Animal Testing Perspectives

Animal testing? Yes, but…

2014-10-21T14:56:44Z

(photo: Thomas Cueni)

The Swiss are somewhat sceptical about animal testing for research purposes. This unsurprising stance was most recently shown in a representative survey of 1000 Swiss voters conducted by gfs.bern on behalf of Interpharma. However, when asked whether animal testing should be banned even where universities and pharmaceutical firms have no other means of advancing research, only 34 per cent of respondents said it should be banned whereas 58 per cent would accept animal testing in such circumstances. There was greater consensus – 70 per cent – regarding approving animal testing for general medical research and research into drugs for the treatment of diseases. There has been barely any change to this critical but approving stance since the last survey in 2009. This is unsurprising considering much medical progress has its roots in animal testing – like the knowledge of the three neuroscientists awarded the Nobel prize in Medicine last week.

It has a lot to do with the conviction of a significant majority of those surveyed – 55 per cent – that Switzerland has a strict animal welfare law. Only 22 per cent of respondents consider animal welfare in Switzerland to be too lax. The remainder do not know or are undecided. They are very capable of deciding however, when it comes to where animal testing should take place. 91 per cent of those surveyed consider it preferable to allow animal testing under strict conditions in Switzerland than for it to be outsourced abroad to where regulations are less strict.

This critical but favourable opinion of animal testing is also the result of efforts by animal welfare organisations, lawmakers and researchers in Switzerland. Instead of the sometimes radical but unsuccessful opposition to animal testing in the 80s and 90s, there is now dialogue. Undeniable progress has been made. The laboratory animal welfare charter, which Interpharma firms adopted in 2010, is not just attracting interest in Switzerland. The industry is recognising that the legitimate interests of animal welfare campaigners should not simply be pushed aside. However, animal welfare organisations and the research-driven pharmaceutical industry continue to evaluate the necessity of animal testing differently. They agree that animal testing should only be carried out when there is no alternative and authorisation has given following careful weighing of the suffering and distress caused to the animal against the expected gain in knowledge.

As such, both sides – the industry and animal welfare organisations – strongly support a national research programme that should increasingly develop alternatives to animal testing following the principles of the 3Rs. These aim to reduce animal testing, replace it as much as possible with alternatives such as computer simulations, testing cells and tissues and refine methods to minimise the stress caused to the animals. This is widely supported in Switzerland: 83 per cent of respondents were in favour of a research programme exploring alternative methods to animal testing. This wish must be taken seriously, particularly given the importance attributed to animal welfare in Switzerland.

About Thomas Cueni

Thomas B. Cueni is Secretary General of Interpharma, the association of the Swiss pharmaceutical research companies. He is a member of the Board and Council of the European Federation of the Pharmaceutical Industries’ Associations (EFPIA) and of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). Prior to his appointment with Interpharma, Mr. Cueni had a career as an economic and political journalist for two leading Swiss newspapers and spent four years as a London correspondent. After that he joined the Swiss Foreign Service as a career diplomat with postings in Vienna (UNIDO, UN, IAEA) and in Paris where he was a member of the Swiss Delegation to the OECD. Mr. Cueni has a degree in economics (University of Basle) and a Master of Science from the London School of Economics.

Report: Putting animal welfare principles and 3Rs into action – 2012 Update

2014-02-12T15:48:24Z

Putting animal welfare principles and 3Rs into action

European Pharmaceutical Industry Report 2012 Update

Beyond Compliance:

How do we ensure that animal welfare standards and practices are put into action throughout the sector both in our industry and among the laboratory and research community more broadly?
How do we make sure that global regulations reflect 3Rs strategies?
What internal and external industry initiatives facilitate the implementation of training programmes on animal welfare and care?
How do scientific advances help progressing 3Rs and Welfare? *New

Leading by Example:

How do we share and encourage good practices based on 3R principles across the pharmaceutical industry?
How do we stimulate putting into practice global animal welfare standards?
What is being done to rapidly implement and enforce across Europe the revised European Directive 2010/63/EU on the protection of animals used for scientific purposes?
Are companies independently assessed on how animal welfare standards are applied?

Committing to Open Communication:

How do we contribute to an open and constructive dialogue on animal welfare?
How is industry communicating the progress made with animal welfare activities, specifically the 3Rs?

Getting back into the swing of things with Nobel Prize News

2013-10-16T07:07:03Z

It’s been some time since we’ve written but we’ll now be getting back to regular updates. Last week’s big Nobel Prize announcement for medicine/physiology seemed the perfect opportunity to kick things off again. The award went to three scientists who discovered how cells in the body transport material – research with major potential implications for progress in areas like diabetes and brain disorders

So why is the Nobel Prize inspiring a blog, here? As with most Nobel Prize research, animal studies were integral to the researchers’ success. In this case, yeast, cows and genetically modified mice were involved in the research process. Looking back, nearly all Nobel Prizes in Physiology or Medicine have required some form of animal research. According to Americans for Medical Progress, in the past 34 years, all awards but one have been dependent on animal research.

The impact of this year’s prize-winning discovery could be big news for patients suffering from diabetes or brain disorders. The three researchers discovered that vesicles – membranous structures that store and transport cellular products – transport these materials to a precise target, similar to a fleet of ships. This is crucial to many processes – from the release of hormones in the body to brain communication. Defective vesicle transport systems are associated with diabetes and brain disorders – and knowing more about them could help us improve treatment options in these areas.

So congratulations to James Rothman, Randy Schekman and Thomas Sudhof for their Nobel Prize win, and for bringing research a step further.

What are your thoughts on the big Nobel Prize news? Let us know in the comments section below

Whoosh! There goes another deadline

2014-11-17T14:20:09Z

“I love deadlines. I love the whooshing noise they make as they go by.”

– Douglas Adams

It had all been going so well. The path EU legislation must navigate is notoriously complex. Consultations, proposals, amendments – input from MEPs and compromises between national governments – the road is long and winding.

But for the EU’s directive on how animals are used in medical research, this lengthy process appeared to have produced a compromise which governments agreed would raise standards of animal welfare, reduce red tape by harmonising rules across Europe, and promote the 3Rs.

Scientists, some of whom initially worried that the new rules would make research more difficult, had their say during the consultation period and broadly accepted the final outcome. Yes, there will always be some who hope for less regulation – just as others will be disappointed that the law could not go further – but EU policy is a world of compromise and this directive looked to have struck a reasonable balance after a robust debate.

So you might have expected that the final step in the journey – turning the EU directive into national law – would be the least complex. Not so!

All 27 Member States should have had laws, regulations, and administrative provisions in place by November 2012 so that these could be in force by the beginning of this year.

At last count, most governments were behind schedule and struggling to meet the deadline. Perhaps this is because not all costs could have been anticipated at adoption of the directive and only now has everyone realised some additional bureaucratic and financial burdens that stem from the way countries interpret the provisions.

While local political and economic crises might be dominating the agenda in several Member States, the directive has been coming down the tracks for some time, so its transposition ought to be a fairly routine technical matter.

Never-ending story

The painstaking process of agreeing on a final EU text has been concluded; the debate is over – or at least it should be…

Let’s look at Italy as an example. Efforts to transpose the directive into Italian law have been complicated by amendments proposed by Italian politicians. Scientists in Italy have already raised concerns about this, warning that medical research in Italy could be jeopardised if the country fails to implement European law.

Italy, which has endured its share of controversies over animal research in recent months, could even be hit with fines for non-compliance with a law its government signed up to.

Are national parliaments set to re-fight the battles that were fought before the directive was agreed?

And, in light of our Shall It Stay or Shall it Go debate, is this the latest signal that animal research is no longer welcome in Europe? If so, what would this mean for European patients and for animal welfare standards?

We want to hear from you

Controversy over animal transport

2014-11-03T08:13:19Z

I’ll be honest: I had never given much thought to how animals are transported to laboratories for scientific research projects.

It was only when animal rights groups began to put pressure on airlines and ferry companies to stop transporting laboratory animals that this came to our attention.

Researchers are concerned that research on non-human mammals, as well as studies involving frogs, insects and fish, could be hampered if companies refuse to transport animals which will be used in labs. This, according to scientists, could even disrupt the fruit fly research used to study genetics.

Interestingly, scientists and policymakers in India managed to convince Air India to reverse an earlier decision to stop transporting animals.

From a European perspective, one wonders whether researchers and politicians in India are more willing to publicly support medical research by working with transport companies and animal welfare groups to find solutions.

What do you think?

Now that the issue is on the agenda, it prompts a number of thorny questions. If animals could not be transported to labs, resulting in a decline in medical research, would this be a price we’re willing to pay?

Should animal welfare campaigners focus on the conditions under which animals are transported – and the length of the journeys they take – rather than on banning transport altogether?

Let us know…

What would happen if animal research was no longer conducted in Europe? Might it be an incentive to accelerate progress on alternative research models?

2014-11-03T08:13:54Z

We want to hear from you.
Please use the comment box below to submit your views.

Editorial team of Animal Testing Perspectives

Could pharma’s problem redefine animal research?

2014-11-03T08:14:01Z

While many medical needs still remain unaddressed, the number of new therapies and preventions is decreasing.

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.

Animal research: a global issue

2014-11-03T08:14:07Z

Medical research is a global endeavour regulated locally. Researchers move, patients move – even animals move (sometimes) – and ideas, of course care little for borders. But could more be done to agree common standards for animal research and for validating non-animal testing models?

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…

The role of animal testing in orphan drug development

2014-11-03T08:14:13Z

Much of the debate over the use of animal testing in drug development is a cocktail of facts, emotions and ethics. Regulators have tried to strike a balance between these factors in the forthcoming EU Directive 2010/63/EU, but there is still considerable pressure to stop animal testing altogether. What would happen to drug development, and where would it take place, if animal testing were banned? It’s difficult to find the ‘right’ answers, particularly when rare, or orphan, diseases are involved.

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.

EU research funding: going, going….gone?

2014-11-03T08:14:19Z

Whether you’re in favour of animal research or you would prefer more research on non-animal experimental models, this one is for you.

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!