The 3Rs in medicine research
Research using animals is a small, yet vital, part in the development of our medicines, vaccines and consumer health products. When animals are used in research, we are committed to acting ethically and practising good animal welfare.
A key aspect of animal welfare is covered by what the biomedical community refers to as the three Rs (3Rs). These are:
- replacing animal research with other methods where possible
- reducing the number of animals used in a study while still providing information of a given amount and precision
- refining techniques to minimise pain and distress and improve the welfare of animals
How we follow the the 3Rs
Our scientists always try to devise experiments that do not require animals. When that is not possible, the researchers work to design experiments that allow us to obtain the necessary information from the smallest number of animals possible, with the least effect on individual animals.
All our proposed animal research is reviewed by an ethical panel, which is independent of the scientific group commissioning the studies. This panel considers the 3Rs and alternatives to animal studies prior to the approval of studies.
Advances we have made in applying the 3Rs
Over the years, our researchers have identified many ways of replacing, reducing, and refining animal research. For example, we have:
- replaced some research in animals with computer simulations and ‘in vitro’ techniques, where tests are done on individual cells, cultures or tissues
- applied statistical methods to our work, so that we can be confident in results obtained using many fewer animals
- introduced the use of imaging that can track physical and chemical changes caused by treatment over time, removing the need to compare treated animals with non-treated animals
How our work is monitored
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, often unannounced.
In addition, our animal facilities in Belgium, France, Hungary, Spain, UK and USA are accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALACI). This independent group reviews and assesses our animal care programme against published standards and industry practices.
We are working to extend this accreditation to all of our animal facilities.
Working with others on animal welfare
We share our practices with other scientists and regulatory authorities and publish the results of our research in scientific journals. This helps all of us work towards the 3Rs.
We are also involved with other organisations that aim to reduce the need for animal testing and promote animal welfare including, but not limited to:
- UK National Centre for the 3Rs (NC3Rs)
- European Centre for the Validation of Alternative Methods (ECVAM)
- European Partnership for Alternative Approaches to Animal Testing (EPAA)
- Center on Alternatives for Animal Testing (CAAT)
- Scientist Center for Animal Welfare (SCAW)
- Institute for Laboratory Animal Research (ILAR)
Replacement, reduction and refinement in practice
GSK’s ethical policies and the regulatory framework within which we operate mean that we are constantly trying to replace, reduce and refine our animal testing.
Some examples of new tests and procedures that we have developed or adopted include:
- blood spot technology
- an award-winning screening system to identify safety issues very early in the development of possible medicines
- magnetic resonance imaging (MRI)
Blood spot technology
Blood samples from animals are often required in research for a range of measurements, such as examining the distribution and concentration of a potential new medicine in the body. Traditionally, scientists have used plasma (the liquid part of the blood) to carry out these measurements.
The blood is commonly removed from animals – such as a rat – in the same way blood would be taken from a person - using a needle and vials. The plasma and the blood cells are then separated so the plasma can be tested.
Advances in analytical methods mean that some of these measurements can now be carried out using whole blood collected as blood spots. Whole blood spots can be gathered through the ‘heel prick’ or ‘Guthrie’ test – a method that has been used for years to screen newborn babies for a range of disorders. Each blood spot is collected by placing a drop onto a special blood spot card. We can then analyse samples from the cards in a manner similar to that used for plasma samples.
The advantage to the blood spot method is that it uses significantly less blood – about a tenth of the volume required with the traditional sampling method. The smaller volume is an important advance. If less blood volume is required, then samples collected over a time period can be provided by fewer animals, rather than needing several animals for large volumes of blood. We predict this approach could reduce the number of animals used by up to 40% for some types of studies.
One of our teams has developed a software system that allows a computer to screen possible new medicines for potential safety issues at a much earlier stage than before. The system, known as Molecular Clinical Safety Intelligence (MCSI), compares the profiles of possible medicines to those that have already been tested.
It is the first system to bring together knowledge of chemistry, human and animal safety, drug metabolism, and pharmacology. It allows scientists to evaluate new medicines as they are being designed and synthesized in the laboratory and before they are researched in animals or humans. This saves researchers from spending years on developing promising new medicines that ultimately cannot be licensed because of potentially harmful side-effects. It also prevents any animal testing that would have been required during development.
The team that developed MCSI won the 2008 Wall Street Journal Technology Innovation Award for Healthcare IT for this new system.
Magnetic resonance imaging (MRI)
MRI allows us to see soft tissues in fine detail. It is a very powerful tool as it can show researchers changes in organs and tissues by studying images from one animal or human taken over a period of time.
Because we can see what is happening during and after treatment, we can use less invasive experiments. In addition, the number of experiments and the number of animals involved is reduced. This is because we can compare the changes that happen to a single animal over time, instead of needing to study separate animals at different points through the process.
Awards for putting the 3Rs into practice
We believe it’s important that individual efforts to achieve the 3Rs are recognised. We therefore offer an Animal Welfare Award to those in GSK who successfully develop alternative testing methods and other practices that demonstrate our commitment to the 3Rs.
We also sponsor the annual UK National Centre for the 3Rs prize, which recognises published work that advances, or has the potential to advance, knowledge in the 3Rs.