frame news 71 - 2013

New FRAMEessay contest

Laboratory dogs —FRAME concerns

Three Rs aroundthe world

Latest animal use figures

www.frame.org.uk

FRAME NEWS

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

OCT 2013

Legislation and the future 3

of animal research

Minister stresses Three Rs 3

support

Cosmetics tests and public 4

perception

Three Rs changes worldwide 6

Friends of FRAME 7

Science shorts 8

FRAME Gifts 9

Laboratory dogs — FRAME 11

concerns

Home Office statistics 12

Science news 14

Dorothy Hegarty Award 15

News round-up 16

FRAME News October 2013

Published by: Fund for the Replacement of Animalsin Medical Experiments

Russell & Burch House,96-98 North Sherwood Street, NottinghamNG1 4EE

Phone 0115 958 4740

Registered charity number: 2596666464

Editor: Anne Jeffery

www.frame.org.uk

Perspectives in Laboratory AnimalScience (PiLAS)

www.atla.org.ukHuman 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.

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.

2 FRAME News October 2013

Contents A letter from the Editor

Thank you for your continued

support of FRAME’s search

for new methods that will

replace the old animal

research models.

Best wishes

(FRAME News Editor)

Anne Jeffery

Minister stresses ThreeRs support

New Italian Law

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

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).

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

FRAME News October 2013 3

LegislationFuture Of Animal Research

AndThe

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

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.

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.

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

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, Director-

General 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 Bans1. 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

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’ ClaimsThe 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.

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 Bans3. 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


Failed communication on cosmetics message


Communicating Science

Cosmetics testing changesIt 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.”

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

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.

Three Rs changes worldwideOrganisations, companies and official bodies around the world have been updating andextending 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.

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.

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.

On your bike!

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.

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.

Average yearly charitydonations

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.

Michelle’s maternity

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.


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.

To join Friends of FRAME send

£20 and your name and

address to:

96-98 North Sherwood Street

Nottingham

NG1 4EE

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

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 Drosophilamodel 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 cost-

effective 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.”

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; 368:1800-

1808 May 9, 2013 DOI:

10.1056/NEJMoa1205409


Omega 3 supplements don’t prevent heart attacks

Fruit flyblast model

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.

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.”

Mouse reduction


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

Key ring

Handy key ring with

detachable pound-sized

token for use in shopping

trolleys and lockers.

Trolley token keyring £3

Travel wallet

Perfect for travel passes, bus

or rail tickets, this travel

wallet can even carry

banknotes.

Travel wallet £2

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

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

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

FRAME Stickers

Three sheets

of 35 useful

stickers.

£1.50

Silk Tie

100% silk tie

featuring the

FRAME bunny

among lettuces.

£13.50

FR

AM

E G

ift

s

New

Gift Aid DeclarationI confirm that I am a UK Income or Capital Gainstaxpayer. I have read this statement and want FRAME toreclaim tax on the donation detailed below, given on thedate shown. I understand that I must pay an amount ofIncome Tax and/or Capital Gains Tax in the tax year(April 6 one year to April 5 the next) at least equal to theamount of tax that all the charities and CommunityAmateur Sports Clubs I donate to, will reclaim on mygifts for that tax year. I understand that other taxes suchas VAT and Council Tax do not qualify.

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

Please treat the enclosed donation of £ qas a Gift Aid Donation.

Please treat any future gifts I make to FRAME qas Gift Aid donations.

Please treat any past donations I have made to qFRAME as Gift Aid.

Please tick all relevant boxes and enter the amount.

Signed:

Name:

Address

Postcode

All prices for goods, postage & packing (but not

donations) are inclusive of VAT.

Send your completed order form to:

FRAME,

96-98 North Sherwood Street,

Nottingham, NG1 4EE

with a cheque for the final total.


Item Price No. Total

Fairground notelets £2.00

Countryside notelets £2.00

Bird notelets £2.00

Flower notelets £2.00

Animal notelets £2.00

Notelets offer (3 packs) £5.00

Recycled pens (set of 3) £2.00

Woodland notepaper £2.50

Dogs notepaper £2.50

Bubbles notepad £2.00

FRAME stickers £1.50

Window sticker £1.75

Tote bag £4.50

Trolley token keyring £3.00

Travel wallet £2.00

FRAME tie £13.50

Lucky dip box £8.00

P&P £3.50 1 £3.50

Donation

TOTAL £

(October 2013)

Order FormPlease...

The Gift Aid scheme allows charities toreclaim tax paid on money we receive fromUK taxpayers.

Basic rate income tax is currently 20 percent, so that means that if you give £10using Gift Aid, it’s worth £12 to us, with-out costing you anything extra.

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

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.

An historicperspective

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

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

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

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


FRAME and the use of

Dogs in Laboratories

Changes in numbers

of experimental

procedures involving

animals, from 2011 to

2012

Number of ChangeAnimal procedures from 2011type 2012 (%)

Mouse 3,058,821 14.1

Rat 278,386 2.5

Guinea-pig 12,740 10.4

Other rodent 5589 –12.6

Rabbit 13,866 –10.3

Cat 247 5.1

Dog 4843 6.4

Ferret 348 –49.6

Other carnivores

713 –10.3

Pig 3379 –59.7

Sheep 42,871 13.7

Cattle 5482 7.4

Other ungulate

10,217 14.9

Primate 3020 22.0

Other mammal

533 –2.2

Bird 153,933 –5.3

Reptile/amphibian

14,210 –12.8

Fish 500,830 –10.9

Total 4,110,028 8.3

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.

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.

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).

PrimatesFRAME 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 of12 FRAME News October 2013

Home Office Statistics of Scientific

Primary purpose of

experimental

procedures on

animals in 2012

“Other” includes education,training, forensic enquiriesand direct diagnosis.

Fundamentalbiological research32%

Human medicine or dentistry12%

Breeding48%

Other 1%100

90

80

70

60

50

40

30

20

10

0

Veterinarymedicine 4%

Protection ofman, animals orthe environment3%

Concerns over GAFRAME 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, non-

animal methods, rather

than giving priority to

creating a great many

new genetically

modified animal

models.

Future Annual StatisticsEuropean Directive 2010/63/EU

requires EU Member States to collect

and pub lish 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.

A more detailed report andcomment on the 2012 statisticswill appear in FRAME’s journalATLA 41(4).


Procedures on Living Animals 2012

Numbers of experimental

procedures performed and

numbers of animals used in

Great Britain since 1987

= number of procedures; = number of animals.

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

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

0 1 2 3 4

year

millions

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.


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

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.”

New Essay Competition

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 Werkstoff-

und 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.

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.

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 insilico 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 recently-

introduced microsystems to

emulate human organs in ‘organ-

on-a-chip’ devices. Finally, it

focuses on an in-depth analysis of

the first devices that aimed to


Dorothy Hegarty Award

Abstract

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.

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.

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 invitro by studying cell cultures.

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 invitro 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.

FRAME’s

new Life

President

Book success Exercisecauses fatcell changes


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