Hostname: page-component-8448b6f56d-xtgtn Total loading time: 0 Render date: 2024-04-15T11:27:56.842Z Has data issue: false hasContentIssue false

Building an Ethical Foundation for First-in-Human Nanotrials

Published online by Cambridge University Press:  01 January 2021

Extract

The biomedical literature and popular media are full of upbeat reports about the health benefits we can expect from medical innovations using nanotechnology. Some particularly enthusiastic reports portray nanotechnology as one of the innovations that will lead to a significantly extended human life span. Extreme enthusiasts predict that nanotechnology “will ultimately enable us to redesign and rebuild, molecule by molecule, our bodies and brains….”

Nanomaterials have special characteristics that could contribute to improved patient care. But the same characteristics that make nanotechnology promising also present risks to humans exposed to nanomaterials. A failure to appreciate these risks could jeopardize the research effort. As others have pointed out, if nanomedical interventions produce unexpected human harm, a loss of public and government support for nanomedicine is likely to follow.

Like other forms of medical innovation, novel nanomedical interventions require human testing to evaluate their safety and effectiveness.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Kurzweil, R., The Singularity Is Near: When Humans Transcend Biology (New York: Viking, 2005): at 227.Google Scholar
Hansen, S. Maynard, A. Baun, A., and Tickner, J., “Late Lessons from Early Warnings for Nanotechnology,” Nature Nanotechnology 3, no. 8 (2008): 444–47; Jotterand, F. and Alexander, A., “Managing the ‘Known Unknowns’: Theranostic Cancer Nanomedicine and Informed Consent,” in Biomedical Nanotechnology: Methods and Protocols, Hurst, Sarah, ed., (New York: Humana Press 2011): 413–429.CrossRefGoogle Scholar
Id., at 419.Google Scholar
Id., at 426.Google Scholar
Riehemann, K. Schneider, S. Luger, T. Godin, B. Ferrari, M., and Fuchs, H., “Nanomedicine Challenge and Perspectives,” Angewandte Chemie, International Edition 48, no. 5 (2009): 872897.CrossRefGoogle Scholar
National Institutes of Health, National Cancer Institute Alliance for Nanotechnology in Cancer, “Our Focus,” available at <http://nano.cancer.gov/about/focus> (last visited November 7, 2012).+(last+visited+November+7,+2012).>Google Scholar
See Riehemann, et al., supra note 5, at 883–885; Kim, B. Rutka, J., and Chan, W., “Nanomedicine,” New England Journal of Medicine 363, no. 25 (2010): 24342443; Jotterand, and Alexander, , supra note 2, at 413.Google Scholar
See Riehemann, et al., supra note 5, at 885.Google Scholar
Hoet, P. Bruske-Hohlfeld, I., and Salata, O., “Nanoparticles – Known and Unknown Health Risks,” Journal of Nanobiotechnology 2, no. 1 (2004): 12.CrossRefGoogle Scholar
Priestly, B. Harford, A., and Sim, M., “Nanotechnology: A Promising New Technology – But How Safe?” Medical Journal of Australia 186, no. 4 (2007): 187188.CrossRefGoogle Scholar
See Riehemann, et al., supra note 5, at 891.Google Scholar
Gwinn, M. and Vallyathan, V., “Nanoparticles: Health Effects – Pros and Cons,” Environmental Health Perspectives 114, no. 12 (2006): 18181825.CrossRefGoogle Scholar
See Priestly, et al., supra note 10, at 187.Google Scholar
Oberdorster, G., “Safety Assessment for Nanotechnology and Nanomedicine: Concepts of Nanotechnology,” Journal of Internal Medicine 267, no. 1 (2010): 89105, at 90; Riehmann, et al., supra note 5, at 891.CrossRefGoogle Scholar
Spagnolo, A. and Daloiso, V., “Outlining Ethical Issues in Nanotechnologies,” Bioethics 23, no. 7 (2009): 394402; Jotterand, and Alexander, , supra note 2, at 415.CrossRefGoogle Scholar
See Priestly, et al., supra note 10, at 187; Kim, et al., supra note 7, at 2442.Google Scholar
Faunce, T., “Nanotherapeutics: New Challenges for Safety and Cost-Effectiveness Regulation in Australia,” Medical Journal of Australia 186, no. 4 (2007): 189–91; Oberdorster, , supra note 14, at 97–98.CrossRefGoogle Scholar
See Spagnolo, and Daloiso, , supra note 15, at 398.Google Scholar
Kostarelos, K. Bianco, A., and Prato, M., “Promises, Facts and Challenges for Carbon Nanotubes in Imaging and Therapeutics,” Nature Nanotechnology 4, no. 10 (2009): 627633, at 631. The authors also reported that only one animal study of carbon nanotubes had documented prolonged survival in animals given the intervention.CrossRefGoogle Scholar
Resnik, D. and Tinkle, S., “Ethical Issues in Clinical Trials Involving Nanomedicine,” Contemporary Clinical Trials 28, no. 4 (2007): 433–41.CrossRefGoogle Scholar
Food and Drug Administration Nanotechnology Task Force, Nanotechnology (July 25, 2007), at 11, available at <http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/UCM2006659.htm> (last visited November 13, 2012).+(last+visited+November+13,+2012).>Google Scholar
Id., at 13.Google Scholar
Goldstein, B., “The Scientific Basis for the Regulation of Nanoparticles: Challenging Paracelsus and Paré,” UCLA Journal of Environmental Law & Policy 28, no. 1 (2010): 728, at 8.Google Scholar
See Food and Drug Administration, supra note 21, at 16–19.Google Scholar
Id., at 16.Google Scholar
See Gwinn, and Vallyathan, , supra note 12, at 1818; Jotterand, and Alexander, , supra note 2, at 422.Google Scholar
See Spagnalo, and Daloiso, , supra note 15, at 400.Google Scholar
See Food and Drug Administration, supra note 21, at 9 n. 13.Google Scholar
Editorial, “The Same Old Story,” Nature Nanotechnology 3, no. 12 (2008): 697.CrossRefGoogle Scholar
Center for Drug Evaluation and Research, Food and Drug Administration, Reporting Format for Nanotechnology-Related Information in CMC Review, available at <http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM214304.pdf> (last visited November 7, 2012).+(last+visited+November+7,+2012).>Google Scholar
See Oberdorster, , supra note 14, at 102.Google Scholar
See, e.g., Hansen, et al., supra note 2; “The Same Old Story,” supra note 30; Spagnolo, and Viviana, , supra note 15.Google Scholar
See “The Same Old Story,” supra note 30.Google Scholar
See also Hamburg, M., “FDA's Approach to Regulation of Products of Nanotechnology,” Science 336, no. 6079 (2012): 299300; Culliton, B., “Is Special FDA Regulation of Nanomedicine Needed? A Conversation with Norris E. Alderson,” Health Affairs 27, no. 4 (2008): w315–w317, available at <http://content.healthaffairs.org/content/27/4/w315.full> (last visited November 9, 2012).CrossRefGoogle Scholar
See Faunce, , supra note 17, at 189; Jotterand, and Alexander, , supra note 2, at 425.Google Scholar
Bawa, R., “Regulating Nanomedicine – Can the FDA Handle It?” Current Drug Delivery 8, no. 3 (2011): 227–34, abstract available at <http://www.ncbi.nlm.nih.gov/pubmed/21291376> (last visited November 9, 2012). In a 2010 paper, two FDA staff members discussed the possibility that nanoscale materials might present distinct health hazards, as well as the need for new testing approaches. Malghan, S. and Pena, Carlos, “Safety Issues in Pre-Clinical and Clinical Evaluation of Nanotechnology-Based Products,” in National Cancer Institute Cancer Nanotechnology Plan (2010), available at <http://nano.cancer.gov/objects/pdfs/CaNanoPlan.pdf> (last visited November 14, 2012).CrossRefGoogle Scholar
See Jotterand, and Alexander, , supra note 2, at 420–21.Google Scholar
Kimmelman, J. and London, A., “Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty,” PLoS Medicine 8, no. 3 (2011): 111, available at <http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001010> (last visited November 9, 2012).CrossRefGoogle Scholar
London, A. Kimmelman, J. Emborg, M., “Beyond Access vs. Protection in Trials of Innovative Therapies,” Science 328, no. 5980 (2010): 829–30.CrossRefGoogle Scholar
Dresser, R., “First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless,” Journal of Law, Medicine & Ethics 37, no. 1 (2009): 3850; Levin, L. and Danesh-Meyer, H., “Lost in Translation: Bumps in the Road Between Bench and Bedside,” JAMA 303, no. 15 (2010): 1533–1534.CrossRefGoogle Scholar
Kimmelman, J., Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation (New York: Cambridge University Press, 2010): at 3.Google Scholar
Kimmelman, , id.Google Scholar
Kimmelman, , id., at 117.Google Scholar
Kimmelman, , id., at 127–128.Google Scholar
See Hackam, D. G. and Redelmeier, A., “Translation of Research Evidence from Animals to Humans,” JAMA 296, no. 14 (2006): 17311732.CrossRefGoogle Scholar
Dresser, , supra note 41, at 40–41.Google Scholar
Kimmelman, , supra note 42, at 93.Google Scholar
See Wilson, J., “A History Lesson for Stem Cells,” Science 324, no. 5928 (2009): 727–28, discussing this danger in the context of embryonic stem cell research.CrossRefGoogle Scholar
See Kimmelman, , supra note 42, at 127; Hackam, and Redelmeier, , supra note 46; Leslie, M., “Immunology Uncaged,” Science 327, no. 5973 (2010): At 1573.Google Scholar
Kimmelman, and London, , supra note 39.Google Scholar
Jansen, L. Appelbaum, P. Klein, W. Weinstein, N. Cook, W. Fogel, J., and Sulmasy, D., “Unrealistic Optimism in Early-Phase Oncology Trials,” IRB: Ethics & Human Research 35, no. 1 (2011): 18.Google Scholar
See Bawa, , supra note 37.Google Scholar
NCI Alliance for Nanotechnology in Cancer, Nanotechnology in Clinical Trials, available at <http://nano.cancer.gov/learn/now/clinicaltrials.asp> (last visited November 9, 2012).+(last+visited+November+9,+2012).>Google Scholar
NCI Alliance for Nanotechnology in Cancer, Mission and Goals, available at http://nano.cancer.gov/about/mission (last visited November 14, 2012).Google Scholar
NCI Alliance for Nanotechnology in Cancer, Safety of Nanotechnology, available at <http://nano.cancer.gov/learn/now/safety.asp> (last visited November 9, 2012).+(last+visited+November+9,+2012).>Google Scholar
Hansen, , supra note 2, at 267.Google Scholar
See Lo, B. and Grady, D., “Strengthening Institutional Review Board Review of Highly Innovative Interventions in Clinical Trials,” JAMA 302, no. 24 (2009): 2697–98; Saunders, P. T., “The Duty to Register Phase I Trials,” American Journal of Bioethics 9, no. 8 (2009): 41–42.CrossRefGoogle Scholar
Wood, A. and Darbyshire, J., “Injury to Research Volunteers – The Clinical-Research Nightmare,” New England Journal of Medicine 354, no. 18 (2006): 18691871.CrossRefGoogle Scholar
Bawa, , supra note 37.Google Scholar
See Wolf, S. Gupta, R., and Kohlhepp, P., “Gene Therapy Oversight: Lessons for Nanobiotechnology,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 659684.CrossRefGoogle Scholar
See Lo, and Grady, , and supra note 59.Google Scholar
See Jotterand, and Alexander, , supra note 2, at 416–417.Google Scholar
See e.g., Jonsen, A., “The Artificial Heart's Threat to Others,” Hastings Center Report 16, no. 1 (1986): 911; Pierson, R., “Current Status of Xenotransplantation,” JAMA 301, no. 9 (2009): 967–969; King, N., “Accident and Desire: Inadvertent Germline Effects in Clinical Research,” Hastings Center Report 33, no. 2 (2003): 23–30.CrossRefGoogle Scholar