The reasons for this are many and varied. For one thing, the low-hanging fruit was picked a couple of decades ago so the diseases for which we now need new therapies are the most difficult to treat. This requires a huge investment of time, effort and resources and call for a more collaborative approach to innovation.

For another thing, the cost of conducting research has risen at a time when the rewards are on the wane. A recipe for new drugs it is not.

Yet the world is facing fresh public health challenges due to shifts in demography and lifestyle. Our ageing population means conditions such as Alzheimer’s will become a much greater burden. At the same time diabetes rates are through the roof in develop – and in developing – countries across the world.

What’s this got to do with animal research?

Glad you asked. This slow-motion crisis is paving the way for new approaches to drug development.

One area which shows considerable promise is personalised medicines. The primary goal of research in this field is to develop medicines which are best suited to individual patients or to particular categories of patients. This would mean, for example, that if you had a certain gene, your doctor would choose the medicine most likely to work for people like you.

The push towards deepening our scientific knowledge in this area is changing how research is conducted. In search of more precise and predictive methods of treating people, scientists are developing new models for testing drugs.

Innovation through collaboration

The need for more open collaborative approaches is spawning exciting public private partnerships like the Innovative Medicines Initiative (IMI). NEWMEDS – Novel Methods leading to New Medications in Depression and Schizophrenia – a five-year IMI project funded by the EU and pharmaceutical industry is committed to finding new treatments for psychiatric illnesses.

One of the key elements of the NEWMEDS project will be the search for better animal models. ‘Better’ means more accurate and predictive but using fewer animals.

The investment in better animal models which can more accurately represent human diseases should give scope for using fewer animals in the years ahead. Good news for delivering on scientists’ commitment to pursue the 3Rs of animal research – reduction, refinement and replacement.

Diabetes is a case in point. Around 350 million people worldwide are affected by diabetes and this number is rising steadily. Research using animal models has been central to pretty much all the therapies currently available for managing diabetes but the revolution in personalised medicine might help deliver better medicines using fewer animals. This is addressed by another IMI project, IMIDIA.

So, perhaps the headlines of recent years might be caused for concern given the essential role of the medicines sector in improving public health and generating wealth, but the concerted response for public and private players is cause for hope.

Crises can be catalysts for change. In the future, we could have better medicines developed using fewer animals.

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 research budget – a major source of support for medical science – is under serious threat and could be about to fall victim to a much wider political spat over public spending.

It’s an almighty row. The European Commission and the European Parliament would like the EU’s main research funding programme (to be known as ‘Horizon 2020’) to have a budget or around €80 billion over six years. National governments want to slash this in half to just €40 billion. The European Research Council (ERC) is also targeted by some EU leaders.

All of this takes place at a time when widespread austerity means national research budgets are shrinking too. For medical researchers, EU funds are often their best hope of securing funding for ambitious projects designed to push the boundaries of medical knowledge.

But scientists are not about to take this lying down. A group of Nobel prize winners have written an open letter calling for the research budget to be protected and a new petition – ‘No Research Cuts’ – has been launched by the Initiative for Science in Europe.

We’ve been discussing the future of medical research in Europe and whether the EU wants to be a research hub. The outcome of this debate – which is due to come to a head at a crunch November EU Summit – could provide the answer!

As part of our ‘Shall it stay or shall it go?’ campaign we’ve been asking you about the future of animal research in Europe.

Well it seems that some of the scientists who work in this area have given their verdict: they want it to stay and are more than a little worried about what they see as myths around animal studies.

The folks who run the Understanding Animal Research website have brought together concerned researchers from the UK to create the Science Action Network.

The group wants scientists to enter the debate which it says has been characterised by inaccuracies and confusion, partly because scientists have been reluctant to speak up.

They are asking scientists to give five minutes per week to reply to misinformation on the internet and social media channels. There’s even a dedicated Twitter hashtag – #ARnonsense – which they want scientists to use when debunking myths, and a Facebook page where researchers are encouraged to weigh in on videos and articles about animal science.
 

So, dear reader, the question is: will it work?

Are scientists the right people to discuss the ethics of animal research? Does the campaign target the right people through the right channels? What about the tone? Do you find it abrasive, irreverent – or both?

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!

Some 3.8 million procedures were carried out on animals including dogs, cats, mice and monkeys last year, according to press reports.

The numbers are less important than the trend. The total figure is the highest since 1981.

[Here’s one for Europhiles: If you want a sense of how long ago that was, 1981 was the year when Roy Jenkins handed over the Presidency of the European Commission to Gaston Thorn; Greece joined the European Communities; and Bucks Fizz won the Eurovision Song Contest for the UK!]

The report was published by the UK Home Office and was met with some disappointment among animal welfare proponents. This comes after years of political commitments to reduce the number of animals used in research, refine experiments which rely on animals and, ultimately, replace animal models with viable alternatives (the 3Rs).

In light of the latest numbers from the UK, it might be tempting to claim that the ‘3Rs’ commitment is no more than a fig-leaf; an empty PR promise not reflected in the daily reality of research labs. Or maybe there are simply more research projects than before?

Digging into the data

On closer inspection of that 3.8 million headline figure, it emerges that some animals were operated on more than once so we are talking about 3.8 million procedures rather than 3.8 million animals. Large numbers nonetheless but details are important.

There’s also a matter of definition. The genetic modification of animals – which is done so that an animal carries certain genes or has particular symptoms that are to be studied – is classed as a ‘procedure’. The same is true of taking a blood sample.

In fact, the number of procedures classed as ‘significant’ was just 5% of the total.

Given the particular sensitivities about the use of primates, it’s also worth asking what animals were involved.

71% of the animals used in the UK in 2011 were mice; 15% were fish; 7% were rats and 4% were birds. 235 procedures were carried out on cats, although all of that work was aimed at improving nutrition and health in cats.

Meanwhile, there was a dramatic decrease – by 75% – in the number of new world monkeys used in research.

Inspiring progress

For all of that, the headlines generated by the report, coming as they do at a time when governments are converting the new EU directive into national law, should add extra impetus to the drive towards applying the 3Rs.

One thoughtful response to the figures came from a group of scientists who took the opportunity to suggest that European funds should be tapped to fund investment in non-animal research. In fact a lot of research of this type has been funded without much genuine progress. So rather than focusing researchers on non animal research methods, wouldn’t it be better to invest in the development of more effective research tools that would bring clear 3R benefits?

Perhaps the EU’s Horizon 2020 research and innovation funding programme has the firepower and forward-looking mandate needed to support large projects of this kind.

Maintaining momentum

So while the total number of procedures on lab animals in the UK last year was up, there might be reason to hope that the momentum generated by the report will encourage timely transposition and implementation of the EU directive – and maybe even inspire policymakers to focus on and invest further in innovative research tools which could bring us faster to non animal alternatives.

Post the adoption of Directive 2010/63/EU in September 2011, this law is now being translated and implemented at national level, across Europe.

Take a look at the current status in your country and if you think it’s not up to date, and the process has moved to another stage, we’d love to here from you.

The people who work with laboratory animals are a compassionate bunch who would gladly use alternative methods if they could deliver the same results.

Like many people who do what I do, I’d quite like to become redundant. That is, I’d be content if my current job were made obsolete by advances in science.

As a vet in charge of laboratory animal science at a large research-based pharmaceutical company, I would be delighted if other mechanisms were available that could answer the questions we need to answer.

Nobody becomes a vet without first having a love for animals. For those of us who work with laboratories, we are the ones who guarantee round-the-clock care for the animals and safeguard their welfare.

Some people wonder how one can describe themselves as an animal lover yet do this kind of work. I give the example of my own wife who is a heart fibrillation survivor. Thankfully she leads a normal life, having taken a drug for 20 years now, and she is in great shape.

However, the reality is that the drug that has helped her stay healthy was developed through research on animals. We love cats in our house and I have to explain to my kids that a lot of the basic research that led to better treatments for their mother’s disease was actually done on cats and dogs.

The promise of unimaginable

As things stand today, it’s hard to imagine a world where animal research has been replaced with alternative methods. To be frank, I don’t foresee this happening any time soon, but such is the beauty of science that it tends to throw up all manner of unforeseen – even unforeseeable – advances.

Using animals is complicated but for much of our research, they are the best we have.

Advances in cell culture have taken us a long way but there are times when we need to see how a potential therapy responds to hormones and biochemicals from several organs of the body. The only option is to test the drug in a whole animal.

Of course, the research methods of the past are not as good as those available today. Perhaps in the future we’ll look back and think today’s methods to be primitive.

As I said in my last post, the beauty of science is its uncertainty.

According to the World Economic Forum/Harvard School of Public Health, the NCDs are responsible for 63% of all deaths and are currently the world’s main killer. Eighty percent of these deaths now occur in low- and middle-income countries. Over the next 20 years, NCDs will cost more than 22.68 trillion EUR, representing 48% of global GDP in 2010. The WHO European action plan 2012 – 2016 and the OECD both stress the importance of gathering research evidence in the battle against NCDs.

As far as cancer is concerned, for example, Cancer Research UK stated, in 2011: “Thanks to decades of research, survival from cancer has doubled in the last 40 years”. But this progress simply wouldn’t have been possible without animal research. At Cancer Research UK, research using animals is an unavoidable part of our efforts to beat cancer. For a start, it’s a legal requirement in this country that all new drugs (not just cancer drugs) are tested in animals before they’re given to patients, to make sure that they’re safe to use. In April 2012 the organisation Animal Aid has called for Cancer Research UK and other medical research charities to stop funding animal research. In a perfect world, animal research wouldn’t be necessary. But cancer kills more than 400 people every day in the UK, and all our work is aimed at reducing this death toll.”

However, in marking World Laboratory Animal Day on 28 April, animal activists in Hyderabad, India, called for an end to using laboratory animals and suggested moving towards computer-based alternatives. Speaking on the occasion, Dr. Anjani Kumar, director of the animal welfare division in the ministry of environment and forests said: “Though it is far-fetched, there is a hope that in the near future super-computers and DNA-based models could replicate the human body’s functions virtually to enable drug trials.”

When asked whether the animal activists will force the government to ban the use of animals in laboratories, Mahesh Agarwal, secretary for a city-based animal rights organization said: “I do not see any new technology replacing the use of animals in the laboratories. So, until such ways emerge, it would seem futile if we press for a ban on the method, which will seriously impact new drug discovery. What we can say is handle animals with care and less cruelty.”