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Progress — Minus The Animals
Kinship Circle Presentations, 2013

MADE FOR YOU: Promote human-focused research instead of animals. Bookmark this page to use for letters, articles, academics, media sound-bites… This year, Kinship Circle's Brenda Shoss presented on vivisection and strides in animal-free biotechnology in: Rome, Italy; Gainesville, FL; Washington DC; St. Louis; and Los Angeles. After recent talks for AR2013 and The Ethical Society, she streamlined extensive research into a page of compelling and timely facts. U.S. CITIZENS CAN TAKE ACTION: Urge regulators to approve more non-animal methods, so product developers aren't required to conduct animal experiments.

OBSTACLES TO CHANGING THE RESEARCH STATUS QUO
►  MEDICAL GROUPIES: God-like reverence for doctors and all forms of
      medical research. White-coat heroes. Seen as gatekeepers to life-death.
►  MEDIA TABOO: Sacred-cow subject. Beyond scrutiny in TV, film, news.


1. MOVIE: Multi-Billion Dollar Lie - Animal Experimentation
As part of her presentation, Kinship Circle's Brenda Shoss showed Multi-Billion Dollar Lie. Data from animals artificially induced with human disease or injury is non-predictive, with potential to mislead experimenters. Plus, no medical degree is required to recognize systematic infliction of pain as indefensible. If you care about taxpayer waste, human health, medical progress and animals…you can help make animal research a mainstream concern.


2. ECONOMIC ISSUES: Government overspending; Taxpayer waste; Corporate-political corruption…

An estimated 12-18 billion taxpayer dollars annually fund animal research. National Institutes of Health is a chief grant giver. The full scope of cross-agency funding for a system flawed by duplication, fraud and human harm is unknown.

EXAMPLES / TAX DOLLAR WASTE & INSIDER CORRUPTION
  • $3 MILLION (SO FAR): A decades-long Univ. of Wisconsin-Madison sound localization lab mangles cats to gain data on how human brains process sound. Holes are drilled in a cat's brain to screw in a steel column that stops head motion. Second surgery opens cat's head to destroy inner ears and lodge electrodes. The cat awakens deaf to undergo drills…before killed to dissect her brain. "Funding violent experiments on cats means $3 million less is spent on research to actually improve human health. This can be conducted ethically with sophisticated brain imaging-recording techniques in humans." Dr. Lawrence Hansen, neuroscience-pathology professor, Univ. Calif-San Diego; named in top 100 brain researchers, Journal of Alzheimer's Disease.

  • $5,075,798 (SO FAR): Maternal deprivation tests in infant monkeys began (1960s) with Harry Harlow's Well Of Despair. Univ. of Wisconsin still places infants, within 24 hours of birth, with a live snake or wire "surrogate peer" to simulate adverse rearing conditions. They're further traumatized with human intruder "skits," brain scans, spinal taps, etc. before killed for brain dissection. The mom-baby bond is well-documented. 10-year NIH study: Isolated infant monkeys self-mutilate, etc. Testing for half century+ wastes time, money.

  • ACADEMIC RESEARCH: A highly competitive grant culture creates pressure to churn out protocols, regardless of existing data or scientific validity. Schools get grants that help pay for overhead unrelated to labs. Quick money comes from animals, not human-focused clinical or cell-line studies. "NIH under-funds patient-oriented research," (Committee on Addressing Career Paths for Clinical Research. Nat'l Academy Press, Bethesda, MD) with biggest cut for animal studies.

  • BIG PHARMA & ACADEMIA - FORGING MILLION-DOLLAR RELATIONSHIPS: "Big Pharma and an academic institution agree jointly on which projects to fund, and in return for financing, company gets first option to commercialize results." Sharing An Umbrella, MoFo Tech (science/tech-based trends) 2012.


3. HEALTH & SAFETY ISSUES: Drug recalls; Flawed baseline for product development; Delayed progress…

BASELINE FOR ALL MEDICAL PRODUCT DEVELOPMENT?
  • Animal data creates false assumptions that speed new drugs from clinical trials to market, with unforeseen adverse drug reactions. I.E., Mice, the go-to human disease model, supply 100% inaccurate data for sepsis, burns, trauma. Species discrepancy may render mice useless in cancer and heart disease tests as well. For sepsis (full-body inflammation from infection) investigators found that humans suppress a gene similar to a gene actively used in mice. When researchers disable this gene in lab mice, a test drug is successful. In humans, the same variable ups fatality. Genomic responses in mouse models poorly mimic human inflammatory diseases. National Academy of Sciences, Feb 2013.

  • The animal model presumes an effect in one species occurs in another. Yet science says genetic, metabolic, physiological and psychological traits vary significantly from species to species. A drug metabolized in a pig, dog or mouse doesn't look like the same drug in a person. Its physiological pathways (way a drug interacts with body parts) are unique in each species.

  • ADVERSE DRUG REACTIONS ARE 4TH LEADING CAUSE OF U.S. DEATH (FDA). 2 million+ people annually suffer ADR disability and hospitalization; 100,000 die (Journal of American Medical Association). FDA records show 1,734 drug recalls, 2004-2011. But recalls average once a month, say Brigham & Women's Hospital researchers (2012 Archives of Internal Medicine). FDA recalls just half of Class 1 medical products that may harm or kill humans.

EXPERIMENTERS SAY REPETITION = ANSWERS.
  • ANIMALS EXIST IN PERPETUAL DISTRESS from handling, confinement, noise, isolation, pain, fear… Stress hormones influence animal data (Laboratory Animal Science 2004). Repeating the same experiments again and again, for decades, is a hard sell — given the lack of cures from animals induced with human disease/injury in settings humans never encounter.

  • SUBJECTIVE SCIENCE, CAN'T BE REPLICATED: One 2012 study found 47 of 53 landmark findings can't even be reproduced! "It was shocking. Pharmaceutical industry relies on these findings" (Journal: Nature, March 2012, C. Glenn Begley, former head of global cancer research at Amgen). Failure was blamed, in part, on animal models irrelevant to diseases, in an arena that fosters poor science, even fraud, as researchers fight for funds.


4. KNOW THE FACT-BASED TRUTH. BE A SOUND-BITE: Source industry information — not animal rights groups.

WHERE DO YOU FIND CREDIBLE STUDIES, STATS, QUOTES?
  • REFERENCE ANIMAL-USE INDUSTRY JOURNALS, PAPERS, WEBSITES: I.E., While researching Kinship Circle educational literature, I read a smoking (tobacco) study abstract that stated: Results are inconclusive because no animal mimics evidence found in studies of human smokers.

  • OVERSIGHT AND INSPECTION AGENCIES: I.E., U.S. Food & Drug Administration (FDA) devotes a website page to adverse drug effects (ADRs), the 4th leading cause of U.S. death. By law, all drugs are animal-tested.

  • NEWS REPORTS: I.E., A 2013 report that swept media outlets dubbed mice, the go-to model for human disease, 100% inaccurate as data sources for inflammatory diseases — plus all immune studies, including cancer and heart disease (Genomic responses in mouse models poorly mimic human inflammatory diseases. National Academy of Sciences. Feb 2013). "I was stunned by just how bad the mouse data are. It's really amazing, no correlation at all," (Dr. Mitchell Fink, sepsis expert, Univ. of California, Los Angeles).
5. BROKEN SYSTEM: Why do we justify animal cruelty for methods so flawed they even hurt people?

WE CAN DO BETTER, FOR ANIMALS AND PEOPLE
  • Experimenters extract some valid knowledge from animals because they are alive with physiological processes. But if the science is fundamentally unreliable, with potential to harm humans, why do we defend it? Once questioned in the realm of ethics, it becomes clear: Animal research is inherently cruel.

  • BUT DON'T WASTE TIME DEBATING EXPERIMENTERS THEMSELVES. It's a no-win debate. In the lab, animals are a means to an end. Experimenters see themselves as "heroes" with noble careers. I.E., one experimenter told me I am not qualified to recognize animal cruelty, and thus my so-called evidence was invalid. They speak condescendingly, with intellectual arrogance, and paint activists as "terrorists." Anyone against animal research is an "extremist."


6. HUMAN-BASED: Focus on non-animal technology.

Biotechnology is evolving with human-relevant cellular, genomic and computational tools. But funding and support are needed:
  • To accelerate development and validation of animal-free methods.
  • To advance biologically viable models that simulate entire-body function and interaction, not just isolated cells or organs.

HUMAN-RELEVANT RESEARCH:
  • I don't describe animal-free research as "alternative," a word that suggests animal experiments are the "real" or "gold standard" way to gain knowledge while non-animal systems are less sophisticated. In fact, the reverse is true.


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ANIMAL-FREE RESEARCH
Not an "alternative." A better way.

FUNCTIONAL IN VITRO
In vitro cell and tissue analysis uses human-derived cells, cell lines, or cellular components. MatTek cultivates human tissues from donor cells to reproduce tissue behavior. Admet's In Vitro Labs screen drugs against liver cells and tissues. VaxDesign simulates an immune system with a dime-sized Modular Immune In Vitro Construct. MIMIC advances vaccine research for AIDS and studies autoimmune diseases (multiple sclerosis, rheumatoid arthritis) and inflammatory conditions (Crohn's disease). 3D FORMATIONS: Living models replicate human tissue design and function. Layered cells from building blocks of active human cells interact. Vascularized 3D tissues, engineered for cardiac tissues with "perfusable blood vessels," [have] potential therapeutic applications" (Nature Communications 4, Article number: 1399. 1/29/13).

MICRODOSING
Assesses human metabolism data (metabolomics) for safe human trials earlier in product development. Nearly half of all drugs flunk Phase 1 clinicals. An accelerator mass spectrometry (AMS) measuring system screens out doomed drugs quickly, economically. Microdosing more precisely predicts human metabolic response to a new drug.

9 out of 10 experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies.   Mike Leavitt, former U.S. Health and Human Services Secretary

GENOMICS & SYNTHETIC BIOLOGY
Use of recombinant DNA, DNA sequencing, and bioinformatics to assess genome structure and function. Vast potential for genomic data on entire populations. Assimilation of informatics (diverse data formats) with genomic data can show genetic origins of disease and drug reaction.

DNA CHIPS
Genes or DNA fragments on a glass slide interact with a test drug to reveal which genes are activated or depressed. DNA chips facilitate an individualized medicine concept based on each person's different genetic blueprint.

MICROFLUIDICS CHIPS
Containers on a 2-cm wide chip each hold a tissue specimen. A test compound is added to a blood surrogate that circulates via mircrochannels for small-scale replication of the body's response. Chip sensors relay data for computer analysis. Hurel (Human RELevant) Corp. is breaking new ground in this method.

HUMAN TISSUE ANALYSIS
"In human tissue, we'll find answers to Alzheimer's, Parkinson's and other neurodegenerative diseases " (Dr. John Xuereb, Director, Cambridge Brain Bank and Wolfson Brain Imaging Centre). All viable data about HIV/AIDS comes from patient tissue/blood, Usable data on Alzheimer's and Parkinson's stems from patient tissue analysis. Researchers can ethically acquire tissue from informed donors (surgery-biopsy patients; donated at death) prior to testing drugs in microdose studies.

COMPUTER MODELING
Enables the molecular architecture of drugs to hone in on specific receptors. Research innovators worldwide are devising a "virtual human " to foretell drug metabolism and metabolite interaction for any organ — data that can never come directly from animals. In mere minutes, scientists can reproduce experiments in silico (on computer) to gain insight that takes months to years in a lab or clinic.

AUTOPSY/BIOPSY
Post-mortem studies analyze full-body disease impacts and amend common misdiagnoses. I.E., Brain studies may mix post-mortem exam, brain tissue and psychophysics (sensory effects on mental states).

EPIDEMIOLOGY
Population studies to find parallels have tied tobacco to cancer; cholesterol to heart disease; pregnancy folic acid deficit to spina bifida…

STEM CELL RESEARCH
Stem cells, ethically sourced from donated adult and umbilical cord stem cells, hold promise for many disease therapies. Human stem cells have already remedied some cases of leukemia, heart attack recovery, Parkinson's.

ADVANCED MAGNETIC IMAGING
Magnetic resonance imaging (MRI), functional MRI (fMRI), magnetoencephalography (MEG), magnetic resonance spectroscopy (MRS), and positron emission tomography (PET) all assess organ structure and function.

POST-MARKET DRUG SURVEILLANCE
Regular tracking of new medical products can identify repercussions in a faster time frame.

CLINICAL RESEARCH
Wide-scale clinical reviews are key to long-term efficacy of any drug or treatment. I.E., Some traditional prescriptions like hormone replacement therapy to deter heart disease or corticosteroids to reduce brain injury wound up hurting, rather than helping, people.

ACTION ALERT: ICCVAM hasn't kept pace with biotech breakthroughs.

ICCVAM VALIDATES NO-ANIMAL TESTS FOR REGULATORY USE.
The Interagency Coordinating Committee on Validation of Alternative Methods (ICCVAM Authorization Act of 2000) includes 15 federal agencies. U.S. law stipulates that new tests be deemed valid before regulatory agencies accept them. Modes that reduce or eliminate animals must "provide equivalent or improved protection compared to existing methods." Safety Testing: Moving Toward Alternative Methods, doi:10.1289/ehp.0901704.

2000-2009: ICCVAM approved 4 non-animal tests (from 185 reviews): acute oral toxicity, dermal and ocular irritation/corrosion tests, and allergic contact dermatitis. By 2010, ICCVAM had gained U.S. and/or global regulatory acceptance for 17 animal-free tests. Comparatively, European Center for Evaluation of Alternative Methods (ECVAM) okayed 34 non-animal tests in 2009, with 170 more in evaluation. The European Commission also set a phase-out of cosmetic animal tests.


ASK ICCVAM TO DO ITS JOB - TALKING POINTS
  • Ask ICCVAM to accept more animal-free test methods for regulatory decision-making, so developers aren't legally obligated to conduct animal experiments in order to get their products on the market.

  • Urge Congress to enact legislation that requires non-animal methods and to boost ICCVAM funding for faster development of human-relevant research.

  • Encourage regulators and lawmakers to keep pace with biotech advances in cellular, genomic and computational tools.

  • Stress that human-based research generates data applicable to human health-safety. Conversely, animal research is flawed, with potential to:

  • WASTE MONEY in million-dollar tests that analyze animals for years.

  • MISLEAD RESEARCHERS with false assumptions. Vastly different genetic, metabolic, anatomic, physiological and psychological traits between species make predictive extrapolation to humans unreliable.

  • DELAY PROGRESS by postponing effective remedies that look unsafe for human use in animal tests — or, by speeding new products from clinical trials to market (based on initial animal studies) that cause unforeseen harm in people.


WHAT'S THE MATTER WITH ICCVAM?
ICCVAM has acknowledged "positive impact on animal welfare" from "alternative methods." Yet the under-funded committee has drifted into bureaucratic inertia, out of step with strides in non-animal biotechnology.

"Use of alternative methods has lagged behind. Critics have repeatedly pointed out that alternative test methods have not been accepted for regulatory decision making and that expectations for real reductions in animal use in toxicology testing have always outpaced documented progress." Linda S. Birnbaum, Ph.D., Director, NIEHS/NTP. 15 Years Out: Reinventing ICCVAM, Environ Health Perspect 2013

Birnbaum, who directs federal funding for biomedical research, says a partner-driven approach will replace Nat'l Institute of Environmental Health Sciences (NIEHS) as ICCVAM's administrator. She notes a focal shift from "observations in animals to mechanism-based biological outcomes in vitro," and stresses a move from "animal studies to in vitro assays and computational modeling."

Still, independent studies estimate that over 20 million animals are caged, poisoned, mutilated…and killed in U.S. labs each year. Precise figures are unknown. U.S. Agriculture Dept. omits birds, rats, mice, and farmed animals from totals. These animals are NOT protected under the Animal Welfare Act, though they comprise 90% of animals used in research. Moreover, the Licensing and Registration Information System (LARIS) database is incomplete, with facilities submitting late or never. USDA tallies exclude animals confined for breeding and conditioning. I.E., some 70,000 primates bred in colonies go uncounted.

A 76% spike in primate use is taxpayer-funded. Recent USDA data shows at least 60,000 monkeys perish in labs per year. Carbon-copy experiments are routine. I.E., Some 170 NIH projects assess neural data in macaque monkeys. Taxpayers spend $49.5 million yearly, just for these redundant tests alone.



ABOUT

Brenda Shoss is founder/director of Kinship Circle, an international nonprofit focused in: Animal Advocacy, Education and Disaster Rescue. Kinship Circle aids animals harmed in disasters and acts for all who suffer at the hands of human greed and cruelty.

Brenda, a former SHAC-USA (Stop Huntingdon Animal Cruelty) spokesperson, creates alerts, literature and presentations for the effort to end Huntingdon Life Sciences, a corrupt animal testing lab. She's spoken about animal experimentation at schools, conferences…
in the U.S. and abroad.

CONTACT INFORMATION

~ ICCVAM REPRESENTATIVES ~
NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
Nat'l Institute of Environmental Health Sciences
P.O. Box 12233, Mail Stop K2-16
Research Triangle Park, NC 27709
phone: 919-541-3398
email: niceatm@niehs.nih.gov, iccvam@niehs.nih.gov

Warren Casey, Ph.D., D.A.B.T., Nat'l Institute of Environmental Health Sciences (NIEHS)
Senior Toxicologist and Acting Director NICEATM
phone: 919-316-4729, fax: 919-541-0947
email: Warren.Casey@nih.gov

Elizabeth A. Maull, Ph.D., National Institute of Environmental Health Sciences (NIEHS)
Toxicologist; Program Administrator
P.O. Box 12233 , Mail Drop K2-17
Research Triangle Park, NC 2770
phone: 919-316-4668, fax: 301-480-3008
email: maull@niehs.nih.gov

Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S.
Director, NIEHS & NTP

National Institutes of Health
Department of Health and Human Services
P.O. Box 12233, Mail Drop B2-01
Research Triangle Park, NC 27709
phone: 919-541-3201; fax: 919-541-2260
email: birnbaumls@niehs.nih.gov

Christine A. Kelley, Ph.D.
National Institutes of Health (NIH)

Director, Division of Discovery Science/Tech
National Institute of Biomedical Imaging and Bioengineering NIH/DHHS
6707 Democracy Blvd, Suite 200, MSC 5477
Bethesda, MD 20892-5649
phone: 301-451-4778, fax: 301-480-4973
email: kelleyc@mail.nih.gov

Abigail C. Jacobs, PhD Co-Chair
Food and Drug Administration (FDA)

Center for Drug Evaluation and Research
Assoc. Director Pharmacology/Toxicology CDER
DHHS/FDA/CDER/OND
10903 New Hampshire Ave, Bldg 22, Rm 6484
Silver Spring, MD 20993-0002
email: abigail.jacobs@fda.hhs.gov

SEND COMMENTS TO ALL ICCVAM REPS:
2013 ICCVAM Agency Representative Roster


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