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The history of animal testing begins in antiquity with Aristotle. The philosophical writings of René Descartes, who denied any mental life in animals, accelerated the growth of animal research. It is impossible to accurately estimate the number of animals used in research today because different countries differ in what they count. It is known that animal testing is a multibillion-dollar industry.
Societal concern about the use of animals in research peaked in Britain in the 1870s leading to the Cruelty to Animals Act of 1876 governing research for the ensuing 100 years. In the USA, the creation of the National Institutes of Health after World War II led to legislation growing out of public fear that their pet animals would be stolen for research purposes. In the 1980s, also, British law and European Union directives pressed forward new legislation. Many other countries followed suit. Increasing costs of animal testing led to extending research activities to developing countries to save money, avoid strict regulatory environments, and escape close scrutiny by the public. However, the three goals guiding the creation of regulatory structures for animal testing – assuring a high-quality science environment, assuring the maximization of animal welfare, and assuring the public that animals are being treated properly – are very difﬁcult to achieve across multiple cultures. The most plausible approach to creating uniform universal standards has been that developed by AAALAC International. AAALAC accredits laboratory animal facilities worldwide using the NIH Guide to the Care and Use of Laboratory Animals as a basis for accreditation. Currently, AAALAC numbers over 900 research institutions around the world as accredited.
For most of its history, animal testing has been a European phenomenon and more recently an American one and eventually spread into the developing world, as shall be shown. The earliest known uses of animals in science were for dissection and took place in ancient Greece. Pursuant to his primary scientiﬁc interest in zoology, Aristotle (384–322 BC) dissected numerous animal specimens. Other early scientists had a primarily medical orientation, such as Herophilus (323–255 BC), known as “the father of anatomy,” who did pioneering work on the nervous system. Detailed descriptions of such procedures were later provided by Galen of Pergamum (126–199 AD).
Not surprisingly, animal experimentation, like much of the rest of science, was signiﬁcantly slowed during the Dark Ages. The Muslim physician Al-Razi (ninth century) perfected surgical procedures on a goat and also tested the toxicity of medicaments on animals. Little documented work was done in Europe until the Renaissance, when Andreas Vesalius (1514–1564) and his school in Padua began performing public dissections on living animals. One barbaric experiment, performed by Vesalius’ student Realdo Colombo, involved cutting a living fetus out of a pregnant dog’s womb and observing her frenzied reaction when he hurt the pup. Colombo remarked in passing on the providential wisdom of the Creator in creating such a vivid example of maternal love.
Shortly thereafter, William Harvey demonstrated the circulation of blood in a live animal. Further use of living animals for purposes of scientiﬁc advancement was signiﬁcantly accelerated by the philosophical writings of René Descartes in France. In Descartes’ account, which in essence served as the manifesto for the rise of modern science, both physical and biological, the world consisted of two substances, res cogitans (thinking substance) and res extensa (substance occupying space or material substance). All material substances obeyed the mechanical laws governing the motion of matter. Human beings were a combination of the two, mind and matter. Animals for Descartes had no component of mind, operated strictly according to the laws of physics, and thus enjoyed neither any sort of mental life nor feelings, including pain. The school of Port Royal zealously adhered to Descartes’ principles, cavalierly performing all manner of “vivisection,” leading to reports of horriﬁed visitors recounting major atrocities perpetrated upon animals. Though British philosophers such as David Hume patently disavowed Descartes’ principles concerning animal life, Hume explicitly afﬁrming animal mind, Cartesianism dominated both theory and practice in continental Europe. The experimental use of animals signiﬁcantly proliferated in the mid-nineteenth century with the work in France of Claude Bernard and the roughly co-temporaneous invention of anesthesia.
It is virtually impossible to document the number of animals currently utilized per year in research for a variety of reasons. For one thing, every country deﬁnes the “number of animals used in research” in different ways, so summing the numbers cannot be done. For example, by a federal law in the USA, even though approximately 90 % of the animals used in research are rats and mice, these animals are not animals for purposes of law or regulation – thus an accurate number cannot be determined or even approximated. (The pharmaceutical companies in the USA have prevented these animals from counting as animals, allegedly because of the signiﬁcant additional cost of record-keeping.) One estimate gives the number of animals used in the USA as 26 million while freely admitting that this estimate is grossly inaccurate. A British publication on this question in 2008 concluded with a worldwide estimate of minimally 58.3 million animals used in 179 countries and a likelier estimate of 115.3 million animals. Even the latter number, say the authors, is likely to be an underestimate. Twenty-three countries, wherein 100 or more scientiﬁc papers utilizing animals are published in each country in a year, maintained no records of animals used in research.
It is therefore reasonable to conclude that very large numbers of animals are deployed in research today, with the numbers continuing to grow as scientiﬁc expertise in ﬁelds using animals in developing countries continues to expand. It is also reasonable to conclude that animal research is a multibillion-dollar industry across the world. With the rise of animal research and such philosophical justiﬁcations for it as Descartes’ denial of consciousness, awareness, and pain in animals, it is clear that not everyone welcomed such innovations. In a fascinating book opposing Descartes’ view of animals as machines, entitled From Beast Machine to Man-Machine, historian of science Leonora Cohen Rosenﬁeld chronicled a contemporary vigorous opposition to Descartes, including the views of theologians who emphatically afﬁrmed that Descartes must be wrong about animal souls because “heaven would not be heaven without my dog.” Inevitably, such opinions, as well all as the strong moral feelings toward animals inherent in common decency, gave rise to strong social opinions opposing animal testing and favoring anti-vivisection, particularly in Great Britain. Indeed, even some of the early researchers utilizing animals were highly ambivalent about such use, but relied on the use of cost-beneﬁt to justify it.
Societal Concern About Animal Research: Britain
Societal concern about animal experimentation peaked in the 1870s in Britain. One reason for this was clearly the rise of utilitarian philosophy as articulated by the pioneering utilitarian philosopher Jeremy Bentham, who argued that only one characteristic rendered a being worthy of moral consideration – could the organism feel pain and suffer? The same utilitarian approach, as articulated by Peter Singer, helped to catalyze social concerns about invasive animal research in the USA and Europe 100 years later. As British society grew increasingly concerned about animal treatment, it was inevitable that public attention turned to animal research.
In 1875 controversy over animal research had reached such a fevered pitch that a Royal Commission designed to examine the issues was appointed. Unfortunately, for research interests, a French physiologist named Emmanuel Klein presented their position in such a callous and uncaring manner that legislation became inevitable, and thus was born the Cruelty to Animals Act of 1876, the ﬁrst piece of legislation directed toward regulating animal research in history. Drafted in part by Charles Darwin, who vigorously opposed animal cruelty, but feared the curtailment of what he saw as a necessary scientiﬁc experimentation, the Act licensed research facilities and individual experimenters and governed British animal research for the ensuing hundred years.
Societal Concern: USA
Animal testing in the USA continued to grow during the twentieth century with relatively little opposition. The creation of the National Institutes of Health (NIH) after World War II sparked a major acceleration in animal research. Beginning in the 1940s, state laws, known as “pound seizure laws,” allowed research establishments to conﬁscate animals, particularly dogs, from local animal shelters to be used for research. This activity was extremely controversial and galvanized public opposition. By the 1960s, stories of family pets being kidnapped by unscrupulous animal dealers and sold to research were rife. Such activities, rather than moral reservations about animal research, drove the passage of legislation in the 1960s (Rollin 2006, 2008, 2012).
In 1965, a family dog that ended up dead in a research facility led Congress to consider legislation. At the same time, a LIFE magazine photojournalist visited a research dog dealer and took stark photographs of the emaciated and terriﬁed animals. It is essential to note that we are not even close to dealing with rational animal ethics in this legislation (the Animal Welfare Act). The unabashed reasons for these laws are protection of human sensibilities – concern that their beloved possessions, their pets, not be dognapped or catnapped and end up in experiments. Nothing in the Act authorizes the prescribing of standards for the handling, care, or treatment of animals during actual research or experimentation. In other words, the Act is supposed to assure research animal welfare without prescribing standards for “handling, care, or treatment during actual research or experimentation.” This is relevantly analogous to a sex manual that covers foreplay but disavows concern with anything having to do with sexual intercourse. In 1970, the Act was amended to include an assurance of the proper use of anesthesia, analgesia, and tranquilization by the research facility during an experiment. However, the absurdity therein was that the regulatory requirement could be met by the research facility afﬁrming in its annual report that it saw no need for anesthesia, analgesia, or tranquilization, even if performing painful research.
The obvious inadequacy of this legislation was partially remedied over the ensuing two decades, as societal concern for animals used in the production of food, research and testing, and entertainment continued to increase. New laws passed in the USA in 1986 amended the Animal Welfare Act to mandate control of pain and distress, to be overseen by local Institutional Animal Care and Use Committees, and also granted the status of law to the National Institutes of Health Guide to the Care and Use of Laboratory Animals. The latter law could punish infractions by seizing all federal research funding to an institution.
1986 also witnessed the passage of Directive 86/609 of the European Union (EU) with regard to the care and use of animals in research. This Directive set minimum care standards for research animals, housing standards, and training standards for personnel involved in research activities. In contrast to the US law, the Directive placed heavy emphasis on the development of alternatives to live animals for research. The concept of alternatives was ﬁrst promulgated by Russell and Burch in Britain in 1959 in their seminal book Principles of Humane Experimental Technique, London: Methuen wherein the authors articulated the “3 Rs” guiding the search for alternatives – reduction of the number of animals used in a procedure, reﬁnement of a procedure to decrease invasiveness, and replacement of live animals by nonanimal methods. (In recent years, a fourth R was added, namely, respect for the animals.) In September 2010, in recognition of the fact that Directive 86/609 was too vague and subject to interpretation, the EU promulgated Directive 2010/63, which made the previous Directive more precise, banned the use of great apes in research, and stressed training and best practices for controlling pain and distress in animal research. In 2013, the Directive was further modiﬁed to ban the use of live animals in the toxicity testing of cosmetics.
Also in 1986, Great Britain passed a new law pertaining to animal research, both to update the Act of 1876 and make British law compatible with the EU directive. (Note that individual countries in the EU can have their own variations on laws governing animal experimentation, as long as they are compatible with the Directive.) This law was called the Animals (Scientiﬁc Procedures) Act. The law regulates the use of vertebrate and cephalopod animals in scientiﬁc research. Any animal procedure requires three licenses, a personal license for the investigator, a speciﬁc project license, and a facilities license. No licenses may be issued until the Secretary of State is satisﬁed that the project cannot be done without animals. A national committee consisting of scientists, veterinarians, physicians, lawyers, animal welfare advocates, and philosophers advises the Secretary of State on the issuance of licenses. A cost-beneﬁt assessment weighing cost to the animals against scientiﬁc beneﬁt must be conducted for licenses to be issued. Animals may not be used in multiple experiments. Local review committees comparable to IACUCs are also authorized.
Other European countries have very similar rules, with numerous local variations. Japan too has a similar system guided by concern for the 3 Rs, but the Japanese system is generally seen as more self-regulatory than Europe or the USA. China has only recently begun to develop the science of laboratory animals and still has a lax regulatory structure. In South America, Brazil is moving toward a system similar to the USA.
Aside from the bewildering number of political differences dividing animal research regulation globally, there are also vast cultural differences. For example, during the 1970s, India banned the export of rhesus macaques for research. These animals are viewed as sacred in India. The ban was established when it became known that idle curiosity in the USA was driving their use in radiation research. On the other hand, baboons are perceived as pest animals in South Africa, so researchers simply go out and harvest them when needed. Islamic scholars argue that only experimentation directly essential to human life is permitted; toxicity testing or experimentation arising out of idle curiosity is disapproved.
What Does Animal Research Encompass?
It is worth pausing to examine the various ways in which animals are used in research. The different usages are fairly well accounted for by the following seven categories:
Basic biological, behavioral, or psychological research, that is, the formulation and testing of hypotheses about fundamental theoretical questions, such as the nature of DNA replication, mitochondrial activity, and brain functions or learning, with little concern for the practical effect of that research.
Applied basic biomedical and psychological research. The formulation and testing of hypotheses about diseases, dysfunctions, genetic defects, etc., which, while not necessarily having immediate consequences for treatment of disease, are at least seen as directly related to such consequences. Included in this category is the testing of new therapies: surgical and gene therapy, radiation treatment, treatment of burns, etc.
The development of drugs and therapeutic chemicals. This differs from the earlier categories, again in degree, but is primarily distinguished by what might be called a “shotgun” approach; that is, the research is guided not so much by well-formulated theories that suggest that a certain compound might have a certain effect, but rather by hit-and-miss, exploratory, inductive “shooting in the dark” methods. The primary difference between this category and the others is that here one is aiming at discovering speciﬁc substances for speciﬁc purposes, rather than at knowledge per se.
Food and ﬁber research is aimed at increasing the productivity and efﬁciency of agricultural animals. This includes feed trials, metabolism studies, some reproductive work, the development of agents like BST to increase milk production, etc.
The testing of various consumer goods for safety, toxicity, irritation, and degree of toxicity. Such testing includes the testing of cosmetics, food additives, herbicides, pesticides, industrial chemicals, and so forth, as well as the testing of drugs for toxicity, carcinogenesis (production of cancer), mutagenesis (production of mutations in living bodies), and teratogenesis (production of monsters and abnormalities in embryo development).
The use of animals in educational institutions and elsewhere for demonstration, dissection, surgery practice, induction of disease for demonstrative purposes, high-school science projects, etc.
The use of animals for extraction of drugs and biological products – vaccines, blood, serum, monoclonal antibodies, TPA from animals genetically engineered to produce it in their milk, etc.
Research In The Developing World
Managing these different variations on research required differing degrees of expertise and sophistication on the part of those running the diverse sorts of laboratories required. In many cases, the creation of such facilities and stafﬁng them with properly trained individuals was prohibitively expensive in the USA and Europe. At the same time, numerous industries were moving to developing countries that historically did little animal research in order to cut costs signiﬁcantly and to deﬂect negative publicity. (The founding of the African Journal of Animal and Biomedical Sciences in 2006 is a good indicator of the rise of research in places historically devoid of such research.) In addition, the rules in such countries were far less strict. As one online article put it, “Because animal rights groups make it difﬁcult for drug companies to build or expand animal testing laboratories in the United States, Europe, and India, (CEOs) are outsourcing work to China, where scientists are cheap and plentiful and animal rights protesters are mufﬂed by an authoritarian state.. .. So now big Pharma is looking to move to China in a big way.”
Such considerations rapidly accelerated the movement of European and American animal research businesses into developing countries far less scrupulous about animal use. As one CEO pointed out, “(China) is a country with a large number of canines and primates, and if we establish preclinical testing facilities here, we can change the dynamics of the industry.” Even more darkly, as a July 4, 2011, article in the Guardian pointed out, “ethics [are] left behind as drug trials soar in developing countries.”
The article goes on to claim that “the number of clinical trials in developing countries has surged in recent years but the legal and ethical frameworks to make them fair are often not in place. By 2008, for example, there were three times as many developing countries participating in clinical trials registered with the US Food and Drug Administration than there were in the entire period between 1948 and 2000, with many “transitional” countries, such as Brazil, China, India, Mexico and South Africa, taking part. For the pharmaceutical industry, the attractions are the lower costs and the availability of “treatment-naive” patients, who are much less likely to have been previously exposed to drugs or trials.. .. However, the process of putting in place a legal and ethical framework to protect participants is not going at the same pace in many of these countries.”
“Less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation make carrying out research in the developing world less demanding,” said Ames Dhai, director of the Steve Biko Centre for Bioethics at the University of Witwatersrand, South Africa. While many countries have set ethical standards for clinical trials, this is not a guarantee they will be respected by those who perform the trials. “The problem is implementing these [ethical] guidelines and the imperialistic attitude of researchers and sponsors who come to the country and frequently disregard our process,” Dhai added.
Places such as South Africa – where mostly vulnerable poor people with low literacy levels are recruited and the culture is to accept authority without question – are fertile land for ethical misconduct, speakers said. Up to 80 % of patients recruited in some developing countries are not informed about the nature of the study they are taking part in. In addition, “many of them do not feel free to quit the trial, because they think that they or their children will lose out on good healthcare or treatment if they abandon it.”
The implications to be drawn from the above report are clear. If the research community does not cavil at violating the well-established rights of human research subjects, thrown into bold relief by atrocities revealed at the Nuremberg trials, the chances are increased that the needs and interests of research animals will not be respected where there is no meaningful enforcement structure. As the history of human nature evidences, moral requirements are often cast aside in the face of convenience and ﬁnancial incentives, where there are no powerful sanctions against doing so.
The preceding discussion is not intended to present a deﬁnitive argument in favor of the claim that research in the Third World just discussed is necessarily cavalier about research animals. It is simply meant to raise a warning ﬂag alerting interested parties to a potential source of heedlessness with regard to the well-being of research animals. It is very possible that the warnings implicit in our discussion may be trumped and overridden by cultural considerations that are regnant in the countries under consideration. While it is extremely difﬁcult to ﬁnd a reference material pertaining to ethical attitudes toward animals in many of these countries, there is in fact an extremely valuable article dealing with “Animals in the Traditional Worldview of the Yoruba,” written by Ajibade George Olusola, an African academic from the Yoruba tribe who has lived for many years in the USA and enjoys both an African and a Western perspective on the relevant ethical issues. The Yoruba represent one of the largest ethnic groups in Africa (some 35 million people), and the author is highly knowledgeable regarding their culture. Interestingly enough, in discussing the Yoruba’s view of animals, the author Bibliography : one of this author’s articles on animal ethics in order to buttress his claim regarding the Yoruba’s view of animals, the only piece of Western ethics he refers to.
According to Olusola, the Yoruba have a very ethically solid husbandry ethic toward animals, reminiscent of the one that dominated Western agriculture before its industrialization. It is clear that the Yoruba see animals as capable of experiencing pleasure and pain as well as the full range of emotions that humans experience. In essence, animals are seen as “equal with humans” and therefore worthy of signiﬁcant moral concern and of having their needs and dignity respected. Signiﬁcantly, the author argues that we are obliged to respect the full range of animals’ welfare needs, yet they should not be said to have rights, else such rights could well get in the way of our human uses of them.
All told, what we ﬁnd in this entry is a very sensible, decent, and pragmatic view of human obligations to animals, which permits our use of animals, while at the same time limiting the abuse they are subjected to. This account meshes well with what I have been told by African colleagues. When I asked one of them, a biomedical researcher and veterinarian, to summarize how Africans would look at animal research, he replied that if the research was relevant to increasing animal productivity from which we can beneﬁt, that would elicit widespread approval. The further removed the research was from tangible human beneﬁts, the less likely it is to garner favorable support.
These considerations signiﬁcantly mitigate the negative picture I painted by extrapolating from human research. Nonetheless, I would argue that it is worthwhile to continue to examine animal treatment in the course of their deployment in research, so that the native ethic of decency continues to dominate.
Standardizing Animal Research
Given the morass of regulatory differences between countries – and sometimes even between regions of countries – it is very difﬁcult to see how the three goals of a regulatory structure discussed at a recent conference can ever be met. The three goals are assuring a high-quality science environment, assuring the maximization of animal welfare, and assuring the public that animals are being treated properly and well. The ﬁrst goal can certainly not be met with such vast differences between physical accommodations and husbandry requirements across laboratories. Expecting it to do so would be equivalent to dragging an MRI machine to work behind a pickup truck over a dirt road and expecting it to work perfectly thereafter. Animals are incredibly complicated entities highly susceptible to all sorts of minute changes in their ambient physical environment and even in their social environment.
In fact, recent data published in the last month indicates that the animal shows more stress responses when the caretaker is male rather than female, though we have no way of knowing how the animal knows one from another.
Precisely the same obstacle exists regarding animal welfare. If people do not know the relevant variables affected by how animals are kept, housed, and managed, how can they manage the animals’ well-being? In fact, the 1986 US law amending the Animal Welfare Act mandates control of pain and distress, and the USDA should be inspecting control of distress just as control of pain is inspected, yet they do not do so, because no one knows the signs of distress or what the concept means. A fortiori, the problem is even more acute regarding husbandry and housing variables, since no one knows the links between them and distress. And given the points we have just made, how can the public be reassured if the scientiﬁc community is ignorant?
Obviously, what is needed is a set of standards regulating all research across the world. Yet this is clearly incompatible with national sovereignty, as well as with the incredible ignorance of most scientists regarding laboratory animal science. As close as we have been able to come is the creation of AAALAC International, the American Association for Accreditation of Laboratory Animal Care. AAALAC accredits laboratory animal facilities worldwide using the NIH Guide to the Care and Use of Laboratory Animals as a basis for accreditation, just as AAALAC does with US laboratories. Currently, AAALAC numbers over 900 research institutions around the world as accredited. AAALAC comes as close as any currently extant agency to standardizing research facilities, animal welfare, and public assurance. The major problem is that “animal welfare” is partially an ethical notion, and AAALAC assumes that what animal welfare is is self-evident. This is far from the case, and a great deal of philosophical research and analysis is required before (if ever) we can agree on a universally accepted standard. If we are to genuinely engage in animal welfare, we would do well to stop seeing animals strictly in biochemical and mechanical terms, but concentrate instead on what they do, their way of life, what Aristotle calls their telos – the “pigness” of the pig, the “dogness” of the dog – and attempt to satisfy those interests (Rollin 2007a, b).
In keeping with the latest edition of the Guide, AAALAC uses a harm/beneﬁt analysis when accrediting facilities. This is a major step forward, only recently instituted in the USA. More bioethicists working on issues of animal testing could help further create uniformity of standards.
- Olusola, A. G. (2005). Animals in the traditional worldview of the Yorùbá. http://www.folklore.ee/folklore/ vol30/olusala.pdf. Accessed 09 June 2014.
- Rollin, B. E. (2006). The regulation of animal research and the emergence of animal ethics: A conceptual history. Theoretical Medicine and Bioethics, 27(4), 285–304.
- Rollin, B. E. (2007a). Animal research: A moral science. EMBO Reports, 8(6), 1–5.
- Rollin, B. E. (2007b). Overcoming ideology. ILAR Journal, 48(1), 47–53.
- Rollin, B. E. (2008). The moral status of animals and their use as experimental subjects. In P. Singer & H. Kuhse (Eds.), A companion to bioethics (2nd ed.). Oxford: Blackwell (1st ed. 2001).
- Rollin, B. E. (2012). The moral status of invasive animal research. Hastings Center Report, 42(6), S4–S6.
- Kesel, M. L., & Rollin, B. E. (1989). The experimental animal in biomedical research (Vols. 1 and 2). Boca Raton: CRC Press.
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