Biomedical Engineering Reference
In-Depth Information
procedures, and rapid escalation of costs, the general trend
in the use of primates in research and testing actually
showed signs of growth. Annual report data compiled from
registrants by the USDA's Animal and Plant Health Inspec-
tion Service (
http://www.aphis.usda.gov/animal_welfare
)
showed more than an 8% increase in annual usage of
nonhuman primates over the 5-year period between 2001
and 2006. Also, the US Fish and Wildlife Service's
nonhuman primate import data through 2008 showed
a continued rise to over 28 000, an increase of more than one-
third over the preceding 5-year period. More than two-thirds
of the imports were long-tailed macaques exported by the
PRC. However, data available from the Wisconsin NPRC's
PrimateLit database showed that the number of scientific
articles referencing the use of nonhuman primates had
grown from 3077 in 1975 to peak at 8951 in 2006 (
http://
primatelit/library/wisc/edu/
). However, that number
declined in the following three years to 7783. Perhaps such
factors as the increasingly high cost of doing nonhuman
primate research and the regulatory environment were
having a greater impact on nonhuman primate use in
academic research than they were in pharmaceutical
development and testing.
supporting its primate centers were probably the longest
running in the NIH's grant portfolio. Additionally, the NIH
along the way did allocate more funds for special needs
such as facility improvement and for breeding more SPF
macaques, primarily to meet the needs of AIDS research
(J. D. Harding, personal communication, 2010).
CDC Import Data, CRO, and Pharmaceutical
Activity
Nonhuman primate import data provided by both the CDC
(G. Galland, personal communication, 2007) and US Fish
and Wildlife Service (B. Perez, personal communication,
2008) showed much more dramatic growth between 2001
and 2006. According to the CDC data, imports rose to more
than 26 700 in 2006 from about 15 000 in 2001, a 78%
increase. By far, most of the imports were captive-bred
long-tailed macaques from the PRC, Viet Nam, Indonesia,
Mauritius, and the Philippines. During this period the
activity of CROs had also grown significantly, primarily to
meet the research, development, and testing needs of the
biotechnology and pharmaceutical industries. A number of
these were not only interested in meeting their immediate
research and testing needs but in acquiring breeding stock
as well.
The NPRC Program
NCRR support for its National Primate Research Centers
Program also continued to grow but not at the pace of the
overall NIH budget, which essentially doubled through the
1990s and beyond. During earlier times, direct support for
research resources had been the second largest item in the
NIH's extramural budget, but this was no longer the case.
The centers also experienced escalating costs from adapt-
ing to newer research needs such as biocontainment,
meeting the requirements of new regulations, updating or
replacing outdated physical facilities, and the addition of
another center to the NPRC's already painfully squeezed
center budgets. For example, the macaque that could be
purchased in 1970 for $400 cost $3500 to $7000 or higher
in 2010 depending on the source and species. Efforts by
centers to try and charge more of their costs directly to
research sponsors met with some success, but the price of
doing so often meant making sacrifices in those more
indirect center functions that had contributed to enhancing
their value to the broader scientific community, such as
improving animal management and quality assurance or
providing leads for new research. What became clearer
than ever during this time was the continued necessity of
providing adequate long-term core support for maintaining
and operating research resources such as primate centers.
While sponsors of research hoped that providing start-up or
seed money for such resources would be enough to even-
tually make them self-sustaining, actual experience showed
that
International
Data from Europe did not reflect the growth that occurred in
the USA. Use of nonhuman primates in the European
Union was reported to be relatively stable during this
period at about 10 000 per year (
Medical Research Council,
2006
). However, conspicuous growth occurred in a number
of Asian countries, particularly the PRC, where there were
already active monkey breeding programs. Such advan-
tages as lower costs, more dependable access to animals,
and a more relaxed regulatory environment almost natu-
rally led to extending breeding programs to include CROs.
The development and operation of such activities often
involved the close cooperation of western firms with
experience in managing and staffing CROs and catering to
the drug discovery and testing needs of small biotech-
nology and pharmaceutical firms. Foreign investment for
supporting such projects reportedly totaled millions of
dollars even in countries such as Viet Nam and Cambodia,
not to mention the PRC and Indonesia (G. Pucak and
P. Houghton, personal communications, 2008). Such CROs
were even making their appearance in India, where urban
populations of wild rhesus monkey populations, paradoxi-
cally regarded as pests, belligerent nuisances, and likely
unfit for research because of their endemic and zoonotic
disease status, were reportedly resurgent (
Southwick et al.,
2005; Maliq, 2007
). Whether CROs in developing coun-
tries could reliably provide the setting and data quality to
meet the regulatory requirements of developed countries
this seldom happened. To its credit,
the grants
