A researcher of any experimental discipline able to correctly analyze and interpret will only come to one conclusion from his/her experiment: that an animal under given conditions suffers a certain reaction or functional change of the organism or has survived the operative procedure more or less well. Any other extrapolation to humans is mere speculation, at best hypothesis. The experiment will always have to be repeated the same way in humans.

Who is Entitled to Evaluate the Findings of Animal Experiments?

Quality and consequences of a method to gain knowledge can only be assessed based on their results on the reference object, i.e. humans, using principles of scientific logics. Therefore, it is the experienced physician who is probably best able to evaluate the value and consequences of experiments on animals in human medicine. Veterinarians or biologists seem to be less appropriate for this job. However, it's them who rigorously support the use of animals for experiments and make their predominantly interest-tied ideas prevail with competent authorities.

In their interpretation, they put the human organism and its course of disease biologically at the same level as that of animals, quite in the sense of Darwin's evolution theory, entirely ignoring the countless compatibility, effect and compensation differences between humans and animals and the great variety of absolutely non-comparable psychosomatic developments of a disease. With this mode of thinking, medical science as an empirical healing method is shifted into the world view of natural science and physics; the organism is reduced to some sort of machine while matter is viewed as the basis of the living processes. However, by doing so, essential dimensions of the invidual »human« remain unconsidered, i.e. the spiritual, mental and social areas that are of the utmost importance to the body' s physiological and pathological processes.

If human diseases and their healing, the action mechanisms of exogenic substances and their envolvement in the pathological process could be assessed in that way by veterinarians, biologists and genetical engineers according to the analytically recorded, elementary, not only for each animal species different and especially between animals and humans incalculably different physiological functions, we could well do without medical schools and clinical research in the future and allow veterinarians or microbiologists to treat us!

Considerations on Diseases

Many physicians see a general difference between influences on the physiological functions of a body caused by chemical exogenic substances and a lasting normalization in the sense of disease healing. Yet, the only criterion for a doctor to evaluate a therapeutical method is the healing success and not a scientifically measurable functional change in the biological system. In a doctor's way of thinking it's impossible to refer to the drug-induced removal of clinical symptoms of a polycausal disease that has developed over years of function-changing influences as healing. This essential difference in the physician's approach may not always be accepted by scientifically oriented researchers, however, they are familiar with it, which is why in pharmacology there is a clear differentiation between effect and effectiveness, without always including this fact in the evaluation principles.

The great clinician Prof. Dr. Heinz Much specifies this difference between chemically caused functional change with symptom suppression and healing of a human disease as follows:

»The largest damage caused by animal experiments is the simple extrapolation of functional findings to humans. The physician on the bedside knows that the science offered to him/her changes its robe every few years. The observation and experience on which a physician's actions are based are independent of natural science. This explains why only a physician on the bedside is able to discuss medical sciences and their results!«

Critizising the Mode of Thinking

It already requires an exceptionally unilateral approach to ignore the annual tens of thousands of drug-related deaths in Germany, the harmful effects of chemical exogenic substances in the sense of their cancerogenic, mutagenic, organ-, birth defect- and increasingly allergy-causing reactions, the for decades growing number of cardiovascular deaths and deadly tumor formations and the 30% of drug-related side-effects during hospital stays (5).

In some cases, supporters of animal experiment-based research try to depreciate the criticism on methodology common and necessary in science as being polemic and emotional, and thus put themselves outside an objective result assessment.

The physician and nobel laureate Pauli, like other unprejudiced scientists, only considers an experiment scientific and usable if it provides reproducible measuring results that keep their unchanging statement even when taken out of the context and that are free of falsifying impacts. The one-time measuring of a quantity is of no informative value, only the prove of its reproducibility makes it a useful knowledge factor. A method doesn't gain informative safety by believing it but by continuously doubting it (1).

Thus, methodology criticism is an indispensible part of scientific objectivity and not polemic. Rather, this unjustified reproach may be considered polemic.

Another accuse also requires rectification: the antivivisectionists' alleged emotional irrationalness used in the hope to disqualify their arguments. Emotionalism is a moral outrage requiring, of course, a certain base of knowledge but not at all excluding intellectual control. It is, of course, not understood by those who have replaced the christian-ethical ideas of compassion, mercy and love for creation by the pursuit of advantage to meet one's own or sectional self-interests. It is therefore being tried to discredit emotionalism by a rationalism that actually is a mere respectless exploitation mentality, freed of ethics of any kind.

Moral-ethical Considerations

It is shocking how easily animal experiments are, in general, declared indispensible not only by experimenters claiming that they »contribute« to fighting human diseases and disabilities.

Intellectual and physical superiority does not entitle humans to take advantage of animals and abuse our fellow earthlings by submitting billions of them to suffering and painful death. Furthermore, any self-determined »contribution« - whatever this might be - would serve to justify just any experiment on animals.

It is exactly this mode of thinking which has led to todays animal destruction through experiments which is excessive in type, number and suffering. It is based on the fatal belief that other creatures exist for only one purpose: to be used at any time and without restrictions- just like slaves once were- for personal advantage and profit.

Already the number of experiments, carried out by numerous institutes worldwide and in our own country to answer the same questions, clearly proves that the »indispensible quantity« refered to by Animal Protection Law finds no consideration at all and that the dimension of animals killed in experiments clearly is the result of a competitive thinking, personal interests and economic motives.

Apart from the fact that even among humans the clear statement of the Fifth Commandment: »Thou shalt not kill» hardly finds any consideration, all religious and philosophical moral values consider the abuse and painful killing of our fellow earthlings as immoral and therefore ban it. Unethical actions, however, do not become ethical by justifying them with personal profit, advantage or so motivated gain of scientific knowledge. It also is of no importance whether or not the experimenter's conscience allows him/her to perform the experiment. The only thing that matters is whether his/her actions are acceptable to the public based on pure ethical values. If the own conscience was a criterion for the integrity of an action, any infringement of a law would have to be tolerated since the person committing the infringement is, of course, acting in compliance with his/her own conscience.

As a christian and a human, one will have to follow the ideas of Pope Pius XII who, from a theological-dogmatic point of view, declared:

»The animal kingdom reveales to us, just as the whole creation, the power of God, his wisdom and charity. It therefore deserves unrestricted human respect and protection. Any respectless acting including the killing of animals, any cruelty and hardness are therefore in clear contradiction to a sane human sensibility. The role of the animal kingdom within the creation concept is not that of a subject to exploitation of any kind!« (2)

This is a competent assessment of the questionable justification of such behavior, however not a comment on the alleged usability of animal experiment results for humans. Regarding this point, economics and science experimenters shall give their own comments:

Usability, Extrapolability, Scientific Aspect

The leading physician of Ciba-Geigy, Prof. Dr. W. Koella, shall be cited with his comment on drug side effects:

»We have learned that many of our positive forecasts are not correct, that a therapeutical effect on a given clinical picture is non-existing. Furthermore, we will have to accept that substances show impacts on certain diseases that come unexpected based on our screen (experimental preliminary testing on animals/the author).«

And Prof. Dr. D. Lorke of the Bayer Corporation says:

»There would be no ideal model (he means animal/the author) serving to simulate all processes in a human organism. There are, no doubt, even today medical fields of application where no satisfying »model« was found for certain reactions of a human organism.«

Prof. Dr. H. Weidmann, Head of the Pharmacological Department at Sandoz, states:

»The animal experiment results of the cancer tests, the birth defect tests and the mutagenic tests are of no significance to humans. The only possibility to determine the teratogenic, mutagenic and carcinogenic effects of newly introduced substances is an intensive clinical monitoring of humans. Toxic reactions of the human immune system cannot be simulated using the animal model!«

Prof. Dr. Überla, former Head of the BGA (Federal Health Authority) of Germany, states in an expertise (October 19, 1987):

»An extrapolation of animal experiments to humans is, in general, impossible!«

Even Hoechst AG states in »Welt am Sonntag« dated December 19, 1976:

»The effectiveness of a drug can only be tested in humans. Therefore, a long-term clinical evaluation with patients is indispensible!«

Disease aspects

But not only according to the cited scientists it is clear that gaining human medicine knowledge through animal experiments is just as impossible as is a prediction of the effects, getting drug safety or evaluating the toxicity of exogenic substances with yet unknown effects. Also, gaining knowledge about human diseases and the means to heal them has proven impossible if we look at the people's general state of health.

This qualification remains unaffected even if scientists and supporters who are tied to interests keep repeating themselves. It is, however, speaking for itself that a large number of animal experimenters have quitted their job after careful evaluation of their human medicine research method and its results and even dared speaking out for the animals in public defending their decision in favor of the animals regardless of any personal consequences!(4)

Despite the hecatombs of animals killed in experiments, medical science has so far neither been able to clearly identify the object of investigation - the human disease - and the reasons for its development nor to clarify the term »healing« in its final functionality. There wouldn't be so many therapeutical, partly contradicting methods and the WHO wouldn't have been able to find that with any healing method of the world - from classical medicine to homeopathy, spagyrics, holy ghost healing, mediumistic healing processes, voodoo healing, phioppono healer to shaman healing - and to an almost uniform share one third of the diseases can be healed, another third can be improved and one third of the sick cannot be helped at all.

Regarding disease development it is generally believed that the human disease is a fateful disturbance of one or several biological processes and chemical-physiological reactions which may be »healed« using a pharmacological substance and that the consequences of many years of multi-factor impact of noxious substances could be eliminated.

From a biological-medical point of view, the reasons for disease processes are, however, mainly a failure of the body's own immune system and healing power, something that cannot be compared to a damage artificially inflicted on the organism. In experiments, only artificial damage can be caused to an animal, i.e. only the symptoms can be produced, but not a natural human disease. The genuinely healthy animal's starting point for a healing is entirely different from that of a sick person which is why it will, in most of the cases, fight the inflicted damage to or disturbances of its biological system with its own force.

Also, the animal experiment is tailored to certain aspects and facts and all the other causes and partial causes of the considerably interlinked reality are suppressed. The great number of factors involved in causing a disease with a joint and often even potentiating effect are in an unnatural way reduced to one or a few ones, thus contradicting reality.

Findings

If despite of decades of destroying billions of animals in experiments humans get sicker and sicker, if malignant tumors and fatal cardiovascular diseases keep increasing and, with an annual growth rate of about 3%, actually make two thirds of the deaths, if the number of acute and chronic diseases continuously increases, if the costs for diseases that require treatment slowly but surely grow so excessively that they cannot be covered anymore while new diseases of unknown origin keep developing, and if with a waiting time for certain operative procedures some sort of class medicine starts to become apparent, then the immense and unvoluntary animal victims have obviously not resulted in useful and successful findings - or have been interpreted the wrong way. (6)

Despite of this negative end result that is available to anyone it is claimed again and again, for justification and also for self-confirmation, that most of the medical diagnostic and therapeutical methods were elaborated or even »found« through animal experiments although such statements are inconsistent with any scientific-logical thinking:

A researcher of any experimental discipline, able to correctly analyze and interpret, can only learn one thing from his/her experiment: that an animal under the given conditions suffers a certain reaction or functional change of the organism or has survived the operative procedure more or less well. Any other extrapolation to the human situation is mere speculation, at best hypothesis. The experiment must always be repeated in the same manner in humans, and only when animal and human experiment results are available for comparison, a possible comparability of the pharmacological effects may be recognized, offering a possibility to evaluate the extrapolability. However, any statement regarding the countless possibilities of undesired side effects, versatile toxicities or other secondary damages is impossible based on experiments using animals. The animal test result allows no conclusion as to human reaction, compensation or toleration.

Effect and Compatibility Evaluation

Regarding their effect and/or compatibility chemical exogenic substances often differ by more than a thousand times between humans and animals and, in case of a defined prove of effectiveness using the »animal model«, they often show no effect at all on the human organism, an opposite or even completely different effect or the same effect at an unknown dimension between 0 and 100. And considering that the metabolic decomposition of these substances with the often produced toxic intermediate products and interactions with other substances as well as their detoxification and exudation mechanisms are unpredictable and mostly also uncomparable, and that the biomechanical compatibility, reactions and the organisms' ability to compensate doesn't provide a usable statement, and that carcinogenic or organ-damaging side effects, genetic changes, birth defects, allergies or long-term damages cannot be assessed and predicted based on animal experiments, the interpolating transfer of the results to the human situation is an unqualifiable risk which no experimenter would be willing to take. Furthermore, it cannot be considered a model for humans since this would require at least a calculable comparability which, again, is missing. This uselessness regarding predictability and safety still remains no matter how much the extrapolability rate is praised if you consider that the latter can only be assessed if values of identical human experiments are available.

Until then, this ratio remains unknown and uncalculable. Also, the selection of comparable animal species used for justification requires knowledge about the effects and effectiveness in humans! Without this knowledge it is impossible to select the corresponding animal!

With other words: When risk and result are impossible to be assessed, the same experiments will have to be performed in humans. Only in a retrospective manner, a comparative statement will be possible as to whether at all, whether not at all or if, to what degree, the human body reacts like an animal organism or to what dimension the experimental findings are transferable. This is called a »clinical trial« and comprises of four stages. (7)

Legislation, too, being advised by the same scientists, shares this opinion and considers the simple interpolating transfer of values obtained in animal experiments as unacceptably dangerous. This is why the law requires that despite the extensive findings from experiments any drug and diagnostic and therapeutical method must have proven effective, compatible and harmless in humans prior to obtaining a marketing clearance!

Even if often claimed otherwise, neither the relatively unrisky dosing of drugs nor the safe application of other medical measures or surgical techniques nor any other »success of animal experiments« in human medicine is the result of experiments using animals but has exlusively been assured through the legally required clinical trials with humans.

If knowledge regarding effect, dosage and compatibility can only be achieved through humans it's mere nonsense to claim that animal experiments are a medical necessity! Any knowledge regarding reactions of and effects on the human organism can only be obtained with humans, not with animals.

New Drugs

We are often advised, even by experts, that exogenic substances with their unknown effects - key word: »new drugs« - could not be tested right away in humans because it was probably too dangerous. For reasons of safety they should first be »tested« for their harmfulness using animals. It is completely incomprehensible what the pharmacological findings are that are used to justify such »safety requirements«, take them over without reflection and continuously pass them on. Based on such animal experiments for the therapeutical usability of chemical exogenic substances, the substances proven incompatible and toxic in animals are separated and not tested any further.

Those substances, however, found animal-compatible and pharmacologically effective are further tested in humans, i.e. in clinical trials.

Taking a closer look on these measures from a method-critical and science-logical point of view it would be easy to determine that the substances are evaluated, eliminated or further tested on humans based on their toxicity and compatibility in animals. The finding, however, that they were non-toxic in animals doesn't necessarily lead to the conclusion that they will be equally unharmful in humans. Independent of an unpredictably different pharmacological effect they may well be highly toxic and harmful. Considering these aspects, it is a scientific logics verging on the incomprehensible to pretend that exogenic substances would have to be tested on animals first in order to ensure application safety. Risks and side effects of test stages I and II in humans document this fact as impressively as the damages caused by drugs later on.

Furthermore, as experience shows, the substances excluded from further investigation because of their incompatibility in animals might well be compatible and therapeutically useful in humans!

Scientific Aspect of the Experimental Method

The self-established criteria of science for a »scientific aspect» are among others: predictability, calculability and reproducibility of a method or effect. No animal experiment supposed to provide useful information to humans meets these requirements.

To what dimension an exact scientific basis is missing here is best documented through an BGA poll involving 1,526 scientists and researchers of any discipline at universities, the industries and both state and private research institutes dealing with assessing the evidential value of animal experiments. There turned out to be significant differences of opinion already with the most elementary form of toxicity evaluation. 35% of the interviewees considered the LD50 test being of no or only low importance while the discrepancies regarding the required number of animals were even larger. Surprisingly, 60% of the university community and 34% of the industry scientists approved a general carcinogenicity testing of long-term drugs although there was consent regarding the insufficient evidence of animal experiments about the cancer risk for humans: 77% of all interviewees believed that the cancer risk could not at all or only partly be covered using animal experiments! (8)

Already in 1961, the American toxicologist Litchfeld published comparative results of toxic reactions in animals and side effects in humans:

• 68% of the toxicity symptoms that were found in rats and dogs were also found in humans.
• 26% found in dogs but not in rats were also encountered in humans.
• 7% of the symptoms found in rats but not in dogs were also found in humans.

This already insufficient evidence was even worsened by the fact that some intoxication symptoms were only encountered in animals, others only in humans. And inbetween, there would be a large number of toxic symptoms of incalculable frequency found in humans and animals (9). I leave aside more factors that would make a usability of the results impossible.

There are more recent investigations by the Hamburg experimenter Leuschner. Using animal experiments and the latest of scientific criteria, he has examined for an average of 16 years a total of 23 chemical compounds which may be considered an optimum experimental technique. It resulted in the finding that only in 50.3% of the tested substances human side effects were observed. This comparative evaluation, however, does not include the carcinogenic and embryotic damages since no analyzable clinical results were available. This equals more or less the safety forecast of a fortune-teller, i.e. 50%. Considering the most important carcinogenic effects and birth damages of these substances, a confidence coefficient of far less than 50% is obtained. (3)

It may have been these facts that led the reputed toxicologist and pharmacologist H.Hensel of the Marburg University to his statement that this procedure has less chances for a hit than a lottery. The comprehensive testing of a new substance of yet unknown effect for its toxicity to humans and the environment costs more than two million DM which is the lower limit of the average. These costs are later included in the production, which means that the consumer and tax payer does not only take the application risk but also pays the enormous expenses for this unsafe assessment (10).

The queen of scientific logics - theoretical physics - from which all branches of knowledge have derived defines the conditions of a scientifically quantifiable method as follows:

1. With each measurement as the basis for a theoretical forecast of results, a quantification is only usable in any field of science if a mathematical relation can be established between the measures. Without this relation, the method will be of no use to the objective.
2. A one-time measurement of a quantity is of no evidential value. Only the proof of reproducibility will make it a useful factor of knowledge.
3. The quantifying method doesn't provide a description of reality but of a reductionistic, model-like partial aspect only. If the failure source area that is relevant for the objective cannot be limited, the method is dangerously faulty.
4. Stating a measuring value without simultaneously giving quantifying information regarding the measuring error limits makes no sense. Such measuring errors may be of statistical or methodological origin. If they cannot be quantified or at least assessed in a calculable manner, the measuring value is of no scientific value and useless.
5. Measuring values do not gain safety and evidential value through belief, but through doubt and verification.
6. Depending on the error sources, ideas and wishes of the measuring person add to the measuring results and reflect rather the objectives of the experimenter than true facts. Psychologists call this well-known phenomenon the Rosenthal effect.
7. Only if the measuring person is able to step back and look at things with sufficient distance to his or her own wishes and ideas, the measuring results will possibly be reproducible, independent of other prerequisites. (1)

Transitoriness of Scientific Knowledge

The greatest problem with all the knowledge gained is whether or for what period of time it will be able to provide a scientific basis. Many of the most important findings in research supposed to be a »break-through« in fighting diseases were obsolete or even found incorrect within a short time. Medical historians believe that two thirds of the medical and biological findings being awarded nobel prizes are found to be incorrect after only a decade. In 1929, for example, the Danish Dr. J.A. Grib-Fibinger was awarded this prize for discovering the »Spiroptera neoplastica carcinomatosa« being present in cockroaches and supposed to be carcerogenic. None of his experimental results could ever be reproduced.

This conclusion is not meant to depreciate the efforts of this scientist. It shall, however, encourage to look at research results in a realistic and objective manner within the corresponding limits.

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