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Fund for the Replacement of Animals in Medical Experiments Researching alternatives to animal testing

Laboratory dogs — FRAME concerns New FRAME essay contest Latest animal use figures Three Rs around the world

OCT 2013 www.frame.org.uk


Contents Legislation and the future of animal research

3

Minister stresses Three Rs support

3

Cosmetics tests and public perception

4

Three Rs changes worldwide

6

Friends of FRAME

7

Science shorts

8

FRAME Gifts

9

Laboratory dogs — FRAME concerns

11

Home Office statistics

12

Science news

14

Dorothy Hegarty Award

15

News round-up

16

A letter from the Editor Welcome to the new look FRAME News. We hope you like its cleaner, more-modern design, and find its contents interesting. There have been a number of changes around the FRAME office lately, and not just to do with our image, but one thing has not changed. We are still as committed as ever to the search for alternatives to the use of animals in laboratories. We will continue to campaign for better science through more relevant, and more valid, systems. Animals can never provide a fully-functional model of human diseases. At best they are an approximation. At worst they can give misleading results.

Thank you for your continued support of FRAME’s search for new methods that will replace the old animal research models. Best wishes

Anne Jeffery

(FRAME News Editor)

FRAME News October 2013

Published by: Fund for the Replacement of Animals in Medical Experiments Russell & Burch House, 96-98 North Sherwood Street, Nottingham NG1 4EE Phone 0115 958 4740 Registered charity number: 2596666464 Editor: Anne Jeffery www.frame.org.uk Perspectives in Laboratory Animal Science (PiLAS) www.atla.org.uk

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FRAME News October 2013

Human liver tissue culture with viable blood vessel system. One of the models discussed in this year’s Dorothy Hegarty Award winning paper in FRAME’s scientific journal ATLA. For the full story, see page 15.


Legislation

And The

Future Of Animal Research Experts from across the field of animal experimentation gathered at a seminar to discuss the potential impact of EU legislation on animal research policy in the UK. Eight speakers considered legal, scientific and political factors that influence trends and looked in particular at the question of animal pain and distress. Among the speakers was solicitor David Thomas, who has been involved with several animal protection organisations including the RSPCA and Compassion in World Farming. He said that suffering of laboratory animals is a key point in public views on research. “Opinion polls show that that is what the public is most exercised about. The greater the suffering, the greater the concern. Even if people support animal

experiments, they expect suffering to be kept as low as possible.” It is also central to regulations, he stressed, but warned that many campaigners are concerned that restrictions are not properly considered or implemented. “Many campaigners believe that the Home Office routinely fails to regulate severity properly – by asking itself the wrong legal questions, by underestimating severity (for example, by failing to take into account psychological distress) and by assuming that there is an appropriate care regime in place when there is not.” Head of the Animals in Science Regulation Unit at the Home Office Judy MacArthur Clark told the meeting that animal research can be

managed through regulations, but only up to a point. It is often more effective to develop a culture of care among those responsible for the research and expecting individuals involved to act responsibly. “Individuals must accept responsibility for what they do and work within an environment in which individual accountability is an expectation.” Other speakers said that economic drivers could have a big impact on the future of animal research because it is not only of limited effectiveness, it is also expensive. The meeting was held as part of a series called “Animals, Ethics and Public Policy” and was arranged by the Centre for Animals and Social Justice (CASJ).

More details of the speakers and their talks can be found online at http://www.casj.org.uk/news/exploring-future-uk-animal-experimentation/

Minister stresses Three Rs support A Home Office minister has stressed the Government’s commitment to the Three Rs in a written statement to Parliament. Lord Taylor of Holbeach made the announcement when the annual statistics on Scientific Procedures on Living Animals were issued. He described the use of animals in scientific research as a ‘small but essential function’ in investigating medical conditions and developing new drugs and treatments. But he went on to say that replacing animals in laboratories, reducing the numbers needed for research, and minimising the suffering

for those that are still used, were priorities. He said: “Scientific advances in knowledge and new technologies present significant opportunities to replace animal use, reduce the use of animals, and, where animal use is unavoidable, to refine the procedures involved so as to minimise suffering (Three Rs). It is key that we take these opportunities to ensure that replacement, refinement and reduction in the use of animals is integral to conducting animal research recognising that this not about baseline numbers.” The Home Office is the regulatory authority for the Animals (Scientific Procedures) Act 1986, as amended by European Directive 2010/63/EU.

New Italian Law The Italian Lower House of Parliament has passed new restrictions on the use of animals in research, testing and teaching, which include a ban on all animal tests on substances of abuse. As well as recreational drugs, the ban covers alcohol and tobacco, and it includes research on addiction. The changes also prevent future breeding of dogs, cats and primates with intent to use them in laboratories. FRAME News October 2013

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Failed communication on cosmetics message

In spite of changes to legislation across Europe it appears that many consumers are still unaware that cosmetic products are no longer tested on animals. The labels ‘not tested on animals’ and ‘cruelty free’ hold a lot of power for many shoppers, who still seek them out before making purchases, even though standardised legislation now bans animal tests on all cosmetic products manufactured in the EU. Here Dr Chris Flower, DirectorGeneral of the Cosmetic, Toiletry and Perfumery Association, sets out the new regulations. The European Cosmetic Products Regulation (the CPR, officially called (EC) No. 1223/2009), was published in December 2009 and is law in the UK. All cosmetic products on the market throughout the EU must comply with all of its provisions. One section covers animal testing and although much has been written on the subject, you could be forgiven if you are not clear because a lot of the information to date has been incorrect or misleading. For example, many people still believe cosmetics are routinely tested on animals and that it is necessary to seek out specific ‘animal friendly’ companies to be sure that the products are ‘cruelty free’, but that is not true. Here are the facts, based on the law.

Testing Bans 1. Testing cosmetic products on animals is illegal both in the UK and throughout the EU. Therefore, none of the cosmetic products you buy in Europe will have been tested on animals (in the EU and since the date the ban came into 4

FRAME News October 2013

effect in September 2004; no such testing has taken place in the UK since 1997). However, it is true that some other countries do allow, and in some cases require, animal testing. The cosmetics industry is fully supportive of all efforts to help those countries abandon animal testing for cosmetics and adopt alternative ways of ensuring product safety. 2. Testing ingredients for cosmetic products on animals is illegal both in the UK and throughout the EU. Therefore, none of the cosmetic products you buy in Europe will contain ingredients tested on animals (in the EU and since the date the ban came into effect in March 2009 if that testing was for the purposes of complying with the CPR). However, many substances used as cosmetic ingredients have other uses and other laws (such as REACh and medicines legislation) may require animal testing of these same substances. That testing would still happen

whether or not the substance is used as an ingredient in cosmetics. Because the EU laws do not apply in other countries, these testing bans only apply to animal tests carried out in the EU. However, this does not leave a loophole whereby someone could test outside of the EU, because additional bans are in place to cover that.

Marketing Bans 3. Marketing (i.e. placing a product on the shelf) cosmetic products that have been tested on animals anywhere in the world in order to comply with the European CPR is

illegal. This ban came into effect in March 2009. 4. Marketing cosmetic products containing ingredients tested on animals anywhere in the world in order to comply with the European CPR is illegal. This ban came into effect in March 2009 except with regard to three complex types of test when the marketing ban for these came into full effect in March 2013. However, as above, many substances used as cosmetic ingredients will be used for other purposes and the laws of other countries regarding those purposes may require animal testing. Most if not all cosmetic products on the market in the EU will contain ingredients that have been tested on animals by someone, somewhere and for some other purpose than for the European CPR.

‘Cruelty free’ Claims The CPR states that it should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. However the Commission wants to ensure that any such claims do not mislead the consumer. Some companies apply their own cut-off point before which any animal testing of ingredients is not deemed to be applicable when they claim to be ‘cruelty free’. It must though be acknowledged that they still make use of that information, even indirectly, when deciding their product is safe to market. Additional information is available on the CTPA’s consumer website www.thefactsabout.co.uk where there are sections on the animal testing bans and animal testing myths.


Communicating Science The obvious public misunderstanding over cosmetics testing highlights the gulf that exists between scientists and the rest of the population when trying to communicate new developments. FRAME staff attended a conference at the University of Nottingham earlier this year, which addressed the problems that surround informing lay people about often complex scientific themes and data. The event was part of the University’s Making Science Public programme, which grew from a realisation that science communication often failed to get across an accurate and full message. In the keynote address Professor Harry Collins of the University of Cardiff said there was a strong, but incorrect argument that, if scientists revealed more of their work to citizens, then citizens would be better able to contribute to scientific and technological decision-making. He went on: “I argue, however, that this is a dream. Not even other scientists can understand the intricacies of what goes on within the core-set of a disputed technical domain.” A conference report states that, in spite of UK government initiatives in promoting scientific literacy and engaging the public in the subject, there is a widely held perception of lack of public trust in science. Increased commercialisation and a rise in the importance of intellectual property have led to science becoming more private. For more information and conference reports see scienceinpublic.org

Cosmetics testing changes It has been reported that India has banned animal tests on cosmetics made in the country. Dr G N Singh, India’s Drugs Controller General, was quoted on the news monitor ChemicalWatch as saying: “Given the cruelty towards animals involved, the testing of cosmetics on animals will now not be allowed in the country. There are alternatives which are already being used in other countries, so I don’t think the ban will have a detrimental effect on the industry. Our concern is animal welfare, not the cosmetics industry.” Although an official announcement is still awaited, it is believed that the Bureau of Indian Standards (BIS) has decided to ban lab tests on cosmetics as a commitment to animal welfare. The ban does not apply to cosmetics manufactured outside India and there is no restriction on companies

outsourcing tests in other countries. India banned two tests, for skin irritation and oral toxicity, earlier this year. An official announcement about the total ban is expected on the BIS website in the near future. And in Japan, one of the country’s largest cosmetics manufacturers, Shiseido, has announced that it will no longer use animal tests when developing new products. The company aims to ensure safety through the use of previous data, and in vitro testing. However, it has announced that it will still need to carry out animal tests on some existing products, which it exports to countries that require them. FRAME News October 2013

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Three Rs changes worldwide Organisations, companies and official bodies around the world have been updating and extending their regulations concerning the use of animals in research.

Australian rules The Australian government has published the latest version of its guidelines for researchers working with laboratory animals. The eighth edition of the Australian Code for the Care and Use of Animals for Scientific Purposes was issued in summer by the National health and Medical Research Council (NHMRC). It contains a number of new instructions. Following public consultation, definitions have been updated and the title changed to reflect current best practice in laboratory operation. A statement from NHMRC Chief Executive Officer Warwick Anderson, accompanying the new document, said: “The new edition of the Code provides clearer, stronger and up-to-date information on the ethical, humane and responsible care and use of animals for scientific purposes.� Underlying the new document is an obligation to respect animals. It requires that their use must be justified, must have scientific or educational merit, must be beneficial to humans, animals or the environment and must be conducted with integrity. It gives clear guidance on the responsibilities of everyone involved in animal-based research, including organisations and institutions, ethics committees and carers, as well as those carrying out the project. One aspect that has not changed is the assumption that procedures and conditions that would cause pain and distress in humans cause pain and distress in animals, unless there is evidence to the contrary.

USA chimps In the USA the National Institutes of Health (NIH) announced earlier this year that it will retire the majority of the 360 chimpanzees still held in its laboratories. The move follows a study by an independent advisory group, that determined chimps are not needed for most biomedical and behavioural research. The organisation will keep a colony of 50 chimps for potential use, although they will be housed in more appropriate surroundings, including large social groups, with outdoor access and environmental enhancements. The decision will be monitored periodically by an independent body to assess whether the ban should be maintained, or whether the remaining animals should also be retired to sanctuary. The NIH has also pledged to reduce the number of government grants issued to research on chimpanzees and discourage breeding for research purposes. Also in the USA, students in Connecticut have been given the right to opt out of animal dissections following implementation of a new state law. The Act Concerning Dissection Choice requires schools to excuse students from participating in, or observing, dissection as part of classroom instruction, if they wish. Millions of animals, including cats, turtles and frogs, are dissected in US schools every year in spite of the availability of alternatives such as 3D models, computer programs and videos.

Korean legislation In Korea, legislation governing animal use in scientific research, testing, and education is relatively new, but a campaign by animal activists, scientists and veterinarians begun in 1999, led to the introduction of certification for animal technicians. By 2006 the country had established the Korean College of Laboratory Animal Medicine (KCLAM), which is rapidly becoming the central organisation for animal welfare in the field of biomedical science in Korea. Two years later there was a major revision of the Korean Animal Protection Act (APA) that included the Three Rs concept of replacement, reduction, and refinement. That was extended in 2011 with stricter regulations and increased fines for violations of the law. The changes were still not seen as tight enough by some organisations and an ad hoc committee comprising members of the National Assembly, the Green Party Korea, and Korea Animal Rights Advocates (KARA) is currently looking at further revisions to create the Animal Welfare Act, that is expected to be finalised by the end of 2013. Together with the 2009 Laboratory Animal Act (LAA), regulations have strengthened the responsibilities of the government and local authorities on matters relating to animal protection and humane animal use.


Friends of ☺ FRAME Friends of FRAME is a group of devotees who support FRAME through regular donations and by helping to spread the word about FRAME’s mission. They are not part of our commercial support network, but individuals who believe in what we do, and want to help in whatever way they can. We are always grateful to them for the backing they give us.

On your bike!

Michelle’s maternity

FRAME Patron David Greenaway, Vice Chancellor of Nottingham University, has taken part in a 1,100 mile cycle ride covering the capital cities of the UK and Republic of Ireland, to raise funds for Stroke Rehabilitation Research.

One of FRAME’s longest serving members of staff is expecting a baby. Scientific Programme Manager Michelle Hudson-Shore married husband Danny last year and the couple spent an extended honeymoon in Australia. “It was perfect news when we confirmed earlier this year that I was going to have a baby,” she said. She knows she is expecting a little boy. “We weren’t sure whether we wanted to know in advance but when I went for my scan I noticed by accident. I’m really pleased, and so is Danny.” She plans to spend her maternity leave enjoying motherhood but will be back in the office next year. Michelle has worked as part of FRAME’s scientific staff for nine years.

The team of 12 riders who took part hope to raise £300,000 to fund aftercare for stroke survivors and research into how best to help survivors deal with the sometimes severely debilitating effects of strokes.

To join Friends of FRAME send £20 and your name and address to: 96-98 North Sherwood Street Nottingham NG1 4EE

Average yearly charity donations A survey of more than 28,500 UK residents has shown that more than half give less than £50 a year to charity. Even among those who give more, the average is only £303. The study was carried out on behalf of New Philanthropy Capital, an advisory group that supports and advises charities. When asked why, 60% of those who gave less than £50 said financial reasons were the main limiting factor. In the higher income bracket, a quarter of those asked said they distrusted charities. Around a fifth said they would be prepared to switch support to a different charity if it tied in better with the areas they cared about. Among the people who give no money at all to charities, indifference was blamed for 3% of low income individuals and 13% of high earners.

FRAME News October 2013

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Omega 3 supplements don’t prevent heart attacks A new human volunteer study suggests that taking omega-3 oil supplements does not help prevent heart attacks. Researchers investigated data from more than 12,500 people who took part in a prevention study in Italy over a period of five years. The results showed no improvement in hospitalisation or death levels among those taking a supplement, compared with patients who took a placebo. The study, carried out by a group of researchers at the IRCCS–Istituto di Ricerche

Farmacologiche Mario Negri in Milan, took no account of participants’ eating habits, only whether they took a 1g supplement of n-3 fatty acid, compared with those who were given an olive oil placebo. The results were published in the New England Journal of Medicine. Roncaglioni, M C et al. 2013 n–3 Fatty Acids in Patients with Multiple Cardiovascular Risk Factors N Engl J Med 2013; 368:18001808 May 9, 2013 DOI: 10.1056/NEJMoa1205409

Mouse reduction Scientists who work with laboratory mice have been shown how to reduce the number of animals they use in their work by FRAME trainers. As part of a two-day training course in Cambridge, FRAME staged a session based on the highly successful experimental design schools. Called “Managing Mouse Colonies: Genetics, Breeding and Welfare” the course was held jointly by the RSPCA and Wellcome Trust. It was aimed at those working with genetically altered rodents and around 30 delegates from universities and commercial laboratories throughout the UK and Europe took part.

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FRAME News October 2013

FRAME’s training schools demonstrate how careful experimental design and effective statistical analysis can combine to reduce the number of animals required to provide data. There have been several schools run around the UK and Europe, and elements have since been incorporated into training modules at various universities. The session during the Cambridge course was run by FRAME Scientific Programme Manager Michelle Hudson-Shore and Dr Derek Fry of the University of Manchester. Michelle said: “It went very well and the delegates asked some very pertinent questions.”

Fruit fly blast model A team of researchers from Virginia, USA, is investigating a new model for blast injuries that should help reduce the number of mammals needed for future studies. Existing models require the use of mammalian species, but the new one uses the fruit fly Drosophila. Fruit flies have been used in several

models of other human diseases, particularly those involving neurodegenerative disorders such as Parkinson’s and Alzheimer’s diseases. One of the researchers, Dr Beverly Rzigalinski, from the College of Osteopathic Medicine at Blacksburg, Virginia, told FRAME: “Over the years, research has found that Drosophila models may be used to effectively mimic many human diseases. Although they cannot completely represent the human state, nor can they reproduce mammalian models 100%, Drosophila does provide a good starting point. “Development of the Drosophila model for blast has the potential for providing a high-throughput model for studying numerous biochemical facets of traumatic brain injury rapidly, across a lifespan of an organism, and in large numbers – difficult to do in existing rodent models. Once fully developed, this model will permit researchers to hone in on pathways, biomarkers or drug candidates in a relatively costeffective model in which large numbers can be generated, allowing for more focused studies in mammalian models – reducing the numbers of mammalian species required for testing.”


FRAME Gifts

Notelets Handy notelets in packs of 5, with envelopes. Six different designs: our brand new ‘compliments of the season’ set, plus there are new pictures in the animals and flowers sets as well as birds, fairground or countryside scenes. For the special offer simply mark how many of each design you would like and put the cash total into the ‘offer’ line on the order form. Notelets £2 a pack or 3 packs for £5

Tote bag This natural cotton shopper is sturdy enough to carry your shopping but light enough to keep in a handbag. Tote bag £4.50

FRAME Stickers Three sheets of 35 useful stickers. £1.50

New

Dogs Notepaper A5 with two dog designs. 24 sheets and 20 envelopes. £2.50 a pack

Window Sticker Self cling sticker for car or house. Can be repositioned. £1.75

Key ring Handy key ring with detachable pound-sized token for use in shopping trolleys and lockers. Trolley token keyring £3

Bubbles pad A6 size, 50 page notepad with bubbles pattern. Bubbles notepad £2

Pens Three environmentally friendly pens made from recycled plastic. Be greener with FRAME. Set of 3 pens £2

Woodland Notepaper 20 A4 sheets and 20 envelopes with woodland design. £2.50 a pack

Silk Tie Travel wallet Perfect for travel passes, bus or rail tickets, this travel wallet can even carry banknotes. Travel wallet £2

100% silk tie featuring the FRAME bunny among lettuces. £13.50

FRAME News October 2013

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(October 2013)

Order Form Item

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The Gift Aid scheme allows charities to reclaim tax paid on money we receive from UK taxpayers.

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Basic rate income tax is currently 20 per cent, so that means that if you give £10 using Gift Aid, it’s worth £12 to us, without costing you anything extra.

Notelets offer (3 packs) £5.00

You will find a Gift Aid declaration below. Please consider a donation and allow us to reclaim the tax you paid on it.

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Gift Aid Declaration

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I understand the charity will reclaim 25p of tax on every £1 that I have given.

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Please treat any future gifts I make to FRAME as Gift Aid donations. Please treat any past donations I have made to FRAME as Gift Aid. Please tick all relevant boxes and enter the amount. Signed:

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I confirm that I am a UK Income or Capital Gains taxpayer. I have read this statement and want FRAME to reclaim tax on the donation detailed below, given on the date shown. I understand that I must pay an amount of Income Tax and/or Capital Gains Tax in the tax year (April 6 one year to April 5 the next) at least equal to the amount of tax that all the charities and Community Amateur Sports Clubs I donate to, will reclaim on my gifts for that tax year. I understand that other taxes such as VAT and Council Tax do not qualify.

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Send your completed order form to: FRAME, 96-98 North Sherwood Street, Nottingham, NG1 4EE with a cheque for the final total.

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FRAME News October 2013


FRAME Dogs in Annual lecture This year’s FRAME Annual Lecture will tackle the topic of the use of dogs as laboratory animals. The speaker is Dr Jarrod Bailey, science advisor and consultant to a number of animal protection organisations in Europe and the USA. His lecture “An Analysis of the Use of Dogs in Testing Drugs Intended for Humans” will address the problems of using dogs as a model for treatments for human diseases. The lecture will be held, appropriately, at the Kennel Club in London. The venue can accommodate only a limited number of guests, so admission is strictly ticket only, and the event is already fully booked. However, FRAME hopes to make a video of the lecture available online soon after it takes place.

and the use of

Laboratories

terms of regulatory toxicity testing? It cited figures from 1997, when 7,490 scientific procedures were carried out on dogs in the UK. The report said: “The use of the dog in regulatory toxicology represents a considerable expenditure of animal life with the attendant moral dilemmas that this creates. It also causes serious animal welfare concerns. Toxicity testing in itself causes suffering, but this is further compounded in the case of dogs in that their behavioural and

An historic perspective FRAME has been concerned for many years about the use of dogs in laboratory experiments. In 1999 it carried out a joint study, with the RSPCA (Royal Society for the Prevention of Cruelty to Animals), into their use in regulatory toxicity testing of pharmaceuticals. The study focused on toxicity tests because that was where the majority of dogs were used at the time. It aimed to address questions on the need for and validity of using dogs as the second species in such tests. It said: i) is the routine use of the dog justified? ii) what replacement alternatives could be implemented? iii) what reduction alternatives could be implemented, and iv) how should the cost/benefit assessment under the 1986 UK Animals (Scientific Procedures) Act be interpreted in

psychological needs - for extensive exercise, environmental stimulation and structured interaction with humans — are especially difficult to accommodate within a laboratory environment.” Regulations state that pharmaceutical tests should be carried out on at least one rodent and one non-rodent species before human trials begin. Dogs have been used as the ‘second species’ in toxicity testing for many years. The reasons given for the choice of dog as second species are both practical and scientific. Dogs are easy

to handle, a convenient size, and there is a considerable database of previous investigations on them. Scientific reasons include their contribution to the identification of effects that could be relevant to humans, including potential ocular and cardio-vascular problems. Their use, it is claimed, leads to better prediction of safe levels of exposure in humans. The 1999 study looked at published literature and showed that, in the majority of cases, adverse effects seen in dogs had already been identified in rat studies, and that, 92% of cases using dogs did not provide any additional relevant information on drug toxicity. Since the publication of that report there have been a number of changes. The 1986 Act has been overtaken by European Directive 2010/63/EU. The latest statistics issued by the UK Home Office show that dog use increased in 2012. A total of 4,843 procedures were carried out on 3,214 animals, compared with 4,552 procedures on 2,865 animals in 2011. The 2012 statistics show that a large proportion (78%) of the total procedures involving dogs were done for toxicology reasons, mostly for pharmaceutical safety and efficacy evaluation. Broadhead, Caren L, Jennings, Maggy & Combes, Robert D (1999). A Critical Evaluation of the Use of Dogs in the Regulatory Toxicity Testing of Pharmaceuticals. FRAME & RSPCA Anon. 2013 Annual Statistics of Scientific Procedures on Living Animals Great Britain 2012. Home Office

FRAME News October 2013

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Home Office Statistics of Scientific Primary purpose of experimental procedures on animals in 2012 100

Other 1% Human medicine or dentistry 12%

90

Once again the Home Office Statistics of Scientific Procedures on Living Animals have disappointingly shown an increase. In spite of regulations that state alternatives should be used wherever they are available, the number of procedures carried out on animals in UK laboratories goes up each year.

Veterinary medicine 4% 80

70

Fundamental biological research 32%

60

50

Protection of man, animals or the environment 3%

40

30

Breeding 48% 20

10

The 2012 figures are slightly misleading, in that the reason for the rise is entirely explained by the dominance of genetically altered (GA) animals. The definition, as used in the statistics, includes genetically modified animals and those carrying harmful mutations. Breeding GA animals rose from 43% to 48% of all procedures and they were involved in 59% of the total number. If breeding was not included, the actual total of procedures would have fallen by 2%. The statistics for 2012 show that just over 4.1 million procedures were conducted on 4.0 million animals. This is 8% more than in 2011, and exceeds the highest number of procedures conducted since the Animals (Scientific Procedures) Act 1986 (ASPA) came in to force ― 45% more procedures than the smallest number ever conducted, in 2001. The main types of animals used were mice, fish and rats, which together were involved in 94% of all the procedures. In contrast primates, cats and dogs account for 0.1% of procedures. The largest increases in procedures in 2012 involved primates (up 22% to 3,020), mice (up 14% to 3,058,821), guinea-pigs (up 10% to 12,740) and dogs (up 6% to 4,843). Notable decreases were in procedures involving reptiles and amphibians (down 13% to 14,210), fish (down 11% to 500,830) and rabbits (down 10% to 13,866).

Primates 0 “Other” includes education, training, forensic enquiries and direct diagnosis.

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FRAME News October 2013

FRAME is disappointed that figures for procedures on non-human primates have risen. Although work using great apes has not taken place in the UK for many years, and their protection was enshrined in law last year, a significant number of

Changes in numbers of experimental procedures involving animals, from 2011 to 2012 Number of procedures 2012

Change from 2011 (%)

Mouse Rat Guinea-pig Other rodent Rabbit Cat Dog Ferret Other carnivores Pig Sheep Cattle Other ungulate Primate Other mammal Bird Reptile/ amphibian Fish

3,058,821 278,386 12,740 5589 13,866 247 4843 348

14.1 2.5 10.4 –12.6 –10.3 5.1 6.4 –49.6

713

–10.3

3379 42,871 5482

–59.7 13.7 7.4

10,217

14.9

3020

22.0

533

–2.2

153,933

–5.3

14,210

–12.8

500,830

–10.9

Total

4,110,028

8.3

Animal type

procedures are carried out on monkeys every year. The 2011 figures showed an encouraging drop of 47%, but that trend has changed and the 2012 numbers rose 22% to 3,020. In the context of the overall animal experimentation numbers, the use of primates appears minimal, accounting for only 0.1% of all procedures. However, using primates in laboratories is particularly worrying because of their nature. These highly intelligent animals have a level of sentience and social awareness that make the costs to them of experimentation and captivity very high. Because they are often the last species used before human trials, they are subjected to quite severe procedures and are used as models for very serious diseases.


Procedures on Living Animals 2012 Numbers of experimental procedures performed and numbers of animals used in Great Britain since 1987

FRAME has always been concerned about the use of GA animals in research, for a number of reasons. Although techniques used to produce them are improving, some methods are still relatively inaccurate and create a huge number of animals that do not have the necessary genetic alteration an investigation calls for. A large proportion of the resulting animals are therefore bred and killed, without serving any other purpose. A small number might provide tissue for other experiments, but most are simply a waste by-product. There is also potential suffering for the animals involved, both from the techniques used to produce genetically altered animals, and from the results of the mutations they carry. Some members of the breeding stock will be raised to adulthood and used to produce the next generation, even though the genetic modification they carry might be painful and distressing. It is also important to realise that, even with genetic alteration, a mouse is still a mouse, or a fish is still a fish. They can never provide a fully accurate model for any human disease. FRAME believes that more emphasis should be placed on searching for valid, nonanimal methods, rather than giving priority to creating a great many new genetically modified animal models.

1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 year

Concerns over GA

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 0

1

2 millions

= number of procedures;

3

Future Annual Statistics European Directive 2010/63/EU requires EU Member States to collect and publish statistics on animal experimentation in a common format. To comply with this requirement the UK Home Office plans to replace the current data collection system. FRAME responded to a consultation on the proposals earlier this year, but no response has been released yet. The new proposals left several gaps, which FRAME argued should be retained. They included: information on the production of biological materials and detailed data on breeding GA animals. The new statistics will require licence holders to report the actual severity that animals have encountered. Animals will now be counted at the end of procedures. Current statistics report animals at the start of a procedure and severity is estimated, so the new system will provide much more accurate information on animal welfare, but may lead to some initial double counting. The timetable for implementation is as follows: From 1 January 2013 establishments must collect information on regulated procedures started and begin to collect data on the actual severity of procedures completed. In January 2014 the data collected for 2013 animal use (but not severity) must be submitted to the Home Office. These will then be published in the same format as the present statistics. From 1 January 2014 establishments must collect data on regulated procedures completed including actual severity. In January 2015, data for 2014 animal use and actual severity must be submitted to the Home Office, then be published in the new format. The figures must be given to Parliament and sent to the European Commission by 10 November 2015.

4

= number of animals.

Numbers of animals used in procedures were not reported in the annual statistics until 1990. The number of animals used each year is less than the number of procedures, as some animals may undergo more than one procedure, e.g. having a compound applied and then having a blood sample taken.

A more detailed report and comment on the 2012 statistics will appear in FRAME’s journal ATLA 41(4). FRAME News October 2013

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New Essay Competition FRAME has launched a new essay competition aimed at 16 to 19-year-olds. The theme of the competition is: “What are the alternatives to using animals in laboratories?” and there are three cash prizes for the best entries: £300, £200 and £100. The best works could also be published in one of FRAME’s scientific journals, Alternatives to Laboratory Animals (ATLA) and Perspectives in Laboratory Animal Science (PiLAS). More than 450 schools with sixth forms have been invited to take part, but entries do not have to be made through a school. Anyone resident in the UK and aged between 16 and 19 on the closing day of January 12, 2014. Essays should be between 750 and 1000 words and written, typed

Members of the media and entertainment worlds who have contributed to public awareness of animal protection matters are to be honoured at a gala next Spring. Nominations are being collected for the Genesis Awards, an annual event held by the Humane Society of the United States (HSUS). The awards honour individuals from the television, film, print, and music industries, as well those producing more specialised works.

or printed, single-sided on A4 paper. The topic should be related to the question “What are the alternatives to laboratory animals?”. It can be the author’s views on the subject, new developments in the field of alternatives, the ethics of using animals in experiments, the laws governing their use in scientific procedures, or any other aspect of laboratory animal science. Full instructions, entry form, terms and conditions can be found on the FRAME website at www.frame.org.uk. The competition is designed to raise awareness of the subject among young people. FRAME Scientific Programme Manager Michelle Hudson-Shore said: “If non-animal experiments are ever going to become mainstream it is important to inspire a new generation to think beyond traditional science, and to support more effective and more relevant methods that use fewer or no animals in the laboratory.”

Until relatively recently in the USA, animal abuse and exploitation received only scant attention in mainstream media. But stories of animal use and abuse, including factory farms, puppy mills, animal fighting, and animals used in research, are increasingly covered by newspapers, TV, online, and in many areas of entertainment such as movies and drama series. The awards are overseen by the HSUS Hollywood Outreach

Program. Its call for nominations said: “It isn’t just big news stories that we recognize and celebrate, it’s movies, documentaries and all categories of TV programming which, by incorporating animal protection themes or messages into their storylines, help increase public consciousness, reminding us that compassion for animals is one of our core human values.” Awards will be presented at a gala event in Beverley Hills, California next March.

Genesis Awards

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FRAME News October 2013


Dorothy Hegarty Award A chip modelling interconnected organs and their blood supply. This type of model could be used for drug testing or toxicity tests.

Every year FRAME presents The Dorothy Hegarty Award for the best article published in ATLA. The prize for volume 40, 2012, was presented to Uwe Marx, Silke Hoffmann, Gerd Lindner, Reyk Horland and Roland Lauster (Department of Biotechnology, Technische Universität Berlin, Germany), Heike Walles (Universität Würzburg, Germany), Frank Sonntag and Udo Klotzbach (Fraunhofer-Institut für Werkstoffund Strahltechnik IWS, Dresden, Germany), Dmitry Sakharov (SRC Bioclinicum, Moscow, Russia), and Alexander Tonevitsky (Moscow State University, Russia). Their paper, ‘Human-on-a-chip’ developments: A translational cutting-edge alternative to systemic safety assessment and efficiency evaluation of substances in laboratory animals and man?, appeared in ATLA 40, pp. 235– 257.

Abstract Various factors, including the phylogenetic distance between laboratory animals and humans, the discrepancy between current in vitro systems and the human body, and the restrictions of in silico modelling, have generated the need for new solutions to the ever-increasing worldwide dilemma of substance testing. This review provides a historical sketch on the accentuation of this dilemma, and highlights fundamental limitations to the countermeasures taken so far. It describes the potential of recentlyintroduced microsystems to emulate human organs in ‘organon-a-chip’ devices. Finally, it focuses on an in-depth analysis of the first devices that aimed to

mimic human systemic organ interactions in ‘human-on-a-chip’ systems. Their potential to replace acute systemic toxicity testing in animals, and their inability to provide alternatives to repeated dose long-term testing, are discussed. Inspired by the latest discoveries in human biology, tissue engineering and microsystems technology, this review proposes a paradigm shift to overcome the apparent challenges. A roadmap is outlined to create a new homeostatic level of biology in ‘human-on-a-chip’ systems in order to, in the long run, replace systemic repeated dose safety evaluation and disease modelling in animals. FRAME News October 2013

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FRAME’s new Life President

FRAME has awarded the title of Life President to its long-time Chairman Professor Michael Balls. He resigned from the FRAME Trustees in early summer, for personal reasons. There have been many messages of appreciation for his work over many years in the field of alternatives to animal experiments. Professor Balls has been associated with FRAME since 1979 and during that time has played a significant part in promoting the Three Rs (Replacement, Reduction and Refinement) to the scientific community. He was instrumental in the drafting and passage through Parliament of the Animals (Scientific Procedures) Act 1986 and has received many awards and honours for his work in the search for alternatives to laboratory animals, both in the UK and overseas. The FRAME Trustees presented him with a computer and a crystal decanter in honour of his long service. Dr Anna Cadogan is now Chair.

Book success An online version of a text book FRAME collaborated on has been downloaded more than 2,000 times. The book, called New Technologies for Toxicity Testing, is published jointly by Landes Bioscience and Springer in America and Germany. It is a collection of chapters offering insights into new toxicity testing strategies and techniques, written by leading researchers. It was made available online after its publication in February 2012, and since then there have been 2,446 chapter downloads, putting it in the top 25% of downloaded eBooks in its sector. A notice from Springer said: “The electronic version reaches a broad readership and provides increased visibility for the work. This is especially noticeable in the long run: statistical data shows that the usage of electronic publications remains stable for years after publication, so this is what we can expect for the book for the years to come.” The book has its own homepage on Springer’s website, where researchers, journalists, editors and bloggers can see a preview, download the book, or order a hardcover copy. The new methods described in the book broaden the range of testing techniques and improve sensitivity of experiments, both in vitro and in vivo, hence providing helpful information that will reduce the number of laboratory animals required. The book was edited by FRAME’s Honorary Life President Professor Michael Balls, and two former staff, Dr Robert Combes and Dr Nirmala Bhogal. 16

FRAME News October 2013

Exercise causes fat cell changes Researchers in Sweden have thrown new light on how exercise helps to prevent type II diabetes. A team from Lund University studied a group of slightly overweight but healthy men in their mid-thirties who had never previously taken regular exercise. The men were asked to attend spinning and aerobics classes three times a week and then tests were carried out on their DNA to try to identify any effects. The team found that methyl groups attached to the DNA, which help determine gene expression, underwent changes. It is believed that the changes affect how the body stores fat, which in turn determines the risk of obesity-related diseases such as diabetes. The changes were noted even though the men attended only an average of 1.8 exercise sessions a week. The findings have since been confirmed in vitro by studying cell cultures.


FRAME News 71 - 2013