ANIMAL EXPERIMENTAT

ION

C h a n d a n S a h a

ANIMAL EXPERIMENTATION, also known as animal testing, animal research, and in vivo testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study.

Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 150 million used annually

TYPES OF ANIMAL TESTING

Fundamental Research• ‘Fundamental’ biological research is designed to answer ‘interesting’

scientific questions that animal researchers speculate might be useful medically in the future. Fundamental biological research constitutes the most common use of animals in experiments around the world.

• The likelihood of such speculative research actually leading to advances in human medicine is very slim. For example, a review of 101 high impact discoveries based on fundamental animal experiments found that only 5% resulted in approved treatments within 20 years.

Genetically Modifying Animals• The use of genetically modified animals (GM) has been an increasing trend

for the last 20 years. Mice and other animals are being bred with specific genes ‘knocked out (deleted)’ or ‘knocked in (inserted)’ into the cells of their bodies. These genes are known to be important in human medical conditions.

• Psychological Research - Psychological research often involves controlling the eating, movement or choices of experimental animals and as such may cause distress and frustration.

TYPES OF ANIMAL TESTING (cont.)

Testing For Regulations• Regulatory testing is standardized testing designed to see if medicines,

chemicals (including paints, dyes, inks, petrol products, solvents, tars and waste materials), cosmetics and other products are safe for use, and that they do their job effectively.

• In these experiments, animals are forced to eat or inhale substances, or have them rubbed onto their skin or injected into their bodies. The animals are then subjected to further monitoring and testing before almost always being killed, so that researchers can look at the effects on their tissues and organs.

GLOBAL ANIMAL EXPERIMENTS

• Top 10 animal testing countries in the world are the USA, Japan, China, Australia, France, Canada, the UK, Germany, Taiwan and Brazil, in that order.

• Animal experiments are sadly not in decline, and in many parts of the world are on the increase (e.g. China) or remain at the same level as they were in the 1980s or 1990s (e.g. the UK, Europe).

EUROPEAN UNION ANIMAL EXPERIMENTS• The latest figures show that in 2015, almost 11.5 million animals were used in

experiments across Europe, only a slight decrease on 2008. France, Germany and the UK were the top 3 users of animals in experiments, in that order.

• The countries of the EU in 2011 reported that they used 17,896 dogs, 3,713 cats, 358,213 rabbits, 6,686 horses, 6,095 monkeys, 675,065 birds, 77,280 pigs, 28,892 sheep, 30,914 cattle, over 1,000,000 fish and over 8,500,000 rodents.

• Fundamental biological research accounts for 46% of the total number of experiments, while the use of animals for research and development of human and veterinary medicines only accounts for 19% of the total number used.

• 34% of old world monkeys are still imported from non-EU countries. France, Germany and the UK are the biggest users of monkeys, in that order.

• Six of the EU countries conducted a total of 977 animal tests for household products, with Denmark as the biggest tester.

WHY ANIMAL TESTING SHOULD BE REPLACED?

• Alternative testing methods now exist that can replace the need for animals.

• Animals are very different from human beings and therefore make poor test subjects.

• Drugs that pass animal tests are not necessarily safe.• Animal tests may mislead researchers into ignoring potential cures and

treatments.• 95% of animals used in experiments are not protected by the Animal

Welfare Act.• Animal tests do not reliably predict results in human beings.• Animal tests are more expensive than alternative methods and are a waste

of government research money.• Most experiments involving animals are flawed, wasting the lives of the

animal subjects.• Animals can suffer like humans do, so it is speciesism to experiment on

them while we refrain from experimenting on humans.

THE THREE Rs

The Three Rs (3Rs) in relation to science are guiding principles for more ethical use of animals in testing. They were first described by W. M. S. Russell and R. L. Burch in 1959

• Replacement• Reduction• Refinement

REPLACEMENT

• Higher animal to lower animal, like- Microorganism, Plants, Eggs, Reptiles, Amphibians, and invertebrates

• Live animal may be replaced by Non-animal Model, such as dummies and dissection, mechanical or computer model

ADVANTAGE• Utilizing pre-existing knowledge• Applying known principal to new system• Less expensive animal model to screen large no of agents for toxicity

DISADVANTAGE• Some unique reaction can’t be noticed in model

REDUCTION

• Minimizing the number of animal needed to perform an experiment• Performing pilot studies to determine sum of the potential problem• Designing the study to utilize animal• Gathering maximum amount of information from each animal• Statistical pattern study• Performing appropriate literature

REFINEMENT

• Refining experimental protocol to minimize pain or distress• Identifying pain and distress and making plans for preventing or relieving it• Relieving adequate training prior to performing a procedure• Ensuring that procedure with going to take for an experiment on the animal

are reasonable for the species• Using proper anesthetics• Performing appropriate post-surgical care

BATESON'S CUBE

Bateson's cube is a model of the cost–benefit analysis for animal research developed by Professor Patrick Bateson, president of the Zoological Society of London.Bateson's cube evaluates proposed research through three criteria:• the degree of animal suffering• the quality of the research• the potential medical benefitBateson suggested that research that does not meet these requirements should not be approved or performed, in accordance with the Animals (Scientific Procedures) Act 1986.

ALTERNATIVES TO ANIMAL TESTING

IN VITRO TESTING• Harvard’s Wyss Institute has created “organs-on-chips” that contain human cells grown

in a state-of-the-art system to mimic the structure and function of human organs and organ systems. The chips can be used instead of animals in disease research, drug testing, and toxicity testing and have been shown to replicate human physiology, diseases, and drug responses more accurately than crude animal experiments do.

• A variety of cell-based tests and tissue models can be used to assess the safety of drugs, chemicals, cosmetics, and consumer products.

• CeeTox developed a human cell–derived skin model that replicates key traits of normal human skin. It replaces the use of guinea pigs or mice, who would have been injected with a substance or had it applied to their shaved skin to determine an allergic response.

• Researchers at the European Union Reference Library for alternatives to animal testing developed five different tests that use human blood cells to detect contaminants in drugs that cause a potentially dangerous fever response when they enter the body. The non-animal methods replace the crude use of rabbits in this painful procedure.

ALTERNATIVES TO ANIMAL TESTING (Cont.)

COMPUTER MODELING• Researchers have developed a wide range of sophisticated computer

models that simulate human biology and the progression of developing diseases. Studies show that these models can accurately predict the ways that new drugs will react in the human body and replace the use of animals in exploratory research and many standard drug tests.

• Quantitative structure-activity relationships (QSARs) are computer-based techniques that can replace animal tests. Companies and governments are increasingly using QSAR tools to avoid animal testing of chemicals.

ALTERNATIVES TO ANIMAL TESTING (Cont.)

RESEARCH WITH HUMAN VOLUNTEERS• A method called “micro dosing” can provide vital information on the safety

of an experimental drug and how it is metabolized in humans prior to large-scale human trials. Volunteers are given an extremely small one-time drug dose, and sophisticated imaging techniques are used to monitor how the drug behaves in the body.

• Advanced brain imaging and recording techniques—such as Functional Magnetic Resonance Imaging (fMRI)—with human volunteers can be used to replace experiments in which rats, cats, and monkeys have their brains damaged.

• Strikingly life-like computerized human-patient simulators that breathe, bleed, talk, and even “die” have been shown to teach students physiology and pharmacology better than crude exercises that involve cutting up animals.

• For more advanced medical training, systems like TraumaMan—which replicates a breathing, bleeding human torso and has realistic layers of skin and tissue, ribs, and internal organs—are widely used to teach emergency surgical procedures.

ALTERNATIVES ARE BETTER

• Crude skin allergy tests in guinea pigs only predict human reactions 72% of the time. But a combination of chemistry and cell-based alternative methods has been shown to accurately predict human reactions 90% of the time.

• The Draize skin irritation test in rabbits can only predict human skin reactions 60% of the time. But using reconstituted human skin is up to 86% accurate.

• The standard test on pregnant rats to find out if chemicals or drugs may harm the developing baby can only detect 60% of dangerous substances. But a cell-based alternative has 100% accuracy at detecting very toxic chemicals.

• The cruel and unreliable toxin testing on live mice has now been fully replaced with a far superior analytical chemistry method that is better at protecting humans.

ROLE OF ANIMAL WELFARE ORGANIZATIONS

Animal welfare organizations promotes non-animal research methods and coordinates the scientific and regulatory expertise of its members. They brings scientific expertise and extensive knowledge of the international regulatory environment to the development of testing protocols.

India has a number of domestic animal welfare organizations, as well as chapters of international animal nonprofits including-

• People for the Ethical Treatment of Animals• World Animal Protections• Humane Society International• In Defense of Animals• Animal Welfare and Protection Trust

Alternative methods endorsed by the European Union Reference Laboratory for Alternatives to Animal Testing, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and/or the Organization for Economic Co-operation and Development (OECD) are can find in bellow link- http://www.piscltd.org.uk/alternatives-approved-by-regulators/

WHAT & HOW THEY DO

They and their members are involved in the development, validation, global implementation and harmonization of alternatives to testing on animals including:

• Advising its members with regard to providing financial support toward the development and validation of non-animal test methods

• Organizing expert working groups to tackle the development of new methods to address regulatory requirements when non-animal methods do not exist or require further optimization

• Providing technical support to companies and researchers seeking to replace, reduce or refine the use of animal tests

• Publishing manuscripts, developing technical analyses, presenting posters at international scientific conferences and hosting webinars to ensure that information regarding the use of alternatives methods is accessible to all audiences

• Interacting with national and international regulatory bodies and standards organizations to ensure that opportunities exist to increase and harmonies the use of validated non-animal test methods

INDIA ON ANIMAL EXPERIMENTATION

• In 1960 - The Prevention of Cruelty to Animals Act, 1960, criminalizes cruelty to animals, though exceptions are made for the treatment of animals used for food and scientific experiments.

• India's 1960 anti-cruelty law created the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) to regulate animal experimentation.

• The objective of CPCSEA is to ensure that animals are not subjected to unnecessary pains or suffering before, during or after performance of experiments on them. For this purpose, under the delegated powers, the Committee formulated the ‘Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998’ which were amended in 2001 and then in 2006, to regulate the experimentation on animals.

• Federation of Indian Animal Protection Organizations (FIAPO) is a collective of animal protection organizations in India to help, represent, connect up, and inform, animal protection organizations and activists across India.

ON THE WAY

• The Ministry of Environment and Forests (MoEF) advised the MCI to replace the use of animals in teaching with modern non-animal methods, such as simulation software, for both graduate and post-graduate medical students. (2012)

• Minister of State for Human Resources Development, the Medical Council of India (MCI) has amended its education regulations to call for the use of modern non-animal teaching methods. (May, 2014)

• Rule “148-C. prohibition of testing of cosmetics on animals – No person shall use any animal for testing of cosmetics”. (May, 2014)

• The Indian Ministry of Health & Family Welfare has officially banned animal-tested cosmetics from being imported into India. Rule “135-B. Import of cosmetics tested on animals prohibited. (Oct, 2014)

• India Ends Re-Testing of Drugs on Animals for New Drug Registrations (March, 2016)

• The Ministry of Health & Family Welfare has prohibited the use of Draize irritation tests using rabbits. (Nov, 2016)

• Veterinary Council of India Minimum Standards of Veterinary Education Regulations, 2016, will change the way students are taught veterinary science in India. The new regulations phase out calf killing, introduce computer simulation, require an ethically sourced body-donation program to be set up, and call for other humane teaching methods to be used.

• Through a recently released notification in The Gazette of India, the Ministry of Health & Family Welfare has progressed towards humane drug-products testing by mandating the use of currently available non-animal test methods instead of forcing rabbits to endure eye and skin irritation and corrosion tests. (Nov, 2016)

GREAT EXAMPLE

THE NETHERLANDS has already passed a MOTION IN PARLIAMENT to phase out experiments on non-human primates, and now, its goal is to be using only human-relevant, non-animal testing methods by 2025.

• The law requires that each institution installs an Animal Welfare Body (AWB, or IvD in Dutch). The tasks of the AWB are to advise personnel and implement procedures regarding animal welfare, the 3 R's, new technical an scientific developments and supervise the design and execution of animal experiments.

• This ground-breaking decision is the first of its kind taken by any country. It reflects both today’s innovations in cutting-edge science and changing attitudes about the morality of using animals in experiments.

During a government meeting about funding for research, former U.S. National Institutes of Health director Dr. Elias Zerhouni admitted that experimenting on animals to help humans has been a major failure. He told his colleagues:

“We have moved away from studying human disease in humans. … We all drank the Kool-Aid on that one, me included. … The problem is that [animal testing] hasn’t worked, and it’s time we stopped dancing around the problem. … We need to refocus and adapt new methodologies for use in humans to understand disease biology in humans.” —Dr. Elias Zerhouni

CONCLUSION

Each of us can help prevent animal suffering and deaths by buying cruelty-free products, donating only to charities that don’t experiment on animals, requesting alternatives to animal dissection, demanding the immediate implementation of human, effective non-animal tests by government agencies and corporations.With the help of Animal Welfare Organizations and supporters we can expose and end the use of animals in experiments. Doing-

• Groundbreaking undercover work and campaigns to educate the public• Pushing government agencies to stop funding and conducting experiments

on animals• Encouraging pharmaceutical, chemical, and consumer product companies to

replace tests on animals with more effective non-animal methods• Helping students and teachers end dissection in the classroom• Funding humane non-animal research• Publishing scientific papers on the superiority of non-animal test methods• Urging health charities not to invest in dead-end tests on animals

REFERENCES

• https://en.wikipedia.org/wiki/Animal_Welfare_Board_of_India• https://en.wikipedia.org/wiki/Animal_welfare_and_rights_in_India• https://en.wikipedia.org/wiki/Federation_of_Indian_Animal_Protection_Organisations• http://www.petaindia.com/issues/animals-experimentation/• http://www.petaindia.com/living/products/caring-consumer/• http://features.peta.org/cruelty-free-company-search/cruelty_free_companies_search.aspx?Country=88• http://www.petaindia.com/blog/?page_38_10_0=61• http://www.petaindia.com/issues/animals-experimentation/• http://animal-testing.procon.org/• http://animalsaustralia.org/issues/animal_experimentation.php• http://www.bbc.co.uk/ethics/animals/using/experiments_1.shtml• http://www.statisticbrain.com/animal-testing-statistics/• https://www.crueltyfreeinternational.org/why-we-do-it/facts-and-figures-animal-testing• http://www.humaneresearch.org.au/statistics/• http://www.humaneresearch.org.au/statistics/statistics_2014• https://www.dosomething.org/us/facts/11-facts-about-animal-testing• https://en.wikipedia.org/wiki/Animal_testing• https://en.wikipedia.org/wiki/Animal_rights• https://en.wikipedia.org/wiki/Laboratory_animal_sources• http://www.peta.org/issues/animals-used-for-experimentation/animal-testing-101/• http://www.peta.org/issues/animals-used-for-experimentation/animals-laboratories/• http://www.peta.org/issues/animals-used-for-experimentation/primates-laboratories/• http://www.peta.org/issues/animals-used-for-experimentation/alternatives-animal-testing/

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