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Handling worker and third-party exposures to nanotherapeutics during clinical trials.

Authors
Ramachandran-G; Howard-J; Maynard-A; Philbert-M
Source
J Law Med Ethics 2012 Dec; 40(4):856-864
NIOSHTIC No.
20042038
Abstract
Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnologybased drugs and delivery systems had entered preclinical, clinical, or commercial development. The European Medicines Agency (EMA) reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health (NIH) data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast- enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells. In the short and medium term, the main use of nanoparticle medicinal products is to provide vectors carrying active components or to deliver materials that can be activated and/or detected at the site of interest. This includes reformulation of existing therapeutics as small particles to aid delivery - a strategy used in several products already marketed like Doxil and Abraxane. However, most current work is in the area of third-generation vectors that combine a biodegradable core and a polymer envelope (PEG) with a membrane recognition ligand. While previous uses of nanomedicines have included using liposomes as passive vehicles for drug transport, active nanomaterials with complex properties and functions in drugs are not too far in the future. These include self-assembling peptide nanofibers, scaffolds for tissue regeneration, sensors of biomarkers, artificial retinas, and chip-based nanolabs. These developments hold the potential to provide immense benefits for disease treatment in the near future. At the same time, the novel technologies also raise safety and ethical concerns in human subjects research (HSR) that may challenge the existing system of oversight. One aspect of HSR that has not received robust attention are concerns about occupational exposures of researchers and lab workers, and exposures of bystanders such as health care workers, family members, and caretakers during HSR using nanomaterials ("third-party" exposures). In principle, exposures can occur during the handling and administering of the pharmaceutical by the health care workers or the family members (if they are involved in drug administration). The high nanoparticle content of biological wastes excreted by research subjects also has been cited as a concern for potential exposure to bystanders and the environment. Laboratory containment and disposal practices, as well as excretion and shedding, can additionally release nanomaterials into the environment. There are several stages that precede the clinical trial phase of nanomedicine research, including the production of the raw nanomaterials, synthesis of the pharmaceutical in a lab or manufacturing setting, and preclinical drug studies in animals and in vitro. Most of the somewhat limited exposure information that we have so far is associated with such production, synthesis, and preclinical studies in industrial settings. Less is known about occupational exposures in the clinical trial phases and the post-marketing phase - both in terms of the types and magnitudes of the nanomaterial exposures as well as the types of workers who may be exposed. This paper provides a description of the types of potential nanomedicine exposures, the existing oversight framework for handling worker and third-party exposures, the deficiencies of that framework in clinical and residential settings, and possible new approaches to oversight.
Keywords
Nanotechnology; Medical-research; Medical-care; Drugs; Medical-treatment; Diagnostic-techniques; Cancer; Therapeutic-agents; Particulates; Biomarkers; Exposure-levels; Pharmaceuticals; Health-care-personnel; Health-care; Biological-material; Biological-agents; Biological-effects; Biological-factors; Environmental-exposure; Medical-personnel
CODEN
JLAEEO
Publication Date
20121201
Document Type
Journal Article
Fiscal Year
2013
NTIS Accession No.
NTIS Price
Identifying No.
B20130124
Issue of Publication
4
ISSN
1073-1105
NIOSH Division
OD
Source Name
Journal of Law Medicine & Ethics
State
MN; GA; MI
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