Thursday, December 10, 2009

Alternatives: Testing Without Torture

Alternatives: Testing Without Torture

Besides saving countless animal lives, alternatives to animal tests are efficient and reliable. Unlike crude, archaic animal tests, non-animal methods usually take less time to complete, cost only a fraction of what the animal experiments that they replace cost, and are not plagued with species differences that make extrapolation difficult or impossible. Effective, affordable, and humane research methods include studies of human populations, volunteers, and patients as well as sophisticated in vitro, genomic, and computer-modeling techniques.

Forward-thinking companies are exploring modern alternatives. For example, Pharmagene Laboratories, based in Royston, England, is the first company to use only human tissues and sophisticated computer technology in the process of drug development and testing. With tools from molecular biology, biochemistry, and analytical pharmacology, Pharmagene conducts extensive studies of human genes and how drugs affect those genes or the proteins they make. While some companies have used animal tissues for this purpose, Pharmagene scientists believe that the discovery process is much more efficient with human tissues. “If you have information on human genes, what’s the point of going back to animals?” says Pharmagene cofounder Gordon Baxter.(1)

Alternatives to Animals in Research
Comparative studies of human populations allow doctors and scientists to discover the root causes of human diseases and disorders so that preventive action can be taken. Epidemiological studies led to the discoveries of the relationship between smoking and cancer and to the identification of heart disease risk factors.(2) Conversely, tobacco company executives relied on misleading animal-based studies to deny the link between smoking and cancer as recently as 1994.(3)

Population studies demonstrated the mechanism of the transmission of AIDS and other infectious diseases and also showed how these diseases can be prevented, whereas animal studies have produced no real results in terms of preventing or treating AIDS.(4) The National Institutes of Health have reported that more than 80 HIV/AIDS vaccines that have passed animal testing have failed in human clinical trials.(5) As the associate editor of the British Medical Journal stated, “When it comes to testing HIV vaccines, only humans will do.”(6)

In the course of treating patients, much has been learned about the causes of diseases and disorders. Studies of human patients using sophisticated scanning technology (e.g., MRI, fMRI, PET, and CT) have isolated abnormalities in the brains of patients with schizophrenia and other disorders.(7)

Cell and tissue culture (in vitro) studies are used to screen for anti-cancer, anti-AIDS, and other types of drugs, and they are also a means of producing and testing a number of other pharmaceutical products, including vaccines, antibiotics, and therapeutic proteins. The U.S. National Disease Research Interchange provides human tissue to scientists investigating diabetes, cancer, cystic fibrosis, muscular dystrophy, glaucoma, and other human diseases. In vitro genetic research has isolated specific markers, genes, and proteins associated with Alzheimer’s disease, muscular dystrophy, schizophrenia, and other inherited diseases. A 3-dimensional model of breast cancer has recently been developed that will allow investigators to study the earliest stages of breast cancer and test potential treatments. Rather than studying cancer in rodents, this model, which uses both healthy and cancerous human tissue, effectively allows the study of cancer as it develops in humans.(8)

Those who experiment on animals artificially induce disease; clinical investigators study people who are already ill with naturally occurring diseases or who have died. Animal experimenters want a disposable “research subject” who can be manipulated as desired and killed when convenient; clinicians must do no harm to their patients or study participants. Animal experimenters face the unavoidable fact that their artificially created “animal model” can never fully replicate the human condition, whereas clinical investigators know that the results of their work are directly relevant to people.

Alternatives to Animals in Testing
Alternatives to the use of animals in toxicity testing include replacing animal tests with non-animal methods, as well as modifying animal-based tests to reduce the number of animals used and to minimize pain and distress. Non-animal tests are generally faster and less expensive than the animal tests they replace and improve upon.

To date, several non-animal test methods have been formally validated and accepted by some countries as replacements for an existing animal test. Examples include the following:

• An embryonic stem cell test, using mouse-derived cells to assess potential toxicity to developing embryos, has been validated as a partial replacement for birth-defect testing in rats and rabbits.(9)
• The 3T3 Neutral Red Uptake Phototoxicity Test uses cells grown in culture to assess the potential for sunlight-induced (“photo”) irritation to the skin.
• Human skin model tests are now in use, including the validated EpiDerm™ test, which has been accepted almost universally as a total replacement for skin corrosion studies in rabbits.(10)
• The use of human skin leftover from surgical procedures or donated cadavers can be used to measure the rate at which a chemical is able to penetrate the skin.
• Microdosing can provide information on the safety of an experimental drug and how it is metabolized in the body by administering an extremely small one-time dose that is well below the threshold necessary for any potential pharmacologic effect to take place.(11)

While effective non-animal test methods become more and more numerous, animal-based toxicology remains, as researcher Thomas Hartung wrote, “frozen in time, using and accepting the same old animal models again and again, often without stringent examination of their validity.”(12)

For more detailed information about non-animal test methods that are available or under development, visit ECVAM.jrc.it and StopAnimalTests.com.

Alternatives to Animals in Education
The majority of medical schools in the U.S., including Harvard, Stanford, and Yale, have replaced their use of live animals in physiology, pharmacology, and/or surgical-training exercises with humane and effective non-animal teaching methods, including observation of actual human cardiac bypass surgery, patient simulators, cadavers, sophisticated computer programs, and more. An increasing number of veterinary schools have been able to employ similar humane educational alternatives, thereby saving the lives of countless animals who in the past would have been killed for the purposes of dissection or suffered through unnecessary surgeries.

In addition to being more humane, non-animal teaching tools such as computer simulations, multimedia CD-ROMs, and models are also more economical than traditional animal-based teaching exercises.(13) Whereas the “traditional” approach involves the acquisition and disposal of animals on an ongoing basis, purchasing a set of CD-ROMs represents a one-time expenditure for a product that can be used repeatedly for many years. Schools can save tens of thousands of dollars each year by implementing reusable replacements for animal “specimens.”

Studies, including the following examples, have shown that non-animal teaching methods are as effective as animal methods are:

• A study of first-year biology undergraduates found that examination results of those students who used model rats were equivalent to those of students who had performed rat dissections.(14)
• A similar study examined a class of first-year biology students, half of whom used traditional “hands on” laboratories while the remainder used computer software. The knowledge of biology among the computer-taught students increased significantly more than did that of the traditional “hands on” group.(15)
• A study of students who learned anatomy by doing something as simple as building clay sculptures of each body system found that they scored significantly higher on both low- and high-difficulty questions than their classmates who performed animal dissections.(16)

Several Web sites provide descriptions, prices, and ordering information for thousands of alternative learning materials. The following are two excellent databases that focus specifically on alternatives in education:

• Humane Society Veterinary Medical Association
• InterNICHE
• Norwegian Inventory of Audiovisuals (NORINA)

The following animal protection organizations have established “alternatives loan” programs for students who need to borrow a non-animal software program or other teaching tool in order to satisfy a course requirement so that they will not have to bear the financial burden of purchasing the product:

• Ethical Science Education Coalition
617-367-9143
• Humane Society of the United States
301-258-3041
• National Anti-Vivisection Society
1-800-888-NAVS


Some veterinary schools have also established willed body donation programs. These programs allow clients of veterinary clinics to donate the bodies of their companion animals after they have died a natural death. The cadaver can then be used to train students. Animal cadavers obtained in this way are considered “ethically sourced.”(17)

What You Can Do
Nearly all federally funded research is paid for with your tax dollars. Two of the main funders of animal-based research in North America, the U.S. National Institutes of Health and the Canadian Institutes of Health Research, need to hear that you don’t want your tax dollars used to underwrite animal experiments, whatever their purpose.
Write to the heads of the U.S. Environmental Protection Agency, the Food and Drug Administration, the National Toxicology Program, and Health Canada and urge them to stop requiring cruel and obsolete animal tests for pharmaceuticals and to allow companies to substitute in vitro tests.

Whether you are a student, a parent, or a concerned taxpayer, you can act to end the use of animals in your city’s educational system. If you are expected to perform or observe a dissection, talk to your teacher as early as possible about alternative projects. Call the Dissection Hotline at 1-800-922-FROG (3764) for tips on what to say and how to proceed. If there is an animal rights group at your school or in your community, ask for help. Parents can urge their local Parent-Teacher Association to ask the area superintendent of schools or school board to consider a proposal to ban animal-based teaching exercises in public schools or at least give all students the option of doing a non-animal project. It may help to collect signatures on a petition and to present the school board with information on the cruelty of animal-based teaching exercises and on readily available alternatives.

If you are applying to medical or veterinary school, be sure to inquire about the teaching methods at any school that you are considering.

If you own stock in a company that conducts animal tests, introduce a shareholder resolution opposing the use of animals.

Visit www.StopAnimalTests.com to view current action alerts and learn more about how you can help put an end to the harmful use of animals in education.



References
1) Andy Coghlan, “Pioneers Cut Out Animal Experiments,” New Scientist 31 Aug. 1996.
2) Christopher Anderegg et al., “A Critical Look at Animal Experimentation,” Medical Research Modernization Committee, 2002.
3) Stanton Glantz, “A Selection of OSHA Comments on Lung Cancer,” Tobacco.org, last accessed 14 May 2009.
4) Samuel Baron, M.D., et al., Medical Microbiology, 4th ed., University of Texas: Churchill Livingstone Inc., 1996.
5) National Institute of Allergy and Infectious Diseases, “Clinical Trials of HIV Vaccines,” National Institutes of Health, 19 Sept. 2008.
6) Alison Tonks, “Quest for the AIDS Vaccine,” British Medical Journal 334 (2007): 1346-8.
7) Kelvin O. Lim et al., “In Vivo Structural Brain Assessment,” The American College of Neuropsychopharmacology, 2000.
8) Michael Balls, “The Use of Scientifically-Validated In Vitro Tests for Embryotoxicity,” European Centre for the Validation of Alternative Methods, 3 June 2002.
9) Deborah L. Holliday et al., “Novel Multicellular Organotypic Models of Normal and Malignant Breast: Tools for Dissecting the Role of the Microenvironment in Breast Cancer Progression,” Breast Cancer Research,” 11 (2009): R3.
10) Michael Balls, “Statement on the Application of the Epiderm™ Human Skin Model for Skin Corrosivity Testing,” European Centre for the Validation of Alternative Methods, 21 Mar. 2000.
11) Center for Drug Evaluation and Research (CDER). Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, Rockville, Md.: CDER, 2006.
12) Marcel Leist et al., “The Dawning of a New Age of Toxicology,” ALTEX 25 (2008): 102.
13) Jonathan Balcombe, Ph.D., The Use of Animals in Higher Education: Problems, Alternatives, and Recommendations, Washington, D.C.: Humane Society Press, 2000.
14) Balcombe.
15) Balcombe.
16) Waters et al., “Cat Dissection vs. Sculpting Human Structures in Clay: An Analysis of Two Approaches to Undergraduate Human Anatomy Laboratory Education,” Advances in Physiology Education 29 (2005): 27-34.
17) Nick Jukes. “Toward a Humane Veterinary Education,” Journal of Veterinary Medical Education 32.4 (2005): 454-60.

1 comment:

Unknown said...

Amy:

Very nice post on this subject! Thank you for mentioning MatTek's EpiDerm human tissue equivalent and its approval for use as a full replacement to animal testing for measuring the dermal corrosion potential (skin destruction) of a test substance. Another EpiDerm test was recently approved (validated) to replace animals for measuring the skin irritation potential of chemicals and other test substances. MatTek has produced a video of that test method to help scientists around the world learn how to perform this non-animal test method. You and your blog readers may be interested in viewing the first 4 minutes of the video – it explains the test and how EpiDerm tissues are produced. Here is a link to the Web page containing the video:

http://www.mattek.com/pages/abstracts/528

Dave Ingalls
MatTek Corp.
www.mattek.com

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