Clinical Nanobioethical Problems: A Value Approach

Chapter 43

Clinical Nanobioethical Problems: A Value Approach Jorge Alberto Álvarez-Díaz, MD, PhD Departamento de Atención a la Salud, Universidad Autónoma Metropolitana—Unidad Xochimilco, México

Keywords: nanobioethics, bioethics, nanoethics, bionanoethics, nanites, nanates, moral experience, obligation, facts, instrumental values, intrinsic values, material values, vital values, spiritual values, duties, responsibility, deliberation, constructivism, axiology, ethics

43.1 From Nanoethics and Bioethics to Clinical Nanobioethics Medicine has been practiced since prehistory, and classic ethical reflection (medical ethics) has remained practically unchanged from the historical origins of medicine to the birth of bioethics. This birth occurred in 1970 and 1971 after the publication of a couple of works by Van Rensselaer Potter (even though the word appeared in German in 1927 in a work by Fritz Jahr, the idea lacked continuity). On the other hand, the development of ethical reflection on nanotechnology has been carried out during the second half of Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk Edited by Raj Bawa, Gerald F. Audette, and Brian E. Reese Copyright © 2016 Pan Stanford Publishing Pte. Ltd. ISBN 978-981-4669-22-1 (Hardcover), 978-981-4669-23-8 (eBook) www.panstanford.com

1058

Clinical Nanobioethical Problems

the twentieth century. The year 2003 can be considered the year in which “nanoethics” was born. A number of key events concerning nanoethics occurred during that pivotal year. On April 9, 2003, the U.S. House of Representatives Committee on Science held a hearing to examine the societal implications of nanotechnology and to consider H.R. 766, The Nanotechnology Research and Development Act. During Langdon Winner’s speech, a new kind of professional was mentioned, the “nanoethicists” (those who would deal with a new discipline, the “nanoethics”; the available literature does not seem to support that the words “nanoethics” and “nanoethicist” existed before this speech). In June of 2003, a brief article commented on the desire of the Congress to study the negative effects of nanotechnology [1], again using the word “nanoethicist.” In October of the same year, a workshop was carried out by the National Academy of Engineering, the central topic being called “Emergent Technologies and Ethical Issues in Engineering” [2]. Furthermore, during an analysis of the nanotechnology ethics [3], fundamental reflections regarding the status of nanoethics as well as specific areas which deserve special attention (catalysis, molecular computing, nanomaterials, military applications, space applications, biomedical applications, energy, etc.). During the same month, the “International Conference on Discovering the Nanoscale” was held in Germany, producing a book that included two chapters on the topic. The first chapter discussed several ethical problems that nanotechnology raises [4], while the second included the word “nanoethics” and described the possibility of a new discipline [5]. Finally, in December of 2003, the Third Session of the COMEST (Commission Mondiale d’Éthique des Connaissances Scientifiques et des Technologies) met and approached the topic of “ethics and nanotechnology” [6] (UNESCO had already included the topic in the agent during a meeting of the Committee of Ethics of the Scientific and Technological Knowledge of the Year 2000 [7]). Relating life and health sciences to nanotechnology generates two possibilities [8]: “nanobiotechnology” and “bionanotechnology.” There are publications that use the terms as synonymous [9], but the distinction between them is relevant. “Nanobiotechnology” appears in PubMed database in 2000 [10], whereas “bionanotechnology” does not appear until 2003 [11]. The first term is much more

From Nanoethics and Bioethics to Clinical Nanobioethics

common than the second is, though the use of the second term would have been much more appropriate in many cases. A simple definition of “bionanotechnology” is as follows: the use of biotechnology in nanotechnology (the use of biological pieces for different applications that cannot be directly related to biology; some biological tools might be self-assembled structures, bioinspired materials, biomolecular electronics, etc.). On the other hand, “nanobiotechnology” refers to the application of nanotechnology to develop and improve of the processes and products of biotechnology (in other words, it is the use of the nanotechnology for specific biological applications as tissue engineering in nanotemplates, etc.). Therefore, ethical reflection on bionanotechnology behooves “bionanoethics” [12], whereas ethical reflection on nanobiotechnology behooves “nanobioethics” [13]. In other words, nanobioethics studies the ethical issues of nanotechnological application in biology. The following fields have been highlighted as most important in this discussion [14]: human enhancement, synthetic biology, nanomedicine, nanotechnology in agri-food, and animal testing. Nanomedicine is a very new discipline. The first citation in the PubMed database that includes this word was made in 1999 [15]; it is also extraordinarily rare to encounter a prior reference to that citation [16]. Even though the publishing of the first detailed study of a medical nanorobot’s technical design by a peerreviewed and indexed journal occurred one year prior [17], bibliometrics shows that the term “nanomedicine” is almost a daughter of the twenty-first century [18]. Nanomedicine can be defined as both the application of nanoscience to benefit a patient [19] and as the medical application of nanotechnology [20]. Nanomedicine would thus correspond to a particular form of nanobiotechnology application in healthcare [21, 22]. It is indeed possible to find broader definitions of nanomedicine [23, 24], with many national organizations giving their own description (such as the National Institutes of Health of the United States). Additionally, some supranational organizations have provided definitions (such as the European Science Foundation [25] and the European Community through the European Technology Platform on Nanomedicine [26]). Overall, it becomes clear that there is no standard international

1059

1060

Clinical Nanobioethical Problems

definition of nanomedicine [27], even though it likely encompasses the largest set of interventions and advances to revolutionize healthcare in the twenty-first century [28, 29]. As a result, if medical ethics is reciprocal to classical medicine (in the same manner that bioethics is to contemporary medicine, nanoethics to nanotechnology, bionanoethics to bionanotechnology, and nanobioethics to nanobiotechnology), this chapter proposes the use of clinical nanobioethics (a field of nanobioethics) to analyze ethical issues in nanomedicine (understood as a specific application of nanobiotechnology). The idea includes considering aspects of both bioethics and nanoethics, since it is not possible to approach the ethical issues generated by nanomedicine if we rely solely on bioethics or nanoethics.

43.2 What Is (and What Is Not) an Ethical Problem?

Identifying ethical problems is crucial if one is to adequately analyze those problems. However, one must be careful to not raise pseudo-problems (problems that are irrelevant to the true task), which requires a couple of considerations. First, there is a common nanotechnology [30] associated with nanates [31] (nanomaterials or passive applications of nanotechnology with relatively simple processing, which are already on the market). Nanates are modern devices produced by sustained innovations (discontinuous or transformational, and continuous or evolutionary) whose regulation and public policy have normative and institutional precedents. Second, there is a futuristic nanotechnology [4] associated with nanites [32] (nanomachines or active applications of nanotechnology with complex processing, which are not yet marketed). Nanites, then, are hypothetical devices that would be the product of disruptive innovations [33, 34], therefore having no historical precedent regarding potential public policy and regulation. The ethical issues associated with common nanotechnology are those issues which need to be confronted with the highest level of urgency. Ethical problems arising from futuristic nanotechnology are different, since the management of imagined future scenarios

A Foundation for Ethics

is not urgent. In fact, attention given to just probable futuristic scenarios often uses time and critical resources to address problems that may or may not arise. UNESCO, addressing the issues of ethics and politics with respect to nanotechnology, discusses in a specialized publication some “Distractions—Ethical issues” that aren’t [35], and points out that “Two recent discussions surrounding nanotechnology have received a lot of attention when it comes to ethical or social implications and risks: the so-called ‘grey-goo’ scenario and the concerns about ‘post-humanism.’” An example of a problem not mentioned by UNESCO is that of considering whether robots can have rights [36] (assuming the existence of android robots with artificial intelligence similar to humans). Another example of an irrelevant nanobioethical problem concerns the possibility of extending human life (to such a degree as eventually attaining human immortality) [37]. For all the above reasons, UNESCO emphasizes that “if policymakers, elected and appointed officials, and non-governmental and advocacy organizations can be convinced to look beyond these two distractions, a number of other pressing issues present themselves as being in need of serious discussion and creative forms of policy and regulatory oversight. These include toxicity and environmental hazard and exposure risks; labeling, consumer awareness, and product regulation; intellectual property, secrecy, and the reliability and legitimacy of international scientific research; the potential for international scientific and technical divides; and, most importantly, the promotion of uses for nanotechnology that help solve the most pressing needs for the greatest number of people.” One of these needs is healthcare and nanomedicine in it.

43.3 A Foundation for Ethics: The Experience of Obligation

A foundation for clinical nanobioethics is essential because, without a foundation, one cannot determine whether an action is ethical or not. A second reason why clinical nanobioethics needs a foundation is that without a foundation, it is impossible to seriously

1061

1062

Clinical Nanobioethical Problems

discuss the ethical issues raised by nanomedicine. Third, an ethical foundation allows humans to propose processes and procedures that attempt to solve moral problems (a foundation without a procedure is inoperative, and a procedure without a foundation is a combination of ambiguity and frivolity). This chapter proposes that it is possible to found clinical nanobioethics on phenomenological philosophy. There are data about which all humans can agree and use to determine how human beings make moral judgments. This seems an adequate proposal given the postmodern horizon in front of us. Thus, the first reasonable and indemonstrable arguments (so that the system is coherent) follow. First, every human endeavor in the realms of philosophy and science has a precedent in a pre-existing object of study: Biomolecules precede biochemistry; drugs are prior to pharmacology, etc. Yet, what existed before humanity’s ability to develop “ethics” as a discipline (with theories, foundations and subsequent procedures, etc)? We will refer to that “what” that already existed as “moral experience.” Second, what does the term “moral experience” truly mean? According to the Spanish physician, philosopher, and bioethicist Diego Gracia, moral experience is the experience of obligation [38]. This type of human experience is a primordial, concrete, individual, and irreducible datum (it is not possible to go beyond such experience). Facts comprise all of the content of that human experience; all statements about that experience are theoretical. Moral experience is universal (every human being possesses it) and imperative (in order to make and yet avoid specific behaviors). All humans make moral judgments; all humans feel that they are forced (by themselves) to do certain things, while simultaneously feeling that they are forced not to do others. Specific actions vary from person to person, yet the experience of obligation is always present. All great religious leaders felt compelled to take certain actions due to the basic human experience of obligation. Moreover, all the worst tyrants throughout history felt compelled to carry out different actions since they also possessed that basic human experience of obligation. The quintessential ethical question is thus revealed: What must I do? The answer will come according to the content of the ethical problem. If all human

A Foundation for Ethics

beings feel compelled to carry out actions, the duty in each situation is somehow made known.

43.3.1 Facts: Clinical Nanomedical Facts

“Facts” (from the Latin factum, past participle of facere) are data that have actually happened or that are true. Human beings are aware of facts through perception; stated more simply, facts are perception data. Clinical facts are by no means an exception to this rule. For example, a clinician can use X-rays to observe a fracture (indirect perception), while a health professional can make an incision to see the same thing (direct perception). In nanomedicine, nanoparticles cannot be observed directly, but there are many methods to observe them indirectly and follow their behavior. In a more complicated manner, “facts” are the result of a complex construction; they are the product of what is called “science.” In order to affirm that “nanates are current devices” or that “nanites are hypothetical devices,” the scientific method must be applied in the field of nanomedicine. If a nanocarrier is useful in clinical pharmacology, research, both preclinical and clinical, becomes a necessity. Our discussion of facts as being based in data reminds us that scientific facts are the product of an immense construction. Human beings make judgments about these facts. Such judgments are called “descriptive judgments” and are employed in everyday life. Descriptive judgments follow a structure in which “S is P.” If a person says that “today is a sunny day,” it is a descriptive judgment, based on perception data. If a doctor says “the patient is sick,” we still the same type of judgment, not only with perception data, but also with the complex construction made possible by the results of diagnostic tests (based, in turn, on scientific and technological development). However, one must remember to always be cautious. If we say on a daily basis that “the day is beautiful,” or if we state that “the disproportionately low possibility of developing nanomedicine in developing countries is unfair,” an important observation can be made. First, these judgments have the same structure of “S is P.” Second, these judgments do not address perception data, for beauty and justice are not perceived (not seen, heard, nor touched); they are instead esteemed. Such realities are not “facts,” but “values.”

1063

1064

Clinical Nanobioethical Problems

43.3.2 Values: Not Merely Personal Beliefs At times, human beings make judgments that have a descriptive structure (“S is P”), yet which are not used to describe perception data. We refer to such judgments as “value judgments.” Values​​ are not perception data (the senses are not useful in capturing them). However, human beings have another ability, that which is referred to as esteeming. The human brain not only perceives, it also dreams, imagines, esteems, etc. Values ​​are the product of esteeming something. Following Moore’s rule, it is possible to affirm [39] that values ​​are those that, were they to disappear; the world would lose something important. What would the world be without beauty, justice, or health? The word “value” has been used extensively yet analyzed to a far lesser extent. It is often thought that values ​​are subjective or the result of personal beliefs, but arriving at such a conclusion is a huge mistake. If I esteem something as beautiful and doing so were merely subjective, no one else would esteem it in the same manner. However, when several human beings appreciate that a buckminsterfullerene is beautiful [40], it is clear that the conclusion is more than purely subjective, but rather intersubjective [41]. If I state that a certain molecule is beautiful, it does not mean that the molecule is beauty in and of itself; rather, “beauty” is an attribute that the molecule possesses. Therefore, “beauty” has certain degree of objectivity. Therefore, facts (as evidenced by the example of the molecule) serve to support values. Values ​​are not “floating” around in human subjectivity, but are instead “hanging” from the facts that support them. In other words, one cannot esteem without perceiving. At first glance, values seem to be weaker ​​than facts, yet it is impossible to doubt the great strength and importance of values. Human beings have given life or taken it from their neighbors in the name of values, not facts. Human beings build their projects and dreams with values, so it is no wonder that ethical problems arise when values are in conflict [42]. Testing a nanoparticle with pharmacological properties or testing a nanocarrier is valuable, since society could benefit from another useful molecule in the therapeutic arsenal. Protecting human health in particular (those who participate in a clinical trial) and protecting health in general (all citizens, through nanotoxicity controls, environmental

A Foundation for Ethics

protection, etc.) is also valuable. These values ​​conflict during nanomedical research, thus generating ethical problems. The study of values ​​is performed in a philosophical discipline called “axiology”; therefore, it is necessary to elaborate on the specificity of ethics: duties. We will now assume that the ethical question par excellence is “what must I do?” The mere existence of the question indicates that the problem likely has some type of solution. People usually think about ethical problems as dilemmas (a choice between only two possibilities); dilemmas often prove useful in the theoretical study of ethics. Nevertheless, in the real world, human beings face ethical problems (a choice among many possibilities).

43.3.3 Duties: Always the Same

The third moment of moral experience is duty. Therefore, there are three momenta: facts, values, and duties. Human beings process the three kinds of information at the same time: facts through sensation and perception, values through esteeming, and duties through construction. Since there is no separation of the three in the real world; there is no time preference concerning facts; this is merely a didactic way showing how duties “appear.” Ethics specifically addresses duties; a widespread misconception is that ethics addresses values, yet this is not so, at least not directly. Duties require the attainment of values and are subsequently supported by them. There is a duty to do research, just like there is a duty to protect human subjects participating in research or those who might benefit from it. We must now grapple with a problem: By esteeming the value of research, human beings desire to propel scientific investigation ever forward; however, it is impossible to conduct research that satisfies all values. Values ​​are like a guide to reach an ideal world; they offer what “should be.” Values are something unreal that people try to attain in the real world. Yet in everyday life in a world composed of facts, every human being looks for what “must” be done in each case (and therefore a clinical trial may be suspended or not even allowed to start). A value must frequently yield a bit to another value. Such yielding will eventually be the content of the moral experience of obligation in a particular case. This is not relativism, but rather

1065

1066

Clinical Nanobioethical Problems

an attempt to produce in the real world the utopias traced by the complete and absolute attainment of values. Ethics looks neither for the good (as Aristotle said in the Nichomaquean Ethics [43]) nor for the better (as the Spaniard Julian Marias thought [44]); ethics instead seeks the best (as the Spaniard Diego Gracia has widely defended). As an example, research on nanomedicine is a group of facts and supporting values that might be attained through duties. Should research on nanomedicine be carried out? Certainly. Should it be done at any cost, under all circumstances? Certainly not. We therefore conclude that it is necessary to evaluate every concrete case. Values are always required if we are to arrive at duties, so values ​​are the support system of duties. Only in this sense can ethics treat values: through duties. Duties always demand the achievement of values [45]. Unfortunately, humans do not have the aptitude to achieve all values in a full, complete, and absolute way; people are therefore forced to make value choices by preferring one value to another every time are faced with a values conflict. The search for the best attempts to achieve values ​​in a complete manner, yet such a task is not feasible. This leads to a significant paradox found in every human being: Every moral life is frustrated because no one does everything that he or she “should” do, even though the individual always does everything that he or she “must” do. This paradox is called the “moral gap” [46]. Axiology has studied some characteristics of values, classifying them into two groups. The first corresponds to instrumental values, which are values serving to arrive at another value. Examples in health care are everywhere: Any device used to establish a diagnosis or to provide treatment (all drugs!) is an instrumental value. They are such since their value is not in and of themselves, but because they are valuable to obtain another value that stands by itself: health. From this perspective, nanotechnology corresponds to a complicated universe of instrumental values [47]. The second group includes intrinsic values, which are valuable by themselves; the best example for those involved in health care is health. According to the World Health Organization (WHO), “health is a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.”

A Foundation for Ethics

The definition has not been amended since 1948. A deeper explanation of the usage of the word “well-being” could be given, but this is neither the time nor the place. Rather, need now is to fundamentally define “health” by a value (wellbeing-discomfort). This wellbeing, as a value, is supported by facts (of biological, psychological, and social nature, at least according to the definition). The duty of everyone, particularly that of healthcare professionals as experts in knowledge of the health-disease process, is to achieve the value of health both in general and in specific areas (such as mental health, reproductive health, sexual health, etc.). Axiology has also shown that values ​​have a hierarchy. From lowest to highest in this hierarchy are material, vital, and spiritual values. This hierarchy is based on the kind of support of each value. Material values ​​are supported by everything having matter (big-small, expensive-cheap); a gemstone and a grain of sand support this kind of value. In healthcare, there are many material values, as has already been mentioned (they are also instrumental values since they are serve to arrive at intrinsic values, such as health). In fact, nanites and nanates both correspond to material values. Vital values ​​are supported by everything having life (lifedeath, health-disease, pain-painless); the reality called “stone” supports material values, but not life values. On the other hand, the reality called “guinea pig” support material values ​​(it has matter) and life values ​​(because it is composed of living matter). A stone cannot get sick; however, a guinea pig can certainly be expensive or cheap. Spiritual values ​​are supported by human life (sacred-profane, right-wrong); in other words, only human realities can support spiritual values. It is crucial to identify the uniqueness of human beings (they have matter) and then support material values ​​(bigsmall). They have life and therefore support life values ​​(healthdisease, life-death, pleasure-displeasure). Finally, humans possess something peculiar, something unique, which allows them to support spiritual values. A fact usually supports many values, and values ​​in turn support specific duties. The question for every human being now becomes the following: What must everyone do in each situation? According to previous exposition, to attain a value, a person must

1067

1068

Clinical Nanobioethical Problems

do all. Is it possible to properly implement all values and do so in a complete way? Clearly not. There are several difficulties: There are usually problems in achieving a value to the furthest degree of completeness (this is the reason for the existence of war, disease, and death, and thus, in the real world, there are antivalues everywhere). Another difficulty is the impossibility of fully exercising all values simultaneously. Moral responsibility partially consists of choosing which values to put into practice, the order in which they are achieved, and to what extent each value should be utilized.

43.4 A Methodology to Propose Solutions for Ethical Problems: Deliberation

Gracia suggests that moral deliberation is the methodological counterpart to the foundation exposed prior. The proposal is as follows: To recommend a solution for a value conflict (an ethical problem), people must deliberate. Gracia has studied deliberation as both a process and a procedure [48–50]. Gracia mentions three ways of understanding deliberation as a process: one in a general sense and two in a specialized sense. Within the specialized sense, the two ways of understanding deliberation are the improper (or Platonic) and the proper, or strict, way (Aristotelian) ​​[51]. In a general sense, the English definition of “deliberate” is “to think or consider carefully and fully; especially, considering reasons for and against a thing in order to make up one’s mind.” Deliberation also refers to the “consideration and discussion of alternatives before reaching a decision” [52]. Deliberation is a method of knowing [43] and is used in practical reasoning (other kinds of reasoning do exist). The aim of deliberation is to gain knowledge for proposing solutions to specific problems; therefore, deliberation must evaluate the context and consequences that can be foreseen. Deliberation always concerns the future. Deliberation is contingent; therefore, it is always affected by uncertainty. The human mind searches deeper for reasonable solutions in situations of uncertainty, instead of for categorical statements. Deliberation shows that possible solutions to a problem are manifold, provided they are based on the strongest reasons given in the best arguments. Deliberative

A Methodology to Propose Solutions for Ethical Problems

reasoning is the world’s “opinion”; every human being who deliberates can and must express his or her opinions. The best view, the possible solution to a problem, will be the view supported by arguments high in both quantity and quality. Anyone has the potential to be right, but nobody is ever absolutely right; two individuals will always have different knowledge of and perspectives on the same problem. Deliberation is a radically democratic procedure [53]. Since the days of Aristotle, the language of ethics does not employ demonstrations or apodictic arguments; instead, its language uses dialectics with probabilistic arguments. The expression of opinions through dialogue is an exchange of reasons that aspires to be prudent, but not certain. Demonstrations and certainties do not exist in ethics (nor can they exist) because human actions are not always the same. Ethics does not seek certainty or truth, but prudence. Moral decisions in reality attend to both reason and emotions. To deliberate properly, one must analyze reasons and emotions. Moral decisions cannot be prudent if they are purely rational or purely emotional. Prudence, then, does not follow apodictic truth (like mathematics), but instead behaves like dialectical arguments (rational) and rhetorical arguments (emotional) when both are used properly. Human beings must assume that human reason is not, nor can it be, “pure.” When human beings seek prudence, and not certainty, they risk the possibility of making a mistake [54]. Prudence consists of rational decision-making in the presence of uncertainty [55]. The process of globalization has steered the world toward multiculturalism and moral pluralism, so much so that deliberation is becoming an obligation in contemporary society concerning ethical and political processes [56]. Does this mean that deliberation will always be possible? No. It means that there is a moral obligation to deliberate. Deliberation presupposes dialogue, giving way to many implications. One implication is the need for equity among speakers. In other words, if it is not possible to deliberate, human beings must create conditions that ultimately make proper deliberation possible. Obviously, this does not occur in the real world, but ethics has never been concerned with what happens, but with what should happen.

1069

1070

Clinical Nanobioethical Problems

43.4.1 Facts: Non-Moral Deliberation about Facts Every human being continuously deliberates about facts. A non-specialized daily fact might concern overtaking a car: It is necessary to postulate arguments for and against such action, find the best solution among the possible arguments, etc. A specialized fact requires deliberation: When a physician establishes a treatment, deliberative analysis is required. In other words, there are non-moral deliberations. It is necessary to specify that there are no “pure” facts since there are no facts unrelated to values. The work of David Hume gave birth to the belief that facts could be isolated from values ​[57]. The idea of “pure” science is its maximum expression. In “pure” science, scientists would work with only “pure facts.” However, the dichotomy between fact and value has collapsed, and today it seems clear that is not easily sustainable. It is possible to analyze proposals made by Hilary Putnam [58] to see how “pure facts” are difficult to sustain. Facts always support values. It is not acceptable to say nowadays that nanomedicine is “good” or “bad” (a common mistake). One must always remember that facts, simply put, are perception data; in a complex fashion, facts are the product of an immense construction. Anything that can be said about nanotechnology, nanobiotechnology, and nanomedicine as “fact” is indeed the result of a huge construction. The legitimacy of these theoretical constructions has been demonstrated by the consensus of what is considered “scientific” or not. In addition, Gracia has emphasized that one of the great contributions of bioethics (as a model of applied ethics) to ethics in general is its careful analysis of facts. Science and morality are based on facts, but not exclusively on them; furthermore, science and morality are not based on facts in the same manner. It is impossible at present to avoid rigorous analysis of facts before analyzing values ​​and duties.

43.4.2 Values: Moral Deliberation and Constructivism of Values

Another clarification is that values ​​are not “pure,” that is to say, that there is no abstract essence or quality detached from world events, which are immovable and unquestionable. This line of

A Methodology to Propose Solutions for Ethical Problems

thinking was used in all of the work done using phenomenological axiological objectivism, with Max Scheler [59] and Nicolai Hartmann [60] heading the philosophical reflections. Today, virtually no one, with the exception of some individuals in certain religious circles, accepts this objective way of understanding values, [61]. Hereby, values ​​are also constructed; values ​​also correspond to huge constructions. Friedrich Nietzsche [62] saw this clearly. Of course, we do not arrive at these constructions arbitrarily since there are facts in the real world supporting values. In other words, saying that not everyone shares the same understanding of “beauty” does not negate that everyone can value a fact as beautiful. Facts are made by consensus and values ​​are constructed through deliberation (personal and collective). Besides this value construction through deliberation, there are value scales that are the product of social construction. Social groups (societies) discover values in a historical form, while social options construct the scales shared by the majority of citizens. Overall, there is a multitude of possible solutions to an ethical problem, and there will not necessarily be only one potential solution all cases. It is possible to prefer a value according to the Scheler’s hierarchy criterion [7] or based on Hartmann’s strength criterion [22]. It is possible that choosing a value could be correct in one social group, yet incorrect in another. All values must be properly attained, but this attainment depends on the context. Now, are some values ​​purely instrumental or purely intrinsic? The answer is no. One of the most common criticisms of value theory states that intrinsic values are not really intrinsic since they are instruments to achieve other values. For example, health is important to hold a job and then to obtain money. However, even if an individual has neither job nor money, health is still important and valuable (a value). All intrinsic values have in varying degrees an instrumental dimension. This does not disqualify them from being intrinsic values; rather, this demonstrates that reality is far too complicated to be explained in a simple manner. All of these factors contribute to deliberation’s being a complex process. Human beings need to construct ways to choose which value will be given precedence (and to justify the decision). A criterion proposed by Scheler is the hierarchy: Higher values

1071

1072

Clinical Nanobioethical Problems

​​ are more important than lower ones. Using this approach, a Jehovah’s Witness could choose his or her religious value (sacredprofane) instead of the vital value of life (life-death) when he or she refuses a transfusion. In life-threatening circumstances, the patient dies. Does it make sense that in order to save a religious value one must disregard a vital value? (Also, when the human being dies, the support of religious value is lost, regardless of its superiority). Hartmann proposes another criterion, strength; material values are stronger than life and spiritual values for the mere fact that they support the rest. Therefore, if a Jehovah’s Witness chooses to save his or her life by temporarily sacrificing a religious value (which would have to be reconstructed later in life), he or she does not commit any immoral deed. This is simply a different criterion, and its use depends on the circumstances. This has important implications for clinical nanomedicine. It is not permissible to suggest that, on behalf of life in general or human life in particular, nanotechnology development be halted just because it is principally a group of instrumental values. Similarly, an absolute development of nanotechnology is not possible if its origins severely conflict with higher values ​​(vital or spiritual). In procedural matters, it is not possible to believe that privileged human reason will produce a final answer (the “experts”). Ever since Aristotle, prudence remains crucial in these issues, thus leading to the final criterion for choosing one value over another (understanding that the delayed value should also achieved, though it is delayed in time). That criterion consists of prudence, is reasonable, and is not purely the result of the dichotomy strength or hierarchy.

43.4.3 Duties: Moral Deliberation and Constructivism of Duties

Duties are not “pure” either. At present, a code of ethics or practice has no reason to exist without the attainment of values ​​supported by facts. The carrying out of duty through mere duty is a goal of idealism, untenable today. Of course, such thinking does not fall into the “naturalistic fallacy” (Moore called the unjustified step from “is” to “must” use this term [37]). An enormous mistake is made if we derive duties directly from facts without any mediation. It is instead suitable to establish the connection between facts

Disclosures and Conflict of Interest

and duties through values. Today, it would be illusory to claim that the ethical problems arising in clinical nanomedicine will be answered by applying a code of ethics only. As a consequence, it is possible to propose a sequence of analysis to propose solutions for a clinical nanobioethical problem (clinical activity is done “in patient’s bed”; kline means “bed” in Greek). The procedure would be as follows:

(1) Deliberation about nanomedical facts: (a) Presentation of the case problem by the person responsible for making the decision. (b) Discussion of clinical nanomedical facts based on one’s medical record. (2) Deliberation about values: (a) Identifying moral problems that arise. (b) The person responsible for the patient chooses the moral problem that concerns him or her and that he or she wishes to analyze. (c) Determining that values are in conflict (at least the two fundamental values in conflict). (3) Deliberation about duties: (a) Identifying extreme courses of action (to totally damage one value in order to attain another; the solution for a “dilemma,” which is unreal). (b) Identifying middle courses of action (avoiding damage to inferior values, trying to achieve superior value; this suggests trying to attain all values, even those with time disparities; the possible solutions for “problems,” thus real solutions). (c) Identifying the best course of action (that which causes the least amount of damage to values and simultaneously attains values in the best way). (4) Deliberation about responsibilities: (a) Decision control consistency: time test (“would you arrive at the same decision in a few more hours or a few more days?”), publicity test (“would you be prepared to defend it publicly?”), and legality test (“is this decision legal?”). (b) Making the final decision.

Disclosures and Conflict of Interest

The author declares that he has no conflict of interest and has no affiliations or financial involvement with any organization or entity discussed in this chapter. This includes employment, consultancies, honoraria, grants, stock ownership or options,

1073

1074

Clinical Nanobioethical Problems

expert testimony, patents (received or pending) or royalties. No writing assistance was utilized in the production of this chapter and the author has received no payment for its preparation. Nothing contained herein is to be considered as the rendering of legal advice.

Corresponding Author

Dr. Jorge Alberto Álvarez-Díaz Universidad Autónoma Metropolitana Unidad Xochimilco, Edificio A 2o Piso. Área de Postgrados en Ciencias Biológicas y de la Salud Calzada del hueso 1100, Colonia Villa Quietud Delegación Coyoacán, CP 04960 México DF Email: [email protected]

About the Author

Jorge A. Álvarez-Díaz is visiting professor at the Universidad Autónoma Metropolitana, Unidad Xochimilco (Departamento de Atención a la Salud). After finishing his MD, he obtained an MS in molecular biomedicine, an MS in human sexuality, and an MA in bioethics. He finished his PhD in bioethics under Diego Gracia’s supervision at Complutense University of Madrid, Spain. He is the first Mexican to obtain the Award for Excellence in Bioethics on 2007 from PAHEF & PAHO/WHO (Pan American Health Education Foundation and the Pan American Health Organization/World Health Organization). He is the first Iberoamerican to obtain the 2014 Mark S. Ehrenreich Prize in Healthcare Ethics Research, by the International Association of Bioethics and The Pacific Center for Health Policy and Ethics at the University of Southern California. He is member of several Royal Academies in Spain: the Royal Academy of Medicine and Surgery of Cadiz; the Royal Academy of Medicine and Surgery of Galicia; the Most Illustrious Academy of Science, Technology, Education and Humanities; and the Royal Academy of Medicine and Surgery of Valladolid. His name is listed with biographical notes in “Who’s who in medicine and healthcare” on 2009 and 2011 editions; also

References

in “Who’s who in the World” on 2013 and 2014 editions; and in “The Latino who’s who 2011.” He has published 48 papers, 17 book chapters, and 4 edited books.

References

1. Malakoff, D. (2003). Nanotechnology research. Congress wants studies of nanotech’s “dark side”. Science, 301(5629), 27.

2. National Academy of Engineering of the National Academies. (2004). Emerging technologies and ethical issues in engineering. Papers from a workshop October 14–15 2003, National Academy Press, Washington, DC. 3. Khushf, G. (2004). The ethics of nanotechnology: Vision and values for a new generation of science and engineering. In: National Academy of Engineering of the National Academies. Emerging Technologies and Ethical Issues in Engineering. Papers from a workshop, October 14–15 2003, National Academy Press, Washington, DC, pp. 29–55. 4. Robison, W. L. (2004). Nano-Ethics. In: Baird, D., Nordmann, A., Schummer, J., eds. Discovering the Nanoscale, IOS Press, Amsterdam, pp. 285–300.

5. Moor, J., Weckert, J. (2004). Nanoethics: Assessing the nanoscale from an ethical point of view. In: Baird, D., Nordmann, A., Schummer, J., eds. Discovering the Nanoscale, IOS Press, Amsterdam, pp. 301–310.

6. United Nations Educational, Scientific and Cultural Organization. (2003). COMEST Third Session. UNESCO Rio de Janeiro, Brazil, December, 1–4, 2000, UNESCO/COMEST, Paris, pp. 29–32.

7. United Nations Educational, Scientific and Cultural Organization. (2000). Informal meeting of the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST). UNESCO Headquarters, December 4–5, 2000, UNESCO/COMEST, Paris, p. 7.

8. Gazit, E. (2007). Introduction: Nanobiotechnology and bionanotechnology. In: Gazit, E., ed. Plenty of Room for Biology at the Bottom: Introduction to Bionanotechnology, Imperial College Press, London, pp. 1–15. 9. Gao, J., Xu. B. (2009). Applications of nanomaterials inside cells. Nano Today, 4(1), 37–51.

10. Laval, J. M., Mazeran, P. E., Thomas, D. (2000). Nanobiotechnology and its role in the development of new analytical devices. The Analyst, 125(1), 29–33.

1075

1076

Clinical Nanobioethical Problems

11. He, X. X., Wang, K., Tan, W., Liu, B., Lin, X., et al. (2003). Bioconjugated nanoparticles for DNA protection from cleavage. J. Am. Chem. Soc., 125(24), 7168–7169.

12. Jotterand, F. (2008). Beyond feasibility: Why ethics is important for bionanotechnology. In: Jotterand, F., ed. Emerging Conceptual, Ethical and Policy Issues in Bionanotechnology, Springer, New York, pp. 3–10.

13. Ach, J. S., Siep, L. (eds.) (2007). Nano-Bio-Ethics. Ethical Dimensions of Nanobiotechnology, LIT Verlag, Berlin, Germany.

14. Malsch, I., Hvidtfelt-Nielsen, K. (2010). Nanobioethics. ObservatoryNano 2nd Annual Report on Ethical and Societal Aspects of Nanotechnology. ObservatoryNANO, Glasgow. 15. Weber, D. O. (1999). Nanomedicine. Health Forum J., 42(4), 32–37.

16. Glenn, J. C., Gordon, T. J. (1997). The millennium project: 1997 state of the future: Implications for actions today. Technol. Forecasting Soc. Change, 56(3), 203–296.

17. Freitas, R. A., Jr. (1998). Exploratory design in medical nanotechnology: A mechanical artificial red cell. Artif. Cells Blood Substit. Immobil. Biotechnol., 26(4), 411–430.

18. Kostarelos, K. (2006). Establishing nanomedicine. Nanomedicine (London), 1(3), 259–260.

19. Hunziker, P. (2008). Nanomedicine: The application of the nanosciences to the benefit of the patient. Eur. J. Nanomed., 1(1), 2.

20. Freitas, R. A. Jr. (1999). Nanomedicine, Volume I: Basic Capabilities. Landes Bioscience, Georgetown, TX. 21. Jain, K. K. (2007). Applications of nanobiotechnology in clinical diagnostics. Clin. Chem., 53(11), 2002–2009.

22. Jain, K. K. (2008). Nanomedicine: Application of nanobiotechnology in medical practice. Med. Princ. Pract., 17(2), 89–101. 23. Freitas, R. A. Jr. (2005). Current status of nanomedicine and medical nanorobotics. J. Comput. Theor. Nanosci., 2(1), 1–25.

24. Freitas, R. A. Jr. (2005). What is nanomedicine? Nanomed. Nanotechnol. Biol. Med., 1(1), 2–9.

25. European Science Foundation. (2005). Nanomedicine. An ESF— European Medical Research Councils (EMRC) Forward Look Report. European Science Foundation, Strasbourg.

26. European Commission. (2005). European Technology Platform on NanoMedicine—Nanotechnology for Health. Vision paper. Office for Official Publications of the European Communities, Luxembourg.

References

27. Webster, T. J. (2006). Nanomedicine: What’s in a definition? Int. J. Nanomed., 1(2), 115–116.

28. Johnson, S. (2007). Nanomedicine: Is it hype, will it harm, or will it heal? Nanomed. Nanotechnol. Biol. Med., 3(4), 354.

29. Johnson, S. (2009). The era of nanomedicine and nanoethics: Has it come, is it still coming, or will it pass us by? Am. J. Bioethics, 9(10), 1–2.

30. O’Manthúna, D. P. (2009). Nanoethics. Big Ethical Issues with Small Technology, Continuum, London. 31. Suchman, M. C. (2001). Envisioning life on the nano-frontier. In: Roco, M. C., Bainbridge, W. S., eds. Societal Implications of Nanoscience and Nanotechnology, Kluwer Academic Publishers, Boston, MA, pp. 271– 276. 32. Suchman, M. C. (2002). Social science and nanotechnology. In: Roco, M., Tomellini, R. Nanotechnology: Revolutionary Opportunities and Societal Implications, Office for Official Publications of the European Communities, Luxembourg, pp. 95–99. 33. Bower, J. L., Christensen, C. M. (1985). Disruptive technologies: Catching the wave. Harv. Bus. Rev., 72(1), 43–53.

34. Christensen, C. M. (1997). The Innovator’s Dilemma: When New Technologies Cause Great Firms to Fail, Harvard Business School Press, Boston, MA. 35. Division of Ethics of Science and Technology of UNESCO. (2006). The Ethics and Politics of Nanotechnology, United Nations Educational, Scientific and Cultural Organization, Paris.

36. Coeckelbergh, M. (2010). Robot rights? Towards a social-relational justification of moral consideration. Ethics Info. Technol., 12(3), 209–221.

37. Petersen, A., Seear, K. (2009). In search of immortality: The political economy of anti-aging medicine. Med. Stud., 1(3), 267–279.

38. Gracia, D. (2007). Origen, fundamentación y método de la bioética. In: Martínez Martínez, J. A. de Abajo, F. J., eds. La bioética en la educación secundaria, Ministerio de Educación y Ciencia, Madrid, pp. 9–50.

39. Moore, G. E. (1993). Principia Ethica, 2nd ed. Cambridge University Press, New York.

40. Toumey, C. (2009). Truth and beauty at the nanoscale. Leonardo, 42(2), 151–155. 41. Levi, I. (1999). Value commitments, value conflict, and the separability of belief and value. Philos. Sci., 66(4), 509–533.

1077

1078

Clinical Nanobioethical Problems

42. Koivisto, W. A. (1955). Moral judgments and value conflict. Philos. Sci., 22(1), 54–57.

43. Aristotle (1984). Nichomaquean Ethics, Princeton University Press, Princeton, NJ. 44. Marías, J. (1995). Tratado de lo mejor. La moral y las formas de la vida. Alianza Editorial, Madrid.

45. Gracia, D. (2011). La cuestión del valor, Real Academia de Ciencias Morales y Políticas, Madrid. 46. Hare, J. E. (1996). The Moral Gap, Oxford University Press, New York.

47. Verbeek, P. P. (2009). The moral relevance of technological artifacts. In: Sollie, P., Düwell, M., eds. Evaluating New Technologies, Springer, Heidelberg, pp. 63–77. 48. Gracia, D. (2001). La deliberación moral: El método de la ética clínica. Med. Clín. (Barcelona), 117(1), 18–23.

49. Gracia, D. (2001). Moral deliberation: The role of methodologies in clinical ethics. Med. Health Care Philos., 4(2), 223–232.

50. Gracia, D. (2003). Ethical case deliberation and decision making. Med. Health Care Philos., 6(3), 227–233.

51. Gracia, D. (2001). La deliberación moral, Boletín de la Academia Chilena de Medicina, 38, 29–45.

52. Neufeldt, V., Guralnik, D. B. (1991). Webster’s New World Dictionary of American English, 3rd ed., Prentice Hall, New York, p. 364. 53. Gracia Guillén, D. (2001). Democracia y bioética. Acta Bioethica, 7(2), 343–354.

54. Wiland, E. (2003). Psychologism, practical reason and the possibility of error. Philos. Q., 53(210), 68–78.

55. Gracia, D. (2004). Como Arqueros Al Blanco. Triacastela, Madrid, p. 419.

56. Durante, C. (2009). Bioethics in a pluralistic society: Bioethical methodology in lieu of moral diversity. Med. Health Care Philos., 12(1), 35–47.

57. Athanasopoulos, C. (2006). Fact-Value distinction. In: Grayling, A., Pyle, A., Goulder, N., eds. Continuum Encyclopedia of British Philosophy, Vol. 2, Thoemmes Continuum, New York, pp. 1047–1048.

58. Putnam, H. (2002). The Collapse of the Fact/Value Dichotomy and Other Essays, Harvard University Press, Cambridge, MA.

59. Scheler, M. (1973). Formalism in Ethics and Non-Formal Ethics of Values: A New Attempt Toward the Foundation of An Ethical Personalism, Northwestern University Press, Evanston, IL.

Further Readings

60. Hartmann, N. (1932). Ethics, George Allen & Unwin, London.

61. Ślipko, T. (2006). The concept of value in the ethical thought of Cardinal Karol Wojtyla. Forum Philosophicum, 11, 7–28.

62. Nietzsche, F. (2006). Thus spoke Zarathustra, Cambridge University Press, Cambridge.

Further Readings

1. Allhoff, F. (2007). On the autonomy and justification of nanoethics. Nanoethics, 1(3), 185–210. 2. Allhoff, Fritz, P. Lin, D., Moore. (2010). Nanotechnology: What It Is and Why It Matters, Wiley-Blackwell Publishing, Oxford.

3. Bawa, R., Johnson, S. (2008). Emerging issues in nanomedicine and ethics. In: Allhoff, F., Lin, P., eds. Nanotechnology & Society: Current and Emerging Ethical Issues, Springer, Dordrecht, pp. 207–223. 4. Bawa, R., Johnson, S. (2007). The ethical dimensions of nanomedicine. Med. Clin. North Am., 91(5), 881–887. 5. Tinkle, S., McNeil, S. E., Mühlebach, S., Bawa, R., Borchard, G., Barenholz, Y., Tamarkin, L., Desai, N. (2014). Nanomedicines: Addressing the scientific and regulatory gap. Ann. N. Y. Acad. Sci., 1313, 35–56.

6. Allhoff, F. (2016). The coming era of nanomedicine. In: Bawa, R., Audette, G., Rubinstein, I., eds. Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, Pan Stanford Publishing, Singapore, Chapter 5. 7. Goldstein, A. H. Nanomedicine’s Brave New World. Available at: http:// www.salon.com/2005/11/28/nanomedicine/ (accessed on April 22, 2015). 8. Resnik, D. B., Tinkle, S. S. (2007). Ethics in nanomedicine. Nanomedicine, 2(3), 345–350.

9. Spagnolo, A. G., Daloiso, V. (2008). Outlining ethical issues in nanotechnologies. Bioethics, 23(7), 394–402.

10. Evers, J., Aerts, S., De Tavernier, J. (2008). An ethical argument in favor of nano-enabled diagnostics in livestock disease control. Nanoethics, 2, 163–178. 11. White, G. B. (2009). Missing the boat on nanoethics. Am. J. Bioeth., 9(10), 18–19.

12. Resnik, D. B., Tinkle, S. S. (2007). Ethical issues in clinical trials involving nanomedicine. Contemp. Clin. Trials, 28, 433–441.

1079

1080

Clinical Nanobioethical Problems

13. Khushf, G. (2007). Upstream ethics in nanomedicine: A call for research. Nanomedicine, 2(4), 511–521.

14. Gordijn, B. (2005). Nanoethics: From Utopian dreams and apocalyptic nightmares towards a more balanced view. Sci. Eng. Ethics, 11, 521–533.

15. McGee, S. J., Bawa, R. (2016). Ethics in nanomedicine: Where are we headed? In: Bawa, R. (Editor), Audette, G. F., Reese, B. E., (Assistant Editors): Handbook of Clinical Nanomedicine: Law, Business, Regulation, Safety, and Risk, Pan Stanford Publishing, Singapore, Chapter 52.

16. Hunt, W. H. (2004). Nanomaterials: nomenclature, novelty, and necessity. J. Materials, October Issue, pages 13–18. Available at: http:// www.tms.org/pubs/journals/JOM/0410/Hunt-0410.html (accessed on April 23, 2015). 17. Torchilin, V. (ed.) (2014). Handbook of Nanobiomedical Research: Fundamentals, Applications and Recent Developments. World Scientific Publishing Co., Hackensack, NJ. 18. Bawa, R. (2016). What’s in a Name? Defining “Nano” in the Context of Drug Delivery. In: Bawa, R., Audette, G., Rubinstein, I. (Editors), Chapter 4, Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, Pan Stanford Publishing, Singapore.

19. Bagchi, D., Bagchi, M., Moriyama, H., Shahidi., F., eds. (2013). Bionanotechnology: A Revolution in Biomedical Sciences and Human Health. Wiley Blackwell, UK. 20. Prasad, P. N. (2012). Introduction to Nanomedicine and Nanobioengineering. John Wiley & Sons, Inc., Hoboken, NJ.

21. Bawa, R., Audette, G., Rubinstein, I., eds., (2016). Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, Pan Stanford Publishing, Singapore.