Submitted To The House Of Lords Select Committee on Animals In Scientific
I have long been opposed to
the use of the use of live animals in laboratory experiments. I am opposed to
this practice for several reasons. I believe that the use of live, sentient
creatures in this way is barbaric, unnecessary and immoral. And I believe that
it is the reliance of drug companies on animal experiments which is largely
responsible for the current epidemic of iatrogenesis - diseases caused, in
general, by doctors and, in particular, by prescription drugs. (I have, in the
past, proved beyond doubt that animal experiments are utterly unreliable,
unpredictable and therefore quite worthless. On every occasion when I have
debated this issue with vivisectors I have won.)
I recently appeared
before the Animals in Scientific Procedures Committee at the House of Lords. The
Committee, the most important official inquiry into the use of animals in
experiments for decades, will report its findings direct to the Government.
After my appearance, the Committee wrote asking me to review papers
which had been submitted by the Department of Health in an attempt to
substantiate their argument that animal testing is both necessary and
The report which follows is a precis of the report which I
sent to the Committee; a report which clearly shows that none of the DoH papers
prove that animal testing is either necessary or efficacious.
Summary of Conclusions by Vernon Coleman
On the basis
of this evidence, and assuming that this is the best scientific evidence that
the Department of Health can find in support of its argument that toxicological
testing on animals is of value, then, assuming that the Committee intends to
base its conclusions on sound scientific evidence, the Committee has no choice
but to at the very least call for an independent inquiry (for example a Royal
Commission) into the relevance of animal experimentation.
do not substantiate the claims made by the Government. Indeed, on the contrary,
the evidence available here proves my point: animal experimentation is
unpredictable, unreliable and of no value whatsoever to human beings. I would be
happy to appear before the Committee again if the Committee has any questions
based on my analysis of these papers. I would also be happy to appear before the
Committee and debate with any expert witness provided by the Department of
In an attempt to prove the validity of
animal experimentation the DoH supplied seven scientific papers. I examined each
of the papers in turn.
1. Backmann, K et al (1996) `Scaling basic
toxicokinetic parameters from rat to man' - Environmental Health Perspectives
This paper is barely relevant since it refers only to
`values for half life' and does not purport to offer conclusions about the value
of animal experimentation in drug testing.
Even so, there are some
remarkable statements made. For example, on page 402, the authors claim: `when
explicit weights were not provided rat weights were set at 0.25kg and human
weights at 70kg.' Are we to assume that in the absence of accurate figures the
authors merely adopted average weights? This hardly seems scientific. The
authors list eleven other potential sources of error, including, for example,
the fact that `there was insufficient technical detail...to determine whether
all studies from which kinetic data were gathered were structured appropriately
(i.e. the goodness of the underlying data cannot be validated).'
Conclusion: This paper does not support the claim that animal testing is
of value to humans.
2. Migaki G and Capen CC (1984) `Animal models in
biomedical research' in Laboratory Animal Medicine, edited by Fox, JG et al
(Aademic Press Inc)
This paper merely investigates anatomical and
disease similarities between animals and humans and makes no attempt to assess
the value of vivisection to doctors or patients.
Some of their
observations seem to me to be rather bizarre.
For example, in assessing
the value of dogs for experiments on atherosclerosis the authors point out: `It
appears that the dog requires a high cholesterol diet rich in hydrogenated
coconut oil for the lesions of atherosclerosis to develop...The necessity of
adding coconut oil to the diet substantiates its atherogenic property. In
contrast to those in humans, the lesions in the dog tend to be located in the
small arteries...' (Page 674).
My observation here would be that if you
feed a dog on high hydrogenated coconut oil you are changing the dog's normal
The obvious question I would like to ask is: `Just
how can results from experiments on this artificially devised morbidity be
regarded as relevant to humans?'
This is not a question the authors even
attempt to answer.
Conclusion: The Department of Health cannot be
seriously suggesting that this paper supports the use of animals in experiments
allegedly performed to help protect humans.
3. Cronin MTD and Dearden JC
(1995) `QSAR in Toxicology. 2. Prediction of Acute Mammalian Toxicity and
Interspecies Correlations', Quantitative Structure-Activity Relationships 14/2.
This paper can best be summarised with a couple of quotes:
1) `QSAR predictions for mammalian toxicity are generally poorly
(from the Abstract page 117)
2) `In conclusion
QSAR analysis can be applied to acute mammalian toxicity data, but more work is
required. An investigation of possible modes of toxic action is necessary and
also comparison with toxicity data for other species to see whether
extrapolation is feasible. Progress will ultimately be hampered by the lack of
reliable data, and by the fact that this is undoubtedly an area of toxicology
where it would be difficult morally and scientifically to justify further
testing simply in order to improve QSAR models.'
Conclusion: This paper does not prove the Department of Health's claim
that animal experiments are essential or of value.
4. Gad SC (1990)
`Model Selection in Toxicology: Principles and Practice' , Journal of the
American College of Toxicology, 9/3, 291-302
Gad claims (on page 292)
that `adverse effects found in two separate and diverse model species have a
much higher predictive power for the outcome of exposure in humans...'
would refer the Committee to the following quote from Zbinden's paper (also
submitted in the bundle of papers supplied by the DoH):
`One of the
principal arguments in favour of using two distinct species in toxicity testing
has always been that this measure increases the likelihood of detecting adverse
effects that are relevant for man. In this simplistic form, this conclusion is
Gad concludes his introduction with this comment:
`...there are times when adverse effects have nothing to do with what will
happen in humans.'
My point precisely.
And if you don't know
when those times are (and we don't) that makes ALL animal experiments pointless.
(If you were given several thousand aeroplane take off times, warned that most
of the times were wildly inaccurate, but not told which were the inaccurate
times, would you take any notice of ANY of the times?)
Gad continues in
his paper to explain that `there is no animal species that mimics humans in all
He makes a list of criteria for selection of ideal test
species and then writes: `It is all too easy to suggest that the animal of
choice should fit the criteria enumerated above, but in actuality these are
empty words. Actual selections are made generally on practical and `political'
criteria rather than these logical points.'
Hardly good support for the
Gad goes on to explore the ways in which species are selected
`First, economic considerations such as ease of
commercial production and availability, housing, lifespan, etc have, as was
pointed out above, favoured the use of small laboratory animals.'
presumably, vivisectors use whatever animals are lying around in cages and can
be used cheaply - regardless of whether or not those animals are likely to prove
`The second major set of factors can only be classified
generally as custom or habit. What the scientists and technicians are used to
using, and what the regulators are used to interpreting data from, is generally
what we tend to continue doing. The resulting inertia is the greatest impediment
not only to proper model selection, but also to adaptation of new or improved
study designs and to the development and use of in vitro models.'
this is supposed to be science?
I would like to thank the DoH for
drawing my attention to this remarkable paper.
In a section headed
`Limitations of Models' Gad writes: `Despite our best efforts, when human
exposures to a chemical entity (such as a drug) occur, the results do not always
come near what was expected based on animal studies.'
Exactly my point.
Gad then lists ten reasons `why data obtained in animal studies do not
always match human experience'. The first reason on his list is: `The animal
species selected differs in response from humans.'
The other nine
reasons are also excellent arguments for abandoning animal experimentation.
In Table 3 Gad gives `Reasons why high dose toxicity testing is usually
not predictive of human effects.' In relation to this table I would like to draw
the Committee's attention to the paper by Morton below. Morton describes an
experiment in which: `The doses necessary to cause the hepatic effects in rats
were therefore approximately 2000 fold those that produced similar toxicity in
On page 296 Gad continues his excellent paper with a
section dealing with `Cross Species Extrapolation'. `There are,' he writes,
`life span (or temporal) differences that are not adequately considered, nor
have they been in the past.' And he continues:
`Another difficulty is
that the lifespan of humans is from 4.4 to 66 times that of common test species.
Thus, there is generally a much longer time available for many toxicities to be
expressed or developed in people than in test animals. These sorts of temporal
considerations are of considerable importance, and this area of chronotoxicology
has not yet begun to really be explored.'
with an admission that the `best scaling factor is not generally agreed upon.'
(Transforming results from one species to another is called scaling.)
And finally he admits (page 299) that `there are many factors which can
alter the physiological state of an individual' and `there are also individual
animal-to-animal variations in temperature, health and sensitivity to toxicities
which are recognised and expected by experienced animal researchers but are only
In the introduction to this
paper Gad writes: `Although there are differences in the responses of various
species (including humans) to carcinogens, the overall predictive value of such
results (when tempered by judgement) is clear.' (page 291/292)
judgement? Who does the tempering? Conclusion: This paper does not substantiate
the Department of Health's case. Indeed, I am grateful to them for drawing it to
5. Morton DM (1998). `Importance of Species Selection in
Drug Toxicity Testing', Toxicology Letters, 102-103, 545-550
of this paper claims (on page 545) that `...only a few new compounds have been
terminated during clinical trials due to toxicity'.
This is, presumably,
offered as evidence in support of the value of animal experiments.
the corollary to this is that iatrogenesis (doctor induced disease) is now
widely recognised to be a major cause of illness in people. Illnesses caused by
prescription drugs are recognised as one of the main causes of morbidity in
If animal testing was of value then toxicity problems would be
picked up at an early stage and iatrogenesis would not be such a significant
Morton's paper continues to give support to my argument in
`Caution is always required in interpreting toxic effects in
different species since such effects may have little relevance in humans.' (page
`...adverse effects of drugs in humans, not easily predicted by
animal studies, include nausea, headache, dizziness, tinnitus, vision
disturbances and hypersensitivity and skin reactions.' (page 546)
page 547 Morton writes: `One of the more controversial areas of discussion in
toxicity study design and choice of test species has been that of
carcinogenicity testing. For many years, carcinogenicity studies in rodent
species have been required by worldwide regulatory agencies for drugs proposed
for chronic administration in humans.'
But, as I have pointed out, when
drugs are shown to cause cancer in animals they are still prescribed for people
- on the grounds that animal tests are irrelevant. For example, tamoxifen,
currently being prescribed for thousands of healthy women, is known to cause
cancer of the liver in rats and cancer of the gonads in mice.
also comments that: `It was later established that rats and mice are highly
responsive to the induction of hepatocellular neoplasms with peroxisome
proliferators but that dogs, monkeys and humans are much less responsive.' (page
and: `The doses necessary to cause the hepatic effects in rats were
therefore approximately 2000 fold those that produced similar toxicity in human
This is significant because other authors have
claimed that massive dosages produce irrelevant results.
example, the list entitled `Reasons why high dose toxicity testing is usually
not predictive of human effects' in the paper by Gad (listed no 4 above)
submitted by the Department of Health.
summary, toxicity studies in animals often provide value data to predict adverse
effects of new drugs in humans.' (page 550)
I could find no evidence to
support this summary in this paper. The author might as well have written that:
`In summary, Gordon Brown's next budget will be wonderful.'
This paper provides no evidence supporting the Department of Health's claims for
the value of animal experiments.
6. Olsen H et al (2000), `Concordance
of the Toxicity of Pharmaceuticals in Humans and in Animals', Regulatory
Toxicology and Pharmacology 32, 56-67
I do not understand why this paper
was submitted. The first two sentences of the discussion are:
study did not attempt to assess the predictability of preclinical experimental
data to humans. What it evaluated was the concordance between adverse findings
in clinical data with data which had been generated in experimental animals
Surely it is the very predictability of
preclinical experimental data which the Department of health is attempting to
prove? Retrospective studies are of no value.
Looking through a pile of
animal experiments and searching for ones which match known data in humans is of
no value whatsoever - except, perhaps, to the vivisection industry and the
authors of scientific papers.
There are, nevertheless, some interesting
comments in this paper:
`There are few published analyses of comparative
animal-human toxicity data on pharmaceuticals, with progress presumably
inhibited by the perceived confidential nature of such data.' (page 57)
`...toxicities that occurred in rats only were rarely observed in humans
and those in dogs only occurred slightly more frequently in humans, while those
that occurred in both rats and dogs showed about a 70% concordance with humans.'
`Despite its relatively high incidence in all species,
hepatobiliary toxicity in humans was surprisingly poorly predicted from animal
`Two reviews addressed those drug cases where
the clinical toxicity was so severe as to lead to withdrawal from marketing in
the approximate period 1960-1990....In one report only 4 of 24 cases were
predictable from animal data; in the other report, only 6 of 114 clinical
toxicities had animal correlates.'
`A knowledge of
pharmacology in various species, including humans, tells us that species can
differ markedly in their responses to pharmacological agents.'
`In addition to the fundamental differences between species in
biological response, Zbinden (1991) cautioned against too great an expectation
from animal toxicology studies for a host of reasons inherent in the designs of
such studies and of clinical trials.'
paper does not prove that animal testing is of value to people.
Gerberick et al (2001), `Contact Allergenic Potency: Correlation of Human and
Lymph Node Assay Data', American Journal of Contact Dermatitis, Vol 12 No 3
September 156-161 I received an incomplete copy of this paper.
discussion section of this paper begins: `To increase our ability to conduct
sound skin sensitization risk assessments, it is imperative that improved
methods for quantifying allergen potency and exposure be developed.' (page 159)
I would agree with that statement at least.
I am a little bewildered by
this paper. I could find no reference to the number of patients or animals
involved. I do note that: `Twenty chemicals were assigned to 1 of 5 human
potency classes....based soley on the expert clinical judgement of the authors.'
Conclusion: The part of this paper which I received does not prove that
animal testing is essential for human safety. I note that this paper came, in
part, from the Human and Environmental Safety Division of Procter and Gamble,
USA, that the contact address of the author of this paper is The Procter and
Gamble Company in the USA and that the research was supported in part by a grant
from the United Kingdom Health and Safety Executive. I find it difficult to
understand why British taxpayers supported this work.
The DoH also
enclosed several other papers which were not on their list. I have also reviewed
8. Zbinden G, 1993, `The Concept of Multispecies Testing
in industrial Toxicology', `Regulatory Toxicology and Pharmacology 17, 85-94
A review of this paper reveals the following quote on page 89:
`One of the principal arguments in favour of using two distinct species
in toxicity testing has always been that this measure increases the likelihood
of detecting adverse effects that are relevant for man. In this simplistic form,
this conclusion is untenable: if the toxicological responses in the rodent and
the nonrodent species are different, then the prediction of a toxic effect in
man of at least one, and possibly of both, findings is in error. If rodents and
nonrodents respond identically, the prediction for man that is based on such
findings may be correct or false.'
Zbinden concludes (on page 93):
`contrary findings in rodents and nonrodents occur frequently'.
Proponents of animal testing often claim that the weakness of tests on
individual species can be overcome by testing on multiple species.
Conclusion: This paper does not substantiate the Department of Health's
claim for the value of animal experiments.
9. Tomatis L, et al, 1990.
`The contribution of experimental studies to risk assessment of carcinogenic
agents in humans', Exp Pathol, 40 251-266
This paper begins with an
extraordinary statement: `...aetiological factors have not yet been identified
for cancers that occur in some of the most frequent target organs, such as
prostate and colon in men, breast and colon in women.' (page 251)
authors continue (on page 252) with the equally extraordinary statement that:
`the list of etiological factors of human cancer ...still reflects the absolute
preponderance of environmental chemical agents.'
This is, quite simply,
not true. Both the British and American governments have listed the causative
factors for cancer, and environmental chemical agents are of relatively minor
significance. The National Academy of Sciences in the USA (founded in 1863 by
Act of Congress to serve as an official advisor to the US Government in all
matters of science and technology), has reported that researchers have estimated
that almost 60% of women's cancers and a little more than 40% of men's cancers
are related to nutritional factors. In 1982 the National Research Council in the
USA published a technical report entitled `Diet, Nutrition and Cancer' which
showed that diet was probably the single most important factor in the
development of cancer and there was evidence linking cancers of the breast,
colon and prostate to particular foods or types of food.
Details of over
20 scientific papers proving the relationship of diet to cancers of the colon,
prostate and breast can be found in my book `Food for Thought'. (I will happily
supply copies of this book if the Committee would like to see them.)
Tobacco is, apart from food, the other main cause of cancer in humans.
In my view, the authors do, however, do better with their direct
comments on the value of animal experiments: `The attitude prevailing today is
that only epidemiological studies may provide unequivocal evidence that an
exposure is carcinogenic to humans. This has as a consequence that the
experimental evidence, in particular that obtained in long-term animal tests,
has been often regarded as a sort of second-rate type of evidence: it is claimed
that chemicals proven to be carcinogenic in animals cannot be considered human
carcinogens until there is epidemiological proof.' (page 252)
257 they continue: `The main objective support for the value of experimental
data in predicting a qualitatively similar effect in humans comes from the fact
that experimental evidence of carcinogenicity has on several occasions been
obtained before the epidemiological evidence.'
The words `on several
occasions' are a remarkable admission since many pro vivisectionists claim that
animal experiments are crucial for toxicology testing. But if experimental
evidence is only rarely valid it must always be ignored. (Would anyone trust a
train timetable which contained 1,000 times, knowing that 700 of those times
The fact is that in practice animal tests are so unreliable
and unpredictable that tests which show carcinogenicity are ignored unless there
is also reliable human epidemiological evidence. If you are going to ignore the
animal experiments there is clearly no point whatsoever in doing them in the
I would remind the Committee that the widely prescribed
drug tamoxifen, currently being prescribed for thousands of perfectly healthy
women because it is believed that it may help prevent breast cancer, is known to
cause cancer of the liver when given to rats and cancer of the gonads when given
to mice. These results are ignored on the grounds that animals are different to
people and that the fact that the drug causes cancer in rats and mice is of no
significance to people. (Why do the tests in the first place if you are merely
going to ignore them?)
Later in this paper (on page 258) the authors
admit that: `The fact that concordance is imperfect between data in humans and
results in experimental animals (namely for 11 of the 35 human carcinogens
tested in experimental animals the evidence is less than sufficient) is often
taken as an argument to downgrade the value of results from experimental animals
in predicting similar effects in humans.'
At the end of
their paper these authors conclude (on page 264): `The role of carcinogenicity
tests in the quantitative estimation of risks is still questionable...'
Conclusion: The paper does not prove the Department of Health's case.
These papers do not prove the value of animal
experiments. On the contrary they clearly prove that animal experimentation is
so unpredictable and unreliable that it is worthless to human beings.
can understand why drug companies support vivisection: it is a double edged tool
which enables them to sell drugs for a mass market without the danger of
performing tests which might prove that a potentially profitable drug causes
dangerous side effects and cannot therefore be marketed. If a test on animals
shows that a drug causes cancer (as, for example, with the very widely
prescribed drug tamoxifen) the test will be ignored on the grounds that animals
are different to people. If a test on animals shows that a drug does not cause
cancer the results of the test will be used to help substantiate the claim that
the drug is safe for humans. Drug companies just cannot lose when performing
animal tests. The Committee will be aware that I submitted a list of 50 drugs
which are currently prescribed for human beings but which are known to cause
cancer or other serious health problems in animals. These adverse results are
all ignored on the grounds that animals are different to people - proving quite
conclusively that initial toxicology testing on animals is utterly pointless.
I am perfectly happy to accept that animal testing is more expensive
than other forms of testing.
But the evidence supports the view that
drug companies perform animal tests because, although they may be more expensive
than more effective forms of testing, they enable them to mass-market new drugs
without the risk of having to withdraw potentially profitable products in the
The big question is: `Why does the Government continue to
support vivisection when the Department of Health cannot provide one jot of
evidence in support of its claim that animal experimentation is valid and of
value? Indeed, on the contrary, the evidence supplied by the Department of
Health proves my argument much more effectively than it proves their argument.'
Surely the Department of Health should devote itself to finding the
truth, and protecting the interests of patients, rather than simply attempting
(in vain) to protect the commercial interests of the pharmaceutical industry?
Assessing animal experimentation alongside non animal experimentation would be a
good starting point.
Finally, I would like the Department of Health to
explain why it allows doctors to prescribe a huge number of drugs which cause
cancer in animals and yet, at the same time, considers animal experiment results
essential for the granting of licences to drug companies.
If you are
going to demand that drug companies perform animal tests, and then going to
ignore the results of those tests when they are inconvenient, why do the tests
in the first place?
Four out of ten patients in the UK suffer
unpleasant, severe or fatal side effects after taking prescription drugs. The
cost of all these side effects puts a great burden on the NHS. If animal tests
were abandoned, and drugs were tested more effectively, the nation would be
healthier and the demands on the NHS would be much lighter.
Vernon Coleman 2003