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