Useful
Quotes
The
following quotes are taken from Specious Science (NewYork/London: Continuum,
2002), by Doctors Ray and Jean Greek.
'A person who develops
nearly any type of cancer, common skin disease, asthma, or psychiatric or neurological
illness is unlikely to be much better off than if they were receiving the best
available treatment 30-40 years ago. Even in the cardiovascular area, in which
there seems to have been a great deal of innovation, improvements are small
and are shown only by very large scale trials..
Innovation in the development
of effective specific drugs and preventative measures had a golden age between
about 1930 and 1965. Much less of significance has happened since then... Innovators
are rare. Most people involved in the regulation of the innovation process have
no idea what it feels like to have an original idea, or to believe passionately
that such an idea may transform the lives of patients'. David F. Horrobin, 'Effective
clinical innovation', vol.359, 25 May 2002, p.1857.
The following quotations
are supplied in Vernon Coleman's June 2002 Newsletter. Incredibly, the papers
cited are amongst those which the Department of Health submitted to the House
of Lords 'Animals in Scientific Procedures Committee' to *support* its pro-vivisection
stance. Consequently, this must surely indicate a dire shortage of scientific
material which offers evidence to support animal experimentation. Vernon Coleman
has extracted the following statements from the material which clearly shows
that even the papers which the Department of Health chose to offer to the Committee
failed to support its argument;
'There are times when
adverse effects [in animals] have nothing to do with what will happen in humans'.
'There is no animal species that mimics humans in all respects'. 'It is all
to 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 ...logical points'.
'First, economic considerations
such as the ease of commercial production and availability, housing, lifespan,
etc., have...favoured the use of small laboratory animals...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'.
'Despite our best efforts,
when human exposures to a chemical entity (such as a drug) occurs, the results
do not always come near to what was expected, based on animal studies'.
'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'. 'There are many factors
which can alter the physiological state of an individual...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 broadly understood'. (S. C. Gad, 'Model selection in toxicology; Principles
and practice', Journal of the American College of Toxicology, 3, 1990, 291-302).
'Caution is always required
in interpreting toxic effects in different species since such effects may have
little relevance in humans'. 'Adverse effects of drugs in humans, not easily
predicted by animal studies, include nausea, headache, dizziness, tinnitus,
vision disturbances and hypersensitivity and skin reactions'.
'The doses necessary
to cause the hepatic effects in rats were therefore approximately 2000-fold
those which produced similar toxicity in human patients'. (D, M. Morton, 'Importance
of species selection in drug toxicity testing', Toxicity Letter, 1998, 102-
103, 545-550).
'Despite its relatively
high incidence in all species, hepatobiliary toxicity in humans was surprisingly
poorly predicted from animal studies'. '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 the 24 cases were
predictable from animal data; in the other report, only 6 of the 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'. (H.
Olsen, et al, 'Concordance of the toxicity of pharmaceuticals in humans and
animals', Regulatory Toxicology and Pharmacology, 32, 2000, 56-67).
'One of the principle
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'.
'Contrary findings in
rodents and nonrodents occur frequently'. (G. Zbinden, 'The concept of multispecies
testing in industrial toxicology', Regulatory Toxicology and Pharmacology, 17,
1993, 85-94.
'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'.
(L. Tomatis, et al, 'The contribution of experimental studies to risk assessment
of carcinogenic agents in humans', Exp. Pathol., 1990, 40, 251-266).
'One proof of this may
be found in an examination of cost and cost-effectiveness reports for oncology
drugs published between 1988 and 1998. It found significant differences between
the studies paid for by pharmaceutical companies and those sponsored by non-profit
organizations. Only five percent of corporate-sponsored studies reached unfavourable
qualitative conclusions, compared with thirty-eight percent of non-profit studies.
He who pays the piper calls the tune.
Not surprisingly, but
still appallingly, drugs, whether questionable or not, stand a far greater chance
of reaching the market - seven times the chance - when pharmaceutical companies
pay for their testing. And a primary mechanism used by drug companies to support
the merit of their product is animal testing'. (Ray and Jean Greek, Specious
Science (New York/London: Continuum, 2002), p.130).
'The Times reported
in the UK on 8 August 2000, that two-thirds of the members of the government's
pharmaceutical-licensing board have financial interests in pharmaceutical companies'.
(Ray and Jean Greek, Specious Science (New York/London: Continuum, 2002), p.130).
'Another syndrome that
keeps animal labs and their suppliers in business is the media. Medical 'miracles'
grab virtually everyone. Hence, television and newspaper reports of prospective
new drugs exaggerate their efficacy and minimize the obstacles and side-effects.
Considering the slanted
press releases the editors receive, it is easy enough to do. These news items
almost invariably involve animals. Apparent advances garnered through animal
studies get lots of publicity, but when these same drugs later perform poorly
in clinical trials, there is barely a whisper'. (Ray and Jean Greek, Specious
Science (New York/London: Continuum, 2002), p.132).
'A study conducted by
Dr. John P. A. Ioannidis of Tufts University School of Medicine and Dr. Joseph
Lau of the New England Medical Center in Boston examined a total of 192 randomized
drug trials, each involving a minimum of a hundred patients with at least fifty
patients per arm. Just thirty-nine percent of randomized drug trials adequately
reported clinical adverse effects of the medications being studied. Only twenty-nine
percent did a good job of reporting the toxicity of a drug revealed through
an abnormal lab test result. Eleven percent and eight percent only partially
reported clinical adverse events and laboratory-determined toxicity'. (Ray and
Jean Greek, Specious Science (New York/London: Continuum, 2002), p.132).
'Medication testing
on animals continues for the same reasons that any failed politics-based agenda
continue. Positive animal-modeled results work short-term by inspiring public
confidence. This allows pharmaceutical companies to sell their products, while
effective public relation obscure the negative long-term consequences of using
those products. Animal experimentation provides jobs, as well as research money
for universities and other testing facilities. It gives liability protection
to the manufacturers, it benefits opportunistic politicians who are eager to
appear concerned about...drug supply. And it gives long-established bureaucracies
the appearance of legitimacy'. (Ray and Jean Greek, Specious Science (New York/London:
Continuum, 2002), p.132).
'Knowledge deriving
from animal experimentation is never entirely applicable to the human species'.
(Professor Rene Dubos, Pulitzer prize-winner and professor of microbiology,
Rockefeller Institute of New York, in Man, Medicine and Environment, Praeger,
New York, 1968, p.107).
Dr Dileep Gal, the American
Cancer Society's president, stated that two-thirds of cancer deaths in America
are linked to tobacco use, poor diet, obesity and insufficient exercise. Eating
red meat is also 'implicated in the development of certain cancers', whereas
a high fruit and vegetable consumption reduces the risk of over 10 different
forms of cancer. (CA 1999, 1999:49:327-328). In sum, two-thirds of all cancers
could be avoided.
The Federal Register
of 17 July 1993 stated that many substances classified as carcinogens would
be removed from that list. This clearly showed that 'rodent-to-human extrapolations
used in animal screening programs are invalid'. (Paul R. Gross and Norman Levitt,
Higher Superstition (John Hopkins University Press, 1994).
When William Campbell,
the president and CEO of Phillip Morris, testified under oath in 1993 he was
questioned and answered thus:
'Q. Does cigarette smoking
cause cancer?
Answer. To my knowledge,
it is not proven that cigarette smoking causes cancer.
Question. What do you
base that on?
Answer. I base that
on the fact, at this time there is no evidence that they [researchers] have
been able to reproduce cancer in animals from cigarette smoking'. (The New York
Times, 6 December 1993).
DR Tyler Jacks of Massachusetts
Institute of Technology said: 'Animals apparently do not handle the drugs in
exactly the same way as the human body does'. (Science, vol.278, 7 November
1997, p.1041).
DR Richard Klausner,
the NIH Director, said to the Los Angeles Times: 'The history of cancer research
has been a history of curing cancer in the mouse. We have cured mice of cancer
for decades, and it simply did not work in humans'. (Los Angeles Times, 6 May 1998).
'Mice are actually poor
models of the onset of the onset of the majority of human cancers.' (Lab Animal,
June 2001, vol.30, no.6, p.13).
'Most human cancers
differ from the artificially produced animal model'. (Harrison, Clinical Oncology,
1980:16:1-2).
'[animal models] may
not offer an uncomplicated straightforward means of discovering preventable
causes for the majority of human cancers, and at the very least it certainly
does not seem likely that they can offer a reliable means of estimating quantitative
human hazards'. (Journal. Nat. Cancer. Inst., 1981,6:1215).
'Fifteen years after
inducing cancer in normal mouse cells, scientists decided to attempt the same
thing in human cells. And it did not work'. Ray and Jean Greek, Specious Science
(New York/New York: Continuum, 2002), p.86).
'Extrapolating from
one species to another is fraught with uncertainty'. (DR Lester Lave, et al,
Nature, vol.336, 1988, p.631).
'The standard carcinogen
tests that use rodents are an obsolescent relic of the ignorance of past decades'.
Philip H. Abelson (Deputy Editor of Science), Editorial, Science, vol.249, 1990,
p.1357).
-
'Meat and dairy products
compromise the colon, and colorectal cancer is three times more common in meat
eaters'. Ray and Jean Greek, Specious Science (New York/London: Continuum, 2002),
p.88).
'Some findings in colon
cancer mice, which were very good models, actually led to clinical trials in
humans which resulted in an increase in cancer'. (Dr. J. E. Green of the National
Cancer Institute Laboratory, Journal of the National Cancer Institute, 2001,
93:976).
'Most available chemotherapeutic
agents have been developed using serially transplantable rodent tumors. Unfortunately
their biological behavior and chemotherapeutic sensitivities do not closely
resemble those found in human solid tumours. Chemotherapeutic data derived from
these experimental systems [i.e. animal] may therefore be misleading with the
result that patients in clinical trials frequently receive ineffective agents'.
(Dr A. J. Shorthouse, et al, British Journal of Surgery, 1965, 67:715-722).
'The National Cancer
Institute haboured mice that were growing forty-eight different kinds of human
cancers. Scientists treated them with twelve anticancer drugs that were currently
and effectively used in humans. In thirty out of the forty-eight, the drugs
did not work. That means in sixty-three per cent of the time, the mouse was
not predictive'. (Ray and Jean Greek, Specious Science (New York/London: Continuum,
2002), p.93).
'We had basically discovered
compounds that were good mouse drugs rather than good human drugs'. (Edward
Sausville, associate director of the division of cancer treatment at the National
Cancer Institute, quoted in Science, Vol.278, 7 November 1997, p.1041).
Bayer ceased their studies
of MMPIs for cancer treatment after failure in human patients. Bayer's director
of oncology research, DR Mel Sorensen said: 'the finding was very surprising
to us and contrary to pre-clinical [animal] data which confirmed the drug inhibited
tumors in rodents'. (Reuters Health, 27 September 1999).
'Drug companies conduct
a lot of animal tests so that, in case the drug makes people sick or kills them,
they can later point to the rigorous animal tests that they performed and claim
that they did their best to ensure against such tragedy - and thus minimizing
the monetary judgement against them'. (Ray and Jean Greek, Specious Science
(NewYork/London: Continuum, 2002), p.107).
'There is at present
no hard evidence to show that the value of more extensive and more prolonged
[animal] laboratory testing as a method of reducing eventual risk in human patients.
In other words, the predictive value of studies carried out in animals is uncertain.
The statutory bodies such as the Committee on Safety of Medicines that require
these tests do so largely as an act of faith rather than on hard scientific
grounds. In this particular case [thalidomide], it is unlikely therefore that
specific tests in pregnant animals would have given the necessary warning: the
right species would probably never have been used'. (Prof. George Teeling-Smith
in 'A question of balance: The benefits and risks of pharmaceutical innovation',
p.29, Publishers Office of Health Economics, 1989).
'I think very often
the carcinogenicity studies are a waste of everybody's time and a fearful waste
of animals. They are conducted partly because we are not sure what to do instead,
and partly because they are a political gesture and a very miserable one at
that'. (Prof. Andre McLean, Dept. of Clinical Pharmacology, University College
MCM, London, Reported in Animals and Alternatives in Toxicology, ed. M. Balls,
J. Bridges, and J. Southee (Macmillan, 1991).
'As a very approximate
estimate, for any individual drug, [only] up to twenty-five per cent of the
toxic effects observed in animal studies might be expected to occur as adverse
reactions in man'. (DR A. P. Fland, Journal of the Royal Society of Medicine,
vol.71, 1978, pp.693-696).
'This use of animal
models for predicting risks for man is beset with difficulties: it is rarely
possible to ensure that the animal model properly represents the relationship
in man'. (Risk Assessment. Report of a Royal Society Study Group. 1983, pp.72-73).
'These examples should
serve to illustrate that interspecies differences in the absorption of organic
compounds do indeed exist and that in specific instances the degree of difference
can be appreciable. Of the thirty-eight organic compounds reviewed here, more
than one third of them appeared to be differently absorbed by animal models
when compared to human subjects'. (Principles of Animal Extrapolation, Calabrese,
Edward J. Lewis Publishing, 1991, p.5).
'The National Academy
of Sciences stated, 'No presently used species, including simians, resembles
man in all respects. It is evident that the degree of similarity to man exhibited
by a given species varies from one test substance to another'. (Ray and Jean
Greek, Specious Science (New York/London: Continuum, 2002), p.123).
'Considerable variation
occurs among animal species in their response to drugs used to alleviate pain
and distress. The comparative pharmacodynamics and kinetics of most agents are
unknown for many species, especially the smaller laboratory animals. Extrapolation
of data from one species to another is fraught with error and should be avoided'.
(JAVMA, 1987:191:1227-30).
'It is impossible to
establish the reliability of animal data until humans are exposed'. (Op Flint,
Bristol-Myers Pharmaceutical, in Neurotoxicology In vitro, ed. V. W. Pentreath,
Taylor and Francis, 1999, p.9).
'The best guess for
the correlation of adverse reactions in man and animal toxicity data is somewhere
between five and twenty-five percent'. (Dr. Ralph Heywood, director of Huntingdon
Research Centre (now Huntingdon Life Sciences), cited Animal Toxicity Studies:
Their Relevance for Man (Quay, 1990), p.57).
'Because of the increasingly
observed species differences in metabolism, during the development of the drug
testing process, in pharmacokinetics and in mechanisms of toxicity, a variety
of animals had to be exposed, including rodents, rabbits, dogs, monkeys and
baboons, to warrant that no aspect of toxicity was missed. Yet this extensive
screening in various experimental animals for potential toxicity in humans still
threw up numerous false negatives such as the drugs perhexiline, benoxaprofen
and tienilic acid, which subsequently caused human deaths. So, there are indeed
more appropriate alternatives to experimental animal studies and, for the safety
evaluation of new drugs, these comprise short term in vitro tests with micro-organisms,
cells and tissues, followed by sophisticated pharmacokinetic studies in human
volunteers and patients'. (Dr Denis Parke, Dept. of Biochemistry. University
of Surrey, UK, writing in ATLA, Vol.22, 1994, pp.207-209).
'There may be better
tests around, but we have no incentive whatsoever to look for them at the moment.
In fact, quite the reverse'. (Dr. R. Brimblecombe, Vice-President of Research
and Development, Smith, Kline and French Laboratories, in Risk-Benefit Analysis
in Drug Research, ed. Cavalla, 1981, p.153).
'The weakness and intellectual
poverty of a naive trust in animal tests may be shown in several ways, e.g.,
the humiliatingly large number of medicines discovered only by serendipitous
observation in man (ranging from diuretics to antidepressants), or by astute
analysis of deliberate or accidental poisoning, the notorious examples of valuable
medicines which have seemingly 'unacceptable' toxicity in animals, e.g., griseofulvin
producing tumours and furosemide causing hepatic necrosis in mice [and] the
stimulant action of morphine in cats. The rapidly increasing interest in clinical
pharmacology, and the drive to better means of measurements in man, also reflect
the uncertainty of animal experimentation and realization that the study of
man alone can ever prove entirely valid for other men'. (DR Anthony Dayan, of
Wellcome Research Laboratories, in Risk-Benefit Analysis in Drug Research, ed.
Cavalla, 1981, p.97).
'Though Rezulin killed
hundreds of people and obliged hundreds more to undergo liver transplants, Warner-Lambert
[the manufacturer] made over two billion dollars before the drug was withdrawn
in 2000'. (Ray and Jean Greek, Specious Science (New York/London: Continuum,
2002), p.118).
'Unfortunately, there
is no absolutely certainty that a substance that has not been found to produce
any adverse effects in animal models will also be safe for humans. The use of
animal testing is often criticized on several levels simultaneously. Examples
have been frequently presented in the literature as to how medically important
drugs were discovered by luck in humans that would not have been found by current
testing procedures had the initial studies been with animal models. There are
inherent problems in trying to make interspecies comparisons. By taxonomic definition,
a rat is a rat and not a human. Human beings have been reproductively isolated
for millions of years and numerous other metabolic differences have also developed;
in fact, these differences may be so significant as to cause rats and humans
to respond very differently to a same agent'. (Principles of Animal Extrapolation,
Calabrese, Edward J. Lewis Publishing, 1991, pp.5-7).
'A recent article in
the Journal of the American Medical Association revealed that physicians involved
in clinical trials regularly under-report drug safety problems. The authors
of the study state: 'We found no instances where the safety reporting can be
deemed satisfactory'. Physicians adequately report side-effect severity only
thirty-nine percent of the time, and toxicity only twenty-nine percent of the
time. Only forty-six percent of the time do they say why patents withdrew from
the trial'. (Ray and Jean Greek, Specious Science (New York/London: Continuum,
2002), p.119).
'That species may differ
in their abilities to absorb compounds via the digestive tract should not be
unexpected'. (Principles of Animal Extrapolation, Calabrese, Edward J. Lewis
Publishing, 1991, p.45).
'Prediction of human
lethal and toxic doses is poor due to species differences between animals and
humans, and the toxic mechanisms of the chemicals cannot be directly predicted
using current animal tests'. (Dr. Bjorn Ekwall, Chairman of the Cytotoxicology
Laboratory., Toxicolog In vitro, August-October 1999).
'That humans are not
at all protected by these animals tests is evident in all the illness and mortality
that occur during the clinical trial phase. For instance, 122 deaths were associated
with Lotrafiban, a drug designed to fight strokes and heart attacks, before
the trials were halted. So much for animal testing to protect those undergoing
clinical trials'. (Ray and Jean Greek, Specious Science (New York/London: Continuum,
2002), p.111).
'The extensive animal
reproductive studies to which all new drugs are now subjected are more in the
nature of a public relations exercise than a serious contribution to drug safety'.
(Prof. R. W. Smithells, in Monitoring Drug Safety, ed. Inman, 1980, pp.306-313).
[After a lengthy list
of drugs which have been re-labelled or withdrawn]. 'The drugs enumerated here
are just a smattering of the total calamities. Total reports of adverse drug
reactions filed to the FDA by health professionals, consumers and drug manufacturers
increased eighty-nine per cent from 1993 through to 1999. More than 250,000
side-effects linked to prescription drugs, including injuries and deaths, are
reported each year. The reports are only those filed voluntarily and do not
include adverse events that are no reported. Neither laws nor financial incentives
encourage physicians to report'. (Ray and Jean Greek, Specious Science (New
York/London: Continuum, 2002), p.115).
'In the last ten years,
drug companies have steered 44 million dollars in contributions to the major
[American] political parties and candidates. What this means is that the FDA
is effectively financed by the pharmaceutical industry'. (Ray and Jean Greek,
Specious Science (New York/London: Continuum, 2002), pp.115-116).
[Referring to how fen-phen,
an animal-tested but faulty diet drug remained on the market]: 'Why weren't
these problems noticed before? Dieters in Europe had used Dexfenfluramine for
decades. DR Friedman [an FDA official] said he could only speculate. No one
had initially thought to examine patients' hearts, he said, because animal studies
had never revealed heart abnormalities and heart valve defects are not normally
associated with drug use'. (Gina Kolata, New York Times, 16 September 1997).
'It has been obvious
for some time that there is generally no evolutionary basis behind the particular-metabolizing
ability of a particular species. Indeed, among rodents and primates, zoologically
closed related species exhibit markedly different patterns of metabolism'. (J.
Caldwell, 'Species differences in metabolism and their toxicological significance',
Toxicology Letters, 64, 5, 1992, p.106).
'David E. Semler of
G. D. Searle and Company writing about these discrepancies in Animal Models
of Toxicology* goes onto describe differences between male and female rats,
between different strains of rats, and between the results of studies on rats
conducted at different research institutions. Even when the same rats are used
for the same experiment at different research institutions, the results are
different'. *Animal Models of Toxicology, ed., S. C. Gad and C. P. Chengelis,
Marcel Dekker Inc, 1992, pp.21-76. (Ray and Jean Greek, Specious Science (New
York/London: Continuum, 2002), pp.121-122).