ABSTRACT
One critical aspect of digital databases and how effective they are is who is responsible for them and who has access to them? There are vast numbers of laboratories, companies, and communities that are involved in the creation and preservation of scientific data, each with its own legal and ethical protocols and with varying degrees of openness to outside users. 42.1.3 ProteomicsProteomics is the study of the entire set of proteins expressed or modified by an organism, and will require access to the databases previously discussed. It provides methods for correlating the vast amounts of genomic data with protein information that is being produced through analysis of cells under normal and altered states. It consists of high-throughput identification and characterization of proteins and integrating it with genomic data. Characterization of novel catalysts using proteomics will allow synthetic biologists to expand their protein toolbox in order to design bioprocesses for biopharmaceuticals and bioproducts. One of the challenges is being able to identify the function of all the various protein parts within cellular systems; better identification of these parts will
allow a better description of the entire biological system that could be used as a cell factory [12]. Johnson et al. suggest that the solution to many of the technical challenges in proteomics and protein-based molecular diagnostics is nanomaterials and that nanoproteomics will provide platforms for the discovery of next-generation biomarkers, which will enable the molecular diagnostics field to take off [13]. Advances in nanotechnology have allowed the identification of low-abundance proteins, for example [14]. Johnson et al. conclude that in the near term nanotechnology will have a major impact on proteomics and diagnostics, leading to new devices and sensing modes and augmenting existing methods. As bioinformatics and proteomics advance the support of computational biologists, mathematicians, and statisticians will be required to be able to analyze and interpret the vast amounts of data the field is generating [15]. 42.2 Personalized MedicineGoldstein predicted that by 2016 doctors will be able to scan their patients’ entire genome in a matter of minutes [16]. While that prediction was a bit optimistic the technology and medicine in general are moving toward genetic-based personalized therapies. Weston and Hood predict that in the next 20 years there will be a fundamental shift in healthcare, moving from a reactive model to one that can predict and prevent cellular dysfunction, capable of determining a probabilistic, individualized future health history [15]. Gonzalez-Nilo et al. conclude that implementing the tools of nanoinformatics, which they define as the intersection of bioinformatics, computational chemistry, and nanobiotechnology, will open the door toward personalized medicine by accelerating the design of highly specific biomedical treatments, increasing the efficacy, bioavailability, and specificity of nanomaterials and reducing side effects [17]. As the “omics” technologies (i.e., genomics and proteomics) improve, they are exposing the weaknesses of traditional therapeutics, which do not allow for different patients’ “physiologic idiosyncrasies.” Doctors no longer rely primarily on images such as a mammogram or a patient’s pathology. They now
include the molecular profile or genetic map of a patient [18]. Nanotechnology, along with systems biology and the convergence of the other “omics” technologies, is predicted to play a critical role in being able to develop patient-specific therapies.Nanotechnology is predicted to “provide access to previously inaccessible data as related to ‘omic’ technology components” and “enable innovative therapeutic modalities that leverage the validated systems biology outputs for exquisitely specific individualized therapy” [18]. Areas of nanotechnology that are predicted to aid personalized medicine are early detection diagnostics, implantable drug delivery devices, nanobased injectable therapeutics, nanobased contrast agents, and tissue engineering.The ability of patients to control the most important aspects of their care (a diabetes patient to measure his or her glucose level) is very appealing and is why self-care testing is the majority of the point-of-care testing market [19]. Nanotechnology has led to significant technological advances in the miniaturization of devices, particularly in point-of-care testing. These devices encompass a variety of applications from in vivo testing to handheld glucose tests. The market was worth $11.3 billion in 2007 and was predicted to grow to $18.7 billion in 2013 [20]. New lab-on-a-chip manufacturing techniques are enabling them to be connected to and embedded in smartphones and USB drives, turning your phone into a portable diagnostic device capable of communicating directly with your doctor’s office [21]. Macklis and Sharma predict that within the next few years nearly all medical devices will be controlled or monitored remotely or via Internet-accessible interfaces, making the electronic medical records system a much more important monitor and response network with the potential for automated responses [22]. Intrabody communication and personal network security are needed to evaluate and act upon the continuous test results that come with continuous monitoring, potentially leading to less aggressive and less expensive therapeutics [23]. Beyond point-of-care diagnostics, the nanomedicine market is estimated to reach $1 trillion by 2015 [19].Personalized medicine requires the analysis of massive amounts of genomic data using miniaturized biomedical devices and lab-on-a-chip technologies that have been influenced by
nanotechnology and nanofabrication [24]. Personalized medicine is also based on a systems biology approach utilizing modern molecular medicine and the analysis of large datasets for complex diseases [25]. However, personalized medicine will only be successful if medicines with subtle differences designed for individuals on the basis of their DNA can be manufactured reliably and at small scales [26].As these technologies take hold, a new governance structure may be needed to regulate the transmission of medical data, the sharing of devices between users, the potential of “homemade” or hacked instruments, and the standardization of results and analysis methods amongst various countries. Lymberis suggests that micro-and nanotechnologies will change the way that healthcare is organized and priced and ultimately remove the barriers between medical and pharmaceutical practices and home care and test laboratories [27]. New ethical issues may arise with personalized medicine and home diagnostic tests. For instance, would it be ethical to make available a point-of-care cancer diagnostic test? Many doctors believe that counseling is vitally important for such diagnoses and wonder if making such tests available is ethical [1]. 42.2.1 Size/Scope of the Nanomedicine MarketAccording to BCC Research the global nanomedicine market reached $63.8 billion in 2010 and $72.8 billion in 2011 and is expected to grow to $130.9 billion by next year [28]. In 2006, Wagner et al. analyzed the emerging nanomedicine landscape and found more than 150 start-ups and small and medium-sized enterprises focused on nanomedicine research and development projects: 38 nanoenabled products with sales totaling $6.8 billion. Twenty-three of those products were drug delivery systems, with three of them accounting for $3.2 billion. They found that three quarters of the research market was focused on drug delivery applications [29]. Resnik and Tinkle reported in 2007 that drug delivery accounted for 78% of sales and 58% of patent filings worldwide [30]. Moving a new nanosized drug or product to market requires support from large pharmaceutical companies. Small start-ups are pursuing a host of ideas utilizing nanotechnology in order to improve treatment and
diagnosis. Despite this, Wagner et al. found that these small companies and industry R&D managers agreed that large pharmaceutical companies are skittish on emphasizing nanotechnology in their business strategy [29]. The Project on Emerging Nanotechnologies (PEN) maintained an interactive map showing the locations of companies, universities, and government labs across the U.S. that are/were involved in nanotechnology research, development, and commercialization, currently with over 200 entries in the medicine and health fields (https://www.nanotechproject.org/inventories/map/). 42.3 Ethical and Policy Implications
Surrounding NanomedicineMedicine is moving toward being able to predict what you will die from and when. As nanomedicine, genetics, and diagnostics improve they promise the ability of healthcare professionals to diagnose, treat, and share medical information nearly instantaneously. The potential development of a lab on a chip that could be implanted into a human that monitors the person’s health raises concerns about who monitors the information, who has access to the information, and whether or not the chip can be used for purposes other than medical surveillance [31]. This chip can not only diagnose current disease but also analyze your DNA to determine which diseases you may be susceptible to in the future. This raises ethical concerns of the patients’ right to know, right not to know, and duty to know. This has been referred to as the principle of autonomy [32]. The European Group on Ethics in Science and New Technologies forecasted that the long-term ethical issues will surround civil liberties in regard to implants that will potentially make life safer but will also create privacy debates [33].Spagnolo and Daloiso suggest that ethical issues should take a back seat to determining the scientific merit of a medicine if the potential benefit justifies the use of nanoparticles, even if the design and effects of the nanomedicine are not completely understood [31]. The shift to personalized medicine not only in terms of targeted drug deliver but also in terms of personalized diagnosis and treatment creates a potential for patients becoming autonomous, increased technology use, and dependence causing
reduced personal interactions and will inevitably change the way medicine is currently practiced. While technology advances reduce the invasiveness of medical treatments and improve efficiency, they have the potential of shifting the responsibility away from doctors to patients [31].“Good facts of course are essential to the development of good ethics but the same set of facts may result in very different ethical arguments and conclusions for different people” [34]. White argues that from an ethical perspective, considerations of benefits and harms would supersede issues of profitability in terms of importance [34]. While ethically this should be how things work, the reality is that profitability in the eyes of pharmaceutical companies is priority number one, albeit it goes hand in hand with weighing the risks versus the benefits of a particular drug, medical device, or diagnostic tool. 42.3.1 Clinical TrialsA recent search using the keyword “nanoparticles” of the website ClinicalTrials.gov produces 116 clinical trials that have been approved, completed, or are currently being conducted. The European Group on Ethics in Science and New Technologies proposed a series of questions surrounding nanomedicine [35]: (1) How should the dignity of people participating in nanomedicine research trials be respected? (2) How can we protect the fundamental rights of citizens who may be exposed to free particles in the environment? (3) How can we promote responsible use of nanomedicine that protects both human health and the environment? (4) What are the specific ethics issues, such as justice, solidarity,
and autonomy, that have to be considered in this scientific domain?The ethical issues surrounding nanomedicine are not necessarily about the technology but about the implications of the technology and how we look, think, and feel about our bodies (assuming the applications nanomedicine promises come to fruition). Bawa and Johnson ask whether nanobased therapies have the potential to further marginalize those individuals who are perceived as disabled [36].
