Their life before death… 70,000-75,000 dogs are used for research in the U.S. annually. In 2012, 72,149 dogs were held in laboratories, with over 25,000 subjected to painful experiments. Beagle dogs are a favored species in toxicology studies as they’re small, docile and easy to handle. Charles River claims EACH test is for a 26-week period, and C.R. continues testing OVER and OVER for the life of the dog. Pain and distress are often part of the testing protocol. Charles River was founded in 1947 and has 70 facilities in 70 countries with headquarters in Wilmington, Massachusetts. In the fiscal year ending in December of 2010, the company reported sales of approximately $1.133 billion dollars and had 7,500 employees. Animals differ to humans in anatomy, biochemistry, physiology, pharmacokinetics, and toxic responses, and test results are often flawed. Alternative methods, especially incorporating human cells and tissues, are more predictable to humans. Animal Studies Do Not Reliably Predict Human Outcomes
- Acetaminophen, for example, is poisonous to cats, but is therapeutic in humans.
- Penicillin is toxic in guinea pigs, but has been an invaluable tool in human medicine.
- Morphine causes hyper-excitement in cats, but has a calming effect in humans.
- Oral contraceptives prolong blood-clotting times in dogs, but increase a human’s risk of developing blood clots.
Many more such examples exist. Even within the same species, disparities can be found among different sexes, breeds, age and weight ranges, and ethnic backgrounds. Also, psychopathology, cancer, drug addiction, Alzheimer’s, and AIDS, are species-specific. As a result, accurately translating information from animal studies to human patients can be an exercise in speculation. Reliance On Animal Experimentation Can Impede and Delay Discovery Drugs and procedures that could be effective in humans may never be developed because they fail in animal studies. Some notable cases: Lipitor, (reduces cholesterol), did not seem promising in early animal experiments, but when the drug was tested on human volunteers – its effectiveness was demonstrated. Smoking significantly increases the risk of lung cancer. However, researchers wasted time, money, effort, and animal lives trying to create an effective animal model for the inhalation tests. 30 years later the U.S. Surgeon General finally issued the warning on cigarettes. The polio vaccine. Researchers spent decades infecting non-human primates with the disease, and conducting other animal experiments, but failed to produce a vaccine. The key event, which led directly to the vaccine and a Nobel Prize, occurred when researchers grew the virus in human cell cultures in vitro. Pfizer reported in 2004 that it had wasted more than $2 billion over the past decade on drugs that “failed in advanced human testing or, in a few instances, were forced off the market because of liver toxicity problems.” The FDA has reported that “adverse events associated with drugs are the single leading contributor to preventable patient injury, may take the lives of up to 100,000 Americans, account for more than 3 million hospital admissions, and increase the nation’s hospitalization bill by up to $17 billion each year.” The agency estimates that drug-related injuries outside the hospital add $76.6 billion to health care costs. The dogs deserve a chance to live out their lives in a home environment. It is not unreasonable to require a two-year limit of testing procedures; and given a timeframe, researchers will be encouraged to explore the in-vitro procedures that are currently available as well as those processes in the developmental stage. Having a two-year limit on testing of the dogs is not only possible, but it is more HUMANE. Alternatives Used in the US In the U.S., the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) lists the following information: National Library of Medicine Visible Human Project utilized actual human cadaver cross-sections, CAT scans, and computer programs to develop new surgical techniques and research perspective. Organotypic cultures of human brain slices are used to study neurobiochemistry, neurophysiology, and drug efficacy. I-MAb Gas Permeable Tissue Culture Bags are used to produce monoclonal antibodies for research diagnostic and clinical purposes. Developed by the ARDF, could replace up to one million mice a year. Short, direct non-invasive magnetic pulses allow precise stimulation of brain cells/regions in human volunteers for neurosciences. Use of mathematical models and computer simulations in physiology, cardiovascular, pharmacology, and neurosciences (e.g., neural networks). Use of non-invasive functional magnetic resonance imaging (fMRI) and magnetoencephalography (MEG) to study neuroanatomy and neurophysiology in human patients and volunteers. Use of three-dimensional human cell cultures to study drug penetration and characteristics of the blood-brain barrier. Use of echocardiography, color-coded dopler imaging and abdominal sonography as non-invasive methods for cardiovascular research in human patients and volunteers. Use of normal and pathological human cell and tissue cultures to identify disease processes and treatments. Use of three-dimensional bioengineered human skin cultures to study effects of burns and ultraviolet exposure.
- Acute Toxicity In Vitro Starting Procedure, 3T3 Cells
Using rodent cells to estimate starting doses for in vitro acute oral toxicity tests, this 3T3 basal cytotoxicity test is a reduction method that minimizes the number of animals used in each procedure.
- Acute Toxicity In Vitro Starting Procedure, NHK Cells
This NHK basal cytotoxicity method uses human cells to estimate starting doses for in vivo acute oral toxicity tests, reducing the number of animals used for each test.
- Bovine Corneal Opacity and Permeability (BCOP) Test Method
An in vitro test for detecting eye irritants, the BCOP test method uses tissues obtained from slaughterhouses to replace the use of live animals. Federal agencies have accepted ICCVAM’s recommendation to use this test for identification of products that may cause severe or permanent eye damage. However, live animals must still be used to confirm negative results.
- Isolated Chicken Eye (ICE) Test Method
The ICE test method uses tissue obtained from slaughterhouses, which would otherwise be discarded, to detect eye irritants. Federal agencies have accepted ICCVAM’s recommendation to use this test for identification of products that may cause severe or permanent eye damage. Live animals, however, must still be used to confirm negative results.
An in vitro test to determine skin corrosion, Corrositex® uses a biomembrane and chemical detection system that changes color when in contact with corrosive substances. In some cases, this could replace the use of rabbits in corrosivity research; however, ICCVAM concluded that in certain cases Corrositex® should be used in conjunction with animal tests.
A model of reconstructed human epithelium, developed to test skin corrosion. This method was first validated by the European Coalition on the Validation of Alternative Methods (ECVAM) as a complete replacement for animal tests. In contrast, ICCVAM has validated EPISKINTM for reduction purposes, suggesting that some substances may need to be tested on animals after using this method.
Used in the study of skin corrosion and toxicology, EpiDermTM is a layered model of human-derived epidermal keratinocytes. This method was first approved by ECVAM for use as a stand-alone assay. However, ICCVAM recommended that EpiDermTM be used only as part of a tiered assessment strategy, which may or may not involve animals.
- Rat Skin Transcutaneous Electrical Resistance (TER) Assay
Replacing the use of rabbits in skin corrosivity tests, the Rat Skin TER Assay utilizes rat skin samples instead. Despite the fact that ECVAM recommended the Rat Skin TER Assay for use in all corrosivity tests, ICCVAM deemed this method unreliable in testing certain classes of chemicals, and suggested that traditional animal studies still be used.
- Murine Local Lymph Node Assay (LLNA)
The Murine LLNA is used as an alternative to guinea pig tests that screen for allergic reactions on the skin. Unfortunately, the Murine LLNA uses mice as a substitute to test substances topically.
- Up-and-Down Procedure (UDP)
Used to estimate acute oral toxicity, the UDP is an in vivo test that reduces the number of rodents used.
- Ames Test
This test has been used for years prior to the passage of ICCVAM. Uses specific strains of common bacteria to detect genetic changes caused by test substances.
In vitro Pyrogen