Reducing animal testing

In the light of the recent House of Lords report on animal testing, Dr Trevor Jones, ABPI Director General, discusses the search for alternative methods of testing drugs safely

Ensuring the safety of medicines has always been a priority for researchers in the development of new treatments. From the first stages of research into a potential new medicine, safety factors are paramount - and this inevitably means that considerable testing must be carried out before it is appropriate to give a compound to humans. This is why animal research has traditionally been used to give researchers crucial information, not only about the disease but also about the way in which a new medicine will react in a living body.

However, those involved in medicines research are increasingly using a variety of alternatives to animal testing. As a result, the number of animal experiments has dropped to a record low, despite the fact that the amount of research into new medicines being conducted by the UK-based pharmaceutical industry is higher than ever.

This has primarily been achieved thanks to the use and development in medicines research of non-animal alternatives - an area where it is estimated that in Britain alone the pharmaceutical industry spends some £300m a year.

decreasing numbers

Latest Home Office statistics show that the number of scientific procedures involving animals decreased last year to 2.62m - the lowest since the introduction of the Animals (Scientific Procedures) Act 15 years ago.

While animal procedures are used for a variety of purposes, the principal use is for research into the causes of diseases and how to treat them.

Non-animal alternatives are extremely important to the industry, and today's medicines research could not exist without using such methods. The industry is working hard with academia and elsewhere to try to reduce the number of animals involved in research as much as possible. These figures reflect the great strides that have been made.

Examples of the alternatives being used by the industry include:

• high-throughput screening - this enables thousands of chemicals to be checked at high speed for those that might have a specific, desired characteristic. For example, this technique has been used to identify potential new compounds against cancer;

• high-speed computer technology - used to investigate families of potential medicines for characteristics known to create unwanted side-effects. Unsafe compounds can then be eliminated before animal studies are undertaken;

• molecular modelling - where computers design a particular structure to act as a 'key' to fit into a 'lock' that blocks a disease's progress. An example is the molecular design of protease inhibitors to combat HIV/AIDS;

• laboratory tissue culture - this is used in the evaluation of medicines to eliminate substances that are not going to become effective, and safe medicines without the need to go into animal testing. An example is medicines for coronary heart disease;

• genomics - where identifying a link between gene(s) and a disorder allows researchers to find new and better ways of treatment. An example is helping to understand the causes of Alzheimer's disease;

• use of stem cells - e.g. in the discovery of new medicines for the treatment of diseases such as Parkinson's.

But despite all these advances, animal research is still necessary. Because there are still big gaps in our biological and technical knowledge, researchers cannot predict how a compound will work in the entire human body.

No new medicine could be developed or even begin to satisfy the strict safety criteria of regulatory authorities in Britain and the rest of the world if animal testing were not part of the process. It is a stark choice: either animals have to be used, or there will be no new medicines, and the medicines we rely on simply would not exist.

Strict regulations surround the use of animals in medical research. The number used per medicine decreases as advances are made in our knowledge of biology coupled with better and more sophisticated technology, and non-animal methods are sought wherever possible. But, for the foreseeable future, animal testing will be an essential part of developing new medicines.

And if animal testing is not carried out in the UK, essential research will either not take place at all or will have to be carried out elsewhere. The only alternative is to condemn to a lifetime of suffering those people with a condition for which there is either no medicine, or where the current treatment is not adequate for people all of the time.

essential research

The computer has not yet been invented that can simulate the workings of even one of the body's major organs - for example, the heart, lungs, liver, and, especially, the brain - let alone the extraordinary complexity of the interactions between them.

Nevertheless, it is very encouraging that - despite the enormous amount of research into disease that is being carried out in the UK - the pharmaceutical industry is still able to reduce the number of animals involved.

The development of a medicine is a lengthy, costly process. It takes an average of 10-12 years and costs some £350m to bring a medicine to the stage when it can be prescribed by doctors - and the development process is complex. It involves research by dedicated and highly skilled scientists, using a variety of techniques to make sure that the medicine not only works but also that it is sufficiently safe.

This research requires the use of a variety of methods, starting with laboratory equipment and finishing with the people who need the medicine - the patients themselves.

Reducing the number of animal experiments is a priority. But as long as this remains the safest way of determining a medicine's safety before it is tested on humans, it will continue to be a necessary requirement in the development of new medicines that help to save and improve lives for patients.