Biomedical Engineering Reference
In-Depth Information
past seemed prohibitive, government regulation, and
protests against the use of animals in research, the long-
term use of nonhuman primates in research and testing
seems likely to continue. While such use in the USA was
unquestionably buoyed up by the public support for AIDS
research, the creation of breeding and infrastructure
resources that accelerated during this period represent long-
term investments, both domestically and abroad, that have
removed the supply uncertainties the National Primate Plan
addressed in the 1970s. Now that it is clear that nonhuman
primates will be available for research and testing and that
there are research sponsors and users prepared to pay the
costs, attention has focused on improving and assuring
animal health and quality and on developing and providing
nonhuman primate models that better meet the needs of
biomedical research.
As in the past, basic research in the future will justify
the use of nonhuman primates for providing the models
essential for research in microbiology and infectious
disease including AIDS and most recently, bioterrorism;
the neurosciences including the dementias, cognitive,
behavioral, and neurological disease; reproductive biology;
new models of pediatric medicine; biochemistry; genetic
and molecular biology; pharmacology; and drug safety
assessment (
Medical Research Council, 2006
).
More of this work is likely to be done too in those Asian
countries that have already become homes to CROs, where
there is less social opposition to animal research, less
regulation, and lower costs are an attraction. However, this
attraction may prove to be temporary. Those firms gener-
ating data from nonhuman primates to support new drug
applications will ultimately have to meet the regulatory
requirements of those countries offering the most attractive
markets, and, as well-publicized violations of human rights
have shown, off-shoring may not provide immunity from
public concerns at home about how research animals are
cared for and used elsewhere in the world. The number of
animal care and use programs that presently are accredited
in Asia, 16 in the PRC and six in India for example, most of
them CROs, provided just one indicator that meeting
internationally acceptable scientific and ethical standards
was regarded as important to the success of these activities
(
www.aaalac.org
, 2010).
Conclusion
In basic and publicly sponsored research, it is likely that
more research in the future involving nonhuman primates
will be done in fewer places and that those places will be
full-scale primate centers. With new knowledge, such as the
application of breakthroughs in genomic research, this
work will be done with greater sophistication and perhaps
offer more opportunities along the way to implement the
three R's, conserve animal use, and limit costs. It may well
become impossible to get a paper published or a new drug
approved based on work done anywhere in nonhuman
primates that are not SPF and genetically tested.
The constraints upon using nonhuman primates in
research, as this history suggests, may very well become
tighter. Some investigators, who might earlier have been
able to justify using nonhuman primates in their research,
will not choose or be able to do so in the future. Unfor-
tunately, rather than being in mainstream, goal-oriented
appliedresearchandtestingwheremuchoftheworkin
nonhuman primates occurs, these investigators are more
likely to occupy the fringes in basic research which has
proven to be such a fertile area in the past for discovery. It
is easy to imagine in an increasingly constrained research
climate that initial proposals for performing the Nobel
prizewinning work of Hubel and Wiesel in monkeys and
cats on the postnatal development of the visual cortex
(
Hubel and Wiesel, 1979
), Harlow's work on the psycho-
logical impairments of social deprivation (
Suomi and
Leroy, 1982
), or even the efforts connected with the
serendipitous circumstances surrounding the discovery of
SIV (
Apetrei et al., 2006
) might not be warmly embraced
by institutional animal care and use committees. More
than ever, it may prove harder to assure that the support
Pharmaceutical and Biotechnological
Research
Research, development, and testing in industry, namely
pharmaceuticals, biologicals, and biotechnology, has
depended heavily on the use of nonhuman primates and
this may well, as the case has been in Europe, continue to
grow to the point in the USA and elsewhere where it
eventually may overshadow their use in basic research.
The pharmaceutical industry is exquisitely sensitive to
public and regulatory demands to assure the safety and
effectiveness of products it brings to market and the
potential rewards are huge. Regardless of the availability
of other models, these industries and their regulators will
likely continue to prefer the use of nonhuman primates as
the most expeditious, and final, pre-clinical means to
assess the promise and assure the safety of products for
human use. While much of this preference in the past has
been broadly based on the close physical resemblance and
phylogenetic relationship of nonhuman primates to man,
genetic and molecular research is providing more evidence
all the time that this preference is warranted. For example,
the unique value of using nonhuman primates is clear
where potential new products are only pharmacologically
active in primates or where a cross-reactive expression of
activity occurs only in nonhuman primates (
Johnson and
DeTolla, 2009
).
