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Questions
and answers
What
law protects animals used in research?
UK research involving laboratory
animals is conducted under the Animals
(Scientific Procedures) Act 1986,
widely recognised as the most comprehensive
law of its kind in the world. Its
aim is to balance the legitimate
needs of research with the welfare
of animals. The law has many provisions.
All the research, including a detailed
explanation of its purpose, the
likely effects on the animals and
why the research cannot be done
in other ways, must be approved
in advance by the Home Office -
the government department that oversees
the Act.
What
animals do you use and how can they
help?
More than 80 percent of animals
used in UK medicines research are
rodents. Because of the similarities
between the human and animal body
and its functioning, most of the
research can be done in rodents.
Dogs, cats and monkeys together
make up less than .05 percent of
the total. Most of the other animals
are birds (mainly chickens, including
eggs more than halfway through gestation),
fish and rabbits. Except in special
circumstances that require the permission
of the Home Secretary, all animals
must be specially bred for research.
Stray pets are never used. Animal
studies tell researchers much more
about how a medicine is likely to
affect people than would be possible
using non-animals methods alone.
New medicines also go through extensive
tests in people once the preliminary
research indicates it is safe to
do so.
Why
don't you use alternatives?
We do. Some people may think that
the researcher has a choice between
an animal and a non-animal method.
But the researcher has no such choice.
If a validated alternative can provide
the necessary information, it must
be used. Whole areas of medicines
research that used to have to be
done in animals are now done in
other ways. However our biological
knowledge is still limited, so computer
simulations and test-tube methods
give only part of the picture. Some
questions must be addressed in the
whole living body. The pharmaceutical
industry is well known to work at
the forefront of technology and
use it to the full.
How
can you justify using animals to
make human medicines?
The use of animals in medicines
research is a complex moral issue
with no easy answer. Most of us
want to do the best for people and
animals but most people would accept
that human health and well being
come first. As few animals as necessary
should be used and they should be
spared all unnecessary distress.
But if we want to have new and better
medicines without taking unacceptable
risks with human life, then for
the foreseeable future, we have
to accept that animals will be needed.
Aren't
medicines developed for profit?
Of course medicine manufacturers
have to make profits. Today a medicine
takes an average of 12 years and
over £300 million to develop
and there are never any guarantees,
even right up to the end of that
period, that the medicine will ultimately
be safe and effective enough to
be approved for use by patients.
Only profit making organisations
can withstand this level of financial
risk and fund the next generations
of medicines. It is profits made
today which pay for research in
the future.
Why
are most procedures carried out
without anaesthetics?
Because most procedures are too
mild to justify the upset that would
be caused by giving a general anaesthetic.
Most procedures cause only mild
or momentary distress, so it is
right and proper that most experiments
are conducted without anaesthesia.
Giving a medicine orally, injections
or taking blood would not warrant
the disturbance caused by an anaesthetic
in animals, any more than it would
be in people.
The law requires that any pain,
distress or discomfort likely to
be experienced by the animal is
prevented or reduced to the minimum
possible given the nature of the
research, for instance, by using
pain killers, and by ensuring that
those doing the research have all
the necessary skills to perform
procedures in a way that causes
as little distress as possible.
Any animal suffering severe pain
or distress that cannot be alleviated
must, by law, be humanely killed
immediately, regardless of whether
the object of the research has been
achieved.
How
quickly can animal tests be reduced?
There has already been enormous
progress. Many areas of the research
process that leads to a new medicine
now require very few animals, one
of the main reasons why there are
about half as many animals used
in the UK now as was the case 20
years ago.
At the same time, advances in our
understanding of the genetic basis
of disease means that there is important
new research being conducted that
could not have been done in the
past. Millions of people are affected
by genetic disorders.
It is important, and morally right,
to keep the use of animals to a
minimum but it would be morally
wrong to put our concern for animals
first and thereby deny people living
with incurable, and sometimes untreatable,
conditions the chance of a healthier
future.
For more comprehensive information
on how numbers of animals needed
may vary from year to year - click
here
Animals
and people are different, so how
can information from animals help?
There are enormous biological similarities
between humans and other animals.
Certainly, there are differences
but compared to the similarities,
these differences are minor. Researchers
understand many of these differences
and design studies to take these
differences into account. As a result,
most of those effects that cannot
yet be predicted from computer and
test tube methods can be seen in
animals.
No one expects animals to tell
us everything we need to know. All
new medicines are also studied in
patients but only after scientists
and doctors feel confident it is
safe to do so. The information needed
to make these judgements cannot
currently be obtained from non-animal
methods alone. Because of the similarities
between humans and other animals,
coupled with the knowledge of researchers
and the veterinarians who work with
them, animal studies bridge the
gap between the test tube and the
patient.
But
what about medicines that are later
found to have problems, despite
animal testing?
Those same medicines have been
through years of human testing as
well and the problem was still not
found. Yet no one says that human
testing is therefore unnecessary.
There are many reasons why rare
side effects may not be seen until
after a medicine becomes available
and a great many people are taking
it (such as underlying medical conditions
of which the patient and doctor
were unaware or genetic factors
that will only affect a small portion
of the population). But it should
be remembered that no one expects
animal testing to give all the answers.
The aim is to find out as much as
realistically possible before the
tests in patients begin. That way,
the risks are greatly minimised
and doctors have a good understanding
of how those tests should be conducted.
Isn't
there a lot of repetition of animal
studies when there are similar medicines
to treat a medical problem?
No, that is not the case. Potential
new prescription medicines that
are different enough to be patentable,
(which means that the company is
protected from copying for a limited
number of years), are different
enough to have varied effectiveness
and safety profiles.
Data on different medicines based
on the same class of molecule, for
instance taxanes for breast and
ovarian cancer, triptans for migraine
or protease inhibitors for HIV and
AIDS, are not interchangeable. Neither
the company nor the Department of
Health could use data from one to
justify approval of another.
Nor would it be in the interest
of patients to suggest that different
but chemically similar medicines
should not be developed. Different
people respond better to different
medicines within the same chemical
group. In addition, people with
long-term conditions are likely
to need a range of medicines over
the years.
New prescription medicines should
not be confused with older prescription
medicines on which the patent has
expired and which can therefore
be copied without going through
the animal testing stage.
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