Biomedical Engineering Reference
In-Depth Information
stages, respectively. Products are heralded as providing more targeted drug delivery that may be the
key to greater success in treating cancer and other illnesses. At the same time, there are those who
sound a note of caution due to the perceived potential for serious human adverse health effects because
of the different characteristics of materials at the nanoscale level that come into contact with biological
systems. It is postulated that generally smaller particles may be more toxic, with doses increasing as
particle size decreases. It is claimed that present risk assessment methodologies are not sufficient to
address this toxicity because they generally consider mass alone, whereas with nanotechnology the
assessment must be of the number of particles and surface area. The critics claim that there are little or
no data on the physiological response to nanoparticles. AÂ recurrent concern, for example, is the mobil-
ity of nanoparticles, such as the potential for particles to pass freely in the bloodstream and cross the
blood-brain barrier to affect neurological function. Because of the severe consequences of these and
other anticipated biological interactions, some call for strict regulation of medical products utilizing
nanotechnology, or even the ban of such products, until such time as controlled research establishes
the safety of nanoparticles in specific applications. Conversely, proponents of the use of nanotechnol-
ogy point to the lack of substantiated reports of harm and argue against overregulation that could stifle
the development of products and material that could greatly benefit society.
Governments reviewing the need to regulate the use of nanotechnology to respond to questions
of safety are faced with the most difficult sort of decision. There are at least identifiable theoretical
risks that must be considered, but there are equally compelling arguments that most of the materi-
als being developed on the nanoscale, such as nanosilver and titanium dioxide, pose no more risk
of adverse health consequences than do their macro counterparts. There is strong pressure on a
national level in many countries to support the development of products using nanomaterials, or fall
behind the relentless press of competition for commercial strength throughout the rest of the world.
Nanotech companies are also under pressure to justify the extensive investment already made and
that needs to continue to be made into the future in advance of successful commercialization.
Companies state repeatedly that they cannot survive and prosper in the face of stifling regulation.
Regulatory bodies must take all these factors into account and develop a rational system that will
signal to the public that its health and safety interests are being protected, while assuring developers
and supporters that their effort will not be compromised if certain safeguards are observed.
15.3 REGULATORY CHALLENGES
A major problem confronting any governmental body considering the need to regulate nanotechnol-
ogy is how new the technology is, the lack of evidence regarding the nature of the materials being
used, and the effect they might have, individually and in the aggregate, on biological systems, and
the short- and long-term effects on the environment. There is little agreement in the scientific com-
munity on the protocols for studying nanomaterials; little commonality in terms of the materials
being tested; little in the way of long-term results; considerable inconsistencies in results, making
comparisons difficult; and virtually nothing in the way of clinical testing.
The governing bodies of nations in the global nanotechnology race do not have the option of
doing nothing when dealing with medicines or hardware used in serious situations, and the release
of nanomaterials in the environment. The specter of some potential disaster resulting from the
perceived lack of regulatory attention lurks in the background, and critics are unrelenting in their
push to get attention for regulation. Evidence of potential harm, such as alleged harm resulting
from exposure to some types of carbon nanotubes (CNTs), cannot be ignored. At the same time, as
mentioned above, there is little hard evidence of any adverse effects being reported from the use of
nanomaterials in humans, and that cautions against overreacting—particularly given the national
and company competitive concerns.
A tempting choice for a regulatory body is the application of existing regulatory provisions
for pharmaceuticals and medical products to ones produced by, and/or containing, nanomateri-
als. Doing so would circumvent the delays caused by the rulemaking process that developing an
