PRESS RELEASE EQUIVITA 07/09/10

Biomedical research: THE  USA MOVE FORWARD WHILE THE EU FALLS BEHIND

in case the common position adopted at first reading (5.5.2009) on the
Revision of Directive 86/609 is not rejected
 
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The National Research Council (NRC) of the United States:
“A transformative paradigm shift is needed […] to provide broad coverage of chemicals […] to develop a more robust scientific basis for assessing health effects of environmental agents […]  to reduce the cost and time of testing […]. Toxicity testing will be transformed from a system based on whole-animal testing to one founded primarily on in vitro methods that evaluate changes in biologic processes”. (Report, “Toxicity Testing in the XXI Century: a Vision and a Strategy”, 2007).
 
VII World Congress on animal experimentation, 2009:Herman, Koeter co-chair of the Congress: “These new technologies, bringing together so much more knowledge of possible adverse effects of substances on biological systems than we were able to detect and understand ever before, will make us consider the use of animals for such purposes as extremely old-fashioned in the foreseeable future”.
 
Silvio Garattini, director of the main private Institute of Biomedical Research in Italy:
“Animal experimentation is irreplaceable and necessary: opponents will have to assume their responsibilities. Research cannot be stopped and no alternatives to these studies exist.”
 

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At the time when
The NRC, National Research Council of the USA has published the report “Toxicity testing in the XXI century: a vision and a strategy” (2007) which reads, in the Summary: “Change often involves a pivotal event that opens the door to a new era, as the discovery of penicillin, the elucidation of the DNA double helix, the development of computers. Toxicity testing is reaching such a scientific pivot point. It is poised to take advantage of the revolutions in biology and biotechnology. Advances in toxicogenomics, bioinformatics, systems 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 processes using cells […] preferably of human origin […]. The envisioned change is expected to generate more robust data on the potential risks to humans posed by exposure to environmental agents […] This report speaks to scientists […] it also seeks to inform and engage decision-makers and other leaders who shape the nature and scope of government regulations.”
The report, prepared in response to EPA’s request, concludes that “a transformative paradigm shift is needed to provide broad coverage of chemicals, reduce the cost and time of testing and “develop a more robust scientific basis for assessing health effects of environmental agents”.
 
At the time when
of the AAAS (American Association for the Advancement of Science) the NRC proposals were endorsed by the main Government Regulatory Agencies: the NIEHS, National Institute for Environmental Helth Sciences, the EPA, Environment Protection Agency, the NHGRI, National Human Genome Research Institute. These agencies signed a Memorandum of Understanding on a nation-wide 5-year cell toxicology project. The US initiative, supported by international organizations like OECD, raised the interest and expectations of the scientific community worldwide.
 
At the time when
the Press Release at the Closing of the “7th World Congress on Alternatives & Animal Use in Life Sciences” (Rome, 30.08.09 – 03.09.09) reads:
“At the 7th World Congress both the global animal welfare community and the leading scientific community embraced current developments in regulatory risk assessment in North America, Europe and Japan. These developments aim at the strategic implementation of current tools in genomics, computational technologies and high through-put testing systems to assess the safety of chemicals including pharmaceuticals, vaccines, food additives, pesticides and cosmetic products. Within the next decade this approach will result in an unprecedented decrease in the use of experimental animals. It is considered the start of a world wide process in regulatory safety testing which will likely make the use of experimental animals for safety testing totally redundant within 20 years from today […]
Participants agreed that current knowledge of the human genome and the genomes of many animal species have resulted in such a level of scientific progress in the area of gene mapping and expression (genomics) that it will make it possible in the near future to apply these tools, together with current computational technologies (linking and analysing massive data bases) and sophisticated second generation in vitro test systems, to assess the hazards and risks of chemical and microbiological substances without the use of experimental animals.
Ending the Press release, Herman Koëter, co-chair of the congress with Thomas Hartung, said: “These technologies, bringing together so much more knowledge of possible adverse effects of substances on biological systems than we were able to detect and understand ever before, will make us consider the use of experimental animals for such purposes as extremely old-fashioned in the foreseeable future,”
Signed: 1 - Thomas Hartung: (Fmr. Director of ECVAM, European Centre for the Validation of Alternative Methods), currently Director of CAAT, “Center for Alternatives to Animal Testing”, Johns Hopkins University, and Professor of Toxicology in  Baltimore, MD. – 2 - Herman B. W. M. Koëter: Fmr. Scientific Director of EFSA, the European Food Safety Authority.

At the time when
A growing number of the most prestigious scientific journals, (like Nature, British Medical Journal, New Scientist, Science, Scientific American,  Environmental Health Perspectives, Sapere, Biologi moderni, etc.) published articles criticising animal testing, whereby they ever-more resolutely disseminated the scientific paradigm that rejects the use of animal models. The following are just a few examples:
Nature, 10/11/05, editorial: “Scientists at the European Centre for the Validation of Alternative Methods (ECVAM) argue that animal tests are badly flawed. They say the new drive for 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 than the existing methods”.
Nature, 15.11.07: Thomas Hartung, Fmr. Director of ECVAM, now Director of CAAT, “Center for Alternatives to Animal Testing”, J.Hopkins University, and Professor of Toxicology in  Baltimore, MD., defines animal testing as “bad science” and declares that “REACH is a unique opportunity for toxicology to turn itself at last into a respectable science” (dropping animal tests).
L’Espresso, 15/11/07: article by Jeremy Rifkin:
“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-progress 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. While the new methodologies for toxicity testing […] hold the promise of saving the lives of millions of human beings.”

At the time when
the EU has urgent need to test 30,000 chemicals already released into the environment to regulate their use (see the REACH Regulation);

At the time when
the advancement of scientific knowledge in genetics, biology, informatics and other brand new branches of science enable us to protect the environment and our health with methods that are:
a) much more reliable
b) much faster
c) dramatically cheaper
d) able to collect quickly and cheaply a wealth of additional information, such the cumulative effects of various toxic substances.

The European Parliament, despite our information and repeated appeals, has adopted at first reading (05.05.2009) a draft text which, with the declared aim of "streamlining bureaucracy," ignores all considerations of logic and ethics and disregards the mandate received by European citizens to act for the common good.
Such text not only reintroduces the principle of the scientific validity of animal testing - now increasingly discredited - but gets Europe to close its doors to the scientific progress, welcomed in other continents, by not requiring the use of substitutive methods even where these exist and by not encouraging (in any way) the approval on new ones. This, unlike what was mandated in the REACH Regulation and despite the European Parliament’s earlier commitment to favour the development and use of new reliable tests (see EP Resolution 22/05/2008).
 
The current text for the Revision of Directive 86/609 also overturns the promises initially made to reduce animal suffering. The following is a list of some of the AGGRAVATING elements proposed: the possibility of experimenting over and over on the same animal; greater lenience on experiments without anaesthesia and/or pain-killers; greater lenience on experimenting on primates (also without serious motivation), as well as on stray dogs and cats; freedom to create transgenic animals, etc. etc.
 
It is time for our representatives to understand that the expectations of both those who care for the progress of science and those who wish to promote animal rights can be met,
 
provided thatthe current text for the Directive revision is rejected
and debate is opened again on the basis of the principles herein outlined.
 
The opposite decision would give rise to:
  - unlimited squandering of money
- human health and environmental hazard (neurodegenerative diseases, cancer, endocrine disorders, sterility, etc ..., whose steep increase (in Europe) has been demonstrated to be caused by harmful chemicals;
- further delay in biomedical science and failure in the implementation of the REACH Regulation;
- discontent among the citizenry: both among those who completely refuse animal experimentation as well as among all the rest, who accept it on condition that it produce reliable results;
- legal problems: animal experimentation never underwent the mandatory “validation” process required for every new research method.

We therefore urge European LEGISLATORS to reject the text for the Revision of 86/609 approved in first reading
A letter to all members of the European Parliament has been sent by our organizations:
Signed:             COMITATO SCIENTIFICO EQUIVITA (Italy)
ANTIDOTE EUROPE (France)

Information: Scientific Committee EQUIVITA (ITALY)
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