Panel Discussion with All Speakers

DR. DELL: We have heard a great deal of information today, and I am sure that people have many questions. I invite the speakers and other people in the audience to ask questions and share additional information that would be useful.

DR. DE HAVEN: I would be remiss if I did not say that this workshop has been hugely helpful. Although you would expect me to make that statement, I genuinely believe we have heard a very broad spectrum of perspectives and ideas, and I think that you have given us much to think about. I particularly appreciate the fact that ILAR and NIH have hosted this forum. You understand that there is a law called the Federal Advisory Committee Act that would keep us from simply assembling without going through a very complicated and due process and enlisting a group of experts to help us draft a policy, a regulation, or even guidelines. However, nothing keeps anyone from making suggestions to us, and we can assure you that we will give all suggestions due consideration, whether they are coming from an individual, an organization, or an association; from industry, the animal protection community, or simply the general public at large. In spite of those limitations, we greatly appreciate these kinds of public meetings (whether we or someone else hosts them), and we certainly look forward to your comments through the advanced notice of proposed rule making, which we intend to publish.

After we publish a notice in the Federal Register and solicit your comments on that advance notice of proposed rule making, the end result could be that we will decide to do nothing, or that we will indeed decide to initiate some kind of rulemaking process. If so, we will then publish a proposed rule and provide an opportunity for comment.

Let me return to the advance notice of proposed rulemaking, which we hope to have published in the Federal Register in the next month or less. One of the



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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 Panel Discussion with All Speakers DR. DELL: We have heard a great deal of information today, and I am sure that people have many questions. I invite the speakers and other people in the audience to ask questions and share additional information that would be useful. DR. DE HAVEN: I would be remiss if I did not say that this workshop has been hugely helpful. Although you would expect me to make that statement, I genuinely believe we have heard a very broad spectrum of perspectives and ideas, and I think that you have given us much to think about. I particularly appreciate the fact that ILAR and NIH have hosted this forum. You understand that there is a law called the Federal Advisory Committee Act that would keep us from simply assembling without going through a very complicated and due process and enlisting a group of experts to help us draft a policy, a regulation, or even guidelines. However, nothing keeps anyone from making suggestions to us, and we can assure you that we will give all suggestions due consideration, whether they are coming from an individual, an organization, or an association; from industry, the animal protection community, or simply the general public at large. In spite of those limitations, we greatly appreciate these kinds of public meetings (whether we or someone else hosts them), and we certainly look forward to your comments through the advanced notice of proposed rule making, which we intend to publish. After we publish a notice in the Federal Register and solicit your comments on that advance notice of proposed rule making, the end result could be that we will decide to do nothing, or that we will indeed decide to initiate some kind of rulemaking process. If so, we will then publish a proposed rule and provide an opportunity for comment. Let me return to the advance notice of proposed rulemaking, which we hope to have published in the Federal Register in the next month or less. One of the

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 ideas we are considering and on which we would like you to comment is a proposed definition of distress. We will suggest various pain and distress categorization schemes. We would certainly like your comments on anything we include in that Federal Register notice, but at the same time, please do not feel limited in giving us your comments regarding an example we might publish. In the interim, we indeed will pursue a change to Policy 11. Because any rulemaking effort we might undertake is at best a 3-year process, I think we owe it to you and to our inspectors to establish a working definition of distress if we are going to require the same kind of considerations with distressful procedures as we have in the past with painful ones. Such an interim policy could be changed through a regulatory effort to become a much more enforceable definition or one that would carry more weight than a policy. Of course, one of the benefits of the definition or anything we put into policy is that it is much easier to change. MS. LISS (Cathy Liss, Animal Welfare Institute): I have a question regarding remarks made by Dr. Harkness, who I believe has left. He mentioned a protocol that was put before an IACUC that called for two major operative procedures for cats. I wondered how that situation was resolved. First, my hat is off to the IACUC for having done the right thing in admonishing the researcher about having two major procedures. Apparently they discussed it extensively and resolved it to prevent a recurrence. Second, Dr. Harkness mentioned that NIH had provided funding in the meantime, so, I am wondering where it went from there. DR. GARNETT (Nelson Garnett, Office of Laboratory Animal Welfare, NIH): That description shocked me as much as everyone else. Under NIH grants review policy, it is actually not allowed for the study section even to review the application without evidence of protocol review. That situation may very well be the subject of an investigation. DR. NEWCOMER (Christian Newcomer, University of North Carolina): At the University of North Carolina, we have a large number of hemophilic dogs and pigs. We currently do not record these animals in Category E although, of course, we do think that when they have bleeding episodes (which are frequent in those animals), they do experience distress despite the fact that they are given analgesics in response to visibly painful conditions, joint bleeds, and so forth. If you do revise Policy 11 with an acceptable definition of distress, it is very likely that these animals would clearly fit that definition of distress, and there still would be no place to record those animals on the annual report other than in Category C and/or E depending on their particular situation. This then is an example of where, despite what you do for the animal, you recognize that the animal has distress when you have finished administering therapies. It appears that there is no appropriate place to include that information in the form. Furthermore, it appears that it would require only a brief explanation because bleeding is intrinsic to their disease. I am interested to hear how you think that kind of event would be properly recorded in the future and in the present.

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 DR. DE HAVEN: You may be making a good case, Dr. Newcomer, for a reason we need to modify the existing categories because these animals do appear to fit currently in Column E. More importantly, and I think you and others have made the point throughout the day, that many people (not the least of whom is our inspector) must exercise good, professional judgment. Whether we like it or not, the role of the inspector is to monitor the exercise of professional judgment at the institution (whether by the IACUC, the investigator or indeed by the attending veterinarian) and clearly to give the benefit of the doubt to the institution unless it is clearly departing from established policy and then indeed, as distasteful as it may be, correct the institution. That correction may be in the form of nothing more than a discussion at the time of the inspection; it may generate some correspondence after the inspection; it could in fact be a citation on the inspection report depending on the situation. I would hesitate to make policy on hemophilic drugs in pigs from this podium without knowing all of the facts and so I will not do so. Nevertheless, it is critical to compose a definition of distress, and then we would hope that at your institution and everyone else 's there would be good use of professional judgment regarding which category is selected among the categories we have in place at the time. DR. DELL: I would like to follow up on Dr. Newcomer's question. We heard from Dr. Rich, who is just one of many who have recently shared information with ILAR as we try to project the future, changing use of animals and identify the resulting cost implications. We have heard from a great number of people that because of our ability to manipulate the mouse genome, we will actually be able to actually create real models of real human disease and then try to understand the complex molecular events, identify some point where one could develop a small molecule that would interrupt the pathway, and ultimately develop a drug that could be used in humans to treat disease. Particularly in mice, it is anticipated that there will be a huge number of human disease models, many of which will be associated with episodes or continuous pain. For example, arthritis has a painful component to it. In the hemophilia model, the animals are fine most of the time. They have trouble only during acute episodes. How do you try to categorize or deal with models like that? DR. DE HAVEN: I would ask the same question. The whole area of transgenics, as Dr. Rich has indicated, will change the norm in the next 20 (or probably fewer) years. I think we are just beginning to deal with those issues, and perhaps we need to set aside a whole separate process to look at the area of transgenics. In the meantime, I think we are starting to deal with it when we talk about distress for example. Distress would include such things as induced disease processes that cause the animal to suffer the consequences, feel uncomfortable, feel discomfort, or whatever condition it might be. Whether a disease process is induced because of genetic manipulation or because of infecting an animal with an infectious agent, I think we should ultimately question the effect

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 on the animal—not so much the process, again as Dr. Rich said, but the end result, the outcome for the animal. If the animal experiences pain and/or distress, then it needs to be put into the appropriate category, whatever category we have in place at the time. DR. HAMPSHIRE (Victoria Hampshire, Advanced Veterinary Applications): Many people who breed transgenics actually breed heterozygotes so that the heterozygote is not typically sick; they cross two heterozygotes. There are ways of managing transgenic populations to offset or mitigate distress, although people without previous experience in managing distress would benefit from the exemplars Dr. Rich described. You could perhaps require a pilot of a small number of breeding pairs, with the retrospective classification back from the IACUC, to focus more on the wording. Careful wording will provide both the efficiency the scientist wants and the answers the IACUC wants. Then you are reporting much more accurately. DR. RICH: Basically, I do not disagree with what you are saying, although I would point out that the majority of diseases likely to be created will be created not by transgenic manipulation but instead by gene knockout manipulation. In most cases, heterozygotes will not have the phenotype because most of the diseases will be complex, just as most diseases we see are not autosomatognotic. Most will be complex diseases involving multiple interactions between genes and often requiring double hits. The issue is really very complicated. The best thing we can do in terms of reducing animals in the process of the extraordinarily expensive as well as lengthy process of breeding transgenic and knockout animals is to encourage the development of embryo freezing so that we can maintain the lowest possible number of necessary colonies. We grow up the animals as we are ready to study them, as opposed to breeding up large numbers of animals and not being able to study them in a timely way. Whenever we develop substantial transgenic and knockout facilities, we should also develop embryo freezing programs. MS. WOLFE (Lisa Wolfe, People for the Ethical Treatment of Animals): To seek knowledge, to cure, and to prevent disease is noble; but to seek knowledge at any cost is not. To seek knowledge by experimenting on animals or any other involuntary participant is to do so at great cost. That cost is the dulling of our society's values of nonviolence, justice, compassion, and empathy. No one has the right to exploit another being for one's own benefit without his or her consent. If our goal is truly to minimize pain and distress in animals used in experiments, the most effective way, and indeed the only way, is to recognize that we do not have the right to use them. DR. BENNETT (Taylor Bennett, University of Illinois at Chicago): This has been a very informative day. We have been discussing a very important issue, which I believe calls for a more formal regulatory process, which publicizes the issues. Through that process, people have the chance to think through and discuss

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DEFINITION OF PAIN AND DISTRESS AND REPORTING REQUIREMENTS FOR LABORATORY ANIMALS: PROCEEDINGS OF THE WORKSHOP HELD JUNE 22, 2000 the issues and then end up with something that most of us can accept. I think that what we have done here today is very important; however, I think we need more time and advance notice to consider and respond to this and other new policies in the future. More input from a group such as our laboratory animal community will result in more “buy-in ” when policies are in place.

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