Supplementary memorandum by NAVS
GM ANIMALS/PARTICULAR
REFERENCE TO
ALTERNATIVES
The suffering involved in the production of
GM animals is horrifying and, unfortunately, the scientific community
has a tendency to present these animals to the public and media
as if they suffer less than other animals.
Experience of our studies into working practices
in several UK laboratories, in animal breeding and supply companies,
and academic research through available literature, has led us
to the conclusion that the smaller in physical size of the animal,
the less consideration given to its environment.
Prolonged distress and suffering is caused to
genetically modified animals by the whole process of genetic engineering,
including—
The process of genetic modification (females
suffer surgery, egg collection & implantation, and repeated
blood and tissue sampling for the offspring). Transgenic animals
can suffer:
— higher birth weights (even offspring
unable to stand by themselves);
— increased deaths at birth;
— foreign gene can cause mutations,
resulting in premature death;
— severe health problems.
Consequences of products made by genes (causing
ill-effects in the animal):
Caused by the action of the gene product, and
the amount of it circulating in the blood, harming the animal.
Also when the gene product appears in the wrong part of the body.
Effects of the modification:
The animals can suffer because of side-effects
of the foreign proteins (the foreign product made by the gene)
circulating in their bodies. Or, they can suffer the results of
the modification (such as a disease caused by the modification).
Such animals are born to suffer forms of cancer, cystic fibrosis,
Alzheimer's, Huntingdon's, and other diseases (despite the fact
that these diseases are not the same as the human version of the
disease).
The NAVS considers that the harm suffered by
transgenic animals can never outweigh any purported benefits.
The majority of transgenic animals are used as models for human
disease yet, so far, none of these "models" has accurately
of adequately replicated the condition seen in humans.
Thus, "cures" are being tested on
unreliable models, in a different species, compounding the variables
to be managed. This is not good science.
Wastage of life:
— transgenic animals without the desired
gene are killed in vast numbers (only 1-10 per cent of the offspring
will incorporate the desired gene);
— producing transgenic animals involves
multiple surgical procedures for females.
Environment deprivation:
These animals live in barren, sterile environments,
in confined spaces, lacking in normal enrichment to provide stimulation.
— animals used for xenotransplantation
are worse off, because they must be as disease-free as possible.
So no bedding, or foraging, for these pigs, cattle, or sheep.
For example in order to obtain "disease-free"
piglets for organs for transplants, the animals are delivered
by caesarian section, placed in isolators, and then reared in
sterile environment; the offspring are also subjected to repeated
procedures, blood and tissue is taken.
The same considerations apply for "pharming"
(pharmaceutical production, or proteins to make pharmaceuticals).
These animals, whose bodies are being used as
"bioreactors" or factories to make products, must be
kept in sterile environments if the products they are producing
are to be used in humans.
Again, these are mostly farm animals—sheep,
pigs, cows, although more recently rabbit "pharming"
has been announced.
Suffering caused by increased desensitisation
of laboratory personnel:
Overloading systems and building capacities
will see more animal suffering through inhumane killing. Quantities
being killed due to being surplus stock make truly humane procedures
impossible; staff will either leave the industry, or become less
sensitive to what they are doing.
NAVS undercover Field Officers have filmed laboratory
personnel behaving inappropriately towards laboratory animals,
apparently desensitised by the level of killing.
In 1999, the chairman of the Institute of Animal
Technicians announced the counselling could be arranged for technicians
emotionally disturbed by their role in this killing.
The products that it is hoped can be produced
from genetically modified animals:
Bioreactors to make products: transgenic animals
that are used as bioreactors for pharmaceutical proteins (producing
medical products, in their milk, eggs, urine, blood, or semen)
are being used for convenience, when there are other, non-animal
methods of production available. These animals can suffer severe
illness when the protein is produced in the wrong part of the
body.
Agriculture: animals are given genetically engineered
hormone products to make them produce more, or are genetically
modified themselves, in order to grow faster, produce more and
leaner meat, more eggs, growth hormone to produce more milk, or,
more and better wool. Sometimes the aim is to try to improve their
resistance to disease, like GM crops.
Other areas of use for genetically modified animals:
Fundamental research: to obtain knowledge, projects
with no particular application.
Safety-testing and other procedures, similar
to those carried out on non-GM animals, despite the fact that
there are now many superior non-animal methods already available.
Cloning experiments, refining and developing
techniques to clone organisms, to produce a flock of clones with
the same genetic defect (of perhaps, although presently illegal
in the UK, with the hope that ultimately, human beings can be
successfully cloned). A flock of cloned sheep, for example, could
be used as living factories to produce a pharmaceutical product
in their milk.
Gene therapy:
The mapping of the human genome is unlikely
to bring with it the great promised of curing all with gene therapy,
provision of an understanding of disease and the development of
drugs to suit the individual. Gene therapy for curing diseases
with a single defective gene has a disastrous track record. Worldwide,
there have been no cures, a number of deaths and at least 1,000
reported serious side effects.
Growing spare body parts for humans:
Genetically modified animals are used to grow
spare body parts for people to be used in transplants (xenotransplants).
It is important to realise that the animals
are not growing a human organ. The organ simply has a human gene
added. If an animal's organ is transplanted into a human, the
person's immune system mounts an attack to repel the invader.
These animals are given the gene to "trick" the human
immune system into not attacking the animal's organ once it is
transplanted into a person. This does not make the organ human.
All the body products generated by the cells
remain non-human, and will migrate around the patient's body.
The animal's organ is still designed for an animal's body, and
is programmed for the lifespan of that animal, not a human lifespan.
A pig's heart and lungs were designed for a
different size, horizontal animal: a pig's heart would need to
be modified to pump the right volume of blood, at the right pressure.
It has been suggested that animals go through treadmill training
in an attempt to ameliorate this fault.
There are fundamental physiological and metabolic
differences between, say, organs of a pig and those of a human.
Some researchers believe that an animal's organs, particularly
liver and kidney, are metabolically incompatible with humans.
The species differences remain—the liver
of a pig lacks an enzyme that regulates various functions, including
the body's immune response—a pig's liver will not suddenly
start producing this enzyme after it is transplanted into a human.
It is unknown whether the animal's cells, once migrating around
the body, will be attacked by the immune system, of cause health
problems.
Transplant patients will still have to take
drugs to suppress their immune-system; such drugs leave them exposed
to other diseases, and can also cause cancer.
Furthermore, the risks to the human population
need to be considered. Because animal organs contain unknown animal
viruses, these will be passed to the patient. A virus that is
forced across the species barrier in this way can mutate, and
cause a new disease, releasing an epidemic on the human population.
A current idea is that patients can be asked to restrict their
social contacts, and especially sexual contacts. This is not a
viable plan. Human acquired immunodeficiency virus (the AIDS virus)
is an example of disease created by cross-species mutation; whilst
nvCJD/BSE (caused by a prion, a rogue protein) is an example of
cross-species infection.
Alternatives to the use of GM Animals
In much the same way as non-GM research, methods
which are based around human tissues and human data are preferable
to using data gained from a different species, even if it is a
genetically modified strain of animals.
Alternatives to the use of genetically modified
animals in genetics research, which are already in use, include—
Population studies/genetic and biochemical data
from human/coronary artery disease: to evaluate the genetic disposition
and dietary influence on the development of coronary artery disease.
This involved analysing DNA and blood samples.
Cell/tissue culture/lung disease: genes can
be transferred via viral vectors and the affect on cell biochemistry
investigated. This method has been used to investigate gene therapy
for and inflammatory lung disease.
Human vascular tissue/diabetes/atherosclerosis:
studies have identified the mechanism behind the over-expression
of a particular gene which makes diabetics susceptible to atherosclerosis.
Researchers were unable to identify this mechanism in genetically
modified diabetic mice.
Human tissue/arthritis: studies of human tissue
surrounding joints has shown that gene therapy activated by a
lack of oxygen (hypoxia) could be delivered to rheumatoid arthritis
patients.
In vitro expression system/anti-inflammatory
treatment: a human liver (hepatoma) cell line was treated with
specific gene promoters. This allowed gene promoters to be investigated
as a method of controlling inflammatory diseases by gene therapy.
Cell culture from human blood/human tissue culture.
A commercially available in vitro test kit/cancer gene
therapy: the commercially available "Angiogenesis model"
mimics the growth of blood vessels to supply blood to tumours.
Using this model anti-cancer genes can be studied on human cells
in hypoxic conditions, ie oxygen deprived conditions such as those
found in cancer tumours.
Development and introduction of "alternatives"
During the hearing on 12 March, we mentioned
the suggestion we had floated to the Home Office and various non-animal
research funding organisations when the new Labour Government
was elected. We would line to recommend this idea to the Select
Committee, as one which would make a huge difference to British
research as well as the nature of the debate on this issue in
the UK.
Centre for the Development of Alternative Methods
A Centre for the Development of Alternative
Methods need not be a physical centre in one location but act
as a co-ordinating body, drawing together research efforts in
a number of different sites.
The Home Office and the Animal Procedures Committee
could co-ordinate and direct activity, which would allow the non-animal
research funding bodies, industry, and government to pool resources
and work together, to set up the Centre.
The UK Centre need not duplicate the activity
of the European Centre for the Validation of alternative methods
because it would concentrate on development rather than validation
of alternative methods.
We believe that such a centre in the UK would
be better funded and supported than abroad, as there is a great
public desire to see animal experiments replaced, public donations
towards such work are generous, and there is much good will towards
such work in the UK.
The UK Centre could also promote the use of
alternatives, co-ordinate and exchange information with ECVAM,
and it could have input into the animal project licensing process
(but without holding up the process).
It would be important for the Centre to be joint
funded, and the Home Office is a natural point from which to co-ordinate
such an effort as there is already a structure in place, and in
addition, the Animal Procedures Committee already has volunteers
co-ordinating their own research spend in this field. For example,
the Lord Dowding Fund plans to spend in the region of £220,000
on non-animal research projects during 2002, and the Animal Procedures
Committee spends slightly more. Drawing together research effort,
budgets, and expertise in this field would be a logical step.
At present, the development of non-animal techniques
has little appeal to research as most are interested in obtaining
advances in medical research via whatever means are currently
available. A Centre would be a driving force to advance the development
of alternatives.
Establishing such a centre in the UK would put
our scientific community ahead of other countries as non-animal
techniques will become the favoured way to advance research. With
such a high standard of scientific research in the UK and with
a strong pharmaceutical industry it seems obvious that we should
lead the way in this.
Contribution to the licensing process
If the Home Secretary decides to abandon Section
24 of the Animals (Scientific Procedures) Act 1986 (the statutory
bar to access to information), and to draw animal experiments
under the Freedom of Information Act 2000, the UK Centre for Development
Alternatives could be of assistance in the licensing process.
The NAVS has campaigned for access to the technical
details of project licence applications, so that we can suggest
non-animal methods, or other sources of the information being
sought. If these technical details were made available as part
of the licensing process, the Centre for Development of Alternative
Methods could draw together experts to assist with this work.
The licensing process would not be held up in
any way. The project licence applications would simply be open
to input, and any organisations or individuals wishing to contribute
would be required to put forward their suggestions within the
normal time frame currently set by the Home Office Inspectorate
(we understand that project licence applications are presently
processed in approximately forty days).
Areas of research where animals are used could
be identified, and a strategy for developing alternatives could
be planned.
Freedom of Information/Repeal of Section 24 of
the A(SP) Act 1986/Board of Assessment
The blanket of secrecy over animal experiments
has existed for over a hundred years. Information could not be
released under the previous legislation, the 1876 Cruelty to Animals
Act. Section 24 of the 1986 Act makes it a criminal offence to
divulge information on animal experiments.
This policy of total secrecy, pursued by successive
governments, only to convince a concerned public that there is
something to hide. It also fuels anger and frustration amongst
those who are opposed to the use of animals in research, but feel
that their voice is not heard and that there is little that they
can do to make a difference.
In order to move this debate forward, a radical
step needs to be taken by a Government with the courage to make
a difference.
The debate about whether animals should be used
in research currently takes place several years after the event,
if the work is published. This debate needs to take place before
the licence is granted.
Yet, under Section 5(5) of the 1986 Act, the
Home Secretary should only sign a licence to allow animal experiments
if he is satisfied that non-animal methods have been explored.
In view of the current arrangements for the licensing process,
no-one (public, anti-vivisection groups, supporters, media) believes
that this exercise is carried out with any commitment or rigour.
It is not good enough for the Home Office to
have a "tick box" on a form, and now recently, a list
of papers, to reassure the public that non-animal methods have
been properly explored.
This Select Committee has an opportunity to
make a difference on this issue. If the technical details (personal
information is not necessary) of project licence applications
were put open to wider scientific scrutiny, organisations like
the NAVS could put forward experts to suggest non-animal alternatives,
or other sources of the information being sought.
These details are already held centrally, and
provision for a national, and international, scientific review
of project licence applications would be superior to the poorly-resourced
Local Ethical Review Process. It would also carry more weight
in the eyes of the public.
This need not hold up the licensing process.
The technical details could simply be made available as part of
the current process, with a time limit set for submissions.
Animal experiments should be drawn fully under
the Freedom of Information Act 2000. Currently, the Home Office
is still considering whether Section 24, the statutory bar which
needs to be reviewed, will be repealed. The Freedom of Information
Act already provides for protection of personal details, and for
protection of commercial confidentiality.
Section 38(1) of the Freedom of Information
Act deals with protecting personal information if disclosure could
endanger a person's health, and Section 41(1)(b) provides for
commercial confidentiality.
What should be challenged: Examples of duplication/other
methods available/information available (NAVS studies in UK Labs):
1991: St Bartholomews Medical School. An
NAVS Field Officer filmed rats undergoing an arthritis experiment,
severity classed as "substantial" pain. Yet the drugs
being examined (indomethacin, D-penicilliamine, dexamethasone,
cyclophosphamide) were already in use in patients, therefore previous
animal data, and human data, were available.
1993: Toxicol Laboratories (now Quintiles)
in Herefordshire, an NAVS Field Officer discovered a series of
tests being conducted for a weedkiller, ethofumestate (Nortron).
Yet this product had been on the market since 1972, was already
licensed under UK and USA regulations, and therefore had been
previously tested on animals. Furthermore, data on the product's
effect on humans, and the environment, would already be available.
1993: Toxical Laboratories, Herefordshire.
A study on dogs involving the drug artemether, and anti-malarial.
26 dogs were force-fed the drug for a Belgian company, Profarma.
Yet this drug had already been given to over a million patients
worldwide, with "remarkably few adverse effects." Therefore
both previous animal data, and human data, was available.
1995: Institute of Neurology: An NAVS Field
Officer observed rats being used in experiments in a study of
dexfenfluramine (and related molecules), a drug which had already
been given to five million patients worldwide over a 10 year period.
This group of drugs has been used in people as antidepressants,
and to suppress appetite. At the time of this report, a parent
compound, fenfluramine, had been taken by more than 20 million
people over a 30 year period, in more than 100 countries. Therefore
extensive human data, as well as animal data, were already available.
1994-95: Charing Cross & Westminster
Medical School: Pacemakers were given to dogs to induce heart
failure. The dogs suffered swollen abdomens and paws, loss of
appetite, and fluid-filled lungs. Yet results even differed between
breeds of dog (subspecies differences), whilst the differences
in coronary blood flow between dogs and humans are well known.
1998-99: Oxford University: Sheep were filmed
being used as part of an ongoing series of projects, studying
a pump designed to assist the heart after injury. The researcher
responsible for the pump had already conducted similar experiments
in the USA, and similar pumps were already in clinical use. Over
50 sheep were used; some had open and infected wounds, others
broke plates in their heads when they repeatedly head-butted the
walls. The researchers described some of this suffering as a "learning
curve."
Board of Assessment
Opening technical details to scrutiny by individual
members of the public in one level of commitment to replacing
the use of animals, but the NAVS would suggest that a more co-ordinated
approach would be more effective.
As we discussed at the hearing, it is not possible
for organisations with a remit to oppose all animal experiments
to become involved in the licensing of animal experiments. However,
there is a great deal that such organisations can contribute,
and would like to contribute, in terms of bringing in other expertise,
and promoting non-animal research.
We therefore suggest that a jointly-funded Board
of Assessment be set up to:
— scrutinise project licence applications;
— suggest non-animal techniques or
other sources of the information required;
— identify duplication or other techniques
being used elsewhere;
— create a centralised database of
non-animal alternatives;
— develop a strategy for replacing
the use of animals;
— advise the Animal Procedure Committee.
The Board could be comprised of experts in various
fields, representing the groups on the Board, and costs to be
shared by the members and the Home Office. This Board could work
closely with the Centre for the Development of Alternative Methods,
and it would work alongside the licensing process.
Animal Procedures Committee
The NAVS believes that a major overhaul of the
structure and administrative arrangements for the 1986 Act is
urgently required. The basic structure (in terms of administrative
arrangements and an advisory committee) that we have now is, after
all, the same as under the 1876 Act.
The animal research industry has grown enormously
since these arrangements were set up, and the use of GM animals
is growing at an alarming rate. The simple system of an Inspectorate
authorising licences for signature by the Home Secretary in not
sophisticated enough to meet the need.
We believe that Animal Procedures Committee
should be given real power, and should be in control of the licensing
process. It should be expanded, become a full-time governing and
assessment body, and be given a larger budget. It could then co-ordinate
effort through the alternatives development centre and through
the board of assessment.
Home Office Inspectorate: A Policing Force
The public has no confidence in the Inspectorate
because of the secret nature of its operations and deliberations,
and because it is unable to protect laboratory animals from suffering.
During the debates over the introduction of
the 1986 Act, the public and media were given the impression that
the series of three licences (personal, project, designated establishment),
together with the Named Animal Care and Welfare person, the Named
Veterinary Surgeon, Designated Establishment Certificate holder,
backed up by an Inspectorate, would all provide laboratory animals
with protection. None of these certificates, and none of the named
persons, and certainly not the Inspectorate, has a priority of
animal protection over industry interests. In fact, none of these
responsible persons and certificate and licence holders can actually
prevent suffering.
Feldberg
In 1991 the Medical Research Council (MRC) published
the report of its enquiry into the Feldberg case, at the National
Institute of Medical Research. Professor Feldberg had been burning
rabbits with lamps, and the animals had been drifting in and out
of consciousness. He had also cut open conscious and struggling
animals. Considerable suffering had been caused by lack of anaesthesia,
and by crude and sloppy laboratory practice.
The MRC report exposed the sham of the 1986
Act:
— the Home Office Inspectorate had
expressed concerns about Feldberg's methods as far back as 1998;
— Home Office inspectors do not consider
it their job to seek out and report upon improper laboratory practice
(this position was supported by the MRC and the Home Office);
— the Named Veterinary Surgeon only
spent the equivalent of one day a week at a laboratory using 1,000
animals per week, on 50 projects;
— the Named Day to Day Care & Welfare
person did not consider it to be their job to check on the handling
of animals once they were in the hands of the researchers;
— the Designated Certificate Holder
had been aware but did not feel empowered to take action.
Thus, every level of "protection"
afforded in the 1986 Act and its Code of Practice was shown to
be worthless in the day-to-day laboratory environment.
Huntingdon Life Sciences/Channel 4
Laboratory workers abusing animals. This report
is well known to the Committee and therefore we do not need to
reiterate the facts here.
NAVS Investigations
The NAVS has studied working practices at seven
UK laboratories during the past decade. Our Field Officers filmed
and photographed what they saw.
Charing Cross & Westminster Medical School.
Of 52,435 rodents bred at the laboratory, just
15,198 were used in experiments. 3,889 died before they were weaned,
and a staggering 33,348 were gassed because they were surplus
to requirements. Our Field Officer observed inadequate killing
procedures and inadequately trained staff; live animals being
thrown into bags with the dead; animals struggling over each other
to escape the gas; animals suffering through sheer volume of killings.
Our report resulted in the suspension of the laboratory's licence,
and re-training of staff. The Home Office report had never been
made public.
The issue of overbreeding has still not been
addressed, despite the fact that this is one of a series of similar
examples.
Institute of Neurology
We observed cats suffering and dying in excruciating
pain after sciatic nerve/vaccine experiments. In one instance,
laboratory personnel were unable to relieve the suffering promptly,
due to being unable to get permission to kill the animal; then,
several attempts were made to kill the animal before it was finally
relieved of its suffering. Following our report, the experiments
were suspended and the veterinary surgeon reviewed the experiments.
The Home Office report has never been made public.
A Code of Practice/Primate Facility issue: A
mentally-disturbed primate, Alice, was filmed constantly circling
her cage. She had various injuries about her body. The Institute
claimed that she had arrived in that state. Alice had been supplied
by Cambridge University some months previously.
Oxford University
NAVS Field Officer observed a generally casual
attitude towards animal care amongst the laboratory personnel.
Technicians were filmed laughing and joking as they smashed mice
against lab benches in order to kill them. In one instance, a
technician missed the side of the bench, let go of the animal's
tail and sent it hurtling to the floor. The still living animal
was then picked up and killed. Technicians played football in
a corridor alongside rodents being gassed. Mice that escaped from
cages and were running loose were flicked hard against the wall
to stun them, making capture easier. Rabbits were left with large
wounds to the throats during experiments. A rabbit was found dead
in a cage following a bone cutting/stretching procedure which
should not have been terminal.
A Code of Practice issue/Severe overcrowding:
One researcher had 16 experimental mice crammed into one cage.
A different role for the Inspectorate
As a minimum, there should be one Inspectorate
per establishment.
Although the scientific assessment side of the
Inspectorate's role must remain, the NAVS strongly advocates that
the Inspectorate should become a policing force, in addition to
the assessment role.
Currently, the Inspectorate and Home Office
officials regard the 1986 Act as an industry-regulating measure,
not an animal welfare Act. This philosophy must change. The Inspectorate
must take more account of the interests of the animal.
Successive government assurances have led them
to believe that there exists a policing force in UK laboratories.
It is important that animal experimenters know
that when they are licensed to subject animals to pain and suffering,
they will be monitored by a policing force which should represent
the welfare of the animal, not just the interests of academics
and industry.
Any role less than one representing the interests
of animals will inevitably result in lack of public confidence
in the role of a government Inspectorate.
NAVS Policy on violence
The NAVS is opposed to all violence to humans
or other animals. We believe that people have the right to demonstrate
outside laboratories, provided that activities stay within the
law.
Jan Creamer
Director, NAVS, Lord Dowding Fund
March 2002
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