Ricky Gervais, with beautiful Beagle Betsy.

FLOE's Patron, Peter Egan, with Betsy.

Photos © Joseph Sinclair/FLOE

Science Campaign

 

Historical Perspective

Animal experiments, for human patients, were first institutionalised in 1847 by a French doctor Claude Bernard, who went on to reject the Theory of Evolution.  In the 19th century, scientists based their actions on creationist beliefs, founded upon reductionist theories, which have today been surpassed by our knowledge of evolutionary biology, complex systems, genetics and complexity science, underlined by the mapping of the human genome in 2003.

How do we know, today, that animal testing is failing human patients?

Experts working in the wider scientific community, outside the vested interests of animal-based research, agree that animals are today demonstrated to be entirely failing as predictive models of humans. These experts are far too many to name here, but they include:

Pharmaceutical companies, which acknowledge the failure of animal models in their drug development process, and write about this openly and often in the scientific literature.

Former Secretary  for the US Department of Health and Human Services, Mike Leavitt said:

“currently 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”.

The National Cancer Institute says ‘we have lost cures for cancer because studies  in rodents have been believed’. [1]

The Editor in Chief of the British Medical Journal highlighted the lack of predictive value animal tests have for humans, in an Editor’s Choice tiled How Predictive and Productive is Animal Research [2] This article concluded by quoting from 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”.

Inventor of the polio vaccine, Dr. Albert Sabin, testified under oath to the U.S. House of Representatives, stating progress for his vaccine “was long delayed by the erroneous conception of the nature of the human disease based on misleading experimental models of the disease in monkeys.” [3]

Award winning oncologist Dr. Azra Raza:

Medical doctor Ray Greek states::

“Testing new drugs on animals does not make those drugs less likely to harm humans: animal models have misled scientists in the past and this has resulted in human deaths. Penicillin stayed on the shelf for over a decade because the rabbits Fleming tested it on led him to believe it would be ineffective in humans. Scientists were misled about the way HIV enters the human cell because of studies on monkeys. The polio vaccine was delayed by decades because the way monkeys responded turned out to be very different from the way humans reacted. Studying strokes and brain haemorrhage in animals has led to multiple medical treatments that worked in animals but that resulted in harm to human patients. HIV vaccines that protected monkeys have actually increased the risk of contracting HIV in the volunteers that took the vaccine. 

An immense body of empirical evidence has supported the position that animal models offer no predictive value for human response to drugs and disease. But perhaps more importantly, recent developments in evolutionary and developmental biology, genetics, gene regulation, gene expression, and gene networks gained in large part as a result of the Human Genome Project, in addition to advances in understanding complex systems, have significantly increased our understanding of why animals have no predictive value for human response to drugs or the pathophysiology of human diseases.”

The Home Office states that majority of dog experiments, 67%, are conducted to fulfil outdated regulatory requirements, as claimed toxicity tests for new human medicines. The vast majority of these dogs are Beagles, and the experiments typically involve being force-fed chemicals directly into dogs’ stomachs for up to 90 days, with no pain relief or anaesthetic. Our recent Daily Mirror exclusive revealed the true horror of this force-feeding procedure, which is classified as ‘mild suffering’ by the Home Office. These experiments are falsely claimed by the vested interests to be capable of measuring toxicity levels for new human medicines. In reality, peer reviewed studies show these specific tests fail around 70% of the time. This is not science; it’s less than the toss of a coin and worse than guessing. [1-7]

Trans-Species Modelling Theory

In 2009, foremost experts at Americans and Europeans for Medical Advancement (AFMA/EFMA)  named Trans-Species Modelling Theory (TSMT) which is akin the Theory of Relativity and Theory of Evolution in that it places decades of practical evidence within a wider scientific context to explain why something will always occur. In this case, TSMT places decades of evidence illustrating the failure of animal testing within the wider context of evolutionary biology and complexity science, to explain why animal experiments fail as predictive models of humans, and why they will always fail. 

Award winning oncologist Dr. Azra Raza delivered her TED-X talk against using animal models of cancer for human patients, below:

For more referenced examples of experts who agree that animal models are now shown to fail human patients, please visit this link. 

What does having ‘predictive value’ mean in medicine?

For a test to be accepted as having ‘predictive value’ by our hospital doctors and GPs – for example, to diagnose if a patient has cancer or HIV AIDS – that test needs to predict the correct answer for patients around 90 – 95% of the time, otherwise it is abandoned. The following excerpt illustrates this well, for the full paper please visit Are Animal Models Predictive for Humans? 

‘By definition, when we speak of animals predicting human response in drug testing and disease research we are addressing the risks of wrong predictions and how much risk society is willing to tolerate. Troglitazone (Rezulin™) is a good example of the margin of error for medical practice tolerated in society today. Troglitazone was taken by well over 1 million people with less 1% suffering liver failure, yet the drug was withdrawn because of this side effect [33]

Rofecoxib (Vioxx™) is another example of the small percentage of morbidity or mortality tolerated in the practice of medicine vis-à-vis introducing a new drug. Figures vary, and are controversial, but it now appears that apparently less than 1% of people who took rofecoxib experienced a heart attack or stroke as a result, yet it was also withdrawn [35]

This is an important point. Medical practice does not tolerate risks (probability of being wrong) acceptable in some experiments conducted in labs. In basic research we might proceed with a study based on the outcome being more likely than not. For basic research this is acceptable. However, getting the answer wrong in medical practice has consequences; people die. Societal standards for medical practice today demand very high sensitivity, specificity, PPV and NPV from its tests.’

Why does animal testing continue?

Animal testing for human patients in now demonstrated to have outlived its scientific usefulness, but it has also grown into a multi-million dollar enterprise which serves its vested interests in academia: the animal-based researchers working at universities globally, as well as the industries that breed lab animals and manufacturers which make lab equipment. For more on this financial perspective please scroll down to the bottom of this page.

Concordat On Openness On Animal Research

The Concordat On Openness On Animal Research proclaims to develop communications with the media and public – and has been signed by most universities and institutions which received grants to conduct animal experiments. However, none of these institutions have yet agreed to provide a scientist to debate their claims – that animal experiments can predict the responses of human patients – in the hearing now called for by over 100 cross-party MPs.

 

References

1. Gura T: ‘Cancer Models: Systems for identifying new drugs are often faulty’. Science. 1997, 278 (5340): 1041-1042. 10.1126/science.278.5340.1041.

2. BMJ 2014; 348: g 3719  (available here). 

3. Sabin. A: Testimony before the subcommittee on Hospitals & Health Care, Committee on Veterans’ Affairs, House of Representatives, April 26th 1984, serial no. 98-48.

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. Shanks N, Greek R, Greek J, Are Animal Models Predictive for Humans? Philosophy, Ethics and Humanities in Medicine, available here.

6. Kramer A, Greek R, Human Stakeholders and the Use of Animals in Drug Development, Business Society and Review, available here.

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