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Animal testing (also referred to as '''animal research''') refers to the use of non- and Mice to Non-human Primates . {Link without Title}

Animal experiments fall into three broad and overlapping categories: basic or '' Pure Research ''; studying diseases and developing medicines, also known as '' Applied Research ''; and '' Toxicology testing'' of chemicals, also known as safety testing. See Types Of Experiment below.

The topic is controversial, with supporters and opponents arguing about (mice), Organ Transplant (dogs), and work on Poliomyelitis that led to a vaccine (mice, monkeys). Whether animal research was necessary to achieve these breakthroughs has been questioned by animal rights groups [http://www.peta.org/about/faq-viv.asp and critics of the animal model [http://www.curedisease.com/faqinsulin.htm].

The moral basis of the pro-testing position was summarized by a British s have similar Pain receptors and Central Nervous System pathways and may feel physical pain in the same way, non-human mammals suffer less because they have a reduced capacity to Remember and to Anticipate pain. {Link without Title}
Opponents of animal testing strongly contest these views.


HISTORY

’s dogs with a saliva-catch container and tube surgically implanted in his muzzle. Pavlov Museum, 2005]]
The earliest references to animal testing are found in the writings of the Greeks in the third and fourth centuries BCE, with Aristotle (384-322 BCE) and Erasistratus (304-258 BCE) 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." {Link without Title}

Although the term " Vivisection " means literally the "cutting up" of a living animal, and originally referred only to experiments that involved Dissection of, or Surgery on, live animals, it is now commonly used to refer to any experiment on a living animal, which is also known as '' In Vivo '' testing (Croce 2000). [http://www.britannica.com/ebc/article-9382118?query=Vivisection&ct=

Animals have played a role in numerous well-known experiments. In 1796, Edward Jenner extracted pus from pox-infected cows to inoculate James Phipps against Smallpox . In the 1890s, Ivan Pavlov famously used dogs to describe Classical Conditioning . On November 3 , 1957 a Russian Dog named Laika became the first of many Animals To Orbit The Earth , and in 1996 Dolly The Sheep was born, the first mammal to be Cloned from an adult cell.


REGULATION


United States

In the (IACUC), which is responsible for enforcing the Act. Institutions are subject to unannounced bi-annual inspections. There are 96 inspectors to monitor around 8,800 institutions, including research universities and industry (compared to the UK's 29 inspectors for 230 institutions).

Another regulatory instrument is the Public Health Service 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'' published by the Institute for Laboratory Animal Research, [http://dels.nas.edu/ilar_n/ilarhome/ which includes all vertebrate species in its care protocols, including rodents and birds [http://www.nap.edu/books/0309053773/html/1.html] (Introduction, p.1). In 2004, the species in research, even if they are not covered by federal legislation. OLAW does not carry out scheduled inspections, instead only visiting when there is a suspected or alleged violation.

Some companies and universities also receive accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a non-governmental, nonprofit association, which accredits 680 institutions in 27 countries. Inspections occur once every three years without prior notice. {Link without Title}


Europe

Experiments on vertebrate animals in . {Link without Title}


United Kingdom

mice in a UK laboratory, 2000. Provided by RDS/Wellcome Trust Photographic Library {Link without Title} ]]
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%) {Link without Title} (pdf).

The 1986 Animals (Scientific Procedures) Act 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 licence 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)). [http://www.publications.parliament.uk/pa/ld200102/ldselect/ldanimal/150/15004.htm#a4]

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. There are 29 qualified inspectors covering 230 establishments, which are visited on average 11-12 times a year. [http://scienceandresearch.homeoffice.gov.uk/animal-research/publications/publications/reports-and-reviews/annual-report (See also Animal Procedures Committee .)


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. [http://www.ebra.org/regulat/france.html


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 (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. [http://www.publications.parliament.uk/pa/ld200102/ldselect/ldanimal/150/15004.htm#a10


NUMBER OF ANIMALS AND SPECIES USED


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 {Link without Title} (pdf)
and 1,101,958 in the United States in 2004 (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" [http://www.nuffieldbioethics.org/fileLibrary/pdf/RIA_Report_FINAL-opt.pdf] (pdf). 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 per cent of research animals. The Laboratory Primate Advocacy Group has used these figures to estimate that 23-25 million animals are used in research each year in America. {Link without Title}

Figures released by the British Home Office show that, in 2004, 2,854,944 procedures were carried out on 2,778,692 animals, an increase of 63,000 from 2003. [http://education.guardian.co.uk/businessofresearch/story/0,,1663535,00.html 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 [http://www.buav.org/pdf/UK-Legislation.pdf](pdf).

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".


Species

Listed in descending order of numbers of individual animals used:


Invertebrates

The greatest number of animals used for animal testing are the Invertebrate s, '' Drosophila Melanogaster '' and '' Caenorhabditis Elegans ''. This is in part because of the short generation time of under a week, and in the case of ''C. elegans'' details being known about the precise lineage of all of the organisms cells. However, with the exception of some Cephalopod s, invertebrate species are not protected under most animal research legislation, and therefore the total number of invertebrates used remains unknown.


Rodents

Rats and mice, the most commonly utilized vertebrate species, are used in large proportion because they are small, inexpensive, easy to handle and care for, and can produce up to 100 pups in a year. Mice are considered the prime model of Inherited Human Disease , are Genetically Tractable and share 99% of their Gene s with humans. 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 the U.S., the numbers of rats and mice used are not reported, but are estimated at 15-20 million. [http://www.fbresearch.org/Education/quickfacts.htm


Fish and amphibia

In the UK, 194,562 fish and 18,195 amphibia were used in 2004 {Link without Title} (pdf). 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. Albino rabbits are used in eye irritancy tests because they have less tear flow than other animals. 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 {Link without Title} (pdf).


Dogs

in Leicestershire .


Non-human primates

In the United States, 54,998 non-human primates were used in 2004, according to the U.S. Department Of Agriculture , an annual figure that has been more or less steady since 1973 (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. [http://education.guardian.co.uk/businessofresearch/story/0,,1663535,00.html [http://scienceandresearch.homeoffice.gov.uk/animal-research/publications/reports/267440?view=Html]

Most of the NHPs used are Baboon s, Macaque s, Marmoset s, and Chimpanzee s. The use of Great Apes , also known as Hominidae — humans, Gorilla s, chimpanzees, and Orangutan s — is prohibited in Britain, but chimpanzees are still used in the U.S., with an estimated 1,300 in use at any given time, according to the Humane Society of the United States. {Link without Title}

There are indications that NHP use is on the rise. In the U.S., the Oregon and California National Primate Research Centers and New Iberia Research Center have expanded their facilities; the National Institutes of Health is inviting applications for the establishment of new breeding colonies; and a new breeding colony expected to house 3,000 NHPs is being set up in in the UK is building a new animal-research center that protesters say may house a new primate facility, [http://www.guardian.co.uk/animalrights/story/0,11917,1268819,00.html though Oxford has said that 98% of the animals housed will be rodents and fish, and "there may also be some ... primates." [http://www.admin.ox.ac.uk/biomed/facts.shtml]

Contrary to this, the British government reported in 2004 that "there is a definite long-term downward trend" in the use of NHPs {Link without Title} (pdf, p16).


Cats

In the UK, 819 cats were used in 2004 {Link without Title} (pdf).


TYPES OF EXPERIMENT

Experiments can be split into three broad, overlapping categories.


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 and Armadillo s . In the UK in 2004, 76 macaques, 141 dogs and 204 cats were used in basic research to investigate topics such as social behaviour, vision, nutrition and suckling(pdf).

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





Drug testing

in a UK facility, 2000. Provided by RDS/]
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:



Testing cosmetics on animals

not tested on Animal s carry this symbol]]
logo]]

Cosmetics testing is particularly controversial. It is banned in the , 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. {Link without Title}

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,
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. [http://www.thebodyshopinternational.com/web/tbsgl/values_aat.jsp

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 [http://www.animalaid.org.uk/news/2004/0401boto.htm [http://www.sarconline.co.uk/modules.php?op=modload&name=News&file=article&sid=129&mode=thread&order=0&thold=0&POSTNUKESID=f070fc85519cfcb46ad4f3d2d92abb1c].

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 Culture s 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.


CONTROVERSY


Advocates of animal testing

Testing advocates argue that:
  • It would be unethical to test substances or drug with potentially adverse side-effects on human beings. {Link without Title}

  • Controlled experiments involve introducing only one Variable at a time, which is why animals are experimented on while confined inside a laboratory. Human beings could not be confined in this way. {Link without Title}

  • There is no substitute for the living systems necessary to study interaction among Cell s, Tissue , and Organs . Animals are good Surrogate s because of their similarities to humans. {Link without Title}

  • There is no substitute for Psychiatric Studies (e.g., Antidepressant clinical trials) that require Behavior al data.

  • Animals have shorter life and Reproductive spans, meaning that several generations can be studied in a relatively short time.

  • Animals can be bred especially for animal-testing purposes, meaning they arrive at the laboratory free from disease.

  • Humans in some parts of the world are healthier in large part due to advances in medical research derived from animal testing. {Link without Title}

  • Animals receive more sophisticated medical care because of animal tests that have led to advances in Veterinary Medicine . {Link without Title}

  • There have been several examples of substances causing death or injury to human beings because of inadequate animal testing. {Link without Title}



Opponents of animal testing

Opponents argue that:


ALLEGATIONS OF ABUSE

inside Huntingdon Life Sciences in the UK. The footage showed staff punching and screaming at Beagle s.]]

Undercover investigations by the British Union for the Abolition of Vivisection and People For The Ethical Treatment Of Animals (PETA) have documented and filmed what appear to be examples of animal abuse in laboratories.


Huntingdon Life Sciences

PETA filmed staff inside a British laboratory owned by television in the UK in 1997, as a result of which Stop Huntingdon Animal Cruelty was formed, an international campaign to close HLS. In the United States, HLS technicians were filmed screaming and laughing at monkeys, and appearing to dissect one that was still alive. {Link without Title} (video)


Covance

BUAV filmed 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.

lab during an undercover investigation in 2004-5. {Link without Title}


University of Cambridge

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 Monkey s 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 their Brain s exposed and no Veterinary care, because staff only worked from nine to five.

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: "Cambridge staff work 9-5pm, so animals who had just been brain damaged were left overnight without veterinary attention. Some were found to be dead in the morning, some were found to be in a worse condition. Yet there is an obligation of licence holders to keep suffering to a minimum. The whole system is very secretive and the public does not get to see what is really going on." {Link without Title}

The Cambridge experiments involved the use of hundreds of macaque monkeys, who were deliberately brain damaged for pure- and applied-research purposes, in the interests of research into Stroke s and Parkinson's disease. The macaques were first of all 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. After this, the monkeys were re-tested to determine whether the damage had affected their skills. The macaques were deprived of food and water to encourage them to perform the tasks, both before and after the surgery, with water being withheld for 22 out of every 24 hours for the duration of the experiment, with intermittent respite. [http://www.buav.org/zerooption/video/lessi.mpg (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. [http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWHC/Admin/2005/530.html&query=buav&method=all

The Research Defence Society, a lobby group representing 5,000 medical researchers and institutions in the UK, wrote a summmary of the case, including a description of the macaque research criticized by BUAV. It says: "In fact, for 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." {Link without Title}


University of California, Riverside

say they found him. {Link without Title} ]]


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. {Link without Title} (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, {Link without Title} 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'').


Columbia University

In 2003, according to CNN, a post-doctoral "whistleblowing" , 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.'" {Link without Title}

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" {Link without Title} (pdf).


ALTERNATIVES TO ANIMAL TESTING


Most scientists and governments say they agree that animal testing should cause as little suffering to animals as possible, and that animal tests should only be performed where necessary. The "three Rs" {Link without Title} are guiding Principles for the use of animals in research in many countries:

  • Reduction refers to methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.

  • Replacement refers to the preferred use of non-animal methods over animal methods whenever its possible to achieve the same scientific aim.

  • Refinement refers to methods that alleviate or minimize potential pain, suffering or distress, and enhance animal welfare for the animals still used.


Animal welfare groups are divided in their position on the 'three Rs'; some support the principles while others accept replacement as the only valid action [http://www.carn-age.org.uk/joining.html . There are a number of scientific studies and institutes [http://caat.jhsph.edu/ researching alternatives to animal tests. However, critics say these facilities perpetuate the industry, which estimates more than £300 million (of a total UK R&D budget of £3285 million) is spent on 'three R' development and implementation annually [http://www.abpi.org.uk/press/media_briefings_03/2003/Brief_%20Ani.pdf] (pdf).

The two major, widely accepted alternatives to animal testing under development are Computer Simulation s and '' In Vitro '' cell culture techniques. However, some claim they are not true alternatives since simulations use data from prior animal experiments and cultured cells often require animal derived products, such as Serum . Others say that they cannot replace animals completely as they are unlikely to ever provide enough information about the complex interactions of living systems Examples of computer simulations available include models of diabetes [http://www.entelos.com/science/metabolic.html#diabetes , asthma and drug absorption [http://www.simulations-plus.com/products/gastro_plus/what_is_gastro_plus.html , though though potential new medicines identified using these techniques are currently still required to be verified in animal tests before licensing.

Cell culture is currently the most successful, and promising, alternative to animal use. For example, cultured cells have also been developed to create Monoclonal Antibodies , prior to this production required animals to undergo a procedure likely to cause pain and distress {Link without Title} .

A third alternative now attracting considerable interest is so-called Microdosing , in which the basic behaviour of drugs is assessed using human volunteers receiving doses well below those expected to produce whole-body effects {Link without Title} (pdf).

Institutes researching (and organizations funding) alternatives to animal testing include:


SEE ALSO



REFERENCES



FURTHER READING