European Union approves new alternatives to animal testing of drugs and chemicals

The new tests use cell cultures rather than animals to establish the toxicity of cancer drugs and identify contaminated drugs. The tests approved today will not only reduce the number of animals needed for testing, but will also increase the accuracy of the tests, thereby making the products concerned safer. The role of ECVAM, which is based at the European Commission’s Joint Research Centre, is to replace, refine and reduce methods of animal testing for cosmetics, drugs and chemicals. Tests validated by ECVAM must be approved by its Scientific Advisory Committee, composed of representatives of the 25 member states, academia, industry and animal welfare organizations before they can be used in labs across Europe.

One of the tests is designed to assist the dosage of some highly toxic drugs used in chemotherapy for cancer, a disease which causes almost a million deaths in the EU every year. Using bone marrow culture from mice and cord blood cells from humans, a test has been developed that will decrease the risk of a lethal overdose in the first cohort of patients to which they are administered, a risk that cannot be identified during current preclinical testing strategies.

International studies have shown that this new test can provide more accurate predictions than testing on animals, so the new method will not only reduce the number of animals needed, but also increase the safety of patients.

Five of the new tests address the issue of bacteria. Our immune system is designed to guard us against bacteria. However it cannot distinguish between live and dead bacteria, and will react also against dead bacteria or part of them. A drug may be sterilised, but not necessarily free from all traces of bacteria and this can lead to side-effects such as fever, pain and shock. 200,000 rabbits are used every year to test the drugs before they are put on the market. The new method uses human immune cells grown in the laboratory, which can detect bacteria just as the human immune system does. This test will not only reduce the number of animals used in labs, but also the costs of testing. An added bonus is that these new tests are far more effective in finding contaminated drugs than the previous animal tests.

The work of ECVAM is funded from the EU’s Research Framework Programme, with support from Member States, industry and animal welfare organisations. By using advances in scientific knowledge, ECVAM will help to increase patient safety and animal welfare.

A conference in Brussels on 7 November 2005 entitled “Europe goes alternative” saw the adoption of a European Partnership with industry to promote alternative approaches to animal testing.