Human Stakeholders and the Use of Animals in Drug Development

Please watch the brilliant new lecture titled ‘Human Stakeholders and the Use of Animals in Drug Development’, delivered at Toronto University on March 4th, by Professor of finance, Lisa Kramer.

To watch the lecture please visit this link or click the image below:

This lecture shows that: constrained by regulations which date back to WWII, the pharmaceutical industry is being constrained to use animal models in the drug development initiative, which is stopping the development of harmful drugs from reaching the market place – and hindering the development of useful drugs.
 
If we were to revise the way we regulate the pharmaceutical industry and the entire drug development enterprise this could greatly benefit the human stakeholders – of which patients are those with the most at stake.
 
The lecture underlines that we have many viable human-based methods that are addressing the personal needs of each individual patient; but even if we had no viable human-based methods we would still have no grounds for continuing to employ animal models. We’d be better off literally tossing a coin to decide which drugs to use for humans, as animals correlate with human outcomes less than 50% of the time. Cherry picking data, after the event, ignores the fact that there’s no way you’re going to know which animals will be predictive for humans, and which won’t, in advance.  Anecdotes are not compelling, the proof is in the mathematics of predictive value.
 
And because we’re allocating all our resources to the status quo, we don’t know what we might be forgoing had we reallocated those resources to existing cutting edge human-based methods.
 
Drugs that have been ruled out after animal tests are later discovered accidentally to be useful for humans; for example Fleming discovered penicillin for humans after he saw it fail as an effective treatment of infections in animals. Fleming went on record stating that if animal testing had been required at the time he was developing penicillin, he fears that the “whole field of antibiotics might never have been realized”.
 
All of the above is underlined by the fact that the number of  effective and safe new drugs approved has slowed to a crawl, it’s ‘no greater than it was 50 years ago’, (Munos, 2009, page 259, Nature Reviews Drug Discovery) – and this, despite all the technological advances.
 
There are also huge financial costs 
 

Sepsis, for which animal models have yielded no effective treatment, costs US hospitals at least 14$billion annually (Mayr and Yende, 2014).

Cancer, coronary artery disease, congestive heart failure, stroke lung disease and other affliction which have been extensively explored with animal models also continue to be extremely costly to treat, with treatment outcomes nevertheless still extremely risky.

The costs of existing successful treatments are considerably inflated in order to underwrite the high costs of animal modeling, most of which fails.

Other stakeholders apart from patients are affected.
 
It is useful to examine the drug development industry’s costs relative to revenues:
 

The pharmaceutical industry spends more on R&D than any other industrial sector, (Pham 2010).

The majority of the costs to industry of developing drugs comes from human clinical trials.

The top reason for failure in human clinical trials are safety and efficacy (the very properties animal models are intended to asses)

Drug companies would actually prefer not to be required to do the animal tests. When Prof. Kramer presents her work at pharmaceutical scientists’ conferences they nod their heads “yes we need to bypass this costly and misleading aspect of the development process”.
 
Other Stakeholders
 

Clinical trial participants: these are among the first humans exposed to compounds that perhaps appeared safe in animal models, and they often aren’t informed of the significant risks they face based on the methodological problems with animal models.

New generations of scientists: those being trained to continue to employ animal models are missing the opportunity to advance scientific progress through use of better methods.

Tax payer and donors who fund these initiatives

Lower bound on annual cost to society: $10-12 billion of the annual NIH budget directly funds animal-based research at universities.

Non profit charities which use tax payers donations e.g. the for ice bucket challenge, lots of that money directly funded animal-based research.

Investors: constraining drug development firms to employ animal models prevents them from putting investment capital to its best use, and arbitrarily limits the firms’ financial returns.

Why does animal-based research continue?
 

Laws continue to codify animal models prior to human clinical trials.

The FDA and its counterparts around the world likely has the power to revise these laws but are unlikely to do so without action from legislative bodies.

Other obstacles include conflict of interest, status quo bias (including the 3Rs sector) and various other behavioral tendencies on the part of researchers and the public.

It often takes a better model to replace a model: in this case that effectively means 100% predictive value. Prof. Kramer argues these exist, so instead of looking where it’s easy to look – like the old drunk looking for his keys where the light happens to be, instead of somewhere else where he actually lost them – Prof. Kramer argues this is what we are doing by continuing to use animal models.

  • Instead we could be using the technology of personalized medicine:
  •  
  • Examples of personalized medicine include genetically matched treatments where we can determine – based on your specific genetic makeup – whether you’re going to have the desired outcome from a drug or an adverse response. Immunotherapy: this is already being used in treating many forms of cancer where the treatment is targeted to the patient’s specific genetic makeup. Microdosing: where we can administer compounds to humans at doses far below therapeutic levels to determine safety and efficacy, at the cellular level. Personalized medicine is literally happening, it’s not some far fetched futuristic idea. At the University of Toronto there’s an example of personalized medicine in action: they’ve grown heart tissue from human stem cells and here you can see the tissue beating in the lab. Scientists can use this to study the effect of potential drug molecules on actual human heart tissue. This can help us determine safety and efficacy, particle implications that could never be possible by looking at animal tissue. This is human technology for human application for human benefit – which is the whole point.
 
CONCLUSION
 

Constrained by outdated standards, the pharmaceutical industry is effectively required to employ animal models in early stages of the drug development process.

The reliance on animal models is unable to prevent the development of harmful drugs and is hindering the development of useful drugs.

Humans are significantly harmed, including patients, clinical trial participants, researchers, tax payers and many others.

Elimination of policies and regulations that require the use of animal models will greatly benefit stakeholders of the pharmaceutical industry.

It’s time for the EDM 66 science debate – judged by independent experts from the relevant fields of science.

Human stakeholders – including patients – are being harmed by the claims of vested interest groups, which continue to make huge profits from animal modeling, at the expense of the rest of society.

Decision makers and the public need to be given the opportunity to make an informed decision about current scientific knowledge, and this can be achieved by our called-for medical debate, as outlined by Prof. Kramer and Dr. Ray Greek, in their new book chapter.

PLEASE TAKE ACTION TO HELP!

Please ask your MP to sign the current Parliamentary EDM 66, calling for our science hearing. Simply type in your postcode at this link to send your MP a letter now!

Thank you for your time and support.

 

Animal experiments are sold to society as a claimed scientific endeavour, so it is absolutely vital to make sure  correct and up-to-date scientific language is employed to oppose this non-scientific practice, which is now proven to also cause harm and fatalities to human patients.

Animal protection organisations are actually getting in the way of abolishing animal testing, because they don’t work with science experts who are sufficiently qualified in this highly specialist medical field. We’d like those animal protectionists to work with our experts.

Cruelty Free International, for example, have a page where they say animal testing must be replaced with ‘alternatives’. Calling for animal testing – now proven to cause harm and fatalities to humans – to be replaced with an ‘alternative’ is clearly conceptual linguistic nonsense. Human-based research is viable – not an alternative: animal testing fails patients, human-based research saves lives. These are opposites, not alternatives. Words have meanings, and in science those meanings have far reaching, life and death consequences.

Calling for animal tests to be replaced with ‘alternatives’ is part of an outdated system called the 3Rs – the National Centre for 3Rs , for ‘humane experimental technique on animals’ – and the Animals in Scientific procedures Act, which falsely holds that animal experiments do have predictive value for humans and that these experiments must continue “unless there is an alternative”.

The main PR organisation for animal experiments, ‘Understanding Animal Research’, has a page dedicated to the 3Rs and replacing animals with ‘alternatives’.

Cruelty Free International also claims that the stress of animals in labs will affect the ability of animals to predict the responses of human patients: ‘stress inherent to laboratory life and experiments affects not just welfare but also the reliability and human relevance of results’. This is not true. Animals cannot predict human responses because of millions of years of evolution which separates them from the animals in question – and all that that this brings to bear on species differences and their impact on complexity science principles in genetics and complex systems. For more on this please visit Trans Species Modeling Theory (Drs. Shanks and Greek) and watch the science lecture by our senior doctor, below:

To end animal experiments, animal protectionists need to understand that they are playing with patients’ lives when they get the science wrong – and they are playing into the hands of the animal experimentation community, who need the 3Rs and sloppy science to survive.

Our senior doctor Ray Greek has responded to a letter from the television vet personality Noel Fitzpatrick, ‘Supervet’ who promotes the false and deeply damaging medical concept that animal experiments hold predictive value for human patients.

Please find Dr Greek’s response to Noel’s letter below, which is reproduced in the indented text.

We are reproducing this here whilst Dr Greek’s website undergoes repairs.

Dr Greek’s response begins:

On October 24, 2017, The Humanimal Trust sent a letter to Patients Campaigning For Cures that I have indented and reproduced below.

“In acknowledgement of your recently launched petition addressed to our founder Professor Noel Fitzpatrick, we would like to take the opportunity to clarify a key point about what our organisation, The Humanimal Trust, has been set up to achieve. We strongly believe that human and animal health are intrinsically linked.”

This sentence has no meaning unless The Humanimal Trust is endorsing some form of mysticism or pantheism or New Age nonsense. Evolutionarily speaking, all life shares commonalities but the details differ dramatically and scientists do not usually use language like the above.

“We believe that progress in one could and should inform the other, if there were an effective platform for doing so.”

Again, this sounds more like New Age nonsense than it does science or philosophy. As I have pointed out numerous times, animal models have no predictive value for humans when considering diseases or medications. The use of the word inform is an attempt to be vague so that when, once again, the fact that animals and humans respond dramatically differently to drugs and disease is raised, The Humanimal Trust can deny that predictive value is what they meant and instead claim that they meant something like use to stimulate thought or some equally vague notion.

“We hope that the growing acceptance of this fact will reduce and perhaps one day eliminate the need for animal testing.”

I see no evidence that this is their goal but regardless the claim is not science-based. There is no need for animal testing currently as animal models are not capable of delivering predictive value for human response to drugs and disease despite the fact that this is how their use is sold to society. Giles, for example, writing in Nature stated: “In the contentious world of animal research, one question surfaces time and again: how useful are animal experiments as a way to prepare for trials of medical treatments in humans? The issue is crucial, as public opinion is behind animal research only if it helps develop better drugs. Consequently, scientists defending animal experiments insist they are essential for safe clinical trials, whereas animal-rights activists vehemently maintain that they are useless.” (Giles 2006)

The Humanimal Trust continues.

“Illustrated plainly, our hope is that while treating a much loved family dog with cancer, one might provide data that can be shared and inform a similar cancer in a human, thereby reducing the need to falsely create that disease in an animal model.”

This illustrates incompetence in The Humanimal Trust’s understanding of science in general, as well as the evolution of complex systems like humans and other animals. Case reports or anecdotes, such as observing a family dog, would be classified has little value in science. Randomized, blinded, multi-institutional, controlled studies are the accepted methodology when studying medical interventions. Furthermore, society already has a very good idea what the value of animal models of cancer provide, as 95% of drugs that were safe and effective in animal models failed in human clinical trials. I would probably look for another model if I were serious about finding cures for cancer in humans.

“Currently there is no infrastructure that supports this sharing of information”.

That’s because it has no value.

“and opportunities are missed for both animals and humans to benefit from that information.”

This is attractive fiction, nothing else.

“Today humans are treated for a number of conditions that animals are also afflicted with, particularly in the areas of oncology, joint disease, the nervous system and areas where regenerative medicine may be of benefit.”

Just because one disease superficially resembles another disease in another species has no relationship to whether the causes are the same, or to whether a treatment in one will benefit the other. The reason veterinarians use cancer treatments from humans on animals is because there is very little financial incentive for developing drugs for animals and much financial incentive for developing drugs for humans. Hence, vets borrow treatments from human medicine and attempt to find something that the drug will treat in animals. Even different animals respond differently to the same drug, so a drug that treats cats and humans might not be effective for dogs or monkeys. To imply otherwise is again attractive fiction that will appeal to the uninformed. But it does result in a continuation of the status quo.

“We respectfully submit that as living creatures on this planet we are all looking for answers and solutions and that medical and veterinary professionals would be better off working together rather than separately to aid one another in research to protect both human and animal life.”

Attractive fiction. Veterinarians, physicians, and PhDs have been working together for over a century using animals as models for humans and the results have been disastrous. (Shanks and Greek 2009, Shanks, Greek, and Greek 2009, Greek and Greek 2010, Greek 2012, Greek, Menache, and Rice 2012, Greek and Hansen 2013a, Greek and Hansen 2013b, Jones and Greek 2013) More and more scientists are admitting this and working to abandon animal models. Moreover, not everyone is seeking answers. Some are just seeking to continue the status quo howbeit for various reasons.

“Contrary to what you imply, our organisation does not experiment on animals and The Humanimal Trust will never support research where animals are used as experimental models.”

I don’t recall anyone ever claiming that The Humanimal Trust employed animal modelers. (Maybe someone has and I just am not aware of it.) But the underpinnings of their philosophy of science is the same as that for animal experimentation in general, they just add more outdated science to it. Moreover, statements like the following, from their website, refute the above claim. “It is the law in the UK and elsewhere that most new medical treatments, devices, drugs and therapies intended for human and veterinary use need to be tested on animals, and we accept that based on current scientific knowledge, there is sometimes no alternative way of proving the safety and efficacy of these innovations.  Research into how the body works (in health as well as in disease) and the development of potential new therapies and treatments for humans and animals also involve some animal research.” (Emphasis added.)

The Humanimal Trust continues.

“We care about a fair deal for animals in medical science and the paradigm of One Medicine.”

The entire concept of One Medicine is refuted by current science especially the science of complex systems and evolutionary biology (see references above). Also see my blog titled Many Species Many Responses to Drugs and Diseases for more on this.

“We therefore invite any representative from your organisation to discuss with us how our respective organisations may work toward a better future for animals within the guidelines proposed by the National Centre for the Replacement, Refinement and Reductions of Animals in Research (NC3Rs) (https://www.nc3rs.org.uk/the-3rs). It is our aim to work closely with organisations such as the NC3Rs.”

The above refutes their attractive fiction as the NC3Rs supports the notion that animals have predictive value for humans. The NC3Rs exists to continue the status quo regardless of their verbiage.

“We sincerely feel that awareness is very important and that there is much to be gained from understanding rather than discord. We respectfully submit that there is much more to be derived from a positive rather than a negative approach with regard to potential benefit for the animals we all care about.”

This is a straw man as no one wants discord, but a positive approach to nonsense is not beneficial to society. I understand their position completely and since it is not science-based, I reject it. I would be happy for The Humanimal Trust to work with For Life On Earth to arrange a peer-reviewed debate as outlined in several Early Day Motions in the UK Parliament.

“We would welcome a direct discussion with you on these matters conducted personally rather than through social media.”

I understand why The Humanimal Trust would rather keep these things behind closed doors as open exposure to their position results in society seeing the complete lack of scientific support for it.

For more on why animal models have no predictive value for human responses to perturbations like drugs and diseases, see the section titled Article published in the peer-reviewed literature available at the AFMA website.

References

Giles, J. 2006. “Animal experiments under fire for poor design.”  Nature 444 (7122):981. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17183281

Greek, R., and J. Greek. 2010. “Is the use of sentient animals in basic research justifiable?”  Philos Ethics Humanit Med 5:14. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=20825676

Greek, Ray. 2012. “Book Review. Zoobiquity: What Animals Can Teach Us About Health and the Science of Healing.”  Animals 2 (4):559-563. http://www.mdpi.com/2076-2615/2/4/559

Greek, Ray, and LA Hansen. 2013a. “The Strengths and Limits of Animal Models as Illustrated by the Discovery and Development of Antibacterials.”  Biological Systems: Open Access 2 (2):109. doi: 10.4172/BSO.1000109 http://omicsgroup.org/journals/the-strengths-and-limits-of-animal-models-as-illustrated-by-the-discovery and-development-of-antibacterials-BSO.1000109.php?aid=14441

Greek, Ray, and Lawrence A Hansen. 2013b. “Questions regarding the predictive value of one evolved complex adaptive system for a second: exemplified by the SOD1 mouse ”  Progress in Biophysics and Molecular Biology 113 (2):231-153. http://www.sciencedirect.com/science/article/pii/S0079610713000539

Greek, Ray, Andre Menache, and Mark J. Rice. 2012. “Animal models in an age of personalized medicine.”  Personalized Medicine 9 (1):47-64. http://dx.doi.org/10.2217/pme.11.89

Jones, R. C., and R. Greek. 2013. “A Review of the Institute of Medicine’s Analysis of using Chimpanzees in Biomedical Research.”  Sci Eng Ethics:1-24. http://www.ncbi.nlm.nih.gov/pubmed/23616243

Shanks, N, and R Greek. 2009. Animal Models in Light of Evolution. Boca Raton: Brown Walker.

Shanks, N., R. Greek, and J. Greek. 2009. “Are animal models predictive for humans?”  Philos. Ethics Humanit Med. 4:2. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19146696

In response to our tweet yesterday, a member of the animal experimentation community, Lars Dittrich, has today cited the Olson study, claiming it proves that animal testing holds predictive value for humans.

The Olson study is a favourite of animal modelers, but it fails on every account. Our senior doctor Ray Greek addresses the false claims made by the Olson study, below, in his peer reviewed paper written with Dr. Niall Shanks: Are Animal Models Predictive for Humans?

Below we quote a section of Shanks and Greeks’ paper, summarising the Olson study’s main errors. For those wanting to read Shanks and Greeks’ complete analysis please visit this link,  scroll down – or type in ‘Olson’ in the ‘find box’.

BEGIN QUOTE

‘The Olson Study, as noted above, has been employed by researchers to justify claims about the predictive utility of animal models. However we think there is much less here than meets the eye. Here’s why:

1. The study was primarily conducted and published by the pharmaceutical industry. This does not, in and of itself, invalidate the study. However, one should never lose sight of the fact that the study was put together by parties with a vested interest in the outcome. If this was the only concern, perhaps it could be ignored, however, as we will now show, there are some rather more serious flaws.

2. The study says at the outset that it is aimed at measuring the predictive reliability of animal models. Later the authors concede that their methods are not, as a matter of fact, up to this task. This makes us wonder how many of those who cite the study have actually read it in its entirety.

3. The authors of the study invented new statistical terminology to describe the results. The crucial term here is “true positive concordance rate” which sounds similar to “true predictive value” (which is what should have been measured, but was not). A Google search on “true positive concordance rate” yielded twelve results (counting repeats), all of which referred to the Olson Study (see figure 5). At least seven of the twelve Google hits qualified the term “true positive concordance rate” with the term “sensitivity” – a well-known statistical concept. In effect, these two terms are synonyms. Presumably the authors of the study must have known that “sensitivity” does not measure “true predictive value.” In addition you would need information on “specificity” and so on, to nail down this latter quantity. If all the Olson Study measured was sensitivity, its conclusions are largely irrelevant to the great prediction debate.

4. Any animals giving the same response as a human was counted as a positive result. So if six species were tested and one of the six mimicked humans that was counted as a positive. The Olson Study was concerned primarily not with prediction, but with retroactive simulation of antecedently know human results.

5. Only drugs in clinical trials were studied. Many drugs tested do not actually get that far because they fail in animal studies.

6. “…the myriad of lesser “side effects” that always accompany new drug development but are not sufficient to restrict development were excluded.” A lesser side effect is one that affects someone else. While hepatotoxicity is a major side effect, lesser side effects (which actually matter to patients) concern profound nausea, tinnitus, pleuritis, headaches and so forth. We are also left wondering whether there was any independent scientific validity for the criteria used to divide side effects into major side effects and lesser side effects.

7. Even if all the data is good – and it may well be – sensitivity (i.e. true positive concordance rate) of 70% does not settle the prediction question. Sensitivity is not synonymous with prediction and even if a 70% positive prediction value rate is assumed, when predicting human response 70% is inadequate. In carcinogenicity studies, the sensitivity using rodents may well be 100%, the specificity, however, is another story. That is the reason rodents cannot be said to predict human outcomes in that particular biomedical context.

The Olson Study is certainly interesting, but even in its own terms it does not support the notion that animal models are predictive for humans. We think it should be cited with caution. A citation search (also performed with Google on 7/23/08) led us to 114 citations for the Olson paper. We question whether caution is being used in all these citations.

Conclusion

Mark Kac stated, “A proof is that which convinces a reasonable man.” Even though the burden of proof is not on us to prove animal models are not predictive, we believe we have presented a proof that would convince a reasonable man.

There are both quantitative and qualitative differences between species. This is not surprising considering our current level of knowledge vis-à-vis evo devo, gene regulation and expression, epigenetics, complexity theory, and comparative genomics. Hypotheses generate predictions, which can be then proven true or false. Predict has a very distinct meaning in science and according to some is the foundation of science itself. Prediction does not mean retrospectively finding one animal that responded to stimuli like humans and therefore saying that the animal predicted human response nor does it mean cherry picking data nor does it mean occasionally getting the right answer.

When a concept such as “Animal models can predict human response” is accepted as true, it is not functioning as a hypothesis. We have referred to this as an overarching hypothesis but could have easily referred to it as an unfounded assumption. An assumption or overarching hypothesis might in fact be true but its truth must be proven. If a modality such as animal testing or using animals to predict pathophysiology in human disease is said to be a predictive modality, then any data generated from said modality should have a very high probability of being true in humans. Animal models of disease and drug response fail this criterion.

In medicine, even positive predictive values of .99 may be inadequate for some tests and animal models do not even roughly approximate that. Therefore, animal models are not predictors of human response. Some animals do occasionally respond to stimuli as do humans. However, how are we to know prospectively which animal will mimic humans? Advocates who maintain animals are predictive confuse sensitivity with prediction. Animals as a group are extremely sensitive for carcinogenicity or other biological phenomena. Test one hundred different strains or species and one is very likely to react like humans. But the specificity is very low; likewise the positive and negative predictive values. (Even if science did decide to abandon the historically correct use of the word predict, every time an animal-model advocate said animal species × predicted human response Y, she would also have to admit that animal species A, B, C, D, E and so forth predicted incorrectly. Thus justifying the use of animals because animal models per se to make our drug supply safer or predict facts about human disease would not be true.)

Some have suggested we should not criticize animal models unless we have better suggestions for research and testing [27]. It is not incumbent upon us to postpone criticizing animal models as not being predictive until predictive models such as in silico, in vitro or in vivo are available. Nor is it incumbent upon us to invent such modalities. Astrology is not predictive for foretelling the future therefore we criticize such use even though we have no notion of how to go about inventing such a future-telling device.

Some have also suggested that animal models may someday be predictive and that we should so acknowledge. While this is true in the sense that anything is possible it seems very unlikely, as genetically modified organisms have been seen to suffer the same prediction problems we have addressed [16, 81, 82, 83, 84, 85, 86, 87] and, as mentioned different humans have very different responses to drugs and disease. Considering our current understanding of complex systems and evolution it would be surprising if one species could be used to predict outcomes in another at the fine-grained level where our study of disease and drug response is today and to the accuracy that society demands from medical science.

There are direct and indirect consequences to this misunderstanding of what prediction means. If we did not allow on the market any chemical or drug that causes cancer, or is teratogenic, or causes severe side effects in any species, then we would have no chemicals or drugs at all. Furthermore, there is a cost to keeping otherwise good chemicals off the market. We lose: treatments perhaps even cures; the income that could have been generated; and new knowledge that could have been gained from learning more about the chemical. These are not insignificant downsides. Since we now understand vis-à-vis personalized medicine that even humans differ in their response to drugs and disease and hence one human cannot predict what a drug will do to another human, it seems illogical to find models that are predictive using completely different species from humans. If we truly want predictive tests and research methods (and we do), it would seem logical to start looking intraspecies not interspecies.

Have you heard our senior doctor’s radio interview which is currently being shared on social media?

Please click the video below to hear Dr. Greek explain how today’s medical knowledge understands that each human patient is entirely different and unique. Dr Greek refers to the very varied effects of a mouse model – which actually killed several patients – to illustrate the now widely recognised medical position that one size no longer fits all: we have truly entered the age of personalised medicine, where each human patient is understood to be the sole owner of his or her personal genetic profile, for which treatments can now be tailored to suit, exactly.

All medical research funding needs to go towards this advanced human-based knowledge and research – away from now the proven damaging effects of animal models.

We are delighted that Ricky Gervais and Peter Egan have been spotlighted by K9 Magazine this month, in their continued call for a public science hearing to judge claims: that animal experiments can predict the responses of human patients.

Read the article with Ricky Gervais.

Ricky and Peter are photographed with a beautiful ex-laboratory dog called Scarlett, who is joining the science-based campaign FLOE, as Beagle Ambassador.

Thank you K9 Magazine for all your help; thank you Ricky and Peter for this life-saving focus.

Ricky Gervais says:

“Meeting Scarlett and sensing her painful past will stay with me forever. Like all dogs she is incredibly gentle with a heart of gold, but the horrors of two years in a toxicology laboratory are etched in her eyes and body language. This was clear, even in the relatively short time I spent with her. I’m delighted to have signed an Open Letter calling for animal experimenter Prof. Colin Blakemore to face the world’s leading medical opposition to such experiments, in a public science hearing judged by independent experts. I want people to be able to understand how these shocking experiments are now proven to also fail humans.”

Read the Open Letter signed by Ricky and Peter, including signatories Chris Packham and Dr. Jane Goodall. The letter is addressed to leading advocate of animal models for human patients – Prof. Colin Blakemore – and asks him to agree to a rigorous public scientific debate, judged by independent experts from the relevant fields of science: a debate now called for by over 100 MPs.

 

 

The National Centre for 3Rs (NC3Rs) promotes an animal testing legislation policy called the 3Rs – ‘reduce, refine and replace’ –  established in 1959 for ‘humane experimental technique on animals’.

The 3Rs is now enshrined in the outdated Animals in Scientific Procedures Act , which entirely ignores current scientific knowledge proving that animals have never held predictive value for the responses of humans, in disease research and medical testing. [1-4]

Predictive value in science means getting the answer right around 90 – 95% of the time.

For a test to be accepted as having predictive value by our hospitals and GPs, that test needs to predict the correct outcome for patients around 90-95% of the time. Examples of such tests include those to diagnose if a patient has cancer or HIV AIDS. Animal testing entirely fails to meet this standard. Nine out of ten potential new medicines fail to reach the market shelf because tests on animals are not capable of predicting the responses of humans, in clinical trials. Pharmaceutical companies write about this failure of animal models in their drug development process, openly and often in the scientific literature.

In toxicology testing alone – where rats and Beagles are used to measure the toxicity levels of potential new human medicines – the animal test outcomes correlate with humans around 31% of the time: that’s less than a toss of a coin and worse than guessing. The National Cancer Institute has said we have lost cures for cancer because such studies in rodents have been believed. [5]

There is no doubt that the wider scientific community – outside the vested interests – agree that animals have never held predictive value for humans. But the 3Rs community continue to ignore this, calling for ‘alternatives’ to a method that has never existed. The correct medical term for human-based research is ‘viable’ – this is not an alternative: animal testing is not an interchangeable alternative with human-based research, which has a track record of success.

The 3Rs also calls for a worthless scientific endeavour to be reduced and refined. For more details on the human medical catastrophe which is the 3Rs, please visit this page.

For an example of how animal modelers use the 3Rs to maintain false science, please visit this tweet, below:

148 MPs have now signed four Parliamentary EDMs calling for a science hearing to judge and end animal experiments

These MPs include Jeremy Corbyn MP, Tom Watson MP, Zac Goldsmith MP, Caroline Lucas MP, Diane Abbott MP, Sir Edward Leigh MP, Tim Farron MP and Nigel Dodds MP.

To ask your MP to sign the current EDM please type in your post code at this link .

References

  1. 1. BMJ 2014; 348: g 3719  (available here)
  2. 2. Shanks N, Greek R Animal Models in Light of Evolution Boca Raton: Brown Walker Press; 2009.
  3. 3. Shanks N, Greek R, Greek J: ‘Are Animal Models Predictive for Humans?’ Philos Ethics Humanit Med 2009, 4:2
  4. 4. Lumley CE, Walker S Lancaster, Quay, editors, 1990, ‘Clinical Toxicity – Could it have been predicted? Post-marketing experience’, 57–67; Heywood R. Animal Toxicity Studies: Their Relevance for Man.  
  5. 5. Gura T: ‘Cancer Models: Systems for identifying new drugs are often faulty’. Science. 1997, 278 (5340): 1041-1042. 10.1126/science.278.5340.1041.

We are delighted that Paul O’Grady has joined Ricky Gervais, Peter Egan, Dr. Jane Goodall and many others in signing the Open Letter to Prof. Colin Blakemore, Britain’s leading advocate for the false scientific concept that animals are able to model human patients, in disease research and medical testing.

The Open Letter, below, calls for Prof. Blakemore to agree to debate his position in the rigorous science hearing called for by EDM 66 now supported by over a hundred cross-party MPs who have signed 5 EDMs to this effect.

Dear Prof. Colin Blakemore,

A freedom of information request provided your letter to the Planning Inspectorate, recommending the extension of a Beagle Breeding Farm at B&K Universal in Grimston Hull. The farm will purpose breed around 2,000 dogs annually, destined for painful and traumatic laboratory experiments – typically involving dogs being force-fed chemicals in experiments lasting ninety days with no pain relief or anaesthetic. According to current medical knowledge the results of such experiments are not capable of predicting the responses of human patients, a position highlighted by The British Medical Journal in its Editor’s Choice, June 2014. Over a hundred MPs, to date, have signed Parliamentary EDMs to hear this evidence in a public scientific debate, overseen by independent judges from the relevant fields of scientific expertise. In your letter, you claim to have ‘always tried to engage with those who oppose animal research and take proper account of their objections’, and that it is ‘unacceptable’ that research ‘is impeded or prevented by extreme action’. We therefore call upon you to agree to participate in the thorough scientific debate, as called for by the Parliamentary EDMs and their growing support.

Yours sincerely,

Ricky Gervais, Chris Packham, Peter Egan, Paul O’Grady, Dr. Jane Goodall DBE, Lesley Nicol, Jill Robinson MBE, Jane Fallon, Rick Wakeman and Rumer

Colin Blakemore declined to be interviewed but released a statement in response to the Open Letter, in which he promoted the misleading 3Rs which is an ethical policy for ‘humane experimental technique on animals’.

Louise Owen, founder of the science-based campaign FLOE, was able to respond to Colin Blakemore, live on the BBC, you can listen to her interview below:

 

We have launched a new petition asking TV ‘Supervet’ Noel Fitzpatrick to close down his misleading ‘Humanimal Trust’ and agree to participate in the scientific debate called for by Parliamentary EDM 66.

Noel Fitzpatrick has formed the ‘Humanimal Trust’ which promotes the false medical notion that animal experiments can predict the responses of human patients, in disease research and the safety testing of new human medicines. Noel is using naturally occurring illnesses in his veterinary patients and applying that data to humans, to conform to the misleading 3Rs Govt.  policy – which ignores current medical knowledge by asking for the numbers of lab animals to be merely reduced. Make no mistake: whether they are veterinary patients or lab animals, the same science applies: animals do not hold predictive value for humans.

Given that there is an ethical issue here too, reducing animal numbers does not address those individual dogs, cats, primates and rodents still left lingering in laboratories after their numbers have been reduced.

In May 2016, the Humanimal Trust submitted incorrect science evidence to Parliament’s Science and Technology Committee, in order to secure funding. Our medical Board has written a detailed blog about this, not to be missed, you can read that here.

For examples of the harm and fatalities caused to human patients, by trying to apply data from animals, please visit this link .

For a brochure on why you don’t go to the vet when you are sick, please visit this link. 

Rudolph Virchow, advocate for ‘One Medicine’, opponent of Evolution and the Germ Theory of Disease

It’s worth mentioning that the Humanimal Trust cites a 19th century physician, Rudoplh Virchow, as one of the earliest advocates of ‘One Medicine’. Virchow also made the mistake of opposing Darwin’s Theory Of Evolution and never relented in his opposition. In 1877, Virchow said that the idea that man had descended from apes was an attack on society’s moral foundations and he voiced his opinion that teaching Evolution should not be permitted in Germany’s public schools. This was then acted upon by the Prussian education policy in 1882, when it was forbidden to teach natural history lessons. Virchow also opposed the Germ theory of Disease. Virchow’s own belief was that cells became diseased as a result of internal processes resulting from imbalances in the body. Virchow was partly correct: imbalances in the body can lead to cells malfunctioning and becoming diseased. However, cells can also become diseased when they are attacked by microorganisms. Virchow was wrong to oppose the Germ Theory. Virchow also opposed life-saving evidence for cleanliness and hygiene when examining human patients. Ignaz Semmelweis was the doctor in charge of a birthing ward in Vienna, Austria. In 1847 he showed that if medical staff washed their hands before examining patients, death rates dropped dramatically. Many scientists, including Virchow, dismissed Semmelweis’s work as rubbish. Semmelweis died in tragic circumstances in 1865 following the ongoing unreasonable rejection of his work by other scientists. A very large number of unnecessary deaths were caused by the dismissal of Semmelweis’s work.

139 MPs , to date, have now signed four Parliamentary EDMs calling for a rigorous science debate, judged by independent experts from the relevant fields of science – to stop the funding of animal experiments and ‘One Medicine’, now proven to also fail humans. To ask your MP to sign the current EDM simply type in your post code at this link and send your letter today!

Watch the Science Lecture

This insightful and accessible science lecture guides the viewer step by step through how and why using veterinary patients – or lab animals – to try and predict human outcomes has no scientific basis whatsoever: a MUST SEE!

Please sign and share our new petition asking Noel Fitzpatrick to close the Humanimal Trust, or agree to the EDM 66 science debate; sign and share at this link.

The New Statesman publishes our piece today, about the vital need for a rigorous public scientific debate – judged by experts from the relevant fields of science – about claims that results from animal experiments can predict the responses of human patients, in medical research and drug safety testing.

The New Statesman piece closes by printing the Open Letter to kitten experimenter Prof. Colin Blakemore, signed by Ricky Gervais, Chris Packham, Peter Egan, Dr. Jane Goodall DBE, Jane Fallon, Lesley Nicol, Jill Robinson MBE, Rumer and Rick Wakeman. This letter calls upon Prof. Blakemore to agree to participate in the thorough scientific debate, as called for by 138 MPs, to date, who have signed four Parliamentary EDMs calling for this vital science hearing. The hearing will stop the funding of worthless animal models and speed up cures for humans, by re-directing valuable finance to state-of-the-art human based methods, which are viable – not ‘alternatives’.

To read the New Statesman article, please visit this link.

To read why human-based research is viable – not an ‘alternative’ to animal testing – please visit this link.

If you live in the UK you can ask your MP to sign EDM 66, calling for this science hearing. Simply type in your post code at this link and send your letter today.