Helping Make the Miracles of Medicine Happen The Humane Use of Animals in Biomedical Research This workforce solution was funded by a grant awarded under the President’s Community-Based Job Training Grants as implemented by the U.S. Department of Labor’s Employment and Training Administration. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This solution is copyrighted by the institution that created it. Internal use by an organization and/or personal use by an individual for non-commercial purposes is permissible. All other uses require the prior authorization of the copyright owner.

The Drug Development Process The Drug Development Process  Computer Models  Chemical Models  In-Vitro Models  In-Vivo Models  Human Models

 After literature searches and comparison of data to previous research ;  After computer model simulations and cell and/or tissue culture research;  After an IACUC-approved animal use protocol;  After extensive training and education on the handling, care, and use of animals;  But, before HUMAN clinical testing. When are Animals Used in Research?

Do we really have the right to experiment on animals? Do we really have the right to experiment on animals? What about their rights?

Code of Respect for Animals  We will treat animals in our care with respect.  We will strictly follow all applicable laws and regulations for animal treatment.  We will employ alternative scientific methods to animal use where appropriate under applicable regulation and scientific validity.  We will minimize animal discomfort.  We will take steps to ensure that our employees and processes meet these standards.

Humane Treatment of Animals  It is the right thing to do morally and ethically.  When animals are stressed, data research results may be different.  Regulatory guidelines require humane treatment.  Policy and practice does not tolerate animal abuse.  Humane treatment gives animal rights activists no justification to their claims of abuse.

 Organs and body systems similar to humans and other animals;  Susceptible to the same diseases that affect humans;  Short life span allows animals to be studied throughout their entire life;  Environment easily controllable to keep experimental variables to a minimum Why are Animals Used in Research?

What if We Didn’t Use Animals?  Cystic fibrosis - 30,000 young Americans would have little hope of a normal life span  Diabetes - A Cure would be beyond reach  MS - 350,000 people would have little promise for treatments for their symptoms  Schizoprenia ’s of people would be institutionalized  HIV - There would be no hope of finding a safe and effective vaccine  Cancer - Research and treatment would be severely curtailed  Alzheimer’s - Bleak hope of ever finding a cure or more help for patients The bottom line: people and pets would get sick more often, stay sick longer, and die much sooner than they do today.

Examples of Drugs That Were Not Tested in Animals Before Humans  Clioquinol – was not tested before it was introduced in humans in 1930s.  Thalidomide – was not tested in pregnant animals before it was introduced in 1961 for human use.  Sulphanimide (with diethylene glycol) – drove US legislation to test using animal models.  Diethylstilbestrol (DES) - a synthetic form of estrogen used between 1940 and 1971, was not tested on animals and later was found to cause cancer in daughters of women who took it.

Who Benefits From Research...? WE ALL DO...

Examples of Human Benefits from Animal Testing  Smallpox  Polio  Whooping Cough  Insulin for Juvenile Diabetes  Medication for High Blood Pressure  Medication to Control Epilepsy Seizures  Treatment for Asthma Attacks  Bone Marrow Transplants for Leukemia Patients

Animals Also Benefit From Research Animals Also Benefit From Research  Vaccines: canine and feline distemper, feline leukemia distemper, feline leukemia  Surgical procedures: canine hip dysplasia  Treatment for diseases: equine encephalitis, lyme disease, diabetes  Illness  Allergies  Pet Nutrition

Animal Use  In the U.S., million vertebrate animals are used each year for research*  90% of research animals are rats, mice, and other rodents  <1% are dogs and cats  <0.3% are primates  In Europe, percentage breakdown of animal use is similar to U.S.  87% rodents; 0.3% dogs and cats; 0.1% primates  Majority of animals used are bred specifically for this purpose. *Data from US OTA, and

Putting the Numbers into Perspective  The number of animals used in research is <1% of the animals used for food annually.  For each dog or cat used in research 100 animals are killed in pounds or shelters.  Primates make up about 1/3 of 1% of animals used in the USA for research.  Humans are used as research subjects far more often than animals.  Over 15 times more animals are killed by automobiles than are used in research annually.

The 3 R’s of Research 1 Reduction - incorporation of techniques and approaches that decrease the number of animals used in research - tissue sharing - using same animal as control and experimental - eliminating duplication - maintaining a database of information - regarding the species/strain - t he number of animal models used has declined 50% since 1968

The 3 R’s of Research 2 Refinement - Reduction of pain or distress for the animals used in research. The scientific integrity of the research project weighs into refinement decisions. - Use of analgesia/anesthesia - Environmental enrichment - Humane euthanasia

The 3 R’s of Research 3 Replacement - alternative methods used to accomplish the same result(s). - In vitro - invertebrates - computer/plastic models

The All Important 4th R... OUR ROLE Responsibility - to ensure the humane care and use of animals via training. Each Covance employee who works with animals is responsible for following approved laboratory practices which includes husbandry, housing, feeding, and research techniques. Special training is provided to all animal care employees.

Who Regulates Animal Use In Research? USDAUnited States Department of Agriculture NIHNational Institutes of Health IACUCInstitutional Animal Care and Use Committee AAALACAssociation for Assessment and Accreditation of Laboratory Animal Care International FDAFood & Drug Administration (under Good Laboratory Practices) EPAEnvironmental Protection Agency Inside the United States :

Who Regulates Animal Use In Research? Council of Europe Convention ETS (123) Home OfficeDepartment of the UK Government AWC/ERPAnimal Welfare Committee/Ethical Review Process GERMANYFederal Government via the German Animal Welfare Act State Government executes the Act. District Government approves individual tests through a notification process. Veterinary Office licenses laboratories to house and use animals. Ethics Commission oversees non-regulatory studies. Outside the United States :

Where Do We Have Animals at Covance?  Covance Research Products  Pennsylvania, Texas, Michigan, Virginia, California  Purpose-bred animal breeding  Medical device development services  Antibody Production, Processing and Testing  Covance Laboratories North America  Wisconsin, Virginia  Pre-clinical Studies  Covance Laboratories Europe  United Kingdom, Germany  Pre-clinical Studies

Animal Welfare/Animal Rights: Is There a Difference?  Animal Welfare  The humane care and use of animals.  Animal Rights  The belief that animal rights are equal to human rights.  Opposed to all animal research for any reason  “A rat is a pig is a dog is a boy.” -- Ingrid Newkirk, PETA President & Co- Founder  “If the use of animals were to lead to a cure for AIDS/HIV, we’d be against it.”-- Ingrid Newkirk, PETA Remember This!

Animal Rights versus Animal Welfare

 How can we be sure that lost or stolen pets are not used in research?  Why do veterinarians, who are supposed to take care of sick animals, work with researchers who do experiments on them? Frequently Asked Questions about the Use of Animals in Medical Research

 Why is it important to conduct product safety tests on animals when “cruelty-free” products are available?  What happens to animals once an experiment is completed? More Frequently Asked Questions

 Why can’t alternatives such as computer models and cell and tissue cultures replace animals in medical research?  Is it true that nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies? More Frequently Asked Questions

For Questions or Concerns  More information and literature on Covance intranet.  Intranet:  Website:.  Discuss the question or concern with your manager.  Contact a member of your facility’s Crisis Team Here are some of the options available :

Our Dedication to the Animals

With the knowledge gained through research on animals, we can continue improving the lives of not only humans, but our pets, wildlife, and other animals.