February 2, 2001
Volume XXXIV, No. 5


Of Note

Media Report


In the battle over animal welfare, truth is not always what it seems

By Dr. Joseph R. Haywood and Molly Greene

Reprinted from the January/February 2001 issue of Academic Physician & Scientist, a publication of Lippincott Williams & Wilkins. This publication is endorsed by the Association of American Medical Colleges.

It should have been recognized as a warning shot at the biomedical research community. In 1991, a commentary titled "Joint Resolutions for the 1990s by American Animal Protection Organizations" appeared in The New York Times, outlining the agenda for animal activists into the next century. Among the resolutions of significance to the biomedical research community was one that supported legislation requiring the U.S. Department of Agriculture (USDA) to afford laboratory rats, mice and birds "protection" under the Animal Welfare Act (AWA) and to "initiate and support legislation, regulations and litigation aimed at reducing animal use, pain and suffering." Signed by many organizations, these resolutions presented a carefully crafted plan to end the use of animals in biomedical research‹the ultimate goal of the activist movement, then and now.

Unfortunately, the research community failed to respond to this challenge. Had we recognized the movement's intent then, we would not be surprised to find ourselves in the midst of a battle that is now being fought on several fronts.

Rights groups wage ongoing campaign Some background is necessary here: When the AWA was developed in the 1960s and 1970s, it specifically excluded rats, mice and birds used for research purposes because the public was primarily interested in protecting dogs, cats and non-human primates. The government chose to use its limited resources elsewhere. It is currently estimated that nearly 95 percent of all animals used in research are rats, mice and birds that are specifically bred for this purpose.

Of course rats, mice and birds should receive the care and consideration afforded any other research animal. But even the activists' leaders agree that virtually all rodents and birds used in biomedical research presently receive the state-of-the-art care that would be mandated by their inclusion under the AWA. The NIH Office of Laboratory Animal Welfare (for institutions receiving Public Health Service funding) and the Association for the Assessment and Accreditation for Laboratory Animal Care, International, generally provide oversight for this care.

So why are animal activists involving themselves in this issue? It goes back to their unstated goal: to end the use of animals in biomedical research.

The activists planned to start the long process of rulemaking with a petition to the USDA to include rats, mice and birds under the Animal Welfare Act. When the USDA did not proceed immediately, they took the USDA to court on the issue. This aspect of the battle plan was important because it provided more than one front of attack, it took the issue directly to the courts and, most importantly, it sought legal "standing" on behalf of experimental animals.

Animal rights groups have aimed to achieve "standing"‹or legal representation on behalf of laboratory animals‹for at least the past 20 years. In the early 1990s, the Humane Society of the United States (HSUS) and others attempted to include rats, mice and birds under the AWA; however, that attempt was overturned on appeal because none of the plaintiffs were granted legal standing. At the end of the decade, animal activists scored a victory when an individual was recognized by the full U.S. Court of Appeals as having "standing" on behalf of non-human primates at a roadside exhibit.

Until recently, however, these groups had been unable to show that their members were directly harmed by the exclusion of rodents under the AWA. All that changed with a decision handed down by a U.S. District Court judge. The ruling that a student researcher "who witnesses the mistreatment of rats" must have standing (Science 289:377, 2000) opens the door for anyone working in the lab to challenge the experimental conditions of any animal in a research setting. This ruling could initiate a flood of lawsuits designed to bring animal-based research to a halt. The judge also wrote that despite the USDA's current implementation of the AWA, the agency does not have "unreviewable discretion" to exclude rats, mice and birds.

While the battle over rats, mice and birds continued throughout the 1990s, HSUS launched a campaign to eliminate pain and distress in laboratory animals by the year 2020. Among its plans, the HSUS said it would develop a technical report on pain and distress in laboratory animals, invite Institutional Animal Care and Use Committees (IACUCs) to join its campaign, and petition the USDA to provide guidelines for the definition of distress and to reconsider its pain and distress classification system.

Although a panel of "experts" has been named, no report has been prepared. In addition, given longstanding concerns about HSUS motives, the IACUCs were reluctant to join the campaign. Meanwhile, the HSUS petition to the USDA on pain and distress issues is working its way through the rulemaking process. A public comment period recently ended regarding the HSUS proposed definition of distress and change in the pain and distress classification system.

Why is the HSUS pressing this pain and distress campaign?

Using the AWA as a basis, the USDA makes an annual report to Congress on the use of animals in procedures likely to produce pain or distress in any animal. Research facilities provide this information in an annual report to the USDA that indicates by species the number of animals in which pain or distress is relieved by drugs; those in which pain or distress is not relieved by drugs, and those animals which experience no pain or distress. The report does not recognize the use of non-pharmacological pain- or distress-relieving agents or methods. While this information is intended for Congress, these reports are posted on the USDA Web site and freely available to activists.

How can pain and distress be eliminated?
Short of not using animals in research, it is not clear how their pain and distress can in fact be eliminated. Last summer, the Federation of American Societies for Experimental Biology convened renowned investigators, professional societies, laboratory animal veterinarians and IACUC administrators to provide scientific input on these pain and distress reporting issues. The participants agreed that while pain could be defined, distress was exceedingly difficult to describe as a distinct state encompassing specific physiological or behavioral criteria. The group decided that the best way to address pain and distress in animals is for investigators, veterinarians and IACUCs to work together within the institutions to ensure appropriate care of each animal. The group further concluded that any changes in regulations must clearly benefit the animals and be simple to understand and implement to ensure voluntary incorporation to all.

More regulatory burden The bottom line is really quite simple: if proposed changes do not help the animal, then they amount to no more than unnecessary regulatory burden. If the activists succeed in convincing the USDA to adopt a broad and vague definition of distress and an elaborate system of pain and distress reporting categories, more animals will have to be reported as having been subject to pain and distress. More elaborate justifications will then be required for using animals, and individual investigators, IACUCs and institutions will have to spend more time and money to develop those justifications and to monitor and document the research. The new paperwork and oversight requirements will draw time and money away from our primary purpose, biomedical research.

The scientific community must work together to bring reason and common sense to the regulatory process so that its important work can continue. Fortunately, the Association of American Medical Colleges and the National Association for Biomedical Research, in collaboration with several other associations representing research-intensive institutions, successfully garnered congressional support to provide a year's respite before the USDA seeks to extend its regulatory umbrella to rats, mice and birds. We suggest that this time be used wisely.

Dr. Haywood, who formerly chaired the animal research committee of the American Physiological Society, a member of the AAMC Council of Academic Societies, is a professor in the department of pharmacology at the UTHSC. Greene is director of the office of academic support at the UTHSC.