Norbert W. Paul

Building bridges: Future directions for medical error disclosure research

OBJECTIVE The disclosure of medical errors has attracted considerable research interest in recent years. However, the research to date has lacked interdisciplinary dialog, making translation of findings into medical practice challenging. This article lays out the disciplinary perspectives of the fields of medicine, ethics, law and communication on medical error disclosure and identifies gaps and tensions that occur at these interdisciplinary boundaries. METHODS This article summarizes the discussion of an interdisciplinary error disclosure panel at the 2012 EACH Conference in St. Andrews, Scotland, in light of the current literature across four academic disciplines. RESULTS Current medical, ethical, legal and communication perspectives on medical error disclosure are presented and discussed with particular emphasis on the interdisciplinary gaps and tensions. CONCLUSION The authors encourage interdisciplinary collaborations that strive for a functional approach to understanding and improving the disclosure of medical errors with the ultimate goal to improve quality and promote safer medical care. PRACTICE IMPLICATIONS Interdisciplinary collaborations are needed to reconcile the needs of the stakeholders involved in medical error disclosure. A particular challenge is the effective translation of error disclosure research into practice. Concrete research questions are provided throughout the manuscript to facilitate a resolution of the tensions that currently impede interdisciplinary progress.

Ethical aspects of genome diversity research: genome research into cultural diversity or cultural diversity in genome research?

The goal of the Human Genome Diversity Project (HGDP) was to reconstruct the history of human evolution and the historical and geographical distribution of populations with the help of scientific research. Through this kind of research, the entire spectrum of genetic diversity to be found in the human species was to be explored with the hope of generating a better understanding of the history of humankind. An important part of this genome diversity research consists in taking blood and tissue samples from indigenous populations. For various reasons, it has not been possible to execute this project in the planned scope and form to date. Nevertheless, genomic diversity research addresses complex issues which prove to be highly relevant from the perspective of research ethics, transcultural medical ethics, and cultural philosophy. In the article at hand, we discuss these ethical issues as illustrated by the HGDP. This investigation focuses on the confrontation of culturally diverse images of humans and their cosmologies within the framework of genome diversity research and the ethical questions it raises. We argue that in addition to complex questions pertaining to research ethics such as informed consent and autonomy of probands, genome diversity research also has a cultural–philosophical, meta-ethical, and phenomenological dimension which must be taken into account in ethical discourses. Acknowledging this fact, we attempt to show the limits of current guidelines used in international genome diversity studies, following this up by a formulation of theses designed to facilitate an appropriate inquiry and ethical evaluation of intercultural dimensions of genome research.

Historical development and current status of organ procurement from death-row prisoners in China

BackgroundIn December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners.DiscussionIn the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to “voluntarily donate” organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards.ConclusionsOrgan sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with “consent” are now simply labelled as “voluntarily donations from citizens”. The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain.

Captious certainties: makings, meanings and misreadings of consumer-oriented genetic testing

Members of the scientific and medical communities concerned with genetic testing might wonder, why cultural and ethical analyses of genetic testing are increasing again, especially since legal frameworks have, by now, come to provide more solid grounds for the routine application of genetic testing on both levels of application, diagnostics, and prediction. This contribution aims to shed light on the changing concept of genetic testing as it is raised by novel cultural practices and perceptions mainly triggered by direct-to-consumer predictive testing, including the phenomenon of a new genetic exceptionalism “from below”. We are seeking to determine what is at stake in this practice and what consequences arise from it for the medical and scientific community. What exactly happens as we move from diagnostic to prognostic medicine? Above all, this article pivots on the notion of captious certainties, a concept, which we will elaborate on as our argument progresses.

Medizinische Prädiktion, Prävention und Gerechtigkeit: Anmerkungen zu ethischen Dimensionen eines biomedizinischen Ideals

ZusammenfassungDas Ideal einer vorhersagenden Medizin in Kombination mit wirkungsvollen, kausalen Strategien der Prävention auf molekularer Ebene ist noch immer weit davon entfernt, klinische Realität zu werden. Es ist jedoch schon heute festzustellen, dass zwischen Medizin und Gesellschaft verhandelte Konzepte von Gesundheit in immer stärkerem Maße auf zukünftige Gesundheit ausgerichtet sind, mithin einen immer präventiveren Charakter aufweisen. Der vorliegende Beitrag untersucht die Frage, ob neue Konzepte einer prädiktiv-präventiven Medizin – insbesondere Public Health Genetics bzw. Public Health Genomics – das Kriterium der Verbesserung der sozialen Erreichbarkeit von Gesundheit erfüllen. Diese Analyse wird vor dem Hintergrund der Rolle sozialer Grundwerte, insbesondere dem der Gerechtigkeit, für Funktionen der Medizin in unserer Gesellschaft einerseits sowie der Bedeutung des Wandels der medizinischen Schlüsselkonzepte „Gesundheit“ und „Krankheit“ andererseits vorgenommen.AbstractDefinition of the problem The ideal of a truly predictive medicine vested with effective causal strategies of prevention down to the molecular level is far from being reality. However, we have to appreciate the fact that the concepts of health negotiated at the intersection of medicine and society are becoming increasingly directed towards a prediction of future health and the notion of prevention. This paper investigates whether novel concepts of a predictive–preventive medicine—especially public health genetics or public health genomics—are likely to promote the social achievability of health. Arguments The analysis presented is based on an assessment of the role of fundamental social values for the function of medicine in society, on the one hand, and on the role of the key concepts of medicine—health and disease—at the interface of medicine and society, on the other. Conclusion We observe a transition of medicine toward increasingly more predictive concepts of disease. With this shift, the normative characteristics of the key concepts of health and disease shared between medicine, individuals, and society are also subject to profound changes. This is a challenge to social values in their function as pillars of health care systems, particularly the social value of justice and its societal perceptions in the realm of health.

The Chinese herbal formula Free and Easy Wanderer ameliorates oxidative stress through KEAP1-NRF2/HO-1 pathway

Posttraumatic stress disorder (PTSD) gains a lot of attention due to high prevalence and strong psychological upset, but the etiology remains undefined and effective treatment is quite limited. Growing studies demonstrated the involvement of oxidative stress in various psychiatry diseases, suggesting anti-oxidation therapy might be a strategy for PTSD treatment. Free and Easy Wanderer (FAEW) is a poly-herbal drug clinically used in China for hundreds of years in the treatment of psychiatric disorder. We hypothesized that FAEW exerts clinical effects through the activity against oxidative stress with fluoxetine as antidepressant control drug. Our results revealed that FAEW significantly reduced both endogenous and H2O2-induced exogenous ROS levels in the human glioblastoma T98G and neuroblastoma SH-SY5Y cell lines. Transcriptome-wide microarray analysis indicated NRF2/HO-1 as the common target of FAEW and fluoxetine. Western blotting assay proved that the two drugs promoted NRF2 release from KEAP1 in the cytoplasm and translocation to the nuclei in a KEAP1-dependent manner, the expression of the protein HO-1 increased accordingly, suggesting the participation of KEAP1-NRF2/HO-1 pathway. The chemical constituents of FAEW (i.e. paeoniflorin, baicalin) bound to KEAP1 in silico, which hence might be the effective substances of FAEW. In conclusion, FAEW counteracted H2O2-induced oxidative stress through KEAP1-NRF2/HO-1 pathway.

Human rights violations in organ procurement practice in China

BackgroundOver 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China’s organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained.DiscussionWe have collected and analysed available evidence on human rights violations in the organ procurement practice in China. We demonstrate that the practice not only violates international ethics standards, it is also associated with a large scale neglect of fundamental human rights. This includes organ procurement without consent from prisoners or their families as well as procurement of organs from incompletely executed, still-living prisoners. The human rights critique of these practices will also address the specific situatedness of prisoners, often conditioned and traumatized by a cascade of human rights abuses in judicial structures.ConclusionTo end the unethical practice and the abuse associated with it, we suggest to inextricably bind the use of human organs procured in the Chinese transplant system to enacting Chinese legislation prohibiting the use of organs from executed prisoners and making explicit rules for law enforcement. Other than that, the international community must cease to abet the continuation of the present system by demanding an authoritative ban on the use of organs from executed Chinese prisoners.

Personale Autonomie: Diskussion eines zentralen ethischen Konzepts am Beispiel von fertilitätsprotektiven Maßnahmen bei Krebspatientinnen

Die bei Krebserkrankungen junger Frauen erforderliche Chemo- bzw. Strahlentherapie kann in der Folge bei den betroffenen Patientinnen zur Unfruchtbarkeit führen. Somit werden die Betroffenen oft gleichzeitig mit einer potentiell lebensbedrohlichen Erkrankung und einem potentiell kinderlosen Leben konfrontiert. Die derzeitigen Methoden zum Erhalt der Fertilität sind experimentell, mit therapeutischer Unsicherheit und gesundheitlichen Risiken belastet, dennoch werden sie zunehmend nachgefragt. Die mit dem Angebot fertilitätserhaltender Maßnahmen verbundene derzeitige Beratungspraxis wird in dem hier vorliegenden Beitrag aus ethischer Perspektive hinterfragt. Ausgehend von einer kritischen Würdigung des nach wie vor häufig angewandten Autonomiekonzepts von Beauchamp und Childress wird diskutiert, auf welche Weise die normative Belastbarkeit der Entscheidungsfindung durch die Vulnerabilität der Patientin limitiert sein kann. Als Alternative zum Autonomiekonzept von Beauchamp und Childress wird anschließend eine Entscheidungsfindung auf der Grundlage biographischer Identität in Anlehnung an das Konzept der personalen Autonomie nach Quante erörtert. Definitions of the problem Fertility preservation is an important issue in young cancer patients. Young women are not only confronted with a life-threatening diagnosis, but at the same time with the likelihood of therapy-induced infertility. Unfortunately options for fertility preservation are rather experimental, not free from the risk of health hazards, and limited. This article aims to discuss the capacity of decision-making in consideration of normative concepts of autonomy and authenticity in this particular situation.Arguments We discuss respect for autonomy as a part of the well-known ethical framework presented by Beauchamp and Childress. An autonomous decision in this particular situation is not applicable due to the following arguments: relationships to the partner and the unborn baby are not considered, the concept is disembodied, and it cannot be guranteed that the required information for an autonomous decision is communicated properly. As an autonomous decision is not possible, authentic decision-making is suggested as an appropriate alternative. Based on the deliberations of personal autonomy championed by Quante, an applicable concept of authenticity is presented.Conclusion Counseling young female cancer patients in the field of fertility preservation is both a normative and communicational challenge. Perception of this topic needs to be improved. Patients’ decisions should be made on the basis of authenticity.

Threats to human health by great ocean garbage patches

www.thelancet.com/planetary-health Vol 1 November 2017 e301 The medical relevance of environmental topics can be blurred by politicised debates and the global scale of the environmental impact of human life. However, a seemingly remote serious health threat is currently floating in our oceans and needs to trigger the attention of the medical community, as its clinical manifestation is only a matter of time. Plastics are one of the most important materials in industrialised countries. Despite huge annual inputs of plastic litter into the oceans (4·8–12·7 million metric tons), the hazards to both the environment and human health are widely neglected. Marine plastic contamination has spread across the globe. Several garbage patches have formed in the Pacific and Atlantic oceans. Clockwise ocean currents lead to the retention and convergence of plastic debris. These subtropical gyres prevent plastic debris from moving towards mainland coasts. Plastic pollution substantially threatens marine life. Numerous chemical monomers are used to produce plastic polymers, which are characterised by high longevity. Partial degradation in seawater leads to generation of macro-waste and micro-waste, which causes physical and biological hazards to marine organisms. Release of ecotoxic chemicals from plastic particles provokes chemical and toxicological threats (figure). Furthermore, plastic litter is frequently mistaken for food by marine life, leading to health complications and death. Plastic ingestion has been observed in numerous animals. Plastic parts were found in the stomachs of turtles, and seabirds die from obstruction of their respiratory or digestive tracts by bottle caps. Turtles and seals are trapped by abandoned fishing nets—so-called ghost nets. However, the long persistence of plastic debris is also problematic for other reasons. Combinations of weathering by ultraviolet light, seawater, and mechanical action partly degrade and fragment larger pieces of plastic down to microplastics (<0·5 mm). When they sink, small plastic pieces and microplastics are colonised by certain marine organisms, which affects submarine organisms and entire ecosystems, including non-human and human food chains. Via the intake of microplastics or their chemical compounds, which are set free in various decomposition processes, ocean garbage has become a latent threat to the health of future generations, and already affects human health on a global scale. Human biomonitoring shows that compounds used for plastic production are already ubiquitous in human blood and cells. Major sources of chemical pollutants are polychlorinated biphenyls, dioxins, perfluorinated carboxylic acids, and perfluoroalkyl acids, which cause hepatotoxicity. Xenobiotic compounds are metabolised in the liver by the phase 1–3 detoxification system. Phase 1 consists of oxidation reactions to increase hydrophilicity of xenobiotics and facilitating extrusion. In phase 2, xenobiotics are coupled to transfer carrier molecules and in phase 3, xenobiotic compounds are transported out of liver cells for excretion out of the organism. Plastic debris-related pollutants induce cytochrome P450 monooxygenase isoenzyme 1A (CYP1A) phase 1 enzyme activity. Polychlorinated biphenyls, polychlorinated dibenzofurans, and polynuclear Threats to human health by great ocean garbage patches

Biopiracy versus one-world medicine – from colonial relicts to global collaborative concepts

BACKGROUND Practices of biopiracy to use genetic resources and indigenous knowledge by Western companies without benefit-sharing of those, who generated the traditional knowledge, can be understood as form of neocolonialism. HYPOTHESIS The One-World Medicine concept attempts to merge the best of traditional medicine from developing countries and conventional Western medicine for the sake of patients around the globe. STUDY DESIGN Based on literature searches in several databases, a concept paper has been written. Legislative initiatives of the United Nations culminated in the Nagoya protocol aim to protect traditional knowledge and regulate benefit-sharing with indigenous communities. The European community adopted the Nagoya protocol, and the corresponding regulations will be implemented into national legislation among the member states. Despite pleasing progress, infrastructural problems of the health care systems in developing countries still remain. Current approaches to secure primary health care offer only fragmentary solutions at best. Conventional medicine from industrialized countries cannot be afforded by the impoverished population in the Third World. Confronted with exploding costs, even health systems in Western countries are endangered to burst. Complementary and alternative medicine (CAM) is popular among the general public in industrialized countries, although the efficacy is not sufficiently proven according to the standards of evidence-based medicine. CAM is often available without prescription as over-the-counter products with non-calculated risks concerning erroneous self-medication and safety/toxicity issues. The concept of integrative medicine attempts to combine holistic CAM approaches with evidence-based principles of conventional medicine. CONCLUSION To realize the concept of One-World Medicine, a number of standards have to be set to assure safety, efficacy and applicability of traditional medicine, e.g. sustainable production and quality control of herbal products, performance of placebo-controlled, double-blind, randomized clinical trials, phytovigilance, as well as education of health professionals and patients.