Tuesday, June 12, 2007

Unalleviated Pain or Distress (Introduction)

The Animal Welfare Act (AWA, frequently referred to as the Act) is enforced by Animal Care (AC) [and here], a division of the Animal and Plant Health Inspection Service (APHIS), a unit of the United States Department of Agriculture (USDA).

APHIS is required (and frequently meets its requirement) to inspect annually most U.S. laboratories using species of animals covered by the Act to ascertain whether they are operating in compliance with the Act. (The inspections are superficial; the frequently noted instances of non-compliance have little impact on a lab’s practices; but that’s another essay.) Invertebrates, fish, and purpose bred mice and rats (accounting for the overwhelming majority of animals used) and birds (except wild-captured birds) are exempt from the Act’s oversight and regulation. Federal facilities are exempt.

One of the forms sometimes appended to an APHIS inspector’s inspection report is APHIS Form 7023, a document prepared by the lab that lists the number of each species used over the past year. It categorizes the animals by the pain or distress they were likely to experience and whether or not they received drugs to alleviate their pain or distress. (Lab animal journals frequently publish articles about the difficulty in perceiving and judging pain and distress in animals (here, here, and here, for instance.) It is likely that few animals in laboratories receive sufficient drug dosages often enough over a long enough period of time to alleviate their pain or distress, but that too is another essay.)

Category C is reserved for animals unlikely to have experienced pain or distress. (Compelling documentation and research has demonstrated that standard laboratory housing and experiences are profoundly distressing (here, here, and here, for instance, but Category C is reserved for animals used in ways that in-and-of-themselves were claimed unlikely to cause pain or distress.)

Category D is reserved for animals likely to have experienced pain or distress and which were treated with pain relieving drugs (whether or not their pain or distress was alleviated.)

Category E is reserved for animals likely to have experienced unalleviated pain or distress.

It is much more common to see animals in Category E in reports from contract toxicology labs because animals are intentionally poisoned in such labs. When labs of this sort report that no animals were in Category E, it is a near certainty that they are intentionally lying.

Why would a lab lie about the pain and distress category? The simple fact is that even APHIS inspectors – calloused by frequent exposure to the suffering in the labs –look more carefully at a lab’s procedures and practices when they see animals reported in Category E, and labs are required to append justifications for their decision to withhold anesthesia and/or analgesia if they report animals in Category E. It’s more paper work associated with a can of worms.

The motivations for public universities not reporting animals in Category E are like those above, but are more likely to include other factors as well.

An illuminating article appeared in the June 2007 issue of the trade journal Lab Animal. The article was part of the regular column, “Protocol Review.” It was titled “Categorizing pain and distress in a Parkinson's model,” and begins with this scenario:
Parkinson's disease is a neurological disorder usually diagnosed in persons over 65 years of age. Some of the symptoms include limb tremors, slow movement, and loss of balance. Dr. Golda Sherman [a hypothetical vivisector] studied the disease using an adult rhesus monkey model. Her basic procedure was to give regular subcutaneous injections of the neurotoxin N-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) over a period of at least 4 months. Then, after a stabilization period, Sherman evaluated the efficacy of various drugs for treating the animals. Many of the clinical signs of Parkinson's in the animals mimic those seen in humans. More often than not the monkeys required assistance with feeding, and this help was routinely provided by the research group. Recently, in collaboration with colleagues at another university, Sherman developed a research interest in using adeno-associated virus-based vectors (AAV2) that encode a therapeutic human gene as a potential treatment for animals with Parkinson's.

Sherman's new IACUC protocol had three study groups: (1) MPTP only, (2) MPTP plus AAV2 without the gene of interest, and (3) MPTP plus AAV2 with the gene. The protocol called for the latter two groups to have the AAV2 injected intracranially using stereotaxic surgery. These AAV2-treated animals were to be placed in USDA pain/distress Category D (pain or distress alleviated by drugs) because of the surgery. The MPTP-only animals were to be placed in Category C (no pain or distress), the same category in which Great Eastern University had previously approved Sherman's studies. The protocol went through veterinary 'pre-review' without incident, and was then presented to the IACUC.

At the full committee meeting one of the newer members raised two questions. First, if an animal was going to develop signs of Parkinson's disease, why place it in Category C rather than Category E (unalleviated pain or distress)? Further, why not consider the animals undergoing surgery as part of multiple major operative procedures? Malcolm Michaels, the IACUC Chairman, explained that because Sherman provided the non-surgical animals with adequate medical and husbandry attention, Category C was appropriate for them. Moreover, because only one invasive surgical procedure was being done on the remaining animals, there was no need to consider this study as encompassing multiple major operative procedures.

Do you agree with the IACUC's determination that this is a Category C study for the non-surgical monkeys and Category D for the others? Should the IACUC consider Sherman's research as multiple major operative procedures on the same animal, or is it a single major operative procedure?
The scenario was responded to by four current vivisectors:

Ellen M. Levee, DVM, Director, Department of Comparative Medicine, and Assistant Professor, Departments of Physiology and Pathology, New York Medical College, Valhalla, NY. "Response to Protocol Review Scenario: Gimme an 'E'"

Sylvia J. Singletary, DVM, DACLAM, Director, Division of Comparative Medicine, Institutional Veterinarian, and Assistant Professor, Physiological Sciences, Eastern Virginia Medical School, Norfolk, VA. "Response to Protocol Review Scenario: Depends on context"

Colleen A. Cody, BS, Associate Director, Animal Welfare Compliance, Novartis Institutes for Biomedical Research, Inc., Cambridge, MA.

Jessica Hoar, LATG, CMAR, IACUC Manager II, Millennium Pharmaceuticals, Inc., Cambridge, MA.

Cody and Hoar collaborated on their response, "Response to Protocol Review Scenario: Category E (with caveats)"

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