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Biomedical Research and Animals

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					WIL Research Labs
       School Name




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   Biomedical Research
       and Animals
Biomedical Research

   History of Legislation
   Evolution of Animal Research
   Medical Advances from Animals




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Paracelsus
   Phillipus Aureolus Theophrastus
    Bombast von Hohenheim
   Concept of Dose-Response

   “All substances are poisons; there is
    none that is not a poison. The right
    dose differentiates a poison and a
    remedy.”

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Early Acts
   1902 Biologics Act
     10Children Died
     Contaminated Diphtheria Toxins

   1906 Pure Food and Drug Act
     USDA   Bureau of Chemistry
     Poison Squads
     Prohibited Misbrandings
     Post-Facto Convictions Only

   1911 Sherley Amendments
     Prohibited       False Therapeutic Claims
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Lash Lure®
   1933
   Eyelash Dye “Lash Lure®”
   p-phenylenediamine
   Sensitize external ocular tissues
   Corneal Ulceration
   17 Women Blinded
   One Death


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Minimata Disease
   Mercury Waste from Acetaldehyde
    Production
   Methyl Mercury
   1956 - Discovered
   Chisso Corporation
   Minimata Bay, Japan
   Effects
   1966 - Release Stopped


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       Thalidomide
    1950s - Morning Sickness
    1960 FDA Review
    Frances Kelsey
    Tingling Extremities
    ~12K Cases Eurasia, Canada
    Phocomelia
    1962 - Banned Worldwide
    Animal Studies
    Revised Data Requirements
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DES




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Medical Advances

     Treatments
     War on Cancer
     Heart Disease
     Current Research




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Early 1900s
   Pellagra treatment developed using
    monkeys, dogs

   Rickets treatment developed using
    dogs

   Cardiac catheterization developed
    using dogs, rabbits

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1920s

   Discovery of thyroxin utilized
    many species

   Discovery of insulin using
    dogs



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1930s
    Tetanus vaccine developed using
     horses

    Anticoagulants were developed
     using cats

    Modern anesthesia developed
     using dogs

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               1940s
                  Rheumatoid arthritis treatments
                   developed using rabbits and monkeys
                  Antibiotics tested on many species
                  Streptomycin used in treating TB,
                   pneumonia, typhoid, and spinal
                   meningitis developed using chickens,
                   guinea pigs
                  Diphtheria vaccines developed using
                   horses
Discovery of
 Rh Factor
                  Whooping cough vaccine created using
                   rabbits, guinea pigs
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    1950s
   Polio vaccine developed using
    rabbits, monkeys, rodents
   DNA discovered using rats, mice
   Chlorpromazine and other
    tranquilizers developed using rats,
    rabbits, monkeys
   Chemotherapy techniques developed
    using monkeys, rabbits, rodents

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1960s

    Rubella vaccine developed using
     monkeys
    Lithium developed for human manic-
     depressives using rats, guinea pigs
    Antipsychotics, antidepressants
     developed using rats, mice



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1970s
   Measles vaccine created using many
    species

   Hansen’s Disease cure developed
    using armadillos, monkeys

   Coronary artery bypass surgery
    developed in dogs


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1980s
     Organ transplant techniques
      advanced using dogs, sheep,
      cows, swine

     Antirejection Drugs

     Gene therapy


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1990s
   Isolation of AIDS Virus

   Laparoscopic Techniques

   Gene Therapy for Cystic Fibrosis

   Breast Cancer Links


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War on Cancer
    Chemotherapeutics
    Radiotherapy

    Chemoprevention




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Heart Disease
   1923 - First Human Open-Heart
    Surgery
   Heart Valve Replacement
   1953 - First Heart-Lung Machine
     600,000         People/Year
   1950s - Cardiac Pacemaker
   1970 - Balloon Angioplasty
     200,000         People/Year

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Current Research
    Multiple Sclerosis
    Muscular Dystrophy
    Cerebral Palsy
    Sickle-Cell Anemia
    Parkinson’s Disease
    ALS
    Alzheimer’s Disease
    AIDS

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     Toxicology Defined

   A science that deals with poisons
    and their effect and with the
    problems involved (as clinical,
    industrial or legal)




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Government
   Internationally Mandated Safety Testing
     Pharmaceuticals
     Environmental Chemicals
     Workplace Chemicals
     Household Chemicals
     Cosmetics
     Food
     Animal Medicine



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Environmental Chemicals
         EPA
         MAFF

         Pesticides
         PCBs
         Petroleum
         Solvents
         Lead

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Developmental Toxicology
      Maternal Toxicity
      In Utero Exposure
          Death, Malformation, Growth
            Retardation, Functional Deficit
      Malformations
          Variations
          Historical         Control


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    Reproductive Toxicology
   Gonadal Function, Estrous Cyclicity,
    Mating Behavior, Conception, Gestation,
    Parturition, Lactation, Weaning, Offspring
    Growth and Development

   Two-generation study
     F0 - Prior to Mating and through Breeding
     F1- In Utero through Breeding
     F2- Cumulative Effects

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Statistical Requirements



       vs.




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In-Vitro Assays
     Screens
     Limited Acceptability
       Poor       correlation with in-vivo tests
     Skin 2/Corrositex
     Whole-Animal Test




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Department of Agriculture
   Animal Welfare Act (AWA)

   Animal and Plant Health
    Inspection Service (APHIS)

   Regulatory Enforcement and
    Animal Care (REAC)


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Animal Welfare Act (9 CFR 1-4)
       All Research Facilities Using Live
        Animals Except: Birds, Rats, Mice
       Registration, Identification, Records
       Prohibits Use of Stolen Animals
       Attending Veterinarian
       Minimum Standards of Care
       Exercise, Socialization


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IACUC Membership
   A doctor of veterinary medicine
   At least one public member
     Not affiliated with institution
     Not a laboratory animal user
     Not immediate family of an employee

   At least one practicing scientist involved
    with laboratory animals
   One nonscientific member

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IACUC Inspections
    Facility Review
      Requiredby law every six months
      Review animal areas
      Review activity areas (e.g., necropsy)

    Surprise Inspections
      Conducted at least monthly
      Observe animal procedures




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      Animal Activism
   Animal Welfare v. Animal Rights
   1992 - Animal Enterprise Protection Act
     Federal Crime to cause damage in
      excess of $10,000
   “A rat is a pig is a dog is a boy.”
     Ingrid   Newkirk



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Animal Sources
   Tightly Regulated by USDA

   Controlled Source

   Purpose-Bred

   Transgenic Models

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Research Facilities
   Standard Operating Procedures
   Environmental Concerns
     Temperature
     Humidity
     Lighting

   Caging
     Construction
     Size
     Maintenance

   Waste Disposal
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Animal Husbandry

      Feeding
      Watering
      Sanitation
      Separation
      Veterinary Care



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    Mice
   Hold gently, but firmly
   Grasp tail near base for removal from cage
   Scruff Hold (Grasp skin at base of neck,
    tail held between fourth and fifth fingers
   Clear Plastic Restraint Devices
     When   additional restraint is required
     Adjustable Size
     Easily Sanitized



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Rats
   Hold firmly, but without excessive
    pressure
   Gasp tail near base for removal from
    cage
   Hold around thorax, just behind
    forelimbs
   Tail and/or hindlimbs may be restrained
    if necessary
   Monitor breathing to ensure it is
    unrestricted
   Clear Plastic Restraint Devices
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Rats
    Teeth can become malaligned:
     must be trimmed because they
     grow throughout life
    Take care to prevent sloughing of
     tail
    Group house to aid in acclimation
     to automatic water system



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Guinea Pigs
   Hold firmly, but without excessive
    pressure
   Hold around pectoral girdle, with thumb
    and forefingers directly behind forelimbs
   Support hindquarters
   Easy to handle due to docile nature and
    limited agility
   Prone to wandering off working surfaces
   Prone to vocalization during handling
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Rabbits
   Gentle but firm manual restraint
   Use scruff hold while supporting back
    and hindquarters
   Tuck rump under arm or support back in
    crook of arm for thorough examination
   Allow rabbit to tuck head in crook of arm
   Never restrain by grasping the ears
   Hindquarters support prevents injury to
    animal and handler
   Avoid loud or sudden sounds
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Canine Exercise

   Mandated by the AWA
   By group and sex
   Use anteroom
   Clean room between rounds, prevent
    exposure to contaminated excreta




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Ruminants
    Safety
       Horns
       Hooves

    Manual Restraint
    Mechanical Restraint
       Cages
       Slings
       Head        Gates
    Chemical Restraint
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Nonhuman Primates

    Why nonhuman primates?
    Socialization
    Enrichment
    Safety Training
        Serology
        PPE




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