Well, yes. International cooperation is climbing steadily up the agenda as scientists and policymakers from Europe, the US, China, Brazil and elsewhere share their views on how to support medical progress while making meaningful strides forward towards the 3Rs – reduction, refinement and replacement.

It makes perfect sense, regardless of your view of animal research. Collaboration is at the core of science; it’s where some of the best ideas come from. So if we are serious about finding therapies for diseases like cancer and Alzheimer’s disease we should encourage international cooperation.

And if we want to see the highest standards of animal welfare and the sharing of best practices – not to mention the adoption of viable non-animal testing methods by regulators – then a global approach is needed.

Fostering cooperation

That’s why it was encouraging to see experts and regulators from the US and China joining their EU counterparts for a conference in Brussels this month. The 8^th annual EPAA conference in Brussels took international cooperation as its theme and looked beyond Europe rather than focusing within. 

The Platform signed a memorandum of understanding with the US-based Institute for In Vitro Sciences dedicated to international dissemination of alternative techniques for safety evaluation, and the EPAA will provide up to €100,000 in sponsorship over two years to the IIVS to support training in several regions including China and Brazil.

Why should Europe care?

In this age of austerity, you might ask why Europe would want to help an American company to train scientists and regulators in China. Fair question! The answer is partly that better global standards will be good for medical research, good for animal welfare and good for us.

But the full answer is also that Europe should encourage standards in medical research to rise in tandem across the globe. Not only does this help to discourage migration of research to areas with weak regulation, it also incentivises European industry to invest in non-animal methods – if companies are confident that these models will be acceptable to authorities around the world they are more likely to take the risk of developing them.  

Here at Animal Testing Perspectives we have been asking you about the future of research in Europe, pointing to some of the discouraging signs which suggest medical research was unwelcome here.

But at the EPAA conference it was tempting, at least for a moment, to imagine a future where Europe not only sets the standard for animal and non-animal testing but also brings others with it in a way that preserves its global competitiveness.

Are we being too optimistic? Let us know…

Orphan diseases, affect not more than 5 in 10000 people, With some 29 million sufferers in the EU;

The EU offers the pharmaceutical industry some incentives to investigate rare illnesses. According to the General Director of LEEM, Philippe Lamoureux, European-backed research into drugs for the treatment of orphan diseases has led to 68 new medicines approved between 2000 and 2011. But there are between 6,000 and 7000 different rare diseases, so these drugs help just a fraction of sufferers.

Where does animal testing fit into the orphan drug equation? It is present in preclinical trials – as is the case with all drugs – but would it be right to ban the use of animals in research when patients have so few treatments to choose from in the first place? The Journal of Animal Ethics proposes that doctors tell patients, or their carers, the role that animals played in the development of their medicines. If sufferers of rare illnesses had access to this information, would they refuse treatment?

Stopping experimentation on animals in the EU probably wouldn’t stop European patients using drugs that have been tested on animals. The problem would simply be relocated, with testing taking place further away, in countries with less stringent regulations. Banning animal testing could also lead to a slowdown in research, as scientists consider alternative means of testing. The question remains: would sufferers of rare diseases be able to wait?

Some believe that not enough is being done to develop orphan drugs. According to work published by three Italian pharmaceutical researchers, a lack of testing on recommended animal species may have affected the investigations of 24 molecules, candidates for treatment of rare diseases. So when it comes to orphan drugs, should there be more, rather than less, research?

Sufferers of orphan diseases already face limited treatment options. Take animal experimentation out of the equation, and drug development options shrink even further.

The EU also celebrated last week when Professor Serge Haroche, the recipient of a European Research Council (ERC) grant, picked up the Nobel Prize for Physics. Europe plans to increase ERC funding from €7.5 billion to €13 billion from 2012 to help “the very best researchers to conduct pioneering research across Europe”.

But what about health research? Well, the Nobel Prize for Physiology or Medicine went to researchers from Britain and Japan for their work on reprogramming mature cells into stem cells.

They basically found ways to trick cells into reverting back to their immature days when they had the potential to become other kinds of cells. It’s like they turned ‘adult’ cells which were set in their ways into teenagers that can become anything they want if they are given the right environment.

The point is that this work was done using frogs and mice.

In fact, over the past 40 years, every single Nobel Prize in Physiology or Medicine – with one exception in 1983 when a plant geneticist collected the award – has depended on animal studies.

As if that wasn’t enough, this year’s Nobel Prize for Chemistry went to US scientists whose work in genetically-altered mice could lead to new and better medicines.

We’ve been asking you what the future of animal research is in the EU. The question now is whether waving goodbye to animal research would mean farewell to Nobel Prizes in Medicine

Is Europe content to be a beacon for peace and a dab hand at physics while leaving excellence in medicine to scientists in the US and Asia?

Or could future Nobel Prizes go to breakthroughs in non-animal models for medical research? Would that be the kind of game-changing incentive needed to make a giant leap towards the 3Rs?

Share your thoughts!

Read the Europe 2020 strategy and the Innovation Union policy and the message from EU policymakers is clear. Europe says it needs to be in the Premier League of scientific R&D, not just because research delivers solutions that help improve our lives, but because we want to develop and produce things that have value; things people in the US, Japan, China and elsewhere will buy from us.

Rhetoric vs reality

But what is the reality behind the rhetoric? And is Europe sending mixed signals about its support for research?

Last month the European Commission adopted a new regulation on clinical trials explicitly designed to make it easier to do research in the EU.

Just days later a court in Italy ordered the temporary closure of one of Europe’s leading dog-breeding facilities.

The move followed claims by animal rights groups that the Green Hill facility, a major supplier of animals for research use, was mistreating animals. The company flatly denies this. The judge granted the campaigners ‘custody’ of the animals and effectively cast a serious doubt over the future of the company.

Seeds of doubt

This raises questions about the future of dog breeding in Europe given the prominent role that the Green Hill facility played in the research landscape here, and the likelihood that other breeders will be unnerved by the incident.

And, crucially, it sows seeds of doubt too about how European policy is evolving in this area. A number of Italian politicians joined the campaign against Green Hill, tapping into an anti-research sentiment among some sections of their electorate.  

Would the human clinical trials that Europe has vowed to attract and keep be possible without animal research?

Would fewer of us consider enrolling in a trial to test the power of a new medicine if the drug had not been through safety checks on animals first?

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.

Related posts:

Can new research methods save money and animals?

Brussels conference puts spotlight on alternatives to animal testing

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.

In this second video, Neil goes into detail on what drove his decisions that shaped the final legislation; policy regarded by some as contradictory and by others as too pro-science.

However, Neil is made of sterner stuff and I respect his final comment in the video, “I wasn’t going to be dictated by just the popular view, I was actually going to take a view that I could stand up in [sic] my conscience and live with”.

I’d be interested to hear your views on our chat with Neil, particularly his comments on the 3Rs (Replacement, Reduction, Refinement) policy. He believes the 3Rs focuses science and industry on reducing and find alternatives to using animals in research, do you?

Related content
How did we arrive at the 3 Rs: Replacement, Reduction, Refinement?

Understanding Directive 2010/63: the new legislation governing the use of lab animals

Finding the right balance between animal welfare & human welfare

In online searches, animal testing is the most commonly used term and is used to represent any use of animals by scientists. However animal testing actually refers to the use of animals to test a substance – a drug, cream or chemical – that will be released into the environment. The substance is tested to see if it works, how it distributes in the body and whether it is toxic. Fewer than 20 per cent of lab animals are used for this purpose and it is a legal obligation demanded by various authorities before performing human testing (clinical trials).

‘Testing’ is done by the chemical industry, the pharmaceutical industry and academics. I was surprised to learn that the pharmaceutical industry is keen to stop animal testing and is actively looking for reliable replacements that will not compromise patient safety.

Animal experimentation is a general term to describe both testing and research and has a negative connotation. The term vivisection, is also negative and mainly used in the UK. It is associated to any type of animal-related testing and research. However vivisection actually refers to the dissection of living animals; the definition includes human surgery. In previous times this was done without anesthesia.

While the proportion of animals used for testing is declining, the proportion of animals used in ‘research’ is growing.

Animal research is carried out by the biomedical community – the pharmaceutical industry and academia. In terms of research, scientists are not obliged to do studies with animals, they use animals as models to better understand diseases and find ways to influence the cause of them. Essentially they look for an animal that has a disease similar to man, either naturally occurring or one that they can recreate through genetic modification. This is not testing, where an animal is exposed to compounds, this is research and accounts for 60 – 80% of the animals are used.

We regularly hear about medical advancement for diseases like cancer, which are reported in the press –“research with mice has uncovered a cure for x disease”. Yet do we, the general public, consciously make this connection between medical breakthroughs and the use of animals?

Some argue that it doesn’t matter what you call it, as animals are still suffering for the protection of man. However I think it’s important that we understand the terminology and use it properly to ensure we know what we fighting for, or against, and how this might impact our own lives.

Also read:

Finding the right balance between animal welfare & human welfare

What’s driving the increase in animal research?

What is animal research?

Research is the use of animals as a model, to better understand how the body works, how diseases affect it and find ways to influence the cause of the disease. This is essentially different to testing. The biomedical community use more than 80% of the total number of lab animals in this way, even though the overall number of  lab animals used is still much lower than 30 to 40 years ago , the numbers have grown in recent years.

How are researchers using animals to research?

Researchers look for an animal that has a disease similar to man, either naturally occurring, for example blindness in dogs, or which can be introduced by changing the animals’ environment or through genetic modification. For example to understand how anxiety effects health, we induce stress in mice to see how their hearts beat, how it affects their vision and breathing. To understand how cancer works, we alter genes in mice, so they automatically develop cancer after a certain time. Alternatively we use normal mice and transplant a human tumor into them to see how it develops over time.

Why are mice used so often?

They are small, easy to house with a short breeding cycle, which enables researchers to see many generations in a relatively short period of time. Unlikely many other animals, mice are easier to manipulate genetically.

Are mice really that similar to humans?

In terms of testing, a human is not a 60kg mouse. Testing in mice is valid but not the perfect model. However evolution is quite conservative; 90% of the genes of a mouse and the genes of a human are identical making them a very valid model.

It’s hard to believe a zebra fish is a good human model…

Fish are vertebrates too. The more you go into genetics and embryology you can learn a lot from fish to understand when a gene mutates, especially as their embroyos are transparent. If you look at an embryo of a mouse, fish, cow and man on a metabolic level during embryonic development, until the second or third week of pregnancy there isn’t much difference between them. Nature doesn’t reinvent itself; it improves existing ‘material’.

Why are we still using monkeys in research?

Academics and neuroscientists use monkeys in research when they try to understand how the brain is wired. Industry also uses monkeys for testing vaccines and hormones (biologics) as these interfere with the immune system. Unlike genetic studies, the immune system in humans is quite different from that of a dog or a mouse. So vaccines have to be tested in a non-human primate.

What would happen if we simply stopped research with animals?

If we phase out animal research there would be no suitable alternative to understanding disease mechanisms. You can’t mimic this in a computer model, at least not today. Many people have tried without animals, but it doesn’t work. It’s even getting more complex, and the number of animals will rise, because we have many more scientific questions to address.

In former times we only looked at genes, but we have now discovered epigenetics. This looks at how the body turns genes on and off during a lifetime. We have learnt that those ‘switches’ can be inherited. For example fasting periods in early adulthood can have an effect on your grandchildren leading to diabetes. This kind of research can’t be done in humans, for time or ethical reasons.

Why are woman who have children less likely to get breast cancer? We know it but we don’t know why? What is happening to make people with Huntington’s disease gene become sick and die at 45 years old? Or Alzheimer’s, we can see what’s happening to the brain, but we don’t understand the mechanism behind it and unless we understand that we can’t find a cure or prevention.

How can we motivate researchers to look for alternative methods?

Researchers don’t get a budget to do animal studies, they get a budget to develop research as fast as possible, as safely as possible and as predicatively as possible to find a cause of a disease. Researchers choose their method of research selecting the most effective route that is also the quickest and cheapest. By law, they are not allowed to use animals in their research if an alternative method is available. Moreover, if there’s a way to do research outside the animal model they will, because using animals in research is more expensive and takes longer.

Do we need to continue medical research to find cures or preventive therapies for today’s and tomorrow’s illnesses and diseases?

The argument that we should just stop research and die at some age of something naturally…. what is nature? What is a natural life without therapy? Does it start with vaccines? Or when we use antibiotics? Or when we start using chemotherapy against cancer? The general public want to get healthier and grow older healthier, so industry and academia are following a societal mandate.

Women dying of breast cancer today aren’t old they are mothers raising kids. Nor are men with prostate cancer. People of all ages have allergies and asthma, plus with the impact of global warming, diseases like malaria will return to Europe. Advancing medical knowledge and therapy is a civil society choice. This isn’t something that industry can answer, this is something that society needs to answer and civil society is very clear; they want it.

Also read:

Zebrafish at the cutting edge of heart research

How did we arrive at the 3 Rs: Replacement, Reduction, Refinement?