During our two hours discussion, Professor Nouët touched on different aspects of the use of animals in scientific research, including alternatives and the 3Rs. We will be publishing parts of the interview over the coming weeks, however looking at your comments and questions over the past months, we thought the following topic was a good one to start with.

Professor Nouët, what does ‘alternative to animal testing’ mean exactly?

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A couple of months ago we had the privilege to go to Paris and interview Professor Jean-Claude Nouët, Honorary President and cofounder of the Ligue Francaise des Droits de l'Animal, éthique et science (LFDA).
During our two hours discussion, Professor Nouët touched on different aspects of the use of animals in scientific research, including alternatives and the 3Rs. We will be publishing parts of the interview over the coming weeks, however looking at your comments and questions over the past months, we thought the following topic was a good one to start with.

Professor Nouët, what does ‘alternative to animal testing’ mean exactly?
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Testing chemicals that are used in the pharmaceutical, agrochemical and consumer-products industries to establish the likelihood of their causing cancer (carcinogenicity testing) still requires a great deal of animal experimentation, with up to 800 rodents used for each substance and around 12,500 laboratory animals used annually in the UK.

Finding alternatives to animal tests for assessing cancer risks to humans that are faster, more efficient and which benefit animal welfare is an urgently important issue, as the current carcinogenicity studies are time consuming and expensive and are of limited practical use in large-scale chemical evaluation programmes such as REACH, the European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals. In addition, the 3Rs (‘Replacement’, ‘Reduction’ and ‘Refinement’ of animal research) focus on an area of biological research where there is a real need to advance one or more of these legislation criteria concerning animal testing and research. NC3RS are confident that their grants to Professors Newbold and Jenkins will deliver tests that will benefit both animals and the industries in which they are used across the EU and Europe.

In particular, rodent cell-based in vitro tests for detecting a chemical’s potential to damage DNA and/or cause mutations (genotoxicity assays) are already used in regulatory carcinogenicity testing strategies, but are felt to be limited as stand-alone tests, due to their high rate of misleading positives (where chemicals that do not damage DNA in vivo are wrongly classified as potential carcinogens), which then require animal experiments for clarification. For more information concerning the awards, click here.

It has taken ten years for a dedicated company task force to get rid of all redundant product control tests in living animals or to replace them with other methods of testing. Working in close collaboration with regulatory authorities around the world, the task force has replaced all obsolete tests at Novo Nordisk using live animals. The alternative testing method, the use of animal cells rather than living animals, had first to prove its efficacy before being approved by regulators.

Novo Nordisk have been phasing out the use of live animal tests over several years, with the final test performed at the end of November 2011.

Animal testing is not to be confused with animal research. This will continue at the pharmaceutical. The company said these are “essential for all pharmaceutical companies in the processes of discovery and development of new pharmaceuticals” with authorities demanding drug candidates are tested in living animals before they can be tested in humans.

Watch the video to find out more about the phasing out of animal testing, Novo Nordisk ending the use of living animals to test the quality of batches of medicines.

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Can new research methods save money and animals?

Brussels conference puts spotlight on alternatives to animal testing

What if I told you that these technologies already exist and the trick now is to pull them together, apply them and have them accepted by authorities? Well, it’s true.

Some of these tools can be used by themselves, others can be combined to find innovative approaches to research and testing.

By using so-called Integrated Testing Strategies (ITS), major progress could be made in moving towards the 3Rs.  This approach means using tailor-made combinations of animal and non-animal research methods in developing and testing new medicines, although hurdles remain before Europe makes the leap into this new era.

As we mentioned recently, the European Partnership for Alternative Approaches to Animal Testing (EPAA) – a joint effort by policymakers and industry – devoted its annual conference in Brussels to ITS.

The beauty of so-called Integrated Testing Strategies (ITS) is that it can mean using fewer animals which also generally means lower costs. As Dr Thomas Foerster of Henkel put it, this appeals “not just for ethical reasons but also for budget reasons”.

Ready for total replacement?

So why are some of the non-animal methods which are part of ITS not used universally instead of animals? Why can’t we replace animals altogether? Well, right now, even the best available non-animal methods are imperfect.

In some cases, testing how a group of cells in a dish respond to a new drug can be very useful but scientists also need to know how whole organs interact in the presence of the new substance.

Translation: dropping a new medicine on a few brain cells tells you lots of things about how the brain will respond. Testing this drug on some liver cells also tells you something about how the body will deal with this drug. But it’s not quite the same as seeing how the whole brain, liver, kidneys, heart and so on will respond as a whole.

For now then, it seems ITS can be used to reduce the reliance on animal models, but some animals will still be required.

Show me the data!

More research is certainly needed. The other big hurdle to clear is convincing regulators to accept these new kinds of experiment instead of traditional animal-based testing. According to several speakers at the EPAA event, the industry is reluctant to invest heavily in developing these kinds of non-animal methods unless regulators can guarantee that they will accept them.

For their part, regulators have been slow to make such a commitment until they’ve seen data proving that the new non-animal methods are as good as existing tests.  It’s a classical catch-22. Perhaps the only option is to jump together.

Human nature is also a drag on progress. Scientists working in industry and toxicologists in regulatory bodies are used to current animal-based methods. They understand the techniques; they trust the results.

If ITS are to be embraced, experts who are familiar with them will need to be trained or recruited – which is no easy feat. There is also the global aspect. If new ITS were acceptable in Europe but regulators in the US, China and elsewhere would only accept traditional animal-based testing then new medicines would have to be tested twice – which would increase costs rather than reducing them.

Europe can take the lead in this innovative area but there’s no point running too far ahead of the pack.

The take-home from this year’s EPAA annual event was that ITS offer real promise for reducing the use of animals but making this kind of quantum leap is never easy. It looks like we’re at the beginning of a long but exciting story.

The EPAA is an independent platform which brings together the European Commission and industry groups to collaborate on implementing the 3 Rs Declaration. It has been running since 2005 and has done a lot to bring together people who don’t talk as much as they should – like companies and regulators, or scientists and EU officials.

Last year’s event put the focus on ‘reduction and refinement’ while this time around the spotlight is on Integrated Testing Strategies (ITS) in animal research.

ITS can be tricky to define but is essentially a way to connect animal research methods, non-animal testing techniques and computer-based modelling to advance the cause of our old friends, the 3Rs.

Last month the EPAA ran a workshop on ITS so the annual conference is a natural follow-on from that.

The discussion will look at how ITS can be applied in a way that delivers efficient science-based results while reducing the use of animals, but at the same time meeting the growing demands of authorities and legal risk assessors.

Given Europe’s current obsession with innovation and competitiveness, it will be interesting to see whether ITS can really be the silver bullet that delivers all the information scientists need without compromising on speed, cost, or product safety. Plus, given that we’re in Brussels, one wonders what the EU can do to promote the use of appropriate ITS?

Can public and private stakeholders work together on non-competitive projects that will ultimately benefit all, perhaps along the lines of the Innovation Medicines Initiative?

The conference programme looks busy so hopefully we’ll get some answers on 9 November. We’ll be attending with a video to capture feedback from the day.

The European Partnership for Alternative Approaches to Animal Testing (EPAA) competition theme this year is ”Integrated Testing Strategies (ITS) and their impact on the implementation of the 3Rs”. It will be interesting to read the winning article as ITS doesn’t necessary mean non-animal alternatives.

The winning entry should help to inform the wider policy community and decision-makers and general public about the opportunities and challenges of Integrated Testing Strategies, including limitations, offered by scientific and technological progress.

Find out more and submit your essay.

We will be linking to the final article and seeking feedback from the community about the winner’s point of view.

These methods are very useful for studies on particular types of tissue and help considerably to limit the number of animals used. However they are still not able to simulate an entire organism with all its cells, tissues and systems working together.

Read also:

What are the key issues?
Why are animals used for testing?