Letter to the members of the European Parliament
Rome, 11 March 2009
Esteemed Member of the European Parliament,
We would like to draw your attention upon the following considerations concerning the Proposal of Revision of Directive 86/609 ("Protection of animals used for experimental and other scientific purposes"), which also entail important implications for human health.
I) Introduction
The media has so far only voiced ethical criticisms with respect to the Proposal of Revision of Directive 86/609 issued by the European Commission, basically debating once again the extent to which we have a right to torture animals for the sake of our health.
But the media has consistently failed to report the well-grounded scientific criticisms of animal experimentation. Such criticisms, widely shared throughout the continents, are not aimed at undermining the importance of the ethical issue, but intend to prove – on the basis of solid evidence - that using animal models does not represent a benefit for us, but rather a risk.
We therefore ask you to kindly read the following considerations before discussing the Commission’s Proposal for the Revision of Directive 86/609. II) Whereas:
- the fundamental principle underlying Directive 86/609 (as proved by its very name) is that animal experimentation is an inalienable method of research, the scientific validity of which cannot be questioned.
- the Revision proposed by the European Commission, limitedly focused on bringing only some amendments to the law, does not modify this fundamental principle. It is therefore based on outdated knowledge and beliefs.
- an extremely long validation process is required at the European Center for the Validation of Animal Experiments (ECVAM) for a new research method to be officially approved (10 years on average). But animal experimentation - unbelievable but true - not only has never been scientifically validated but is also used as a “gold standard” against which new tests are compared (this has made the validation of new scientific methods an almost complete failure).
Animal experimentation is thus considered a real dogma, in spite of its evident unreliability, which causes frequent pharmaceutical disasters (see www.equivita.it/risorse.htm)
III) Whereas:
At present, our health is seriously threatened by chemical pollution, which is widely identified as being the cause of the currently recorded constant increase in diseases such as cancer - especially in children - neurodegenerative illnesses, disorders in the endocrine system, birth defects, sterility, etc. Being aware of this major emergency, the European Union has committed to address the problem of chemical safety by issuing the REACH regulation and more recently (January ’09) a regulation aimed at reducing the use of dangerous pesticides. While requiring the toxicological evaluation of 30,000 chemicals already present in our environment, the REACH project still considers animal experimentation to be a reliable method for the required toxicity tests!
IV) Whereas:
Some major International Scientific Institutions have welcomed and promoted a new paradigm in scientific research, according to which animal experimentation is badly flawed and toxicological evaluations have to be updated with the outcome of existing modern tests based on genetics, molecular biology and chemistry, mainly performed on human tissues and human cells. These modern tests are described as being a great improvement for toxicology, as they are better predictors and also more economically viable.
Testing results in many new fields of science, such as proteomics, toxicogenomics and epigenetics, are better suited to the complex task of protecting human health in our modern environment. Mainly performed on human tissues or cells, these tests can be computerised and robotised and make it possible to assess the combined effect of different chemicals. They also hugely reduce both costs and time.
Here are a few important evidences:
A) Report of the National Research Council (NRC) of the United States on the future of toxicology: "Toxicity Testing in the 21st Century: A Vision and a Strategy", commissioned by EPA (Environmental Protection Agency). It highlights the need to switch from tests made on animals to in vitro tests made on human tissues and cells. The Executive Summary reads as follows:
“Change often involves a pivotal event that builds on previous history and opens the door to a new era. Pivotal events include the discovery of penicillin, the elucidation of DNA double helix, and the development of computers … Toxicity testing is approaching such a scientific pivot point ...
Advances in toxicogenomics, bioinformatics, system biology, epigenetics and computational toxicology could transform toxicity testing from a system based on whole-animal testing to one founded primarily on in vitro methods that evaluate changes in biologic process using cells, cell lines, or cellular components, preferably of human origin”. The NRC’s opinion is that an efficient strategy should be adopted to counter the strong opposition that the new paradigm is bound to meet. However, the Report’s indications have been promptly applied by US main institutions: at the annual Congress of AAAS, the American Association for the Advancement of Science (15/2/08), three major government agencies, the NIEHS (National Institute for Environmental Health Sciences), the EPA (Environment Protection Agency) and the NHGR (National Human Genome Research Institute), signed a Memorandum of Understanding (MOU) to develop a great national project of cellular toxicology. Francis Collins, director of NHGR, said: “Animal tests are time-consuming, expensive and do not always work”.
B) Jeremy Rifkin (l’Espresso, 15/11/07) writes: “Anti-vivisection societies have been making this argument for a long time, only to be scorned by scientific bodies, medical associations and industry lobbies, who accuse them of being anti-propgress and caring more about animals than people. Now it is the scientific establishment that has come to the very same conclusion. Toxicity testing in animals is bad science.”
C) Nature (editorial, 10/11/05): “Scientists of ECVAM (European Center for the Validation of Alternative Methods) argue that animal tests are bdly flawed. They say alternative methods will improve the science of toxicity testing. And public safety demands that the new tests are shown to be better predictors of toxicity.”
D) Scientists opposing the use of animals in medical and toxicological research on scientific grounds is a growing trend all over the world. Well-documented articles have appeared in the most influential magazines (Nature, British Medical Journal, New Scientist, Science, Scientific American, New England Journal of Medicine, Sapere, Biologi Italiani, etc.). Thomas Hartung, former director of ECVAM and now scientific consultant for the European Union, said (Nature, 10/11/05) animal experimentation is “bad science (…) REACH is a unique opportunity for toxicology to turn itself at last into a respectable science” (dropping animal tests).
V) We wish to denounce that:
The Revision Proposal of Directive 86/609 currently under discussion applies the 3R principle (Reduce, Refine and Replace) introduced by Russel and Burch in 1959. This principle has never been used to abolish or reduce animal experimentation. On the contrary, it has enabled a few compassionate concessions to animals to be used as a façade for the confirmation and officialization of animal experimentation, an unreliable and illogical scientific procedure.
For half a century, the 3R principle has also confined the debate on animal experimentation to ethics and has allowed interest-bearing parties to avoid facing the scientific objections.
Why is animal experimentation still being used?
It is still used because of mental sloth and a generalised inertia in the face of cultural change and especially because of its links to corporate interests. For example:
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It allows companies to market new drugs claiming they have undergone the required tests while concomitantly claiming that “humans and animals give sometimes different answers" after the occurrence of any pharmaceutical disaster (think of TGN 1412 trials in London, of Vioxx in the US, etc. etc.), thus avoiding liability because of the “uncertainty of evidence”.
Support to a Revision of Directive 86/609, based on the 3R principle, which omits to consider the important new scientific paradigm, does harm
- it contributes to wasting the investments necessary for an effective evaluation of drugs and chemicals in our environment.
- it increases Europe’s delay with respect to other countries.
For all the above reasons we believe that re-launching animal experimentation, which would occur if the Proposed Revision of Directive 86/609 was applied, is today unacceptable and would cause serious harm to human health.
VI) Our request, esteemed Member of the European Parliament,
is that you play an active role:
- To take a step back with respect to the draft of the Proposed Revision of Directive 86/609. It is mandatory to take into serious consideration all the points detailed above.
- To consider the necessity of scientifically validating - which was never done up to now - animal experimentation, with the comparison between existing studies on animals and available human data (meta-analysis).
- To propose a new law, to be named “for the renewal of medical and toxicological research”, rather than a Revision of Directive 86/609. This law should indicate the path to follow and define the steps necessary to reach the total substitution of animal experimentation in medical and toxicological research.
Signatory Associations:
Comitato Scientifico EQUIVITA, president: Gianni Tamino
Antidote Europe, president: Claude Reiss
Safer Medicines Campaign, president: Margaret Clotworthy
Animalisti Italiani, president: Walter Caporale
Movimento Ecologico Nazionale UNA, president: Ebe Dalle Fabriche
Coordination:
Fabrizia Pratesi, secrétaire du Comitato Scientifico EQUIVITA
Via P.A. Micheli, 62 – 00197 Roma, Italia
Tel: +39.06.3220720 cell: +39.335.8444949
"Our choice is not between a child and a mouse,
but between good science and bad science", Pietro Croce
Dossier of scientific documents: www.equivita.it/Risorse.htm
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