<<

major public investments are directed at only in the longer term. While it makes a References treatments and thus at attempts compelling case for these promises, it also 1 : Responsible Action on Issues in Society and Ethics: http://nanobio-raise.org/ 2 Mauro Magnani Eythrocyte Engineering for and Targeting. New York: Kluwer, 2003. further to reduce mortality in developed asks for our patience. And as with all basic 3 Volker Wagner and Axel Zweck Nanomedizin: Innovationspotenziale in Hessen für Medizintechnik und societies where it is already comparatively research, something is bound to come of Pharmazeutische Industrie Wiesbaden: Hessisches Ministerium für Wirtschaft, 2006. • A Brief History of Nanomedicine low. it, though not perhaps the full mastery of 4 Robert A. Freitas (1999): Nanomedicine, Volume I: Basic Capabilities, Georgetown, TX: Landes Bioscience. • Theranostics 5 physiological complexities that is envisioned Cancer : Going Small for Big Advances – Using Nanotechnology to Advance Cancer Diagnosis, • Targeted Drug-Delivery Prevention and Treatment. Washington, DC: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Nanomedical ethics should not serve to in the name of theranostics, individualised Institutes of Health, National Cancer Institute, 2004. • Polymer Therapeutics validate an uncertain future, for example, , and cell repair. Some of its 6 Nanomedicine: Nanotechnology for Health – European Technology Platform. Brussels: European Commission, • by assuming too readily an increase of most important contributions will consist Research DG, 2006, p. 12. • Ethical and societal issues 7 Ibid., p. 10, see also p. 6 and especially p. 12. diagnostic powers or an impact on life- of progress in instrumentation and analytic 8 Nanomedicine: An ESF – European Medical Research Councils (EMRC) Forward Look report. Strasbourg: European expectancy. Instead, it might contribute methods that is now considered primarily Science Foundation, 2006. to public deliberation on the research a stepping-stone towards bigger and better 9 Like , nanomedicine is thus poised to become an off-shoot of nanotechnology that claims its own, The aim of this briefing paper is to provide at least partly separate identity and integrity. – Two of the authors of the ESF-report reflect on this quite explicitly, agenda for nanomedicine. Once one starts things. concise, correct and balanced information to see Ringsdorf and Duncan "nanogames gaining ground" 2006. Nanomedical sectors questioning its primary focus on cancer and 10 The European Technology Platform subsumes new pharmaceuticals under "targeted delivery": "Seamlessly advance public debate among consumers, • Drug delivery cardiovascular , one might have to One should therefore not expect connecting Diagnostics, Targeted Delivery and Regenerative Medicine: Diagnostics, targeted delivery and media, policy makers, producers and • Biomaterials consider the very definitions of illness and nanomedicine to revolutionise medicine. regenerative medicine constitute the core disciplines of nanomedicine. The EuropeanTechnology Platform on researchers as part of the European • In vivo imaging NanoMedicine acknowledges and wishes to actively support research at the interface between its three science 1 health and the medicalisation of society. It is one promising avenue by which areas." This research at the interface can establish theranostics (p. 9). Commission-funded Nanobio-RAISE project. • In vitro diagnostics Similarly, one might consider the metaphors medicine can advance. At the end of the 11 Alfred Nordmann "Knots and Strands: An Argument for Productive Disillusionment," Journal of Medicine and It results from the combined contributions of • Active implants we use to describe the human being or the day, it will have contributed new treatment- Philosophy, 32:3, 2007, pp. 217-236. natural and social scientists, industrialists, and • Drugs & 12 ESF-report, p. 11. changing boundaries of human bodies as options for certain diseases, some new 13 This constructive principle also distinguishes nanomedicine (as a kind of nanotechnology) from biotechnology which governmental and public interest organisations the body's own tissue or insulin, for example, , better imaging-techniques is developing and deploying as active agents. across Europe. It is intended to provide course, all kinds of medical devices profit from might be generated outside the body or by and other diagnostic tools. These will 14 ETP, p. 16. information and does not represent the views the miniaturisation of electronic components 15 Matthias Adam "What to expect from rational drug design,"Expert Opinion on Drug Discovery 2 (6), 2007, way of an implanted device. add significantly to the currently available or policy of the European Commission or any as they move beyond micro to nano. This NanoBio-RAISE Co-ordination office: 773-776. arsenal of and , raising 16 Joachim Schummer "The Impact of on Developing Countries," in Fritz Allhoff, Patrick Lin,, James other body. affects diagnostic tools, pace-makers, Julianalaan 67 Conclusion similar ethical and societal concerns as Moor, John Weckert, eds., Nanoethics: The Ethical and Social Implications of Nanotechnology, Wiley, 2007. “cameras in a pill,” etc. Nanoparticulate 2628 BC Delft 17 mean more people on Earth. But how many A 2007 nanomedical bulletin offered the did the medical advances of the past. Andreas Jordan "From Science to Business in 15 Years" in the Proceedings of EuroNanoForum 2005: Introduction pharmaceutical agents can penetrate cells The Netherlands Nanotechnology and the Health of the EU Citizen in 2020, edited by Michael Mason, Sophia Fantechi, Renzo 22 more people can the Earth sustain?" In Ethical and societal issues following news item: "Working with an Demonstrations of efficacy have to be Tomellini, Brussels: EC DG Research, 2006, p. 16. A broad array of present and future research more effectively as well as being able to t +31 (0)15 278 66 26 a similar vein, the European Technology Traditionally, medical ethics is patient- and organic semiconductor, researchers at considered together with physiological and 18 The European Group on Ethics in Science and New Technologies to the European Commission "Opinion on the developments are generally lumped together cross the -brain-barrier. After injecting f +31 (0)15 278 23 55 Platform notes that one large impact of treatment-centred rather than research- the University of Arkansas have fabricated environmental side-effects and general ethical aspects of Nanomedicine (Opinion N° 21)," January 17, 2007, section 5.5.1, p. 57. as “nanotechnology.” A common feature is only into tumours, these can be [email protected] 19 While the European Technology Platform considers regenerative medicine one of nanomedicine's three core nanomedicine will be "increased costs of and -centred. In other words, most and tested two similar but slightly different quality-of-life issues, comparing all of these disciplines, the ESF's Forward Look treats it only under the heading of new materials (in particular, scaffolding for that they are concerned with large and small stimulated electromagnetically from outside www.nanobio-raise.org social security systems due to of medical ethics is focused on doctor-patient biosensors that can measure physiological to alternative treatment options. And like all tissue growth and repair). The US-report on Cancer Nanotechnology does not refer to it at all. things where at least some relevant measures the body – by emitting heat, the stimulated population."23 relations, on end-of-life decisions, on signs. Integrated into 'smart' fabrics – disease-oriented research, it requires public 20 ETP, p. 6. are in the nanometre range (10-9 to 10-7 particles can then destroy the tumour 21 Paul Miller and James Wilsdon “The man who wants to live forever” in Paul Miller and James Wilsdon (eds.) Better resource-allocation, on treatment choices, garments with wireless technology – the deliberation on which diseases should be metres) and thus in the size-range of DNA- cells. Antibacterial surfaces incorporating Humans? The Politics of and , London: DEMOS, 2006, pp. 51-58. It is important to be clear about the informed consent, and the like. Biomedical sensors will be able to monitor a patient's prioritised in the context of global health 22 Ivan Amato Nanotechnology - Shaping the World Atom by Atom, Washington: National Science and Technology molecules or . More stringent definitions photocatalytic or biocidal nanoparticles reduce achievable goals of nanomedicine that are in research becomes significant only as it respiration rate and body temperature in care. Council, Interagency Working Group on Nanoscience, Engineering and Technology, 1999, p. 8. require that nanotechnological research be the risk of in doctors’ offices and 23 ETP, p. 24. the public interest. Popular fascination with enters clinical trials. Accordingly, medical real time."26 In many ways, this appears restricted to the scientific investigation and public buildings. Portable testing kits allow 24 Richard Jones Soft Machines Oxford: Oxford University Press, 2004. envisioned technologies of life extension ethics has been rather indifferent to the to be nanotechnology at its best and is 25 Jean-Pierre Dupuy in Journal of Medicine and Philosophy, 32:3, 2007. technical exploitation of novel properties that for self- and speedy diagnosis. does not render a public good. level of medical intervention. While the therefore not at all unique to the University 26 NanoMedicine News (www.euronanotechnews.com), #71, July 20, 2007. appear discontinuously at the nanoscale: a New contrast agents and visualisation tools Conversely, before worrying about increased removal of the causes of disease is generally of Arkansas. It is an example of highly ton of gold has the same chemical properties provide a closer look at cellular processes. life-expectancy as one of the potential preferable to symptomatic treatments, it interdisciplinary research that integrates as a milligram, but a gold But this, too, is nanotechnology in action: impacts of nanomedicine, one should does not appear to matter much whether functionalities at the nanoscale, namely shows interesting and initially surprising new nanoparticulate steroids are introduced into ensure that nanomedicine gets off the diseases are addressed at a molecular or the otherwise separate nanotechnological behaviours. This more stringent definition of the body’s own red blood cells; as the cells ground and meets the formidable challenge cellular or whole-organ level. fields of point-of-care diagnostics and nanotechnological research remains quite die their natural deaths, the steroids are to convert even its more modest ambitions 'smart' fabrics. This kind of medical unspecific regarding technological applications: released to the body in very small doses, thus into reality. As the previous sections indicated, however, nanotechnology may enable a profound nanotechnology is all that these newly minimising, if not excluding the side-effects of the nanomedical research programme reconfiguration of the relations between discovered properties and processes might many steroid treatments.2 As it is converted from vision to reality, the raises issues that serve to expand the doctors, patients, and hospitals. It can be good for. And here, the imagination runs notion of cell repair will be a testing ground scope of medical ethics. This concerns, also promote the further medicalisation of wild, challenging us to identify and support These examples and many more of ongoing for the very idea that cellular processes for example, the distinction between drug society, that is, of bringing social behaviours promising, feasible as well as beneficial short- developments can be found in various involve a nanotechnological machinery and device and its regulatory implications. (risk taking, dietary practices, stress and and medium-term developments. reports on the prospects and promises of that can break down and that can also be It also concerns the recognition and anger) into the realm of medical supervision. nanomedicine. But though these examples are repaired. This metaphor of nanomachinery acknowledgment of limits of knowledge and These developments are likely to be On first sight, nanomedicine is the rather more nothing to frown at, nanomedicine has been has proven productive for understanding control, in other words, care to avoid hype contested and call for the debate of their well-defined application of nanotechnology conceived as a far more ambitious enterprise: cellular mechanisms but it is unclear as and to state achievable goals credibly and ethical and societal implications. in the areas of healthcare and disease "Nanomedicine comes into being where a of yet how far this metaphor carries when responsibly. Regenerative medicine in the diagnosis and treatment. But here, too, one molecular understanding of cellular processes it comes to the precision control of highly service of and quality of life It is unlikely that nanomedicine will be as encounters a bewildering array of programmes is strategically combined with capabilities to complex biological realities.24 It also leads should be distinguished from the notion transformative. It defines itself as basic and projects. Artificial bone implants already produce nanoscale materials in a controlled to the ethical question of whether we may that life-extension is a public good. Finally, medical research, and is application- benefit from nanotechnologically improved manner."3 With these greater ambitions mechanically reduce the human being to a nanomedical research raises questions oriented like all medical research. As such, materials. Nanostructured surfaces can serve comes the formidable challenge to assess sum of physical traits.25 of distributive justice and global equity as nanomedicine can realise its promises For Pictures: © copyright CEA as scaffolding for controlled tissue-growth. Of more visionary programmes not only for their Design: Gerritsma Vormgeving bno, Leiden, e [email protected], w www.1enof2.nl The Images: Courtesy of the Molecular Group at Delft University of Technology hospital with its traditional doctor-patient regenerative medicine.10 The prospects and disease – in the hope that these models can an uncertain, though potentially profound when the active ingredient is already known. relationships. problems of each warrant a brief review. one day be operationalised for the diagnosis impact. It needs public support on its Since the approval of medical devices and treatment of individual patients. merits and not on the promise of a short- or proceeds at a considerably faster pace, this Nanomedicine, in other words, is disease- As indicated by the term "theranostics," Like all basic scientific research, therefore, medium-term return. could speed up nanomedical development. centred, trying to do better and on a its promise consists in the fusion of therapy nanomedicine requires long-term funding In one instance, at least, this route has molecular level what physiology, , and diagnostics. As diagnostic capabilities strategies. It is only in the long run that Polymer Therapeutics been chosen successfully. By creating iron and the various specialised medical improve, one might come up with one might realise the promised healthcare The programme of oxide nanoparticles that are accumulated sciences have been doing so far. Because treatments well before a disease manifests savings that would result from earlier requires new nanomedicines which consist by cancer cells and then applying to it is disease-centred, nanomedicine itself symptomatically. Ideally, diagnosis intervention into the disease process. of at least two components: one of them them an external , tumours leaves to medical nanotechnologies the and treatment could be performed in a the active ingredient, the other a transport can be destroyed very effectively. The more general and perhaps more profound single step through a monitoring process Targeted Drug-Delivery device or conjugate that attaches its cargo coated nanoparticles are here taken to be transformations of : these that automatically introduces appropriate The idea that pharmaceutical agents should at the right place.12 It is this construction of components of a technical device, as parts concern public health monitoring, the corrections (e.g., plaque detection and be delivered specifically to diseased cells a technical system that combines different of the machine that creates the magnetic integration of medical practices into daily removal for the prevention of cardiovascular holds the promise of a variety of benefits. functionalities which bring , field and thus induces a vibratory motion patterns of work and leisure, the redefinition diseases). The benefit of beginning Especially if, in addition, the pharmaceutical polymer- conjugates, , in those particles which then leads to the of the physiological body as a body of data, treatment before there is a disease depends agent were to be adapted to the cell's and other nanoparticles into the realm heating and destruction of the tumour. Since and the reorganisation of the therapeutic on the quality of diagnostic information. genome, these benefits would be grouped of nanotechnology proper, as opposed to the particles are not introduced for their feasibility, but also for the proper balancing “revolution in molecular imaging in the context with its medical experts, insurance Here, the lengthy history of therapy under the heading "personalised medicine." traditional pharmacology or supramolecular chemical properties or as pharmacologically body after destruction of the cancer cells? them. In the case of , of public investment and societal need, and, foreseeable future, leading to the detection companies, state interests, and health- offers a sobering lesson with its initial, but However, "individualised medicine" is the chemistry.13 Also, it is this modularity which active agents, they do not need to be In its published reports, the nanomedical for example, this might take the form of thus for their likely benefits. These ambitions of a single molecule or a single cell in a care institutions. By the same token, as yet only partially fulfilled, promise of more appropriate term since this form of answers nanomedicine's call for "design on a regulated as drugs. It is largely because of community generally urges caution and growing tissue on an external scaffold revolve mainly around the concepts complex biological environment.”6 This nanomedicine inherits its focus on certain repairing specific that are responsible treatment is addressed at a specific disease- disease-specific basis." this that the procedure moved swiftly "From close ethical as well as regulatory review. such that the patient's body recognises “theranostics (i.e. the combination of statement elegantly glosses over the fact diseases from ongoing medical research. for specific diseases. process, perhaps an individual genome, but Science to Business in 15 Years."17 it as its own, thus avoiding the need to diagnosis and therapeutic functionality that the problems of detecting molecules Accordingly, it is primarily concerned to disregards the biographic, cultural, and legal While EU and US reports on nanomedicine Regenerative Medicine suppress an immune response. Diabetes in one device, enabling pre-symptomatic and cells are magnitudes apart: Cells are reduce mortality from non-infectious Rather than looking for genetic causes of particulars that define a person. emphasise the notion of design, the On the other hand, nanoparticulate After diagnostics and theranostics, patients could be helped by restoring insulin treatment)”, “polymer therapeutics a hundred to a thousand times larger than disease, especially cancer. That is, it aims disease, nanomedical expectations rest European Technology Platform takes pains iron oxide may well pose risks to the individualised medicine and the production within the body. Among the most (rational design of nanomedicines)”, molecules and it is certainly much easier to to incrementally reduce mortality where on vast improvements in imaging and The promise of individualised medicine is to point out that the relevant design features patient's health or, after secretion, to nanomedicines required for it, ambitious goals of regenerative medicine “targeted drug-delivery (individualised imagine a or marker attached it is already low, namely in the highly measuring techniques. Indeed, considerable that it is efficient. Targeted drug-delivery can be achieved by "rational design or by the environment. While this risk may be regenerative medicine remains as the is to stimulate the growth and to reconnect medicine)”, “regenerative medicine (cell to or inside a cell. In the same report, the developed world where cancer and coronary progress is made on the road towards allows doctors and patients to benefit from high throughput screening or even by a acceptable in the treatment of an otherwise last of nanomedicine's core interests. severed nerves or to restore neural function repair).” The promise associated with speculative spirit of Eric Drexler and Robert disease have become the most prominent in vivo imaging as well as lab-on-a-chip small dosages at just the right place and combination of the two."14 Indeed, the deadly disease, the approval of these iron To be sure, regenerative medicine is not in neurodegenerative diseases such as these terms is that of therapeutically more Freitas informs a vision of cell-monitoring physiological causes of death. technologies that simultaneously determine thus from fewer side-effects. Even without ambition to construct nanomedicines is oxides as drugs may still be called for. The a single discipline but draws together Alzheimer's or Parkinson's. In the words of effective, individualised, dose reduced and repair: The detection of disease will thousands of parameters in a tiny drop having to understand the cause of the reminiscent of previous programmes of difficulty of this dilemma is illustrated by the a variety of medium- and long-term the European Technology Platform, "The and more affordable medicine. Before happen as early as possible and “ultimately Another potential limitation of the narrowly of blood. But access to vast amounts of disease, medical researchers expect to "rational drug design," such as attempts to recommendation of the European Group technical approaches, ranging from tissue challenge is to convert this to a reality."20 considering these ambitions and promises this will occur at the level of a single cell, defined nanomedical focus is brought to information does not translate automatically deal with it just as things start going wrong prevent disease by inhibiting RNA expression on Ethics in its opinion on nanomedicine: engineering and wound repair all the way one by one, it helps to place them in the combined with monitoring the effectiveness light by the European Technology Platform: into diagnostic capabilities. As with gene with the molecular machinery inside the and protein formation. If nanomedicine "The mechanism of action is a key factor to various visions of cell therapy. Since To be sure, some would posit even more larger historical context of the development of therapy.7” it is explicitly addressed to an increasingly therapy, this will happen only in a piecemeal cell. Smaller dosages, early and efficient seeks to keep a cautious distance to these in deciding whether a product should be these approaches predate and do not ambitious goals for regenerative medicine, of nanomedicine. sedentary ageing population and its medical manner and in conjunction with research treatment are finally said to translate into programmes, this is because they send a regulated as a medicinal product or a rely on nanotechnology, regenerative namely a kind of cell-repair that might The most balanced overview of problems. Through the lens of disease- in bioinformatics or systems biology. lower health care costs. Of course, as sobering message, having proved unable to medical device."18 In the case at issue, medicine should not be subsumed under prevent, even reverse ageing. Though this A Brief History of nanomedicine to date is the European centred nanomedicine, this translates to Indeed, before we can know whether all the closely as they appear to hang together, it is compete with randomised high-throughput the regulatory question cannot be decided nanomedicine and one should rather speak idea attracts much attention in popular Nanomedicine Science Foundation’s 2006 Forward Look the treatment of painfully arthritic joints. additional physiological information has any important to evaluate these various claims screening as the far more successful by referring to a matter of fact. It will be of nanomedical contributions to it.19 discourse,21 it does not occur in the reports Nanomedicine has been an important on Nanomedicine.8 It is firmly grounded In a wider perspective, of course, the health diagnostic use, it will have to be obtained in for the efficiency of nanomedicine one at approach to drug development.15 Similarly, contested, after all, what the mechanism of nanomedical working groups. It is part of nanotechnology from the very in current research. As it distances itself of joints involves questions of nutrition, order for bioinformatics and systems biology a time.11 Especially the promise of cost- the constructive design ambitions of of action is: is it the action of the iron oxide Regenerative medicine aims to strengthen important to note this clear demarcation beginning. And since nanotechnology began from speculation and hype, it seeks to mobility, and an integrated approach to construct sufficiently robust models of the efficiency might send a wrong signal: like all scientific nanomedicine face a tremendous particles as components of the device or the self-healing processes of the human of nanomedical ambitions from speculative as a visionary enterprise, nanomedicine give shape to a nanomedical research to the problem of obesity. The strictly highly complex dynamics at the origins of of nanomedicine, this is basic research with challenge to master physiological complexity. is it their action in and beyond the either by stimulating or emulating visions. However, the more modest aim to started by applying mainly nanomechanical agenda that is clearly set apart from nanomedical alleviation of chronic pain in Under the best of circumstances, it is understand and treat concepts to the body. In his 1999 book on the grab-bag of nanotechnologies.9 the joints should be a small part, indeed, a matter "only" of packaging an active processes requires a further demarcation: Nanomedicine, assembled In effect, the report drives a wedge between of a “treatment package” that includes ingredient with a successful targeting agent. Support of medical research, in general, an impressive array of ingenious ideas that scientific nanomedicine and something medical nanotechnologies for monitoring Though their origins predate the advent of and nanomedical research, in particular, derive from ongoing developments and lesser that might be called medical and feedback, along with physical "nanotechnology," some nanomedicines should be dedicated to the advance of inevitably lead to extravagant speculations.4 nanotechnology. Nanomedicine is based therapy, geriatric and socio-psychological have already been approved for routine public health and quality of life but not the Freitas's conflation of the short-term with on molecular knowledge of the human approaches, together with even economic use and now have to prove themselves in increase of longevity as an end in itself. the long-term and even with technical body and it involves molecular tools for or political incentives for increased , competition with sometimes less expensive Increased average life-expectancies should impossibilities remains characteristic even the diagnosis and treatment of disease. nanotechnologically improved footwear and alternatives.16 be considered as nothing but welcome of the far more restrained technical papers Medical nanotechnology encompasses all surfaces. side-effects of improved access to health of today. The 2004 presentation of the the other ways in which nanotechnology If only because of the length of the multi- care and better health maintenance overall. cancer nanotechnology initiative in the affects health care, especially all that Theranostics stage approval process, only time will tell Indeed, some proponents of nanomedicine United States revolves around the goal comes from the miniaturisation of devices As distinct from medical nanotechnologies, the success-story of nanomedicines. Their prematurely anticipate just this side-effect. of “eliminating death and suffering from and the integration of information and scientific nanomedicine concentrates definition as designed two-component One of the earliest public documents cancer by 2015”.5 The 2006 European communication technologies in diagnostic on four areas of research and systems suggests a short-cut, namely to to acquaint a general audience with Technology Platform on Nanomedicine tools and health monitoring – including a development: theranostics, a new class of consider them medical devices rather than nanotechnology singles out as a societal is more subtle than this. It speaks of a radical transformation of the present day pharmaceuticals, targeted drug-delivery, and pharmacological substances, especially issue that "longer average lifetimes will hospital with its traditional doctor-patient regenerative medicine.10 The prospects and disease – in the hope that these models can an uncertain, though potentially profound when the active ingredient is already known. relationships. problems of each warrant a brief review. one day be operationalised for the diagnosis impact. It needs public support on its Since the approval of medical devices and treatment of individual patients. merits and not on the promise of a short- or proceeds at a considerably faster pace, this Nanomedicine, in other words, is disease- As indicated by the term "theranostics," Like all basic scientific research, therefore, medium-term return. could speed up nanomedical development. centred, trying to do better and on a its promise consists in the fusion of therapy nanomedicine requires long-term funding In one instance, at least, this route has molecular level what physiology, pathology, and diagnostics. As diagnostic capabilities strategies. It is only in the long run that Polymer Therapeutics been chosen successfully. By creating iron and the various specialised medical improve, one might come up with one might realise the promised healthcare The programme of targeted drug delivery oxide nanoparticles that are accumulated sciences have been doing so far. Because treatments well before a disease manifests savings that would result from earlier requires new nanomedicines which consist by cancer cells and then applying to it is disease-centred, nanomedicine itself symptomatically. Ideally, diagnosis intervention into the disease process. of at least two components: one of them them an external magnetic field, tumours leaves to medical nanotechnologies the and treatment could be performed in a the active ingredient, the other a transport can be destroyed very effectively. The more general and perhaps more profound single step through a monitoring process Targeted Drug-Delivery device or conjugate that attaches its cargo coated nanoparticles are here taken to be transformations of health care: these that automatically introduces appropriate The idea that pharmaceutical agents should at the right place.12 It is this construction of components of a technical device, as parts concern public health monitoring, the corrections (e.g., plaque detection and be delivered specifically to diseased cells a technical system that combines different of the machine that creates the magnetic integration of medical practices into daily removal for the prevention of cardiovascular holds the promise of a variety of benefits. functionalities which bring liposomes, field and thus induces a vibratory motion patterns of work and leisure, the redefinition diseases). The benefit of beginning Especially if, in addition, the pharmaceutical polymer-protein conjugates, dendrimers, in those particles which then leads to the of the physiological body as a body of data, treatment before there is a disease depends agent were to be adapted to the cell's and other nanoparticles into the realm heating and destruction of the tumour. Since and the reorganisation of the therapeutic on the quality of diagnostic information. genome, these benefits would be grouped of nanotechnology proper, as opposed to the particles are not introduced for their feasibility, but also for the proper balancing “revolution in molecular imaging in the context with its medical experts, insurance Here, the lengthy history of under the heading "personalised medicine." traditional pharmacology or supramolecular chemical properties or as pharmacologically body after destruction of the cancer cells? them. In the case of tissue engineering, of public investment and societal need, and, foreseeable future, leading to the detection companies, state interests, and health- offers a sobering lesson with its initial, but However, "individualised medicine" is the chemistry.13 Also, it is this modularity which active agents, they do not need to be In its published reports, the nanomedical for example, this might take the form of thus for their likely benefits. These ambitions of a single molecule or a single cell in a care institutions. By the same token, as yet only partially fulfilled, promise of more appropriate term since this form of answers nanomedicine's call for "design on a regulated as drugs. It is largely because of community generally urges caution and growing tissue on an external scaffold revolve mainly around the concepts complex biological environment.”6 This nanomedicine inherits its focus on certain repairing specific genes that are responsible treatment is addressed at a specific disease- disease-specific basis." this that the procedure moved swiftly "From close ethical as well as regulatory review. such that the patient's body recognises “theranostics (i.e. the combination of statement elegantly glosses over the fact diseases from ongoing medical research. for specific diseases. process, perhaps an individual genome, but Science to Business in 15 Years."17 it as its own, thus avoiding the need to diagnosis and therapeutic functionality that the problems of detecting molecules Accordingly, it is primarily concerned to disregards the biographic, cultural, and legal While EU and US reports on nanomedicine Regenerative Medicine suppress an immune response. Diabetes in one device, enabling pre-symptomatic and cells are magnitudes apart: Cells are reduce mortality from non-infectious Rather than looking for genetic causes of particulars that define a person. emphasise the notion of design, the On the other hand, nanoparticulate After diagnostics and theranostics, patients could be helped by restoring insulin treatment)”, “polymer therapeutics a hundred to a thousand times larger than disease, especially cancer. That is, it aims disease, nanomedical expectations rest European Technology Platform takes pains iron oxide may well pose risks to the individualised medicine and the production within the body. Among the most (rational design of nanomedicines)”, molecules and it is certainly much easier to to incrementally reduce mortality where on vast improvements in imaging and The promise of individualised medicine is to point out that the relevant design features patient's health or, after secretion, to nanomedicines required for it, ambitious goals of regenerative medicine “targeted drug-delivery (individualised imagine a contrast agent or marker attached it is already low, namely in the highly measuring techniques. Indeed, considerable that it is efficient. Targeted drug-delivery can be achieved by "rational design or by the environment. While this risk may be regenerative medicine remains as the is to stimulate the growth and to reconnect medicine)”, “regenerative medicine (cell to or inside a cell. In the same report, the developed world where cancer and coronary progress is made on the road towards allows doctors and patients to benefit from high throughput screening or even by a acceptable in the treatment of an otherwise last of nanomedicine's core interests. severed nerves or to restore neural function repair).” The promise associated with speculative spirit of Eric Drexler and Robert disease have become the most prominent in vivo imaging as well as lab-on-a-chip small dosages at just the right place and combination of the two."14 Indeed, the deadly disease, the approval of these iron To be sure, regenerative medicine is not in neurodegenerative diseases such as these terms is that of therapeutically more Freitas informs a vision of cell-monitoring physiological causes of death. technologies that simultaneously determine thus from fewer side-effects. Even without ambition to construct nanomedicines is oxides as drugs may still be called for. The a single discipline but draws together Alzheimer's or Parkinson's. In the words of effective, individualised, dose reduced and repair: The detection of disease will thousands of parameters in a tiny drop having to understand the cause of the reminiscent of previous programmes of difficulty of this dilemma is illustrated by the a variety of medium- and long-term the European Technology Platform, "The and more affordable medicine. Before happen as early as possible and “ultimately Another potential limitation of the narrowly of blood. But access to vast amounts of disease, medical researchers expect to "rational drug design," such as attempts to recommendation of the European Group technical approaches, ranging from tissue challenge is to convert this to a reality."20 considering these ambitions and promises this will occur at the level of a single cell, defined nanomedical focus is brought to information does not translate automatically deal with it just as things start going wrong prevent disease by inhibiting RNA expression on Ethics in its opinion on nanomedicine: engineering and wound repair all the way one by one, it helps to place them in the combined with monitoring the effectiveness light by the European Technology Platform: into diagnostic capabilities. As with gene with the molecular machinery inside the and protein formation. If nanomedicine "The mechanism of action is a key factor to various visions of cell therapy. Since To be sure, some would posit even more larger historical context of the development of therapy.7” it is explicitly addressed to an increasingly therapy, this will happen only in a piecemeal cell. Smaller dosages, early and efficient seeks to keep a cautious distance to these in deciding whether a product should be these approaches predate and do not ambitious goals for regenerative medicine, of nanomedicine. sedentary ageing population and its medical manner and in conjunction with research treatment are finally said to translate into programmes, this is because they send a regulated as a medicinal product or a rely on nanotechnology, regenerative namely a kind of cell-repair that might The most balanced overview of problems. Through the lens of disease- in bioinformatics or systems biology. lower health care costs. Of course, as sobering message, having proved unable to medical device."18 In the case at issue, medicine should not be subsumed under prevent, even reverse ageing. Though this A Brief History of nanomedicine to date is the European centred nanomedicine, this translates to Indeed, before we can know whether all the closely as they appear to hang together, it is compete with randomised high-throughput the regulatory question cannot be decided nanomedicine and one should rather speak idea attracts much attention in popular Nanomedicine Science Foundation’s 2006 Forward Look the treatment of painfully arthritic joints. additional physiological information has any important to evaluate these various claims screening as the far more successful by referring to a matter of fact. It will be of nanomedical contributions to it.19 discourse,21 it does not occur in the reports Nanomedicine has been an important on Nanomedicine.8 It is firmly grounded In a wider perspective, of course, the health diagnostic use, it will have to be obtained in for the efficiency of nanomedicine one at approach to drug development.15 Similarly, contested, after all, what the mechanism of nanomedical working groups. It is part of nanotechnology from the very in current research. As it distances itself of joints involves questions of nutrition, order for bioinformatics and systems biology a time.11 Especially the promise of cost- the constructive design ambitions of of action is: is it the action of the iron oxide Regenerative medicine aims to strengthen important to note this clear demarcation beginning. And since nanotechnology began from speculation and hype, it seeks to mobility, and an integrated approach to construct sufficiently robust models of the efficiency might send a wrong signal: like all scientific nanomedicine face a tremendous particles as components of the device or the self-healing processes of the human of nanomedical ambitions from speculative as a visionary enterprise, nanomedicine give shape to a nanomedical research to the problem of obesity. The strictly highly complex dynamics at the origins of of nanomedicine, this is basic research with challenge to master physiological complexity. is it their action in and beyond the human body either by stimulating or emulating visions. However, the more modest aim to started by applying mainly nanomechanical agenda that is clearly set apart from nanomedical alleviation of chronic pain in Under the best of circumstances, it is understand and treat degenerative disease concepts to the body. In his 1999 book on the grab-bag of nanotechnologies.9 the joints should be a small part, indeed, a matter "only" of packaging an active processes requires a further demarcation: Nanomedicine, Robert Freitas assembled In effect, the report drives a wedge between of a “treatment package” that includes ingredient with a successful targeting agent. Support of medical research, in general, an impressive array of ingenious ideas that scientific nanomedicine and something medical nanotechnologies for monitoring Though their origins predate the advent of and nanomedical research, in particular, derive from ongoing developments and lesser that might be called medical and feedback, along with physical "nanotechnology," some nanomedicines should be dedicated to the advance of inevitably lead to extravagant speculations.4 nanotechnology. Nanomedicine is based therapy, geriatric and socio-psychological have already been approved for routine public health and quality of life but not the Freitas's conflation of the short-term with on molecular knowledge of the human approaches, together with even economic use and now have to prove themselves in increase of longevity as an end in itself. the long-term and even with technical body and it involves molecular tools for or political incentives for increased exercise, competition with sometimes less expensive Increased average life-expectancies should impossibilities remains characteristic even the diagnosis and treatment of disease. nanotechnologically improved footwear and alternatives.16 be considered as nothing but welcome of the far more restrained technical papers Medical nanotechnology encompasses all surfaces. side-effects of improved access to health of today. The 2004 presentation of the the other ways in which nanotechnology If only because of the length of the multi- care and better health maintenance overall. cancer nanotechnology initiative in the affects health care, especially all that Theranostics stage approval process, only time will tell Indeed, some proponents of nanomedicine United States revolves around the goal comes from the miniaturisation of devices As distinct from medical nanotechnologies, the success-story of nanomedicines. Their prematurely anticipate just this side-effect. of “eliminating death and suffering from and the integration of information and scientific nanomedicine concentrates definition as designed two-component One of the earliest public documents cancer by 2015”.5 The 2006 European communication technologies in diagnostic on four areas of research and systems suggests a short-cut, namely to to acquaint a general audience with Technology Platform on Nanomedicine tools and health monitoring – including a development: theranostics, a new class of consider them medical devices rather than nanotechnology singles out as a societal is more subtle than this. It speaks of a radical transformation of the present day pharmaceuticals, targeted drug-delivery, and pharmacological substances, especially issue that "longer average lifetimes will hospital with its traditional doctor-patient regenerative medicine.10 The prospects and disease – in the hope that these models can an uncertain, though potentially profound when the active ingredient is already known. relationships. problems of each warrant a brief review. one day be operationalised for the diagnosis impact. It needs public support on its Since the approval of medical devices and treatment of individual patients. merits and not on the promise of a short- or proceeds at a considerably faster pace, this Nanomedicine, in other words, is disease- As indicated by the term "theranostics," Like all basic scientific research, therefore, medium-term return. could speed up nanomedical development. centred, trying to do better and on a its promise consists in the fusion of therapy nanomedicine requires long-term funding In one instance, at least, this route has molecular level what physiology, pathology, and diagnostics. As diagnostic capabilities strategies. It is only in the long run that Polymer Therapeutics been chosen successfully. By creating iron and the various specialised medical improve, one might come up with one might realise the promised healthcare The programme of targeted drug delivery oxide nanoparticles that are accumulated sciences have been doing so far. Because treatments well before a disease manifests savings that would result from earlier requires new nanomedicines which consist by cancer cells and then applying to it is disease-centred, nanomedicine itself symptomatically. Ideally, diagnosis intervention into the disease process. of at least two components: one of them them an external magnetic field, tumours leaves to medical nanotechnologies the and treatment could be performed in a the active ingredient, the other a transport can be destroyed very effectively. The more general and perhaps more profound single step through a monitoring process Targeted Drug-Delivery device or conjugate that attaches its cargo coated nanoparticles are here taken to be transformations of health care: these that automatically introduces appropriate The idea that pharmaceutical agents should at the right place.12 It is this construction of components of a technical device, as parts concern public health monitoring, the corrections (e.g., plaque detection and be delivered specifically to diseased cells a technical system that combines different of the machine that creates the magnetic integration of medical practices into daily removal for the prevention of cardiovascular holds the promise of a variety of benefits. functionalities which bring liposomes, field and thus induces a vibratory motion patterns of work and leisure, the redefinition diseases). The benefit of beginning Especially if, in addition, the pharmaceutical polymer-protein conjugates, dendrimers, in those particles which then leads to the of the physiological body as a body of data, treatment before there is a disease depends agent were to be adapted to the cell's and other nanoparticles into the realm heating and destruction of the tumour. Since and the reorganisation of the therapeutic on the quality of diagnostic information. genome, these benefits would be grouped of nanotechnology proper, as opposed to the particles are not introduced for their feasibility, but also for the proper balancing “revolution in molecular imaging in the context with its medical experts, insurance Here, the lengthy history of gene therapy under the heading "personalised medicine." traditional pharmacology or supramolecular chemical properties or as pharmacologically body after destruction of the cancer cells? them. In the case of tissue engineering, of public investment and societal need, and, foreseeable future, leading to the detection companies, state interests, and health- offers a sobering lesson with its initial, but However, "individualised medicine" is the chemistry.13 Also, it is this modularity which active agents, they do not need to be In its published reports, the nanomedical for example, this might take the form of thus for their likely benefits. These ambitions of a single molecule or a single cell in a care institutions. By the same token, as yet only partially fulfilled, promise of more appropriate term since this form of answers nanomedicine's call for "design on a regulated as drugs. It is largely because of community generally urges caution and growing tissue on an external scaffold revolve mainly around the concepts complex biological environment.”6 This nanomedicine inherits its focus on certain repairing specific genes that are responsible treatment is addressed at a specific disease- disease-specific basis." this that the procedure moved swiftly "From close ethical as well as regulatory review. such that the patient's body recognises “theranostics (i.e. the combination of statement elegantly glosses over the fact diseases from ongoing medical research. for specific diseases. process, perhaps an individual genome, but Science to Business in 15 Years."17 it as its own, thus avoiding the need to diagnosis and therapeutic functionality that the problems of detecting molecules Accordingly, it is primarily concerned to disregards the biographic, cultural, and legal While EU and US reports on nanomedicine Regenerative Medicine suppress an immune response. Diabetes in one device, enabling pre-symptomatic and cells are magnitudes apart: Cells are reduce mortality from non-infectious Rather than looking for genetic causes of particulars that define a person. emphasise the notion of design, the On the other hand, nanoparticulate After diagnostics and theranostics, patients could be helped by restoring insulin treatment)”, “polymer therapeutics a hundred to a thousand times larger than disease, especially cancer. That is, it aims disease, nanomedical expectations rest European Technology Platform takes pains iron oxide may well pose risks to the individualised medicine and the production within the body. Among the most (rational design of nanomedicines)”, molecules and it is certainly much easier to to incrementally reduce mortality where on vast improvements in imaging and The promise of individualised medicine is to point out that the relevant design features patient's health or, after secretion, to nanomedicines required for it, ambitious goals of regenerative medicine “targeted drug-delivery (individualised imagine a contrast agent or marker attached it is already low, namely in the highly measuring techniques. Indeed, considerable that it is efficient. Targeted drug-delivery can be achieved by "rational design or by the environment. While this risk may be regenerative medicine remains as the is to stimulate the growth and to reconnect medicine)”, “regenerative medicine (cell to or inside a cell. In the same report, the developed world where cancer and coronary progress is made on the road towards allows doctors and patients to benefit from high throughput screening or even by a acceptable in the treatment of an otherwise last of nanomedicine's core interests. severed nerves or to restore neural function repair).” The promise associated with speculative spirit of Eric Drexler and Robert disease have become the most prominent in vivo imaging as well as lab-on-a-chip small dosages at just the right place and combination of the two."14 Indeed, the deadly disease, the approval of these iron To be sure, regenerative medicine is not in neurodegenerative diseases such as these terms is that of therapeutically more Freitas informs a vision of cell-monitoring physiological causes of death. technologies that simultaneously determine thus from fewer side-effects. Even without ambition to construct nanomedicines is oxides as drugs may still be called for. The a single discipline but draws together Alzheimer's or Parkinson's. In the words of effective, individualised, dose reduced and repair: The detection of disease will thousands of parameters in a tiny drop having to understand the cause of the reminiscent of previous programmes of difficulty of this dilemma is illustrated by the a variety of medium- and long-term the European Technology Platform, "The and more affordable medicine. Before happen as early as possible and “ultimately Another potential limitation of the narrowly of blood. But access to vast amounts of disease, medical researchers expect to "rational drug design," such as attempts to recommendation of the European Group technical approaches, ranging from tissue challenge is to convert this to a reality."20 considering these ambitions and promises this will occur at the level of a single cell, defined nanomedical focus is brought to information does not translate automatically deal with it just as things start going wrong prevent disease by inhibiting RNA expression on Ethics in its opinion on nanomedicine: engineering and wound repair all the way one by one, it helps to place them in the combined with monitoring the effectiveness light by the European Technology Platform: into diagnostic capabilities. As with gene with the molecular machinery inside the and protein formation. If nanomedicine "The mechanism of action is a key factor to various visions of cell therapy. Since To be sure, some would posit even more larger historical context of the development of therapy.7” it is explicitly addressed to an increasingly therapy, this will happen only in a piecemeal cell. Smaller dosages, early and efficient seeks to keep a cautious distance to these in deciding whether a product should be these approaches predate and do not ambitious goals for regenerative medicine, of nanomedicine. sedentary ageing population and its medical manner and in conjunction with research treatment are finally said to translate into programmes, this is because they send a regulated as a medicinal product or a rely on nanotechnology, regenerative namely a kind of cell-repair that might The most balanced overview of problems. Through the lens of disease- in bioinformatics or systems biology. lower health care costs. Of course, as sobering message, having proved unable to medical device."18 In the case at issue, medicine should not be subsumed under prevent, even reverse ageing. Though this A Brief History of nanomedicine to date is the European centred nanomedicine, this translates to Indeed, before we can know whether all the closely as they appear to hang together, it is compete with randomised high-throughput the regulatory question cannot be decided nanomedicine and one should rather speak idea attracts much attention in popular Nanomedicine Science Foundation’s 2006 Forward Look the treatment of painfully arthritic joints. additional physiological information has any important to evaluate these various claims screening as the far more successful by referring to a matter of fact. It will be of nanomedical contributions to it.19 discourse,21 it does not occur in the reports Nanomedicine has been an important on Nanomedicine.8 It is firmly grounded In a wider perspective, of course, the health diagnostic use, it will have to be obtained in for the efficiency of nanomedicine one at approach to drug development.15 Similarly, contested, after all, what the mechanism of nanomedical working groups. It is part of nanotechnology from the very in current research. As it distances itself of joints involves questions of nutrition, order for bioinformatics and systems biology a time.11 Especially the promise of cost- the constructive design ambitions of of action is: is it the action of the iron oxide Regenerative medicine aims to strengthen important to note this clear demarcation beginning. And since nanotechnology began from speculation and hype, it seeks to mobility, and an integrated approach to construct sufficiently robust models of the efficiency might send a wrong signal: like all scientific nanomedicine face a tremendous particles as components of the device or the self-healing processes of the human of nanomedical ambitions from speculative as a visionary enterprise, nanomedicine give shape to a nanomedical research to the problem of obesity. The strictly highly complex dynamics at the origins of of nanomedicine, this is basic research with challenge to master physiological complexity. is it their action in and beyond the human body either by stimulating or emulating visions. However, the more modest aim to started by applying mainly nanomechanical agenda that is clearly set apart from nanomedical alleviation of chronic pain in Under the best of circumstances, it is understand and treat degenerative disease concepts to the body. In his 1999 book on the grab-bag of nanotechnologies.9 the joints should be a small part, indeed, a matter "only" of packaging an active processes requires a further demarcation: Nanomedicine, Robert Freitas assembled In effect, the report drives a wedge between of a “treatment package” that includes ingredient with a successful targeting agent. Support of medical research, in general, an impressive array of ingenious ideas that scientific nanomedicine and something medical nanotechnologies for monitoring Though their origins predate the advent of and nanomedical research, in particular, derive from ongoing developments and lesser that might be called medical and feedback, along with physical "nanotechnology," some nanomedicines should be dedicated to the advance of inevitably lead to extravagant speculations.4 nanotechnology. Nanomedicine is based therapy, geriatric and socio-psychological have already been approved for routine public health and quality of life but not the Freitas's conflation of the short-term with on molecular knowledge of the human approaches, together with even economic use and now have to prove themselves in increase of longevity as an end in itself. the long-term and even with technical body and it involves molecular tools for or political incentives for increased exercise, competition with sometimes less expensive Increased average life-expectancies should impossibilities remains characteristic even the diagnosis and treatment of disease. nanotechnologically improved footwear and alternatives.16 be considered as nothing but welcome of the far more restrained technical papers Medical nanotechnology encompasses all surfaces. side-effects of improved access to health of today. The 2004 presentation of the the other ways in which nanotechnology If only because of the length of the multi- care and better health maintenance overall. cancer nanotechnology initiative in the affects health care, especially all that Theranostics stage approval process, only time will tell Indeed, some proponents of nanomedicine United States revolves around the goal comes from the miniaturisation of devices As distinct from medical nanotechnologies, the success-story of nanomedicines. Their prematurely anticipate just this side-effect. of “eliminating death and suffering from and the integration of information and scientific nanomedicine concentrates definition as designed two-component One of the earliest public documents cancer by 2015”.5 The 2006 European communication technologies in diagnostic on four areas of research and systems suggests a short-cut, namely to to acquaint a general audience with Technology Platform on Nanomedicine tools and health monitoring – including a development: theranostics, a new class of consider them medical devices rather than nanotechnology singles out as a societal is more subtle than this. It speaks of a radical transformation of the present day pharmaceuticals, targeted drug-delivery, and pharmacological substances, especially issue that "longer average lifetimes will

major public investments are directed at only in the longer term. While it makes a References cancer treatments and thus at attempts compelling case for these promises, it also 1 Nanobiotechnology: Responsible Action on Issues in Society and Ethics: http://nanobio-raise.org/ 2 Mauro Magnani Eythrocyte Engineering for Drug Delivery and Targeting. New York: Kluwer, 2003. Nanomedicine further to reduce mortality in developed asks for our patience. And as with all basic 3 Volker Wagner and Axel Zweck Nanomedizin: Innovationspotenziale in Hessen für Medizintechnik und societies where it is already comparatively research, something is bound to come of Pharmazeutische Industrie Wiesbaden: Hessisches Ministerium für Wirtschaft, 2006. • A Brief History of Nanomedicine low. it, though not perhaps the full mastery of 4 Robert A. Freitas (1999): Nanomedicine, Volume I: Basic Capabilities, Georgetown, TX: Landes Bioscience. • Theranostics 5 physiological complexities that is envisioned Cancer NANOTECHNOLOGY: Going Small for Big Advances – Using Nanotechnology to Advance Cancer Diagnosis, • Targeted Drug-Delivery Prevention and Treatment. Washington, DC: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Nanomedical ethics should not serve to in the name of theranostics, individualised Institutes of Health, National Cancer Institute, 2004. • Polymer Therapeutics validate an uncertain future, for example, medicine, and cell repair. Some of its 6 Nanomedicine: Nanotechnology for Health – European Technology Platform. Brussels: European Commission, • Regenerative Medicine by assuming too readily an increase of most important contributions will consist Research DG, 2006, p. 12. • Ethical and societal issues 7 Ibid., p. 10, see also p. 6 and especially p. 12. diagnostic powers or an impact on life- of progress in instrumentation and analytic 8 Nanomedicine: An ESF – European Medical Research Councils (EMRC) Forward Look report. Strasbourg: European expectancy. Instead, it might contribute methods that is now considered primarily Science Foundation, 2006. to public deliberation on the research a stepping-stone towards bigger and better 9 Like synthetic biology, nanomedicine is thus poised to become an off-shoot of nanotechnology that claims its own, The aim of this briefing paper is to provide at least partly separate identity and integrity. – Two of the authors of the ESF-report reflect on this quite explicitly, agenda for nanomedicine. Once one starts things. concise, correct and balanced information to see Ringsdorf and Duncan "nanogames gaining ground" 2006. Nanomedical sectors questioning its primary focus on cancer and 10 The European Technology Platform subsumes new pharmaceuticals under "targeted delivery": "Seamlessly advance public debate among consumers, • Drug delivery cardiovascular diseases, one might have to One should therefore not expect connecting Diagnostics, Targeted Delivery and Regenerative Medicine: Diagnostics, targeted delivery and media, policy makers, producers and • Biomaterials consider the very definitions of illness and nanomedicine to revolutionise medicine. regenerative medicine constitute the core disciplines of nanomedicine. The EuropeanTechnology Platform on researchers as part of the European • In vivo imaging NanoMedicine acknowledges and wishes to actively support research at the interface between its three science 1 health and the medicalisation of society. It is one promising avenue by which areas." This research at the interface can establish theranostics (p. 9). Commission-funded Nanobio-RAISE project. • In vitro diagnostics Similarly, one might consider the metaphors medicine can advance. At the end of the 11 Alfred Nordmann "Knots and Strands: An Argument for Productive Disillusionment," Journal of Medicine and It results from the combined contributions of • Active implants we use to describe the human being or the day, it will have contributed new treatment- Philosophy, 32:3, 2007, pp. 217-236. natural and social scientists, industrialists, and • Drugs & therapy 12 ESF-report, p. 11. changing boundaries of human bodies as options for certain diseases, some new 13 This constructive principle also distinguishes nanomedicine (as a kind of nanotechnology) from biotechnology which governmental and public interest organisations the body's own tissue or insulin, for example, nanomedicines, better imaging-techniques is developing and deploying proteins as active agents. across Europe. It is intended to provide course, all kinds of medical devices profit from might be generated outside the body or by and other diagnostic tools. These will 14 ETP, p. 16. information and does not represent the views the miniaturisation of electronic components 15 Matthias Adam "What to expect from rational drug design,"Expert Opinion on Drug Discovery 2 (6), 2007, way of an implanted device. add significantly to the currently available or policy of the European Commission or any as they move beyond micro to nano. This NanoBio-RAISE Co-ordination office: 773-776. arsenal of therapies and medicines, raising 16 Joachim Schummer "The Impact of Nanotechnologies on Developing Countries," in Fritz Allhoff, Patrick Lin,, James other body. affects diagnostic tools, pace-makers, Julianalaan 67 Conclusion similar ethical and societal concerns as Moor, John Weckert, eds., Nanoethics: The Ethical and Social Implications of Nanotechnology, Wiley, 2007. “cameras in a pill,” etc. Nanoparticulate 2628 BC Delft 17 mean more people on Earth. But how many A 2007 nanomedical bulletin offered the did the medical advances of the past. Andreas Jordan "From Science to Business in 15 Years" in the Proceedings of EuroNanoForum 2005: Introduction pharmaceutical agents can penetrate cells The Netherlands Nanotechnology and the Health of the EU Citizen in 2020, edited by Michael Mason, Sophia Fantechi, Renzo 22 more people can the Earth sustain?" In Ethical and societal issues following news item: "Working with an Demonstrations of efficacy have to be Tomellini, Brussels: EC DG Research, 2006, p. 16. A broad array of present and future research more effectively as well as being able to t +31 (0)15 278 66 26 a similar vein, the European Technology Traditionally, medical ethics is patient- and organic semiconductor, researchers at considered together with physiological and 18 The European Group on Ethics in Science and New Technologies to the European Commission "Opinion on the developments are generally lumped together cross the blood-brain-barrier. After injecting f +31 (0)15 278 23 55 Platform notes that one large impact of treatment-centred rather than research- the University of Arkansas have fabricated environmental side-effects and general ethical aspects of Nanomedicine (Opinion N° 21)," January 17, 2007, section 5.5.1, p. 57. as “nanotechnology.” A common feature is only nanoparticles into tumours, these can be [email protected] 19 While the European Technology Platform considers regenerative medicine one of nanomedicine's three core nanomedicine will be "increased costs of and disease-centred. In other words, most and tested two similar but slightly different quality-of-life issues, comparing all of these disciplines, the ESF's Forward Look treats it only under the heading of new materials (in particular, scaffolding for that they are concerned with large and small stimulated electromagnetically from outside www.nanobio-raise.org social security systems due to ageing of medical ethics is focused on doctor-patient biosensors that can measure physiological to alternative treatment options. And like all tissue growth and repair). The US-report on Cancer Nanotechnology does not refer to it at all. things where at least some relevant measures the body – by emitting heat, the stimulated population."23 relations, on end-of-life decisions, on signs. Integrated into 'smart' fabrics – disease-oriented research, it requires public 20 ETP, p. 6. are in the nanometre range (10-9 to 10-7 particles can then destroy the tumour 21 Paul Miller and James Wilsdon “The man who wants to live forever” in Paul Miller and James Wilsdon (eds.) Better resource-allocation, on treatment choices, garments with wireless technology – the deliberation on which diseases should be metres) and thus in the size-range of DNA- cells. Antibacterial surfaces incorporating Humans? The Politics of Human Enhancement and Life Extension, London: DEMOS, 2006, pp. 51-58. It is important to be clear about the informed consent, and the like. Biomedical sensors will be able to monitor a patient's prioritised in the context of global health 22 Ivan Amato Nanotechnology - Shaping the World Atom by Atom, Washington: National Science and Technology molecules or viruses. More stringent definitions photocatalytic or biocidal nanoparticles reduce achievable goals of nanomedicine that are in research becomes significant only as it respiration rate and body temperature in care. Council, Interagency Working Group on Nanoscience, Engineering and Technology, 1999, p. 8. require that nanotechnological research be the risk of infection in doctors’ offices and 23 ETP, p. 24. the public interest. Popular fascination with enters clinical trials. Accordingly, medical real time."26 In many ways, this appears restricted to the scientific investigation and public buildings. Portable testing kits allow 24 Richard Jones Soft Machines Oxford: Oxford University Press, 2004. envisioned technologies of life extension ethics has been rather indifferent to the to be nanotechnology at its best and is 25 Jean-Pierre Dupuy in Journal of Medicine and Philosophy, 32:3, 2007. technical exploitation of novel properties that for self-monitoring and speedy diagnosis. does not render longevity a public good. level of medical intervention. While the therefore not at all unique to the University 26 NanoMedicine News (www.euronanotechnews.com), #71, July 20, 2007. appear discontinuously at the nanoscale: a New contrast agents and visualisation tools Conversely, before worrying about increased removal of the causes of disease is generally of Arkansas. It is an example of highly ton of gold has the same chemical properties provide a closer look at cellular processes. life-expectancy as one of the potential preferable to symptomatic treatments, it interdisciplinary research that integrates as a milligram, but a gold nanoparticle But this, too, is nanotechnology in action: impacts of nanomedicine, one should does not appear to matter much whether functionalities at the nanoscale, namely shows interesting and initially surprising new nanoparticulate steroids are introduced into ensure that nanomedicine gets off the diseases are addressed at a molecular or the otherwise separate nanotechnological behaviours. This more stringent definition of the body’s own red blood cells; as the cells ground and meets the formidable challenge cellular or whole-organ level. fields of point-of-care diagnostics and nanotechnological research remains quite die their natural deaths, the steroids are to convert even its more modest ambitions 'smart' fabrics. This kind of medical unspecific regarding technological applications: released to the body in very small doses, thus into reality. As the previous sections indicated, however, nanotechnology may enable a profound nanotechnology is all that these newly minimising, if not excluding the side-effects of the nanomedical research programme reconfiguration of the relations between discovered properties and processes might many steroid treatments.2 As it is converted from vision to reality, the raises issues that serve to expand the doctors, patients, and hospitals. It can be good for. And here, the imagination runs notion of cell repair will be a testing ground scope of medical ethics. This concerns, also promote the further medicalisation of wild, challenging us to identify and support These examples and many more of ongoing for the very idea that cellular processes for example, the distinction between drug society, that is, of bringing social behaviours promising, feasible as well as beneficial short- developments can be found in various involve a nanotechnological machinery and device and its regulatory implications. (risk taking, dietary practices, stress and and medium-term developments. reports on the prospects and promises of that can break down and that can also be It also concerns the recognition and anger) into the realm of medical supervision. nanomedicine. But though these examples are repaired. This metaphor of nanomachinery acknowledgment of limits of knowledge and These developments are likely to be On first sight, nanomedicine is the rather more nothing to frown at, nanomedicine has been has proven productive for understanding control, in other words, care to avoid hype contested and call for the debate of their well-defined application of nanotechnology conceived as a far more ambitious enterprise: cellular mechanisms but it is unclear as and to state achievable goals credibly and ethical and societal implications. in the areas of healthcare and disease "Nanomedicine comes into being where a of yet how far this metaphor carries when responsibly. Regenerative medicine in the diagnosis and treatment. But here, too, one molecular understanding of cellular processes it comes to the precision control of highly service of public health and quality of life It is unlikely that nanomedicine will be as encounters a bewildering array of programmes is strategically combined with capabilities to complex biological realities.24 It also leads should be distinguished from the notion transformative. It defines itself as basic and projects. Artificial bone implants already produce nanoscale materials in a controlled to the ethical question of whether we may that life-extension is a public good. Finally, medical research, and is application- benefit from nanotechnologically improved manner."3 With these greater ambitions mechanically reduce the human being to a nanomedical research raises questions oriented like all medical research. As such, materials. Nanostructured surfaces can serve comes the formidable challenge to assess sum of physical traits.25 of distributive justice and global equity as nanomedicine can realise its promises For Pictures: © copyright CEA as scaffolding for controlled tissue-growth. Of more visionary programmes not only for their Design: Gerritsma Vormgeving bno, Leiden, e [email protected], w www.1enof2.nl The Images: Courtesy of the Group at Delft University of Technology

major public investments are directed at only in the longer term. While it makes a References cancer treatments and thus at attempts compelling case for these promises, it also 1 Nanobiotechnology: Responsible Action on Issues in Society and Ethics: http://nanobio-raise.org/ 2 Mauro Magnani Eythrocyte Engineering for Drug Delivery and Targeting. New York: Kluwer, 2003. Nanomedicine further to reduce mortality in developed asks for our patience. And as with all basic 3 Volker Wagner and Axel Zweck Nanomedizin: Innovationspotenziale in Hessen für Medizintechnik und societies where it is already comparatively research, something is bound to come of Pharmazeutische Industrie Wiesbaden: Hessisches Ministerium für Wirtschaft, 2006. • A Brief History of Nanomedicine low. it, though not perhaps the full mastery of 4 Robert A. Freitas (1999): Nanomedicine, Volume I: Basic Capabilities, Georgetown, TX: Landes Bioscience. • Theranostics 5 physiological complexities that is envisioned Cancer NANOTECHNOLOGY: Going Small for Big Advances – Using Nanotechnology to Advance Cancer Diagnosis, • Targeted Drug-Delivery Prevention and Treatment. Washington, DC: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Nanomedical ethics should not serve to in the name of theranostics, individualised Institutes of Health, National Cancer Institute, 2004. • Polymer Therapeutics validate an uncertain future, for example, medicine, and cell repair. Some of its 6 Nanomedicine: Nanotechnology for Health – European Technology Platform. Brussels: European Commission, • Regenerative Medicine by assuming too readily an increase of most important contributions will consist Research DG, 2006, p. 12. • Ethical and societal issues 7 Ibid., p. 10, see also p. 6 and especially p. 12. diagnostic powers or an impact on life- of progress in instrumentation and analytic 8 Nanomedicine: An ESF – European Medical Research Councils (EMRC) Forward Look report. Strasbourg: European expectancy. Instead, it might contribute methods that is now considered primarily Science Foundation, 2006. to public deliberation on the research a stepping-stone towards bigger and better 9 Like synthetic biology, nanomedicine is thus poised to become an off-shoot of nanotechnology that claims its own, The aim of this briefing paper is to provide at least partly separate identity and integrity. – Two of the authors of the ESF-report reflect on this quite explicitly, agenda for nanomedicine. Once one starts things. concise, correct and balanced information to see Ringsdorf and Duncan "nanogames gaining ground" 2006. Nanomedical sectors questioning its primary focus on cancer and 10 The European Technology Platform subsumes new pharmaceuticals under "targeted delivery": "Seamlessly advance public debate among consumers, • Drug delivery cardiovascular diseases, one might have to One should therefore not expect connecting Diagnostics, Targeted Delivery and Regenerative Medicine: Diagnostics, targeted delivery and media, policy makers, producers and • Biomaterials consider the very definitions of illness and nanomedicine to revolutionise medicine. regenerative medicine constitute the core disciplines of nanomedicine. The EuropeanTechnology Platform on researchers as part of the European • In vivo imaging NanoMedicine acknowledges and wishes to actively support research at the interface between its three science 1 health and the medicalisation of society. It is one promising avenue by which areas." This research at the interface can establish theranostics (p. 9). Commission-funded Nanobio-RAISE project. • In vitro diagnostics Similarly, one might consider the metaphors medicine can advance. At the end of the 11 Alfred Nordmann "Knots and Strands: An Argument for Productive Disillusionment," Journal of Medicine and It results from the combined contributions of • Active implants we use to describe the human being or the day, it will have contributed new treatment- Philosophy, 32:3, 2007, pp. 217-236. natural and social scientists, industrialists, and • Drugs & therapy 12 ESF-report, p. 11. changing boundaries of human bodies as options for certain diseases, some new 13 This constructive principle also distinguishes nanomedicine (as a kind of nanotechnology) from biotechnology which governmental and public interest organisations the body's own tissue or insulin, for example, nanomedicines, better imaging-techniques is developing and deploying proteins as active agents. across Europe. It is intended to provide course, all kinds of medical devices profit from might be generated outside the body or by and other diagnostic tools. These will 14 ETP, p. 16. information and does not represent the views the miniaturisation of electronic components 15 Matthias Adam "What to expect from rational drug design,"Expert Opinion on Drug Discovery 2 (6), 2007, way of an implanted device. add significantly to the currently available or policy of the European Commission or any as they move beyond micro to nano. This NanoBio-RAISE Co-ordination office: 773-776. arsenal of therapies and medicines, raising 16 Joachim Schummer "The Impact of Nanotechnologies on Developing Countries," in Fritz Allhoff, Patrick Lin,, James other body. affects diagnostic tools, pace-makers, Julianalaan 67 Conclusion similar ethical and societal concerns as Moor, John Weckert, eds., Nanoethics: The Ethical and Social Implications of Nanotechnology, Wiley, 2007. “cameras in a pill,” etc. Nanoparticulate 2628 BC Delft 17 mean more people on Earth. But how many A 2007 nanomedical bulletin offered the did the medical advances of the past. Andreas Jordan "From Science to Business in 15 Years" in the Proceedings of EuroNanoForum 2005: Introduction pharmaceutical agents can penetrate cells The Netherlands Nanotechnology and the Health of the EU Citizen in 2020, edited by Michael Mason, Sophia Fantechi, Renzo 22 more people can the Earth sustain?" In Ethical and societal issues following news item: "Working with an Demonstrations of efficacy have to be Tomellini, Brussels: EC DG Research, 2006, p. 16. A broad array of present and future research more effectively as well as being able to t +31 (0)15 278 66 26 a similar vein, the European Technology Traditionally, medical ethics is patient- and organic semiconductor, researchers at considered together with physiological and 18 The European Group on Ethics in Science and New Technologies to the European Commission "Opinion on the developments are generally lumped together cross the blood-brain-barrier. After injecting f +31 (0)15 278 23 55 Platform notes that one large impact of treatment-centred rather than research- the University of Arkansas have fabricated environmental side-effects and general ethical aspects of Nanomedicine (Opinion N° 21)," January 17, 2007, section 5.5.1, p. 57. as “nanotechnology.” A common feature is only nanoparticles into tumours, these can be [email protected] 19 While the European Technology Platform considers regenerative medicine one of nanomedicine's three core nanomedicine will be "increased costs of and disease-centred. In other words, most and tested two similar but slightly different quality-of-life issues, comparing all of these disciplines, the ESF's Forward Look treats it only under the heading of new materials (in particular, scaffolding for that they are concerned with large and small stimulated electromagnetically from outside www.nanobio-raise.org social security systems due to ageing of medical ethics is focused on doctor-patient biosensors that can measure physiological to alternative treatment options. And like all tissue growth and repair). The US-report on Cancer Nanotechnology does not refer to it at all. things where at least some relevant measures the body – by emitting heat, the stimulated population."23 relations, on end-of-life decisions, on signs. Integrated into 'smart' fabrics – disease-oriented research, it requires public 20 ETP, p. 6. are in the nanometre range (10-9 to 10-7 particles can then destroy the tumour 21 Paul Miller and James Wilsdon “The man who wants to live forever” in Paul Miller and James Wilsdon (eds.) Better resource-allocation, on treatment choices, garments with wireless technology – the deliberation on which diseases should be metres) and thus in the size-range of DNA- cells. Antibacterial surfaces incorporating Humans? The Politics of Human Enhancement and Life Extension, London: DEMOS, 2006, pp. 51-58. It is important to be clear about the informed consent, and the like. Biomedical sensors will be able to monitor a patient's prioritised in the context of global health 22 Ivan Amato Nanotechnology - Shaping the World Atom by Atom, Washington: National Science and Technology molecules or viruses. More stringent definitions photocatalytic or biocidal nanoparticles reduce achievable goals of nanomedicine that are in research becomes significant only as it respiration rate and body temperature in care. Council, Interagency Working Group on Nanoscience, Engineering and Technology, 1999, p. 8. require that nanotechnological research be the risk of infection in doctors’ offices and 23 ETP, p. 24. the public interest. Popular fascination with enters clinical trials. Accordingly, medical real time."26 In many ways, this appears restricted to the scientific investigation and public buildings. Portable testing kits allow 24 Richard Jones Soft Machines Oxford: Oxford University Press, 2004. envisioned technologies of life extension ethics has been rather indifferent to the to be nanotechnology at its best and is 25 Jean-Pierre Dupuy in Journal of Medicine and Philosophy, 32:3, 2007. technical exploitation of novel properties that for self-monitoring and speedy diagnosis. does not render longevity a public good. level of medical intervention. While the therefore not at all unique to the University 26 NanoMedicine News (www.euronanotechnews.com), #71, July 20, 2007. appear discontinuously at the nanoscale: a New contrast agents and visualisation tools Conversely, before worrying about increased removal of the causes of disease is generally of Arkansas. It is an example of highly ton of gold has the same chemical properties provide a closer look at cellular processes. life-expectancy as one of the potential preferable to symptomatic treatments, it interdisciplinary research that integrates as a milligram, but a gold nanoparticle But this, too, is nanotechnology in action: impacts of nanomedicine, one should does not appear to matter much whether functionalities at the nanoscale, namely shows interesting and initially surprising new nanoparticulate steroids are introduced into ensure that nanomedicine gets off the diseases are addressed at a molecular or the otherwise separate nanotechnological behaviours. This more stringent definition of the body’s own red blood cells; as the cells ground and meets the formidable challenge cellular or whole-organ level. fields of point-of-care diagnostics and nanotechnological research remains quite die their natural deaths, the steroids are to convert even its more modest ambitions 'smart' fabrics. This kind of medical unspecific regarding technological applications: released to the body in very small doses, thus into reality. As the previous sections indicated, however, nanotechnology may enable a profound nanotechnology is all that these newly minimising, if not excluding the side-effects of the nanomedical research programme reconfiguration of the relations between discovered properties and processes might many steroid treatments.2 As it is converted from vision to reality, the raises issues that serve to expand the doctors, patients, and hospitals. It can be good for. And here, the imagination runs notion of cell repair will be a testing ground scope of medical ethics. This concerns, also promote the further medicalisation of wild, challenging us to identify and support These examples and many more of ongoing for the very idea that cellular processes for example, the distinction between drug society, that is, of bringing social behaviours promising, feasible as well as beneficial short- developments can be found in various involve a nanotechnological machinery and device and its regulatory implications. (risk taking, dietary practices, stress and and medium-term developments. reports on the prospects and promises of that can break down and that can also be It also concerns the recognition and anger) into the realm of medical supervision. nanomedicine. But though these examples are repaired. This metaphor of nanomachinery acknowledgment of limits of knowledge and These developments are likely to be On first sight, nanomedicine is the rather more nothing to frown at, nanomedicine has been has proven productive for understanding control, in other words, care to avoid hype contested and call for the debate of their well-defined application of nanotechnology conceived as a far more ambitious enterprise: cellular mechanisms but it is unclear as and to state achievable goals credibly and ethical and societal implications. in the areas of healthcare and disease "Nanomedicine comes into being where a of yet how far this metaphor carries when responsibly. Regenerative medicine in the diagnosis and treatment. But here, too, one molecular understanding of cellular processes it comes to the precision control of highly service of public health and quality of life It is unlikely that nanomedicine will be as encounters a bewildering array of programmes is strategically combined with capabilities to complex biological realities.24 It also leads should be distinguished from the notion transformative. It defines itself as basic and projects. Artificial bone implants already produce nanoscale materials in a controlled to the ethical question of whether we may that life-extension is a public good. Finally, medical research, and is application- benefit from nanotechnologically improved manner."3 With these greater ambitions mechanically reduce the human being to a nanomedical research raises questions oriented like all medical research. As such, materials. Nanostructured surfaces can serve comes the formidable challenge to assess sum of physical traits.25 of distributive justice and global equity as nanomedicine can realise its promises For Pictures: © copyright CEA as scaffolding for controlled tissue-growth. Of more visionary programmes not only for their Design: Gerritsma Vormgeving bno, Leiden, e [email protected], w www.1enof2.nl The Images: Courtesy of the Molecular Biophysics Group at Delft University of Technology