frame news october 2012

New Forum for ThreeRs Discussion

FRAME News Fund for the Replacement of Animals in Medical Experiments Editor: Anne Jeffery No. 69 October 2012

INSIDE...

The Three Rs around the 2world

Dorothy Hegarty Award 3

FRAME and Parliament 4

The Björn Ekwall Memorial 5Award

FRAME helps with new 5text book

Human fetal tissue use — 6FRAME’s view

‘Cruelty free’ 6misinterpreted

New methods in asthma 7research

Home Office statistics 82011

News from the FAL 10

News in brief 11

Corporate support 12

The move will offer professionals in allrelevant fields an opportunity to sharetheir expertise, knowledge and ideasconcerning the scientific, ethical,economic and logistical aspects raisedby laboratory animal use.

Professor Michael Balls, Chairman ofFRAME Trustees, said: “Discussionsin the media on many importantissues are all-too-often of anunacceptably low standard. As aresult, opinions are formed, policiesare determined, and actions are takenon an inadequate basis, which can

FRAME is launching a new initiative aimed at improving the qualityof discussion about issues raised by animal experimentation and theThree Rs. Called Perspectives in Laboratory Animal Science (PiLAS),it will take the form of a stand-alone supplement in FRAME’sscientific journal ATLA (Alternatives to Laboratory Animals) and anew website, www.atla.org.uk, starting this month (October).

lead to regrettable outcomes and theneed to take costly remedial steps.

“This also applies to the use oflaboratory animals as human models,and alternative approaches that couldreduce or obviate the need for suchuse. At the moment, particularissues of concern involve theinternational transport of animalsdestined for laboratory use and theuse of great apes as laboratoryanimals, both of which have arousedconflicting and strong responses, buthave not been given the quality ofdiscussion they need and deserve.”

Those are two of the many topics thatwill be covered in the newsupplement, under these headings:

Opinion; Current Dilemmas; In-depth Discussions; The Wisdomof Russell and Burch; Points ofView; News; Comments andFeedback. Full details of otherissues to be discussed can befound in ATLA 40 (3).

PiLAS has been made possibleby a grant from the Phoebe

Wortley Talbot Charitable Trust,which is gratefully acknowledged.

FRAME News http://www.frame.org.uk

2 http://www.frame.org.uk FRAME News

A new report has highlighted the differentdriving forces in academic study ofalternative, non-animal methods in Europeand the USA. It is based on informationgathered during the 8th World Congress onAlternatives and Animal Use in the LifeSciences last year.

The authors found that, while industrialdriving forces were similar on both sides ofthe Atlantic, the academic influences varied.

In industry, both continents were influencedby the ethical, scientific, and economic needto reduce and eventually replace the use ofanimal models in toxicity testing.

Academic research in Europe needs tocomply with legislation for theprotection of animals used for scientificpurposes, and requires approval bynational government evaluationcommittees. In the United States,legislation and regulation related toalternatives to animals was notconsidered a primary driver for theimplementation of Three Rs alternativemethods.

Academics also faced economic forcesthat differed between continents. TheEuropean Commission and a number ofEU Member States have active policiesfor financing programmes directedtowards the Three Rs application intoxicology, but in the USA the sourcesfor financing academic research in thisarea are limited.

The Three Rs Around the World

The author team was led by ChantraEskes of Services & Consultation onAlternative Methods (SeCAM) inSwitzerland.

The authors also represent the followinginstitutions: Physicians Committee forResponsible Medicine, USA; MarilynAardema Consulting, USA; FreeUniversity of Berlin, Germany; Institutefor In Vitro Sciences, USA; VITO,Belgium; Vrije Universiteit Brussel,Belgium; and Institute for RiskAssessment Sciences, Utrecht University,The Netherlands.

The full report can be found at:http://www.altex.ch/resources/205209_Eskes3.pdfTranslation of The

Principles intoJapaneseThe seminal book that first set out theprinciples of eliminating the need foranimals in laboratories has been translatedinto Japanese.

Noriyuki Kasai, Professor Emeritus andGuest Professor, Tohoku University Centerfor Laboratory Animal Research and TheInstitute for Animal Experimentation, TohokuUniversity Graduate School of Medicine,Japan, spent five months on the initialtranslation, but his work was interrupted bythe earthquake that hit Japan in 2011.Tohoku University and its animal facility areclose to the centre of the disaster.

The Principles of Humane ExperimentalTechnique, by William Russell and RexBurch, described the ideas of the Three Rs,replacement, reduction and refinement,which form the basis of FRAME’s worktoday.

The translation is published by Adthree Publishing Company Ltd, 4-27-37, Higashinakano, Nakano-ku, Tokyo 164-0003, Japan.

A study of medical research insouthern Indian universities hasrevealed significant differences inattitudes to animal use at under -graduate and post-graduate levels.

In India, animal experiments play anintegral role in both undergraduateand post-graduate medical educationin the discipline of pharmacology.

A team led by Syed Ilyas Shehnaz ofthe Department of Pharmacology,Gulf Medical University, Ajman,United Arab Emirates (UAE),compared the perceptions ofpharmacology faculty members insouthern India, regarding the use ofanimal experiments and alternatives atboth levels. They found more supportfor animal use in postgraduateeducation.

Writing in FRAME’s scientific journalATLA (Alternatives to Laboratory

Attitudes to Animal Use in Medical Education in Southern India

Trans-Atlantic Differences in Three Rs Driving Forces

Animals), they called forincreased awareness of alternatives in medical education. Their report said: “Animal experimentshave traditionally been an important toolin the training of undergraduates andpostgraduates in the discipline ofpharmacology in India. Research hasshown that the use of alternatives toanimal experiments in undergraduateteaching, such as simulated clinical trialsor computer simulation models, cancircumvent most of the problemsassociated with animal experiments, whileachieving equivalent learning outcomes.

“As the views of teachers have a strongbearing on the implementation of thecurriculum, the results obtained in ourstudy might help improve the postgraduateand undergraduate curricula that arefollowed in medical colleges of India.”

FRAME News http://www.frame.org.uk 3

The 2011 Dorothy Hegarty Award hasbeen won by a team from the Institute ofPharmacology, Toxicology and Pharmacy,University of Veterinary Medicine,Hannover, Germany.

Professor Wolfgang Bäumer, Dr StephanSchumacher, Dr Jessica Stahl andProfessor Manfred Kietzmann receivedthe award for their paper, The Use of anIn Vitro-cultured Porcine Nasal MucosaModel for the BiocompatibilityAssessment of BiodegradableMagnesium.

The Award is presented annually to theauthors of the paper published in theprevious year’s volume of FRAME’sscientific journal, ATLA, which, in theopinion of the members of the EditorialBoard, is likely to make the mostsignificant contribution to the reduction,refinement and/or replacement of animalexperimentation.

Each member of the ATLA EditorialBoard is entitled to make up to fivenominations for the Award. As inprevious years, a large variety of paperswere nominated, reflecting the diversityof the work published in ATLA, and thewide range of interests of the membersof the Editorial Board.

Dr Stephen Schumacher updated FRAME onthe progress of the team’s work:

“The idea originated from an interdisciplinaryresearch project within the CollaborativeResearch Centre 599 (SFB 599) funded bythe German Research Foundation. The centreis dedicated to the development of innovativenew biomedical implants, and one of its aimsis the production of a biodegradablemagnesium alloy stent for the treatment ofchronic rhinosinusitis.

“The project is designed in a way that allowsfor stepwise elimination of unsuitable implantmaterials. The process starts with materialscience testing, followed by a variety ofbiological in vitro test systems of increasingcomplexity, one of which is the nasal mucosamodel. Then preclinical studies are initiated.By this means, unnecessary animalexperiments can be avoided. Results obtainedat each stage are fed back to the materialscientists thus continuously improving theimplant development from the very beginning.

“We are currently working with acomplementary porcine nasal epithelial cellmodel in order to gain better insight into thecellular and molecular processes occurring atthe tissue–implant interface and themechanisms underlying less than idealbiocompatibility.”

DOROTHY HEGARTY AWARD 2011

Abstract

Stephan Schumacher, Jessica Stahl,Wolfgang Bäumer and ManfredKietzmann.

The Use of an In Vitro-culturedPorcine Nasal Mucosa Model forthe Biocompatibility Assessment ofBiodegradable Magnesium. ATLA39, pages 261–271.

The development of an in vitro-cultured porcine nasal mucosa model isdescribed. The model was subsequentlyused for the biocompatibility testing ofresorbable magnesium-based implants,which are intended for use in the nasalcavity of patients with chronicrhinosinusitis (CRS). Test specimensmade from either pure magnesium ortitanium were incubated with themucosal tissue for 48 hours.Afterwards, tissue viability, PGE2, IL-6and IL-8 release, magnesium ionrelease, succinate dehydrogenaseactivity, apoptosis and 14C amino acidincorporation, were determined. Theresults suggested favourablebiocompatibility, even in the case ofrapidly-degrading pure magnesium.However, presumed effects on proteinsynthesis and apoptosis could not beconfirmed.

Prof. DrWolfgangBäumer

Dr StephanSchumacher

DrJessicaStahl

Prof. DrManfredKietzmann

The award is named afterMrs Dorothy Hegarty whoco-founded FRAME in1969 with biologist DrCharles Foister. In its veryearly days, FRAME was runfrom Mrs Hegarty’s home,in Wimbledon.

APPRG registered

Between 1981 and 2010 there was anAll Party Parliamentary FRAME Group(APPFG), which was particularlyinfluential during the passage throughParliament of what was to become theAnimals (Scientific Procedures) Act1986.

In recent years rules were changed sothat All Party Groups must beassociated with issues, rather thanwith organisations, so after the 2010General Election it was agreed that anAll Party Parliamentary ReplacementGroup (APPRG) should be formed,for which FRAME would provide aSecretariat.

The Group has now been entered into the Register of All-Party Groups. It has ten members from the Govern-ment Party, nine members

FRAME ANDPARLIAMENT

from the Main Opposition Party, andone other member, with Nic Dakin asChair, Annette Brooke, Diana R.Johnson and Henry Smith as Vice-Chairs, Baroness Smith of Basildon asTreasurer, and Jim Dowd and FabianHamilton as Secretaries.

The aim of the Group is to promotethe replacement ofanimal proceduresin medical researchand safety testingby scientificallyproven, relevantand reliable non-animal methods, inthe best interestsof both humanbeings andanimals.

Swift success

The Group has succeeded inestablishing a distinctive andconstructive position in relation to thecomplex issues raised by animalexperimentation and opportunities forits reduction, refinement and replacement. It has

met four times during its first year, and, in addition, met Lynne Featherstone MP,

then Under Secretary of State at theHome Office.

A mutually beneficial line ofcommunication has also beenestablished between the Group andthe Home Office. A number of issueswere raised on behalf of the Group incorrespondence with the Minister,and, in particular, questions related tothe transposition of Directive2010/63/EU into UK law. Thistransposition has dominatedGovernment thinking during 2011–2012, and will continue to do so into2013, in view of the forthcomingdiscussions on the new legislationnecessary for the transposition, andthe publication of the relatedGuidance and Code of Practice.

Great apes

The Group was successful, incollaboration with FRAME and theBUAV, in contributing to thepersuasion of the Government toreverse its proposal to transpose fromthe Directive, without modification,clauses that would have left open thepossibility of using great apes aslaboratory animals in the UK. NicDakin, Chair of the Group, had raisedthis point during a Westminster Halladjournment debate, which wasfollowed by further correspondencewith the Minister, leading to hercategorical assurance at a latermeeting, that the ban on the use ofgreat apes as laboratory animals in theUK would be on the face of theforthcoming bill.


Nic Dakin

models in toxicologicalinvestigations.

Professor Spielmann is beinghonoured in recognition of hisoutstanding scientific work in thefield of in vitro toxicology. Hehas contributed considerably todeveloping methods aimed at

reducing and replacing animals used intesting.

He is a member of several national andinternational boards and advisorycommittees involved in validation of invitro tests. He is also HonoraryProfessor of Regulatory Toxicology at theFree University of Berlin.

The award is made by The Björn EkwallMemorial Foundation (BEMF), which wasestablished in memory of Dr Björn Ekwall(1940–2000), a Swedish scientist in thefield of cell toxicology and the founderof the Scandinavian Society for CellToxicology (SSCT). It marksachievements of outstanding scientistswho have developed or used non-animal

The Björn EkwallMemorial Award

Three FRAME scientists have written a chapter in a newedition of a text book on pharmaceutical research. Thebook focuses on industrial pharmaceutical research. It iswritten by industry experts fromaround the world and discusses newmethods of drug discovery anddevelopment.

FRAME’s chapter is called Translationof New Technologies in Biomedicines:Shaping the Road from Basic Researchto Drug Development and ClinicalApplication – and Back Again. It waswritten by Chairman of the FRAMETrustees Professor Michael Balls,Trustee and Director of the FRAMEAlternatives Laboratory Dr AndrewBennett, and Trustee Professor DavidKendall.

The chapter explains why modelsare needed to develop new drugs,what new technologies exist to help

New Text Bookthe search, and how existing knowledge supports thediscovery. Specific topics include the use of stem cells,examples of in vitro systems, clinical imaging and tissue

engineering.

Professor Kendall said: “Drug discovery isbecoming more difficult and costly as manyof the more obvious approaches to therapyfor some diseases have been exhausted, andmany failures in drug development can belaid at the door of inappropriate testing inanimals. The key in the future is toreconsider the sacred cow of animal testingand to increasingly employ human-focused,new technologies to develop medicinestargeting individual human patients, ratherthan employing a one-size-fits-all strategy.”

Pharmaceutical Biotechnology, DrugDiscovery and Clinical Applications, editedby Oliver Kayser and Heribert Warzecha, ispublished by Wiley Blackwell, Weinheim,Germany.


The latest recipient of the BjörnEkwall Memorial Award is HorstSpielmann. Professor Spielmann is along-time associate of FRAME, andis the European Editor of itsscientific journal ATLA (Alternativesto Laboratory Animals).

Professor Spielmann has published morethan 240 articles in peer-review journals,and written, edited or contributed tomore than 100 books.

Using human tissues avoids the ethicaldilemma of experimenting on animals, aswell as providing more relevant results forhuman medicine, but it raises issuesconcerning their source. Human cells andtissues must be obtained ethically andsafely. Using the system of informedconsent, that can happen when donorsundergo surgery or biopsies, but a fetuscannot give such consent.

It is assumed the enquiry related to theuse of tissues obtained through voluntarytermination of a pregnancy. Abortion canalso be carried out for other reasons,including threats to the mother’s health orbecause the fetus has abnormalities thatwould give it no chance of survival. Thereis also the case of spontaneous abortion,or miscarriage. In that case, tissuedonation can be beneficial to the motherbecause the cells will be put to somepositive purpose. Tissue can also beobtained from unwanted embryos leftover after in vitro fertilisation. (Test tubebaby production)

FRAME’s use of fetaltissues

When the FRAME Research Programmewas established in 1982, staff wereinvolved in a multi-centre study using acell line derived from a human fetus. Theline was later withdrawn because ofadverse publicity over its origin. At thetime, most cell lines were obtained fromembryonic tissues because it was the onlyavailable technique. FRAME has also usedcells in past studies on skin irritation,which were derived from surgically-removed foreskins from children. Todaythe FRAME Alternatives Laboratory workson adult-derived human cells obtainedfrom biopsies, in full compliance withstrict ethical and safety procedures.


Human stem cells

Fetal tissue can also be a source of stemcells, a special kind of cells that hold thepotential to become a range of differenttissue types. Stem cells are also found inother tissues such as bone-marrow, skinand the liver.

In the 1990s, mouse embryonic stem celllines offered new research options,although they carried the sameuncertainties over their relevance tohuman medicine as using any other animalcells. Since then it has become possible toisolate human embryonic stem cells, whichcan be used to create models of illnesses,such as cystic fibrosis, fragile Xsyndrome, and Huntington’s disease. Thisis still controversial because of their

source, so the latestdevelopments use stem cells fromadult donors.

That opens up the futurepossibility of creating bothnormal and damaged cells fromhealthy individuals and those withparticular diseases, so that testswould give more-detailed andmore-relevant results than everbefore.

FRAME Viewpoint:

A US study has revealed that many consumers donot fully understand that a ‘cruelty free’ label ona product has no official meaning.

Researchers from the Universities of Missouri and Oregon havecalled for a legal definition of cruelty free, after discovering thatbuyers did not realise that products carrying the claim could stillhave been tested on animals.

Kim Sheehan, a professor in the University of Oregon School ofJournalism and Communication, and Jooghwa Lee, a doctoralcandidate at the University of Missouri, School of Journalism,carried out an online survey.

They found that many consumers intentionally seek out productssuch as toiletries and cosmetics that carry the label and most areunder the impression that no animals were used to manufactureor test them.

Those who said they actively searched for products that carrythe label were then given information about the range ofstandards covered by the description. After the anomalies wereexplained, most consumers said they were less supportive of thelabel.

The study was presented at the American Academy of Advertising2012 Annual Conference.

FRAME was recently askedfor clarification of its stanceon the use of tissues andcells from human fetuses

Cruelty-Free Labels areOften Misinterpreted


must depend principallyon the application of the best possible scientific principles and procedures, and on thedevelopment and effective and ethicaluse of modern scientific procedures.FRAME is not an animal welfareorganisation, since we believe that thereduction, refinement and replacementof the use of laboratory animalprocedures in biomedical research andtesting is overwhelmingly the best wayforward for humans, as well as in theinterests of animal welfare. FRAME alsoknows that there is no escape fromethical dilemmas, because the solutionof one problem inevitably raisesothers.

FRAME considers it to be possible toprovide human embryonic cells andtissues according to acceptable ethicalstandards. Nevertheless, we are

delighted that the progress being made with the provision of tissues and cells, including stem cells, of post-natalhuman origin promises to end thenecessity or desirability of usingmaterial of embryonic origin, andproud to be contributing to thatprogress.

A more in-depth version of this statementwas published as a Comment in FRAME’sscientific journal ATLA (Alternatives toLaboratory Animals) issue 40(1) and isavailable free online at the FRAMEwebsite.

Admixed Embryos

In 2007, when the Human Fertilisation and Embryology Bill was published, it included a proposal topermit the production of ‘admixedembryos’, by replacing the nuclei ofanimal eggs with human nuclei, in order toincrease the availability of human stemcells for research on a wide range ofhuman diseases, although it was notestablished that they were necessary forthe production of human embryonic stemcells. It was argued, however, that manyserious human diseases could not beunderstood or treated in any other way,and the Bill was passed.

FRAME’s PositionFRAME believes that progress inunderstanding and treating human andanimal disease, in providing productswhich are as a safe as possible to use,and in protecting the environment,

The Use of Human Fetal Tissue in Research

A University of Nottingham researcher has been awarded a nationalfellowship for her work to improve understanding of asthma, while usingfewer animals in tests.

Dr Amanda Tatler, in the University of Nottingham’s School of ClinicalSciences, has been given a David Sainsbury Fellowship from the NationalCentre for the Replacement, Refinement and Reduction of Animals inResearch (NC3Rs).

Her work aims to develop understanding of the mechanisms leading tostructural changes in the airways of patients with severe asthma. She willuse new methods that significantly reduce the numbers of animals, usuallymice, traditionally used to study the disease.

Reducing Animal Usein Asthma Research

Fundamental research

The rise in fundamental research poses aspecific challenge to implementing theThree Rs, and developing alternativemethods to replace animal use. It isparticularly difficult to replace fundamentalstudies with non-animal alternativesbecause of their exploratory andknowledge-acquiring nature. There is alsothe added complication of the competitivespirit of academic research which makescollaboration difficult. The search foralternatives in toxicology has been drivenby regulatory changes, but it would take acomplete ban on animal experiments todrive such innovation in fundamentalresearch. A wide scale change in attitudeis needed toward actively looking foralternatives, rather than just finding themas a by-product of other research.

Toxicology and safetytesting

The number of procedures being carriedout for safety testing and toxicology roseby 2% to a total of 399,000, mainlytaking place in the commercial sector.Most of the toxicological procedures wereconducted on rodent species andperformed for pharmaceutical safety andefficacy evaluation. When toxicologyprocedures were carried out to meetlegislative requirements the majority weredone to meet a combination of suchrequirements. This means that there wasless repetition of tests and signifies animprovement on historical practice.

significant figures. The statisticsdocument points out that thenumber of animals generallycorresponds to the number ofprocedures, although, where an animal hasrecovered fully from a completedprocedure and is used again, that iscounted as a separate procedure.Therefore the number of animals used willalways be slightly fewer than the numberof procedures begun.

Legal requirement topublish statistics

The purpose of the annual statisticalreport is to satisfy the requirement insection 21(7) of the Animals (ScientificProcedures) Act 1986 (ASPA) that theSecretary of State should publish and laybefore Parliament each year, informationabout the use of protected animals inexperimental or other scientificprocedures during the previous calendaryear. The statistics are compiled fromreturns, submitted by project licenceholders at the end of each year, or on thetermination of the licence when thisoccurs during the year.

ASPA will be replaced in early 2013 whenthe European Directive 2010/63/EU istransposed into UK law. The Directive alsocarries a requirement that: ‘Member Statesshall collect and make publicly available,on an annual basis, statistical informationon the use of animals in procedures,including information on the actualseverity of the procedures and on theorigin and species of non-human primatesused in procedures.’

The Home Office has published the latestStatistics of Scientific Procedures on LivingAnimals in Great Britain, revealing anotherincrease in the number of procedurescarried out. More than 3.79 millionscientific procedures were started in GreatBritain in 2011, a rise of 68,100, or 2%.This is the highest number of procedurescarried out on animals in a year since theAnimals (Scientific Procedures) Act 1986(ASPA) came into force.

Unlike in the previous decade, theincrease is not exclusively due to breedingand use of genetically altered animals,although they are still the largest group at1,617,813. The figures suggest a possibleshift toward fundamental researchbecoming the primary cause of increasesin animal experiments. The change forfundamental purposes is indicative of thecontinuing rise in experiments conductedin universities and medical schools, where50% of procedures are now conducted.These include studies on cancer, genetics,immunology and physiology. In 2002, forthe first time, the number of proceduresconducted in universities and medicalschools overtook the number conductedin commercial organisations. Since then,the gap between university-basedprocedures and commercial establishmentshas continued to widen.

How the figures aredefined

Published totals in the Home Officesummary refer to the number ofprocedures started, not the number ofanimals used. Figures are rounded to thenearest 1,000 or 100, or to two


Home Office

Breeding 43%

Veterinary medicine 5%

Fundamental biological

research 35%

Humanmedicine or

dentistry 13% Protection ofman, animals orthe environment

3%Other

1%

Primary Purpose of ExperimentalProcedures on Animals in 2011


Re-use of primates

However, it is of great concern thatnon-human primates areincreasingly being subjected to re-use. Many must have undergonemore than one procedure, becausethere were 1,016 more proceduresthan animals.

Given their ability to rememberdistressing events this must beconsidered a worrying trend. Anumber of studies are currentlyunder way to assess the degree ofsuffering that primates undergo as aresult of cumulative procedures.

Re-use has to be speciallyauthorised by the Home Office, andis generally conditional upon theanimal having suffered no significantadverse effects as a consequence ofthe first use.

It is impossible to get more detailedinformation from the statistics onthe nature of re-use and how manyindividual animals are subjected toit.

No. of % changeAnimal procedures fromType 2011 2010

Mouse 2,679,763 +0.4

Rat 271,535 –11

Guinea pig 11,537 –16

Other rodent 6,398 +2

Rabbit 15,461 +4

Cat 235 +26

Dog 4,552 –21

Ferret 691 –13

Other carnivores 795 +3

Pig 8,380 +37

Sheep 37,714 –0.2

Cattle 5,102 +42

Other ungulate 8,895 +5

Primate 2,475 –47

Other mammal 545 –55

Bird 162,618 +14

Reptile/amphibian 16,298 +6

Fish 562,245 +15

Total 3,794,787 +2

Statistics 2011

Percentage Changes inExperimental Procedures InvolvingAnimals, from 2010 to 2011

There were increases in numbers of procedures for several species, includingcats (+26%), pigs (+37%), birds (+14%) and fish (+15%). Other speciesshowed 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 yearsin that these groups represent the four most often used species. However, thelevels 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. Thecontinued change in 2011 is the latest in a trend that started in 1995.

The birds category contains several species but domestic fowl account for thelargest proportion at 92% of procedures carried out on them.

The combined totals for dogs, cats and non-human primates add up to lessthan a quarter of 1% of the number of procedures started in 2011.

Percentages can be misleading, however, because the actual number of animalsinvolved is often not apparent from the figures. Procedures on cats, forexample, showed a 26% increase but the change represents 48 events.Meanwhile, a 15% increase in procedures on fish actually involved a rise of72,959.

SPECIES USED

Use of non-humanprimates

It is encouraging to see afall in the number of

procedures being carried out on non-human

primates, although it remainsto 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 toremember events that cause them distress, andtherefore can anticipate similar situations. Thelaboratory environment is also very damaging tothem because it is unable to provide for theirsophisticated social needs. These factors meanthat they undergo high levels of suffering duringmedical and scientific procedures, and even theirhousing and general care can cause them intensestress.

The fall in the number of procedures is mirroredby a reduction in the number of animals used.The total number of procedures using primatesdecreased by 2,213 from 4,688 in 2010 to2,475 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).


FRAME LABORATORY HELPINGIN BREAST CANCER RESEARCH

Doctors have found that some womenbenefit from chemotherapy while othersshow little or no response to thetreatment, and it could improve clinicaloutcomes if it was possible to tell inadvance what the effect on an individualmight be.

Genetic source

Research being carried out by ProfessorOleg Eremin from the Division of Surgeryat the University of Nottingham MedicalSchool, has suggested there could be agenetic reason for the different responsesand the FAL is helping to discover itsexact nature.

The FAL has considerable expertise andexperience in investigating the make-up ofDNA and gene expression (the way thatgenes determine a person’s physicalcharacteristics). As a result, the MedicalSchool group approached the FAL for itsassistance.

Expertise

Director of the FAL Dr Andrew Bennettsaid: “We have a great deal of expertise inthis area and we are increasingly beingasked to collaborate on projects such asthis. With our skills and equipment we cancarry out tests on a large number ofsamples quickly and effectively, and so

produce useful and reliabledata.”

Using samples donated bypatients undergoingchemotherapy for breastcancer, the lab hasdemonstrated that thereare two distinct forms ofgene expression, whichcorrelate to the outcomes fromchemotherapy.

Selected ATLA PapersAvailable on InterNICHE Database

InterNICHE has developed a new website on alternatives to animal experiments in medical, veterinary medical and biological scienceeducation and training. One of its resources is a free-access InterNICHE Studies Database, which aims to improve access to informationthat 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 keywordand 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 comparativestudies. This resource can help identify specific alternative tools and approaches to enhance practical classes. It also includes a sectionfor comments.

See www.interniche.org/alternatives and www.interniche.org/studies

Improving patientoutcomes

“Giving chemotherapy to a patient whowill not benefit from it delays othertreatments that would be more helpful. Ifit was possible to predict whether or notchemotherapy would be effective it wouldbenefit outcomes for all patients, as wellas saving time and money. There is stillmuch work to be done, but ultimately thisresearch might lead to a simple blood testthat will predict how a woman wouldrespond to chemotherapy.”

Personalised medicine

Since its launch, the FAL has been at theforefront of alternatives research andplayed a key role in developing non-animalmethods for toxicology testing. In the21st century it is more deeply involved inthe field of personalised medicine, andworks increasingly with human tissuesamples in order to find a more directroute to new medicines and treatments.

The FRAME AlternativesLaboratory (FAL) was foundedin 1983 at the University ofNottingham Medical School. Itis continuing to discover anddevelop real alternatives to theuse of animals in research andtesting.

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.


Increased impactThe impact factor for FRAME’s scientificjournal ATLA (Alternatives to LaboratoryAnimals) went up in 2011 to 1.46.

Recognition for FRAMEtraining schools

FRAME’s training schools in experimentaldesign now qualify for three days’ worthof continuing professional developmentpoints from the Association Suisse des

Vétérinaires Cantonaux (Association ofSwiss District Veterinarians).

The group has looked at the topicscovered during the schools and agreedthat they should be recognised as specialeducation and training for personnelinvolved in animal experiments.

The schools aim to show researchers howto design experiments so that they needfewer animals, as well as extracting higherquality information from the data.

Brain Tumour BiomarkersIdentifiedA team from TheUniversity ofNottingham hasidentified geneticmarkers that couldprovide newdiagnostic tools for a rareand aggressive type of brain tumour. Themolecular characteristics and the besttreatment options are unknown for centralnervous system primitive neuro-ectodermal tumours (CNS PNET), becauselittle research has been done owing totheir rarity.

The study was led by Professor RichardGrundy at the University’s Children’sBrain Tumour Research Centre. Theresearchers obtained 142 samples from20 institutions in nine countries and usedtwo biomarkers to identify how survivalrates vary with age and diseaseprogression. Professor Grundy said: “Aninternational effort was needed to bringsufficient numbers of cases together tomake the breakthrough we needed tobetter understand this disease.”

He hopes the new information will help toidentify better treatments.

Conference on new EUDirectiveFRAME Scientific Programme ManagerMichelle Hudson-Shore was one of thecontributors to a conference looking atthe implications of new European rules onthe use of animals in research. The newEU Directive 2010/63/EU on theprotection of animals used for scientificpurposes, which must be implemented inthe UK by 2013, will shape attitudestowards the use of animals in research.

A two-day conference at NorthumbriaUniversity considered the challenges andopportunities presented by the changes,for animal welfare, science, ethics andsociety. Michelle’s talk concentrated onthe effects the new legislation could haveon the use of non-human primates.

News in Brief

FRAME LETTER in

FRAME responded swiftly when a former Minister of Science made claimsin a national newspaper that a blockade of transport companies whoimport animals into the UK for laboratory use would lead to increasedpatient suffering and deaths.

The statement, by Lord Drayson, was part of a series of articles in TheTimes that blamed animal rights activists for causing the stoppages onairlines and ferry companies.

Professor Michael Balls, Chairman of the FRAME Trustees, immediatelywrote to the paper, calling the claims “scaremongering at its absolute worst”.

The total imports of animals destined for laboratories inthe UK represented only about one per cent of the totalused each year and stopping them could not possiblycause the kind of hazards suggested, he said.

He also pointed out that the majority of the best medicalresearch no longer uses animals at all, because anincreasing number of researchers are realising that animalmodels are unreliable, often irrelevant and sometimesdangerously misleading.

He suggested that the UK’s position in the scientificworld would be best protected by searching for morealternatives to current, outdated approaches to medicaldevelopment.

The letter was published in the newspaper on the dayfollowing the original report.

ATLAAlternatives To Laboratory Animals

Volume 40

Number 2

May 2012

N THIS ISSUE

DITORIAL

Ban on the use of great apes as

aboratory animals in the UK

ARTICLES

The perception of students on the

use of animals in higher education

at the Federal University of

Paraná, Southern Brazil

The comparability of in vitro and ex

vivo studies on the percutaneous

permeation of topical formulations

containing ibuprofen

Refinement of the charcoal meal

study by reduction of the fasting

period

COMMENTS

Comments on UK Options forTransposition of EuropeanDirective 2010/63/EU

Cell transformation assays: are we

barking up the wrong tree?

How will the EU Directive on Great Apes be

transposed into UK law?

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: [email protected]

Registered Charity No. 259464

FRAME relies heavily on its corporatesponsors for income to continue thesearch for alternatives to the use ofanimals in laboratories. Following recentpress reports, some of our supporterswere concerned that one of our sponsorsappeared to condone animal research. Wereceived a letter asking about oneparticular company that was named in thepress in connection with testing overseas.

In response, Professor Michael Balls,Chairman of FRAME Trustees, explainedhow important it is that the charitymaintains links with all kinds ofmanufacturing companies. The companyin question, Avon, has supported FRAMEsince 1981, when the charity first beganlaboratory work on alternative methods.

With FRAME’s influence and support, thecompany was able to replace animal skintests with modern tissue cultures withinonly a couple of years.

Professor Balls said: “The relationshipbetween Avon and FRAME has had manyother important consequences. Forexample, from the outset, FRAME learneda great deal about the safetyassessment of cosmetics,and we were able to passon our experience of non-animal methods.

“When I first visited thecompany in New York, in1981, I saw guinea pigsbeing used in skinirritation testing. When Inext went there a year or

two later, there were no animals, and theanimal rooms had been replaced by amodern tissue culture facility, staffed bythe previous animal technicians, who hadbeen retrained!”

Working with companies in such a wayenables FRAME to share its expertise aswell as learning about the commercial andlegal pressures that bring about animaltests, which leads, eventually, to change.

“Together, we have contributedsubstantially to progress in thinking aboutanimal testing and cosmetics, and aboutthe conduct of safety assessment withoutusing animals. We have worked with themin a number of international, alternativetest validation schemes.”

A full list of FRAME’s corporate sponsorsappears on the charity’s website and ispublished each year in the Annual Report.

FRAME is dedicated to thedevelopment of new and validmethods that will replace the needfor laboratory animals in medicaland scientific research, education,and testing.

Where the use of animals is currentlynecessary, FRAME supports thereduction of numbers involved to anunavoidable minimum andrefinement of the experimentalprocedures to minimise any sufferingcaused.

FRAME relies entirely on grants anddonations to carry out its vital workpromoting the development of newand valid methods that will replacethe need for laboratory animals inmedical and scientific research,education, and testing.

It receives no financial support fromlocal or central government.

As an independent charity, FRAMEwelcomes any donation, howeversmall, either from individuals orcompanies.

FRAME’s ultimate aim is theelimination of the need to uselaboratory animals in any kindof medical or scientificprocedure.

JOIN THE FRAME EMAILING LISTIf you would like to receive regular emails from FRAME simply sign up on our newdatabase 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 withmessages and you can opt out at any time.

We will only use the information to send you news and updates, and we will never passon your details to anyone else.

CORPORATE SPONSORSHIP:A TWO-WAY PROCESS

frame news october 2012

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