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Nanotoxicology and Nanomedicine: Making Hard Decisions ⁎ Igor Linkov, Phd,A, F

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Nanotoxicology and Nanomedicine: Making Hard Decisions ⁎ Igor Linkov, Phd,A, F Available online at www.sciencedirect.com Nanomedicine: Nanotechnology, Biology, and Medicine 4 (2008) 167–171 www.nanomedjournal.com Short Communication: Toxicology Nanotoxicology and nanomedicine: making hard decisions ⁎ Igor Linkov, PhD,a, F. Kyle Satterstrom, MA,b Lisa M. Corey, MSc aUS Army Engineer Research and Development Center, Brookline, Massachusetts, USA bHarvard University School of Engineering and Applied Sciences, Cambridge, Massachusetts, USA cIntertox Inc., Seattle, Washington, USA Abstract Current nanomaterial research is focused on the medical applications of nanotechnology, whereas side effects associated with nanotechnology use, especially the environmental impacts, are not taken into consideration during the engineering process. Nanomedical users and developers are faced with the challenge of balancing the medical and societal benefits and risks associated with nanotechnology. The adequacy of available tools, such as physiologically-based pharmacokinetic modeling or predictive structure-activity relationships, in assessing the toxicity and risk associated with specific nanomaterials is unknown. Successful development of future nanomedical devices and pharmaceuticals thus requires a consolidated information base to select the optimal nanomaterial in a given situation—understanding the toxicology and potential side effects associated with candidate materials for medical applications, understanding product life cycle, and communicating effectively with personnel, stakeholders, and regulators. This can be achieved through an innovative combination of toxicology, risk assessment modeling, and tools developed in the field of multicriteria decision analysis (MCDA). Published by Elsevier Inc. Key words: Nanotoxicology; Risk assessment; Multicriteria decision analysis Nanomaterials have the potential to revolutionize medi- require allowing for an uncertainty in basic knowledge cine because of their ability to affect organs and tissues at the that is much larger than the uncertainty for other materials molecular and cellular levels. Current research is focused on and pharmaceuticals. To combat the uncertainty, decision the medical applications of nanotechnology, whereas side makers need an understanding of product life cycle and the effects associated with their use, especially the environ- ability to communicate effectively with personnel, stake- mental impacts of their manufacture and disposal, are holders, and regulators. This can be achieved through an generally not taken into consideration during the engineering innovative combination of toxicology, risk assessment process. Incorporating environmental concerns into nano- modeling, and tools developed in the field of multicriteria material engineering and nanomedicine development is decision analysis (MCDA). important, but it greatly increases decision complexity. Even though the risk assessment paradigm successfully Biomedical community needs used by the scientific community since the early 1980s may be generally useful, its application to nanomaterials would Nanomaterials have been promoted as a revolutionary technology for cell and tissue engineering, medical device development, and the encapsulation and delivery of drugs, Received 15 April 2007; accepted 28 January 2008. diagnostics, and genes. Advances in nanotechnology have led This study was supported in parts by the US Army Engineer Research to the introduction of many nanomaterials in these areas, and and Development Center. ⁎ the Nanomedicine Initiative of the National Institutes of Health Corresponding author. US Army Engineer Research and Develop- Roadmap for Medical Research initiative predicts that ment Center, 83 Winchester Street, Suite 1, Brookline, Massachusetts 02446, USA. nanomaterials will begin yielding significant medical benefits E-mail address: [email protected] (I. Linkov). within the next 10 years. 1549-9634/$ – see front matter. Published by Elsevier Inc. doi:10.1016/j.nano.2008.01.001 Please cite this article as: I. Linkov, F.K. Satterstrom, L. Corey, Nanotoxicology and nanomedicine: making hard decisions. Nanomedicine: NBM 2008;4:167-171, doi:10.1016/j.nano.2008.01.001. 168 I. Linkov et al / Nanomedicine: Nanotechnology, Biology, and Medicine 4 (2008) 167–171 Despite the widespread use of nanomaterials, under- When a nanomaterial is used for a medical application, it standing of the toxicity and potential health risks associated is intentionally given to a patient because of some unique with nanomaterial use is extremely limited. In fact, toxicity property that its size (and often chemistry) imparts. For issues related to nanomaterials used in nanomedicine are example, the nanosized particles may have the ability often ignored.1,2 Thus, along with the development of to access different tissues than larger particles, such as novel nanoparticles, experts in related scientific fields are crossing the blood-brain barrier, or to be tagged with specific calling for a simultaneous assessment of the toxicological antibodies to home in on and be taken up by specific cells. and environmental effects of nanoparticles.3 Recent in vivo Nevertheless, nanomaterials can cause side effects, and a and in vitro studies have suggested that inhalation and toxicity assessment requires knowledge of their metabolism dermal absorption of some nanomaterials may have adverse and distribution in the body. A variety of techniques are health effects,3,4 and the use of medical products containing currently available for determining the distribution of a nanomaterials may lead to chronic health risks.5 Spurred by nanomedicine in a patient, such as radiolabeling, which can such reports, regulatory agencies, as well as the popular and be used to evaluate distribution and uptake into specific scientific media, are shifting their focus from the initial cells and tissues. Distribution depends on several factors, euphoria about the potential of the technology to concern including the mechanism of targeting. Cancer cells can be about possible deleterious effects resulting from nano- targeted using antibody conjugation to a medication; direct material manufacture and use. targeting can be enabled so the nanomedicine can be taken The US Environmental Protection Agency (EPA) has up by specific cells; and nanomedicine can passively diffuse raised concerns about the use of nanosilver in several into tissues or cells, for example taking advantage of the consumer products already on the market. Uncertainty leaky endothelia in the blood vessels around some solid about the health impacts associated with nanotechnologies tumors. In each case it is possible for the medicine to reach and their potentially uncontrolled market growth has a different population of unintended cells. This situation resulted in calls from environmental and political bodies to is complicated by the possibility of making use of many limit the use of nanomaterials, increase the stringency different delivery routes, including oral, transdermal, intra- of governmental regulations, and, in extreme cases, ban the venous, and inhalation. Further considerations include use of nanomaterials completely. A better understanding of whether the nanomaterial stays localized or re-enters the these materials is clearly needed, yet experience with circulatory system and how it is used or metabolized. inorganic and organic chemicals may not be directly relevant Specific nanomaterials will bring with them their own to nanomaterials, in that their physical and biological specific factors to consider. properties are often determined by novel relationships Multiple variables could also influence nanomedicine between their size, structure, and the presence of added exposure assessment, including characterization of varia- functional groups. tions in biological reactivity, size, shape, charge, and route A framework of underlying questions remains to of administration, as well as factors that complicate the be addressed: straightforward estimation of exposure (e.g., metabolism, excretion, adduction to biological molecules, etc.). For • What are the specific nanomaterial properties that example, several studies on carbon nanotubes have shown should be characterized for nanomedical applications? that the toxicity and distribution of nanoparticles is • What data are available on nanomedicine toxicity, dependent upon the presence of functional groups, impu- exposure, and environmental fate and transport? rities, fiber length, and aggregation status.6,7 When a • Where are the data gaps? nanomaterial is not used for a medical application but • How do nanomaterial characteristics contribute to exposure is instead environmental, exposure estimation may toxicity in relation to nanomedical applications? be even less straightforward. • How do specific delivery mechanisms influence Given estimates of exposure and toxicity, the final step nanomedicine toxicity? involved in estimating the hazard of contaminant exposure • What is the role of concurrent exposures to multiple is the characterization of the dose-response function, that is, nanomedicines and pharmaceuticals? the likelihood of adverse health effects at varying degrees of exposure. By necessity, a dose-response assessment must be developed separately for each nanomaterial. Given the Difficulties in applying traditional risk required effort, detailed dose-response assessments will assessment framework not be possible for all nanomaterials. Decision tools and databases should be developed to facilitate use of all A risk
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