The most commonly asked questions about research using animals are listed below with answers.
Why is animal research necessary?
Because there are still some diseases that can't be treated, prevented or cured. Research is needed to find new medicines and vaccines. Regulatory authorities world-wide require that medicines in development must be researched using animals before they can be researched in people - for safety reasons. Animals could be considered as a 'bridge' between researching a new treatment in a lab and then in a human. Currently there is no non-animal alternative method of researching the effects of a drug in a whole living body.
Back to topWhy can't scientists use alternatives such as computers?
Wherever possible we do. Animals are only used where absolutely no alternative is available. GlaxoSmithKline does a lot of research work using non-animal methods, such as computer modelling and isolated cells and tissues. However it is unlikely that they will replace animal methods in the near future. At this time there is no non-animal alternative method of researching the effects of a drug in a whole living body, or reproduce the complexity of changing the course of a disease in a living creature. In addition regulatory authorities world-wide require animal testing to fulfil the legal requirement for safe and efficacious medicines. It is not possible to obtain regulatory approval for new medicines without using animals.
GlaxoSmithKline is actively engaged in research to develop and validate experimental methods that can provide more and better alternatives to the use of animals in research.
Back to topWhat is an 'alternative'?
The word 'alternative' suggests a choice between two or more options. In the case of animal experiments there is no choice. If a non-animal method is developed to replace animals, then it must be used. Similarly refinements in experimental design which reduce the impact on the animal or available alternative technologies which enable a reduction in animal numbers, must be embraced. No one wants to use animals unnecessarily or to cause them unnecessary distress. The guiding principles in animal research today are called the 3Rs:
Back to topHow is animal research regulated?
Animal research is extremely highly regulated; both by law and by rigorous internal Ethical Review processes. In the UK the Home Office is responsible for regulation. In the US the US Department of Agriculture is the body responsible for regulating animal research. GlaxoSmithKline also seeks voluntary accreditation from an organisation called the Association for Assessment and Accreditation of Laboratory Animal Care ( AAALAC ) who assess animal care and usage.
To give an idea of how regulated the process is in the UK, each person directing and also conducting research must hold a license and the premises where animals are housed are inspected and licensed. All experiments must be approved by both an internal ethical review and by Home Office Inspectors, who are doctors and vets with the knowledge and experience to weigh any distress to an animal involved in an experiment against the benefits of the research.
Back to topWhich areas of research use animals?
All prescription medicines and vaccines must be researched in animals. Specifically animals are used to test vaccine quality and safety, for efficacy testing in the discovery of medicines and toxicology testing for drug safety before clinical trials in humans.
OTC or pharmacy medicines are not usually tested on animals as the ingredients are already well characterised from previous human experience or animal tests in the past.
Non-medicinal consumer healthcare products such as oral care products and toothpaste are never tested on animals unless there is a specific requirement from national regulatory authorities or in the rare event there is clear scientific justification that the study is needed to support safety.
GlaxoSmithKline's Nutritional Healthcare products (Lucozade, Ribena and Horlicks) are not tested on animals.
Back to topDoes GSK use animals because it is cheaper than developing alternatives?
Animal testing is not the cheap option, as is often claimed by animal rights groups. Non-animal methods are much cheaper - computers don't need to be looked after, fed, housed or require 24-hour vet cover. As well as being the ethical thing to do, it also makes business sense to use alternatives wherever possible.
Back to topHow can scientists learn anything useful about humans from research on animals?
Animals are not the same as humans. However there are very many similarities between animals and humans and the differences can be taken into account. Animal testing has to be carried out to find out what a potential medicine does in a living body before it is tested on humans. Then, recognising that animals are different to people, clinical trials are conducted over several years on thousands of human volunteers.
Back to topHow are the animals cared for?
It is vitally important that the animals are well cared for. As well as being morally the right thing to do, for high quality research, it is important that the animals are not in any way sick or stressed as this can make the research invalid. Animals are well cared for throughout their lives by qualified, trained staff. A vet is on site or on call 24 hours a day seven days a week. GlaxoSmithKline strives to maintain high standards of humane care and treatment for our animals.
Back to topHow many animals does GSK use?
GlaxoSmithKline discloses data on the species and number of animals used in research to the appropriate authorities as required by law. GSK's policy is not to release the actual numbers of animals used to the general public as the data may be used out of context. Moreover, we do not believe that the absolute number is the most meaningful metric in this area, as it depends on factors such as the number of compounds in research, regulatory requirements, and the introduction of new non-animal research techniques.
We therefore use a measure which compares the change in numbers used, with 1994 as the base year, with the change in R&D activity since 1994. This demonstrates that the number of animals used within GlaxoSmithKline is broadly the same now as thirteenyears ago, while R&D activity has more than doubled.
R&D activity is the sum of R&D expenditure and vaccines sales. Vaccines sales are used as a measure because vaccine production requires animal testing for the release of each production batch. Animal use is therefore dependent on the volume of vaccines sold.
The date of 1994 was chosen because it is the earliest date at which definitive figures are available, and it is prior to the full implementation of the modern technologies of drug discovery.
Back to topWhat animals are used in research and where do they come from?
Around 99 per cent of the animals used by GSK are rodents. The remaining one per cent includes fish, amphibians, rabbits, pigs, dogs, cats and primates. The vast majority of the animals GlaxoSmithKline uses are bred specifically for research. Pets or strays are NEVER used in medical research.
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