What are the alternatives to animal testing?
FRAME believes that human-based alternatives to animals can provide a better prediction of human outcomes.
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During this time technology has moved on significantly and modern in vitro and in silico techniques are providing new ways to investigate human responses and study human disease. Yet laboratory animals are still relied upon in many areas of scientific research to ‘model’ human reactions to drugs and disease. There is now evidence to show that animals often do not respond in the same way as humans to certain drugs and chemicals and do not suffer from some human conditions. Animals have different metabolisms, life spans and ageing processes, are susceptible to different diseases, are exposed to very different environmental factors and generally have very different life experiences from us. There is a risk that, when using a different species to model human responses, the outcomes will not be the same.
As well as the potential scientific cost, there is an ethical cost that must be weighed every time a choice is made to use laboratory animals for human benefit. This cost is the lives of animals bred and used for research, and their experiences including any discomfort or suffering experienced in scientific procedures or the laboratory setting. This cost is higher for species with complex welfare needs that are harder to meet in a laboratory environment, or for wild-caught animals that have been obtained from their natural environment.
Where there is no other way to answer a scientific question there is an argument for using laboratory animals, but the reasoning should be transparent and clear. This is a complex and nuanced issue and change is slow for many reasons. FRAME is committed to supporting the scientific community to develop and adopt human-based methods for the benefit of human health, and to replace the use of laboratory animals where it is unnecessary or irrelevant.
The use of animals in scientific experiments in the UK can be traced back at least as far as the 17th Century with William Harvey’s experiments on numerous animal species aiming to demonstrate blood circulation. Across Europe, the use of animals in scientific research began to expand over the 19th Century, in part supported by the development of anaesthetics which had previously made animal research impossible. In 1876, parliament passed the Cruelty to Animals Act, the first legislation aimed at regulating animal experiments.
Over the late 19th and 20th centuries, the expansion of medical science meant that the numbers of animals used in research expanded steadily, accelerated by the Medicines Act, 1968, which provided a clearer guide to the requirement to use animals in medical safety testing in the wake of the Thalidomide tragedy. The number of animals used rose to over 5.5 million in 1970 after which point the numbers began to decline rapidly. This large expansion reflected a growing medical field; animals had played a part in most medical advances of the 20th century including insulin discovery, the polio vaccine, penicillin and the elimination of smallpox. In 1986 the Animals (Scientific Procedures) Act was passed, which ensured higher animal welfare standards in laboratories across the UK.
In 2010, EU Directive 2010/63 was passed which is legislation for the protection of animals used for regulated scientific purposes. This regulation harmonised European animal laboratory standards, improving animal welfare across the EU, and was transposed into the laws of member countries. It passed into UK law on 1st January 2013 and has been maintained in UK law post Brexit.
Today animal procedures are still required by law for many chemical and medical safety tests by regulatory bodies. In the UK, post Brexit, this includes all chemical legislation now overseen by the UK Health & Safety Executive (HSE), which incorporates the new UK REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) regulation. The testing and marketing of medical devices under the Medical Devices Regulation 2002 and the testing and sale of medicines under the Human Medicines Regulation 2020. As with the counterpart EU legislation, these regulations require evidence to prove safety and efficacy and the guidance often stipulates particular animal tests.
Whilst the legislation also states the need to implement the 3Rs to reduce animal use and use replacement methods where available, these non-animal methods must first be validated, approved and accepted by the relevant regulatory body which is a time consuming process.
FRAME has always believed that there are scientific, as well as ethical, reasons for replacing animals in testing and research, Where animals are used as a model of the human body, in a significant proportion of cases, they are not fit for purpose and are an insufficient predictor of drug safety in humans. There have been many examples of drugs failing in humans after being considered successful and safe in animal tests, such as the anti-inflammatory drug, Vioxx[i] and Parkinson’s drug, CEP-1347[ii]. This poor translation between animals and humans is a well-known issue, where results seen in animal trials are not replicated in human trials. In addition, a 2018 study by the Massachusetts Institute of Technology showed that 13.8% of drugs that reach clinical trials in the US gain market approval[iii], equating to a failure rate of 86.2%. Whilst this failure can be for many reasons, these drugs have passed safety and efficacy tests using animals. It is therefore critical that we challenge the idea that use of animals in testing is the best way to replicate a human response.
This poor translation has an associated cost. With many potential drug candidates not making it through trials to market and the development cost of producing a new drug regularly quoted as being well over $1 billion and as high as $2.6 billion. Savings in the process could be used to fund more potential drugs and more projects.
Poor reproducibility is also a widely accepted problem in animal research, this is where published research is checked/carried out by other scientists using the same method and procedure, if the same results are obtained then the original research is ‘reproducible’, and therefore more reliable. Sadly with animal research irreproducibility is very common and leads to experiments providing inconclusive or useless outcomes, which is both a waste of animal lives and funding.
Human based methods are those based on human biology and use for example human cells or computer models of the human body to predict disease progression or the bodies response to a new chemical or drug. They have the potential, and in some cases already are, successfully being used in safety tests.
The development of alternative methods must therefore be a priority.
Scientific procedures involving live animals were carried out in Great Britain in 2020, down 15% from the 3.4 million in 2020.
Of scientific procedures involving live animals were carried out on mice, fish and rats.
Scientific procedures involving live animals were for experimental purposes.
Scientific procedures involving live animals were for the creation and breeding of genetically altered animals.