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Animal testing, or animal research, refers to the use of animals in experiments. It is estimated that 50 to 100 million animals worldwide <ref name=buavfaq>"Vivisection FAQ (pdf), British Union for the Abolition of Vivisection.</ref><ref>"Numbers of animals", Research Defence Society.</ref><ref name=nuffield45>"The Ethics of research involving animals" (pdf), Nuffield Council on Bioethics, p. 45.</ref> — from fruit flies and mice to non-human primates — are used annually and subsequently euthanized. The research is carried out inside universities, medical schools, pharmaceutical companies, farms, defense-research establishments, and commercial facilities that provide animal-testing services to industry. <ref name=selectcommintro>"Introduction", Select Committee on Animals In Scientific Procedures Report, United Kingdom Parliament.</ref> Most laboratory animals are bred specifically for research purposes, while a smaller number are caught in the wild or supplied by pounds. <ref name=lar>"Use of Laboratory Animals in Biomedical and Behavioral Research", Institute for Laboratory Animal Research, The National Academies Press, 1988. Also see Cooper, Sylvia. "Pets crowd animal shelter", The Augusta Chronicle, August 1, 1999.</ref>

The Foundation for Biomedical Research, an American interest group supporting animal research, writes that "[a]nimal research has played a vital role in virtually every major medical advance of the last century," <ref name=fbr1>"FBR's Position on Animal Research", Foundation for Biomedical Research.</ref> and that many major developments that led to Nobel Prizes involved animal research, including the development of penicillin (mice), organ transplant (dogs), and work on poliomyelitis that led to a vaccine (mice, monkeys). <ref name=fbr2>"Nobel Prizes The Payoff from Animal Research", Foundation for Biomedical Research.</ref><ref name=aalas> "Benefits of animal research", AALAS </ref><ref name=nobelsurvey>"Survey of Nobel Prize winners", SIMR</ref>

The topic is controversial. Opponents argue that animal testing is unnecessary, poor scientific practice, poorly regulated, that the costs outweigh the benefits, or that animals have an intrinsic right not to be used for experimentation. <ref name=faqinsulin>"FAQ insulin", Americans for Medical Advancement</ref><ref name=peta1>"Animals Used for Experimentation FAQs", People for the Ethical Treatment of Animals.</ref>

Contents 1 History 2 Regulation 2.1 Europe 2.2 Japan 2.3 United States 3 Animals used 3.1 Numbers 3.2 Species 4 Types of experiment 4.1 Pure research 4.2 Applied research 4.3 Toxicology testing 4.3.1 Drug testing 4.3.2 Cosmetics testing 5 Controversy 5.1 Huntingdon Life Sciences 5.2 Covance 5.3 University of Cambridge 5.4 University of California, Riverside 5.5 Columbia University 5.6 University of California, Los Angeles 6 Sampling public opinions on animal testing 7 Alternatives to animal testing 8 The arguments in brief 8.1 Official statements from representative bodies 8.2 Advocates of animal testing 8.3 Opponents of animal testing 9 See also 10 References 10.1 Numbered references 10.2 Other References 11 Further reading

[edit] History

Main article: History of animal testing

The earliest references to animal testing are found in the writings of the Greeks in the third and fourth centuries BC, with Aristotle (384-322 BC) and Erasistratus (304-258 BC) among the first to perform experiments on living animals (Cohen and Loew 1984). Galen, a physician in second-century Rome, dissected pigs and goats, and is known as the "father of vivisection."<ref name=lpag>"History of nonhuman animal research", Laboratory Primate Advocacy Group.</ref>

Animals have had a role in numerous well-known experiments. In the 1880s, Louis Pasteur convincingly demonstrated the germ theory of medicine by giving anthrax to sheep. In the 1890s, Ivan Pavlov famously used dogs to describe classical conditioning. Insulin was isolated first from dogs in 1922, and revolutionized the treatment of diabetes. On November 3, 1957 a Russian dog named Laika became the first of many animals to orbit the earth. In the 1970s, leprosy multi-drug antibiotic treatments were developed first in armadillos, then in humans. In 1996 Dolly the sheep was born, the first mammal to be cloned from an adult cell.

[edit] Regulation

[edit] Europe

Experiments on vertebrate animals in the European Union are subject to the European Union's Directive 86/609/EEC on the protection of Animals used for Experimental and other Scientific purposes. [4] There is considerable variation in the manner member countries choose to exercise the directive: compare, for example, legislation from Sweden, [5] The Netherlands, [6] and Germany. [7]

• France

In France, legislation (principally the decree of October 19, 1987) requires an institutional and project licence before testing on vertebrates may be carried out. An institution must submit details of their facilities and the reason for the use of animals they house, after which a five-year licence may be granted following an inspection of the premises. The project licensee must be trained and educated to an appropriate level. Personal licences are not required for individuals working under the supervision of a project licence holder. [8] [9]

• United Kingdom

The types of institutions conducting animal research in the UK in 2004 were: universities (42.1%); commercial organizations (33.3%); non-profit organizations (4.9%); government departments (2.4%); National Health Service hospitals (0.9%); public health laboratories (0.6%); other public bodies (15.8%) [10] (pdf).

The Animals (Scientific Procedures) Act 1986 [11] requires experiments to be regulated by three licences: a project licence for the scientist in charge of the project, which details the numbers and types of animals to be used, the experiments to be performed, and the purpose of them; a certificate for the institution to ensure it has adequate facilities and staff; and a personal licence for each scientist or technician who carries out any procedure. In deciding whether to grant a licence, the Home Office refers to the Act's cost-benefit analysis, which is defined as "the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the licence" (Section 5(4)). A licence should not be granted if there is a "reasonably practicable method not entailing the use of protected animals" (Section 5(5) (a)). The experiments must use "the minimum number of animals, involve animals with the lowest degree of neurophysiological sensitivity, cause the least pain, suffering distress or lasting harm, and [be the] most likely to produce satisfactory results" (Section 5(5) (b)). [12]

During a 2002 House of Lords select committee inquiry into animal testing in the UK, witnesses stated that the UK has the tightest regulatory system in the world, and is the only country to require a cost-benefit assessment of every licence application. [13] There are 29 qualified inspectors covering 230 establishments, which are visited on average 11-12 times a year. [14] (See also Animal Procedures Committee.) A report by Animal Aid alleges that the law governing animal research in the UK, The Animals (Scientific Procedures) Act 1986, is a "vivisectors' charter," allowing researchers to do as they please and making them practically immune from prosecution. The report says that licences to perform experiments are obtained on the basis of a "nod of approval" from the Home Office Inspectorate, and that the Home Office relies on the researchers' own opinions of the cost-benefit assessment regarding the value of the experiment versus the amount of suffering it will cause.<ref name=AAreport>"Unhappy Anniversary: Twenty years of the Animals (Scientific Procedures) Act 1986", Animal Aid, retrieved July 15, 2006.</ref>

[edit] Japan

The system in Japan is one of self-regulation. Animal experiments are regulated by one clause in the 2000 Law for the Humane Treatment and Management of Animals [15] (pdf), which requires those using animals to cause minimal distress and suffering. There are no inspections, and there is no reporting requirement for the numbers of animals used. [16] A 1988 survey published by the Japanese Association for Laboratory Animal Science reported that eight million had been used that year.<ref>Experimental Animals, 37:105, Japanese Association for Laboratory Animal Science, 1988.</ref>

[edit] United States

In the United States, animal testing is primarily regulated by the 1966 Animal Welfare Act,<ref>"Animal Welfare Act on USDA website</ref> which is enforced by the Animal Care division<ref>[17]</ref> of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). The AWA has been amended five times since 1966, most recently with an amendment in 2002 excluding birds, rats, and mice bred for research (as opposed to wild-captured mice, rats, and birds.) It contains provisions to ensure that members of covered species used in research receive a certain standard of care and treatment, provided that the standard of care and treatment does not interfere with "the design, outlines, or guidelines of actual research or experimentation".<ref>"Animal Welfare Act 1985 Amendment</ref><ref>"Appendix C: Some Federal Laws Relevant to Animal Care and Use", Guide for the Care and Use of Laboratory Animals (1996), Institute for Laboratory Animal Research.</ref> The AWA covers mammals only. Purpose-bred mice, rats, and birds were specifically excluded from coverage by the 2002 Farm Security Act,<ref>"Passage of Farm Bill Denies Protection to Birds, Mice, and Rats"</ref> meaning that relatively few animals used in research in the U.S. are covered by this legislation.[18] The AWA requires each institution conducting animal testing using covered species to maintain an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the Act. Institutions are subject to unannounced annual inspections. There are over 100 inspectors<ref>[19]</ref> to monitor around 1100 research institutions.<ref>"See Facility Lists"</ref> The inspectors also conduct pre-licensing checks for sites that do that not engage in animal research or transportation, of which more than 4000 exist (e.g. dog kennels).<ref>"APHIS AWA FAQ</ref>

APHIS has been criticized by its own inspectors and the USDA Inspector General's office (OIG). Marshall Smith, an APHIS inspector for twelve years, resigned in 1997 recounting a litany of problems at the agency that impeaded his duties. In a prepared statement, Smith made note of a 1992 OIG report citing the agency's inability to ensure the humane care of animals at dealers.<ref>[20] Statement of Marshall Smith, previous APHIS inspector</ref> In 2000, Isis Johnson-Brown D.V.M., another APHIS inspector quit because of problems she documented at the Oregon National Primate Research Center, in Beaverton, Oregon. In a prepared statement Dr. Johnson said, "More than once, I was instructed by a supervisor to make a personal list of violations of the law, cut that list in half, and then cut that list in half again before writing up my inspection reports. My willingness to uphold the law during my site visits at the Primate Center led to me being 'retrained' several times by higher-ups in the USDA.<ref>[21] Statement of Dr. Isis Johnson-Brown, Former United States Department of Agriculture Animal Care Inspector for Oregon</ref> In 2005, the USDA OIG issued another report on APHIS:

Of particular concern, AC management in the Eastern Region is not aggressively pursuing enforcement actions against violators of the AWA. The Eastern Region significantly reduced its referrals of suspected violators to the Investigative and Enforcement Services (IES) unit—from an average of 209 cases in fiscal years (FYs) 2002-2003 to 82 cases in FY 2004. When the region did refer cases to IES, management declined to take enforcement action against 126 of 475 violators (27 percent).
When violators are assessed stipulated fines, the fines are usually minimal and not always effective in preventing subsequent violations. Under current APHIS policy, AC gives an automatic 75-percent discount to almost all violators as a means of amicably reaching an agreement on the amount of the fines and avoiding court.
Finally, we noted that some VMOs when inspecting research facilities do not verify the number of animals used in medical research or adequately review the facilities’ protocols and other records.<ref>[http://www.usda.gov/oig/webdocs/33002-03-SF.pdf Audit Report: APHIS Animal Care Program Inspection and Enforcement Activities. Report No. 33002-3-SF; September 2005.</ref>

Another regulatory instrument is the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, which became statutory with the Health Research Extension Act 1985, and which is enforced by the Office of Laboratory Animal Welfare (OLAW). This Act applies to any individual scientist or institution in receipt of federal funds, and requires each institution to have an IACUC. OLAW enforces the standards of the Guide for the Care and Use of Laboratory Animals[22] published by the Institute for Laboratory Animal Research,[23] which includes all vertebrate species in its care protocols, including rodents and birds[24] (Introduction, p.1). In 2004, the National Institutes of Health provided funds to 3,180 different research institutions and universities.[25] This means that IACUCs oversee the use of all vertebrate species in research at facilities receiving federal funds, even if the species are not covered by the AWA. OLAW does not carry out scheduled inspections, but requires that "As a condition of receipt of PHS support for research involving laboratory animals, awardee institutions must provide a written Animal Welfare Assurance of Compliance (Assurance) to OLAW describing the means they will employ to comply with the PHS Policy."<ref>[26] Compliance Oversight Procedures (PDF) OLAW. NIH. 2002.</ref> OLAW conducts inspections only when there is a suspected or alleged violation that cannot be resolved through written correspondence.

Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC),<ref>[27]</ref> a non-governmental, nonprofit association, is regarded by the industry as the "gold standard" of accreditation.<ref>[28] "AAALAC Accreditation Visit" ILACUC Newsletter. Ohio State University. September, 2005.</ref> Accreditation is maintained through a prearranged AAALAC site visit and program evaluation hosted by the member institution once every three years.<ref>[29] "Preparing for a Site Visit." AAALAC. Powerpoint. 2005.</ref> The accreditation ensures that a reasonable level of compliance to the standards in the Guide for the Care and Use of Laboratory Animals is met, as well as any other national or local laws on animal welfare.

[edit] Animals used

[edit] Numbers

Accurate global figures for animal testing are difficult to collect. The British Union for the Abolition of Vivisection (BUAV) estimates that 100 million animals are experimented on around the world every year, 10–11 million of them in the European Union [30] (pdf) and 1,101,958 mammals (not including rats and mice) in the United States in 2004 [31] (pdf p.3). The Nuffield Council on Bioethics reports that "[e]stimates of the total number of animals used annually in research around the world are difficult to obtain and range from between 50 to 100 million animals."<ref name=nuffield45/> Animals bred for research then killed as surplus, or used for breeding purposes, are not included in the figures.

According to the U.S. Department of Agriculture, the total number of animals used in that country in 2002 was 1,137,718, not counting birds, mice, and rats, which make up around 85% of research animals excluding invertebrates. Other sources estimate the percentage of all lab animals that are rats, mice, or birds at 85-90%,<ref>"National Association of Biomedical Research</ref> or 95%<ref>"Science Magazine, Trull and Rich 1999 Vol. 284. no. 5419, p. 1463</ref> The Laboratory Primate Advocacy Group has used these figures to estimate that 23-25 million animals are used in research each year in America. [32] In 1986, a report produced by the U.S. Congress Office of Technology Assessment reported that "estimates of the animals used in the United States each year range from 10 million to upwards of 100 million," and that their own best estimate was "at least 17 million to 22 million."<ref>Alternatives to Animal Use in Research, Testing and Education, U.S. Congress Office of Technology Assessment, Washington, D.C.:Government Printing Office, 1986, p. 64.</ref> In 1966, the Laboratory Animal Breeders Association estimated in testimony before Congress that the number of mice, rats, guinea pigs, hamsters, and rabbits used in 1965 was around 60 million.<ref>Hearings before the Subcommittee on Livestock and Feed Grains, Committee on Agriculture, U.S. House of Representatives, 1966, p. 63</ref> In 2004, the Department of Agriculture listed 64,932 dogs, 23,640 cats, 54,998 non-human primates, 244,104 guinea pigs, 175,721 hamsters, 261,573 rabbits, 105,678 farm animals, and 171,312 other mammals, a total of 1,101,958, a figure that includes all mammals except purpose-bred mice and rats. Of that total, 615,000 were listed on experiments that did not include more than momentary pain or distress, 399,000 were associated with experiments in which pain or distress was relieved by drugs, and over 86,000 were listed on experiments that planned to cause pain and distress that could not be relieved.<ref>[http://www.aphis.usda.gov/ac/awreports/awreport2004.pdf "USDA Animal Welfare Act Report 2004]</ref> The use of dogs and cats in research in the USA decreased from 1973 to 2004 from 195,157 to 64,932, and from 66,165 to 23,640, respectively<ref>[http://www.aphis.usda.gov/ac/awreports/awreport2004.pdf "USDA Animal Welfare Act Report 2004]</ref><ref>http://www.fbresearch.org/Education/quickfacts.htm "Foundation for Biomedical Research, Quick Facts</ref>

Figures released by the British Home Office show that, in 2004, 2,854,944 procedures were carried out on 2,778,692 animals<ref name=GB14>"Statistics of Scientific Procedures on Living Animals", Great Britain, 2004, p. 14</ref> PDF, an increase of 63,000 from 2003,<ref name=GB14/> the third consective annual rise and the highest figure since 1992.<ref name=Jha>Jha, Alok. "RSPCA outrage as experiments on animals rise to 2.85m", The Guardian, December 9, 2005.</ref> In 2005, the BBC reported that the UK figures continued to "creep up...mainly due to the growing use of genetically modified mice"<ref name=BBC2005return>"Quick guide: Animal testing", BBC News, 24 July, 2006.</ref> with 2,896,198 procedures carried out on 2,812,850 animals in that year.<ref name=HomeOffice>"Statistics of Scientific Procedures on Living Animals, Great Britain, 2005PDF, Home Office.</ref>

The term "procedure" refers to an experiment, which might last several months or even years. The figures show that most animals are used in only one procedure: animals either die because of the experiment or are killed and dissected afterwards.<ref name=BUAVleg>"UK Legislation: A Criticism", British Union for the Abolition of Vivisection.</ref>

Over half the experiments in Britain in 2004 — 1,710,760 — either did not require anesthetic (e.g. behavioral tests, breeding stock, controlled dietary intake) or anesthesia was not used because this would interfere with the experimental results; 880,897 experiments were conducted in connection with pure research; 114,081 were toxicology tests, 982,640 were for breeding, and most of the rest were for applied studies in human medicine, veterinary medicine or dentistry. 9,035 involved the deliberate infliction of "psychological stress".

[edit] Species

Listed in descending order of numbers of individual animals used:

• Invertebrates

Most of the animals used in animal testing are invertebrates, especially Drosophila melanogaster, a fruit fly, and Caenorhabditis elegans, a nematode. In the case of C. elegans, the precise lineage of all the organism's cells is known, and D. melanogaster has various characteristics making it well suited to genetic studies. These animals offer scientists a number of advantages over vertebrates, including their short life cycle and the ease with which large numbers of individuals may be studied. Invertebrates are often extremely cost-effective, as thousands of flies or nematodes can be housed in a single room, but this is not true for all species of invertebrates.

With the exception of some cephalopods, invertebrate species are not protected under most animal research legislation, and therefore the total number of invertebrates used remains unknown.

• Rodents

Rodents commonly used include guinea pigs, hamsters, gerbils, rats and mice. Mice are the most commonly utilized vertebrate species, popular because of their availability, size, low cost, ease of handling, and fast reproduction rate. Mice are widely considered to be the prime model of inherited human disease and share 99% of their genes with humans.<ref name=Sanger>The Measure Of Man, Sanger Institute Press Release, 5 December 2002</ref> With the advent of genetic engineering technology, genetically modified mice can be generated to order. The Mouse Genetics Core at Washington University in St. Louis<ref>[33]Washington University in St. Louis, School of Medicine, Mouse Genetics Core</ref> explains what is required to produce today's widely used transgenic and chimeric mice:

Production of Transgenic Mice The Transgenic Animal Production service consists of injecting each construct into 300-350 eggs, typically representing three days work. Twenty to fifty mice will normally be born from this number of injected eggs. These animals are screened for the presence of the transgene by a polymerase chain reaction genotyping assay. The number of transgenic animals typically varies from two to eight.

Production of Chimeric Mice The chimeric mouse production service consists of injecting embryonic stem cells provided by the investigator into 150-175 blastocysts, representing three days of work. Thirty to fifty live mice are normally born from this number of injected blastocysts. Normally, the skin color of the mice from which the host blastocysts are derived is different from that of the strain used to produce the embryonic stem cells. Typically two to six mice will have skin and hair with greater than seventy percent ES cell contribution, indicating a good chance for embryonic stem cell contribution to the germline.

In the UK in 2004, 1,910,110 mice, 464,727 rats and 37,475 other rodents were used (84.5% of the total animals used that year). In 2005 the total number of rodents used was similar to the previous year: 1,955,035 mice, 414,335 rats and 40,856 other rodents.<ref name=HomeOffice/>

In the U.S., the numbers of rats and mice used are not reported, but have been estimated at 15-20 million. [34] In 2000, the Federal Research Division, Library of Congress, published the results of an analysis of its Rats/Mice/and Birds Database: Researchers, Breeders, Transporters, and Exhibitors. [35]

Over 2,000 research organizations are listed in the database, of which approximately 500 were researched and of these, 100 were contacted directly by FRD staff. These organizations include hospitals, government organizations, private companies (pharmaceutical companies, etc.), universities/colleges, a few secondary schools, and research institutes. Of these 2,000, approximately 960 are regulated by USDA; 349 by NIH; and 560 accredited by AALAC. Approximately 50 percent of the organizations contacted revealed a specific or approximated number of animals in their laboratories. The total number of animals for those organizations is: 250,000-1,000,000 rats; 400,000-2,000,000 mice; and 130,000-900,000 birds.

• Fish and amphibians

In the UK, 194,562 fish and 18,195 amphibians were used in 2004 [36]PDF. In 2005, the number of fish used increased to 230,315 while the number of amphibians used decreased to 13,318.<ref name=HomeOffice/> The major species utilized are the zebrafish, Danio rerio, which are translucent during their embryonic stage, and the African clawed frog, Xenopus laevis.

• Rabbits

Over 20,000 rabbits were used for animal testing in the UK in 2004. This number decreased, in 2005, to 15,348.<ref name=HomeOffice/> Albino rabbits are used in eye irritancy tests because rabbits have less tear flow than other animals and the lack of eye pigment make the effects easier to visualize. They are also used in skin irritancy tests (see Draize test). In 2004 less than 12% of the rabbits were used for safety testing of non-medical products [37].

• Dogs

Beagles are used, because they are friendly and gentle, in toxicity tests, surgery, and dental experiments. Toxicology tests are required to last six months in the UK, although British laboratories carry out tests lasting nine months on behalf of Japanese and American customers. Of the 8,018 dogs used in the UK in 2004, 7,799 were beagles (97.3%). [38]PDF In 2005 the number of dogs used in the UK decreased to 5,373.<ref name=HomeOffice/> Most dogs are bred specifically for the purpose, for example by Harlan in Leicestershire.

• Non-human primates

In the United States, 54,998 non-human primates (NHPs) were used in 2004, according to the U.S. Department of Agriculture (USDA), an annual figure that has been more or less steady since 1973 [39]PDF, p. 10). In the European Union, 10,000 are used each year, with 4,208 used in Britain in 2004, a decrease of 591 from the previous year. [40] This decreasing trend continued in 2005, with 3,115 primates used in the UK.<ref name=HomeOffice/> (p. 20-21)

Primates are the species most likely to be re-used in experiments. Re-use is allowed if the animals have been used in mild procedures with no lasting side-effects, according to the Research Defence Society.<ref>"Scientific study of primate research - call for evidence, Research Defence Society, March 24, 2005.</ref> BUAV report that it is because of re-use that there has been a fall in the number of individual primates used in the UK.<ref name=Langley31>Langley, Gill. "Next of Kin: A Report on the Use of Primates in Experiments," British Union for the Abolition of Vivisection, June 2006, p.31.</ref>

Most of the NHPs used are baboons, macaques, marmosets, and chimpanzees. Licenses approving the use of non-human primates, such as gorillas, chimpanzees, and orangutans (also known as Hominidae), are not currently being issued in Britain, though their use has not been outlawed,<ref>"Testing on apes 'might be needed'", BBC News, June 3, 2006.</ref> but chimpanzees are used in the U.S., with an estimated 1,300 still remaining in research laboratories, according to The Humane Society of the United States.<ref name=Humaneprimate>"An Introduction to Primate Issues", The Humane Society of the United States, retrieved July 13, 2006.</ref> NHPs are used in research into HIV, neurology, behavior, cognition, reproduction, Parkinson's disease, stroke, malaria, respiratory viruses, infectious disease, genetics, xenotransplantation, drug abuse, and also in vaccine and drug testing. According to The Humane Society of the United States, chimpanzees are most often used in hepatitis research, and monkeys in HIV research, and are often housed alone because of the nature of the conditions being studied.<ref name=Humaneprimate/>

There are indications that NHP use is on the rise,<ref name=Humaneprimate/> in part because biomedical research funds in the USA have more than doubled since the 1990s.<ref>"Senate completes NIH doubling in 2003"</ref> In the U.S., the Oregon and California National Primate Research Centers and New Iberia Research Center have expanded their facilities;<ref>"ONPRC Outdoor shelters"</ref><ref>"CNPRC expanding"</ref><ref>New 12,000 sq ft facility at New Iberia</ref> in 2000 the National Institutes of Health (NIH) invited applications for the establishment of new breeding specific pathogen free colonies;<ref>"NIH RFA for new breeding colonies"</ref> and a new breeding colony projected to house 3,000 NHPs has been set up in Florida.<ref>"Panther Tracts at Primate Products"</ref> The NIH's National Center for Research Resources identified a need to increase the number of breeding colonies in its 2004-2008 strategic plan, as well as to set up a database, using information provided through a network of National Primate Research Centers, to allow researchers to locate NHPs with particular characteristics.<ref>"2004-2008 Strategic Plan: Challenges and Critical Choices", National Center for Research Resources, National Institutes of Health.</ref> China is also increasing its NHP use, and is regarded as attractive to Western companies because of the low cost of research, the relatively lax regulations and the increase in animal-rights activism in the West.<ref name=Humaneprimate/>

In 2004, the British government reported "a definite long-term downward trend" in the use of new world primates (for example, marmosets, tamarins, squirrel, owl, spider and capuchin monkeys), but stated that the use of old world primates (for example, baboons and macaques) fluctuates and is more difficult to determine.<ref name=GB16>"Statistics of Scientific Procedures on Living Animals"PDF, Great Britain, 2004, p. 16</ref> Crab-eating macaques and rhesus macaques are the most commonly used species.<ref name=Langley31/> Home Office figures show the number of primates used in the UK rose by 11 per cent in 2005 to 4,650 procedures, 440 more than in 2004.<ref>Randerson, James. "Number of animal tests rises to 2.9m, highest total for 13 years, The Guardian, July 25, 2006.</ref>

Most primate use in the UK is in applied studies, which the Home Office defines as research conducted for the purpose of developing or testing commercial products. Toxicology testing is the largest use.<ref name=Langley33>Langley, Gill. "Next of Kin: A Report on the Use of Primates in Experiments", British Union for the Abolition of Vivisection, June 2006, p.33-34.</ref> The second largest category of research using primates is "fundamental biological research." This includes neuroscientific study of the visual system, cognition, and diseases such as Parkinson's,<ref name=Langley37>Langley, Gill. "Next of Kin: A Report on the Use of Primates in Experiments", British Union for the Abolition of Vivisection, June 2006, p.37.</ref> involving techniques such as inserting electrodes to record from or stimulate the brain, and temporary or permanent inactivation of areas of tissue.

In 1996, the British Animal Procedures Committee recommended new measures for dealing with NHPs. The use of wild-caught primates was banned, except where "exceptional and specific justification can be established"; specific justification must be made for the use of old world primates (but not for the use of new world primates); approval for the acquisition of primates from overseas is conditional upon their breeding or supply center being acceptable to the Home Office; and each batch of primates acquired from overseas must be separately authorized.<ref name=GB87>"Statistics of Scientific Procedures on Living Animals"PDF, Great Britain, 2004, p. 87</ref>

• Cats

Felines are most commonly used in neurological research. In the UK in 2005, 308 cats were used. This is a decrease from 819 cats recorded in 2004 [41].<ref name=HomeOffice/> According to the USDA, over 25,500 felines were used in the USA in 2000, of these around half were reported to have been used in experiments that caused "pain and/or distress". The number of cats used in research in the US has followed a downward trend, from a peak of 74,259 in 1973. [42]

[edit] Types of experiment

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Experiments can be split into three broad, overlapping categories: pure research, in which experiments are conducted that have no direct commercial application, with a view to advancing knowledge, most often inside universities; applied research, conducted in order to solve specific biological problems or to develop commercial products, either for medical or non-medical use; and toxicology or safety testing, in which commercial products are tested on animals to measure potential adverse biological reactions to the ingredients.

[edit] Pure research

Basic or pure research aims to increase knowledge about the way organisms behave, develop, and function biologically.

Both the largest number and greatest variety of laboratory animals are used in this type of research. Drosophila melanogaster, Caenorhabditis elegans, mice and rats together account for the vast majority, though small numbers of other species are used, ranging from sea slugs through blind cavefish [43]. In the UK in 2005, 89 macaques, 114 marmosets, 133 dogs and 237 cats were used in basic research to investigate topics such as social behaviour, vision, nutrition and suckling.<ref name=HomeOffice>"Statistics of Scientific Procedures on Living Animals, Great Britain, 2005PDF, Home Office.</ref>

Examples of the types of animals and experiments used in basic research include:

• Mutagenesis to study mechanisms in embryogenesis and developmental biology. Animals are often treated with mutagenic chemicals or radiation to generate defective embryos. By studying disrupted development, scientists aim to understand both how organisms develop normally and abnormally [44]. The 1995 and 2002 Nobel Prizes in Physiology or Medicine were awarded for research into developmental processes in animals using forward genetic screens [45][46]. Embryos used in experiments are often not covered by legislation and therefore not always required to be reported. Consequently, those that believe embryos are de facto animals claim the published number of experimental animals used is an under-representation.

• Experiments into behaviour, to understand how organisms detect and interact with each other and their environment. Fruit flies, worms, mice and rats are all widely used in research into mechanisms of vision, [47] taste, [48] hearing, [49] touch, [50] and smell. [51] In addition studies of brain function, such as memory and social behaviour, often use rats and birds. [52] Less common is the use of larger mammals in these types of studies.

• Breeding experiments to study evolution and genetics. Laboratory mice, flies, fish and worms are inbred through many generations to create strains with defined characteristics [53] [54]. These provide scientists with animals of a known genetic background, an important tool for genetic analysis that is currently not available when studying outbred subjects (such as most human populations). Larger mammals are rarely bred specifically for such studies due to their longer gestation periods, though some scientists take advantage of inbred domesticated animals, such as dog or cattle breeds, for comparative purposes [55]. Scientists studying mechanisms of evolution use a number of animal species, including mosquitos [56], sticklebacks [57], cichlids [58] and lampreys [59], due to their niche physiology, morphology, ecology or phylogeny.

[edit] Applied research

Applied research aims to solve specific and practical problems, often relating to the treatment or cure of disease and disorder in humans and other animals.

Compared to pure research, which is largely academic in origin, applied research programmes are more likely to be carried out in the pharmaceutical industry, or in universities in commercial partnership. These may involve the use of animal models of disease or condition, which are often discovered or generated by pure research programmes. In turn, such applied studies may be an early stage in the modern drug discovery process. Examples of animal use in this type of research include:

• Genetic modification of animals to study disease. Transgenic animals have specific genes inserted, modified or removed, with the aim of modelling a specific condition. The aim of these models may be to exactly mimic a known single gene disorder, such as Duchenne muscular dystrophy or albinism, then use the model to investigate novel ways it may be treated. Other models are generated to approximate complex, multifactorial disease with a genetic component, such as cancer or Alzheimer's disease, then investigate how and why the disease develops. The vast majority of transgenic models of disease are mice [60], the mammalian species in which genetic modification is most efficient, though there are smaller numbers of other animals such as rats, sheep and pigs [61]. Pharmaceutical companies [62], medical research institutes [63], politicians [64], scientists [65] and professional research bodies widely endorse these techniques, describing an "explosion of research on such disease models" [66] resulting in "an increasingly important role in the discovery and development of new medicines" [67]. However, animal rights and welfare groups regularly question the value and effectiveness of transgenic techniques, [68] [69] as animals do not always model human diseases accurately [70] or in their entirety. [71] [72] Genetic engineering pressure group, GeneWatch UK, call genetic modification "highly inefficient, wasteful of animal lives" and calls for "balancing the needs of people for drugs with the welfare and integrity of animal species." [73]

• Studies on models of naturally occurring disease and condition. Certain domestic and wild animals have a natural propensity or predisposition for certain conditions that are also found in humans. Cats, for example are used as a model to develop immunodeficiency virus vaccines due to their natural predisposition to FIV infection [74]. Their infection with a related feline virus, FeLV, makes cats a common model for leukemia research also. [75] Certain breeds of dog suffer from narcolepsy [76] making them the major model used to study the human condition. Armadillos and humans are among only a few animal species that naturally suffer from leprosy [77]. As it cannot yet be grown in culture, armadillos are the primary source of bacilli used in leprosy vaccines. [78] Non human primates, being closely related to humans, are applied in the study of a number of human conditions, including visual disorders [79] [80] and dental disease [81]. Primates are also used extensively in immunology [82] and reproductive studies [83] [84], a synthesis of which resulted in the discovery of the Rhesus factor and its importance in hemolytic disease of the newborn.

• Xenotransplantation research, primarily using primates as the recipient of pig hearts. The British Home Office released figures in 1999 showing that 270 monkeys had been used in xeno research in the UK during the previous four years. In 1999, three baboons and 79 cynomolgus monkeys were used.

According to licensing agencies, the increased experimentation on xenotransplation is motivated by the desire to save human lives. The US FDA says "The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply. Currently ten patients die each day in the United States while on the waiting list to receive life-saving vital organ transplants. Moreover, recent evidence has suggested that transplantation of cells and tissues may be therapeutic for certain diseases such as neurodegenerative disorders and diabetes, where, again human materials are not usually available.".<ref>[85]</ref> In Great Britain, the government agency UKXIRA states "There is currently, and will continue to be, a shortage of human organs and tissue for transplantation....Xenotransplantation is a potential solution to this shortage."<ref>[86]</ref> Author G. Wayne Miller, in The Xeno Chronicles, suggests another motivation:

Assuming xeno could be perfected, the group that brought xeno to the clinic first would claim not only scientific accolades but also a good share of the market that a Saloman Brothers study had predicted would reach $6 billion by 2010. The estimate did not seem unreasonable. No one could state what a working pig organ would cost, but with so many desperate patients and with waiting lists for all organs growing, the seller could all but command his price.<ref>Miller, G. Wayne. The Xeno Chronicles: Two Years on the Frontier of Medicine, Inside Harvard's Transplant Research Lab. Public Affairs. New York. 2005.</ref>

Medical journalists Jenny Bryan and John Clare have called xenotransplatation experiments "some of the most grisly procedures carried out anywhere in the name of science." They write that: "They do sometimes involve a full transplant of a genetically modified pig heart into a monkey. In some cases, however, the doctors will graft the transgenic hearts onto a baboon's neck arteries, as this allows them to observe the way the pig heart behaves in another species, and monitor the rejection process. The operation is carried out under general anaesthetic and the baboon is humanely killed afterwards. These measures, however, do not pacify animal rights campaigners, who say the experiments are cruel and unnecessary."<ref>Bryan, Jenny & Clare, John. Organ Farm, Carlton Books, 2001.</ref> Details of the effects of these experimental procedures came to light when thousands of documents were leaked to a UK-based animal rights organization. After a legal battle, the documents were published in a report titled Diaries of Despair.[87]

[edit] Toxicology testing

[edit] Drug testing

In response to the teratogenic effects of Thalidomide in the 1960s, many countries passed new laws to ensure all new pharmaceuticals underwent rigorous animal testing before being licensed for human use. Tests on pharmaceutical products involve:

• metabolic tests, which are performed to find out how the drugs are absorbed, metabolized and excreted by the body when introduced orally, intravenously, intraperitoneally, or intramuscularly.
• toxicology tests, which gauge acute, sub-acute, and chronic toxicity. Acute toxicity is studied by using a rising dose until signs of toxicity become apparent. Current European legislation, Directive 2001/83/EC [88] (pdf, p44), demands "acute toxicity tests must be carried out in two or more mammalian species" covering "at least two different routes of administration". Subacute toxicity is where the drug is given to the animals for four to six weeks in doses below the level at which it becomes toxic, in order to discover the effects of the build up of toxic metabolites. Testing for chronic toxicity can last up to two years and, in the European Union, is required to utilize "two species of mammals, one of which must be non-rodent" [89] (pdf, p45). The data gained from this period can be used to calculate the maximum tolerable dose; that is, the dose where signs of toxicity begin to occur.
• efficacy studies, which test whether experimental drugs work by inducing the appropriate illness in animals using an animal model of the disease. The drug is then administered in a double-blind controlled trial. This is intended to allow scientists to determine the effect of the drug and the dose-response curve.
• Specific tests on reproductive function, embryonic toxicity or carcinogenic potential can all be required by law, dependent of the result of other studies and type of drug being tested.

[edit] Cosmetics testing

Cosmetics testing is particularly controversial. It is banned in the Netherlands, Belgium, and the UK, and in 2002, after 13 years of discussion, the European Union (EU) agreed to phase in a near-total ban on the sale of animal-tested cosmetics throughout the EU from 2009, and to ban all cosmetics-related animal testing. [90] France, which is home to the world's largest cosmetics company, L'Oreal, has protested the proposed ban by lodging a case at the European Court of Justice in Luxembourg, asking that the ban be quashed. The ban is also opposed by the European Federation for Cosmetics Ingredients, which represents 70 companies in Switzerland, Belgium, France, Germany and Italy. [91]

Cosmetic testing on animals includes:

• testing a finished product such as lipstick;
• testing individual ingredients, or a combination of them;
• Contracting a third-party company to perform any of the above;
• Using a subsidiary or third-party company to perform the tests in countries where animal testing is not banned.

Some cosmetics companies continue to make the claim that their products are not tested on animals despite using one or more of the above practices.

Re-using existing test data obtained from previous animal testing is generally not considered to be cosmetic testing on animals; however, the acceptability of this to opponents of testing is inversely proportional to how recent the data is.

Due to the strong public backlash against cosmetic testing on animals, most cosmetic manufacturers say their products are not tested on animals. However, they are still required by trading standards and consumer protection laws in most countries to show their products are not toxic and dangerous to public health, and that the ingredients are not dangerous in large quantities, such as when in transport or in the manufacturing plant. In some countries, it is possible to meet these requirements without any further tests on animals. In other countries, it may require animal testing to meet legal requirements. The United States and Japan are frequently criticised for their insistence on stringent safety measures, which often requires animal testing, although the U.S. has also been a leader in developing cell culture alternatives.

Some retailers distinguish themselves in the marketplace by their stance on animal testing. The British Co-op maintains a cosmetic-testing website, [92] which includes statements from all their suppliers about the extent of their animal testing. The Body Shop is also well-known for its campaigns against animal testing. [93]

Although the British Home Office stopped giving licences to test finished cosmetic products in 1998, compounds that have both cosmetic and medical uses, such as those in the "anti-wrinkle" preparations Zyderm, Restylane and Botox, are still bound by the regulations requiring animal testing. According to activists, a raid on a laboratory in 2004 revealed that the LD50 test is still used on every batch of Botox (a toxin that, when administered intravenously, is lethal to humans) to establish potency [94] [95] [96].

While some cosmetics manufacturers have genuinely stopped all animal testing of their products, others continue to test. Companies that continue to perform cosmetic testing on animals may falsely claim that they do not do this in their advertising and on their products — or choose not to state either way.

Cosmetics manufacturers who genuinely do not test on animals generally use the following for safety testing of their products:

• reliance on existing natural or synthetic ingredients, compounds and substances, which have already been extensively tested on animals;
• avoiding novel ingredients or combinations of ingredients that have not been fully tested and may not be safe;
• testing on human volunteers/clinical trials.

This presumes that cosmetics companies are already using computer modeling and cell cultures to simulate human tissue, two techniques that have had ambiguous utility in discovering problems early. Supporters of animal testing say that neither can fully replace live human or non-human animal tests.

[edit] Controversy

[edit] Huntingdon Life Sciences

Main article: Stop Huntingdon Animal Cruelty

PETA filmed staff inside a British laboratory owned by Huntingdon Life Sciences (HLS), Europe's largest animal-testing facility, hitting puppies, shouting at them, and simulating sex acts while taking blood samples<ref name=insideHLS>Undercover video footage of HLS employees beating a puppy, filmed at the Huntingdon Research Centre, England.</ref> (video). Footage shot in the U.S. appeared to show technicians dissecting a live monkey<ref name=scaredmonkey>Undercover video footage of HLS employees apparently dissecting a live monkey, filmed at the HLS Princeton Research Centre, NJ, USA.</ref> (video). A lawsuit filed by HLS against PETA was successful in obtaining a restraining order against PETA, and prohibiting PETA from distributing any materials they had obtained.<ref>[97]</ref> Other non-PETA sources remain free to distribute these materials.

[edit] Covance

Main article: Covance

In 2004, German journalist Friedrich Mülln was hired as a BUAV operative to shoot undercover footage of staff in Covance, Münster, Europe's largest primate-testing center, making monkeys dance in time to blaring pop music, handling them roughly, and screaming at them. The monkeys are kept isolated in small wire cages with little or no natural light, no environmental enrichment, and high noise levels from staff shouting and playing the radio<ref name=Munstervideo>Undercover footage of staff in Covance screaming at and mocking monkeys </ref> (video). A lawsuit by Covance placed an injunction on Mülln from distributing the footage he shot; the same material remains accessible on the web at sites outside jurisdiction of the court.<ref>[98]</ref>

Primatologist Dr. Jane Goodall described the living conditions of the monkeys as "horrendous," and told BUAV that to see them "crazed with boredom, and sadness probably, is deeply, deeply disturbing." Primatologist Stephen Brend told BUAV that using monkeys in such a stressed state is "bad science" and trying to extrapolate useful data in such circumstances is an "untenable proposition."<ref name=Munstervideo/> PETA found similar conditions in Covance's Vienna, Virginia lab during an undercover investigation in 2004-5. [99] Covance sued PETA and their undercover operative as a result of the Vienna operation, and obtained a restraining order preventing the operative from performing any further undercover work for three years, and forced PETA and their operative to turn over all materials they obtained documenting conditions at Covance. PETA is further prevented from attempting to infiltrate Covance for five years.<ref>[100]</ref>

[edit] University of Cambridge

Main article: Primate experiments at Cambridge University

In February 2005, while applying for a judicial review of laboratory practices in the United Kingdom, BUAV told the High Court in London that internal documents from the University of Cambridge's primate-testing labs showed that monkeys had had the tops of their heads sawn off to induce a stroke, and were then left alone after the procedure for 15 hours overnight, with no veterinary care, because staff only worked from nine to five. [101] The BUAV judicial challenge followed a 10-month undercover investigation by BUAV into three research programmes at Cambridge in 1998. BUAV's lawyer, David Thomas, told the court: "The whole system is very secretive and the public does not get to see what is really going on." [102]

The experiments involved the use of hundreds of macaque monkeys, who were deliberately brain damaged for the purpose of research into strokes and Parkinson's disease. The macaques were first trained to perform behavioral and cognitive tasks. Researchers then caused brain damage either by removing parts of the macaque's brains or by injecting toxins. The monkeys were then re-tested to determine how the damage had affected their skills. They were deprived of food and water to encourage them to perform the tasks, with water being withheld for 22 out of every 24 hours. [103] [104] (video)

The Home Office investigated the BUAV report and the judge hearing BUAV's application for a judicial review rejected the allegation that the Home Secretary had been negligent in granting the university a licence. [105] [106] The Research Defence Society, a lobby group representing 5,000 medical researchers and institutions in the UK, wrote in a summary of the case: "[F]or this research into stroke monkeys were fully anaesthetised, a piece of the skull bone was removed (in the same way as for human neurosurgery), one blood vessel was permanently blocked, the skull bone was replaced, the muscle and skin resewn and appropriate pain killers given. On recovery from anaesthesia, monkeys were kept in an incubator, offered food and water and monitored at regular intervals until the early evening. They were then allowed to sleep in the incubators until the next morning. No monkeys died unattended during the night after stroke surgery." [107]

[edit] University of California, Riverside

Main article: Britches (monkey)

One of the best-known cases of alleged abuse involved Britches, a macaque monkey born in 1985 into a breeding colony at the University of California, Riverside, removed from his mother at birth, and left alone and tethered, with his eyelids sewn shut, as part of a sight-deprivation experiment. [108] (video)

Britches was removed from the laboratory when he was five weeks old during a raid by the Animal Liberation Front, along with 700 other animals. The university criticized the ALF, claiming that damage to the monkey's eyelids, [109] allegedly caused by the sutures, had in fact been caused by an ALF veterinarian who examined the monkey after the raid and wrote a report. The experiment was condemned by the American Council for the Blind (Newkirk 2000).

The photograph of Britches on the right is taken from a video made by the ALF during the raid, and later released as a short film by People for the Ethical Treatment of Animals. The university said that the monitoring device attached to the monkey's head had been tampered with by activists before the photograph was taken (ibid).

[edit] Columbia University

According to CNN, a post-doctoral "whistleblowing" veterinarian at Columbia University approached the university's Institutional Animal Care and Use Committee about experiments being carried out by an assistant professor of neurosurgery, E. Sander Connolly. [110] Connolly was allegedly causing an approximation of strokes in baboons by removing their left eyeballs and using the empty eye sockets to reach a critical blood vessel to their brains. A clamp was placed on this blood vessel until the stroke was induced, after which Connolly would attempt to treat the condition with an experimental drug. In a letter to the National Institutes of Health, PETA described one experiment: "On September 19, 2001, baboon B777's left eye was removed, and a stroke was induced. The next morning, it was noted that the animal could not sit up, that he was leaning over, and that he could not eat. That evening, the baboon was still slouched over and was offered food but couldn't chew. On September 21, 2001, the record shows that the baboon was 'awake, but no movement, can't eat (chew), vomited in the a.m.' With no further notation about consulting with a veterinarian, the record reads, 'At 1:30 p.m. the animal died in the cage.'" [111]

In a letter to PETA, neurologist Robert S. Hoffman stated that he regards such experiments to be a "blind alley," and that the baboons are "kept alive for either three or ten days after experiencing a major stroke and in a condition of profound disability. This is obviously as terrifying for animals as it is for humans unless one believes that animals are incapable of terror or other emotional distress" [112] (pdf).

A USDA investigation of the Columbia baboons found "no indication that the experiments...violated federal guidelines." Further, the Dean of Research at Columbia's School of Medicine noted that Connolly stopped the experiments because of threats from animal rights activists, despite the fact that Connolly "remained convinced that his experiments were humane and potentially valuable."<ref>[113]</ref>

[edit] University of California, Los Angeles

In 2006, animal rights activists were successful in getting a primate researcher at UCLA to shut down the experiments in his lab. The researcher's name, phone number, and address were posted on the website of the UCLA Primate Freedom Project, along with a description of his research, which stated that he had "received a grant to kill 30 macaque monkeys for vision experiments. Each monkey is first paralyzed, then used for a single session that lasts up to 120 hours, and finally killed." [114]

Demonstrations were held in front of the professor's home. A Molotov cocktail — which failed to explode but had enough force to be lethal — was placed on the porch of what was believed to be the home of another UCLA primate researcher. Instead, it was accidentally left on the porch of an elderly woman unrelated to the university. The Animal Liberation Front claimed responsi