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Andrew Knight - Official Reporting of Pain and Distress Experienced by
Laboratory Animals 18 March 2008 Michael Budkie AHT Dear Mr Budkie, Official Reporting of Pain and Distress Experienced by
Laboratory Animals As you are aware, I am a practicing veterinarian and
hold licenses to practice within both the US and the UK. I hold a
post-graduate Certificate in Animal Welfare Science and have a special
interest in laboratory animal use. Since 2005 I have published within
peer-reviewed biomedical journals a series of studies analyzing
laboratory animal use, three of which received awards at international
scientific conferences in 2005-2006. You have asked me to comment on the accuracy of
official reporting of pain and distress experienced by laboratory
animals, and the consequent scientific implications. The federal Animal Welfare Act (AWA) prohibits
subjecting animals to experiments likely to cause more than
“momentary or slight pain or distress,” unless written evidence has
been provided demonstrating that a detailed search for non-animal
alternatives was unsuccessful. In such cases, “appropriate sedatives,
analgesics or anesthetics” must be used, unless “withholding such
agents is necessary for scientific reasons,” in which case the
experiment must not continue for longer than necessary. Where it is considered scientifically necessary to
conduct procedures likely to result in significant pain or distress,
without the use of sedatives, analgesics or anesthetics, such
animal use must be correctly categorized as causing “unrelieved pain
or distress” within the Annual Report of Research Facility,
filed by the Facility with the United States Department of Agriculture
(USDA), together with an explanation as to why the procedure and
protocol were necessary. As you are aware, responsibility for oversight
and enforcement of the AWA rests with the USDA Animal & Plant Health
Inspection Service (APHIS). Unfortunately, it appears that these requirements are
met with variable compliance by US animal research laboratories.
Although you have provided only a small number of protocols for comment,
even within these few it appears that violations of these requirements
are common. Examples include: 1. Prolonged water or food deprivation of
primates, for training purposes. Such deprivation results in
situations in which the animals are unable to meet basic biological
needs, within the limitations of their cage environments. The
fundamental urge to meet those needs combined with the inability to
do so inevitably results in stress. It was disturbing to read that
some experimental protocols may deny water for up to 22 hours daily,
for days to weeks on end. 2. The close confinement of primates within
restraint chairs, sometimes with surgical implants, for periods of
several hours, repeated most days, for periods lasting several weeks
or longer. The denial of the ability to engage in normal behavior,
and, indeed, simply to move freely, also frustrates the basic
natural urges of species which are characterized by their relatively
high intelligence, inquisitiveness, and environmental interactivity. 3. The use of animal models of human toxicity
frequently results in distress and suffering when toxic effects are
severe or chronic. Long-term studies such as the common two-year
rodent carcinogenicity assay frequently monitor the progression of
toxic effects over the duration of the subject’s lifespan. In lethal
dose (LD) studies, these effects are sufficiently severe as to cause
death. Many other pathological studies result in the induction of
diseases that may reasonably be expected to cause distress or
suffering, but unfortunately, chemical relief does not appear to be
routinely provided. Such violations of good laboratory practice also
occur elsewhere. Around 60% of procedures are conducted without
anaesthetics within the UK. While the use of anaesthetics or
analgesics undoubtedly alters normal physiology, claims that such
alterations are sufficiently important to hypotheses under
investigation, to warrant their exclusion, require careful scrutiny.
That the failure to relieve pain or distress is an
international, rather than distinctly US problem, is neither an excuse
nor a defense for failing to correctly categorize unrelieved pain or
distress, as required by the AWA. Such failures markedly undermine the
credibility of official reporting of laboratory animal use. It is
reasonable to assume that the intent of such misrepresentation is to
minimize legitimate scientific, regulatory and social concern about, and
possible restriction of, laboratory animal use. For example, unrelieved pain or distress raises
substantial scientific concerns. Recent comprehensive reviews published
in laboratory animal science journals have revealed that even routine
laboratory procedures such as handling, blood collection, and gavaging
(insertion of a throat tube for the forced administration of a test
compound) and standardised laboratory housing may cause significant
stress, to which laboratory animals may not habituate. The results
include the distortion of normal physiology, disruption of hormonal
regulation, impedance of neuroanatomical development and cognitive
ability, behavioral stereotypies, immunosuppression, and increased
susceptibility to adverse drug reactions or other pathologies. From a scientific perspective, such treatment of
these animals damages them as experimental models. The scientific
outcomes that result are likely to be even further removed from human
outcomes than would be achieved by the use of healthy, non-stressed
animals, as intended by the AWA. Such scientific distortion further
compounds the marked biological and mathematical obstacles that impede
the accurate extrapolation of animal test results to predicted human
outcomes. The accurate reporting and disclosure to the
scientific and regulatory communities, and the general public, of the
level of unrelieved pain and distress experienced by laboratory animals,
along with the reasons for the denial of chemical relief in such cases,
are fundamental to good laboratory practice, to maximizing the utility
of laboratory animal models, and the scientific robustness of animal
data, and to minimizing scientific and social controversy surrounding
laboratory animal use. It is clear, therefore, that greater enforcement
of accuracy within official reporting of laboratory animal use is
required. Yours sincerely, Andrew Knight BSc., BVMS, CertAW, MRCVS Knight A, Bailey J, Balcombe J. Animal
carcinogenicity studies: 1. poor human predictivity. Altern Lab Anim.
2006; 34(1):19-27.Hudson M & Bhogal N. An analysis of the Home Office
Statistics of Scientific Procedures on Living Animals, Great Britain
2004. Altern Lab Anim. 2006;34(1):85-103. Balcombe J, Barnard N,
Sandusky C. Laboratory routines cause animal stress. Contemporary
Topics in Laboratory Animal Science 2004;43(6):42-51.Balcombe J.
Laboratory environments and rodents' behavioural needs: a review.
Laboratory Animals 2006;40(3):217-35. See also:
Government Grants Promoting Cruelty to Animals
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