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Biomedical research came dangerously close to a devastating setback last month when the U.S. Department of Agriculture entered into a settlement with animal rights groups that would have sharply increased the paperwork burden and the costs associated with using rats, birds, and mice in research.

The settlement, which was made behind closed doors without the input of the research community, would have imposed hundreds of millions of dollars worth of new regulations on researchers and hindered potentially lifesaving research developments - all without improving the treatment of the creatures the animal rights groups seek to protect.

Thanks to the research community's quick and concerted response, we were able to narrowly, and temporarily, avert a crisis. The AAMC, the National Association of Biomedical Research (NABR), the Federation of American Societies for Experimental Biology, the American Association of Universities, the National Association of State Universities and Land Grant Colleges, and others were instrumental in prompting Congress to take action.

Within days of the settlement, Sen. Thad Cochran (R-Miss.) inserted language in the agriculture appropriations bill that bars the USDA from expanding the Animal Welfare Act's definition of "animal" to include rats, birds, and mice, as called for in the settlement. The senator's rapid response is a clear victory for the research community and reinforces Congress's intention not to include rats, birds, and mice in the act. Nevertheless, the provision is only a one-year "fix," not a long-term solution.

Thus, the battle is far from over. All of us in the research and medical communities need to be aware of the incredible burden associated with such an unwarranted expansion of regulatory authority and actively oppose its adoption. As Johns Hopkins University said when it entered the USDA litigation, the "future of health research is at stake."

Laboratory animals, of which rats and mice make up an estimated 95 percent, are indispensable to research progress. Recent years have witnessed an explosive increase in the use of mice and rats, which are essential in genetics research and as disease models for myriad conditions. The NABR estimates that 23 million mice and rats were needed in 1999, a figure that some suggest could double in the next three years.

Are rats, mice, and birds animals? From the standpoint of deserving humane treatment, of course. Just like every other laboratory animal. The point is that existing standards promulgated by the Public Health Service and Food and Drug Administration already require that research facilities provide these (and all other) animals with high-quality, humane care. So do the accreditation standards of the Association for the Assessment and Accreditation of Laboratory Animal Care International.

You may ask why, if existing standards are so high, we oppose covering birds, rats, and mice under the Animal Welfare Act. The answer is that expansion of the standards would impose extremely cumbersome new reporting requirements as well as duplicate care standards on institutions that conduct animal research.

The paperwork burden alone could cost as much as $280 million, according to NABR estimates. This figure doesn't take into account possible changes in the USDA's "pain and distress" reporting requirements or the countless hours researchers will have to spend completing paperwork rather than conducting research. And despite this tremendous regulatory burden, the care of birds, rats, and mice wouldn't be improved one iota.

But while the cost to research institutions would be great, it is patients who would pay the ultimate price through a slowing of the pace of research and a diversion of scarce resources.

The AAMC, along with the rest of the research community, is strongly committed to the humane care and treatment of all laboratory animals but is equally strongly committed to ensuring that unnecessary regulations do not impede the ability of medical research to bring benefits to patients.



Jordan J. Cohen, M.D.
AAMC President

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