Brussels, Mar 2006
Six new alternative testing methods that can replace animal tests for certain drugs and chemicals have been developed by the EU's European Centre for the Validation of Alternative Methods (ECVAM), and approved by its scientific advisory committee.
The new tests use cell cultures rather than animals to establish the toxicity of cancer drugs, and to identify contaminated drugs. Speaking to CORDIS News, Thomas Hartung, head of ECVAM, said that the new methods will save around 200,000 rabbits per year, which had previously been used to test the substances. The new methods are also more accurate than the animal tests, and will therefore make the products concerned safer.
Dr Hartung also spoke of how pleased he was with the approval of the new methods, saying: 'We have had a 40 per cent increase in validated methods in one day only.' ECVAM now has 23 approved alternative methods, compared to the previous figure of 17.
Changes to EU legislation have required ECVAM to intensify its efforts, said Dr Hartung, and the centre expects to have another four or five methods validated during 2006.
One of the tests is designed to assist the dosage of highly toxic drugs used in chemotherapy. Although rabbits are no longer needed for testing this drug, which can save the life of cancer patients, the method does require the use of mice. The new testing technique involves cord blood cells from humans and bone marrow culture from mice. The mice are anaesthetised before the procedure, but do not survive, explained Dr Hartung.
The new testing method decreases the risk of a lethal overdose in the first cohort of patients that will receive the drug. This risk cannot be identified with current preclinical testing strategies.
The other five tests will assist the detection of bacteria in drugs. The immune system is designed to guard against bacteria, but cannot distinguish between live and dead bacteria. A drug may be sterilised, but still contain traces of dead bacteria. Detection by the immune system can lead to fever, pain and shock.
The new method uses human immune cells grown in the laboratory, which can detect bacteria just as the human immune system does. Again, these new tests are more effective than the previous animal tests.
Research conducted at ECVAM is funded under the EU's framework programmes for research, the current programme being the Sixth Framework Programme (FP6). It is supported by the EU Member States, industry and animal welfare organisations. The centre is part of the EU's Joint Research Centre (JRC).
ECVAM's news has been welcomed by the Eurogroup for Animal Welfare: 'We are delighted to see the progress made under the Sixth Framework Programme, and this bodes well for the Seventh Framework Programme,' said Communications Officer Mark Redgrove.
The approval of these alternative methods comes at a time when new questions are being asked about the value of testing drugs on animals, following news of a drugs trial that led to multiple organ failure in six men in the UK in March.
'Animal experiments tell us about animals, not about people. The results of animal studies can never guarantee the safety or efficacy of human medicines or other products because of the fundamental biological, anatomical and biochemical differences between the species. There are countless examples of drugs tested on animals that have been released as safe only to cause serious side effects and even death in humans,' reads a statement by Alistair Currie from the British Union for the Abolition of Vivisection (BUAV).
It is however unknown whether the participants in the UK trial were affected by unanticipated side effects, or whether there was a problem with the manufacture of the drugs, contamination, or a dosage error. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is currently investigating what went wrong.