surgical procedure causes a particular amount of pain, but because this is science, we are not always doing exactly the same thing. We might be drilling a hole in the femur this week and putting in something that causes more pain than in previous experiments.
In addition, as mentioned in the HSUS April 2000 report, there is no category for procedures that cause pain and distress that were partially but not fully alleviated with drugs. Of course, pain medicine specialists will tell you that you are very seldom going to actually get rid of every single iota of pain felt post-operatively by a subject having surgery. As someone mentioned earlier this morning, a few investigators might give aspirin to their subjects and consider it to qualify as “giving analgesics”; however, these cases do not address the concern of whether pain and distress are adequately alleviated.
Another problem of up-front reporting is that it blinds people to reality: because a study is assigned to Category D, it therefore will remain in Category D. None of my colleagues in the institutions where I have worked have thought we should go back and reclassify a study after a pilot run.
We should ask whose responsibility it is to validate the category assignment. As Dr. Rowan asked, is it a lot of pain? Is it a little pain? Is it the responsibility of the IACUC, the investigator, the attending veterinarian?
With regard to study design, anyone who has been involved in research knows that it is not possible to write a protocol that is 100% accurate. You can try your best to decide what you are going to do, how you are going to do it, how you are going to treat pain, and how you are going to assess pain; but you may have to change it. Pain can last longer than predicted. Events happen. Problems happen. Sometimes a procedure takes longer than is predicted. It is less possible than predicted. Because of those things, flexibility in the way the IACUC views the investigator's protocol is an absolute necessity for optimal animal care.
HSUS also states, and others today have mentioned, the following: “Animal pain, distress, and suffering are not easy to recognize or measure unambiguously. There is considerable opportunity for legitimate disagreement among scientists.” I agree that pain, distress, and suffering are not easy to recognize. As stated in the Guide (NRC 1996), it is necessary to understand species-specific indicators of well-being. Pain and distress can be very difficult to predict and sometimes difficult to recognize; however, when we look at the animal, we are often going to find that it is necessary to revisit either the plan or the category assignment.
An example of this difference is the fact that two people can disagree. In my experience with a dog that had had a laparotomy to biopsy her liver, I worked with a gentleman who was a 20-year veterinary technician. He walked by this dog in the recovery room and said, “She looks great! ” He was referring to the fact that she was sitting up, I think. She was not screaming or making any noise, and he thought the dog was doing very well. I strongly disagreed and thought the dog was showing evidence of severe pain and/or distress. In fact, she was responsive to an additional dose of analgesic, and I saw a behavior change.