Experiments on Animals are scientifically unacceptable - Part 3

Aus Tierversuchsgegner

There are no recognized criteria for the »effectiveness« or »non-effectiveness« in animal testing. Which finally means that the so-called limit values are nothing but scientific fraud.

With scientific precision, the author analyzes what is described as »animal experiments in the service of humankind». A particularly interesting aspect is the so-called threshold value. This value, also known as limit value, that according to »scientific knowledge« is harmless to human health unless exceeded. This value, too, is established using animal experiments. It is up to the experimenter, i.e. the industrial customer to determine the »effectiveness« because there are no generally recognized criteria for the »effectiveness« or »non-effectiveness« in animal testing. Which finally means that the so-called limit values are nothing but scientific fraud.

The Surgical Training

It is often claimed that a surgeon will need animal experimental training pretending that the training on the living creature is indispensable to gain manual skills. However, it must be noted that examination rules do not require operative procedures on an animal, neither for a doctor's exam nor for the recognition of a medical specialist. Instead, they require proof for specialty-related operative procedures having been carried out on humans.

In the generally recognized training a surgeon gains his/her basic knowledge first as a resident in surgery and emergency surgery.

Depending on his/her experience and skills he/she is then allowed to perform operative procedures under supervision until the instructing surgeon decides that he/she is ready to perform these procedures on his/her own responsibility. Special skills in microsurgery are gained the same way since working with a surgical microscope doesn't require training on the living creature either. Learning exercises to adapt the gained operative skills to changed visual conditions are in many countries performed using vascular models or different calibrated vessels of a placenta, if required.

If such operative procedures for training are performed on animals, it's among others because of the lack of manual experience due to insufficient work as a resident and specifically because of time dispositions. Thus they are, however, to be defined as usefulness considerations for personal facilities, not as indispensable training necessities. Thousands of surgeons and their teams have become competent and responsible surgeons without ever using living animals for training.

A similar assessment is appropriate to transplantation surgery: An appropriately trained specialist masters the surgical techniques without any problems. The surgical result will only cause trouble due to the more or less good compatibility of the transplant which leads with varying frequency to transplant rejection. But especially this risk question cannot be answered using the »animal model«, and couldn't be even using another human. And neither dosage nor effect or side effect of the required immunosuppressive for humans may be determined through animal experiments.

The Dissenting Doctor

Despite of these generally recognized facts a doctor objecting animal experiments is often facing blames like being inconsequent in thinking or even illogical because he or she uses drugs that were »tested« in animal experiments. A very simple consideration may help to clarify the mistaken thought behind this:

1. That animal experiments were and are still being conducted is no proof for their necessity because there are a lot of other reasons to carry them out. Furthermore, these experiments do not disprove that even better information would have been or could be gained in other ways.
2. If a physician prescribes a drug and the patient takes it, it doesn't mean that one agrees with their »testing through animal experiments« and believes they are making sense and are useful. Considering that for market approval in human medicine animal experiment results are not accepted but a »clinical trial« and the proof of not being harmful to humans are required, its relatively non-risky dosage and application are not based on animal experiments but on the required tests with humans.
3. The critical doctor doesn't refuse research like it is often implied. Based on his/her unprejudiced evaluation of results and experiences so far, however, it is his/her substantiated opinion that using animals neither the required knowledge of human diseases nor drug safety is obtained and that this use of our fellow earthlings characterized by suffering and death is inconsistent with the humanistic behavior and a human(e) medicine in the true sense of this word independent of supposed, pretended or actual useful results.

The renowned psychiatrist and neurophysiologist of the University of Oxford, Prof. Dr. Ryder, wrote in his book »Victims of Science«:

»From a scientific point of view, animal experiments are justified with the similarity and comparability of animals and humans while the cruel acts done to our fellow earthlings are justified with the dissimilarity of the suffering and the animals' pretended low sensitivity to pain. Either humans and animals are so different that experiment provide none or only insufficient information to us, or the animals equal us so much that the gruesome and deadly experiments are out of the question. I don't think that the suffering I have imposed on test animals - and unfortunately they were so many - has been of any use whatsoever to humans!«

The LD 50 Test

These animal experimental test methods for the toxicity of exogenic substances to humans, too, seem to urgently require some additional information. Even their inventor Trevan described them in 1927 as completely unsatisfying although he didn't want but assess coarsely the acute toxicity of exogenic substances in a workplace. Due to the increasing scientific criticism regarding the usability and continuing public protest against the gruesome treatment of the animals, this test may no more be officially required, but remains to be implied for market approval of a product by main American authorities like the FDA (Food and Drug Administration), the EPA (Environmental Protection Agency), the CPSC (Consumer Product Safety Commission). (26)

Since manufacturers wish to do business with the US and other countries, this test is still common use despite of the rightful objections and its worthlessness for the consumer. And despite of a widespread »general« ban in laws and regulations of several countries, a large number of specifically provided exemptions ensure its continued and easy performance. It is irrelevant that for reasons of appropriateness of a name change now the so-called limit test or FDP test is recommended OECD-wide that is based on a merely insignificantly smaller number of animals and slightly changed experiment criteria. The essential thing from the consumer's point of view remains unchanged, i.e. that the tests do not provide useful information on whether or not the tested substances are as harmless or toxic to humans as they are to animals. The lethal doses thus found using animals are of no significance to humans anyway. Obviously, these measures rather serve for legal protection during transport and application with view to manufacturers' liability. If they were indeed performed in the interest of the consumer, the thus »tested« products should not be put on the market because no evidence can be found that way for their safe application.

For all the highly toxic, carcinogenic and harmful chemical substances that are described today as »contaminated sites«, millions of highly developed mammals were sacrificed in horrifying LD50 tests to assess the compatibility for humans. Now, because of their health and life threatening properties proven by results, tens of billions must be invested to comprehensively decontaminate the land without knowing how to dispose of the contaminated material in the proper manner avoiding any further harm. But this is only the tip of the iceberg! It would be up to the approving scientists, authorities and industries to make clear statements as to whether these tests showed the toxicity in a useful manner or whether the substances were used despite of their proven harmfulness. In both cases, immediate action would be required!

The Nonsense of »Limit Values«

The following outline of calculation modes for the so-called non-toxicity and compatibility limit values of chemical products for every day life shows to what mental acrobatics such »scientific« test methods can culminate under the influence of economic interests: For the purpose of further sale and use of chemicals that may be very harmful depending on the concentration it is simply assumed that they would be non-harmful to the organism if below a certain concentration and that there would be a calculable dose non-harmful to health if the biological system was continuously exposed to it.

With this premise, the »Council of Environmental Experts« calculated in 1974 a so-called non-toxicity limit of exogenic substances to the human organism for the about 5,000 chemical substances with known toxicological effects, naming it NEL - no effect level. The same way a daily compatibility dose was determined that would be non-harmful if taken lifelong, named ADI - acceptable daily intake (14) although any competent scientist believes that such effect threshold values in a biological organism are non-existent and that no dose of an exogenic substance however small it might be remains without effect in a body! (15, 16, 12). They all agree that only a zero dose is an NEL (16) and that the clinical »zero-response« of the organism is no evidence for a »no-response«. (17)

It must be considered non-scientifical and not in the consumers' interest to ignore the function-changing effect of substance quantities below the NEL limit values because they are not directly clinically recognizable and analytically determinable. Any exogenic substance entering the biological system has an impact on its functions and condition and is often the cause of diseases discovered later on. A comparison to music seems apparent: its impact on the entire organism is undisputed even though first not recognizable physiologically and chemically. According to the evaluation criteria of NEL threshold values, musicians would have to hit the audience and produce injuries and skull fractures with their instruments before the »effect« of music would be »scientifically« recognized!

Nevertheless, these threshold values serve ever since as administrative law base for reasonableness regarding the health of the consumer although more than another 80,000 substances of unknown effect have been approved for application! These non-toxicity and compatibility limit values were »calculated« from several undetermined and undeterminable factors based on the clinically recognizable and analytically recordable effect in animal experiments. But here already, the incalculabilities start insofar as for animal experiments there are no defined and generally recognized criteria of »effect« or »non-effect« which means that their determination remains exclusively to the subjective and interest-tied evaluation of the experimenter or his/her coworkers. Another problem of this smart calculation mode are the scientific theories on which it is based regarding the effects of exogenic substances in the biological system, effects supposed to have varying effect-specific cell-receptors and a dosage-effect relation taking place there. However, there a several cell-receptor theories none of which may provide an explanation for all pharmacological effects or disprove the others conclusively.

There is no theoretical base able to explain all the effect phenomena reliably and irrefutably. (18)

There are further inadequate criteria in that contrary to the scientific opinion of a substance's effect dimension merely the dose and the exposure time are considered, leaving aside a preload of the organism through other chemical substances. Compatibility, reaction and toxic effect in the biological system, however, mainly depend from the organism's stability and ability to compensate, i.e. health, compared to which dose and exposure time are of secondary importance. Furthermore, human and animal organisms have been exposed livelong to unknown types and quantities of other chemical substances that cumulate in the body in an unknown manner. Such preload due to residual exogenic substances cannot be evaluated, each one causing a different compatibility level for the substance to be tested. Thus, a mere approximately correct toxicity evaluation is impossible. (18, 19)

Another incalculable factor are the basic values of this calculation »for consumer safety« originating form animal experiments. The often highly varying compatibilities of exogenic substances up to a completely contrary effect between humans and animals make an extrapolation of the values and thus a mere approximate quantification in humans impossible, independent of the impossibility of a binding evaluation on the »animal model«. (20)

And finally, there is a sixth unknown dimension in this calculation, the so-called safety factor S. However, there are neither scientific nor legally binding dimensions for its application. Therefore it is set by any institution or authority between 0 and 100 depending on requirements, ideas and necessities and changed whenever needed. It is the factor used to continuously correct the compatibility values of our increasingly polluted environment towards the top in order to make the public believe that the exogenic substances are harmless and may be further consumed (21). Of course, such »consumer protection« cannot remain without consequences.

Cancer

In tumor research it is generally known and recognized that 80 to 90% of all cancer diseases in humans are triggered by chemical substances contacting and entering the body through food, drugs, personal care products, clothing and other environmental influences (22). Most of these products that contaminate us every day have been found in animal experiments to be toxic, carcinogenic, organ-damaging, mutagenic, allergenic or to cause other secondary damages (20, 23). Anyone would conclude from these facts that for consumer protection their use should be at least minimized but it is just the opposite. But through the detour of animal experiments and the stated calculation mode the possibility of their continuously increasing use is legalized. Despite their proven carcinogenic side effects, processing, use or formation - such as formaldehyde, asbestos, dioxine, perchloroethylene, furans, propions and others - are still allowed and tolerated claiming that animal experiment results cannot be extrapolated to humans!

Consumers requesting an explanation are calmed down with reference to the »scientifically assured« non-toxicity and compatibility limit values NEL and ADI supposed to exclude any hazard to human health.

In order to complete this strange consumer protection and the incomprehensible scientific logics it may seem worth adding that using this recognized most unsuitable object - the animal - not only the causes of cancer formation have been investigated tirelessly for decades with billions in subvention, but so have further chemical compounds to heal the so produced deadly illnesses and tumors using again other exogenic chemical substances »tested« in animal experiments and declared »non-harmful«! At the Heidelberg Cancer Research Institute, subsidized with more than 100 million DM annually, more than 300,000 different chemical substances have been »tested« in animal experiments for their carcinogenicity. Using the »animal model« nearly 6,000 of these substances showed a promising effect on the tumor but had to be eliminated when they turned out to be effectless in humans. For those who know how to calculate I may add that for testing each substance an average of 100,000 animals of different species are »used«. Animal experiment research is subsidized with far more than an annual 250 million while clinical research on the bedside receives only 400,000 DM (about 205,000 EUR) for the same period of time! (25)

Comprehensive toxicological testing of an exogenic substance of unknown effect costs an average 2.5 million DM (about 1.28 million EUR) and takes about 1.5 years. One can easily calculate the costs that would be involved when subsequently analyzing already approved substances of unknown effect and it is obvious what period of time experimenters consider animal experiments to be a »necessity«.

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Übersetzung: © 2003 Beatrice Plamper

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