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Many areas of biomedical research focus
on the study of human-specific diseases
and medical concerns for which induced animal
models are seldom, if ever, appropriate
or scientifically relevant. This largely
reflects obvious species-specific differences
in anatomy, biochemistry, physiology, pharmacokinetics,
and toxic responses. Use of replacement
alternative methods, especially incorporating
human cells and tissues, avoids such confounding
variables.
A specific example of a basic research
alternative method, and one that potentially
has saved up to one million animals, is
the in vitro production of monoclonal
antibodies (MAbs), which are used in nearly
every field of biomedical research and critical
areas of clinical practice.
The widely-used ascites method of producing
MAbs, involves injecting cells into rodent
abdominal cavities and is extremely painful
and unnecessary. AAVS filed a petition with
the National Institutes of Health (NIH)
in 1997 requesting that the agency prohibit
its researchers from using the ascites method
to produce MAbs.
As a result of this and a scientific workshop
sponsored by AAVS affiliate, the Alternatives
Research & Development Foundation, that
illustrated international support for in
vitro production of MAbs, the NIH changed
its policy to state that its researchers
and those who receive funding from NIH must
use in vitro alternatives as the
default method for MAb production.
EXAMPLES OF RESEARCH ALTERNATIVES
USED IN THE UNITED STATES
- I-MAb Gas Permeable Tissue Culture Bags
are used to produce monoclonal antibodies
for research diagnostic and clinical purposes.
Developed by the ARDF -- could replace
up to one million mice a year.
- National Library of Medicine Visible
Human Project utilized actual human cadaver
cross-sections, CAT scans, and computer
programs to develop new surgical techniques
and research perspective.
- Organotypic cultures of human brain
slices are used to study neurobiochemistry,
neurophysiology, and drug efficacy.
- Short, direct non-invasive magnetic
pulses allow precise stimulation of brain
cells/regions in human volunteers for
neurosciences.
- Use of mathematical models and computer
simulations in physiology, cardiovascular,
pharmacology, and neurosciences (e.g.,
neural networks).
- Use of non-invasive functional magnetic
resonance imaging (fMRI) and magnetoencephalography
(MEG) to study neuroanatomy and neurophysiology
in human patients and volunteers.
- Use of three-dimensional human cell
cultures to study drug penetration and
characteristics of the blood-brain barrier.
- Use of echocardiography, color-coded
dopler imaging and abdominal sonography
as non-invasive methods for cardiovascular
research in human patients and volunteers.
- Use of normal and pathological human
cell and tissue cultures to identify disease
processes and treatments.
- Use of three-dimensional bioengineered
human skin cultures to study effects of
burns and ultraviolet exposure.
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