January 24, 2002
I am writing to you as part of The Humane Society of the United States' (HSUS) Pain and Distress Initiative. The goal of our initiative is to work with Institutional Animal Care and Use Committees (IACUCs) and others to eliminate all significant pain and distress in laboratory animals by the year 2020. While ambitious, we believe that this goal is achievable, especially with regard to the significant pain and distress now experienced by many laboratory animals.
This correspondence, in particular, concerns the apparent under-reporting of animal research that involves unrelieved pain and distress in the United States, especially by those institutions that receive significant government funding. Each research facility regulated by the U.S. Department of Agriculture (USDA) is required to submit an annual report that includes the numbers of regulated animals used in research, broken down by species and pain and distress category. The precise wording of these pain and distress categories can be found in Appendix A. We will be referring primarily to Category E ("Column E") in this letter.
We are sending this letter to the IACUC chairpersons at the "Top 50" research institutions (based on the amount of funding received from the National Institutes of Health during 1998) because these institutions collectively report less than 1% of their regulated animals in Column E (Appendix B). To be more specific, the Top 50 institutions reported that an average of between 0.6% and 0.9% of animals experienced unrelieved pain and distress over the most recent three years for which individual facility reports are available, namely 1996, 1997, and 1998. The HSUS believes that this represents significant under-reporting of the actual distress experienced by these 150,000 or so animals.
Our concerns about apparent under-reporting of unrelieved pain and distress in the Top 50 institutions are underscored by two comparisons. First, while the Top 50 institutions report less than 1% of animals in Column E during 1996–1998, the comparable figures for all regulated facilities nationwide ranged from 8% to 12% over these years. Second, while the reporting systems in other countries differ from that in the United States, their statistics suggest that the figures reported by the Top 50 U.S. institutions are not credible. Canada, Switzerland, and New Zealand reported that 12 to 38% of research animals experienced moderate to severe distress for the years 1996–1998 (Appendix C), far greater than the 1% or less reported in Column E by the Top 50 U.S. facilities. Finally, the United Kingdom categorized 57% of their project licenses in the moderate and substantial severity bands in terms of pain and distress for the year 2000 (the first year for which severity bands were reported), which further casts doubt on the low figures reported by the Top 50 U.S. institutions.
A closer examination of the statistics indicates that the percentage of animals reported in Column E in the United States is similar, for many species, to the severe pain and distress reported by other countries. Therefore, it could be said that moderate pain and distress are ignored/not reported by institutions in the United States. For example, in 1998, U.S. institutions reported 2.7% of dogs in Column E while Switzerland reported 1.5% of dogs as experiencing severe pain/distress and 13.9% as experiencing moderate pain/distress, for a total of 15.4% as experiencing moderate/severe pain/distress. This is also the case when the statistics for dogs are compared between The Netherlands and the United States and when the reported statistics for other species are examined.
Types of Research Reported as Column E
Our analysis of the U.S. annual reports (non-federal facilities only) for 1998 indicates that approximately 93% of all animals reported in Column E are involved in toxicity or vaccine testing, with only 6% involved in research and 0% involved in education (1% unable to be determined). It could be argued that the Top 50 institutions are academic institutions that primarily conduct basic research; therefore that could be the reason for the low reporting in Column E. However, a comparison with other countries shows a discrepancy. For example, according to Canadian statistics for 1999, approximately 26% of the animals reported as experiencing moderate to severe pain and distress were used in basic research and education, in comparison to the 0.5% reported by the United States (according to an analysis of the U.S. annual reports for nonfederal facilities). In addition, Canada reports that approximately 62% of the animals reported as experiencing moderate to severe pain and distress were used in testing, in comparison to 7.4% reported by the U.S. Based on this country comparison (Appendix D), it appears that the United States under-reports pain and distress associated with both research and testing.
Species Comparison
Some may argue that the moderate to severe pain and distress reported by other countries is higher than the unrelieved pain and distress reported in the United States because other countries report mice and rats, while the U.S. does not. However, an analysis of the statistics of other countries indicates that this is not the case. Appendix E includes the pain and distress statistics of three countries and compares rats and mice to the species that would be regulated by the USDA; it can be seen that the reported pain and distress statistics are similar in all species, albeit a bit higher for rats and mice.
Evidence of Misreporting of Pain and Distress
The HSUS has examined published research papers from a number of the Top 50 institutions that have consistently reported zero to few animals in Column E. Appendix F includes several examples from published papers that depict research that, in our judgment, resulted in unalleviated animal pain and/or distress and therefore should have been reported in Column E. The examples in Appendix F also bring to light the fact that humane endpoints could have/should have been used in some of the research studies. For example, those institutions conducting HIV research in primates now know enough about the symptoms and the course of the disease in primates that humane endpoints could be determined and implemented in order to humanely euthanize those animals dying from viral infection, instead of allowing them to die slowly. The use of score sheets, such as the example in Appendix G, would not only assist in determining overall humane endpoints for a certain research protocol or procedure, but would also increase attention to individual animals.
Correspondence/Interactions with Specific Institutions
The HSUS has corresponded with Tulane University and the University of Wisconsin-Madison about the apparent misreporting of pain and distress at those institutions. Correspondence with Tulane led to the discovery of a legalistic loophole in the USDA's annual report form. The following is an excerpt from a Tulane letter: "Column E is reserved for studies involving procedures that may cause pain and distress to animals and where appropriate analgesics, anesthetics or tranquilizers are not used because they may alter or adversely affect the results of the experiment. As stated before, this Center does not have any approved protocols that meet these criteria" (Italics in the original correspondence). This statement takes advantage of the fact that there is not a specific column on the USDA's annual report form that would include procedures that may cause pain or distress and for which the use of analgesics, anesthetics or tranquilizers would not have interfered with the results of the experiment. However, the wording for column E in USDA Policy #11 (noted in Appendix A) does address this issue in that the phrase "because they may alter or adversely affect the results of the experiment" is not included, therefore indicating that "[i]ndividual animals in which needed anesthetics, analgesics, sedatives, and/or tranquilizers are withheld should be reported in column E." Thus, we believe that Tulane's reason for not reporting animals in column E is invalid.
After ten months and three attempts to have some of our questions about USDA reporting at The University of Wisconsin-Madison answered, the university finally sent us a brief letter. This letter did not respond to our specific inquiries and we have begun a process to take the issue to community members of the University of Wisconsin who are not in "official channels of communication."
In addition to the under-reporting of pain and distress, there have been inconsistencies in the reporting of pain and distress among institutions. Two institutions may conduct the same procedure, but one reports it as painful and/or distressful while the other does not. This is not surprising in light of a recent study by Plous and Herzog (July 27, 2001, Science) that found protocol review outcomes to be inconsistent among IACUCs (when protocols were reviewed by two IACUCs, reviews differed in 79% of the cases), as well as between members of the same IACUC. This inconsistency occurred even when the research involved procedures that were expected to be terminal or painful.
Plous and Herzog argued that there are methods by which the protocol review process can become more consistent. For instance, when a pain scale classification was provided (ranging from little or no pain to intolerable pain), there was a higher degree of inter-rater agreement (intraclass correlation coefficient increased from a range of 0.23–0.28 for all other ratings to 0.59). This supports the idea that the adoption of a pain and distress classification system reflecting the levels of pain and distress that animals experience would improve reporting standards, and with this development, attention to pain and distress.
Finally, at a public meeting attended by an HSUS staff member, an individual from one of the "Top 50" institutions commented that they report "zero" animals in column E because they did not want to draw the attention of animal activists. I personally know that other institutions do the same. We wish to note that we believe such non-reporting is a serious problem because it may lead to complacency about whether laboratory animals are being given adequate pain, and more importantly, distress relief.
The HSUS believes that the apparent under-reporting of pain and distress raises the possibility that these issues (especially distress) are not receiving appropriate attention by both research institutions and regulatory agencies. It is important to emphasize that the public is concerned about the treatment of research animals, and a majority support a strengthening of federal regulations and the development and promotion of alternatives that will reduce animal suffering. A recent survey conducted by an independent polling firm for The HSUS found that 75% of Americans disapprove (57% of whom strongly disapprove) of the use of animals in research and testing when the animals experience severe pain and distress. Furthermore, 60% disapprove when the animals experience moderate pain and distress, and 33% disapprove when they experience little or no pain and distress. This is why it is relatively easy to mobilize public concern when examples of research involving animal distress are brought to the public's attention. We believe that it is in the interest of the major research institutions in this country to demonstrate very openly how much attention they are paying to reducing and eliminating the animals' distress that results in research projects.
At this time, it is essential that each of the Top 50 institutions re-evaluates and revises its pain and distress reporting in order to accurately reflect what is happening within research laboratories. Accurate reporting is an important step towards decreasing animal pain and distress in various ways and should be taken seriously. Thank you for your time.
Sincerely,
Andrew Rowan, D. Phil, Senior Vice President for Research, Education and International Affairs
cc: Dr. Chester Gipson, USDA/APHIS
Dr. Nelson Garnett, NIH/OLAW
Appendices
Appendix A. The precise wording of the pain and distress categories found on the Annual Report form and in USDA Policy #11: Painful/distress procedures.
Appendix B. Column E Reporting by the Top 50 University Research Institutions (in terms of NIH funding).
Appendix C. Comparison of category E/moderate to severe suffering as a percentage of total animals used in various countries for 1996–1998.
Appendix D. Percentage of animals reported as experiencing Column E/moderate to severe pain and distress by purpose of animal use; a comparison of the United States and Canada: research versus testing for 1998.
Appendix E. Percentage of animals reported as experiencing moderate to severe pain and distress in three countries: comparison of USDA-regulated species to mice and rats.
Appendix F. Examples taken from papers published by various Top 50 institutions. In the view of The HSUS, the research in these examples resulted in unalleviated animal pain and/or distress and should have been reported in Column E, but, to the best of our knowledge, was not reported as such.
Appendix G. A sample sheet for scoring animals (derived from Hampshire et. al., 2001 Laboratory Animals 35 (3):223–229).
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