Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing (...) to special features of both surgery and innovation. (shrink)

Surgical innovation involves practices, such as new devices, technologies, procedures, or applications, which are novel and untested. Although innovative practices are believed to offer an improvement on the standard surgical approach, they may prove to be inefficacious or even dangerous. This article considers how surgeons considering innovation should reason in the conditions of uncertainty that characterize innovative surgery. What attitude to the unknown risks of innovative surgery should they take? The answer to this question involves (...) value judgments about the acceptability of risk taking when satisfactory scientific information is not available. This question has been confronted in legal contexts, where risk aversion in the form of the precautionary principle has become increasingly influential as a regulatory response to innovative technologies that pose uncertain future hazards. This article considers whether it is appropriate to apply a precautionary approach when making decisions about innovative surgery. (shrink)

Demands for access to experimental therapies are frequently framed in the language of rights. This article examines the justifiability of such demands in the specific context of surgical innovations, these being promising but non-validated and potentially risky departures from standard surgical practices. I argue that there is a right to access innovative surgery, drawing analogies with other generally accepted rights in medicine, such as the right not to be forcibly treated, to buy contraceptives, and to choose to have (...) an abortion, including a post-viability abortion where the mother's life or health is threatened by the pregnancy. I argue that we accept these rights because we believe that people are entitled to try to preserve their lives and health and to make choices of an important and intensely personal kind, and I suggest that a person's choice of medical treatment should be seen in the same light. However, since few rights are absolute, I also consider the circumstances in which it may be justifiable to limit the right to access innovative surgery. In discussing this question, I apply the human rights standard of proportionality, comparing the importance of the reasons for limiting the right with the severity of the invasion on liberty. (shrink)

Excessive prescribing of pain medications after surgery has contributed to the epidemic of opioid misuse and diversion in the United States. Pain specialists may be particularly well situated to address these issues. We describe an attempt to reverse the trend at an orthopedic surgical hospital by implementing a peri-operative assessment and treatment service which minimizes preoperative opioid use, when necessary implements addiction treatment, and encourages early tapering from opioids.

In this article, I am using the example of the introduction of osteosynthesis into surgical routine practice to analyze the use of the notions of art and science in medical innovation. The examination of the renegotiations of power and responsibility associated with the introduction of this new technique shows that proponents and critics actively linked their arguments to more fundamental epistemological and social issues. The proponents claimed to manage the uncertainties of innovation through making surgery more scientific, drawing on (...) the ideals of control, rationality, objectivity, and predictability. The critics mobilized another discursive pattern. They considered surgery an art and emphasized the individuality, contingency, and situatedness of medical practice. I investigate the discursive function of these argumentative patterns and how they played out in the concrete example of this surgical technique. (shrink)

The distinction between clinical practice and surgical research may seem trivial, but this distinction can become a complex issue when innovative surgeries are substituted for standard care without patient knowledge. Neither the novelty nor the risk of a new surgical procedure adequately defines surgical research. Some institutions tacitly allow the use of new surgical procedures in series of patients without informing individuals that they are participating in a scientific study, as long as no written protocol or hypothesis exists. Institutions (...) can justify this practice by viewing human research in narrow terms as an activity outlined in a formal protocol. Application of limited definitions, however, erodes patients' rights and risks losing public confidence in how biomedical research is conducted. I propose an operational definition of human research also be recognised. Enforcing more rigid and less ambiguous guidelines of human research may curtail enrolment into some studies, but it will also protect patients from being used as subjects without their knowledge. (shrink)

Successful innovative ‘leaps’ in surgical technique have the potential to contribute exponentially to surgical advancement, and thereby to improved health outcomes for patients. Such innovative leaps often occur relatively spontaneously, without substantial forethought, planning, or preparation. This feature of surgical innovation raises special challenges for ensuring sufficient evaluation and regulatory oversight of new interventions that have not been the subject of controlled investigatory exploration and review. It is this feature in particular that makes early-stage surgical innovation especially resistant (...) to classification as ‘research’, with all of the attendant methodological and ethical obligations—of planning, regulation, monitoring, reporting, and publication—associated with such a classification. This paper proposes conceptual and ethical grounds for a restricted definition according to which innovation in surgical technique is classified as a form of sui generis surgical ‘research’, where the explicit goal of adopting such a definition is to bring about needed improvements in knowledge transfer and thereby benefit current and future patients. (shrink)

In this paper we argue that surgeons face a particular kind of within-role conflict of interests, related to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed consent. The standard remedies for conflicts of interest are transparency and (...) recusal, which are unlikely to address this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation. (shrink)

Maternal–fetal surgery (MFS) encompasses a range of innovative procedures aiming to treat fetal illnesses and anomalies during pregnancy. Their development and gradual introduction into healthcare raise important ethical issues concerning respect for pregnant women’s bodily integrity and autonomy. This paper asks what kind of ethical framework should be employed to best regulate the practice of MFS without eroding the hard-won rights of pregnant women. I examine some existing models conceptualising the relationship between a pregnant woman and the fetus (...) to determine what kind of framework is the most adequate for MFS, and conclude that an ecosystem or maternal–fetal dyad model is best suited for upholding women’s autonomy. However, I suggest that an appropriate framework needs to incorporate some notion of fetal patienthood, albeit a very limited one, in order to be consistent with the views of healthcare providers and their pregnant patients. I argue that such an ethical framework is both theoretically sound and fundamentally respectful of women’s autonomy, and is thus best suited to protect women from coercion or undue paternalism when deciding whether to undergo MFS. (shrink)

How should one think about innovation in medicine and surgery? Increasingly, the answer to this question has involved reference to what might be called the regulatory ethics paradigm (REP). The regulatory ethics paradigm holds that deviations from standard care involve a degree or kind of experimentation that requires the application of a set of procedures designed to assure the protection of the rights and welfare of the subjects of research. In REP, innovative treatments are regarded as questionable until (...) they are framed in a research protocol with formal mechanisms of informed consent. The protocol must be reviewed and approved by an Institutional Review Board (IRB) or equivalent. The regulatory ethics paradigm in effect imposes the condition that clinical innovations be conducted according to scientific research methodologies. It creates the presumption that without review by an IRB, innovation cannot be conducted in an ethically defensible fashion. The regulatory ethics paradigm also requires the preparation of investigational protocols according to sound evidentiary and methodological standards. In so doing, it creates a presumption that innovations that are not rigorously validated are ethically dubious. These assumptions have deep roots. The Belmont Report, for example, articulated the orienting intuition that “radically new procedures... should... be made the object of formal research at an early stage [emphasis added] in order to determine whether they are safe and effective”.1 The Belmont Report takes the view that formal research to establish safety and efficacy of new interventions is usually feasible at an early stage in the development of a novel intervention. It thus establishes a bias that innovative treatments be conducted and evaluated under a research protocol that has passed muster at an IRB review. Given the …. (shrink)

This issue of The Journal of Medicine and Philosophy brings together an international group of scholars from Hong Kong, Mainland China, and North America, critically to explore whole-body/head transplantation. The proposed procedure raises significant philosophical, ethical, and social/political questions. For example, assuming transplant is successful, who survives the surgery? Does personal identity necessarily follow the head? The contributors to this special thematic issue explore the nature and ground of personal identity, what it would mean to preserve personal identity, given (...) such a significant set of physical changes, as well as the morality of such a procedure. As the authors make clear, careful conceptual philosophical analysis is essential for understanding whether whole-body/head transplantation is a life-saving/life-enhancing technological innovation, or a bioethical morass that should not be attempted. How we come to terms with such conceptual and moral concerns will have a significant impact on the future of medicine and medical technological innovation. (shrink)

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (...) innovation, that we categorised alliteratively under the themes of “purpose”, “place”, “process”, “product” and “person”. These conceptual areas are used in varying—sometimes contradictory—ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term “innovation” carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term “innovation” from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery. (shrink)

Liver transplantation is the treatment of choice for many forms of liver disease. Unfortunately, the scarcity of cadaveric donor livers limits the availability of this technique. To improve the availability of liver transplantation, surgeons have developed the capability of removing a portion of liver from a live donor and transplanting it into a recipient. A few liver transplants using living donors have been performed worldwide.Our purpose was to analyze the ethics of liver transplants using living donors and to propose guidelines (...) for the procedure before it was introduced in the United States. We used a process of research ethics consultation that involves a collaboration between clinical investigators and clinical ethicists. We concluded that it was ethically appropriate to perform liver transplantation using living donors in a small series of patients on a trial basis, and we published our ethical guidelines in a medical journal before the procedure was introduced. We recommend this prospective, public approach for the introduction of other innovative therapies in medicine and surgery. (shrink)

The United States Food and Drug Administration's recent approval of the commercial use of Deep Brain Stimulation (DBS) as a treatment for Obsessive Compulsive Disorder (OCD) will be discussed within the context of the existing USA regulatory framework. The purpose will be to illustrate the current lack of regulation and oversight of the DBS market, which has resulted in the violation of basic ethical norms. The discussion will focus on: 1) the lack of available evidence on procedural safety and efficacy, (...) 2) the numerous conflicts of interest held by research investigators, and 3) the ambiguity of both aforementioned categories due to an inherent lack of transparency in the research. It is argued that in order to address these issues, ethical analyses of DBS for psychiatric disorders must include the role of the industry forces that have become the primary impetus for this research. As such, DBS for OCD serves as an important case example in studies of neurotechnology and innovative surgery. (shrink)

Intersex being a birth impairment in human babies is a fact of humanprecreation. Opposed to normal birth of humans as males and females incidentsof babies with vague gender identity have perturbed people and families asto how to socially place them within the binary system of men and womenin the community. In Islam, it is more important in view of the genderedorientation of some Islamic laws and its system of social ethics. Accordingly,jurists formulated an Islamic blueprint to manage this segment. However,their (...) main criteria to align such individuals to one of the normal genders wereinadequate to assign a specific sex to all intersex. Medical science, on the otherhand, proposes not only to achieve precise diagnoses of intersex conditionsbut also to manage them medically. Accordingly, Muslim jurists and muftisby and large celebrated this medical solution as a better remedy to resolve thisjuridical perplexing question. This study, however, argues that juristic stamp ofapproval needs to be more ethically grounded so as to avoid pitfalls inherent inthis medical innovation. (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)

Surgical advances can provide great benefits to patients but can come at a cost. The successes are often matched by failures that cause harm to patients. The risks of surgery create a strong ethical imperative for research to establish the safety and efficacy of new treatments. Surgical research is, however, challenging for a number of reasons including the lack of a clear boundary between variations in practice, innovation and research, its irreversible nature, the difficulty of performing placebo-controlled randomised trials, (...) confounding factors such as surgeon learning curves and conflicts of interest. In this chapter the ethical issues raised by surgical innovation are explored with the use of a case study based on the uptake of vaginal mesh to treat vaginal prolapse to highlight these issues (Sects. 12.1 and 12.2). In Sect. 12.3 the argument for the value of a structured approach to introducing innovations, such as that developed by the IDEAL Collaboration, which clarifies both ethical and methodological issues at each stage of research is proposed. This chapter recognises that ethical challenges extend beyond adequate ethical evaluation of the innovation in the care of individual patients to include broader issues such as justice in access to any new interventions. (shrink)

An incrementalist view of the R&Dprocess is developed, according to which R&D consists of informed trial and error. One way of avoiding expensive mistakes is to avoid choices within the R&D program that are highly sensitive to a particular scientific claim, because a great deal of time and money may have been spent to no avail should the claim turn out to befalse. The incremental view of R&D therefore entails that no choice within any R&D program is sensitive to any (...) scientific claim made at the time. Two tests are presented, antiseptic surgery and the first atomic pile, both of which confirm the incrementalist thesis. (shrink)

Abstract:Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal (...) class='Hi'>surgery, raises a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus. (shrink)

in Angelique M. Rietsma and Jonathan D. Moreno eds., Ethical Guidelines for Innovative Surgery. (Hagerstown, MD: University Publishing Group) 19-52. [PDF].

Innovations in technology and science form novel fields that, although beneficial, introduce new bio-ethical issues. In their short history, lasers have greatly influenced our everyday lives, especially in medicine. This paper focuses particularly on medical and para-medical laser ethics and their origins, and presents the complex relationships within laser ethics through a three-dimensional matrix model. The term ‘laser’ and the myth of the ‘magic light’ can be identified as landmarks for laser related ethical issues. These ethical issues are divided into (...) five major groups: media, marketing, and advertising; economic outcomes; user training; the user-patient/client relationship; and other issues. In addition, issues arising from two of the most common applications of lasers, laser eye surgery and laser tattoo removal, are discussed. The aim of this paper is to demonstrate that the use of medical and para-medical lasers has so greatly influenced our lives that the scientific community must initiate an earnest discussion of medical laser ethics. (shrink)

Human uterus transplantation is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as (...) face and limb grafts, and shares some of the ethical concerns raised by these non-life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx. (shrink)

The practice of surgery requires consideration of a number of specific aspects of clinical medical ethics that are different from those most influential in other areas of medical care. The nature of surgical care alters the sense of responsibility that surgeons feel for their actions and also alters the relationship between surgeons and patients. Because surgical care requires patients to place such great trust in their surgeons, surgical informed consent must emphasize the importance of that trust. Surgeons must use (...) innovative means to solve individual patient problems even if the result is a novel operation. Surgical procedures may be altered due to the unexpected findings in the operating room and therefore surgeons must have considered how to respond in such situations. The future of surgical practice will inevitably lead to increasing ethical concerns in maintaining the ethical dimension of surgery, in allowing autonomy for trainees while maintaining patients’ safety, and in balancing surgical risks of prophylactic surgery with the genetic predisposition to develop cancer. (shrink)

Medical science brings innovations in patient care at an astounding pace today - new chemotherapeutic agents, coated stents, and minimally invasive surgery are just few recent examples. For physicians, though, the specter of malpractice liability can overshadow the marvel of practicing in this era. Many physicians are working in a volatile liability environment; they face spiraling costs for malpractice insurance, have difficulties purchasing liability coverage at any price, and see record payouts in a growing number of claims against their (...) colleagues. The American Medical Association has declared that at least 20 states are currently in a malpractice “crisis,” with another 24 states showing early signs of an impending crisis.There have been two comparable periods of instability in the last thirty years, but these predecessor crises differ from the current one in important ways. First, while physicians mainly experienced dwindling options for obtaining coverage in the mid-1970s and exorbitant prices in the mid-1980s, the current crisis appears to have elements of both availability and affordability. (shrink)

Medical science brings innovations in patient care at an astounding pace today - new chemotherapeutic agents, coated stents, and minimally invasive surgery are just few recent examples. For physicians, though, the specter of malpractice liability can overshadow the marvel of practicing in this era. Many physicians are working in a volatile liability environment; they face spiraling costs for malpractice insurance, have difficulties purchasing liability coverage at any price, and see record payouts in a growing number of claims against their (...) colleagues. The American Medical Association has declared that at least 20 states are currently in a malpractice “crisis,” with another 24 states showing early signs of an impending crisis.There have been two comparable periods of instability in the last thirty years, but these predecessor crises differ from the current one in important ways. First, while physicians mainly experienced dwindling options for obtaining coverage in the mid-1970s and exorbitant prices in the mid-1980s, the current crisis appears to have elements of both availability and affordability. (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)

Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery (...) at leading cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

Transplantation continues to push the frontiers of medicine into domains that summon forth troublesome ethical questions. Looming on the frontier today is human facial transplantation. We develop criteria that, we maintain, must be satisfied in order to ethically undertake this as-yet-untried transplant procedure. We draw on the criteria advanced by Dr. Francis Moore in the late 1980s for introducing innovative procedures in transplant surgery. In addition to these we also insist that human face transplantation must meet all the (...) ethical requirements usually applied to health care research. We summarize the achievements of transplant surgery to date, focusing in particular on the safety and efficacy of immunosuppressive medications. We also emphasize the importance of risk/benefit assessments that take into account the physical, aesthetic, psychological, and social dimensions of facial disfiguration, reconstruction, and transplantation. Finally, we maintain that the time has come to move facial transplantation research into the clinical phase. (shrink)

Healthcare expenditures account for approximately 9% of GDP in OECD countries and are on an upward trajectory (OECD, 2017). This significant financial burden, combined with an aging global population and increasing demand, emphasizes the imperative for sustained research and innovation to enhance health system efficacy. Key to this transformation are technological advancements, including digital health, which presents novel opportunities for improvement. Emerging digital health technologies, such as virtual consultations, complex imaging procedures, and electronic medical records, are fundamental to modern healthcare (...) infrastructures. However, significant gaps remain in the evaluation and understanding of these innovations, especially for nascent technological areas. This thesis addresses this subject, aiming to delineate how individuals and institutions can bolster their evaluative capabilities, strategic decision-making, and planning for the deployment of emerging digital healthcare technologies. The research methodology amalgamates theoretical exploration, literature scrutiny, and empirical examinations, presenting an integrated perspective that intersects the disciplines of Management & Decision Science, Technology & Innovation, and Health Economics & Outcomes Research. From an applied perspective, this research focuses on developing evidence within the context of pediatric healthcare in Canada — a context notably underrepresented in healthcare management research, despite its disproportionate per capita expenditure. Technologically, the predominant focus is on applications in virtual reality (VR) and three-dimensional (3D) printing and virtualization, though with the aspiration of ensuring the generalizability of results. The current thesis is structured to parallel the progression of the research itself, as three distinct phases; this begins with a comprehensive Background that contextualizes the initial intent, exploring the relationship between technology, innovation, and health outcomes. In this phase, each academic discipline is analyzed to identify base theoretical underpinnings for the research. The second phase of this work includes five empirical studies, each preceded by context-specific literature reviews for the respective technological domain, providing insight into the current state of evidence related to value-based assessment and economic evaluation in that area. Empirical studies included a randomized controlled trial and a cost consequences assessment of VR for pre-procedural preparation for medical imaging. Additionally, novel applications of 3D printing and virtualization are critically analyzed, accompanied by a multi-case study on the implementation of 3D printing in pediatrics, a cost-consequences study of applications for thoracoabdominal surgeries, and an outcomes study on the use of 3D virtualization in medical education during the COVID-19 pandemic. The final phase of this research includes the critical analysis and synthesis of findings into a proposal for a novel value-based assessment and decision-making framework specific to emerging health innovations; this framework integrates insights and resources for clinicians, administrators, and policymakers. The outcomes of this research are skewed toward Knowledge Users, but also aims to advance the theoretical basis for health technology assessment (HTA). (shrink)

The world of work is undergoing major surgery. Future economic historians may yet describe the cumulative impact of globalisation, technological change and new work patterns that are currently shaking the OECD countries as an economic revolution similar in magnitude and significance to the industrial revolution of the 19th century. There is certainly plenty of pain around, but scattered in so many countries and cultures that this late 20th century revolution will probably prove to have been beyond the capacity of (...) any Charles Dickens, or of a Marx and Engels, to chronicle.From the perspective of the European Union, the pain is clearly visible in two areas: a growing insecurity and stress attending many who are at work in the Union, particularly in occupations and employments where earnings have risen a lot; and the level and persistence of long-term unemployment together with the growing number of discouraged workers, primarily men, who are opting out of the labour force altogether. Not visible within the EU, but no less real of course, is the impact on workers in other countries when the Union adopts protectionist or aggressive trading policies.[...]CONCLUSION :The dislocation that is evident throughout the world of work today, and the insecurity and pain it is causing, is influencing political life in the European Union. What Americans would call the ‘feel bad’ factor tempts some to support protectionist measures, abrupt limits to immigration, cuts in taxation and social services, workfare or — if they are outsiders — abuse of the social welfare system and black market activity. It is important to appreciate that very few people are escaping; the upheavals in the world of work are affecting insiders and outsiders. Making common cause requires forging a fresh consensus on fundamental values of which two key ones are the nature of a business enterprise and the place of a job in a person’s life. These are the key areas where social innovation must match the apparently ceasless innovations on the part of technology. They may, hopefully, prove capable of redirecting the process of technological change itself. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.1 (2001) 91-112 [Access article in PDF] Scope Note 40 Animals in Research and Education: Ethical Issues Laura Jane Bishop and Anita Lonnes Nolen Scientific enquiry is inexorably tied to animal experimentation in the popular imagination and human history. Many, if not most, of the spectacular innovations in the medical understanding and treatment of today's human maladies have been based on research using animals. (...) However, the use of animals in research and experimentation has been debated, defended, and protested by both individuals and organizations at various levels. Responses range from personal lifestyle decisions and fervent philosophical treatises to strident arguments, violent demonstrations, and direct action. The continuum of attitudes about animals and the human relationship with animals spans the range between those who support no regulation of the human use of animals and those who advocate absolute animal liberation from all human use (see II, Orlans 1993, p. 22). History The first recorded experimentation on animals occurred in ancient Rome, but not until the Renaissance did scholars begin serious study of how the body works. Leonardo da Vinci (1452-1519) and other artists and anatomists pursued anatomical investigations of muscle and bone structure. William Harvey (1578-1657) discovered the circulation of the blood via his experiments on live deer. During this period, much live animal experimentation both in England and France was based on the view of French philosopher René Descartes (1596-1650) that animals are incapable of feeling pain. Jeremy Bentham (1748-1832), the English utilitarian philosopher, thought otherwise. In his "Introduction to the Principles of Morals and Legislation" in 1789, Bentham declared, "The question is not, can they reason? Nor, can they talk? But can they suffer? Despite Bentham and others, the belief that animals could not perceive pain persisted in many quarters into the twentieth century. Nineteenth century French physiologist Claude Bernard [End Page 91] (1813-1878)-and his teacher, François Magendie (1783-1855)-conducted wide-ranging animal experiments including surgery, use of drugs, and removal of body parts from many species. Bernard argued that while no amount of benefit could justify any harm to human research subjects, even extreme harm and pain for animal research subjects could be justified by the potential benefit to human beings. Although he did use anesthetics in his work after their discovery in 1847, even Bernard's later work was controversial because of the numbers of animals used and the repetitive nature of his research. The experiments of Magendie and Bernard both laid the foundations for animal experimentation as a practice for scientific advance and contributed in large measure to the emergence of the anti-vivisection movement. Public protests over animal experiments conducted in France and the fear that these might come to England led to the passage of the first law controlling animal experimentation, the "1876 Cruelty to Animals Act" in England. This history and the dynamic tension between scientific inquiry and public concern set the stage for the activism and scholarship of the twentieth century.Since the 1960s, the amount of attention, activism, and scholarship related to animal use has increased at a rapid pace. The modern animal protection movement, led by the Australian philosopher Peter Singer in his book, Animal Liberation (II, 1975), based its advocacy on animals' ability to experience pain and suffering (Bentham's argument). Singer's book and other investigations into animal research, such as LIFE magazine's photojournalism piece on pet theft, animal cruelty, and animal experimentation (Concentration Camps for Dogs. LIFE (4 February 1966), pp. 22-29), brought the use of animals in research, testing, and education to the attention of the general public. Activists, advocates, laypersons, scientists, lawmakers, and animals themselves, have created the interesting, complicated, and complex history of animal rights and animal welfare over the last several decades. Current Statistics Worldwide, approximately 35 million animals are used in research each year; the United States alone uses 12 million animals annually--more than any other country. In 1998, the official number of research animals recorded in the United States was 1... (shrink)

In his contribution to the Journal of Medical Ethics, Joseph Mazor1 makes a logical case, based on the premises underlying his reasoning, for his article's primary thesis: he concludes that parents have the prerogative to determine the ‘best interests’ of their infant son in a circumcision decision. If the facts of the matter were ultimately no different from what he adduces, one could admit the soundness of his argument. But the paper is flawed by some questionable assumptions and grievous incompleteness.First, (...) the author insufficiently explores the profound implications of a serious equivocation in the term ‘circumcision’ that is common throughout the literature. He does superficially reference the article on ‘Circumcision’ in The Jewish Encyclopedia, which describes in detail the actual steps involved in brit milah versus brit periah.2 Despite this general allusion, though, he hardly discusses the matter further, as though the distinction were practically irrelevant. It does have fundamental import, however. Milah is merely a token clip of the very tip of the prepuce, which leaves most of the organ system intact. This was evidently the version practiced in biblical times under the old Abrahamic–Mosaic covenant, before the Talmudic guardians of Judaic ethnic and religious identity proposed a means to prevent Hellinising Jewish men from attempting foreskin restoration by stretching their remaining preputial tissue forward. The rabbis mandated the replacement of milah with the more drastic procedure of periah, a radical surgery that cuts and tears from the penis its entire covering, leaving the glans irreversibly denuded. Unlike traditional milah, the innovation of periah necessarily has significant adverse consequences .Second, Mazor concedes that circumcision might cause a ‘moderate’ reduction of sexual pleasure in the lad's …. (shrink)

Objective The objective of this article is to provide an ethical analysis of a high-risk, advanced treatment case where the patient received transcatheter aortic valve insertion, for aortic valve stenosis. Particular emphasis will be placed upon the significance of evidence and the implications for priority setting. Method One paradigmatic case involving a TAVI patient from a large university hospital in Norway is described and analysed. The method used was ethical case analysis modified after Kymlicka by Miljeteig et al. Perioperative mortality (...) risk was estimated using the Euroscore risk-logarithm and the Society of Thoracic Surgeons’ risk model, STS. These predict the risk of operative mortality and morbidity associated with adult cardiac surgery. GRADE, the Grading of Recommendations Assessment, Development and Evaluation, was used to evaluate the evidence. Results In the case analysis, we found that it would be ethically justifiable not to recommend TAVI treatment for this patient. Although the patient had a severe condition in need of treatment, the expected improvement was marginal, the quality of evidence was low and the opportunity costs for other patients and society were higher than usually deemed appropriate. Conclusions Decision-making in the absence of high quality evidence from randomized trials is a complex process involving difficult ethical judgments. Novel high-risk devices often enter the European market with limited clinical evidence. Transparency and improved clinical evaluation are required so patient safety is not jeopardized. We argue that implementation of high risk, high cost interventions should be better regulated at a national level. Background All clinical decisions imply priority setting and therefore indirectly affect other patients and other patient groups. The use of expensive, innovative health technologies has an affect on individual patients as well as on other patient groups competing for the same resources. (shrink)

This essay studies Edie Fake’s award-winning graphic novel Gaylord Phoenix from the perspective of Queer Theory and Transgender Studies. Nikki Sullivan’s use of the term transmogrification from her work on somatechnics provides a critical lens through which to examine Fake’s exploration of the transgender body in his narrative. Fake includes multiple images of bodies undergoing radical transformations through a combination of magic and surgery, blurring the distinction between modern science and the occult. The essay also explores Fake’s status as (...) an innovator in the world of comic books and graphic novels as he creates an idiosyncratic verbal and visual vocabulary largely unprecedented in the world of sequential art. (shrink)

Advances in veterinary orthopaedics are assessed on their ability to improve the function and wellbeing of animal patients. And yet historically veterinarians have struggled to bridge the divide between an animal's physicality and its interior experience of its function in clinical settings. For much of the twentieth century, most practitioners were agnostic to the possibility of animal mentation and its implications for suffering. This attitude has changed as veterinarians adapted to technological innovations and the emergence of a clientele who claimed (...) to understand and relate to the subjective experiences of their animals. While visualising technologies and human analogies have shaped the nuts and bolts of veterinary orthopaedic practices, an emerging awareness of the inability of radiographic images to apprehend or correlate to a patient's experience of their function reliably has required veterinarians to place a greater emphasis on the owner's knowledge of the "selves" inhabiting their animals. Rather than simply basing clinical judgments on the "look" of their patients, the indeterminacy in the connection between form and function has compelled veterinarians to put questions regarding particular human-animal relationships near the centre of their practices, not least in orthopaedic surgery. (shrink)

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

In lieu of an abstract, here is a brief excerpt of the content:Medical Tourism:Crossing Borders to Access Health CareHarriet Hutson Gray (bio) and Susan Cartier Poland (bio)Traveling abroad for one's health has a long history for the upper social classes who sought spas, mineral baths, innovative therapies, and the fair climate of the Mediterranean as destinations to improve their health. The newest trend in the first decade of the twenty-first century has the middle class traveling from developed countries to (...) those with emerging economies to avoid treatment delays, prohibitive costs for life-saving procedures, or simply high costs for elective surgery. Others leave to have access to assisted suicide in countries that have legalized it: Belgium, The Netherlands, and Switzerland. This new era of globalization in health care has arrived without the benefit of international standards, government oversight, or ethical and legal review.Howard Staab, a self-employed carpenter from North Carolina, flew to India for his medically necessary heart surgery, scheduled a side trip to the Taj Mahal, and returned home to work in North Carolina. He spent a total of less than $10,000, instead of the $200,000 required from the local hospital (I, Milstein and Smith 2006).At first blush, the outsourcing of medical care to India seems to be a particular solution for a particular problem. However, the particularity of Mr. Staab is not unique. His experience is emblematic of those patients in the United States with a medical need for major and elective procedures, but who also must bear the total cost of these procedures. These middle-class, under-insured Americans go abroad.In tandem with increasingly aggressive marketing campaigns, American hospitals and companies have begun to leverage their connections in Asia to grow the medical tourism business into a major economic force. What are the consequences of this?Several authors point to the effect on the host country's population, particularly the poor, to be pushed farther down the queue to receive adequate, affordable care. Resources are applied to the foreign trade instead of building the local [End Page 193] medical infrastructure. Another potential problem is the obligation of the home-country physician to provide follow-up care. What are the legal ramifications when the procedure was illegal to begin with? Are there opportunities for redress for medical errors?These factors may be converging into a "perfect storm" for health care in the U.S., in which the potential participation of the major insurance companies in promoting offshore care will be the tipping point in the precarious structure that represents the economic currents in health care. Third-party administrators and self-funded employers may be on the cutting edge in 2009 by providing incentives to employees to travel overseas for care.I. Economic ConsiderationsConnell, John. Medical Tourism: Sea, Sun, Sand and... Surgery. Tourism Management 27: 1093–1100, 2006.As evidence of the interest of traditional tour operators in this newer twist on the industry, the author explores medical tourism as an element of the growth of world tourism. In promoting medical tourism, he urges consideration of such issues as the privatization of health care, the foundational role of technology, and uneven access to health resources.Dunn, Philip. Medical Tourism Takes Flight. H and HN: Hospitals and Health Networks: 40–44, November 2007.Writing for U.S. health care executives, Dunn emphasizes that the reality of medical tourism competes with the local medical center for patients and their insurance dollars in a significant way. He examines the possibility that U.S. insurance plans soon may offer to pay for what is currently a cash only business and that the economic impact to the local medical center could be significant or even devastating.Frontiers of Health Services Management [Selected Articles] 24 (2), Winter 2007.In "Managing Healthcare Services in the Global Marketplace" (pp. 3–18), Bruce J. Fried and Dean M. Harris consider legal, ethical, and financial implications of the international workforce. In "Globalization of Health Care" (pp. 19–30), Lynn Schroth and Ruthy Khawahja point out that the transfer of comprehensive management expertise and intellectual property from U.S. medical centers to international sites is driving the success of collaboration between U.S. and foreign health care centers. In "Is... (shrink)

What are the final limits of medicine? What should we not try to cure medically, even if we had the necessary financial resources and technology? This book philosophically addresses these questions by examining two mirror-image debates in tandem. Members of certain groups, who are deemed by traditional standards to have a medical condition, such as deafness, obesity, or anorexia, argue that they have created their own cultures and ways of life. Curing their conditions would be a form of genocide. Members (...) of other groups are seeking to provide medical treatment to what would conventionally be deemed 'cultural conditions'. Mild neurotics who take anti-depressants to elevate their mood, runners who use steroids, or men and women seeking cosmetic surgery are asking for medical treatment for problems that might be solved culturally, by changing norms, pressures, or expectations in the broader culture. Each of these two debates endeavors to locate medicine's final frontier and to articulate what it is that we should not treat medically even if we could. This volume analyzes what these two contemporary debates have to say to each other and thus offers a new way of determining medicine's final limits. (shrink)

Summary This paper discusses the emergence of new medical experimental specialties at the Medical School of Surgery (Escola Médico-Cirúrgica) and the Faculty of Medicine of Lisbon University (Faculdade de Medicina da Universidade de Lisboa) between 1897 and 1946, as a result of the activities of Marck Athias's (1875?1946) histophysiology research school. In 1897, Marck Athias, a Portuguese physician who had graduated from the Faculty of Medicine in Paris, founded a research school in Lisbon along the lines of Michael Foster's (...) physiology research school in England and Franz Hofmeister's physiological chemistry school in Germany. His research programme was highly innovative in Portugal. Not only did it bring together many disciples and co-workers, but it branched out and created new medical specialties within Portuguese medical science. These new disciplinary areas grew out of the study of the histology of the nervous system but eventually expanded into normal and pathological histophysiology, physiological chemistry and experimental endocrinology. The esprit de corps that existed between research school members ensured the school's success and influence in various fields social and political as well as scientific. Athias's school was strongly influenced by positivist ideals and promoted a teaching and research style that sought inspiration in Humboldt's university model, thus helping to bring about a change in the dominant scientific ethos and to modernize scientific research in Portugal during the first half of the twentieth century. (shrink)

The moral economy of American medicine has been transformed by contentious innovations in organization, administration, regulation, and finance. In many settings old fee-for-service incentives and disincentives have been replaced by those of ``managed care,'' while in other settings they have been diluted or distorted. In the everyday care of patients, old and new may alternate or interact. These innovations may also be having secondary effects on participation in life-sciences research and the development and employment of new technologies, discouraging collective support (...) for preliminary investigation and delaying adoption of improved goods and services until cost-reducing potential has already been realized. This motivational complexity, particularly in its moral dimensions, is hard to address using standard assumptions and methods. I argue for different assumptions, based on the clinical behavior of individual patients rather than the market behavior of aggregated consumers, and I describe a different method, based on an old idea in political economy. I then present a new way to explain the core obligations of clinicians, researchers, and planners and to interpret the policy problems they must now share. (shrink)

This chapter contains sections titled: Introduction History of Experimentation on Human Beings Regulation of Human Experimentation Guidelines, Regulations and Directives to Regulate Human Experimentation Regulation of Experimentation in Surgery and Clinical Medicine Discussion References.

This book analyzes the reasons for organ shortage and ventures innovative ideas for approaching this problem. It presents 29 contributions from a highly interdisciplinary group of world experts and upcoming professionals in the field. Every year thousands of patients die while waiting for organ transplantation. Health authorities, medical professionals and bioethicists worldwide point to the urgent and yet unsolved problem of organ shortage, which will be even intensified due to the increasing life expectancy. Even though the practical problem seems (...) to be well known, the search for suitable solutions continues and often restricts itself by being limited through disciplinary and national borders. Combining philosophical reflection with empirical results, this volume enables a unique insight in the ethics of organ transplantation and offers fresh ideas for policymakers, health care professionals, academics, and the general public. (shrink)