratory animal veterinarian in a large academic institution. The program of laboratory animal care that I have directed for the past 22 of those years is a program in change. It has always been a program in change. The changes have and continue to be directed toward the constant improvement of the program to assure that the animals in our charge receive daily care that meets or exceeds the recommendations of the Guide for the Care and Use of Laboratory Animal (NRC 1996), while at the same time providing the investigators in our institution with a working environment that supports their efforts to conduct high quality research. I provide this background information to point out that even as a somewhat senior member of our specialty, I have not become so set in my ways that I routinely oppose change. I actually seek it and encourage change that will add to our knowledge base and improve the quality of care that laboratory animals receive.
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 HOW I GOT HERE I am here as a representative of the American College of Laboratory Animal Medicine (ACLAM). The key phrase here is “as a representative. ” I am neither an elected officer nor a current member of the board, so I do not represent the leadership or membership of ACLAM. I am completing a 4-year term as one of the original members of the ACLAM Foundation. The Foundation's goal is to increase the body of knowledge in laboratory animal medicine and science by raising money to support research that accomplishes this goal. I also currently serve as ACLAM 's nominee on the 1999 American Veterinary Medical Association's Panel on Euthanasia, and I previously served on the 1993 Panel. It is because of my current involvement on this panel that Dr. Margaret Landi, ACLAM President, called and asked if I could attend this meeting in her absence. WHY I CANNOT SUPPORT CHANGES IN THE EXISTING POLICY The USDA Animal Care Policies are in reality de facto regulations. They are interpretive rules that, although not legally binding, leave us only a challenge in court if we do not agree. There is no mandated public comment period with a subsequent response to those comments as part of publishing the Final Rule. As such, the regulated community, the scientific community, has no mandated opportunity to provide their input or to learn how their input was considered in developing the Final Rule. The policies in effect regulate a scientific activity, without having had the mandated participation of the regulated community in their development. Any changes to existing definitions, addition of new definitions, and revisions to the annual reporting process should take place as changes to the Regulations with publication in the Federal Register, a mandated public comment period, and publication of the Final Rule with USDA commenting on why it accepted or rejected those comments. Why would I ask for more regulations? I am not asking for more regulations, I am asking for a process that gives the scientific community a full opportunity to address the available scientific information on pain and distress and its application in clinical practice. I believe that available scientific information strongly speaks for not adding additional language to the regulations/policies, and I believe that a formal public comment period will make this fact abundantly clear. Pain and distress are responses to environmental and internal events that affect the well-being of those that experience them. Adequate definitions/ explanations can be found in the literature. Such definitions should be incorporated into the policy and procedure documents of every IACUC in the country. They do not need to be redefined in regulations and policies. Pain and distress are medical problems that first require detection, then determination of a cause (the diagnosis), and then alleviation (the treatment). Pain and distress are medical care issues that must be dealt with on a case-by-case
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 basis by a veterinary staff that must apply its didactic and experiential knowledge in managing them. These issues are fundamental to the success and credibility of any program of adequate veterinary care. In my opinion, one of the most important sections of the Animal Welfare regulations is Section 2.33, Attending Veterinarian and Adequate Veterinary Care. This section in part states, “Each research facility shall assure that the attending veterinarian has the appropriate authority to ensure the provision of adequate veterinary care and to oversee the adequacy of the other aspects of the animal care and use.” The institution must make available appropriate facilities, personnel, equipment and services to allow the veterinary staff to use appropriate methods to prevent, control, diagnose and treat diseases/medical conditions. An integral part of this program is providing guidance to principal investigators about issues that have an impact on the well-being of animals being used in research. We all know individuals we turn to for guidance and direction. Why do we rely on these individuals for guidance? It is really quiet simple. We respect them because they have established their credibility with us, and we recognize their professional competency. The key to the success of a program of adequate veterinary care is the mutual respect of the veterinary staff and the investigators, which leads to a confidence level that makes providing guidance the underpinning of the program of adequate veterinary care. The key to the success of a laboratory animal veterinarian in an academic environment is earning the confidence of research colleagues, and we do this by using scientifically sound approaches in dealing with issues involving the use of animals on a given protocol. Our colleagues are accustomed to searching for answers that can be supported and defended with scientific data. With this approach, the necessity of having to implement USDA regulations and policies that are inconsistent with available scientific information compromises our ability to do our job. Because I am already on record concerning how the existing language in Policy 11 undermines the ability of laboratory animal veterinarians to do their job, by forcing us to implement policy that makes neither scientific nor common sense, let me give you an example of why I fear additional changes in the language. Included in the information that I was sent a couple of weeks before this meeting was a 1995 draft of a HSUS document entitled, “AWA Classification of Pain and Distress in Animal Research: A Proposal.” That document includes a reference to Veterinary Service Memorandum 585.2, which provides guidance on pain and distress to area veterinarians in charge. In that memorandum, chronic pain is defined as follows: “Chronic pain results from a long-standing physical disorder or emotional distress that is usually slow in onset and has a long duration. It is seldom alleviated by analgesics but frequently responds to tranquilizers. . . .” The service memorandum proceeds to define anesthesia as “complete unconsciousness.” It is these types of definitions that must be aired in
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 a mandated public forum, before they establish the regulatory environment within which we laboratory animal veterinarians must operate. In reading that draft document, it brought back memories of preparing written comments on the proposed regulations to implement the amendments to the Animal Welfare Act. At that time the USDA proposed language on painful procedures that they did not adopt after the public comment period. To try to adopt a similar system at this time without changing the regulations makes no sense. It has been almost 15 years since this issue was first addressed. Why address it again, and why try to do so by changing a policy? Have things not changed in the last 15 years? Has the well-being of laboratory animals not improved in the past 15 years? Has the number of trained laboratory animal specialists who can provide adequate veterinary care not grown dramatically? Lastly, has not the investigative community not changed in the last 15 years? Yes, Yes, Yes, and, most emphatically, YES! Let us look at that emphatic YES. Today's laboratory animal veterinarians deal with a population of investigators who more and more are made up of scientists who were trained and built their scientific careers since the 1985 amendments. They accept the role of the IACUC. They accept the role of the veterinary staff in providing guidance. Most importantly, they accept the fact that the well-being of the research animals that they use is critical to the success of their research. At a time of tremendous advances in biomedical research, unprecedented growth in the federal research budget, and tremendous competition for those dollars, the new generation of investigators does not just accept the need for quality animal and veterinary care programs, they demand it. They do not need to be reminded, by the development of regulatory definitions for pain and distress and increasing the record-keeping required to complete the annual report, that pain and distress should be minimized. It is a scientific necessity. Minimizing pain and distress is a way of life in designing and implementing research protocols, a process that involves the collaboration of the veterinary staff and the investigators in an environment that relies on the latest scientific knowledge and technology. Cutting-edge science requires cutting-edge support programs and facilities. One of the things that makes laboratory animal medicine an exciting profession is the science that we help advance. So any definitions that affect how we
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 function should be based on scientific data and be clinically relevant. Incorporating ever-changing scientific information into the regulatory process is no small task because the regulatory process is by design slow to get from point A to B, and scientific information is changing daily. The regulatory process is slow because of the many steps required to change regulations in our democratic society that protect the regulated community from counterproductive regulations. Developing new regulations to define pain and distress would be counterproductive at this time. It would slow the progress that our new generation of laboratory animal veterinarians and investigators are making in recognizing and managing pain and distress. Rather than spend our time trying to implement expanding regulations in this area, let us spend our time developing techniques and methodology that minimize pain and distress. Let us not waste our time discussing how to define pain and distress on paper. Let us spend our time defining what pain and distress is and how to manage and alleviate it. Contrary to the good intentions of those who want to eliminate pain and distress from the lives of laboratory animals, laboratory animals must live in the real world, where there is no hope of eliminating pain and distress in our lives, although through research we can certainly find more and better ways to minimize it and its impact on our well-being. This knowledge will certainly lead to even more dramatic changes in the way we laboratory animal veterinarians can manage pain and distress. The progress made in laboratory animal medicine in the last 15 years has been significant. Let us all work together to continue that progress and not waste our time developing new regulations that not only will not accelerate this progress but may also serve to slow it down. The thing that will increase this progress is more research, which brings me to my final point. But before I move on, let me remind you again that I do not routinely object to change. In fact, as I said, I usually encourage change. So if change is needed to address the issue of minimizing pain and distress, let us amend the Animal Welfare Act. Specifically I would propose an amendment to Section 13(a), (3), (C) to change its current wording, “in any practice which could cause pain to animals,” to read, “in any practice which could cause pain and distress to animals,” and add: “(i) that a doctor of veterinary medicine is consulted in the planning of such procedures.” This language would make it clear that pain and distress are medical conditions that should be dealt with by medical professionals. This language would clearly show the public that Congress recognizes the importance of providing adequate veterinary care and has mandated an expansion of the programs of adequate veterinary care to address the issue of distress. WASTING OUR FISCAL AND HUMAN RESOURCES On Sunday, June 11th, I had to carefully manage my time, because I had to organize my thoughts for this meeting and review the information I had received
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 for the scheduled conference call of the ACLAM Foundation to discuss our reviews of 18 proposals that were seeking funding at the level of $15,000 each to address key questions in laboratory animal science and medicine. Of these 18 proposals, 11 clearly addressed questions related to defining and/or managing pain and distress in laboratory animals. In fact, 15 of the proposals addressed issues of refinement and reduction, and the other three addressed issues related to the safety of the work environment. Just look at all of us here today. How many people had to travel to come to this meeting? How many spent at least $500 getting here? More than a $1,000? How many of you would ask for more than $10.00 an hour if you were applying for a new job? $20, $30, $40, $50? Obviously, there is enough money being spent now by our respective organizations to support an ACLAM Foundation grant. We could fund only seven this year. What if we could double that number, afford to give bigger amounts, be able to support multiyear grants? The number of questions that could be asked to find the answers to better define pain and distress for real, not just on paper, could be dramatically increased. The ACLAM board has supported the foundation by committing more than 12% of its operating budget. The membership has provided and is committed to providing hundreds of thousands of their personal dollars to support research to improve animal well-being. Instead of spending our time and resources developing and debating paper definitions, let us make a commitment to support the research that produces information to make it possible for the laboratory animal community to better recognize, manage, and alleviate pain and distress. To persist in this debate in lieu of really “putting our money where our mouths are” is, in my opinion, counter-productive and shows little real commitment to improving the well-being of animals that must be used in research. So, in summary, I stand before you, somewhat reluctantly, as a member of ACLAM. I have been an active participant in laboratory animal medicine for more than 30 years. During that time, I have seen and hopefully participated in many changes that have improved the well-being of laboratory animals by improving the knowledge base of those who care for and use laboratory animals. Today we operate in an environment in which the majority of the care of laboratory animals takes place in programs managed by trained laboratory animal veterinarians working in concert with a new generation of investigators. Together we work on the common goal of reducing pain and distress in laboratory animals because it is the right thing to do and it improves the quality of science. In this environment, we do not need more regulations, we need more information; and I challenge the regulatory, animal welfare, and scientific communities to support research that provides the information that will ultimately lead to our ability to realistically address the issue of pain and distress.
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 REFERENCE NRC [National Research Council]. 1996. Guide for the Care and Use of Laboratory Animals. 7th ed. Washington, D.C.: National Academy Press. QUESTIONS AND ANSWERS DR. DELL (Ralph Dell, Institute for Laboratory Animal Research): Let me begin with a question related to your statement that we are working hard to manage pain and distress in laboratory animals because we are good people and because it results in good science. There are critics who concede that most of you are good people but that a few are not. How are we going to identify the latter group unless we have some sort of an inspection system? DR. BENNETT: I do not have a problem with an inspection system. I have a problem with trying to define basically through the regulatory process what is scientific and needs to be defined by the scientists and change as the science changes. That ability to accommodate change is very difficult to do with regulations. I do not think that one has to change regulations every time we find a negative situation. We simply find better ways in our institutions to deal with those instances. I believe the vast majority of people with whom we work have one common goal, which is to minimize pain and distress. Even if we were not saying that we are good people, it is better science. Practicing scientists cannot afford to waste money creating unnecessary pain and distress in animals. They are under tremendous pressure to produce and they cannot afford to lose animals due to improper management. DR. DE HAVEN (Ron DeHaven, USDA): I appreciate the fact that we get the full spectrum of positions at these public forums. I would therefore like to clarify two points. First, I heard you say that VS Memorandum 595 dates back to 1995; however, it actually goes back to 1985. That memorandum is from the prior organization. DR. BENNETT: I certainly agree. DR. DE HAVEN: The other, more important clarification relates to two initiatives that are under way, one of which involves a potential change to the policy and the other a potential change to the regulation. I think we have been remiss in the past in terms of all of the requirements for minimizing pain that did not include minimizing distress. I think that omission is clear in the act and in the regulation. Any update to Policy 11 will be primarily to include distress and to clarify what kinds of things constitute distress and therefore what kinds of activities would require consideration of alternatives to distressful procedures since the current policy and our practices in the past have focused on pain. As you point out, the change to the policy is the one interpretive rule. Any change to the pain or pain and distress categorization would indeed require a rulemaking change. Any inclusion of a definition of distress in the
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 regulation would require a rule change. It is either a two- or a three-step process for the rule change, which requires, at a minimum, publication of a proposed rule, public comment period, review of those comments, and publication of a final rule. In this case, we will start with a three-step process but include in the beginning an advanced notice of proposed rulemaking and request for comments. The next step, if we decide to proceed, would be a proposed rule. There will, indeed, be ample opportunity for the scientific community and all interested parties to have some input into that process. DR. BENNETT: I believe it is important to note that unless a rule appears as a formal regulatory change, we do not get as much of the scientific community involved in the comment period because they expect these to be adopted ultimately. I formed that impression when I worked with organizations to write responses that appeared in the Federal Register. DR. HAMPSHIRE (Victoria Hampshire, Advanced Veterinary Applications): Are you in fact supporting a revision to the regulation and/or the definition of an attending veterinarian? DR. BENNETT: No. I am saying that the role of the veterinary staff would be strengthened in terms of the issue of distress if it were clearly pointed out that investigators should consult with a veterinarian when a proposal will have the potential for creating not only pain, but also distress. The law does not state that now. It only refers to pain. DR. GEBHART (Gerald Gebhart, University of Iowa): I want to remind people that the way we have been talking about pain and distress seems to suggest that they go hand in hand. However, pain does not inevitably lead to distress; and pain, as Dr. Rowan said, is not a major concern in many respects because it may be addressed with the appropriate use of analgesics. By establishing a category that includes both pain and distress (Category 1, 2, and so forth), even if there were some pain but no distress present, or if only distress were present, an investigator's rating would imply that both conditions were indeed present. I believe we need to be careful about associating those two conditions as always being related because they are not necessarily so. DR. BENNETT: One of the points made previously that I found interesting was that these reports are different from retrospective reports. I cannot imagine that any institution could complete that report without some type of retrospective reporting process that involves looking at the animals and evaluating these things. DR. HAYWOOD (J. R. Haywood, San Antonio): We have discussed these reports as documents that actually provide us with information. However, maybe we should think about why we are actually filling out these reports. What function do these reports truly serve to help the animals? MS. LISS (Cathy Liss, Animal Welfare Institute): I am delighted with what appears to be current support for the 85 amendments to the animal law and actually a cry for a bit of strengthening of those 85 amendments. I am delighted to
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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 hear that coming from you, Dr. Bennett, and that support does appear to be a change. DR. BENNETT: My position has not changed, Ms. Liss. I have always supported reasoned and well-founded regulations. MS. LISS: Finally, you talked about the expense of people coming here and being involved in this kind of process. All I can point to is at countless AALAS annual meetings where there are extensive receptions in which all researchers are eating, drinking, and having a good time. Perhaps those monies could be applied to enriching the lives of animals in laboratories. I would also like to commend USDA for all of the input they are incorporating into changes in their policies. As you have pointed out, former veterinary memoranda and policies were very secret and difficult to obtain, and there was typically no outside input. There has been a significant change, and my hat is off to USDA for a very open process, for accepting this input, and for allowing time for that scientific input. DR. GLUCK (John Gluck, the Kennedy Institute of Ethics): It seems to me that you were arguing earlier that economic factors in research, the competition inherent in good science, and the virtues of the investigators are adequate motivators to ensure proper concern or treatment of animals. DR. BENNETT: I am describing the real world. I am arguing that instead of motivating them, those factors comprise part of reality, and that part of reality makes our job as laboratory animal veterinarians sometimes a lot easier to do. DR. GLUCK: I still think you are saying that these factors influence good conduct on the part of investigators. I am saying that these things have been in place before now. DR. BENNETT: I think the things that influence the conduct of the investigators with whom we work today are different from when I first got involved in this field. People then had been brought up in a different era. Sensitivities toward the issues of animal pain and distress today are totally different than they were 15 or 20 years ago. DR. GLUCK: I am simply saying that these factors have always been in place. It has been the addition of public interest and regulations that I think has helped move that motivation. DR. BENNETT: I am not denying that premise. One of the results of public regulation was to require institutions to provide us, the laboratory animal veterinarians, with the resources we need to do our job.
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