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Protecting Human Health

FOR LIFE ON EARTH (FLOE) is a campaign initiative presented by a wide range of advocates for human health, including patients and their families.

We support Patients Campaigning For Cures, founded by an inspirational young lady, Rebecca Groves, who has multiple sclerosis.

Our position acknowledges the tradition of dedicated individuals who have achieved breakthroughs for science, including Darwin’s Theory of Evolution, Einstein’s Theory of Relativity and Jenner’s Germ Theory of Disease. Our illustration of science highlights the importance of such work, demonstrating that science now has the  Trans-Species Modeling Theory [1] – derived from complexity science and evolutionary biology – which explains immense empirical evidence (spanning decades) against the assumption that animals are able to predict responses in humans.

Up-to-date science has now reached a milestone that enriches our understanding of public health and safety, and provides a framework which supports common sense decisions not to take our children, and other relatives, to the veterinary clinic when they fall ill. This breakthrough for health reinforces standards already required by medical practice: most importantly that laboratory tests are accepted as predictive – and protective of the safety of humans – only if they are reliable in the region of at least 95%. These necessarily high standards are well illustrated when medicines have been withdrawn after side effects in even only 1% of a million patients, (2) and further illustrated when we reasonably expect the results from our blood test, x-ray or urine analysis to be in the range of at least 90% accurate, in order to diagnose and treat any illness we may have.

The criteria required for prediction in medical research and safety should match these appropriately high requirements. However, statistical analysis which determines effectiveness – from drug sniffing dogs to blood tests that diagnose cancer – has measured the claimed ability of animal models to predict responses in humans and exposes a 69% failure rate. (3) This is not an isolated study but one of many in the scientific literature and all conclude that animals have a predictive value for humans in the range of 31%. Again, it is important to realise that this statistical analysis is not anecdotal: there are no studies in the scientific literature that show evidence to the contrary, that animals have a predictive value beyond guesswork – either in medicine testing or disease research. It will be no surprise, therefore, to learn that the National Institute of Cancer has gone on record saying we have lost cures for cancer because of studies in rodents.

For further details please read the article Are Animal Models Predictive for Humans?  Visit FLOE’s RESOURCES and our Medical Ethics tab.

Science and Morality

Science as such is never about any moral issue, including animal welfare. Science addresses cold, objective factual evidence solely. So leaving aside the morality of ethics for a moment, FLOE’s illustration of science acknowledges that seven of the nine main ways animals are used in science – categories 3-9 on the following list – are scientifically viable uses of animals, for which – thankfully today – there exist many more efficient less expensive, modern synthetic or human biology-based alternatives, producing more accurate and safer scientific results. It is only the first two categories in the following list which are scientifically held as demonstrably invalid: specifically meaning the claimed use of animals to predict responses in humans which is now proven to have never worked in the first place. It’s worth taking a moment to pause here, and underline the fact that it does not make sense to call for ‘alternatives’ for a method that has never worked in the first place! Human-based research is not an ‘alternative replacement’ for animal testing – please beware the misleading 3Rs! Human-based research is valid and viable because it has a track record of success. And we should also add that by definition, the scientific position expressed in this list does not enter into a moral dialogue, that is to say, about the entirely separate, vital and equally valid issue concerning the terrible suffering of laboratory animals. Please visit our ‘Laboratory Animals’ tab for our supportive advocates for animals and FLOE’s moral position, thank you.

1. Animals are used as predictive models of humans for research into diseases such as cancer and AIDS.

2. Animals are used as predictive models of humans for testing drugs or other chemicals.

3. Animals are used as “spare parts”, such as when a person receives an aortic valve from a pig.

4. Animals are used as bioreactors or factories, such as for the production of insulin or monoclonal antibodies, or to maintain the supply of a virus.

5. Animals and animal tissues are used to study basic physiological principles.

6. Animals are used in education to educate and train medical students and to teach basic principles of anatomy in high school biology classes.

7. Animals are used as a modality for ideas or as a heuristic device, which is a component of basic science research.

8. Animals are used in research designed to benefit other animals of the same species or breed.

9. Animals are used in research in order to gain knowledge for knowledge sake.

For a great summary blog about the nine main ways animals are used in science please visit this link.

For more details please visit FAQS about the Use of Animals in Science (2009) Drs Greek MD and Shanks PhD, to buy that book.

References: 

1  Greek, R and L.A. Hansen, Questions regarding the predictive value of one evolved complex system for a second: exemplified by the SOD1 mouse Progress in Biophysics and Molecular Biology 2013.

http://www.pulitzer.org/archives/6485 Masubuchi Y: Metabolic and non-metabolic factors determining troglitazone hepatotoxicity: a review. Drug Metab Pharmacokinet 2006, 21:347-356

3  Lumley and Walker: Animal Toxicity Studies: Their relevance for Man: Quay 1990 p73.

Key Points

Statistics are tools that biological science uses to evaluate whether a method is predictive. For example, when we visit our doctor, we reasonably expect the results from our blood test, x-ray  or urine analysis to be in the range of 90% accurate in order to diagnose  and treat any illness we may have. This is reinforced by standards required by medical practise, where laboratory tests are accepted as predictive – and protective of the safety of humans – only if they are reliable in the region of at least 95%.

What defines prediction? In a scientific context, a prediction is a rigorous (often quantative) statement forecasting what will happen under specific conditions. For more on this please click here. In science, guessing correctly or finding correlations are not the same as predicting the answer.

There have been many studies which evaluate the ability of animal models to predict for humans, such as the study by Lumley and Walker: Animal Toxicity Studies: Their relevance for Man: Quay 1990 p73. This took six medicines and retrospectively tested them on animals. How valuable was the method at predicting for humans? In this study animals predicted correctly for humans only 31% of the time. This percentage would be around the same for random guessing - failing to match the standards required and accepted for prediction in medical practise, and entirely unacceptable for human patients who need help now.

It is important to appreciate that the above study is one of many in the scientific literature and all conclude with a predictive value in the same range of 31%. It will be no surprise, therefore, to learn that the National Institute of Cancer has gone on record saying we have lost cures for cancer because of studies in rodents.

It is also important to realise that the above study is not anecdotal: there are no studies in the scientific literature that show evidence to the contrary, that animals have a predictive value beyond guesswork - either in medicine testing or disease research.

Sometimes you do not need statistics to work out the value of a testing method:

Around 100 vaccines have been shown to have protected monkeys from HIV or SIV or SHIV. Each and every one of these has failed to protect humans from HIV. Thousands of neuroprotectant medicines have been tested in animals and shown to be effective. NONE have been effective in humans.

Please visit this leaflet (suitable as a print out) that summarises many further such examples and the reasons why clinical translation from animals to humans fails.

GRAPHS

The scientific literature has also published many graphs which - again - consistently demonstrate no correlation between a medicine's ability to reach its target in primates, rodents, dogs or humans. Watch this science lecture for more details; read one of many examples of senior researchers who confirm  these statistics

Compare all of the above with the laboratory animal model community's literature, illustrated here by Gad S.C's Animal Models in Toxicology Second Edition 2007:

Biomedical sciences use of animals as models (is to) help understand and predict responses in humans, in toxicology and pharmacology...by and large animals have worked exceptionally well as predictive models for humans...Animals have been used as models for centuries to predict what chemicals and environmental factors would do to humans....The use of animals as predictors of ill effects has grown since that time...if we correctly identify toxic agents (using animals and other predictive model systems) in advance of a product or agent being introduced into the market place or environment, generally it will not be introduced...

Ironically, even the laboratory animal model community has difficulty agreeing with its own text book, above, as demonstrated by its  Handbook of Laboratory Animal Science Volume II Animal Models 1994:

It is impossible to give reliable general rules for the validity of extrapolation from one species to another. This…can often only be verified after the first trials in the target species (humans)…Extrapolation from animal models…will always remain a matter of hindsight….[( Salén 1994)  p6] 

Please help FLOE achieve its aims: to free human medicine from the damaging grip of misapplied veterinary principles and help ensure the unobstructed advance of personalised medicine:

TAKE ACTION TO HELP

For more on FLOE's illustration of science please visit AFMA/EFMA