Nanotechnology, which involves manipulation of matter on a ‘nano’ scale, is considered to be a key enabling technology. Medical applications of nanotechnology are expected to significantly improve disease diagnostic and therapeutic modalities and subsequently reduce health care costs. However, there is no consensus on the definition of nanotechnology or nanomedicine, and this stems from the underlying debate on defining ‘nano’. This paper aims to present the diversity in the definition of nanomedicine and its impact on the translation of basic science (...) research in nanotechnology into clinical applications. We present the insights obtained from exploratory qualitative interviews with 46 stakeholders involved in translational nanomedicine from Europe and North America. The definition of nanomedicine has implications for many aspects of translational research including: fund allocation, patents, drug regulatory review processes and approvals, ethical review processes, clinical trials and public acceptance. Given the interdisciplinary nature of the field and common interest in developing effective clinical applications, it is important to have honest and transparent communication about nanomedicine, its benefits and potential harm. A clear and consistent definition of nanomedicine would significantly facilitate trust among various stakeholders including the general public while minimizing the risk of miscommunication and undue fear of nanotechnology and nanomedicine. (shrink)

This paper critically examines the volitional normative model of disease and its underlying nanotechnologic vision of medicine both defended by Robert Freitas. Having provided an account of this vision, we explicate the highlight of the model, which is a concept of disease based on individual values and preferences. The model’s normative positions are then critiqued based on our argument that the epistemic basis of Freitas’s vision of nanotechnologic medicine and, by extension, of his volitional normative model of disease is scientifically (...) flawed. An ethical and social critique of the model is then conducted on the basis of the model’s implicit ethical underpinnings. We argue that Freitas fails to justify the normativity of his model by not addressing the ethical issues that permeate it, one of which is the question of responsibility regarding the development of medical nanotechnology and the practice of new forms of medicine such as the one he envisions. We conclude that, due to its radically individualistic position, the model implies an unjustified view of nanoethics and relegates this field of ethics to the periphery of discussions of nanomedicine. (shrink)

From organ transplants to genetic therapies by way of the manufacture of replacement tissue, regenerative medicine incarnates a biomedical reasoning that is unique to contemporary society. As a re-engineering of the body, regenerative medicine is the most accomplished manifestation of contemporary biopolitics: it concretely announces the emergence of what sociologist Karin Knorr Cetina calls the ‘culture of life’, in which individual existence is symbolically assimilated to biological conditions. This article will examine the symbolic and ethical issues of regenerative medicine, notably (...) regarding representations of the ageing body. In doing so, it will place this new branch of biomedical research back into the context from which it emerged, with the goal of grasping the social and cultural suppositions on which regenerative medicine is based. The growing number of elderly people in Western societies is one such central element. This article therefore intends to demonstrate how regenerative medicine is rooted in the modern biomedical deconstruction of death, which underlies the contemporary technoscientific fantasy of indefinitely extending longevity. (shrink)

Growing public concern and uncertainties surrounding emerging technologies suggest the need for socially-responsible behavior of companies in the development and implementation of oversight systems for them. In this paper, we argue that corporate social responsibility (CSR) is an important aspect of nanotechnology oversight given the role of trust in shaping public attitudes about nanotechnology and the lack of data about the health and environmental risks of nanoproducts. We argue that CSR is strengthened by the adoption of stakeholder-driven models and attention (...) to moral principles in policies and programs. In this context, we examine drivers of CSR, contextual and leadership factors that influence CSR, and strategies for CSR. To illustrate these concepts, we discuss existing cases of CSR-like behavior in nanotechnology companies, and then provide examples of how companies producing nanomedicines can exhibit morally-driven CSR behavior. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to the (...) novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

The convergence of biomedical sciences with nanotechnology as well as ICT has created a new wave of biomedical technologies, resulting in visions of a ‘molecular medicine’. Since novel technologies tend to shift concepts of disease and health, this paper investigates how the emerging field of molecular medicine may shift the meaning of ‘disease’ as well as the boundary between health and disease. It gives a brief overview of the development towards and the often very speculative visions of molecular medicine. Subsequently (...) three views of disease often used in the philosophy of medicine are briefly discussed: the ontological or neo-ontological, the physiological and the normative/holistic concepts of disease. Against this background two tendencies in the field of molecular medicine are highlighted: (1) the use of a cascade model of disease and (2) the notion of disease as a deviation from an individual pattern of functioning. It becomes clear that molecular medicine pulls conceptualizations of disease and health in several, partly opposed directions. However, the resulting tensions may also offer opportunities to steer the future of medicine in more desirable directions. (shrink)

In this paper I focus on the question of whether nanotechnology is giving rise to new ethical problems rather than merely to new instances of old ethical problems. Firstly, I demonstrate how important it is to make a general distinction between new ethical problems and new instances of old problems. Secondly, I propose one possible way of interpreting the distinction and offer a definition of a “new ethical problem”. Thirdly, I examine whether there is good reason to claim that nanotechnology (...) is giving or will give rise to new ethical problems. My conclusion is that there are no new ethical problems in nanotechnology but merely new occurrences of certain well-known types of ethical problems. Fourthly, I consider three arguments by van de Poel (NanoEthics 2:25–28, 2008) which contradict my conclusion. I argue that my negative conclusion is consistent with the claim that certain ethical issues arising in nanotechnology may require new normative standards or new analytical tools. I conclude that it is likely that a number of ethical issues arising in nanotechnology will have a considerable impact on our ethical theories and values – and that ethical reflection on nanotechnology will be one of the mother lodes of future ethical research – in spite of the fact that no ethical problem in nanoethics will actually be “new”. (shrink)

Nanomedicine offers remarkable options for new therapeutic avenues. As methods in nanomedicine advance, ethical questions conjunctly arise. Nanomedicine is an exceptional niche in several aspects as it reflects risks and uncertainties not encountered in other areas of medical research or practice. Nanomedicine partially overlaps, partially interlocks and partially exceeds other medical disciplines. Some interpreters agree that advances in nanotechnology may pose varied ethical challenges, whilst others argue that these challenges are not new and that nanotechnology basically echoes recurrent bioethical dilemmas. (...) The purpose of this article is to discuss some of the ethical issues related to nanomedicine and to reflect on the question whether nanomedicine generates ethical challenges of new and unique nature. Such a determination should have implications on regulatory processes and professional conducts and protocols in the future. (shrink)

In this chapter, I propose the mechanism of cognitive enhancement based on studies of cognitive-enhancing drugs and behavioral training. I argue that there are mechanistic differences between cognitive-enhancing drugs and behavioral training due to their different enhancing effects. I also suggest possible mechanisms for cognitive-enhancing drugs and behavioral training and for the synergistic effects of their simultaneous application.