Development of Alternatives to Animal Use for Safety Testing and Hazard Assessment, continued.

As the powerful science of molecular biology began to be applied in toxicological research, the flaws and limitations of some traditional protocols became apparent. Scientists sought to discover the mechanisms of action of various substances, seeking to understand how a toxin affected the body at the molecular level. Toxicokinetic studies traced the absorption, metabolism, storage and excretion of chemicals in the body. This type of study was carried out in vivo or in the living animal. Toxicodynamic studies attempted to define the biological consequences of chemical activity. Much of this research was undertaken in vitro (in glass) in cells or tissues taken from animals or human beings. Both types of studies began to reveal interesting differences in the manner in which various species metabolized certain chemicals, calling into question the basic assumption that responses observed in rodents were valid predictors of human toxicity. A few studies indicated that some animal tests were not as reliable as predictors of human response as was commonly assumed (Weil and Scala, 1971). Some scientists began to propose the adoption of a “parallelogram approach” to extrapolation for risk assessment. First advocated by Sobels in 1977, the parallelogram approach uses in vitro data to test the hypothesis that a specific mechanism of action is conserved among rodent and human species. As the questions posed (and answered) by molecular toxicology became ever more precise and sophisticated, the gap between those trained in the in vitro approach and in vivo traditionalists became more pronounced.

Despite increasing evidence indicating inefficacy and waste in many standard in vivo tests, such protocols were firmly entrenched as the basis of a complex international regulatory apparatus. In order to make changes to testing protocols recommended by the OECD, all 29 member nations must agree to alterations. Due to the need for consensus, rapid and dramatic changes in OECD policy and recommended protocols are unlikely to occur. Both within member nations and in the international community as represented by the OECD, bureaucratic inertia and the weight of tradition mitigated against any type of large scale critique and replacement of traditional methodologies. But in the late 1970’s, pressure exerted by the nascent animal rights movement created a groundswell of public protest which forced a re-evaluation of testing practices.

Henry Spira

In 1976, Henry Spira, a New York City public school teacher with decades of experience in human rights activism, successfully completed a two year campaign against The American Museum of Natural History in New York City. Spira and his allies exerted sufficient pressure to persuade the National Institutes of Health to stop funding experiments at the Museum on the sexual behavior of cats deprived of various types of sensory functioning. The resulting public protest and dismantling of the Museum’s laboratories served as a stimulus to Spira’s next campaign to repeal the Metcalf-Hatch Act in New York State. This Act, passed in 1952, permitted researchers to use unclaimed dogs and cats from pounds throughout the state as research subjects. In 1979 Spira’s group was able to create a public and legislative dialogue which resulted in repeal of the Act.

The group’s next target was the cosmetic company Revlon. As in previous campaigns, the activists led by Spira contacted the company’s leadership and attempted to persuade them to re-evaluate their testing practices. When, after eighteen months of sustained letters, phone calls and personal interviews, this strategy failed, a coalition of animal protection groups led by Spira launched a public campaign. In April 1980, the coalition placed a full page ad in the New York Times protesting the company’s use of the Draize test for eye irritation. Public protest in the U.S. and Europe resulted in productive discussions between company leaders and activists. The result was a $250,000 grant by Revlon to Rockefeller University to fund research into alternatives to the Draize test. Soon after, Spira and colleagues approached Avon Products and that company, in conjunction with the cosmetics trade group CTFA (Cosmetics, Toiletry and Fragrance Association) donated $1 million to fund a more ambitious alternatives research program based at Johns Hopkins University.

Joanne Zurlo Associate Director of the Johns Hopkins Center for Alternatives to Animal Testing

This group, The Johns Hopkins Center for Alternatives to Animal Testing or CAAT, began sponsoring symposia and workshops to bring together researchers interested in pursuing alternatives research. The group also funded grants for scientists interested in pursuing this work and actively worked to bring together individuals with varying perspectives on the issue.

CAAT was not alone in adopting this strategy of dialogue and collaboration. Andrew N. Rowan, an Oxford educated biochemist who had previously worked as chief scientific officer for FRAME, a British group which champions an approach similar to that adopted by CAAT, played a major role in bringing together individuals and organizations promoting a wide range of views on the subject of animal testing (Rowan, 1987). Rowan, who served as science adviser to Henry Spira on the Revlon campaign, and

Alan Goldberg Director of the Johns Hopkins Center for Alternatives to Animal Testing

Alan Goldberg, director of CAAT, created an Animal Issues Discussion Group in the mid-80’s. Rowan, at that time Director of the Center for Animals and Public Policy at Tufts University, had already created a group composed of both animal protectionists and scientists to further dialogue and to identify common ground. Rowan and Goldberg created a second group, known as the Animal Issues Discussion Group. This corporate group attempted to understand both the ethical and practical implications of the animal rights movement and its effect on their companies.

The group met three times a year, with participation by approximately ten to fifteen high-ranking executives from major multi-national corporations. In most cases, attendees were designated “animal issues” point men and women, who reported directly to their CEO’s on the subject. Rowan and Goldberg brought in outside speakers, bioethicists, animal advocates, lawyers and others who made short presentations on the issue and then participated in question and answer sessions with attendees. The Rowan/Goldberg initiatives were the first attempts to bring together former adversaries on the testing issues in a neutral setting and to begin establishing possible ground for collaboration and cooperation.

The success of these efforts can perhaps be gauged by the fact that five years after the founding of CAAT, in 1985, the CTFA claimed a reduction of over 75% in the number of animals used in acute oral safety testing (LD50) and by the tenth anniversary of Hopkins center, a spokesman for the same group said that the use of animals for eye irritation testing in the United States had declined by 87% (Rudacille, 1992). At CAAT’s tenth anniversary symposium, its director Alan M. Goldberg, commented that “incredible progress has been realized by the coordinated efforts of scientists, educators, policymakers and animal welfarists who have forged a foundation over the past decade for the field of in vitro alternatives.” Henry Spira, who received a Founder’s Award at CAAT anniversary celebration, similarly commented in a 1985 article, “the current promising situation is the result of many individuals working together over a long period of time. Together and cooperatively we helped build a consensus among all parties that these wasteful tests are not needed.” (Spira, 1985)

 

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