As important as penicillin, double helix and computers
The most prestigious scientific body in the world, which advises the US government on scientific issues, the National Research Council of the U.S. National Academy of Sciences, has released in June 2007 a report entitled “Toxicity Testing in the 21st Century: a Vision and a Strategy”.
The report was commissioned by the Environmental Protection Agency (EPA), another US federal body, responsible for thousands of safety (toxicity) tests on animals each year.
It is nothing short of revolutionary, and whoever knows the facts about animal experiments will realize its immense importance. Especially for people who know how much the American scientific establishment has historically been the most staunch supporter of animal research, this new report will be a blow.
The report’s authors convey very well its revolutionary meaning and the feeling that we have reached a turning point in biomedical research, in the very way they start it:
“Change often involves a pivotal event that builds on previous history and opens the door to a new era. Pivotal events in science include the discovery of penicillin, the elucidation of the DNA double helix, and the development of computers. All were marked by inauspicious beginnings followed by unheralded advances over a period of years but ultimately resulted in a pharmacopoeia of life-saving drugs, a map of the human genome, and a personal computer on almost every desk in today’s workplace.
“Toxicity testing is approaching such a scientific pivot point. It is poised to take advantage of the revolutions in biology and biotechnology.” [emphases added]
The report says:
“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, cell lines, or cellular components, preferably of human origin.” [emphasis added]
Non-animal methods outperform animal tests
The superiority of non-animal methods of testing substances for toxicity to humans, compared to animal methods, is acknowledged by the report:
“The envisioned change is expected to generate more robust data on the potential risks to humans posed by exposure to environmental agents and to expand capabilities to test chemicals more efficiently. A stronger scientific foundation offers the prospect of improved risk-based regulatory decisions and possibly greater public confidence in and acceptance of the decisions.” [emphases added]
The report admits that the current animal method of testing has not been evaluated for its usefulness but rather used by inertia:
”The current system is the product of an approach that has addressed advances in science by incrementally expanding test protocols or by adding new tests without evaluating the testing system in light of overall risk-assessment and risk-management needs. That approach has led to a system that is somewhat cumbersome with respect to the cost of testing, the use of laboratory animals, and the time needed to generate and review data.” [emphases added]
There is acceptance in the report of the well-known problem that the extremely high levels of doses to which lab animals are subjected are a further element of unreliability and lack of predictive value of animal tests, given the huge discrepancy with the actual, much lower, doses of chemicals to which humans are exposed:
“Moreover, the vision will lead to a marked reduction in animal use and focus on doses that are more relevant to those experienced by human populations.” [emphasis added]
The report’s vision is that eventually non-animal strategies will completely replace animal-based toxicity tests and revolutionize safety testing.
The report recommends advanced non-animal methods using in vitro human cell lines in combination with computational methods and epidemiological studies. These new methods should also be employed in other areas of biomedical research currently using animals, and there is reason to hope that the new report may influence that development too.
The reference in the report to “paradigm shift” as the description for the new vision outlined there echoes Brute Science: Dilemmas of Animal Experimentation (Philosophical Issues in Science), a revolutionary book written by a philosopher and a biologist. The book uses science historian Thomas Kuhn’s concept of “paradigm” to explain the “sticky” nature of scientific enquiry, the prevailing scientific dogmatism which often makes change in normal scientific activity between “revolutions” so difficult. That echo seems to indicate that this report has taken on board criticisms made by the anti animal experimentation camp, to which the book generally belongs.
The future has already started
This milestone report comes at a crucial moment in the history of toxicity testing. The European Union has last year approved a new Regulation called REACH (Registration, Evaluation and Authorisation of Chemicals) which will require the largest mass animal testing programme in Europe’s history. It has just started and will see the testing of 30,000 chemicals on an estimated 10 to 50 millions animals.
This programme is closely watched by the US and the rest of the world as a pioneering enterprise. So it is the right moment for Europe to introduce the new methods and the new vision that this report so clearly recommends. Otherwise REACH could be an incalculable waste of money, time, resources without any benefit but possible harm to humans, and a totally pointless, immense source of animal suffering. Non-animal tests would provide more reliable data, produced more quickly and at an enormously lower cost than animal tests.
The “Toxicity Testing in the 21st Century: a Vision and a Strategy” report, which has the purpose of guiding future research policy, has already had a momentous application: a Memorandum of Agreement was signed by the Environmental Protection Agency, the National Toxicology Program and the National Institutes of Health on 14th February 2008 aiming to end animal testing of chemicals and drugs.
Another cause for much happiness is that the hugely influential anti-visection Italian-Swiss author, the great Hans Ruesch, who wrote Naked Empress or, the Great Medical Fraud and many other books on animal experimentation, was able to see what appears like the beginning of the end for animal experimentation before he died on 27th August 2007, aged 94. He started me on this path when I was 17 years old and read his books.
This post is also a tribute to his memory. He can rightly be called the founder of the modern scientifically-based anti-vivisection movement. We will continue the fight that he began.