We are honoured that EDM 400 was tabled by Sir Alan Meale MP
The Editor in Chief at the British Medical Journal Highlights the Failure of Animal Experiments to Predict the Responses of Human Patients.
Please Sign EDM 400 Which Calls For Public Scientific Debates on the Claimed 'Predictive' Value of Animal Experiments for Human Patients
The issue of human health and our search to cure diseases is vital to us all. The controversial issue of using animals in experiments has been a heated topic of debate in the media for many years, usually between pro-vivisection scientists and animal advocates.
However, current scientific knowledge now has the evidence to recognise and explain why using animals to predict human response to drugs and disease is, in fact, invalid .
For tests to be scientifically and medically recognised as “predictive”, they need to have a success rate in the region of at least 90% [2-4] Animal models for toxicity testing have a staggeringly low predictive value for humans: their ‘success’ rate consistently falls within the region of 31%, far less than that required to meet the prediction criteria [5-6].
Not surprisingly, a failure rate of 69% is compounded by the fact that scientists will not know the effect on humans until after the medicines have been applied,  thus further highlighting that animal models do not meet the criteria for predicting human response to medicines and disease.
Indeed, 90% of drugs that test well in animals harm or otherwise fail humans, pharmaceutical companies acknowledge the failure of animal models in their drug development process and write about this openly in the scientific literature
EDM 400: Holds the 'Concordat on Openness on Animal Research' to account with Public Scientific Debates In The Spirit Of Open Constructive Dialogue
EDM 400 calls for scientists, who still continue oppose its now known statistics and persist in experimenting on animals, to agree to constructive, public scientific debates with the experts who illustrate the EDM’s evidence.
Validity: Predicting Human Response
Scientific knowledge has now reached a position where the questions we are asking are highly complex to the point where differences between species outweigh the similarities. With advances in technology we are able to study human disease at the genetic level, and this is precisely where species differences are most pronounced .
The causes of most human disease lie in the proteins the body makes, their regulation and how these proteins interact. Gene expression is responsible for all of these interactions. With systems as complex as humans and non-humans, we now know that even very subtle differences may result in completely varied responses to drugs and diseases .
A gene can be removed from members of some species with no consequence, while members of another would die without it. Some genes cause disease in members of one species, but are harmless to those of another. There is also variation within one given species .
Studying genetic variation between humans can convey medically relevant data in ways that animal studies cannot. Studying human-based genes will provide us with human-directed knowledge that we need in order to cure our diseases .
History: How Did We Get Here?
In 1847, Claude Bernard institutionalised the modern use of experiments on animals, claiming they were “entirely conclusive for the toxicology and hygiene of man”. By concentrating on non-human animals, Bernard went on to reject the theory of evolution and minimalised the study of the frequency and causes of disease in different groups of people, now known as epidemiology .
Here and Now: Why Does It Continue?
Many factors contribute to the continued use of animals as claimed predictive models. A massive financial infrastructure has arisen, built on the animal model, upon which many businesses and scientists now depend. Some scientists are reluctant to state concerns through fear of committing career suicide, and are often encouraged to infer “human relevance” from non-human studies . However, some still defend it simply because the animal model is what they were taught to believe in .
Evidence: Acknowledgement Of Failures
As previously stated, the failure rate for animal models falls consistently in the region of 69%. This statistical analysis is not anecdotal. There are no studies in the scientific literature that show evidence to the contrary, including the oft mistakenly cited Olson study. .
Examples of how animal experimentation has harmed human health .
Pharmaceutical companies acknowledge the failure of animal models in their drug development and write about this openly in the scientific literature.
Drugs entering Phase I trials have approximately a 9% chance of coming to market [17-20]. Only 5% of cancer drugs that have an Investigational New Drug Application (IND) eventually go to market . Lack of safety or efficacy accounts for approximately 90% of drug failures during clinical trials [22-23]. Both safety and efficacy determinations rely on animal models. Then-U.S. Secretary of Health and Human Services Mike Leavitt stated in 2006: “Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies” . Jonson et al found that out of 39 anticancer drugs tested on xenograft mice, only one mimicked the response in humans . The National Institute of Cancer has gone on record stating we have lost cures for cancer because studies in rodents have been believed . Visit this link for more examples.
Other Issues: What Are The Other Problems?
Animal-based experiments waste money in that the grants could have funded human-based research and because misleading data in drug development increases the cost of medications. Harmful medications are developed that eventually must be shelved, thus costing more money, and helpful medications are lost because of invalid data from animal models. Animal models also receive the lion’s share of research funding .
Valid Methods: The Future Of Medicine
There are very many ways to conduct valid research, including in vitro research on living tissue, mathematical and computer modelling, microdosing, epidemiology, post-marketing drug surveillance and genetic studies to encourage personalised medicine, which involves the ability of physicians to treat patients individually based on their own unique genetic makeup. Today we also have stem cell research, gene-based medical research such as pharmacogenetics, toxicogenomics, systems biology, and an important but oft-overlooked area of study is evolutionary biology .
VALID SCIENCE: Not Animal Welfare Or Moral Concern
FLOE’s illustration of science, as such, is kept entirely distinct from the separate, moral issue of animal suffering. The medical experts who illustrate this EDM state that animals can be successfully used in science for 7 out of the 9 accepted main ways, failing solely as predictive models for humans. Viable uses include animals as “spare parts”, to study basic anatomy and physiological principles, to train medical students and as bioreactor factories (for example, for the production of insulin) . Even so, for these viable uses there already exist some more efficient, less expensive human biology-based “alternatives” .
FLOE: About For Life On Earth
FLOE is an alliance for evidence based medicine, illustrated by the leading scientific experts against animal experiments as assumed able to predict human responses. The aim of EDM 22 is to initiate public debates; scientist to scientist, while challenging the use of animal models to predict human response to drugs and disease. FLOE comprises a wide range of human health advocates, led by a Patients and Families Group.
As well as concerns for human health, FLOE recognises those who support its scientific evidence and additionally hold moral concerns for laboratory animals. FLOE is therefore proud to be supported by primatologist and television wildlife presenter Dr Charlotte Uhlenbroek, together with the Beagle Association.
EDM 400: Why This EDM Needs Your Support
Human medicine needs to make a fundamental change from using animal experiments to human-based research. This has already begun, but funding needs to increase in this area.
Given the overwhelming and compelling scientific evidence that animal models are not able to predict human response to drugs and disease - the valid yet unanswered questions regarding the continued use of animal models, the need for accountability, the clear vested interests of vivisection advocates, the need to put more funding towards valid research methods and the concern that animal experimentation is at an all time high - it is surely crucial that public scientific debates are encouraged.
INVITATION TO MPS
Please sign EDM 400 and add your voice to our call for public debates, scientist to scientist, in the interests of medical progress for patient safety, and healthy lives. Thank you.
Sources and Further Reading:
1. Shanks N, Greek R: FAQS About The Use of Animals In Science University Press of America; 2009.
2. Shanks N, Greek R, Greek J: Are Animal Models Predictive for Humans? Philos Ethics Humanit Med 2009, 4:2.
3. FDA panel reviews Diabetes Drug linked to dozens of deaths [ http://edition.cnn.com/HEALTH/9903/25/rezulin.review/index.html?iref=allsearch ]
4. Masubuchi Y: Metabolic and non-metabolic factors determining troglitazone hepatotoxicity: a review. Drug Metab Pharmacokinet 2006, 21:347-356
5. Heywood R. In: Animal Toxicity Studies: Their Relevance for Man. Lumley CE, Walker S Lancaster, Quay, editor. 1990. Clinical Toxicity – Could it have been predicted? Post-marketing experience; pp. 57–67.
Spriet-Pourra C, Auriche M. New York. 2 1994. Drug Withdrawal from Sale.
6. Shanks N, Greek R, Greek J: Are Animal Models Predictive for Humans? Philos Ethics Humanit Med 2009, 4:2.
7. Salén, Jörn C W. 1994. Animal Models—Principles and Problems. Handbook of Laboratory Science Volume II. Animal Models. 1st edition., edited by P. Svendsen and J. Hau. Boca Raton: CRC Press.
8. Shanks N, Greek R: FAQS About The Use of Animals In Science, Chapter 3 p 47: University Press of America; 2009.
9. ibid Chapter 3 p 45-46
10. ibid Chapter 3 p 46
11. ibid Chapter 3 p 47
12. LaFollette H, Shanks N: Animal Experimentation: the legacy of Claude Bernard; International Studies in the Philosophy of Science, Volume 8, No 3, 1994.
13. Dr Jim Woodgett Comment in Nature March 2012 [http://www.nature.com/nature/journal/v483/n7391/full/483509a.html ]
14. Shanks N, Greek R: FAQS About The Use of Animals In Science, Chapter 7 p 96: University Press of America; 2009.
15. Shanks N, Greek R, Greek J: Are Animal Models Predictive for Humans? Philos Ethics Humanit Med 2009, 4:2.
16. Shanks N, Greek R: FAQS About The Use of Animals In Science, Chapter 4 p 63: University Press of America; 2009
17. FDA. Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products 2004. Available from http://www.nipte.org/docs/Critical_Path.pdf
18. Sarkar, Susanta K. 2009. Molecular imaging approaches. Drug Discovery World (Fall):33-38.
19. Editorial. 2007. Same old story? Nat Rev Drug Discov 6 (2):97.
20. Paul, S. M., D. S. Mytelka, C. T. Dunwiddie, C. C. Persinger, B. H. Munos, S. R. Lindborg, and A. L. Schacht. 2010. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov 9 (3):203-14.
21. Kummar, S., R. Kinders, L. Rubinstein, R. E. Parchment, A. J. Murgo, J. Collins, O. Pickeral, J. Low, S. M. Steinberg, M. Gutierrez, S. Yang, L. Helman, R. Wiltrout, J. E. Tomaszewski, and J. H. Doroshow. 2007. Compressing drug development timelines in oncology using phase '0' trials. Nature reviews. Cancer 7 (2):131-9.
22. Kola, I., and J. Landis. 2004. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3 (8):711-5.
23. Arrowsmith, John. 2011. Trial watch: Phase III and submission failures: 2008-2010. Nat Rev Drug Discov 10 (2):87-87.
24. FDA. 2010. FDA Issues Advice to Make Earliest Stages Of Clinical Drug Development More Efficient. FDA, June 18, 2009 2006 [cited March 7 2010].
25. Johnson, J. I., S. Decker, D. Zaharevitz, L. V. Rubinstein, J. M. Venditti, S. Schepartz, S. Kalyandrug, M. Christian, S. Arbuck, M. Hollingshead, and E. A. Sausville. 2001. Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. Br J Cancer 84 (10):1424-31.
26. Science; volume 278 Nov 7th p 1041.
27. Shanks N, Greek R: FAQS About The Use of Animals In Science, Chapter 1 p 13: University Press of America; 2009.
28. Ibid Chapter 6 p 75 -76.
29. Ibid Chapter 1 p 1
30. Ibid Chapter 2 p29-33.
Please note that Parliamentary EDM 400 has now closed in the run up to the State Opening of Parliament.
The following information is for reference only, as MPs can no longer sign EDMs until Parliament resumes.
Remember to include your address and all the References and Resources, after you have signed your letter!
TEMPLATE LETTER FOR YOUR MP
PLACE YOUR NAME AND ADDRESS HERE!
The Secretary of State for Communities and Local Government, Greg Clark MP, has overturned a planning decision and in so doing now allows 2,000 Beagles annually to be purpose-bred in Grimston, Hull - dogs destined for laboratory experiments that The British Medical Journal (The BMJ) reports as “misplaced funding”: not capable of predicting the responses of human patients. The Editor in Chief of The BMJ, Dr Fiona Godlee, published her Editor’s Choice in June 2014 titled How Predictive and Productive is Animal Research?  This article concluded by quoting for the paper it cited:
'If research conducted on animals continues to be unable to reasonably predict what can be expected in humans, the public’s continuing endorsement and funding of preclinical animal research seems misplaced'. (Emphasis added).
Debate is the cornerstone of our democracy
Yet animal modelers (including scientists who’ve signed the ‘Concordat On Openness On Animal Research’) are refusing to debate the question of the validity of claiming that Beagles, & other animals, can predict the responses of human patients - a fair public debate called for by EDM 400.
At a public planning inquiry in 2002, the expert medical Board which provides the EDM's scientific evidence defeated plans to build a primate laboratory at Cambridge University. Cambridge wanted to build on Green Belt land and therefore had to prove that their primate experiments were going to be in the 'national interest'. After a two week hearing The Government inspector ruled that ‘On the basis of the technical input, therefore, I could not conclude that need in the national interest is demonstrated insofar as this pertains to the scientific/medical research and procedures undertaken by the University’. Please visit this link to read more about this landmark ruling.
Experts in the Wider Scientific Community
The BMJ’s Editor’s Choice is supported by pharmaceutical companies which openly acknowledge the failure of animal models in their drug development process, and write about this often in the scientific literature, please visit this link for extensive and referenced quotes from the pharmaceutical industry.
And current understanding of evolutionary biology and complexity science means that a rapidly growing number of internationally respected experts are warning about the dangers of the continued use of animal models as surrogate humans [2-4]. One of the most notable being the award winning oncologist Dr Azra Raza, director of the MDS Centre at Columbia University, who stated this in her TEDx Talk:
“...our system for developing drugs for cancer is essentially broke. We CAN and SHOULD do better. I am here on this stage today really because of a mouse. Earlier this year I pointed out that one of the reasons we are not developing novel therapies for cancers fast enough is that we have been relying way too much on animal models. I've been getting hate mails since then, but the fact of the matter is that we cured acute myeloid leukaemia in mice back in 1977, and in humans to day we are using the same drugs with absolutely dreadful results. We have to stop studying mice because it's essentially pointless and we have to start studying freshly obtained human cells". (Emphasis added).
Indeed, the National Cancer Institute has said we have lost cures for cancer because studies in rodents have been believed.
But arguably the most famous example of all – penicillin - is cited in EDM 400. Discovered by Alexander Fleming, penicillin was delayed for human patients by over a decade because it has no effect on rabbits. Here is Alexander Fleming on animal testing:
‘How fortunate we didn’t have these animal tests in the 1940s, for penicillin would probably never have been granted a license and the whole field of antibiotics might never have been realised.’ 
The purification of penicillin, by Howard Florey and Ernst Chain, helped it become the miracle cure which has saved millions of human lives. Here is Howard Florey on the toxicity tests he used:
‘Mice were used in the initial toxicity tests because of their small size, but what a lucky chance it was for in this respect man is like the mouse and not the guinea pig. If we had used guinea pigs exclusively we should have said that penicillin was toxic and we probably should not have proceeded to try and overcome the difficulties of producing the substance for trial in man.’ (Emphasis added) 
Please sign EDM 400, which has fair debate conditions that protect both sides
In his capacity as Patron of the All Parliamentary Group on Animal Welfare (APGAW) acclaimed actor Peter Egan is calling upon MPs to sign EDM 373, highlighting the fact that the conditions for this debate have been endorsed as ‘'well set out and fair” by Britain’s foremost human rights defence barristers, Michael Mansfield QC.
Science not ethics
It should be noted that the EDM must not be confused with ethical debates about animal welfare, including the National Centre for 3Rs (Reduction, Refinement, Replacement) which states: 'The 3Rs are a widely accepted ethical framework for conducting scientific experiments using animals humanely'. Although animal welfare is unquestionably of equal significance and value, ethics about animals cannot enter a debate about medical facts, which, as such, can only ever be about objectively verifiable scientific evidence.
Please support an appropriately serious and thorough scientific debate hearing
All of us are affected in some way by loved ones who need the absolute best standards medical research has to offer in 2016. And science understands so much more than it did in 1847, when animal experiments were first institutionalised by a French doctor who went on to reject the Theory of Evolution! Furthermore, Beagle dogs are our family members, highly valued companions who raise the quality of our daily lives. Surely an open public debate about the use of animals can only be a good thing, helping science serve humanity to the best of its ability.
Please support your colleagues who have signed Parliamentary EDM 400, and help its call for fair, public scientific debate about this crucial medical issue of such significance, for so many.
1.BMJ 2014;348:g3719 (available here)
2. Shanks N, Greek R Animal Models in Light of Evolution Boca Raton: Brown Walker Press; 2009.
3. Shanks N, Greek R, Greek J: Are Animal Models Predictive for Humans? Philos Ethics Humanit Med 2009, 4:2
4. Heywood R. In: Animal Toxicity Studies: Their Relevance for Man. Lumley CE, Walker S Lancaster, Quay, editor. 1990. Clinical Toxicity – Could it have been predicted? Post-marketing experience; pp. 57–67.
5. Parke DV: Clinical Pharmacokinetics in Drug Safety Evaluation. ATLA 1994, 22:207-209.
6. Florey H: The advance of chemotherapy by animal experiment. Conquest 1953, 41:12.
Open Letter by Ray Greek MD: Concerning the Scientific Underpinnings of a Laboratory Beagle Breeding Unit
The British Medical Journal's Editor Choice
The leading medical Board in its field, Americans and Europeans For Medical Advancement (AFMA/EFMA)
Speaking of Human-Based Research - PR company for innovative research
Science-Based Campaign For Life On Earth
Introducing FLOE's Patient, Families and Friends Group.
FLOE needs donations to campaign effectively. Please donate to help us reach out from Parliament at the start of this international campaign.
Photo: courtesy of the Toxic Waste Report: Macaque monkey undergoing experiment to 'predict' toxicity in a new human medicine. Around 95% of all experiments on macaques are for this.
Says Dr Charlotte Uhlenbroek, pictured above with an oragnutan in Borneo: "Please help For Life On Earth raise the necessary finance to promote modern science that protects all life on earth by ensuring the principles of evolutionary biology underpin bio-medical research"
Please donate here. Thank you