Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of the (...) ethical standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation. (shrink)

This article discusses the misalignment of the drug innovation model in the US with broader societal goals. The paper calls for a reconfiguration of this model to prioritize the common good and ensure equitable access to health innovations. The article stresses the importance of adopting a mission-oriented approach to shape the drug market, including reforming intellectual property rights.

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)

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs and the use of biological (...) therapeutics, stem cell-based therapies will have to pass through a series of controlled studies — initially to assess safety and toxicity, then efficacy and comparative efficacy — before they can be justifiably administered to patients outside a clinical trials context. (shrink)

This special JLME symposium addresses ways that federal policy can incentivize innovation in medical therapeutics and make pharmaceuticals more financially accessible.

This compact and innovative book tackles one of the central issues in drug policy: the lack of a coherent conceptual structure for thinking about drugs. Drugs generally fall into one of seven categories: prescription, over the counter, alternative medicine, common-use drugs like alcohol, tobacco and caffeine; religious-use, sports enhancement; and of course illegal street drugs like cocaine and marijuana. Our thinking and policies varies wildly from one to the other, with inconsistencies that derive more from cultural and social (...) values than from medical or scientific facts. Penalties exist for steroid use, while herbal remedies or cold medication are legal. Native Americans may legally use peyote, but others may not. Penalties may vary for using different forms of the same drug, such as crack vs. powder cocaine. Herbal remedies are unregulated by the FDA; but medical marijuana is illegal in most states. Battin and her contributors lay a foundation for a wiser drug policy by promoting consistency and coherency in the discussion of drug issues and by encouraging a unique dialogue across disciplines. The contributors are an interdisciplinary group of scholars mostly based at the University of Utah, and include a pharmacologist, a psychiatrist, a toxicologist, a trial court judge, a law professor, an attorney, a diatary specialist, a physician, a health expert on substance abuse, and Battin herself who is a philosopher. They consider questions like the historical development of current policy and the rationales for it; scientific views on how drugs actually cause harm; how to define the key notions of harm and addiction; and ways in which drug policy can be made more consistent. They conclude with an examination of the implications of a consistent policy for various disciplines and society generally. The book is written accessibly with little need for expert knowledge, and will appeal to a diverse audience of philosophers, bioethicists, clinicians, policy makers, law enforcement, legal scholars and practitioners, social workers, and general readers, as well as to students in areas like pharmacy, medicine, law, nursing, sociology, social work, psychology, and bioethics. (shrink)

The dangers presented by antibiotic resistance have now established themselves as a global health security issue. From an international policy perspective, three key pillars have been established: responsible access, conservation, and innovation. These pillars are intrinsically linked, meaning that any attempt to address one must take into account the implications for the other two.An urgent need exists to address the innovation failure in ABR. In the field of anti-bacterials, the pipeline remains anemic in terms of therapeutics with (...) novel mechanisms of action, new drug classes and strategies involving radically different, innovative approaches. The key reasons for this failure have already been well established. The slow development of new antibiotics is the result of a poor and uncertain commercial market and scientific challenges in research and development. (shrink)

Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that (...) flow from clinical trials — whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) — are open to outside scrutiny. Further, a jurisprudence of drug regulation is needed. I develop two arguments motivated by (1) innovation concerns and (2) the value of good governance in support of openly publishing all final decisions for approved, abandoned, refused, and withdrawn products. After articulating why greater transparency in regulatory decision-making is needed, I distil four essential features of a jurisprudence of drug regulation that prescribe policy changes in terms not only of the transparency of regulatory outcomes and the underlying reasoning, but also regulatory organization. (shrink)

The controversy over the prescription drug, alosetron, is examined in order to investigate what is permitted to count as ‘therapeutic advance’ and ‘therapeutic breakthrough’ within pharmaceutical innovation and regulation. It is argued that those official accounting categories can mask very modest efficacy of some drugs by reference to the official techno-scientific evidence, thus leading to questionable acceptance of risks to public health. This is explained by: the drug availability options set by the commercial interests of manufacturers; the (...) FDA management's need to demonstrate rapid approval of therapeutic advances to their budgetary masters, especially in the context of patient demands for access to new drugs; and the increasing capacity of patient groups, sometimes in collaboration with pharmaceutical manufacturers, to challenge techno-scientific expertise and evidence with experiential testimony. It is concluded that regulatory policy-makers need much more sophisticated accounting systems for differentiating between drugs defined as significant therapeutic advances, and between drugs (‘therapeutic breakthroughs’ fast-tracked to treat serious or life-threatening conditions. Contrary to some STS analyses, the desirability of an ascendancy of patients’ anecdotal evidence in regulatory decisions for public health is questioned. (shrink)

Train crashes cause, on average, a handful of deaths each year in the UK. Technologies exist that would save the lives of some of those who die. Yet these technical innovations would cost hundreds of millions of pounds. Should we spend the money? How can we decide how to trade off life against financial cost? Such dilemmas make public policy is a battlefield of values, yet all too often we let technical experts decide the issues for us. Can philosophy (...) help us make better decisions? Ethics and Public Policy: A Philosophical Inquiry is the first book to subject important and controversial areas of public policy to philosophical scrutiny. Jonathan Wolff, a renowned philosopher and veteran of many public committees, such as the Gambling Review Body, introduces and assesses core problems and controversies in public policy from a philosophical standpoint. Each chapter is centred on an important area of public policy where there is considerable moral and political disagreement. Topics discussed include: Can we defend inflicting suffering on animals in scientific experiments for human benefit? What limits to gambling can be achieved through legislation? What assumptions underlie drug policy? Can we justify punishing those who engage in actions that harm only themselves? What is so bad about crime? What is the point of punishment? Other chapters discuss health care, disability, safety and the free market. Throughout the book, fundamental questions for both philosopher and policy maker recur: what are the best methods for connecting philosophy and public policy? Should thinking about public policy be guided by an ‘an ideal world’ or the world we live in now? If there are ‘knock down’ arguments in philosophy why are there none in public policy? Each chapter concludes with ‘Lessons for Philosophy’ making this book not only an ideal introduction for those coming to philosophy, ethics or public policy for the first time, but also a vital resource for anyone grappling with the moral complexity underlying policy debates. (shrink)

Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC investigative document (...) is reviewed along with standard literature on clinical ethics and clinical data about glioblastoma multiforme (GBM) cancer. Results In this paper I argue that, by tendentiously focusing on policies, regulations, and procedures governing human subjects research, the UCDMC investigation failed to account for the centrality of clinical judgment and clinical ethics pertinent to judicious review of this matter, especially given the unique clinical context of terminally ill patients having exhausted standard care treatment options for glioblastoma multiforme (GBM) cancer. Conclusions The UCDMC investigation raises serious problems for clinicians who are engaged in innovative therapy in the clinical setting, requiring a regulatory framework separate from the normal Institutional Review Board (IRB) process. (shrink)

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for (...) class='Hi'>drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation. (shrink)

This study uses a Corpus Assisted Discourse Studies methodology to provide the first systematic analysis of how trust is discursively constructed in crypto-drug markets. The data come from two purpose-built corpora. One comprises all the forum messages posted on the flag ship crypto-drug market Silk Road during the years in which it traded on the hidden net. The other corpus comprises all the reports published by the United Nations Office on Drugs and Crime during the same period. Our (...) analysis of trust focuses on the identities of those buying and selling drugs. The findings reveal that the Silk Road community members regularly discussed vendors’ identities alongside a continuum of trust–risk calculation, explicitly identifying both ‘good’ and ‘bad’ practices and hence engaging in self-regulatory discourses, and mainly constructed drug users’ identities in relation to values of expertise, integrity and benevolence. The findings also suggest that hard law enforcement activity, such as crypto-drug market closure, may encourage technological innovation within these markets. Moreover, our results show a disconnect between the discursive reality of the policy-making documents we examined and the very crypto-drug markets that they seek to legislate. (shrink)

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and (...) interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

This special edition ofJLMEcenters on a novel proposal for a national PrEP access program with the potential to break through a failed status quo.

Drawing on Sir Ian Kennedy's extensive experience in healthcare law, ethics and public policy-making, this book explores vital issues in the law surrounding healthcare and regulation. The book contains a range of published and unpublished essays and speeches with the addition of notes and commentaries by the author that bring the pieces up to the present day. Those who want to understand developments, from transplants to confidentiality, from COVID-19 to public inquiries to regulation will find a rich seam of (...) rigorous, informed analysis. The author's unique range of experience allows him to share insights on a variety of issues; from the conduct of the disgraced breast surgeon, Ian Paterson, to research at Porton Down, to the economics of innovation in drug development at NICE. His abiding interest in the welfare of children informs his trenchant forensic examination of how children fare in the NHS. Those involved in or with an interest in law, moral philosophy, and public policy will find much food for thought. (shrink)

The third of five commentaries on “Bloomberg's Health Legacy: Urban Innovator or Meddling Nanny?” from the September‐October 2013.

This study focuses on taxonomic and typological methods of innovation policies in the European institutional context. Although many types of policies affect innovation, no universally accepted criteria exist to classify them. As innovation policy in a myriad of thematic areas—systemic model—has become pluralized, this article offers a method for classification. Such policies are grouped and categorized according to biological and neofunctional approaches.

In a knowledge-based economy, the role of regions is regarded as very significant for creating and dispersing knowledge. Particularly, geographical clusters of firms in a single sub-national region and cross-border regions may contribute to transmitting certain kinds of knowledge between and among firms. In addition, markets prefer to favor specialized firms with a coherent body of knowledge when knowledge creation and the use of new knowledge become increasingly important for maintaining and improving a firm’s competitiveness. This means that regional (...) class='Hi'>policy makers may not interfere directly with markets and firms when the process of globalization pushes national economies into a world of learning and innovation because the institutional framework for market exchange favors knowledge exchange in a globalizing economic system. This paper argues how a cross-border cluster in the Öresund region between Denmark and Sweden has been created, and which strategies it focuses on in order to strengthen its competitiveness and to generate a further development that aims to become a global innovative cluster. Moreover, it discuses whether the Nordic cross-border cluster, the Medicon Valley is a unique approach in the EU context or not. Finally, it argues how it has created technology innovation as well as contributed to the regional economic growth. (shrink)

This symposium of the Journal of Bioethical Inquiry illustrates structural competency: how clinical practitioners can intervene on social and institutional determinants of health. It will require training clinicians to see and act on structural barriers to health, to adapt imaginative structural approaches from fields outside of medicine, and to collaborate with disciplines and institutions outside of medicine. Case studies of effective work on all of these levels are presented in this volume. The contributors exemplify structural competency from many angles, from (...) the implications of epigenetics for environmental intervention in personalized medicine to the ways clinicians can act on fundamental causes of disease, address abuses of power in clinical training, racially desegregate cities to reduce health disparities, address the systemic causes of torture by police, and implement harm-reduction programs for addiction in the face of punitive drug laws. Together, these contributors demonstrate the unique roles that clinicians can play in breaking systemic barriers to health and the benefit to the U.S. healthcare system of adopting innovations from outside of the United States and outside of clinical medicine. (shrink)

This article investigates the distribution of power in Poland’s drug reimbursement policy in the early 2000s. We examine competing theoretical expectations suggested by neopluralism, historical institutionalism, corporate domination, and clique theory of the post-communist state, using data from a purposive sample of 109 semi-structured interviews and documentary sources. We have four concrete findings. First, we uncovered rapid growth in budgetary spending on expensive drugs for narrow groups of patients. Second, to achieve these favorable policy outcomes drug (...) companies employed two prevalent methods of lobbying: informal persuasion of key members of local cliques and endorsements expressed by patient organizations acting as seemingly independent “third parties.” Third, medical experts were co-opted by multinational drug companies because they relied on these firms for scientific and financial resources that were crucial for their professional success. Finally, there was one-way social mobility from the state to the pharmaceutical sector, not the “revolving door” pattern familiar from advanced capitalist countries, with deleterious consequences for state capacity. Overall, the data best supported a combination of corporate domination and clique theory: drug reimbursement in Poland was dominated by Western multinationals in collaboration with domestically based cliques. (shrink)

This paper uses basic concepts from sociological process theory to assess new forms of public management in innovation policy and their relevance to business strategy. We describe this policy process as chains of events, outcomes, and re-coupling. It is argued that these process sequences occur in three analytically separate domains, namely the social, the cultural, and the cognitive domain. The paper identifies three collective learning variables of cooperation, collectivity, and content, to arrive at an explanatory scheme to (...) systematically investigate business strategy in complex process dynamics. (shrink)

This article contributes to an emerging literature on the “neo” or “entrepreneurial” developmental state that emphasizes the role of innovation policy in promoting the structural transformation of industry. It finds further evidence that supports this approach and advances it by making two unique contributions. First, it highlights an essential yet underappreciated feature of contemporary innovation policy: the state’s capacity to condition public assistance and discipline private firms that do not adhere to government guidelines. These capacities are (...) necessary to guarantee that the benefits of public investment in innovation—the social and economic spillovers—are not appropriated by private actors but shared more broadly within society. Second, it highlights that politics—reflected in the relations between innovation agencies and key social actors—represents an important causal factor in both the formation and subsequent transformation of these institutional capacities. These points are illustrated through a historical analysis of a crucial case: the state-led development of Israel’s thriving high-tech sector. (shrink)

Industrial policy is a highly controversial issue. The European Union (EU) justifies its industrial policy on the grounds of common problems across countries, its capacity to coordinate and reduce duplication of efforts, its capacity to control and limit member-state subsidies to industries, and its mandate for foreign trade and competition policy. Technology policy has been relatively successful in certain fields such as telecommunications or traffic control systems. In other fields, such as microelectronics and computers, the results (...) have been mixed. Formulating a coherent industrial policy remains a highly complicated venture because there are a number of conflicts that are difficult to resolve. This article attempts to review the role and the implementation of industrial and innovation policies in the EU. Moreover, it will attempt to examine and analyze the effects of these policies on convergence and cohesion for the European member-states. (shrink)

Since its introduction in the 1980s, use of the innovation systems conceptual approach has been growing, particularly on the part of national governments including, recently, the Hong Kong Government. In 2004, the Hong Kong Government set forth a ‘‘new strategy’’ for innovation and technology policy making. Because it marked a significant break from the past, it was necessary to convince a wider audience to accept this new strategy, a strategy that included the IS conceptual approach. Adopting a (...) science and technology studies perspective, I show how the IS conceptual approach is being used as a rhetorical resource by the Hong Kong Government in its innovation and technology policy making in an effort to persuade its perceived audience of the efficacy of its new strategy for its policies—policies that are in fact unrelated to the basic precepts of the IS conceptual approach. The case provides a cautionary tale in the ways in which policy makers transform scholarly work and scientific discovery into rhetorical instruments in support of a political agenda. (shrink)

Contemporary developed western economies are commonly referred to as ?knowledge-based? economies, which compete through drawing on the innovative and creative capacities of their local populations. Economic policy-makers must invest in and conserve the social, cultural and public resources that underpin dynamic and disruptive competitive activities, namely technological innovation and entrepreneurship, which bring new ideas and products to market. But these resources defy orthodox forms of economic knowledge and quantification. Their trajectories and outcomes are intrinsically uncertain. The paper draws (...) on interviews with experts who advise governments on innovation and competitiveness, to understand what expert strategies are used to deal with this epistemological problem. Such experts must project and retain epistemological authority, but without lapsing too far into quantitative, economistic and bureaucratic forms of reason. The paper identifies three ways in which knowledge of the future can be validated, but without disguising uncertainty: it can be presented as practically useful; as aesthetically appealing; and as hinting at some ?ultimate? form of ontological knowledge. (shrink)

It is a commonplace of the critical innovation literature that experiment has replaced mass production as the driving force of accumulation. But while many theorists have explored the politics and dynamics of such economies of experiment under the rubric of ‘immaterial’, cognitive or affective labour, few have examined the intersection of labour, experiment and the speculative in the clinic. Taking the clinic as representative of contemporary transformations in the commodity-form, labour and innovation, this article will look at recent (...) attempts to reform the clinical trial, arguing that these developments represent a far-reaching shift in our understanding of medicine. First, I investigate recent efforts (associated with the discourse of ‘translational medicine’) to rethink the interface between experimental lab-based science and the clinic. I also look at closely associated efforts to reintroduce an element of experimental surprise into the clinical trial process itself, through the adoption of novel trial designs. If the randomized controlled trial was conceived essentially along the lines of a product testing procedure, recent efforts have attempted to reintroduce surprise into the testing process itself – in other words, to invent a trial process capable of producing unexpected events as leads for further innovation. I then move from the experimental clinic to what I call the distributed experiment. Here I focus on efforts to outsource pharmacological innovation to a distributed public of patients through the use of social networking software. These platforms allow drug developers to escape the limits of the conventional clinical trial by tracking the experimental practices taking place in the distributed clinic of unregulated drug consumption. (shrink)

Purpose of this article is to introduce the concept of a new cultural institution, "medialab". Media laboratory is an interdisciplinary institution that combines the tasks of scientific, educational, cultural and artistic institutions. They are spaces in which technology and digital media are designed. Article introduces the main features of medialabs and possible public tasks in the field of regional cultural policy and innovation policy. It also draws attention to the challenges and barriers in the organization and management (...) of these centers. (shrink)

Gender mainstreaming has been prioritised within the national agricultural policies of many countries, including Nepal. Yet gender mainstreaming at the national policy level does not always work to effect change when policies are implemented at the local scale. In less-developed nations such as Nepal, it is rare to find a critical analysis of the mainstreaming process and its successes or failures. This paper employs a critical gender analysis approach to examine the gender mainstreaming efforts in Nepal as they move (...) from agricultural policies to practices. The research involved a structured review of 10 key national agricultural policy documents, 14 key informant interviews, and two focus group discussions with female and male smallholder farmers. Results suggest that gender mainstreaming in national agricultural policy and practice has largely failed. The creation of the Gender Equity and Social Inclusion (GESI) section within the Ministry of Agriculture and Livestock Development is paradoxical to gender-responsive agricultural innovation because it has received limited human and financial resources with an expectation for women to manage this policy development in informal and largely unrecognized ways. At the regional and local levels, implementation of fundamental gender equity and social inclusion procedures—such as gender-responsive planning and budgeting—has become staff responsibility without requisite formal training, gender sensitization, and follow-up. In Nepal, women as smallholder farmers or agricultural labourers are recognized as a vulnerable group in need of social protection, but the welfare approach to gender mainstreaming has achieved little in terms of gender equity, social inclusion, and agricultural sustainability. This paper concludes that what is generally missing is a systemic transformation of gender roles and relations in agriculture, with policies that would support rural women's empowerment through the provision of economic and political rights and entitlement to productive resources. (shrink)

Drawing on a documentary analysis of two socioeconomic policy programs, one Flemish (“Vlaanderen in Actie”), the other Walloon (“Marshall Plans”), and a discourse analysis of how these programs are received in one Flemish and one Francophone quality newspaper, this article illustrates how Flanders and Wallonia both seek to become top-performing knowledge-based economies (KBEs). The article discerns a number of discursive repertoires, such as “Catching up,” which policy actors draw on to legitimize or question the transformation of Flanders and (...) Wallonia into KBEs. The “Catching up” repertoire places Flanders resolutely ahead of Wallonia in the global race toward knowledge, excellence, and growth, but suggests that Wallonia may, in due course, overtake Flanders as a top competitive region. Given the expectations and fears that “Catching up” evokes among Flemish and Walloon policy actors, the repertoire serves these actors as a flexible discursive resource to make sense of, and shape, their collective futures and their regional identities. The article’s findings underline the simultaneity of, and the interplay between, globalizing forces and particularizing tendencies, as Flanders and Wallonia develop with a global KBE in region-specific ways. (shrink)

This volume was initiated to meet the challenges of the increasing contemporary trend to "treat" substance users (in the broadest sense of this concept), whether in institutional settings, ambulatory programs, or even controlled environments such as prisons. Although several essays concentrate more particularly on some of the ethico-moral problems encountered by juridico-moral interventions--problems relating to criminalization, decriminalization, legalization, and interdiction--the main focus is on broadly medical or therapeutic responses to drug use, and in particular on problems encountered within the (...) domain of drug user counseling. Codes of ethics for drug user counselors can be found as an appendix. (shrink)

BackgroundNurse champions are front-line practitioners who implement innovation and reconstruct policy.PurposeTo understand through a network theory lens the factors that facilitate nurse champions’ engagement with radical projects, representing their actions as street-level bureaucrats.Materials and methodsA personal-network survey was employed. Ninety-one nurse champions from three tertiary medical centers in Israel participated.FindingsGiven high network density, high levels of advice play a bigger role in achieving high radicalness compared with lower levels advice. High network density is also related to higher radicalness (...) when networks have high role diversity.DiscussionUsing an SLB framework, the findings suggest that nurse champions best promote adoption of innovation and offer radical changes in their organizations through professional advice given by colleagues in their field network. Healthcare organizations should establish the structure and promote the development of dense and heterogeneous professional networks to realize organizations’ goals and nurses’ responsibility to their professional employees, patients, and society. (shrink)

“Female sexual dysfunction” is the type of contested disease that has sparked concern about the role of the pharmaceutical industry in medical science. Many policies have been proposed to manage industry influence without carefully evaluating whether the proposed policies would be successful. We consider a proposal for incorporating citizen stakeholders into scientific research and show, via a detailed case study of the pharmaceutical regulation of flibanserin, that such programs can be co-opted. In closing, we use Holman’s asymmetric arms race framework (...) as a tool for evaluating policies in industry-funded science. (shrink)

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

The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.

. Foreign policy by indictment: Using legal tools against foreign officials involved in drug trafficking. Criminal Justice Ethics: Vol. 8, No. 2, pp. 3-31.

Gerald Dworkin provides an insightful starting point for determining acceptable paternalism through his commitment to protecting our future autonomy and health from lasting damage. Dworkin grounds his argument in an appeal to inherent goods, which this paper argues is best considered as a commitment to human flourishing. However, socialconnectedness is also fundamental to human flourishing and an important consideration when determining the just limits of paternalistic drug controls, a point missing from Dworkin’ essay. For British philosopher Thomas Hill Green, (...) regulation of alcohol sales emerged from the social ideal. Green argued that policy interventions, including restricted opening hours and locations, improved the conditions for humans to flourish. Green offers a compelling political vision but fails to account for the fact pleasure is also an inherent good. He focused excessively on our social nature, excluding our more pleasure-seeking and egoistic characteristics. In contrast, a more realistic and complete vision of human flourishing can be found in an amended version of Gerald’s Dworkin’s arguments. In conclusion, this paper argues drug policy makers should remain committed to the harm principle as applied to criminal law whereby a person should never be criminalized for self-harm. Such a limit on paternalistic interventions is deemed necessary when eudaimonia is the end of government action. In practical terms, this means that the criminalization of drug use, as opposed to drug production, is always unjust. (shrink)