FRAME News October 2012
FRAME News Fund for the Replacement of Animals in Medical Experiments Editor: Anne Jeffery FRAME is launching a new initiative aimed at improving the quality of discussion about issues raised by animal experimentation and the Three Rs. Called Perspectives in Laboratory Animal Science (PiLAS), it will take the form of a stand-alone supplement in FRAME’s scientific journal ATLA (Alternatives to Laboratory Animals) and a new website, www.atla.org.uk, starting this month (October). No. 69 October 2012 New Forum for Three Rs Discussion INSIDE... The Three Rs around the world Dorothy Hegarty Award The move will offer professionals in all relevant fields an opportunity to share their expertise, knowledge and ideas concerning the scientific, ethical, economic and logistical aspects raised by laboratory animal use. Professor Michael Balls, Chairman of FRAME Trustees, said: “Discussions in the media on many important issues are all-too-often of an unacceptably low standard. As a result, opinions are formed, policies are determined, and actions are taken on an inadequate basis, which can lead to regrettable outcomes and the need to take costly remedial steps. “This also applies to the use of laboratory animals as human models, and alternative approaches that could reduce or obviate the need for such use. At the moment, particular issues of concern involve the international transport of animals destined for laboratory use and the use of great apes as laboratory animals, both of which have aroused conflicting and strong responses, but have not been given the quality of discussion they need and deserve.” Those are two of the many topics that will be covered in the new supplement, under these headings: Opinion; Current Dilemmas; Indepth Discussions; The Wisdom of Russell and Burch; Points of View; News; Comments and Feedback. Full details of other issues to be discussed can be found in ATLA 40 (3). 2 3 4 5 FRAME and Parliament The Björn Ekwall Memorial Award FRAME helps with new text book Human fetal tissue use — FRAME’s view ‘Cruelty free’ misinterpreted New methods in asthma research Home Office statistics 2011 News from the FAL News in brief Corporate support 5 6 6 7 8 10 11 12 PiLAS has been made possible by a grant from the Phoebe Wortley Talbot Charitable Trust, which is gratefully acknowledged. FRAME News http://www.frame.org.uk The Three Rs Around the World Trans-Atlantic Differences in Three Rs Driving Forces A new report has highlighted the different driving forces in academic study of alternative, non-animal methods in Europe and the USA. It is based on information gathered during the 8th World Congress on Alternatives and Animal Use in the Life Sciences last year. The authors found that, while industrial driving forces were similar on both sides of the Atlantic, the academic influences varied. In industry, both continents were influenced by the ethical, scientific, and economic need to reduce and eventually replace the use of animal models in toxicity testing. Academics also faced economic forces that differed between continents. The European Commission and a number of EU Member States have active policies for financing programmes directed towards the Three Rs application in toxicology, but in the USA the sources for financing academic research in this area are limited. Academic research in Europe needs to comply with legislation for the protection of animals used for scientific purposes, and requires approval by national government evaluation committees. In the United States, legislation and regulation related to alternatives to animals was not considered a primary driver for the implementation of Three Rs alternative methods. The author team was led by Chantra Eskes of Services & Consultation on Alternative Methods (SeCAM) in Switzerland. The authors also represent the following institutions: Physicians Committee for Responsible Medicine, USA; Marilyn Aardema Consulting, USA; Free University of Berlin, Germany; Institute for In Vitro Sciences, USA; VITO, Belgium; Vrije Universiteit Brussel, Belgium; and Institute for Risk Assessment Sciences, Utrecht University, The Netherlands. The full report can be found at: http://www.altex.ch/ resources/205209_ Eskes3.pdf Translation of The Principles into Japanese The seminal book that first set out the principles of eliminating the need for animals in laboratories has been translated into Japanese. Noriyuki Kasai, Professor Emeritus and Guest Professor, Tohoku University Center for Laboratory Animal Research and The Institute for Animal Experimentation, Tohoku University Graduate School of Medicine, Japan, spent five months on the initial translation, but his work was interrupted by the earthquake that hit Japan in 2011. Tohoku University and its animal facility are close to the centre of the disaster. The Principles of Humane Experimental Technique, by William Russell and Rex Burch, described the ideas of the Three Rs, replacement, reduction and refinement, which form the basis of FRAME’s work today. The translation is published by Adthree Publishing Company Ltd, 4-27-37, Higashinakano, Nakano-ku, Tokyo 164-0003, Japan. Attitudes to Animal Use in Medical Education in Southern India Animals), they A study of medical research in southern Indian universities has revealed significant differences in attitudes to animal use at undergraduate and post-graduate levels. In India, animal experiments play an integral role in both undergraduate and post-graduate medical education in the discipline of pharmacology. A team led by Syed Ilyas Shehnaz of the Department of Pharmacology, Gulf Medical University, Ajman, United Arab Emirates (UAE), compared the perceptions of pharmacology faculty members in southern India, regarding the use of animal experiments and alternatives at both levels. They found more support for animal use in postgraduate education. Writing in FRAME’s scientific journal ATLA (Alternatives to Laboratory called for increased awareness of alternatives in medical education. Their report said: “Animal experiments have traditionally been an important tool in the training of undergraduates and postgraduates in the discipline of pharmacology in India. Research has shown that the use of alternatives to animal experiments in undergraduate teaching, such as simulated clinical trials or computer simulation models, can circumvent most of the problems associated with animal experiments, while achieving equivalent learning outcomes. “As the views of teachers have a strong bearing on the implementation of the curriculum, the results obtained in our study might help improve the postgraduate and undergraduate curricula that are followed in medical colleges of India.” 2 http://www.frame.org.uk FRAME News DOROTHY HEGARTY AWARD 2011 The 2011 Dorothy Hegarty Award has been won by a team from the Institute of Pharmacology, Toxicology and Pharmacy, University of Veterinary Medicine, Hannover, Germany. Professor Wolfgang Bäumer, Dr Stephan Schumacher, Dr Jessica Stahl and Professor Manfred Kietzmann received the award for their paper, The Use of an In Vitro-cultured Porcine Nasal Mucosa Model for the Biocompatibility Assessment of Biodegradable Magnesium. The Award is presented annually to the authors of the paper published in the previous year’s volume of FRAME’s scientific journal, ATLA, which, in the opinion of the members of the Editorial Board, is likely to make the most significant contribution to the reduction, refinement and/or replacement of animal experimentation. Each member of the ATLA Editorial Board is entitled to make up to five nominations for the Award. As in previous years, a large variety of papers were nominated, reflecting the diversity of the work published in ATLA, and the wide range of interests of the members of the Editorial Board. Dr Stephen Schumacher updated FRAME on the progress of the team’s work: “The idea originated from an interdisciplinary research project within the Collaborative Research Centre 599 (SFB 599) funded by the German Research Foundation. The centre is dedicated to the development of innovative new biomedical implants, and one of its aims is the production of a biodegradable magnesium alloy stent for the treatment of chronic rhinosinusitis. “The project is designed in a way that allows for stepwise elimination of unsuitable implant materials. The process starts with material science testing, followed by a variety of biological in vitro test systems of increasing complexity, one of which is the nasal mucosa model. Then preclinical studies are initiated. By this means, unnecessary animal experiments can be avoided. Results obtained at each stage are fed back to the material scientists thus continuously improving the implant development from the very beginning. “We are currently working with a complementary porcine nasal epithelial cell model in order to gain better insight into the cellular and molecular processes occurring at the tissue–implant interface and the mechanisms underlying less than ideal biocompatibility.” Abstract Stephan Schumacher, Jessica Stahl, Wolfgang Bäumer and Manfred Kietzmann. The Use of an In Vitro-cultured Porcine Nasal Mucosa Model for the Biocompatibility Assessment of Biodegradable Magnesium. ATLA 39, pages 261–271. The development of an in vitrocultured porcine nasal mucosa model is described. The model was subsequently used for the biocompatibility testing of resorbable magnesium-based implants, which are intended for use in the nasal cavity of patients with chronic rhinosinusitis (CRS). Test specimens made from either pure magnesium or titanium were incubated with the mucosal tissue for 48 hours. Afterwards, tissue viability, PGE2, IL-6 and IL-8 release, magnesium ion release, succinate dehydrogenase activity, apoptosis and 14C amino acid incorporation, were determined. The results suggested favourable biocompatibility, even in the case of rapidly-degrading pure magnesium. However, presumed effects on protein synthesis and apoptosis could not be confirmed. Prof. Dr Wolfgang Bäumer Dr Stephan Schumacher Dr Jessica Stahl Prof. Dr Manfred Kietzmann The award is named after Mrs Dorothy Hegarty who co-founded FRAME in 1969 with biologist Dr Charles Foister. In its very early days, FRAME was run from Mrs Hegarty’s home, in Wimbledon. FRAME News http://www.frame.org.uk 3 FRAME AND PARLIAMENT APPRG registered Between 1981 and 2010 there was an All Party Parliamentary FRAME Group (APPFG), which was particularly influential during the passage through Parliament of what was to become the Animals (Scientific Procedures) Act 1986. from the Main Opposition Party, and one other member, with Nic Dakin as Chair, Annette Brooke, Diana R. Johnson and Henry Smith as ViceChairs, Baroness Smith of Basildon as Treasurer, and Jim Dowd and Fabian Hamilton as Secretaries. The aim of the Group is to promote the replacement of animal procedures in medical research and safety testing by scientifically proven, relevant and reliable nonanimal methods, in the best interests of both human beings and animals. then Under Secretary of State at the Home Office. A mutually beneficial line of communication has also been established between the Group and the Home Office. A number of issues were raised on behalf of the Group in correspondence with the Minister, and, in particular, questions related to the transposition of Directive 2010/63/EU into UK law. This transposition has dominated Government thinking during 2011– 2012, and will continue to do so into 2013, in view of the forthcoming discussions on the new legislation necessary for the transposition, and the publication of the related Guidance and Code of Practice. Great apes The Group was successful, in collaboration with FRAME and the BUAV, in contributing to the persuasion of the Government to reverse its proposal to transpose from the Directive, without modification, clauses that would have left open the possibility of using great apes as laboratory animals in the UK. Nic Dakin, Chair of the Group, had raised this point during a Westminster Hall adjournment debate, which was followed by further correspondence with the Minister, leading to her categorical assurance at a later meeting, that the ban on the use of great apes as laboratory animals in the UK would be on the face of the forthcoming bill. Nic Dakin In recent years rules were changed so that All Party Groups must be associated with issues, rather than with organisations, so after the 2010 General Election it was agreed that an All Party Parliamentary Replacement Group (APPRG) should be formed, for which FRAME would provide a Secretariat. The Group has now been entered into the Register of All-Party Groups. It has ten members from the Government Party, nine members Swift success The Group has succeeded in establishing a distinctive and constructive position in relation to the complex issues raised by animal experimentation and opportunities for its reduction, refinement and replacement. It has met four times during its first year, and, in addition, met Lynne Featherstone MP , 4 http://www.frame.org.uk FRAME News The Björn Ekwall Memorial Award models in toxicological The latest recipient of the Björn Ekwall Memorial Award is Horst Spielmann. Professor Spielmann is a long-time associate of FRAME, and is the European Editor of its scientific journal ATLA (Alternatives to Laboratory Animals). investigations. Professor Spielmann is being honoured in recognition of his outstanding scientific work in the field of in vitro toxicology. He has contributed considerably to developing methods aimed at reducing and replacing animals used in The award is made by The Björn Ekwall Memorial Foundation (BEMF), which was established in memory of Dr Björn Ekwall (1940–2000), a Swedish scientist in the field of cell toxicology and the founder of the Scandinavian Society for Cell Toxicology (SSCT). It marks achievements of outstanding scientists who have developed or used non-animal He is a member of several national and international boards and advisory committees involved in validation of in testing. vitro tests. He is also Honorary Professor of Regulatory Toxicology at the Free University of Berlin. Professor Spielmann has published more than 240 articles in peer-review journals, and written, edited or contributed to more than 100 books. New Text Book Three FRAME scientists have written a chapter in a new edition of a text book on pharmaceutical research. The book focuses on industrial pharmaceutical research. It is written by industry experts from around the world and discusses new methods of drug discovery and development. FRAME’s chapter is called Translation of New Technologies in Biomedicines: Shaping the Road from Basic Research to Drug Development and Clinical Application – and Back Again. It was written by Chairman of the FRAME Trustees Professor Michael Balls, Trustee and Director of the FRAME Alternatives Laboratory Dr Andrew Bennett, and Trustee Professor David Kendall. The chapter explains why models are needed to develop new drugs, what new technologies exist to help the search, and how existing knowledge supports the discovery. Specific topics include the use of stem cells, examples of in vitro systems, clinical imaging and tissue engineering. Professor Kendall said: “Drug discovery is becoming more difficult and costly as many of the more obvious approaches to therapy for some diseases have been exhausted, and many failures in drug development can be laid at the door of inappropriate testing in animals. The key in the future is to reconsider the sacred cow of animal testing and to increasingly employ human-focused, new technologies to develop medicines targeting individual human patients, rather than employing a one-size-fits-all strategy.” Pharmaceutical Biotechnology, Drug Discovery and Clinical Applications, edited by Oliver Kayser and Heribert Warzecha, is published by Wiley Blackwell, Weinheim, Germany. FRAME News http://www.frame.org.uk 5 FRAME Viewpoint: FRAME was recently asked for clarification of its stance on the use of tissues and cells from human fetuses Using human tissues avoids the ethical dilemma of experimenting on animals, as well as providing more relevant results for human medicine, but it raises issues concerning their source. Human cells and tissues must be obtained ethically and safely. Using the system of informed consent, that can happen when donors undergo surgery or biopsies, but a fetus cannot give such consent. It is assumed the enquiry related to the use of tissues obtained through voluntary termination of a pregnancy. Abortion can also be carried out for other reasons, including threats to the mother’s health or because the fetus has abnormalities that would give it no chance of survival. There is also the case of spontaneous abortion, or miscarriage. In that case, tissue donation can be beneficial to the mother because the cells will be put to some positive purpose. Tissue can also be obtained from unwanted embryos left over after in vitro fertilisation. (Test tube baby production) FRAME’s use of fetal tissues When the FRAME Research Programme was established in 1982, staff were involved in a multi-centre study using a cell line derived from a human fetus. The line was later withdrawn because of adverse publicity over its origin. At the time, most cell lines were obtained from embryonic tissues because it was the only available technique. FRAME has also used cells in past studies on skin irritation, which were derived from surgicallyremoved foreskins from children. Today the FRAME Alternatives Laboratory works on adult-derived human cells obtained from biopsies, in full compliance with strict ethical and safety procedures. Human stem cells Fetal tissue can also be a source of stem cells, a special kind of cells that hold the potential to become a range of different tissue types. Stem cells are also found in other tissues such as bone-marrow, skin and the liver. In the 1990s, mouse embryonic stem cell lines offered new research options, although they carried the same uncertainties over their relevance to human medicine as using any other animal cells. Since then it has become possible to isolate human embryonic stem cells, which can be used to create models of illnesses, such as cystic fibrosis, fragile X syndrome, and Huntington’s disease. This is still controversial because of their source, so the latest developments use stem cells from adult donors. That opens up the future possibility of creating both normal and damaged cells from healthy individuals and those with particular diseases, so that tests would give more-detailed and more-relevant results than ever before. Cruelty-Free Labels are Often Misinterpreted A US study has revealed that many consumers do not fully understand that a ‘cruelty free’ label on a product has no official meaning. Researchers from the Universities of Missouri and Oregon have called for a legal definition of cruelty free, after discovering that buyers did not realise that products carrying the claim could still have been tested on animals. Kim Sheehan, a professor in the University of Oregon School of Journalism and Communication, and Jooghwa Lee, a doctoral candidate at the University of Missouri, School of Journalism, carried out an online survey. They found that many consumers intentionally seek out products such as toiletries and cosmetics that carry the label and most are under the impression that no animals were used to manufacture or test them. Those who said they actively searched for products that carry the label were then given information about the range of standards covered by the description. After the anomalies were explained, most consumers said they were less supportive of the label. The study was presented at the American Academy of Advertising 2012 Annual Conference. 6 http://www.frame.org.uk FRAME News The Use Tissue in Admixed Embryos In 2007, when the Human Fertilisation and Embryology Bill was published, it included a proposal to permit the production of ‘admixed embryos’, by replacing the nuclei of animal eggs with human nuclei, in order to increase the availability of human stem cells for research on a wide range of human diseases, although it was not established that they were necessary for the production of human embryonic stem cells. It was argued, however, that many serious human diseases could not be understood or treated in any other way, and the Bill was passed. of Human Fetal Research FRAME’s Position FRAME believes that progress in understanding and treating human and animal disease, in providing products which are as a safe as possible to use, and in protecting the environment, must depend principally on the application of the best possible scientific principles and procedures, and on the development and effective and ethical use of modern scientific procedures. FRAME is not an animal welfare organisation, since we believe that the reduction, refinement and replacement of the use of laboratory animal procedures in biomedical research and testing is overwhelmingly the best way forward for humans, as well as in the interests of animal welfare. FRAME also knows that there is no escape from ethical dilemmas, because the solution of one problem inevitably raises others. FRAME considers it to be possible to provide human embryonic cells and tissues according to acceptable ethical standards. Nevertheless, we are delighted that the progress being made with the provision of tissues and cells, including stem cells, of post-natal human origin promises to end the necessity or desirability of using material of embryonic origin, and proud to be contributing to that progress. A more in-depth version of this statement was published as a Comment in FRAME’s scientific journal ATLA (Alternatives to Laboratory Animals) issue 40(1) and is available free online at the FRAME website. Reducing Animal Use in Asthma Research A University of Nottingham researcher has been awarded a national fellowship for her work to improve understanding of asthma, while using fewer animals in tests. Dr Amanda Tatler, in the University of Nottingham’s School of Clinical Sciences, has been given a David Sainsbury Fellowship from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). Her work aims to develop understanding of the mechanisms leading to structural changes in the airways of patients with severe asthma. She will use new methods that significantly reduce the numbers of animals, usually mice, traditionally used to study the disease. FRAME News http://www.frame.org.uk 7 The Home Office has published the latest Statistics of Scientific Procedures on Living Animals in Great Britain, revealing another increase in the number of procedures carried out. More than 3.79 million scientific procedures were started in Great Britain in 2011, a rise of 68,100, or 2%. This is the highest number of procedures carried out on animals in a year since the Animals (Scientific Procedures) Act 1986 (ASPA) came into force. Unlike in the previous decade, the increase is not exclusively due to breeding and use of genetically altered animals, although they are still the largest group at 1,617,813. The figures suggest a possible shift toward fundamental research becoming the primary cause of increases in animal experiments. The change for fundamental purposes is indicative of the continuing rise in experiments conducted in universities and medical schools, where 50% of procedures are now conducted. These include studies on cancer, genetics, immunology and physiology. In 2002, for the first time, the number of procedures conducted in universities and medical schools overtook the number conducted in commercial organisations. Since then, the gap between university-based procedures and commercial establishments has continued to widen. significant figures. The statistics document points out that the number of animals generally corresponds to the number of procedures, although, where an animal has recovered fully from a completed procedure and is used again, that is counted as a separate procedure. Therefore the number of animals used will always be slightly fewer than the number of procedures begun. Home Office Fundamental research The rise in fundamental research poses a specific challenge to implementing the Three Rs, and developing alternative methods to replace animal use. It is particularly difficult to replace fundamental studies with non-animal alternatives because of their exploratory and knowledge-acquiring nature. There is also the added complication of the competitive spirit of academic research which makes collaboration difficult. The search for alternatives in toxicology has been driven by regulatory changes, but it would take a complete ban on animal experiments to drive such innovation in fundamental research. A wide scale change in attitude is needed toward actively looking for alternatives, rather than just finding them as a by-product of other research. Legal requirement to publish statistics The purpose of the annual statistical report is to satisfy the requirement in section 21(7) of the Animals (Scientific Procedures) Act 1986 (ASPA) that the Secretary of State should publish and lay before Parliament each year, information about the use of protected animals in experimental or other scientific procedures during the previous calendar year. The statistics are compiled from returns, submitted by project licence holders at the end of each year, or on the termination of the licence when this occurs during the year. ASPA will be replaced in early 2013 when the European Directive 2010/63/EU is transposed into UK law. The Directive also carries a requirement that: ‘Member States shall collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.’ Toxicology and safety testing The number of procedures being carried out for safety testing and toxicology rose by 2% to a total of 399,000, mainly taking place in the commercial sector. Most of the toxicological procedures were conducted on rodent species and performed for pharmaceutical safety and efficacy evaluation. When toxicology procedures were carried out to meet legislative requirements the majority were done to meet a combination of such requirements. This means that there was less repetition of tests and signifies an improvement on historical practice. How the figures are defined Published totals in the Home Office summary refer to the number of procedures started, not the number of animals used. Figures are rounded to the nearest 1,000 or 100, or to two Breeding 43% Fundamental biological research 35% Primary Purpose of Experimental Procedures on Animals in 2011 Veterinary medicine 5% Human medicine or dentistry 13% Protection of man, animals or the environment 3% Other 1% 8 http://www.frame.org.uk FRAME News Statistics 2011 Use of non-human primates It is encouraging to see a fall in the number of procedures being carried out on non-human primates, although it remains to be seen whether this is the start of a trend or merely a hiatus. FRAME is very concerned about the use of non-human primates in research because of their high level of sentience. They are known to be able to remember events that cause them distress, and therefore can anticipate similar situations. The laboratory environment is also very damaging to them because it is unable to provide for their sophisticated social needs. These factors mean that they undergo high levels of suffering during medical and scientific procedures, and even their housing and general care can cause them intense stress. The fall in the number of procedures is mirrored by a reduction in the number of animals used. The total number of procedures using primates decreased by 2,213 from 4,688 in 2010 to 2,475 in 2011 (–47%) and the number of animals used fell by 1,190 (from 2,649 in 2010 to 1,459 in 2011 or –45%). This represents 752 fewer procedures on new world monkeys (430 fewer animals) and 1,461 fewer on old world monkeys (760 fewer animals). Re-use of primates However, it is of great concern that non-human primates are increasingly being subjected to reuse. Many must have undergone more than one procedure, because there were 1,016 more procedures than animals. Given their ability to remember distressing events this must be considered a worrying trend. A number of studies are currently under way to assess the degree of suffering that primates undergo as a result of cumulative procedures. Re-use has to be specially authorised by the Home Office, and is generally conditional upon the animal having suffered no significant adverse effects as a consequence of the first use. It is impossible to get more detailed information from the statistics on the nature of re-use and how many individual animals are subjected to it. SPECIES USED There were increases in numbers of procedures for several species, including cats (+26%), pigs (+37%), birds (+14%) and fish (+15%). Other species showed decreases, however, for example rats (–11%), guinea pigs (–16%), dogs (–21%) and non-human primates (–47% with new world monkeys –68% and old world monkeys –41%). By far the commonest species used, representing 71% of the total, was mice. Fish accounted for 15%, rats 7% and birds 4%. This is similar to recent years in that these groups represent the four most often used species. However, the levels of use have changed. Mice numbers are up from 68% of the total. As the use of mice has increased use of rats has continued to decline. The continued change in 2011 is the latest in a trend that started in 1995. The birds category contains several species but domestic fowl account for the largest proportion at 92% of procedures carried out on them. The combined totals for dogs, cats and non-human primates add up to less than a quarter of 1% of the number of procedures started in 2011. Percentages can be misleading, however, because the actual number of animals involved is often not apparent from the figures. Procedures on cats, for example, showed a 26% increase but the change represents 48 events. Meanwhile, a 15% increase in procedures on fish actually involved a rise of 72,959. Percentage Changes in Experimental Procedures Involving Animals, from 2010 to 2011 No. of procedures 2011 2,679,763 271,535 11,537 6,398 15,461 235 4,552 691 795 8,380 37,714 5,102 8,895 2,475 545 162,618 16,298 562,245 3,794,787 % change from 2010 +0.4 –11 –16 +2 +4 +26 –21 –13 +3 +37 –0.2 +42 +5 –47 –55 +14 +6 +15 +2 Animal Type Mouse Rat Guinea pig Other rodent Rabbit Cat Dog Ferret Other carnivores Pig Sheep Cattle Other ungulate Primate Other mammal Bird Reptile/amphibian Fish Total FRAME News http://www.frame.org.uk 9 FRAME LABORATORY HELPING IN BREAST CANCER RESEARCH The FRAME Alternatives Laboratory (FAL) is collaborating on research that could lead to a simple test to determine the best course of treatment for women with breast cancer. Improving patient outcomes “Giving chemotherapy to a patient who will not benefit from it delays other treatments that would be more helpful. If it was possible to predict whether or not chemotherapy would be effective it would benefit outcomes for all patients, as well as saving time and money. There is still much work to be done, but ultimately this research might lead to a simple blood test that will predict how a woman would respond to chemotherapy.” Doctors have found that some women benefit from chemotherapy while others show little or no response to the treatment, and it could improve clinical outcomes if it was possible to tell in advance what the effect on an individual might be. The FAL has considerable expertise and experience in investigating the make-up of DNA and gene expression (the way that genes determine a person’s physical characteristics). As a result, the Medical School group approached the FAL for its assistance. Genetic source Research being carried out by Professor Oleg Eremin from the Division of Surgery at the University of Nottingham Medical School, has suggested there could be a genetic reason for the different responses and the FAL is helping to discover its exact nature. Expertise Director of the FAL Dr Andrew Bennett said: “We have a great deal of expertise in this area and we are increasingly being asked to collaborate on projects such as this. With our skills and equipment we can carry out tests on a large number of samples quickly and effectively, and so produce useful and reliable data.” Using samples donated by patients undergoing chemotherapy for breast cancer, the lab has demonstrated that there are two distinct forms of gene expression, which correlate to the outcomes from chemotherapy. Personalised medicine Since its launch, the FAL has been at the forefront of alternatives research and played a key role in developing non-animal methods for toxicology testing. In the 21st century it is more deeply involved in the field of personalised medicine, and works increasingly with human tissue samples in order to find a more direct route to new medicines and treatments. The FRAME Alternatives Laboratory (FAL) was founded in 1983 at the University of Nottingham Medical School. It is continuing to discover and develop real alternatives to the use of animals in research and testing. Available on InterNICHE Database InterNICHE has developed a new website on alternatives to animal experiments in medical, veterinary medical and biological science education and training. One of its resources is a free-access InterNICHE Studies Database, which aims to improve access to information that can support curricular transformation and replacement of animal experiments. It includes references, abstracts and other details from more than 750 published studies, searchable by discipline, author and keyword and full-text content of selected papers from the ATLA archive will shortly be available for downloading. The site contents reflect major themes such as technological innovation, experience of implementation, and assessment and comparative studies. This resource can help identify specific alternative tools and approaches to enhance practical classes. It also includes a section for comments. Selected ATLA Papers See www.interniche.org/alternatives and www.interniche.org/studies 10 http://www.frame.org.uk FRAME News News in Brief Increased impact The impact factor for FRAME’s scientific journal ATLA (Alternatives to Laboratory Animals) went up in 2011 to 1.46. Vétérinaires Cantonaux (Association of Swiss District Veterinarians). The group has looked at the topics covered during the schools and agreed that they should be recognised as special education and training for personnel involved in animal experiments. The schools aim to show researchers how to design experiments so that they need fewer animals, as well as extracting higher quality information from the data. Volume 40 Number 2 May 2012 The study was led by Professor Richard Grundy at the University’s Children’s Brain Tumour Research Centre. The researchers obtained 142 samples from 20 institutions in nine countries and used two biomarkers to identify how survival rates vary with age and disease progression. Professor Grundy said: “An international effort was needed to bring sufficient numbers of cases together to make the breakthrough we needed to better understand this disease.” He hopes the new information will help to identify better treatments. Alternatives To Laborator ATLA y Animals N THIS ISSUE DITORIAL apes as Ban on the use of great UK the aboratory animals in Conference on new EU Directive FRAME Scientific Programme Manager Michelle Hudson-Shore was one of the contributors to a conference looking at the implications of new European rules on the use of animals in research. The new EU Directive 2010/63/EU on the protection of animals used for scientific purposes, which must be implemented in the UK by 2013, will shape attitudes towards the use of animals in research. A two-day conference at Northumbria University considered the challenges and opportunities presented by the changes, for animal welfare, science, ethics and society. Michelle’s talk concentrated on the effects the new legislation could have on the use of non-human primates. ARTICLES on the The perception of students education use of animals in higher ty of at the Federal Universi Paraná, Southern Brazil in vitro and ex The comparability of eous vivo studies on the percutan ions formulat permeation of topical containing ibuprofen meal Refinement of the charcoal the fasting study by reduction of period Brain Tumour Biomarkers Identified A team from The University of Nottingham has identified genetic markers that could provide new diagnostic tools for a rare and aggressive type of brain tumour. The molecular characteristics and the best treatment options are unknown for central nervous system primitive neuroectodermal tumours (CNS PNET), because little research has been done owing to their rarity. COMMENTS for Comments on UK Options Transposition of European Directive 2010/63/EU are we Cell transformation assays: tree? barking up the wrong ve on Great Apes be How will the EU Directi transposed into UK law? Recognition for FRAME training schools FRAME’s training schools in experimental design now qualify for three days’ worth of continuing professional development points from the Association Suisse des FRAME LETTER in FRAME responded swiftly when a former Minister of Science made claims in a national newspaper that a blockade of transport companies who import animals into the UK for laboratory use would lead to increased patient suffering and deaths. The statement, by Lord Drayson, was part of a series of articles in The Times that blamed animal rights activists for causing the stoppages on airlines and ferry companies. Professor Michael Balls, Chairman of the FRAME Trustees, immediately wrote to the paper, calling the claims “scaremongering at its absolute worst”. The total imports of animals destined for laboratories in the UK represented only about one per cent of the total used each year and stopping them could not possibly cause the kind of hazards suggested, he said. He also pointed out that the majority of the best medical research no longer uses animals at all, because an increasing number of researchers are realising that animal models are unreliable, often irrelevant and sometimes dangerously misleading. He suggested that the UK’s position in the scientific world would be best protected by searching for more alternatives to current, outdated approaches to medical development. The letter was published in the newspaper on the day following the original report. FRAME News http://www.frame.org.uk 11 CORPORATE SPONSORSHIP: A TWO-WAY PROCESS FRAME relies heavily on its corporate sponsors for income to continue the search for alternatives to the use of animals in laboratories. Following recent press reports, some of our supporters were concerned that one of our sponsors appeared to condone animal research. We received a letter asking about one particular company that was named in the press in connection with testing overseas. In response, Professor Michael Balls, Chairman of FRAME Trustees, explained how important it is that the charity maintains links with all kinds of manufacturing companies. The company in question, Avon, has supported FRAME since 1981, when the charity first began laboratory work on alternative methods. With FRAME’s influence and support, the company was able to replace animal skin tests with modern tissue cultures within only a couple of years. Professor Balls said: “The relationship between Avon and FRAME has had many other important consequences. For example, from the outset, FRAME learned a great deal about the safety assessment of cosmetics, and we were able to pass on our experience of nonanimal methods. “When I first visited the company in New York, in 1981, I saw guinea pigs being used in skin irritation testing. When I next went there a year or two later, there were no animals, and the animal rooms had been replaced by a modern tissue culture facility, staffed by the previous animal technicians, who had been retrained!” Working with companies in such a way enables FRAME to share its expertise as well as learning about the commercial and legal pressures that bring about animal tests, which leads, eventually, to change. “Together, we have contributed substantially to progress in thinking about animal testing and cosmetics, and about the conduct of safety assessment without using animals. We have worked with them in a number of international, alternative test validation schemes.” A full list of FRAME’s corporate sponsors appears on the charity’s website and is published each year in the Annual Report. FRAME’s ultimate aim is the elimination of the need to use laboratory animals in any kind of medical or scientific procedure. FRAME is dedicated to the development of new and valid methods that will replace the need for laboratory animals in medical and scientific research, education, and testing. Where the use of animals is currently necessary, FRAME supports the reduction of numbers involved to an unavoidable minimum and refinement of the experimental procedures to minimise any suffering caused. FRAME relies entirely on grants and donations to carry out its vital work promoting the development of new and valid methods that will replace the need for laboratory animals in medical and scientific research, education, and testing. It receives no financial support from local or central government. As an independent charity, FRAME welcomes any donation, however small, either from individuals or companies. Published by FRAME Russell and Burch House, 96–98 North Sherwood Street, Nottingham NG1 4EE Phone: 0115 958 4740 www.frame.org.uk E-mail: firstname.lastname@example.org Registered Charity No. 259464 JOIN THE FRAME EMAILING LIST If you would like to receive regular emails from FRAME simply sign up on our new database at http://eepurl.com/hvoVQ Or visit our website www.frame.org.uk and scroll down the front page to find the link. All we need is your name and your email address. We promise not to swamp you with messages and you can opt out at any time. We will only use the information to send you news and updates, and we will never pass on your details to anyone else.