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Johns Hopkins Bloomberg School of Public HealthCAAT

CAAT Newsletter: Vol. 14, No. 2, Winter 1997

Second World Congress Highlights Policy, Ethics, Refinement

By Deborah Rudacille

"We don't always agree, but we don't fight anymore," said Paul de Greeve, senior public health officer for the Ministry of Health, Welfare and Sport in the Netherlands, describing his country's unique approach to balancing the needs of science and animal protection. Tolerance, that great virtue of Dutch culture, was similarly the unofficial theme of the second World Congress on Alternatives and Animal Use in the Life Sciences, held in Utrecht, the Netherlands, October 20-24, 1996. Inclusion of differing points of view within the Congress program was matched by a pragmatic acceptance by most attendees that such pluralism is normal and healthy within science and within society.

Unlike the first World Congress, held in Baltimore in 1993, which was dominated by scientific sessions focused largely on the development and validation of in vitro toxicology, the Utrecht Congress included plenary lectures, workshops and platform sessions which addressed not only relevant scientific issues, but also the ethical, sociological and political ramifications of changing attitudes about animals. This shift in focus was clear from the start of the Congress, which was opened by Mrs. Erica Terpstra, the State Secretary for Health, Welfare and Sport in the Netherlands, a cabinet level position equivalent to Secretary of Health and Human Services in the U.S. system.

Mrs. Terpstra noted that "the role of governments with regard to animal experimentation is a very delicate and complicated one. On the one hand, the government's role is that of guardian of public health and to protect this most fundamental of interests, it is necessary that animal experiments be carried out on the government's behalf, albeit on as limited a scale as possible. On the other hand, governments are bound by the increasingly apparent moral obligation to protect all living creatures. In other words: they must practice a responsible stewardship. The title of this Congress reflects this dilemma very clearly: Alternatives and Animal Use in the Life Sciences."

Commenting upon the reduction in animal experiments in the Netherlands from 1.5 million in 1978 to 750,000 in 1994, Mrs. Terpstra stressed that these numbers and the new legislation just passed by Parliament "truly reflect the opinions of all elements of Dutch society." Robert Garner, Ph.D., a political scientist from the University of Leicester, U.K., who delivered a plenary lecture on "Animal Experimentation and Pluralist Politics," confirmed that this legislatively expressed consensus is evolving, albeit on a more limited scale, in the U.K. and the U.S. as well.

He said that evidence suggests that in both the U.K. and the U.S., public concern has been met with sustained legislative action, including the passing of the 1986 Animals (Scientific Procedures) Act in Britain and the Animal Welfare Act and its many revisions in the U.S. "Legislative controls on the use of animals are not as stringent in the U.S. as they are in Britain," he noted, adding that "this can partly be explained by the climate against government regulation, the influence of the research community and its allies within the National Institutes of Health...The state's role, largely confirmed by the evidence from Britain and the United States, is to balance the demands of competing legitimate interests and to try and promote consensus. To expect anything else, as advocates on both sides of the debate over animal experimentation frequently do, is unrealistic at present."

Are Transgenic Animals Alternatives?

One area in which consensus may be difficult although not impossible to achieve is the development and application of transgenic animals. "Transgenic technology entails the insertion of foreign genetic material into the germ line. Common procedures for accomplishing such gene transfer include pronuclear microinjection of purified DNA, infection of early embryos with recombinant retroviruses, and insertion of DNA into embryonic cells," noted Jon W. Gordon, Ph.D., Mt. Sinai School of Medicine, who published the first paper on the technology and coined the term "transgenic" to describe its outcome. Dr. Gordon delivered a mini-seminar on the topic at the Congress in his plenary lecture, "Impact of Transgenic Technology on Laboratory Animal Use."

Transgenic animals are genetically modified to increase their susceptibility to certain diseases such as cancer or to suppress their immune responsiveness in order to enhance their value as models for diseases of the immune system, such as AIDS. Transgenic technology is also increasingly used in agriculture to create animals with a higher economic value, for example dairy cows which produce greater quantities of milk. Agricultural transgenics were not discussed at the Congress, but a number of sessions were devoted to laboratory animal transgenics and its ethical implications. Genetic manipulation of animals is felt by many animal protection advocates to be ethically problematic, while many researchers believe the increased efficiency of such animals offers substantial scientific and even ethical advantages.

"Transgenic animals have the potential for dramatically reducing animal use," stated transgenics pioneer Gordon in his plenary lecture. "Mice can be modified in order to be made susceptible to viral infections usually limited to primates, so that the testing of vaccines such as the polio vaccine can be adapted to rodents. Disease models can be created with foreknowledge of the specific genetic change underlying the disease state. This advance has the potential of reducing the screening of animals for spontaneous mutations that mimic human disease, and the experiments required to characterize such spontaneous mutations."

A key issue discussed in related sessions was whether enough attention has been paid to animal welfare issues in transgenics and if the welfare of transgenic animals differs at all from that of any other type of laboratory animal. Trevor Poole, Ph.D., International Academy of Animal Welfare Sciences, argued in a point-counterpoint session titled "Transgenic Animals: An Alternative ?" that "although it has been argued that transgenic mice carrying human genes could reduce the use of higher primates in biomedical research and screening, it is more likely that the existence of transgenic rodents will increase the number of experiments that are performed. Particular attention needs to be paid to the ethical justifiability in terms of likely benefit to human health, compared to the suffering of the animal. There is a need for constructive debate on the welfare of transgenic animals that could, perhaps result in specific legislation to control both their production and use."

His adversary in the debate, Eckhard Wolf, a geneticist at Lehrstuhl fur Molekulare Tierzucht (Instutute for Molecular Sciences) in Munich Germany, countered that "because such animals provide a means for directly and specifically addressing difficult scientific questions, the development and use of transgenic animals satisfies the refinement and reduction concepts of the Three Rs. The use of transgenic animals has to be evaluated on a case by case basis to determine whether the costs in animal welfare outweigh the benefits."

Emphasis on Ethics and Refinement

If replacement and reduction alternatives shared center stage at the first World Congress three years ago, then refinement alternatives starred in Utrecht. Professors David B. Morton, Ph.D., University of Birmingham, and Paul A. Flecknell, Ph.D., University of Newcastle upon Tyne (the latter a recent recipient of a $6000 award from the U.S. animal protection organization WARDS) together discussed a battery of refinement issues in numerous sessions including a workshop on Humane Endpoints, which also included presentations by Dutch laboratory animal scientists Vera Baumans and Coenraad Hendriksen. Hendriksen, a vaccines researcher, received the Humane Society's Russell and Burch award at the 1993 World Congress in Baltimore.

This workshop and numerous other sessions discussed physiological and ethological bases for measuring animal suffering to facilitate early recognition and alleviation of pain and distress. Dr. Morton has developed a scoring system for assessing laboratory animal well-being which he says has had the added benefit of increasing collaborative efforts and morale among various categories of laboratory workers, including technicians, veterinarians and principal investigators.

The development of alternatives in toxicology, monoclonal and polyclonal antibody production, and drug receptor research were also discussed in platform sessions, as was the issue of validation of alternative tests for cosmetic product safety. The latter discussions have assumed a particular urgency with the deadline for implementation of the European Union's Cosmetics Directive banning animal-testing of cosmetic ingredients and finished products one year away. Most agree that the ban will likely be extended for at least two years, although it seems clear that the ban will be enforced for at least two endpoints, percutaneous absorption and skin sensitization and perhaps a third, photosensitivity.

Professor Michael Balls, head of the European Center for the Validation of Alternative Methods and chief of the trustees of Fund for the Replacement of Animals in Medical Experiments, laid down a challenge to the meeting's attendees in his plenary lecture, "The Three Rs Concept of Animal Experimentation." Stating that in European history, the Dark Ages were followed by the Age of Reformation which was in turn succeeded by an Age of Revolution, Balls called for a "revolution" in animal welfare science to overtake the reforming efforts of the past decade. Noting that the word "revolution" does not necessarily imply violence, but does indicate "complete change, reversal of conditions, fundamental reconstruction," he quoted biologist Lavinia Pioda who wrote "It should not be forgotten that the real alternatives are in essence revolutions, and revolutions cannot be incorporated into an existing structure."