“It has not worked, and it is time we stopped dancing around the problem,“ Dr Elias Zerhouni, former Director of the US National Institute of Health.
Animal studies have shown many drugs to be useful and safe – in the animals tested on – then they have gone on to have catastrophic effects in humans.
TGN 1412 is a prime example. It is a ‘humanised’ monoclonal antibody designed to help patients suffering from rheumatoid arthritis and lymphoid leukaemia. TGN 1412 was tested in mice, rabbits and monkeys. The monkeys were given doses 500 times that given to human trial volunteers and the monkeys showed no adverse effects. But as soon as it was given to the first six human volunteers it supercharged their immune response – the opposite of what was intended, it was meant to dampen immune response – and caused multiple organ failure.1Then after this disaster, it was found that a non-animal test using human cells would have predicted this if it had been used instead of animal testing.2
There are many examples like this that show the failures of using animal models to predict the human response, but cherry-picking single examples doesn’t necessarily prove the systematic flaws, though it does clearly show they can’t reliably predict human response.
So what are the researchers themselves saying when they look at years of results of animal experiments rather than single examples? Here you can see for yourself…
Ten years of research producing 150 drugs that all worked in mice yet not one of them proven to work in humans? A group of scientists finally asked why and realised no one had bothered to see if the mouse model being used worked. Turns out it didn’t.3
“Given the limitations of animal models, publishing animal studies would mislead the scientific community into futile research and give the public false hope,” Hakan Şentürk, Editor in Chief, The Turkish Journal of Gastroenterology, in 2015, on why they no longer publish any animal research.
“To date, there have been nearly 150 clinical trials testing candidate agents intended to block the inflammatory response in critically ill patients, and every one of these trials failed. Despite commentaries that question the merit of an over reliance of animal systems to model human immunology, in the absence of systematic evidence, investigators and public regulators assume that results from animal research reflect human disease. To date, there have been no studies to systematically evaluate, on a molecular basis, how well the murine clinical models mimic human inflammatory diseases in patients.”3
“Animal models of stroke mimic at best less than 25% of all strokes.”4
“…all of the 100 experimental neuroprotective drugs failed in clinical trials despite promising results in animal models.”5
“Mice are mice, and people are people. If we look to the mouse to model every aspect of the disease for man, and to model cures, we’re just wasting our time…. [The mouse] has cost us a new generation of medicines… The vast majority of the money that we spend in clinical trials based on mouse data is completely wasted… We keep getting led down the garden path. We’ve had thousands of mouse studies of tuberculosis, yet not one of them has ever been used to pick a new drug regimen that succeeded in clinical trials.”6
“Indeed, since the first HIV vaccine clinical trial in humans in 1987, more than 100 clinical trials have been funded by the U.S. National Institute of Allergy and Infectious Diseases through mid-2006. Yet every one of the more than 50 preventive vaccines and more than 30 therapeutic vaccines that were successful against HIV/AIDS in primate studies has failed in human clinical trials.”7
“The limitations of animals as stand-ins for human patients are a major reason [for failure]. Animal disease doesn’t faithfully replicate asthma, for instance. The condition is uniquely human, and animal models can’t capture the constriction of airways and all of the other characteristics of the disease.”8
“We have found great mechanisms that can control asthma in an animal, and most of them have failed.”8
For Pharmaceutical development:
“An over-reliance on animal models at an early stage is now thought to be the biggest cause of failure at phases II and III [clinical trials]. Using animal models is not producing efficacious human medicines. Human tissue research presents the most exciting and advanced approaches that medical science currently has to offer. It is time for the use of human tissue to become the gold standard for the pharmaceutical industry.”9
“The history of cancer research has been a history of curing cancer in the mouse. We have cured mice of cancer for decades — and it simply didn’t work in humans.”10
For Toxicity testing:
“These differences [between animals and humans] often result in inefficient and costly experiments that do not provide accurate answers about the toxicity of a drug in humans…Using a well-designed model of a human organ could significantly cut the cost and time of bringing a new drug to market.”11
“…the best guess for the correlation of adverse reactions in man and animal toxicity data is somewhere between 5% and 25%.”12
“Human findings were compared with experimental data from rats and mice for all chemicals known to cause cancer in people. The outcome was disturbing: in most cases animal tests had given the wrong answer [64% false positive]. The report concluded that we would have been better off to have tossed a coin.”13
And from a textbook on using laboratory animals:
“Uncritical reliance on the results of animal tests can be dangerously misleading and has cost the health and lives of tens of thousands of humans.”14
That’s right, even the vivisectors own textbooks say vivisection has costs tens of thousands of human lives!
1. Attarwala, H. TGN 1412: From discovery to disaster. J Young Pharm. 2010 Jul-Sep; 2(3): 332-336.
2. Stebbings, R. et al., “Cytokine Storm” in the Phase I trial of Monoclonal Antibody TGN 1412: Better Understanding the Causes to Improve PreClinical Testing of Immunotherapeutics. J Immunol; 179 (5); 3325-3331
3. Seok, Warren, Cuenca et al; Genomic responses in mouse models poorly mimic human inflammatory diseases. Proceedings of the National Academy of Sciences; Feb. 26, 2013; vol. 110 no. 9, 3511.
4. Sutherland BA et al. Neuroprotection for ischaemic stroke: translation from the bench to the bedside. International Journal of Stroke: Official Journal of the International Stroke Society 2012; 7: 407–18.
5. Şentürk, H. Moving beyond animal models. Turk J Gastroenterol 2015; 26
6. Dr Clifton Barry, Chief of the Tuberculosis Research Section, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA 2011
7. National Institute of Allergy and Infectious Diseases. Clinical Research on HIV Vaccines May 2005.
8. Dr. Don Nicholson, former vice president of the pharmaceutical company Merck. Rockoff JD. Forget Lab Rats: Testing Asthma Drugs on a Microchip. Wall Street Journal.
Retrieved from http://www.wsj.com/articles/SB10001424127887324049504578545154163286708. 2013.
9. World Pharmaceutical Frontiers 2011, Vol 1, p132
Retrieved from http://www.scribd.com/doc/58341153/World-Pharma-2011-Vol-1
10. Dr Richard Klausner, former Director of the US National Cancer Institute. Cimons M, Getlin J, II THM. Cancer Drugs Face Long Road From Mice to Men. Los Angeles Times.
Retrieved from http://articles.latimes.com/1998/may/06/news/mn-46795. 1998.
11. Kevin Healy, Professor of Bioengineering, University of California, Berkeley 2014
Retrieved from http://news.berkeley.edu/2015/03/09/human-hearts-on-a-chip-to-aid-drug-screening/
12. Dr Ralph Haywood, former scientific director of Huntingdon Life Sciences. Animal Toxicity Studies: Their relevance to man. Lumley & Walker (ed) pp57-67, Quay, 1989
13. D Salsburg, Fundamental and Applied Toxicology, 1983, vol3 63-67
14. Handbook of Laboratory Animal Science Volume II Animal Models, p4, Svendensen and Hau (Eds) (CRC Press).