This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, (...) we convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

Resources of professional companies operating on the medical services market contain data from a huge number of transactional documents. This allows them to collect and process, among other actions, information about medical products. Organized data is obviously more valuable. In this paper, the possibility of supporting the process of organizing information is considered, with the goal to extract values of attributes of medical products from brief descriptions in transactional documents. This helps to build a structured (...) product specification and makes it possible to make comparisons between products. For this purpose, an approach based on regular expressions and their generation with the use of the genetic algorithm is proposed. The results presented in the paper show a great potential of the presented method. (shrink)

The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.

Coreference resolution is the task of finding all expressions that refer to the same entity in a text. It is one of the higher level NLP (Natural Language Processing) tasks. It allows, for example, to extract more information about medical products from larger texts. A product such as ‘ambidextrous gloves’ may appear in a text in many different forms. For example, they could be referred to by the pronoun ‘they’, such as in this sentence. The algorithm presented in (...) this paper finds pronouns and for each of them (except the pleonastic ‘it’) it creates a coreference candidate with entities that appeared earlier in the same sentence or in the previous sentence. Each candidate (pair of mentions) is described by 48 binary features which represent their grammatical and location properties. In the training set, each pair is marked as a coreference or not, based on which a decision tree classifier is trained. A classifier with a high precision of 0.94 and a decent recall of 0.61 were obtained on the training set, still with a good precision out of a sample of 0.64. (shrink)

The recent focus on conflict of interest seriously misfires by fixating on monetary payoffs while ignoring all the other things that people care about, things that can bias their judgment and lead to wrongdoing. Wrongdoing should be the focus, not the temptations and motivations that sometimes result in it. This essay explores the evidence in support of strong regulations against conflict of interest, and I conclude that corruption fears have resulted in social-distancing policies of drug reps from physicians and they (...) have given us sharply constrained information markets. There is some evidence that this may be disadvantageous to patients. Information market restrictions do promote powerful political and corporate interests. Whether there are compensating benefits in reduced expenditures on drugs and devices remains to be seen. We can only hope that our institutional policies eventually will be revised in a manner that better respects physicians as sophisticated consumers of product marketing and holds them accountable for their choices not their motivational states. (shrink)

_The dynamic development of medical technologies, i.e. the use of medicinal products and medical procedures, requires reflection on the ways to ensure the safety of patients and people using such methods of treatment (medical professionals) in legal and ethical terms. This applies in particular to the currently observed influence of the media on the actions taken in the health care system in Poland as well as individual decisions of patients on the use of the offered drugs (...) and other medical procedures._ _The article presents selected legal provisions defining the conditions for the use of medicinal products (drugs) and experimental medical procedures. The basic element of the considerations is to indicate the legal conditions for this type of use of medical technologies understood in this way, also in a broader context – with the characteristics of ethical conditions for „the media message”, including ensuring its proper quality for the protection of public health._. (shrink)

The traditional researcher-driven environment of medical knowledge production is losing its dominance with the expansion of, for instance, community-based participatory or participant-led medical research. Over the past few decades, sociologists of science have debated a shift in the production of knowledge from traditional discipline-based to more socially embedded and transdisciplinary frameworks. Recently, scholars have tried to show the relevance of Mode 2 knowledge production to medical research. However, the existing literature lacks detailed clarifications on how a model (...) of Mode 2 knowledge production can be constructed in the context of medical research. This paper calls for such further clarifications. As a heuristic means, the advocacy for a controversial experimental stem cell therapy is examined. It is discussed that the example cannot be considered a step towards Mode 2 medical knowledge production. Nonetheless, the example brings to the fore some complexities of medical knowledge production that need to be further examined including: the shifting landscape of defining and addressing vulnerability of research participants, the emerging overlap between research and practice, and public health implications of revising the standard notions of quality control and accountability. (shrink)

A robust body of literature analyzes the shift of academic science toward more business-oriented models. This paper presents the findings of an empirical study investigating basic scientists’ attitudes toward publicly funded basic research at the Harvard Medical School and affiliated institutions. The study finds that scientists at the Harvard Medical School construe publicly funded basic research as inquiries that, whether use oriented or not, must be governed by the cognitive and social norms of the traditional mode of knowledge (...) production. They recognize that academic science is vulnerable to access by external capital but maintain that it remains distinct from research done in the private sector. Overall, the study demonstrates that important segments of academia have preserved a traditional approach to knowledge production, which is yet to be transformed by the entrepreneurial turn. (shrink)

Este trabajo está dirigido a fundamentar cómo a través de un proceso de innovación tecnológica se establecieron relaciones entre la universidad, la sociedad y el sector empresarial. La introducción de los productos biológicos en los laboratorios de diagnóstico médico y su impacto en los servicios fue el elemento fundamental que identificó la relación universidad-sociedad, mientras que la transferencia tecnológica de la obtención de biológicos a la unidad productora y comercializadora articuló a la academia con el mundo empresarial. Los modelos seguidos (...) para la gestión de la actividad de innovación le otorgaron al proceso un carácter específico y aseguraron su pertinencia, por lo que constituyó un logro científico-tecnológico. Se demostró un caso peculiar y concreto de fortalecimiento de las capacidades de interacción de las universidades con entidades productivas y de servicios, de modo que se enriqueció la función extensionista del centro de altos estudios. This article is based on a process of technical innovation that allowed establishing a relationship in which the university, society and the managerial sector were involved. The introduction of the biological products in medical diagnosis labs and its impact on services were the main elements that distinguished the university-society relationship, while the technological transfer to the unit of the biologicals obtained, articulated the university and the managerial field. Models put into practice for innovation management granted the process a specific character and ensured its relevance, that´s why it is considered a scientific-technological achievement. The process demonstrated a peculiar case of interaction between the university and production entities. (shrink)

The Vioxx drug recall and other cases of withdrawals of approved pharmaceutical products as a result of reports of serious harm to users indicate that there are many problems associated with the process of getting these products to the end user the ordinary person in the street. The problems include those related to drug/medical device research and development, clinical trials, presentation and publication of research results, approval by regulatory authorities, preparation of clinical practice guidelines, marketing of (...) class='Hi'>products by commercial companies and post-marketing surveillance. This article discusses threats to the integrity of each of these processes and argues that the steady stream of drug recalls indicates the existence of a systemic problem. It concludes with a discussion of possible solutions to these problems. (shrink)

This volume addresses the interdependencies between visual technologies and epistemology with regard to our perception of the medical body. It explores the relationships between the imagination, the body, and concrete forms of visual representations: Ranging from the Renaissance paradigm of anatomy, to Foucault's "birth of the clinic" and the institutionalised construction of a "medical gaze"; from "visual" archives of madness, psychiatric art collections, the politicisation and economisation of the body, to the post-human in mass media representations. Contributions to (...) this volume investigate medical bodies as historical, technological, and political constructs, constituted where knowledge formation and visual cultures intersect. Contributors are: Axel Fliethmann, Michael Hau, Birgit Lang, Carolyn Lau, Heikki Lempa, Stefanie Lenk, Joanna Madloch, Barry Murnane, Jill Redner, Claudia Stein, Elizabeth Stephens, Corinna Wagner, and Christiane Weller. (shrink)

This paper considers proposals for developing ‘co-productive’ medical partnerships, within the UK National Health Service (NHS), concentrating in particular on the potential problem involved in combining professional and lay conceptions of health. Much of the literature that advocates the introduction of co-productive healthcare partnerships assumes that medical professionals and patients share, or can easily come to share, a common set of beliefs about what is valuable with regard to health interventions and outcomes. However, a substantial literature documents the (...) contestability of the concept of health, particular across professional and lay divides. We suggest that this potential disagreement ought to be taken seriously, and suggest that the prospect of a co-productive NHS in which patients and professionals act in partnership is threatened by the existence of unresolved epistemic differences. We suggest that part of the solution may lie in re-framing this potential disagreement in the terms provided by Engel’s bio-psycho-social account of health, and demonstrate how support for this account can be grounded upon a critical realist foundation. What we call a ‘stratified conception of health’ reveals the potential complementarity between health beliefs which may have at first seemed to be essentially contradictory. We consider some of the practical implications this idea has for conceiving and creating co-productive medical partnerships. (shrink)

The nature of the product to be discovered guides the reasoning to discover it. Biologists and medical researchers often search for mechanisms. The "new mechanistic philosophy of science" provides resources about the nature of biological mechanisms that aid the discovery of mechanisms. Here, we apply these resources to the discovery of mechanisms in medicine. A new diagrammatic representation of a disease mechanism chain indicates both what is known and, most significantly, what is not known at a given time, thereby (...) guiding the researcher and collaborators in discovery. Mechanisms of genetic diseases provide the examples. (shrink)

The article reconsiders the nature and location of science in the development of genetic classification. Drawing on field studies of medical genetics, we explore how patient categorization is accomplished in between the clinic and laboratory. We focus on dysmorphology, a specialism concerned with complex syndromes that impair physical development. We show that dys-morphology is about more than fitting patients into prefixed diagnostic categories and that diagnostic process is marked by moments of uncertainty, ambiguity, and deferral. We describe how different (...) forms of evidence are brought into play and how patterns of physical features are identified as genetic or not. We suggest that clinical categorical work helps articulate the genetic as an emergent domain of medical classification and that moments of ambiguity and deferral create an imperative space that helps legitimate the need for more technoscience, and consequently, more clinical judgment with which to fix the genetic future. (shrink)

The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great strides have (...) been made in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research. (shrink)

This article examines some of the interactions between law, science, and society taking place during a trial. By focusing on a restricted set of scientific and nonscientific actors engaged in negotiating the meaning, relevance, and reliability of scientific evidence, the article illustrates how the categories—law, science, and society—are inextricably interrelated in the legal negotiations and outcome. The introduction of scientific evidence into adversarial legal settings produces strategies, opinions, and claims that are not shaped solely by scientists, lawyers, or legal processes. (...) The situated law-science negotiations provide a site where social order and scientific knowledges are mutually constituted. The outcome of specific law-science interactions will be open to a range of readings and constraints that are not reducible to some putatively correct scientific understanding nor adequately described as the distortion of scientific evidence by the legal system. (shrink)

The COVID-19 pandemic will generate vexing ethical issues for the foreseeable future and many journals will be open to content that is relevant to our collective effort to meet this challenge. While the pandemic is clearly the critical issue of the moment, it’s important that other issues in medical ethics continue to be addressed as well. As can be seen in this issue, the Journal of Medical Ethics will uphold its commitment to publishing high quality papers on the (...) full array of medical ethics. At the same time, JME aims to be a premiere home for ground-breaking scholarship on the ethical issues raised by COVID-19. Toward this end, we have a number of papers that are freely available online and for which production has been fast-tracked.1–5 A challenge for authors who want to write about the pandemic is the rapidly evolving nature of the situation and the time it takes for journal content to be reviewed and published, even when fast-tracked. For that reason, all authors who would like to submit a paper on the pandemic can also submit a post to the JME blog prior to submitting a full paper to the journal. Those interested in writing for the JME blog should contact one of its editors, Hazem Zohny or Mike King. Over the last 3 weeks, 30 high-quality commentaries on the pandemic have been posted to the blog. These posts are circulated widely via the JME Twitter and Facebook feeds and have stimulated significant …. (shrink)

Healthcare services should be provided according to contemporary ethical norms that require patients’ active engagement in all the relevant processes. However, authoritarian attitudes and behaviors in healthcare, one of which is paternalism, put patients in a passive role. But, as Avedis Donabedian emphasizes, patients are co-producers of care, reformers of healthcare, informants, and definers and evaluators of quality. Overlooking these significant functions and merely focusing on physicians’ benevolence due to their medical knowledge and skills in the production of healthcare (...) services would leave the fate of patients in the hands of clinicians and impose physicians’ hegemony on patients and their choices. Nevertheless, the concept of co-production is a practical and effective mechanism to redefine the language used in healthcare by recognizing patients as co-producers and equal partners. The application of co-production in healthcare would improve the therapeutic relationship, decrease ethical violations, and promote the patient’s dignity. (shrink)

The field of medicine is generally greeted with great enthusiasm. This can be witnessed in the immense support for medical progress, which is widely hoped to lead to a realization of idealized goals. Indeed, with the help of medicine the human body would be controllable and constructible, human nature perfectible. However, enthusiasm in favor of medical progress is first and foremost a sentiment and, like all sentiments, not necessarily a product of rational contemplation. People are capable of enthusing (...) about the realization of utopian notions, such as life without disease or with the perfect body, without requiring any concrete arguments to back them up. Enthusiasm alone is not a guarantee of ethical desirability, however. Hence, this book takes a closer look at four research fields often referred to in medical utopian literature: 'tissue engineering', 'bioelectronics', 'germ line genome modification' and 'interventions in the biological aging process'. They serve as a basis for analyzing whether ethical arguments can be found to support the euphoric advocacy of the further development of these fields. (shrink)

Conscious existence is the product of a neural brain mechanism, which is largely identical with Immanuel Kant's Oneness Function, a service performed by 200 million neurons in the prefrontal lobe, & makes possible our interior cosmos, the record of our interconnected, or general, experience. Essential for us humans is the well-being of our interior cosmos, or Saint Teresa of Avila's interior castle, in all interactions with each other \& the greater environment. Any disorders of our cosmos are liable to make (...) us fall ill, setting our existence on a path of psychosomatic etiology of a large class of mysterious undiagnosed diseases. (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 (...) 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)

Medical Humanities the journal started life in 2000 as a special edition of the JME. However, the intellectual taproots of the medical humanities as a field of enquiry can be traced to two developments: calls made in the 1920s for the development of multidisciplinary perspectives on the sciences that shed historical light on their assumptions, methods and practices; refusals to assimilate all medical phenomena to a biomedical worldview. Medical humanities the term stems from a desire to (...) situate the significance of medicine as a product of culture. But despite growing usage over half a century the term defies a unifying encapsulation and continues to conjure up a multitude of discourse communities, including scholars working at the interfaces of health and humanities, arts and health, and medical education and bioethics. The field is intellectually capacious and polymorphous, forming and reforming around critical new research questions and teaching tasks spanning disciplines. (shrink)

This article introduces the concept of economic medicalization where non-medical problems are transformed into medical problems in order to achieve the objective of corporate shareholder wealth maximization. Following an overview of the differences in ethical norms applicable to medical ethics and business ethics, the economic medicalization of medical research practice and publication is examined in some detail. This motivates a general discussion of the problems involved in the ethical approval process for medical research that balances (...) the interests of both business and government in the market for medical products and services. (shrink)

Emerging technologies such as artificial intelligence are actively revolutionizing the healthcare industry. While there is widespread concern that these advances will displace human practitioners within the healthcare sector, there are several tasks – including original and nuanced ethical decision making – that they cannot replace. Further, the implementation of artificial intelligence in clinical practice can be anticipated to drive the production of novel ethical tensions surrounding its use, even while eliminating some of the technical tasks which currently compete with ethical (...) deliberation for clinicians’ limited time. A new argument therefore arises to suggest that although these disruptive technologies will change the face of medicine, they may also foster a revival of several fundamental components inherent to the role of healthcare professionals, chiefly, the principal activities of moral philosophy. Accordingly, “machine medicine” presents a vital opportunity to reinvigorate the field of bioethics, rather than withdraw from it. (shrink)

Predictive medical information is used by underwriters to assess the future risk of a claim in medically based insurance products such as health, life, and disability insurance. Medical underwriting involves the science of evaluating medical information to determine the risk for groups of individuals with various medical conditions. In disability insurance, this involves an evaluation of medical information to predict the risk of becoming disabled.Before discussing medical underwriting, an understanding of certain terms used (...) by disability insurance companies and the products that are available is required. The first is the definition of disability. The Americans with Disabilities Act defines disability as the following:A physical or mental impairment that substantially limits one or more of the major life activities; or has a record of such an impairment; or is regarded as having such an impairment even when no impairment exists, no substantial limitation results from the impairment, or the impairment is only substantially limiting because of the attitudes of others. (shrink)

Porcine-derived medical products represent an effective solution for a wide range of human suffering, yet this may contradict Muslim and Jewish religious prohibitions against consuming pig. The present study evaluated the level to which Muslim and Jewish participants are knowledgeable about the conditions permitting porcine-based treatments and explored their attitudes toward the permissibility of these treatments. A questionnaire that presented fifteen medical uses of porcine-derived products was completed by 809 Muslims and 714 Jews. Neither Muslim nor (...) Jewish participants are knowledgeable about the religious rulings of their religions which permit the use of pig for life saving. Participants of both groups objected to the view that porcine-derived materials should be permitted. The findings imply that the attitude toward porcine-derived materials for medical use is contingent upon the knowledge or lack thereof that individuals have regarding the permissibility of such use. We offer useful recommendations to improve the informed consent process before conducting porcine-based treatments. (shrink)

Personal medical information is now bought and sold on the open market. Companies use it to make hiring and firing decisions and to identify customers for new products. The justification for providing such access to medical information is that doing so benefits the public by securing public safety, controlling costs, and supporting medical research. And individuals have supposedly consented to it. But we can achieve the common goods while better protecting privacy by making institutional changes in (...) the way information is maintained and protected. (shrink)

This paper addresses the changing ideology regarding reproduction, an evolving American, and potentially worldwide, value system regarding children and parenthood. Children are increasingly being seen as products, and the new technology of reproduction, including the sale of reproductive material and services and especially prenatal diagnosis and selective abortion, encourage this commodification of the fetus. While the new technology does indeed offer new choices, it also creates new structures and new limitations on choice. In the contemporary American social structure, these (...) choices are inevitably couched in terms of production and commodification, and thus do not offer individuals genuine choice or control. (shrink)

This article considers the issue of expanded access to innovative treatments in the context of recent legislative initiatives in the United Kingdom and the United States. In the United Kingdom, the supporters of legislative change argued that the common law principles governing medical negligence are a barrier to innovation. In an attempt to remove this perceived impediment, two bills proposed that innovating doctors sued for negligence should be able to rely in their defence on the fact that their decision (...) to innovate was “responsible.” A decision to innovate would be regarded as responsible if it followed a specified process. Although these changes to the law of medical negligence were not passed, this article argues that the idea of a process-based approach was sound. In the United States, a number of states have passed “Right to Try” laws that permit doctors to prescribe and companies to provide investigational products without the need for FDA approval. These laws do not purport to and nor are they able to alter the obligations of individuals and companies under federal law. They are consequently unlikely to achieve their stated aim of expanding access to investigational products. This article argues that they nevertheless have a cogent rationale in so far as they highlight the need for rights-based reform to federal regulations governing access. (shrink)

This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that (...) has developed since the 1960s. In general product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility a product is harmful, whereas establishing liability in litigation requires proving that the product was actually harmful.As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control. (shrink)

The article depicts the traditional fishing, the outdoor drying of Stockfish, and its cultural and culinary uses in a historic context and today. The fishing of the North East Arctic cod (Gadus morhua) is a sustainable coastal fishery for millennia in the North of Norway, but climate change challenges the outdoor drying of stockfish. The article follows the stockfish history during the hanseatic office in Bergen until the present trade. The early commercial production of stockfish was due to urban expansion, (...) fasting rules and the need to provide nutritious food to the poor in Northern Europe and beyond. The article follows the traces of stockfish expansion as a staple food, first to Northern Europe, later to central Europe and the Mediterranean countries, before ending up as an important food supply to West-African countries in the nineteenth century. The article explains the early Greek and Renaissance concerns for eating fish and for stockfish in particular due to dietetic and medical beliefs. Then the cultural impact of stockfish is explained by showing some examples of both living and disappearing culinary traditions. The use of lye for soaking stockfish is not only a Scandinavian tradition but a little known shared European craft and culinary practice. Battering the stockfish with a wooden hammer, the use of lye for durability and water for softening the hard fish texture was practiced for preparing stockfish. Finally, the article touches upon rules, regulations and organisations that can help strengthening and preserve the traditional craft and culinary uses of stockfish today. (shrink)

This article is an examination of the Augsburg physician Ieremias Martius’s Catalogus bibliothecae of 1572, which may well by the first printed sales catalogue of a library. The author claims it to be the product of careful selection, covering the whole field of medicine and containing both rare and recent medical books. The catalogue is placed here in the context of Martius’s career, and his contacts in the European medical world. An account is given of the bibliographical resources (...) available to him, before the contents themselves are anatomised. His interest in various fields is revealed here: medieval practical medicine, medical humanism, anatomy, Hippocratism, medical observationes and letter collections, gynecology, astrological medicine, balneology, botany, and the literature of medical secrets. Martius’s eclecticism and open-mindedness is revealed further through a comparison of his library with five other contemporary book collections of doctors. (shrink)

This essay applies Henri Lefebvre’s notion of the production of space, particularly his conceptualization of the tension formed by the perceived-conceived-lived triad to analyze how space is produced in wartime hospitals as demonstrated in Richard Selzer’s “The Whistlers’ Room.” Wounded soldiers participate in producing the triad of the social space of military hospitals through their multilayered performances as fighting soldiers serving the nation and as living human beings longing for human connections. Contradictory performances demonstrate the strategic positioning of wounded soldiers (...) as active producers of different social spaces. By representing the lived spaces produced by wounded soldiers, Selzer challenges the hegemonic representations of the conceived spaces of military hospitals. Selzer’s exploration of soldiers’ contradictory performances opens up opportunities for discussion of writing physicians who assume a similar role by positioning themselves strategically within the medical institution. (shrink)

Early practitioners of the social studies of science turned their attention away from questions of institutionalisation, which had tended to emphasize macrolevel explanations, and attended instead to microstudies of laboratory practice. The author is interested in re-investigating certain aspects of institution formation, notably the formation of scientific, medical, and engineering disciplines. He emphasises the manner in which science as cultural practice is imbricated with other forms of social, political, and even aesthetic practices. The author considers the following topics: the (...) organic physics of 1847; the innovative research program of Carl Ludwig as a model for institutionalising science-based medicine, optics, painting, and ideology in Germany, 1845-95; the Haber-Bosch synthesis of ammonia; and the introduction of nuclear magnetic resonance instrumentation into the practice of organic chemistry. (shrink)

During the last decades, shared decision making (SDM) has become a very popular model for the physician-patient relationship. SDM can refer to a process (making a decision in a shared way) and a product (making a shared decision). In the literature, by far most attention is devoted to the process. In this paper, I investigate the product, wondering what is involved by a medical decision being shared. I argue that the degree to which a decision to implement a (...) class='Hi'>medical alternative is shared should be determined by taking into account six considerations: (i) how the physician and the patient rank that alternative, (ii) the individual preference scores the physician and the patient (would) assign to that alternative, (iii) the similarity of the preference scores, (iv) the similarity of the rankings, (v) the total concession size, and (vi) the similarity of the concession sizes. I explain why shared medical decisions are valuable, and sketch implications of the analysis for the physician-patient relationship. (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)

“It is less a matter of happiness and unhappiness than of darkness and light: one does not consist in a pure and simple privation of the other.” In contrast to Condillac, Diderot begins with the recognition of the mutually reflexive character of the state of suffering, which is independent of an alternation of pleasure and pain. Or rather, the painful state is spontaneously devalued without any invocation of a hypothetical state of constant happiness. The emergence of an affirmation of physical (...) pain belongs to the condition of the living being and assumes an immediate conceptualization of suffering, even in the imaginary state of an eternal suffering. For Diderot, questioning the meaning of existence goes hand in hand with this innate and unconditioned positing of an unhappy state. Such a postulate makes it more difficult to maintain the stereotypical view that the materialist attitude is one of indifference. Recognizing the necessary laws of matter and identifying disorders as rational productions does not amount to saying that whatever turns out to be necessary is in fact allowable. Matter conditions the constitution of morality, feelings, and thoughts. The human being, however, displays signs of revolt, as well as a capacity to adjust to his deficient states by drawing on the universal tendency of living beings to complicate the necessity of determining what is preferable and rejecting what is painful. To persevere in one’s being, and thereby lay down conditions for an assent to existence, is thus to weaken the pessimism of a blind necessitarianism. The establishment of a natural and material axiology then allows one to grasp the metaphysical implications of this medically grounded vitalism. (shrink)

As the functional capabilities of high-tech medical products converge, supplying organizations seek new opportunities to differentiate their offerings. Embracing product sustainability-related differentiators provides just such an opportunity. This study examines the challenge organizations face when attempting to understand how customers perceive environmental and social dimensions of sustainability by exploring and defining both dimensions on the basis of a review of extant literature and focus group research with a leading supplier of magnetic resonance imaging (MRI) scanning equipment. The study (...) encompasses seven hospitals and one private imaging center in the Netherlands and identifies five social aspects that cover 11 indicators. The authors conduct 22 customer perception interviews with key decision-making stakeholders involved in purchasing MRI scanning equipment. Respondents find environmental and social sustainability dimensions personally relevant but professionally secondary to cost, performance, and ability to use the equipment in their organizations' physical infrastructure. Finally, incorporating a product's environmental and social credentials within the marketing of MRI scanning equipment enhances the perception of the product offering in decisionmaking stakeholders' minds and provides a means of differentiation. (shrink)

Medicines and medical devices containing animal-derived ingredients are frequently used on patients without their informed consent, despite a significant proportion of patients wanting to know if an animal-derived product is going to be used in their care. Here, I outline three arguments for why this practice is wrong. First, I argue that using animal-derived medical products on patients without their informed consent undermines respect for their autonomy. Second, it risks causing nontrivial psychological harm. Third, it is morally (...) inconsistent to respect patients’ dietary preferences and then use animal-derived medicines or medical devices on them without their informed consent. I then address several anticipated objections and conclude that the continued failure to address this issue is an ethical blind spot that warrants applying the principles of respect for autonomy and informed consent consistently. There are no data in this work. (shrink)

Medicine is arriving at a new millenium. One of its most urgent tasks is to reconcile social health demands with a renewed medical paradigm capable of including them. This challenge requires a reexamination of the definition of medicine.This work takes up the original greek definition of medicine (Tekhne Iatrike) and the Medical Act according to P. Lain Entrago, and analyzes Heidegger's interpretation of Tekhne. It points out the two main ways in which current medical practice is sustained: (...) the Instrumental Medical Act (IMA), which organizes medical production, and the Productive Medical Act (PMA), which motivates it. (shrink)

Rationale In Belgium, several policies regulating reimbursement of acid suppressant drugs and evidence-based recommendations for clinical practice were issued in a short period of time, creating a unique opportunity to observe their effect on prescribing. Aims and objectives To describe the evolution of prescriptions for acid suppressants and explore the interaction of policies and practice recommendations with prescribing patterns. Method Monthly claims-based data for proton pump inhibitors (PPIs) and H-2-antihistamines by general practitioners, internists and "astroenterologists were obtained from the Belgian (...) national health insurance database (1997-2005). The evolution of reimbursed defined daily doses and expenses after introduction of reimbursement regulations and dissemination of practice recommendations was explored. Results Recommendations had no impact on prescribing. All changes can be related to concomitant policies. Lifting reimbursement restrictions for cheaper products did not control growth or save costs in the Iona term. Only restricting reimbursement of all PPIs managed to curb the growth. We observed an unintended increase of non-omeprazole PPIs by gastroenterologists. Conclusions Reimbursement policies influence prescribing, but their effect can be unintended. A dialogue between policymakers and guideline developers, and evidence-based policies that are linked to clinical guidelines, could be an effective way to pursue both cost-containment and quality of care. (shrink)

Background: Research activities in sub-Saharan Africa may be limited to delegated tasks due to the strong control from Western collaborators, which could lead to scientific production of little value in terms of its impact on social and economic innovation in less developed areas. However, the current contexts of international biomedical research including the development of public-private partnerships and research institutions in Africa suggest that scientific activities are growing in sub-Saharan Africa. This study aims to describe the patterns of clinical research (...) activities at a sub-Saharan biomedical research center. Methods: In-depth interviews were conducted with a core group of researchers at the Medical Research Unit of the Albert Schweitzer Hospital from June 2009 to February 2010 in Lambarene, Gabon. Scientific activities running at the MRU as well as the implementation of ethical and regulatory standards were covered by the interview sessions. Results: The framework of clinical research includes transnational studies and research initiated locally. In transnational collaborations, a sub-Saharan research institution may be limited to producing confirmatory and late-stage data with little impact on economic and social innovation. However, ethical and regulatory guidelines are being implemented taking into consideration the local contexts. Similarly, the scientific content of studies designed by researchers at the MRU, if local needs are taken into account, may potentially contribute to a scientific production with long-term value on social and economic innovation in sub-Saharan Africa. Conclusion: Further research questions and methods in social sciences should comprehensively address the construction of scientific content with the social, economic and cultural contexts surrounding research activities. (shrink)

Porcine-derived products serve as an effective solution for a wide range of human ailments; however, there may be objections to their use due to Islamic religious prohibitions on consuming products derived from pigs. In order to enhance the cultural competence of medical practitioners who treat Muslim individuals, which constitute about one fifth of the world population, this study aimed at evaluating the knowledge and positions of Muslim patients on this subject. A questionnaire presenting 15 uses of porcine-derived (...) materials was filled out by 809 Muslims. The level of knowledge about the permissibility of these uses and participants’ position on whether it should be approved was assessed. Findings show that Muslims are not familiar with Islamic religious jurisprudence that permits the use of porcine products to save lives after it has undergone an essential transformation known as Istihala. The respondents expressed a negative attitude towards the medical use of porcine-derived substances based on imprecise knowledge about the permissibility of use of porcine-derived materials, devices and treatments. We offer recommendations for improving the informed consent obtained from Muslim patients prior to conducting porcine-based treatments. (shrink)