Nanomedicine: Obtaining the Benefits, Managing the Risks
The phrase “small is beautiful” has taken on new meaning to
Some nanomedicine drug-delivery systems and anti-cancer drugs
those involved in the scientific field known as nanotechnology,
are already in use. Many other applications are in various phases
which involves engineering and utilizing materials at the nano-
of clinical or pre-clinical testing, and, if found safe and effective,
meter scale – that is, as small as one-billionth of a meter. Reduced
may reach the market in five to 12 years. More advanced nano-
to these minute dimensions, substances often undergo significant
medicine products – such as biocontainers for medical diagnostics
changes – for example, carbon becomes stronger than steel and
and cell treatment – are in earlier stages of development.
copper is transparent.
The increasing ability of science to compress materials to the submicroscopic level is affecting many fields of human endeavor. Current and emerging nanotechnology applications include advanced energy generation and storage systems, as well as new chemical additives and industrial materials. More than 300 products with nano-scale ingredients are already on the market, ranging from sunscreens to bowling ball coatings.
Regulatory and Risk Issues
Despite the accelerating pace of nanotechnology progress, many fundamental regulatory issues are only now being addressed
by the U.S. Food and Drug Administration (FDA). These include defining what constitutes a nanotechnology product, establishing regulatory authority over various types of products, adopting labeling requirements, and calculating the health and environmental impact of emerging applications.
One rapidly developing area of nanotechnology research is nanomedicine, the process of “using molecular tools and molecular knowledge of the human body” for the purpose of diagnosing and treating illness. (Freitas, R., Nanomedicine, Vol. 1: Basic Capabilities, Georgetown, Texas: Landes Bioscience, 1999.) The swift progress of nanomedicine research makes it necessary to understand the risks and begin the process of limiting potential exposure.
Risk assessment is one of the major challenges facing the FDA, as techniques designed for macroscopic materials may be unreliable for nanotechnology products. A National Research Council report (available at http://www.nap.edu/catalog.php?record_id=11752) noted that until the risks associated with nanotechnology are more clearly understood, “it is prudent to employ some precautionary measures to protect the health and safety of workers, the public
and the environment.”
Nanomedicine may potentially revolutionize our ability to screen,
This precautionary philosophy applies equally to healthcare organ-
diagnose and treat conditions ranging from cancer to cardio-
izations. While the promise of nanomedicine is bright, the risks
vascular disease to diabetes. Scientists are at work on the following
and ethical questions posed by these advances must be consid-
projects, among many others:
ered carefully. Major potential risks include
- infection and genetic testing tools that are faster, more
accurate and less invasive than conventional methods
- nanoneedle and pulsed laser surgery that alters cell
structures without damaging surrounding areas
- targeted drug-delivery systems that transport the drug
exactly where needed and monitor its effect
- nanotube-based biosensing devices that provide in vivo
diagnostic testing capabilities, such as tracking electrolyte and blood glucose levels
- gold-coated nanoparticles that destroy individual tumor
cells while leaving nearby healthy cells unharmed
- “intelligent” synthetic biomaterials that mimic body
- possibly heightened toxicity of free nanoparticles, which may be able to bypass the body’s defenses and interfere
with basic biological...
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