| Frequently
asked questions
Why are animal studies
still used in pharmaceutical research?
Because they are still essential and also a legal requirement
to ensure that new medicinal products are safe and effective.
Only with animal studies is it possible to predict how the
human body will react to an active substance. The government
expressly requires studies to be conducted in animals for
this purpose.
Many vaccines for animals and humans (e.g. against rabies,
polio, hepatitis or meningitis) could not have been developed
without animal studies. The same applies to many drugs used
in the treatment of conditions such as cardiovascular disease,
diseases of the central nervous system, cancer, diabetes or
the immune disorder Aids.
That does not stop us searching intensively for other methods,
of course, and Bayer is researching alternatives intensively.
But these cannot replace animal studies completely.
Can the results from animal studies
actually be extrapolated to humans?
In most cases, yes. Because the body functions of humans and
mammals are similar - extraordinarily so, in fact. On the
basis of animal studies, it is possible to tell what effects
a drug will have in the human body. This applies to most reactions,
both the desired ones and, of course, the adverse ones.
According to the German Animal Welfare
Law, animals are our fellow creatures. How can it be justifiable
at all to sacrifice them for research purposes?
Medical and pharmaceutical studies in animals are not an end
in themselves. They are only justified because they improve
the health and well-being of humans - and also of animals,
by the way: most drugs used in sick or injured animals are
often just slight variations of medicines which also help
people. Active ingredients such as antibiotics, analgesics,
anti-inflammatory and cancer drugs are used equally in human
and veterinary medicine. However, conducting animal studies always demands a high level of responsibility. Animals must be spared any unnecessary suffering - all Bayer employees involved in animal studies are educated about this and receive appropriate training in order to meet this important requirement.
What are “alternative methods”?
These are study and test methods which involve fewer animals
or which dispense with the need for animals altogether. Bayer
works actively to develop such alternative methods and also
uses them, of course. A current example is the 3T3
NRU phototoxicity test .
So why don’t scientists use alternative
methods such as computer simulations more frequently?
Because they are unfortunately still nowhere near as informative
as animal studies. Computer programs are now capable of simulating
simple physiological processes within a limited framework.
Nothing less - but also nothing more. But we do use such alternative
methods wherever it makes sense to do so, of course.
Who monitors animal studies - and what
kind of laws have to be obeyed?
Within Bayer, animal studies are monitored by the Animal Welfare
Officer. The regulatory veterinary authorities also carry
out random inspections. The legal basis for this is the German
Animal Welfare Law. Among other things, this law specifies
that the number of studies conducted must be kept to the absolute
minimum required. It is also necessary to ensure that the
objectives of the study cannot be achieved by other methods,
for example. Bayer must also comply with the German Medicines
Law, of course. This requires an active ingredient to be tested
in animals before it enters clinical trials.
In which research areas are animal
studies conducted at Bayer?
In the areas of health (HealthCare), crop protection (CropScience)
and in the departments responsible for environmental matters
(Industry Services).
Where do the laboratory
animals come from?
Almost exclusively from qualified and specially licensed laboratory
animal breeders who are continuously monitored by the veterinary
authorities and assessed personally by the Animal Welfare
Officer. A few exceptions to this are: agricultural livestock
and fish, for which there are no special breeders. Bayer therefore
obtains these animals from selected farms and fisheries.
Who looks after the
laboratory animals at Bayer?
A committed team of veterinarians, biologists, biology lab
assistants and veterinary nurses who work closely with the
“Animal Welfare Office” and the Animal Welfare
Officer. The basis for their joint efforts are the conditions
of the German Animal Welfare Law. These include feeding and
housing animals in a manner appropriate to their species.
And providing the highest level of hygiene and health care.
In which animal species does Bayer
conduct studies?
Mainly rodents, particularly mice and rats. This is because
their bodies are very similar to the human body and also because
it is very easy to keep them in a manner appropriate to their
species under laboratory conditions.
What role do ethical principles play
in animal studies?
A very important one. Animals are our fellow creatures and
must be protected and treated accordingly. This is also the
ethical basis for the legal requirements and Bayer’s
principles for conducting animal studies. Animal studies may
only be conducted at all if they are expected to be of significant
benefit to the health of humans and animals. At Bayer, it
goes without saying that everything is done to minimize any
suffering by animals. And all new studies are reviewed scientifically
to check whether they are really necessary. One of the consequences
of these efforts is that the number of laboratory animals
at Bayer has decreased
continuously in recent years.
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