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Answers to frequently asked questions
At GSK we know that animal research is a sensitive subject and of interest to many. This section of our website aims to answer the most commonly asked questions you may have about our research involving animals, specifically about:
Alternatives to animal research
Why is animal research necessary?
Animal studies are currently a necessary part of the discovery and development process of new treatments.
In carrying out research, we use alternatives to animals whenever possible and we aim to carry out studies with the fewest number of animals possible. Nevertheless, there are still many diseases that are not understood and cannot be treated, prevented or cured.
Humans are biologically very similar to other mammals, with most of the same organs performing similar functions and controlled by comparable mechanisms (such as the circulatory and nervous systems). In developing a new medicine, we need to be able to see the effects of the compound in a whole living body. There is currently no alternative to animal research that allows us to study these processes and assess whether a compound has the potential to become a medicine.
In addition, the regulatory authorities worldwide that approve medicines for use in humans require compounds undergo safety studies in animals before they will approve their use in clinical trials or licence them for use in humans. Some countries require animal testing of non-medicinal products in order to provide information related to possible health benefits and we undertake this animal research when necessary.
How can animal research be justified if there are still clinical trials that fail and medicines that cause problems?
Animal research used in conjunction with non-animal methods is much more accurate than any other option we have available to study the effects of new medicines and vaccines.
Only about 11 per cent of compounds that are investigated in humans ever make it to market as a medicine. Long before a compound is tested in humans, it has been selected from hundreds of others based partly from findings in animal studies. The entire process of drug discovery relies on information from both animals and humans.
Since the 1970s, the rate of medicines being withdrawn due to serious side-effects has been between 2-3 per cent. In the majority of cases where a medicine is withdrawn, the decision is made because a rare side effect is identified after the medicine becomes widely used by people with complex conditions who are often taking many different medications. With rare side effects, many hundred thousands of people need to be treated before the condition shows up. This is a much larger group than researched in animal or human studies.
In approved medicines, problems are frequently due to improper use: a study from 2004, showed that at least 93 per cent of people being admitted to hospital with an adverse drug reaction had what are called ‘Type A responses’. These responses are side-effects that are known or recognised and that could have been avoided if the medicine had been taken according to its prescribing information or if the doctor had been aware of other medicines being taken by the patient.
Adverse reactions in human clinical trials would definitely increase without animal studies being carried out beforehand, as an estimated 60 to 70 per cent of medicines never reach the stage where we test in humans (clinical testing) because of what we find out in the pre-clinical (animal or laboratory) testing.
Why can’t researchers use alternatives, such as computers?
Our global policy on animal research requires that if there is a way of obtaining the needed information without animals or with fewer animals, we use it. This means that we use alternatives to animal research wherever we can.
However, there are still many diseases that are not understood and cannot be treated, prevented or cured. Animals are only used where there is no alternative, including where we need to look at the effects of a medicine or vaccine in a whole living body or where required by regulatory authorities.
You can find out more about our efforts to replace, reduce and refine animal studies, and some examples of the alternatives that we have adopted on our 3Rs section.
Does GSK use animals because it is cheaper than developing alternatives?
Animal testing is not the cheap option. Alternatives are often less expensive, for example, computers do not need to be fed, housed and cared for 24 hours a day. We employ non-animal models whenever possible and apply the 3R’s to replace, reduce or refine animal research.
About the animals
How many animals does GSK use?
The number of animals is dependent on the number and type of projects and programmes being performed. This number changes over time. Therefore, we make available information that compares the relative number of animals used in research over time with the change in amount of research and development that we are doing.
Change in R&D activity compared to change in number of animals used by GSK#
# These data do not include animal research conducted by external contractors on our behalf. R&D activity combines our R&D budget and our vaccine sales, the two main drivers of animal use.
While we do not place information on animal numbers and species in public venues, we do provide this data where required to appropriate regulatory authorities.
Which areas of research use animals?
Much of our work in animals involves research designed to help us understand specific diseases and identify possible medicines and vaccines to treat and/or prevent them.
We also have to carry out safety assessments in animals for all prescription medicines and vaccines, as required by regulatory authorities. These studies examine the absorption, distribution, metabolism, and excretion of a medicine or vaccine by the body. In addition, toxicology work must be carried out before any medicine or vaccine is administered in human trials. Furthermore, quality tests in animals may be needed for vaccines once they are approved.
It is unusual to use animal research for medicines that are sold without prescription in pharmacies (over-the-counter or OTC medicines), as the ingredients tend to be already well understood by the time they are approved for OTC use. We do not test non-medicinal products on animals unless there is a specific legal or regulatory requirement to do so.
What animals are used in research and where do they come from?
Over 98 per cent of the animals we use in our research are rodents and rabbits. The rest of the animals include fish, ferrets, amphibians, pigs, dogs, cats, and non-human primates.
Most of the animals we use are bred specifically for research. Some exceptions include some fish and amphibians, which we obtain from sustainable sources. We never use pets or strays.
What is actually done to the animals?
What happens to any given animal depends on the specific research project. The vast majority of experiments involve minor procedures such as administering a substance and then taking blood or urine samples or giving a single injection. In most of the remainder, we use anaesthetics or pain-killing drugs to prevent discomfort.
All of our experiments involving animals must be approved by an ethical review committee and in many cases by the relevant national authority.
You can read more about our ethical commitment to replace, reduce, and refine animal studies, and see some examples of the alternatives that we have developed elsewhere in this section of our website.
How are the animals cared for?
It is very important that our animals are well cared for. This is the right thing to do morally. It is also important that the animals that we work with are not in any way sick or distressed as this can make our research invalid.
Our animals are looked after throughout their lives by qualified, trained staff. A veterinarian is onsite or on call 24 hours a day, seven days a week. Regulatory bodies visit our facilities regularly - many of these visits are unannounced.
What happens to animals after they have been used during research?
As many of the experiments that we conduct are minimally invasive – such as taking blood or urine samples - we will often re-use these animals in other similar studies, with the approval of our veterinary team and appropriate regulatory authorities.
In some experiments, we will need to gain information about the effects of products on an animal’s tissues or organs; in such instances the animal will be humanely put down once the study has completed.
Why aren’t the animals re-homed?
As most of the animals we work with are bred in captivity especially for research, they are neither equipped for survival in the wild nor are they domesticated. So in the vast majority of cases it would not be fair to the animals to re-house them as pets or release them into the wild. In addition, there are very strict controls on the release of animals into the wild.
Regulation
How is animal research regulated?
There are laws that govern the conduct of animal studies. In the UK these regulations are the responsibility of the Home Office. In Europe animal research comes under Directive 86/609/EEC and in the US is covered by the Animal Welfare Act.
We also have our own internal policy document, which outlines core principles for animal welfare that must be met. This policy requires that work done on our behalf meets all applicable laws, rules, and regulations governing the care and welfare of animals in research in addition to meeting our core principles.
In addition we continue to seek voluntary accreditation from recognised agencies such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALACI), which has its own set of animal welfare standards.
Public concern and activism
How is GSK addressing public concerns about animal research?
Our policy is to be open about animal research as we know that it is a subject that people are concerned about. The information on this website provides an overview of our approach to animal research and ensuring the welfare of animals in our care.
What is GSK’s position on animal rights organisations and activists?
We support any genuine, justifiable concerns about animal welfare that are raised by law-abiding individuals or organisations, such as the Royal Society for the Prevention of Cruelty to Animals.
However, we conduct a legitimate business within the confines of the law and so it is unacceptable for any of our employees or their families to be intimidated or harassed or subjected to any acts of violence.
There is information elsewhere on this page and in this section of our website about how we minimise both the number of animals that we work with and the impact of research on those animals.
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