Contemporary medical education must train skilled and compassionate health care professionals who are rigorous in their approach to patient care and their pursuit of knowledge and solutions. Problem-based learning has been widely introduced, but there is no evidence that it leads to better outcomes than more traditional programs, and fundamental gaps in conceptual knowledge may result. Recently, emphasis has been placed on a solid grounding in underlying concepts combined with a systems-based approach, and ability to transfer information and solve (...) problems. Integrating traditional scientific and clinical disciplines with progressive and continuous assessment, may be a better means of achieving the combined aims of clinically relevant curriculum design, vertical integration of medical knowledge, and facilitation of the continuum of training. Being adaptable and flexible, cognisant of costs, and driven by evidence are key features of delivering medical education and contemporary medical practice. Educational research should lead to continuous improvement, but innovation without evaluation and attention to costs may create as many, or more, problems as are solved. (shrink)

Because few would object to evidence-based medicine’s (EBM) principal task of basing medical decisionmaking on the most judicious and up-to-date evidence, the debate over this prolific movement may seem puzzling. Who, one may ask, could be against evidence (Carr-Hill, 2006)? Yet this question belies the sophistication of the evidence-based movement. This chapter presents the evidence-based approach as a socio-medical phenomenon and seeks to explain and negotiate the points of disagreement between supporters and detractors. This is done by casting (...) EBM as more than the simple application of research findings to clinical care and improved health outcomes, but rather an umbrella term that harnesses a specific set of pedagogical objectives (some rather radical) under a name that makes it difficult to argue against. (shrink)

While every health care system stakeholder would seem to be concerned with obtaining the greatest value from a given technology, there is often a disconnect in the perception of value between a technology’s promoters and those responsible for the ultimate decision as to whether or not to pay for it. Adopting an empirical ethics approach, this paper examines how five Canadian medical device manufacturers, via their websites, frame the corporate “value proposition” of their innovation and seek to respond to (...) what they consider the key expectations of their customers. Our analysis shows that the manufacturers’ framing strategies combine claims that relate to valuable socio-technical goals and features such as prevention, efficiency, sense of security, real-time feedback, ease of use and flexibility, all elements that likely resonate with a large spectrum of health care system stakeholders. The websites do not describe, however, how the innovations may impact health care delivery and tend to obfuscate the decisional trade-offs these innovations represent from a health care system perspective. Such framing strategies, we argue, tend to bolster physicians’ and patients’ expectations and provide a large set of stakeholders with powerful rhetorical tools that may influence the health policy arena. Because these strategies are difficult to counter given the paucity of evidence and its limited use in policymaking, establishing sound collective health care priorities will require solid critiques of how certain kinds of medical devices may provide a better (i.e., more valuable) response to health care needs when compared to others. (shrink)

Fredrik Svenaeus' book is a delight to read. Not only does he exhibit keen understanding of a wide range of topics and figures in both medicine and philosophy, but he manages to bring them together in an innovative manner that convincingly demonstrates how deeply these two significant fields can be and, in the end, must be mutually enlightening. Medicine, Svenaeus suggests, reveals deep but rarely explicit themes whose proper comprehension invites a careful phenomenological and hermeneutical explication. Certain philosophical approaches, on (...) the other hand - specifically, Heidegger's phenomenology and Gadamer's hermeneutics - are shown to have a hitherto unrealized potential for making sense of those themes long buried within Western medicine. Richard M. Zaner, Ann Geddes Stahlman Professor of Medical Ethics, Vanderbilt University. (shrink)

The design ideas of the postmodern era reflect the general trends of socio-cultural reality, namely the loss of traditional moral guidelines, disharmony and destructiveness combined with absurdity, a sense of crisis, abyss and uncertainty conveyed in signs and in spatial coordinates. Design products become installations in which the viewer is a direct participant, sometimes even the creator. Postmodern design denies finitude, noting the plurality, uncertainty and fluidity of the world. The paradox of postmodern design culture is expressed in a combination (...) of diametrically opposite things, sometimes even mutually exclusive. The era of postmodern design culture has recorded the fusion of "high" and "low" art, the emergence of new trends - neo-conceptual art, art installation, lowbrow art, performance art, digital art, telematic art - has affected. It should be noted the immersion in virtual reality in particular, as a result of the perception of the concept of postmodernism. After all, the purpose of designer items and their perception has already been changed in accordance with the needs of a person in the postmodern world. A striking example is the coronavirus epidemic, which has become the central theme of successful design projects. After all, a protective mask as a medical device becomes the object of design solutions that transform it into a means of self-expression, or the manifestation of social characteristics, or the result of digital achievements.. (shrink)

: Medical ethics often is treated as applied ethics, that is, the application of moral philosophy to ethical issues in medicine. In an earlier paper, we examined instances of moral philosophy's influence on medical ethics. We found the applied ethics model inadequate and sketched an alternative model. On this model, practitioners seeking to change morality "appropriate" concepts and theory fragments from moral philosophy to valorize and justify their innovations. Goldilocks-like, five commentators tasted our offerings. Some found them (...) too cold, since they had already abandoned applied ethics; others too hot, since they still find the applied ethics model to their taste. We reply that the appropriation model offers an empirically testable account of the historical relationship between moral philosophy and medical ethics that explains why practitioners appropriate concepts and fragments from moral philosophy. In contrast, the now fashionable common morality theory neither explains moral change nor why practitioners turn to moral philosophy. (shrink)

Medical Assistance in Dying (MAiD) in Canada has had a tumultuous social and legal history. In the 6 years since assisted dying was decriminalized by the Canadian Parliament in June 2016, the introduction of this practice into the Canadian healthcare system has been fraught with ethical challenges, practical hurdles and grass-roots innovation. In 2021, MAiD accounted for approximately 3.3% of all Canadian deaths annually, and more patients are seeking MAiD year over year as this option becomes more widely know. (...) Unfortunately, some patients who want MAiD are unable to access it in a timely manner because of a lack of willing MAiD providers. This introduction describes statistics about the uptake of MAiD in Canada and the challenges presented by Canadians’ rapid acceptance of this end of life care option. In this special edition of HEC Forum about the implementation of MAiD in Canada, authors depict a range of ethical challenges and strategies to address issues related to MAiD access and quality, organizational engagement, clinician recruitment and retention, and support for a morally diverse workforce. In each article, the authors reflect on the question: What are the practical ethics involved in introducing assisted dying into a new healthcare context, and how can ethicists and ethics resources collaborate with stakeholders to ensure the integration of ethical considerations as this practice continues to evolve? (shrink)

The mind is not structured anatomically, as emphasized by modern pathology. Instead, it is expanded as a whole in a subtle form behind the physical body. In the Indian system of medical philosophy, the mind is considered as the astral nerves made third body, which identified as the ‘Manomaya-sharira’ (subconscious mind). The mind is composed of millions of astralnadis, through which Pranic-energies circulate freely into the astral anatomy of mind. Seven-chakras are found parallel to the spine, serving as the (...) major seven innovation centres in the body. These Chakras facilitate the connection of the mind with the seven dimensions of the inner world. From these dimensions the Pranic-energies including Sattva, Raja, Tama are exported to the mind and its Nadi-tantras, influencing both the outer and inner subconscious minds. Subsequently, these elements, viz., Sattva, Raja and Tama are thrown from the mind to the outer world through the seven sense organs, manifesting as either constructive or destructive activities. Thus the mind exists due to ‘Prana’, (energy of Omkara) which increases through deeper meditation, sound sleep, and breathing exercises (O2). The positional behaviour of the mind shifts according to the physical and mental temperament, namely Triguna and Tridosha, or Panchavikara. The negative energy (Tama-guna) of the fourth dimension enters the astral Nadis-system of the mind via the interspace of the solar plexus, which crushes the mind’s structures, and consequently, all the Chakras are corrupted and the Nadis are blocked, so it generates a break in the circulation of ‘Prana’ into the Nadis. As a result, many socio-economic challenges and psychosomatic disorders occur. (shrink)

Using ideas gleaned from the philosophy of technology of Martin Heidegger and Hans Jonas and the philosophy of health of Georges Canguilhem, I argue that one of the characteristics of emerging medical technologies is that these technologies lead to new conceptions of health. When technologies enable the body to respond to more and more challenges of disease, we thus establish new norms of health. Given the continued development of successful technologies, we come to expect more and more that our (...) bodies should be able to respond to ever-new challenges of environment and disease by establishing ever-new norms of health. Technologies may aim at the prevention and treatment of disease, but they also bring about modifications of what we consider normal for the human being. Thus, new norms of health arise from technological innovation. (shrink)

“An original, compelling, and provocative exploration of ethical issues in our society, with thoughtful and balanced commentary. I have not seen anything like it.” —Alan Lightman, author of Einstein’s Dreams Drawing upon the author’s two decades teaching medical ethics, as well as his work as a practicing psychiatrist, this profound and addictive little book offers up challenging ethical dilemmas and asks readers, What would you do? A daughter gets tested to see if she’s a match to donate a kidney (...) to her father. The test reveals that she is not the man’s biological daughter. Should the doctor tell the father? Or the daughter? A deaf couple prefers a deaf baby. Should they be allowed to use medical technology to ensure they have a child who can’t hear? Who should get custody of an embryo created through IVF when a couple divorces? Or, when you or a loved one is on life support, Who says you’re dead? In short, engaging scenarios, Dr. Appel takes on hot-button issues that many of us will confront: genetic screening, sexuality, privacy, doctor-patient confidentiality. He unpacks each hypothetical with a brief reflection drawing from science, philosophy, and history, explaining how others have approached these controversies in real-world cases. Who Says You’re Dead? is designed to defy easy answers and to stimulate thought and even debate among professionals and armchair ethicists alike. (shrink)

First I discuss the rights as unavoidable part of the human dignity. There are four possible relations: dignity has a wider extension, the volume of both is equivalent, dignity includes in itself a bundle of rights, or it is just a simple right. There are good reasons to support the last two, even the last position. Then I evaluate some of the challenging innovations in the medical technology, if they are acceptable in front of this close connection. The (...) focus falls on three topics: PGD, cloning, and fusion of human-animal cells. Using moral principles such as non discrimination and non instrumentalization I look for some normative framing. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Laying Medicine Open: Innovative Interaction Between Medicine and the HumanitiesLaurence B. McCullough and Warren Thomas ReichThe past three decades have witnessed the emergence and remarkable success of the fields of bioethics and medical humanities. The intellectual landscape of medicine and that of the humanities have been remarkably altered in the process. Twenty-five to 30 years ago in the United States there existed but a few courses in what (...) came to be called “bioethics” in departments of philosophy, religious studies, and theology in colleges and universities, a handful of programs of teaching in medical schools such as the University of Texas Medical Branch at Galveston and Pennsylvania State University School of Medicine at Hershey, and but one independent research center (the Hastings Center) and one university-based research center (the Kennedy Institute of Ethics at Georgetown University). Articles on bioethics began to appear in the peer-reviewed medical, nursing, and humanities literature and some books were published. There was only one journal in bioethics, The Hastings Center Report (which consolidated two previously separate journals from the Hastings Center). Graduate programs in bioethics and medical humanities in colleges and universities and fellowship training in bioethics and medical humanities in medical schools did not exist. Very little existed in colleges, universities, and medical schools in other countries. Now, of course, everything is different.Teachers, scholars, and students of bioethics and medical humanities should not take these remarkable changes for granted, for they represent a sustained and innovative interaction between medicine and the humanities. We have chosen the metaphor of “laying medicine open” to characterize the history of bioethics and medical humanities of the past three decades. This surgical metaphor was used in eighteenth-century Britain by a number of writers who wanted to make medical science and practice more accessible to the sick and to the lay public more generally (Lawrence 1975). We use the metaphor to characterize the efforts of teachers and [End Page 1] scholars over the past three decades and more to make the value-laden dimensions of biomedical science and practice and of health care policy more accessible to patients and to the lay public more generally. The result of this laying open of medicine has gone a long way toward bringing closer together the two cultures of science and the humanities that had, as C. P. Snow famously described, become significantly isolated from each otherAlbert Jonsen (1998) has recently contributed the first book-length history of what he calls the “birth” of bioethics, adding to the work of other scholars such as Warren Reich (1994; 1995) and Robert Baker (1993) and, before them, Corrado Viafora (1990) and David Rothman (1991). The articles in this issue of the Kennedy Institute of Ethics Journal make additional contributions to the developing understanding of the history of the past thirty years of interaction between medicine and the humanities.Laurence McCullough provides an historical context for the three accounts of the recent laying open of medicine that follow. McCullough examines two times in the history of medicine when it has been laid open to accountability (in addition to its being laid open to and by bioethics and medical humanities). The first laying open occurred in the work of the eighteenth-century Scottish physician and philosopher John Gregory, who set out to create a profession of medicine in a true moral sense of a fiduciary profession by making medicine accountable for its scientific and moral quality. The second occurred in the late twentieth century in which the managed practice of medicine in general, and managed care in particular, have begun to lay medicine open to accountability for its scientific and moral quality, as well as its cost and, at least in the public sector, its accessibility. McCullough argues that, just as Gregory responded to the ethical challenges of medicine laid open more than two centuries ago, bioethics should respond to the ethical challenges in the current laying open of medicine.Warren Reich provides an account of André Hellegers, whose premature death left an enormous gap in the field that will never be filled. Reich claims that Hellegers was engaged substantially in much more than the laying open of medicine: he... (shrink)

There are two fundamentally different approaches to innovation: incremental and radical. In Economics as Anatomy, G.M. Peter Swann argues that economics as a discipline needs both perspectives in order to create the maximum beneficial effect for the economy. Chapters explore how and why mainstream economics is very good at incremental innovation but seems uncomfortable with radical innovation. Swann argues that economics should follow the example of many other disciplines, transitioning from one field to a range of semi-autonomous sub-disciplines. In this (...) book, he compares the missing link in empirical economics to being the economic equivalent of anatomy, the basis of medical discourse. Working as a sequel to Swann's Putting Econometrics in its Place, this book will be a vital resource to those who are discontent with the state of mainstream economics, especially those actively seeking to promote change in the discipline. Students wishing to see progress in the teaching of economics will also benefit from this timely book. (shrink)

Is it lawful for a doctor to give a patient life-shortening pain relief? Can treatment be lawfully provided to a child under 16 on the basis of her consent alone? Is it lawful to remove food and water provided by tube to a patient in a vegetative state? Is a woman's refusal of a caesarean section recommended for the benefit of the fetus legally decisive? These questions were central to the four focal cases revisited in this book. This book revisits (...) nine landmark cases. For each, a new leading judgment is attributed to an imagined judge, Athena, who operates within the constraints of the legal system of England and Wales. Her judgments accord with an innovative legal theory, referred to as 'modified law as integrity', and are linked as a line of precedent. The result is a re-spinning of extant judicial threads into a web of legal principles with a greater claim to coherence and defensibility than those in the original cases. The book will be of great interest to scholars and students of medical law, criminal law, bioethics, legal theory and moral philosophy. (shrink)

The rapid, recent emergence of new medical knowledge models has engendered a dizzying number of new medical initiatives, programs and approaches. Fields such as evidence-based medicine and translational medicine all promise a renewed relationship between knowledge and medicine. The question for philosophy and other fields has been whether these new models actually achieve their promises to bring about better kinds of medical knowledge—a question that compels scholars to analyze each model’s epistemic claims. Yet, these analyses may miss (...) critical components that explain how these models actually work and function. Using the case of translational medicine, this paper suggests that analyses which treat these models as a primarily epistemic interventions miss the way that new approaches are increasingly shaped by specific financial and commercial agendas. Ultimately, social epistemological analyses that are attentive to market forces are required to make sense of emerging bioscientific research models, which are increasingly tethered to or a manifestation of increasingly financialized models of science research and innovation. (shrink)

The Private Finance Initiative (PFI) is a specific example of health care privatization within the British National Health Service. In this essay, I critically assess the ways in which various Private Finance Initiatives have increased health care efficiency and effectiveness, as well as encouraged medical innovation. Indeed, as the analysis will demonstrate, significant empirical evidence supports the conclusion that Private Finance Initiatives are a driving force of innovation within the British Health Care System.

Physicians and other medical practitioners make untold numbers of judgments about patient care on a daily, weekly, and monthly basis. These judgments fall along a number of spectrums, from the mundane to the tragic, from the obvious to the challenging. Under the rubric of evidence-based medicine, these judgments will be informed by the robust conclusions of medical research. In the ideal circumstance, medical research makes the best decision obvious to the trained professional. Even when practice approximates this (...) ideal, it does so unevenly. Judgments in medical practice are always accompanied by uncertainty, and this uncertainty is a fickle companion—constant in its presence but inconstant in its expression. This feature of medical judgments gives rise to the moral responsibility of medical practitioners to be epistemically humble. This requires the recognition and communication of the uncertainty that accompanies their judgment as well as a commitment to avoiding intuitive innovations. (shrink)

Introduction. The increasing mediation of human life by medicine necessarily raises the question of philosophical understanding the phenomenon of culture medicalization, since today the vector of growing powerful influence of medicine on forming sociocultural processes has clearly emerged. Along with the positive phenomena of the medicalization of life, the volume of “excessive” phenomena of its medicalization is growing. The purpose of the article is to clarify the philo- sophical foundations of the progressive medicaliza- tion of modern culture. Methods. The methodological (...) basis of the study is presented by dialectical, epistemological, axiologi- cal, philosophical-anthropological, and socio-phil- osophical approaches. The study is based on E. Cassirer’s transcendental philosophy, the phenom- enological transcendentalism of E. Husserl; V.S. Stepin’s concept about the system of informational social codes; and P.D. Tishchenko’s concept on the transformation of bio-power in modern culture. Scientific novelty of the research. The author outlines fundamental foundations of modern cul- ture medicalization as a result of mutually similar processes of transforming bio-power and the progress of biomedical sciences. Results. Unfolding, culture compensated for the bodily weakness of a person with the power of his technical inventions, but today they have surpassed the intellectual capabilities of their creator - the individual has to permanently adapt to the grow- ing volume of mass technogenic innovations. The historically formed human need to master the world through its “humanization” is suppressed, and, as a result, the problem of a modern indi- vidual’s request for self-realization through the creative transformation of the social environment is actualized. In this regard, one of the philosophi- cal and anthropological foundations of modern culture can be recognized as a technogenically determined desire of a person to transform his own corporeality, aimed at expanding the capabili- ties of a natural person. Biomedical sciences, as a result of biotechnological progress, turned out to be exactly the social and scientific sphere, which, building up practical activities within the framework of healthcare, considers the person to be both the subject and the object of the biosocial transforma- tion demanded by cultural evolution. Conclusions. The process of medicalization of culture occurs on the basis of two reciprocal fundamental processes: first, the strengthening of the principles of bio-power as “care for all forms of life”; secondly, the progress and technologization of scientific medicine, which in practice provides a socio-cultural demand for a modern prosperous individual. (shrink)

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive (...) regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. (shrink)

The article is devoted to the observation of the work of The Second International Forum on Higher Medical Education, which was conducted at China Medical University in Shenyang, China in May, 26-27, 2018. About 300 participants from 49 medical higher educational institutions, located in 15 countries took part in this academic event. The main topics, which were discussed during the forum, were internationalization of higher medical education, implementation of modern innovations in teaching and learning processes, (...) quality assurance in medical education and searching for the adequate forms of its assessment. (shrink)

Machine Learning (ML) is on the rise in medicine, promising improved diagnostic, therapeutic and prognostic clinical tools. While these technological innovations are bound to transform health care, they also bring new ethical concerns to the forefront. One particularly elusive challenge regards discriminatory algorithmic judgements based on biases inherent in the training data. A common line of reasoning distinguishes between justified differential treatments that mirror true disparities between socially salient groups, and unjustified biases which do not, leading to misdiagnosis and (...) erroneous treatment. In the curation of training data this strategy runs into severe problems though, since distinguishing between the two can be next to impossible. We thus plead for a pragmatist dealing with algorithmic bias in healthcare environments. By recurring to a recent reformulation of William James’s pragmatist understanding of truth, we recommend that, instead of aiming at a supposedly objective truth, outcome-based therapeutic usefulness should serve as the guiding principle for assessing ML applications in medicine. (shrink)

Advanced therapy medicinal products (ATMP) offer hope for health benefits in all situations where traditional methods of therapy fail or cannot be used for various reasons. The main purpose of this article is to analyze the concept of innovation as applied to the biotechnologies employed in ATMP. In the analysis of the concept, five main contexts of meaning that contribute to its understanding will be distinguished: a change in the way of thinking about the available spectrum of medical procedures, (...) the short time of recognition of technologies in the experimental and theoretical models, lack of clinical data in advance of used technologies, increase of technologies’ complexity and diversity of substrates used in them. The conducted analysis indicates the need to adopt an attitude of far-reaching caution in the evaluation of the safety of ATMP therapies in which innovative biotechnologies are used. (shrink)

ObjectiveTo assess the scientific and ethical basis for clinical innovation in psychopharmacology.MethodsWe conducted a literature review, utilizing MEDLINE search and bibliographic cross-referencing, and historical evidence regarding the discovery and development of new medications in psychiatry. Clinical innovation was defined as use of treatments in a clinical setting which have not been well-proven in a research setting.ResultsEmpirical data regarding the impact of clinical innovation in psychopharmacology are lacking. A conceptual and historical assessment of this topic highlights the ethical and scientific importance (...) of clinical innovation. Ethically, it touches a borderline that, in our judgment, is not adequately framed in contemporary mainstream bioethics. Currently, research is viewed as not at all benefiting the patients who participate in it, while clinical care is viewed as being solely for the benefit of patients. Clinical innovation straddles these two worlds, uncomfortably at times. While many argue that clinical innovation should either be avoided or folded into research projects, we argue that clinical innovation is necessary for progress in psychopharmacology research, and that it can prosper best when guided by the following ethical principles: 1.) The treatment should be based on a viable hypothesis. 2.) Whenever possible, one's clinical observations should be reported so they can be evaluated by the scientific community. 3.) One should be willing to report unexpected observations of drug effects. 4.) A high standard of informed consent should be maintained. Again, this proposal goes against the standard view among bioethicists that research and clinical care are categorically opposed activities, as made clear by the either-or dichotomy of the Belmont Report on bioethics. This approach has so polarized our profession into clinicians versus researchers, that many clinicians will not apply new knowledge produced by clinical research until it eventually gets incorporated into formal treatment guidelines, while researchers have little to guide them as to what kind of new knowledge it is most important to provide.SummaryClinical innovation brings out the ambiguities in our current ethical conceptions of research versus clinical care. Yet, historically, clinical innovation has been an important contributor to progress in psychopharmacology. We argue that clinical innovation should not be discouraged, but rather it should occur under certain ethical conditions."Almost everyone can and should do research...because almost everyone has a unique observational opportunity at some time in his life which he has an obligation to record....If one considers the fundamental operations or methods of research, one immediately realizes that most people do research at some time or another, except that they do not call their activity by that name. There are seven operations....In simple language they are counting, sorting, measuring, comparing, nature-study, guess testing, and reappraisal....Guess testing is of course what most people think of when the word research is mentioned; except that it is bad manners to call a guess a guess. It should be called an hypothesis. Let us make one plea. Guessing becomes merely a game unless it is done in the context of a plan for action. It is a waste of time elaborating untestable hypotheses [1]."John Cade. (shrink)

This volume, the result of an ongoing bridge building effort among engineers and humanists, addresses a variety of philosophical, ethical, and policy issues emanating from engineering and technology. Interwoven through its chapters are two themes, often held in tension with one another: “Exploring Boundaries” and “Expanding Connections.” “Expanding Connections” highlights contributions that look to philosophy for insight into some of the challenges engineers face in working with policy makers, lay designers, and other members of the public. It also speaks to (...) reflections included in this volume on the connections between fact and value, reason and emotion, engineering practice and the social good, and, of course, between engineering and philosophy. “Exploring Boundaries” highlights contributions that focus on some type of demarcation. Public policy sets a boundary between what is regulated from what is not, academic disciplines delimit themselves by their subjects and methods of inquiry, and professions approach problems with unique goals and by using concepts and language in particular ways that create potential obstacles to collaboration with other fields. These and other forms of boundary setting are also addressed in this volume. Contributors explore these two themes in a variety of specific contexts, including engineering epistemology, engineers’ social responsibilities, engineering and public policy-making, engineering innovation, and the affective dimensions of engineering work. The book also includes analyses of social and ethical issues with emerging technologies such as 3-D printing and its use in medical applications, as well as social robots. Initial versions of the invited papers included in this book were first presented at the 2014 meeting of the Forum on Philosophy, Engineering, and Technology, held at Virginia Tech in Blacksburg, Virginia, USA. The volume furthers fPET’s intent of extending and developing the philosophy of engineering as an academic field, and encouraging conversation, promoting a sense of shared enterprise, and building community among philosophers and engineers across a diversity of cultural backgrounds and approaches to inquiry. (shrink)

Peer review is a widely accepted instrument for raising the quality of science. Peer review limits the enormous unstructured influx of information and the sheer amount of dubious data, which in its absence would plunge science into chaos. In particular, peer review offers the benefit of eliminating papers that suffer from poor craftsmanship or methodological shortcomings, especially in the experimental sciences. However, we believe that peer review is not always appropriate for the evaluation of controversial hypothetical science. We argue that (...) the process of peer review can be prone to bias towards ideas that affirm the prior convictions of reviewers and against innovation and radical new ideas. Innovative hypotheses are thus highly vulnerable to being “filtered out” or made to accord with conventional wisdom by the peer review process. Consequently, having introduced peer review, the Elsevier journal Medical Hypotheses may be unable to continue its tradition as a radical journal allowing discussion of improbable or unconventional ideas. Hence we conclude by asking the publisher to consider re-introducing the system of editorial review to Medical Hypotheses. (shrink)

BackgroundOur human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning (...) the scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology.Main textIn this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute “ethics parallel research”. This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients.ConclusionEthics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology. (shrink)

In a time marked by the development of innovative treatments in healthcare and the need for health professionals to deal with resulting ethical dilemmas in clinical practice, this study was developed to determine the influence of the bioethics teaching on the moral competence of medical and nursing students. The authors conduct a longitudinal study using the Moral Competence Test extended version before and after attending the ethics curricular unit, in three nursing schools and three medical schools of Portugal. (...) In this questionnaire the participant is confronted with three ethical dilemmas and asked to evaluate arguments for and against the attitude of the main character. For both nursing and medical students, C-score was lower after the attendance of the ethics curricular units, with a statistically significant decrease in the total score for nursing students and a decrease not statistically significant for medical students. A multivariate analysis did not find any association between this decrease and gender, course, or age. The phenomenon of moral segmentation was observed, with better performance in the worker and judge dilemma, than in the doctor dilemma. These results highlight the need to reflect on the curricular strategies that can be implemented for health professionals to better develop moral competence and decision-making, allowing for the provision of humanized health care. (shrink)

The recent progression in AI, nanomedicine and robotics have increased concerns about ethics, policy and law. The increasing complexity and hybrid nature of AI and nanotechnologies impact the functionality of “law in action” which can lead to legal uncertainty and ultimately to a public distrust. There is an immediate need of collaboration between Central Asian biomedical scientists, AI engineers and academic lawyers for the harmonization of AI, nanomedicines and robotics in Central Asian legal system.

Hynek Bartos does the field of ancient philosophy a great service by detailing the influence of early Greek thinkers (such as Heraclitus, Empedocles, Anaxagoras, Democritus, and Diogenes of Apollonia) on the Hippocratic work On Regimen, and by demonstrating that work’s innovative engagement with contemporary scientific and philosophical concepts as well as its direct influence on Plato and Aristotle. His study usefully counteracts the lamentable tendency among ancient philosophers to ignore or downplay the influence of medical literature on philosophy in (...) general, and to heap scorn on this text in particular, which Kirk, Raven, and Schofield considered ‘an eclectic and very superficial quasi- philosophical treatise’ and Barnes famously called ‘a silly farrago of ill-digested Presocratic opinions’. (shrink)

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that (...) we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we integrate insights from several areas of ethics, translate bioethical principles into the mental health context, and proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna’s notion of ‘layers of vulnerability’ to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis. (shrink)

To contribute to our understanding of the relationship between philosophical ideas and medical and healthcare models. A diachronic analysis is put in place in order to evaluate, from an innovative perspective, the influence over the centuries on medical and healthcare models of two philosophical concepts, particularly relevant for health: how Man perceives his identity and how he relates to Nature. Five epochs are identified—the Archaic Age, Classical Antiquity, the Middle Ages, the Modern Age, the ‘Postmodern’ Era—which can be (...) seen, à la Foucault, as ‘fragments between philosophical fractures’. From a historical background perspective, up to the early 1900s progress in medical and healthcare models has moved on a par with the evolution of philosophical debate. Following the Second World War, the Health Service started a series of reforms, provoked by anti-positivistic philosophical transformations. The three main reforms carried out however failed and the medical establishment remained anchored to a mechanical, reductionist approach, perfectly in line with the bureaucratic stance of the administrators. In this context, future scenarios are delineated and an anthropo-ecological model is proposed to re-align philosophy, medicine and health care. (shrink)

The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is historical. (...) The development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements. (shrink)

The aim of this paper is to understand how evolving ideas about heredity and genetics influenced new medical interests and practices and, eventually, the formation of ‘medical genetics’ as a medical specialism in Britain. I begin the paper by highlighting the social and institutional changes through which these ideas passed. I argue that, with time, there was a decisive convergence in thought that combined ideas about the familial aspects of heredity and the health needs of populations with (...) an omnibus ‘genetic’ approach to health and illness that focused on the structures and activities of chromosomes and genes in individuals. I show how this convergence in thought was spurred on, first, by innovations in genetic science and technology in the years after 1960, and, second, by negotiated protocols and standards of medical practice worked out by bodies such as the relevant royal colleges, the linked associations and societies for medical professionals, affected training and research authorities, and the state. The notion of ‘medical genetics’ in Britain consequently gained a semblance of unanimity over its basic reference points and arrived at a meaning directly tributary to current acceptance of the term in the context of a medical specialism. (shrink)

Despite its vagueness Personalized, Precision, P4, P5, individualized, stratified medicine—or p-medicine in short—has become an increasingly popular term in biomedical literature. Philosophers have attempted to analyze what these various terms involve and have discussed consequences for medical practices. In this article, I argue that an important question remains unaddressed: what has made this project of p-medicine convincing to so many? My argument is that without real achievements, it would never have been. I also make the case that these achievements (...) stem from the domain of monoclonal antibodies, a new type of drug that justifies talks of personalized, precise, stratified, etc., medicine. In conclusion, while it may be possible to label any projection in the future of medicine as ‘p-medicine’, it is impossible to overlook mab-medicine as the spearhead. (shrink)

In the present world, where the sphere of knowledge and social relations have become extremely complex, the problem of insufficient competency and inability to manage efficiently the accumulation and distribution process of various professional skills, has grown very urgent. Paradoxically, the insufficient knowledge,lacking skill or competence may be advantageous. To a certain extent, it reduces the threat of arrogant technocracy and meritocracy, while supporting innovation and creative search process, in which the burden of excessive erudition has often slowed down progress. (...) I will focus on some fallacies common in many countries undergoing modernization process, connected to the lack of clear awareness of the reasonably expected results of the medical university education(not quite professional if related to the background of the scientific state of the matter), to the dangerous “dissemination” of responsibility for a patient in the medical bureaucracy as well as to the overrepresentation of doctors among the managerial staff. To take advantage from some portion of ignorance in the medical life it needs to be acknowledged and reflected on. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Introduction to the 30th Anniversary Issue of Philosophy, Psychiatry, & PsychologyJohn Z. Sadler (bio)This issue marks the 30th anniversary of Philosophy, Psychiatry, and Psychology (PPP). All of us at the journal are grateful to our authors, readers, editors, and publishers for enabling this landmark. To commemorate this event, I invited our Founding Editor and Chair of the Advisory Board, K.W.M. "Bill" Fulford to write a brief essay, along with (...) our panel of smart and industrious senior editors. Their instructions were simple: 500 words on PPP past, present, and/or future. These essays appear in the pages to follow. As Editor-in-Chief, I write about PPP's early commitments as a scholarly journal, situate these in the history of academic publishing, and muse over our current moment.Bill Fulford briefly discusses the early years of the journal in his essay. My perspective emerges from an editor's perspective. As co-editors in the early years, Bill and I were committed to an international authorship with comparable editorial oversight. We wanted to build a journal that would equally recognize clinical science and practice and philosophy, maintaining the rigor of each field. We saw philosophers and mental health practitioners as equal partners, collaborators, innovators, and educators. More important, PPP was intended to offer up the best criticism of the mental health and related fields.The scattershot history of scholarly editing has identified several functions of the editor over the centuries following Gutenberg's invention of the printing press in the mid-1440s. The earliest editors took liberties with the language of the Bible, trying to make it more accessible to the public; the printing press permitted fast and inexpensive reproduction. Not surprisingly, this popularizing of the Bible led to praise as well as outrage. The printing of other scholarly works followed quickly. In 1470, only about 25 years after the invention of the printing press, Niccolo Perroni called for Pope Paul II to censor Andrea Bussi's edition of Pliny the Elder's Natural History, an anthology of then-ancient writings about the natural world. This marked the first recorded instance of censorship of a more-or-less secular scholarly work (Monfasani, 1988). In the ensuing centuries, "editors" initially were the popularizers, and later the gatekeepers of texts worth (and not worth) reading. In the [End Page 1] ensuing centuries into the present, editors have been venerated both as defenders of good reading and reviled as censors or intellectual selfaggrandizers.The current moment, in my view, represents a crisis in the history of editing and editorship. Digital communications have liberated communications worldwide. However, this liberty has come at the cost of colossal amounts of material not worth reading and an explosion of divisive, destructive discourse. Even worse, internet "trolls" on social media have moved bullying out of the schoolyard and into international cyberspace. Determining what is worth reading has moved away from a cluster of (hopefully) responsible editors to anyone who wants to go to the small effort of silencing others through online harassment and even violent threats. Such cyberbullying does not eliminate elitism, but instead substitutes a toxic online "elite" without principle other than self-promotion and the alienation of others. Our contemporary online culture has yet to figure out how to shape what is, and is not, worth reading.My wish and intent for the future of PPP is to maintain and grow our place of rational, deliberative, and open discourse, even in the face of such disruptive cultural change.John Z. Sadler John Z. Sadler, MD, is the Editor-in-Chief of PPP. He is the Daniel W. Foster, MD, Professor of Medical Ethics at the University of Texas Southwestern Medical Center, as well as a Professor of Psychiatry there. He has been a PPP editor since its inception.ReferenceMonfasani, J. (1988). The first call for press censorship: Niccolo Perotti, Giovanni Andrea Bussi, Antonio Moreto, and the editing of Pliny's Natural History. Renaissance Quarterly, 41, 1–31. Google ScholarCopyright © 2023 Johns Hopkins University Press... (shrink)

The Medical Innovation Bill continues its journey through Parliament. On 23 January 2015, it was debated for the final time in the House of Lords and with one final amendment, the House moved to support the Bill, which then moved to the House of Commons on 26 January. It will be debated again on 27 February 2015. The Bill’s purpose is to encourage responsible innovation in medical treatment. Although this goal is laudable, it is argued that the Bill (...) is unnecessary and has the potential to undermine the very cause it aims to advance. More useful for encouraging responsible innovation is the continued education of health-care professionals on how the law already supports practitioners who look to improve care through responsible innovation. (shrink)

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public and bioethicists in Ethics (...) Committees in Japan. Keywords: ethics committees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (shrink)

Bioethics as a field began some years before it was finally named in the early 1970s. In many ways, bioethics originated in response to urgent matters of the moment, including the controversy over disconnecting Karen Quinlan's respirator, the egregious paternalism of Donald Cowart's doctors in the famous “Dax” case, the abuse of research subjects in the notorious Tuskegee Syphilis Study, and the need to devise an intellectual framework for the development of federal regulations to protect human subjects of research. The (...) phrase “new and unprecedented” became a common description of the topics and issues to which people who later came to be called “bioethicists” responded. It should come as no surprise that bioethics and its practitioners soon came to the self-understanding that their work was new and unprecedented, much as the innovations of biomedical science and their clinical applications were thought to be. (shrink)

Les avancées de la médecine comme ses risques, excès ou dysfonctionnements conduisent à nous interroger sur la primauté affichée du techno-scientisme dans le champ de la santé, sur les idéaux de performance et les idéologies de la toute-puissance rationnelle de la biomédecine. A chaque étape de la recherche, du diagnostic, de la thérapie et du soin, la médecine n'est-elle pas toujours confrontée à la totalité d'un être vivant, à la complexité des pathologies, à l'ambivalence des thérapies, à la singularité personnelle (...) du patient? Pour valoriser pleinement le potentiel de savoirs et de savoirs-faire, issu de ses progrès, la médecine ne devrait-elle pas ré-humaniser l'homme malade, pour mobiliser toutes ses ressources biologiques, psychiques et mentales sans lesquelles la médecine risque de manquer ses buts, la santé d'une personne humaine. A l'opposé d'une polémique agressive et d'un scepticisme hostile, l'ouvrage tente de retisser des liens entre la froideur et la surenchère des technosciences de la santé et l'humanisme du soin, centré sur la psychologie relationnelle, l'éthique de la personne vulnérable, dam le contexte d'une anthropologie de l'homme intégral. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Wilhelm Griesinger: Psychiatry between Philosophy and PraxisKatherine Arens (bio)AbstractThis essay discusses Wilhelm Griesinger’s seminal work on mental illness, Mental Pathology and Therapeutics (1867, trans. 1882), in the context of transcendental idealism, as an outgrowth of the work of Kant, Herbart, and Hegel. Griesinger drew on an adaptation of Hegel’s dialectical model of history and science to offer both a new way to interpret mental illness as a product of (...) an individual’s long-term interactions with both nature and culture and a new norm for therapeutic practice based on the patient’s role in his community and history.Mental Pathology and Therapeutics rests on Griesinger’s adaptation of the Hegelian dialectic to the context of pragmatic science, first by adopting its model of the mind, then by describing the etiology of mental disease and a taxonomy of its forms. Griesinger’s work thus stands in a largely unacknowledged tradition alive as late as Sigmund Freud and Jacques Lacan.KeywordsGriesinger, history of psychiatry/psychology, idealism, Hegel, dialecticIn the nineteenth century, Wilhelm Griesinger (1817–68) emerged as a leader in a range of fields: modern-day psychiatric clinical practice, neuropathology, and diagnostics of mental diseases. 1 Griesinger was a theoretician, a clinician, a textbook author, and the founding editor of major professional organs in his field during the political and social ferment in the German-speaking world that allowed new, more socially responsible institutional practices to be considered by intellectual communities. As a consequence of 1849 German civil reforms, theory and practice became mutually enlightening, actually allowing Griesinger to implement his theories into concrete institutional reforms in the German mental health system.Wilhelm Griesinger’s education and career were in many ways typical for his generation. He enrolled at the University of Tübingen in 1834 as a medical student; there, he became politically active (as a member of a forbidden fraternity), and, like many of his contemporaries, became familiar with Hegelian philosophy. After holding several private positions, he was appointed an associate professor (ausserordentlicher Professor) for pathology, “materia medica” and history of medicine at Tübingen in 1847. In 1848, he was called to Kiel; in 1850, to Egypt. Tübingen reappointed him as a full professor for clinical medicine and head of the university clinic in 1854. By 1860, he had moved to Zurich in a professorship for the medical clinic, where, starting in 1863, he was a key person in the planning of a new clinic for mental diseases—the Burghölzli, where Jung later worked. By 1865, he went to Berlin, as director of the Charité (mental institution), among other positions, and he wrote extensively about reform in asylum practice until his premature death in 1868.To a degree, the eminence of this career is contradicted today by his reputation. Contemporary wisdom describes Griesinger as a synthesizer [End Page 147] rather than an innovator, a man who mixed medical psychology with psychology and psychiatric practice, allowing neurology to take a major role in the treatment of mental disease. 2 In one version, Griesinger simply pulled the clinic and the laboratory together, and so bridged Romanticism (i.e., speculative natural philosophy) and materialism (i.e., empirical science) while failing to effect crucial modern reforms. 3 In other descriptions, Griesinger is identified as an activist (Doerner 1981), a key player in the debates between the Hegelian left and right about the reformulation of public institutions (cf. Verwey 1985), 4 or a typical (but effective) member of the intellectual elite of his age. 5 None of these options explains the attractive or threatening aspects of his clinical practice, or suggests why a psychiatrist of his rank could have been so thoroughly refuted after his death. 6The discussion which follows will try to remedy this lack by setting Griesinger’s approach to mental illness in the context of a transformation of a model from philosophy into medical practice. Griesinger’s scientific context strongly combined philosophical theorizing and empirical practice, a synthesis that later generations tended to denigrate as a “speculative” approach to a branch of medicine that required a more empirical foundation. Drawing on an adaptation of Hegel’s dialectical model of history and... (shrink)

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new (...) breakthrough biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment. (shrink)

Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the “golden years” of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting (...) class='Hi'>medical innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments . Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions. (shrink)

Bioethics as a field began some years before it was finally named in the early 1970s. In many ways, bioethics originated in response to urgent matters of the moment, including the controversy over disconnecting Karen Quinlan's respirator, the egregious paternalism of Donald Cowart's doctors in the famous “Dax” case, the abuse of research subjects in the notorious Tuskegee Syphilis Study, and the need to devise an intellectual framework for the development of federal regulations to protect human subjects of research. The (...) phrase “new and unprecedented” became a common description of the topics and issues to which people who later came to be called “bioethicists” responded. It should come as no surprise that bioethics and its practitioners soon came to the self-understanding that their work was new and unprecedented, much as the innovations of biomedical science and their clinical applications were thought to be. (shrink)

A balance needs to be struck between facilitating compassionate access to innovative treatments for those in desperate need, and the duty to protect such vulnerable individuals from the harms of untested/unlicensed treatments. We introduced a principle-based framework to evaluate such requests and describe its application in the context of recently evolved UK, US and European regulatory processes. 24 referrals were received by our quaternary children's hospital Clinical Ethics Committee over the 5-year period. The CEC-rapid response group evaluated individual cases within (...) 48-hours; the main referrers being haematology/oncology, immunology or transplant services. Most requests were for drug/vaccine/pre-trial access or biological/cellular therapies. The majority of individual requests were approved ; neutral or negative opinions were given in 5, including 3 group requests. Recently evolved regulatory processes share common criteria and conditions to our framework including: demonstration of clinical need; sound scientific basis with lack of viable alternative; risks-benefit/best interests evaluation; arrangements for fully informed consent; no compromise of arrangements to test treatment for licensing purposes; consideration of resource implications. There are differences between individual processes and with our framework, with respect to procedures, scope, application format, costs and obligation to make available all outcome data. Our experience has emphasized the need for an independent, principled, consistent, fair and transparent response to the increasing demand for innovative treatment on a compassionate basis. We believe that there is a need for harmonization of the recent proliferation of regulation and legislation in this area. (shrink)