A New Report Details Why Numerous Animal Models Fail Humans
Alternatives to Animal Testing, Experimentation and Dissection - An Animal Rights Article from All-Creatures.org

FROM Marc Bekoff, Psychology Today / Animal Emotions
November 2019

A majority of models lack predictive value and internal and external validity.

"Rodents are the most widely utilized models in biomedical research...The majority of oncology drugs that proved successful in treating tumors within rodents fail to have the same response in humans, with most tested therapeutics never reaching the marketplace." —Shelley Farrar Stoakes, How Appropriate are Animal Models for Studying Human Disease?

"American taxpayers spend $30 billion annually funding biomedical research, but over half of these studies can't be replicated due to poor experimental design, improper methods, and sloppy statistics. Bad science doesn't just hold back medical progress, it can sign the equivalent of a death sentence for terminal patients."

—Richard Harris, Rigor Mortis: How Sloppy Science Creates Worthless Cures, Crushes Hope, and Wastes Billions

It's no secret that numerous nonhuman animal (animal) models of human diseases fail to help a great many humans who suffer from conditions that ultimately incapacitate or kill them. I recently read a comprehensive and data-driven review of this literature in a publication that's available online for free called The Research Modernization Deal 2020, published by People for the Ethical Treatment of Animals (PETA).

Before you roll your eyes and say something like, "Another biased PETA diatribe," please note that the scientists who work for PETA and PETA affiliates have a proven track record of productively assisting many Fortune 100 corporations as well as regulatory and government agencies. Given the breadth and depth of their expertise, they believe that they can make a valuable contribution to developing and implementing a strategic plan for the future of biomedical research and regulatory testing. I agree and was deeply impressed with the nature of the scientific literature they cite.

Also, take the time at least to peruse it and pay careful attention to the references that are cited and note that there are 468 of them, with the vast majority reporting data from peer-reviewed scientific and more focused biomedical journals. Then, I hope you will take the time to read this report, even if you only have time to do it piecemeal.

Because The Research Modernization Deal 2020 is available for free, here are a few snippets to whet your appetite for more. The report begins, "Along with mounting evidence that experiments on animals do not reliably translate to humans and the increasing development and implementation
of technologies that can supplant animal use in laboratories, our society has witnessed growing moral concern regarding animal experimentation. An August 2018 poll conducted by the Pew Research Center found that a majority of U.S. adults oppose the use of animals in scientific research."

• NIH reports that novel drugs fail “in about 95 percent of human studies,”2 even though they appeared safe and effective in preclinical experiments using animals.
• A 2015 investigation concluded that between 50 and 89 percent of all preclinical research, a large part of which involves animal testing, could not be reproduced.8
• At the most conservative U.S. estimate, this [non-reproducible animal research] results in approximately $28 billion per year spent on experimentation that is misleading.9
• The difficulties in applying data derived from animals to human patients are compounded by the confinement and unnatural conditions of laboratory life, which thwart animals’ ability to engage in natural behavior.17,18
• Their investigation of the application of basic science to clinical applications found that fewer than 10 percent of highly promising basic science discoveries enter routine clinical use within 20 years.28
• The literature is replete with examples of contradictions and discordance between animal and human effects, including many cases in which promising animal results have failed to translate to clinically significant efficacy in humans. This is particularly true in some therapeutic areas such as neurodegenerative, psychiatric, and central nervous system diseases, as well as sepsis and inflammatory diseases.33
• Neurologist and public health specialist Aysha Akhtar writes, “Science is showing how other animals are like us in morally relevant ways, but unlike us in medically relevant ways.”79
• Mice, however, apparently use distinct sets of genes to tackle trauma, burns, and bacterial toxins—when the authors compared the activity of the human sepsis-trauma-burn genes with that of the equivalent mouse genes, there was very little overlap. No wonder drugs designed for the mice failed in humans: they were, in fact, treating different conditions! (NIH Director Dr. Francis Collins)220

It's important to understand that animal models don't always fail, but rather, they don't come close to delivering outcomes that are worth the monetary costs of the research and drug production and testing, along with the failure of making it to the marketplace, the unrelenting nuisance of misleading TV ads filled with unreadable warnings about countless side effects, unintelligible talk, and actor portrayals of "patients" and "doctors," or the lives of the animals who are used and abused by the millions.

I could go on and on with summarizing the results of different studies and quoting renowned biomedical researchers. The information provided in this report on 29 areas of research (listed below) and the astonishing failure of animal studies to lead to effective treatments for humans is painstakingly detailed.

My simple suggestion is that people who are interested in the ways in which animal models fail numerous humans because they lack predictive value, internal and external validity, and don't lead to effective treatments for many diseases that kill and incapacitate humans should read this timely and important report. As the authors note, there is a dire need for a paradigm shift in all areas in which the utility of animal models are being investigated.

Stay tuned for further discussions on this extremely important topic. There are serious life and death issues at hand, and open discussions will help to redirect research efforts into efforts that really can and do make a difference.

References

Notes (numbers are from The Research Modernization Deal 2020):

2) National Center for Advancing Translational Sciences (NCATS). About the NCATS. https://ncats.nih.gov/about. Updated November 9, 2018. Accessed January 14, 2019.

8) Freedman LP, Cockburn IM, Simcoe TS. The economics of reproducibility in preclinical research. PLoS Biol. 2015;13(6):e1002165.

9) Ibid.

17) Lahvis GP. Unbridle biomedical research from the laboratory cage. Elife. 2017;6:e27438.

18) Latham N, Mason G. From house mouse to mouse house: The behavioural biology of free-living Mus musculus and its implications in the laboratory. Appl Anim Behav Sci. 2004;86(3-4):261-289.

28) Contopoulos-Ioannidis DG, Ntzani E, Ioannidis JP. Translation of highly promising basic science research into clinical applications. Am J Med. 2003;114(6):477- 484.

33) Pulley JM, Jerome RN, Zaleski NM, et al. When enough is enough: Decision criteria for moving a known drug unto clinical testing for a new indication in the absence of preclinical efficacy data. Assay Drug Dev Technol. 2017:15(8):354-361.

79) Akhtar A. Suffering for science and how science supports the end of animal experiments. In: Linzey A, Linzey C, eds. The Palgrave Handbook of Practical Animal Ethics. Basingstoke, U.K.: Palgrave Macmillan; 2018:475-491.

220) Collins F. Of mice, men, and medicine. NIH. https://directorsblog.nih.gov/2013/02/19/of-mice-men-and-medicine/. Published February 19, 2013. Accessed November 2, 2017.

29 areas of research that are discussed in the report, and the pages on which they appear:

• Cancer, 15
• HIV/AIDS, 16
• Cardiovascular Disease, 17
• Stroke, 18
• Diabetes, 20
• Neurodegenerative Diseases, 21
• Nerve Regeneration, 22
• Sepsis, 23
• Inflammation and Immunology, 25
• Neuropsychiatric Disorders, 26
• Substance Abuse, 28
• Trauma, 29
• Forensic Sciences, 30
• Medical Training, 31
• Skin Irritation/Corrosion, 32
• Eye Irritation/Corrosion, 33
• Skin Sensitization, 34
• Pyrogenicity, 34
• Tobacco and E-Cigarette Testing, 35
• Genotoxicity, 36
• Acute Systemic Toxicity, 36
• a. Acute Oral Toxicity b. Acute Dermal Toxicity c. Acute Inhalation Toxicity
• Carcinogenicity, 37
• Endocrine Disruption, 38
• Repeat Dose, Reproductive, and Developmental Toxicity, 39
• Aquatic Toxicity Testing, 40
• Biologic Drugs, 40
• Exposure-Based Assessment, 41
• Antibody Production, 41
• Fetal Bovine Serum, 42
• Bekoff, Marc. We're Being Bombarded by Ads for Drugs.
• _____. "Mice are lousy models for clinical studies": Animal models in biomedical research.

---

Return to Alternatives to Animal Testing, Experimentation and Dissection