Towards testing medicines without harming animals
Millions of animals, including rats, mice, rabbits, dogs and monkeys, are routinely used every year in laboratories around the world to test the safety and efficacy of drugs for humans.
All conventional drugs are tested on animals at some point as this is required by regulators and in many countries by legislation. We estimate that for each new drug between 4,000 to 5,000 animals will be tested on just for the standard regulatory tests. However, the total number of animals used in the full drug development pipeline – i.e. from laboratory to market – is likely to be much higher.
The discovery and development of new drugs is an excruciatingly long and expensive process and typically takes an average of 10-15 years to complete at a cost of $2.6 billion per drug. Part of the problem is the use of animals in testing. 90% of drugs fail in human trials despite promising results in animal tests. For drugs aimed at treating complex and poorly understood conditions, failure is almost a certainty. For example, the failure rate for Alzheimer’s drugs in human trials is estimated to be higher than 99%.
The scientific literature is rife with concerns over the way drugs are still tested using animals and calls to transition to more predictive and more human-relevant approaches as a matter of urgency. Animal tests are increasingly being replaced with quicker, cheaper and more reliable non-animal methods but more progress, particularly in the pharmaceutical sector, is needed.
The reasons why animal testing persists are often not scientific. Instead it can be due to conservatism within the scientific establishment – it is easier and more comfortable to simply do what has always been done. Test results on animals can be easily compared to earlier tests on animals to give confidence to scientists. Regulators can adopt a ‘tick box’ approach, divorced from the needs of the real world.
What we do
Our science and regulatory affairs team is working to save as many animals as we can by encouraging national and international regulators to challenge the use of animals and accept non-animal methods to animal testing.
We look for cases where non-animal methods are not being used where they should and challenge the relevant drug companies and regulatory authorities to take action.
We write scientific papers and briefings raising the problems with animal testing and providing solutions.
We work with our partner members of the International Council on Animal Protection in Pharmaceutical Programmes (ICAPPP) to prioritise the use of non-animal methods in international guidelines on drug testing. We are currently the secretariat of this group..
We have published a ground-breaking analysis of the use of animals in drug toxicity testing, which calls into serious question the scientific value of using animals to test the safety of new drugs for humans. Our findings are encouraging other scientists and groups to look into the need to test on two species for each new drug.
In the last 10 years we have commented on over 50 draft regulatory guidelines relating to animal testing of drugs. Our work has led to improved language on the use of non-animal methods and the deletion of language supporting the continued use of redundant animal tests.
Calls by our scientific team encouraged the European Medicines Agency to set up its own expert working group on the 3Rs that has projects looking at improving their guidance on non-animal methods and deleting redundant animal tests.