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

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

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)

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

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

In 2014, Lord Saatchi launched his ultimately unsuccessful Medical Innovation Bill in the UK. Its laudable aim was to free doctors from the shackles that prevented them from providing responsible innovative treatment. Lord Saatchi’s principal contention was that current law was the unsurmountable barrier that prevented clinicians from delivering innovative treatments to cancer patients when conventional options had failed. This was because doctors feared that they might be sued or tried and convicted of gross negligence manslaughter if they deviated (...) from standard practice. Concerns about fear of the law and potential negative effects on medical practice are not new. Fear of litigation has been suggested as the reason for doctors practising “defensive medicine,” by opting for treatments regarded as “grievance-resistant,” rather than clinically indicated, for example, by ordering diagnostic tests or performing certain procedures, which are not strictly medically necessary. Whilst this claim is plausible and apparently accepted by the courts, there is limited empirical evidence in support of it so far as practitioners in the UK are concerned. In this paper, we report on our empirical research which provides a snapshot of medical opinion to begin to rectify this gap. We ran focus groups of different medical specialties, asking what these medical practitioners thought the barriers to medical innovation to be. We found that fear of the law was not the principal barrier to be lowered, and that the answer was far more multifaceted. (shrink)

Kesselheim proposes doubling the NIH’s budget to promote clinically meaningful pharmaceutical innovation. Since the effects of a previous doubling (from 1998-2003) were mixed, I argue that policymakers should couple future budget growth with investments in experimentation and evaluation.

Martin Sand and Luca Chiapperino find in the concept of serendipity a versatile umbrella term to reassess their previous work on moral luckLuck (also, Epistemic Luck, Moral Luck) and collectiveCollectiveresponsibilityResponsibility. Moral luck supposedly occurs when someone receives praise or blame for things beyond control. Given the ubiquity of luckLuck (also, Epistemic Luck, Moral Luck), this seems to be a seriously disquieting aspect of ordinary morality. The rewards and recognition for serendipitous discoveries fall into exactly this category. That is: more than (...) the intentions, actions, and characters of scientists matters for discoveries to obtain, just as in cases of moral luckLuck (also, Epistemic Luck, Moral Luck) something beyond morality affectsAffect our moral judgments. Even if a theoretical way of resolving the conceptual ambiguities that underlie this debate were found, there remain practical questions of how to perform stratification in science and innovationInnovation in ways that both hinge on, and yet refrain from, considerations of desert and achievement. With the example of Edward Jenner’sJenner, EdwardluckLuck (also, Epistemic Luck, Moral Luck)- and serendipity-infused discoveryDiscovery (also, Scientific Discovery) of vaccination, the authors attempt to better understand the intricate valueValue trade-offs that underlie stratification policies in science, which have to be constantly re-negotiated to maintain their legitimacy. Thereby, Sand and Ciapperino aim to take a bold step towards understanding the ethicsEthics of serendipity. (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)

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

Throughout its fifty-year history, the role of the medical humanist and even the name “medical humanities” has remained raw, dynamic and contested. What do we mean when we call ourselves “humanists” and our practice “medical humanities?” To address these questions, we turn to the concept of origin narratives. After explaining the value of these stories, we focus on one particularly rich origin narrative of the medical humanities by telling the story of how a group of educators, (...) ethicists, and scholars struggling to define their relatively new field rediscovered the studia humanitatis, a Renaissance curriculum for learning and teaching. Our origin narrative is composed of two intertwined stories—the history of the studia humanitatis itself and the story of the scholars who rediscovered it. We argue that as an origin narrative the studia humanitatis grounds the medical humanities as both an engaged moral practice and pedagogical project. In the latter part of the paper, we use this origin narrative to show how medical humanists working in translational science can use their understanding of their historical roots to do meaningful work in the world. (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)

Volume 19, Issue 6, June 2019, Page 42-44.

Volume 19, Issue 6, June 2019, Page 41-42.

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

In 2017 and 2019, two research teams claimed ‘proof of principle’ for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research–treatment distinction, pervasive in (...) regulation worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue that there is a tendency in the literature to conceptualize AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a ‘beneficial treatment’. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico‐legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed. (shrink)

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of (...) patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)

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

Innovation in ethics pedagogy has continued to evolve and incorporate other forms of storytelling aimed at improving student engagement and learning. The use of bioethics narratives in feature-length films, medical television shows, or short clips in the classroom has a well-established history. In parallel, screenplays present an opportunity for an active approach to ethical engagement. We argue that screenplays and screenwriting provide a rich supplement to current medical ethics teaching and serve as a strong form of reflective learning.

Recent medical innovations like ‘omics’ technologies, mobile health (mHealth) applications or telemedicine are perceived as part of a shift towards a more preventive, participatory and affordable healthcare model. These innovations are often regarded as ‘disruptive technologies’. It is a topic of debate to what extent these technologies may transform the medical enterprise, and relatedly, what this means for medical ethics. The question of whether these developments disrupt established ethical principles like respect for autonomy has indeed (...) received increasing normative attention during the past years. Yet, more fundamental ethical considerations of a possible disruption of the concept of ‘medical necessity’ (and the potential ensuing clinical ramifications) have been limited if not absent. It is our modest – though morally and practically relevant – aim to address this objective in this article, by exploring how the current wave of allegedly disruptive innovation is invoking a resurgence of this concept and related debates on ‘the’ goal(s) of medicine. (shrink)

Development-oriented funding schemes such as the UK Global Challenges Research Fund (GCRF) have opened up opportunities for collaborations between low-middle income countries (LMICs) and high-income country (HIC) researchers. In particular, funding for medical technology research has seen a rise in previously under-represented disciplines such as physics and engineering. These collaborations have considerable potential to advance healthcare in LMICs, yet can pose challenges experienced to researchers undertaking these collaborations. Key challenges include a lack of tradition of HIC/LMIC collaborations within participating (...) departments, lack of experience with development agendas, designing contextually-appropriate technologies and ensuring long-term viability of research outputs. This paper reflects on these key challenges, using the experiences of the authors on the Open Laboratory Instrumentation (OLI) project as a focalizing lens. This project was a GCRF-funded collaboration between physicists in the UK and engineers in Tanzania to develop an open-source, 3D-printed, fully-automated laboratory microscope. The paper highlights key ethics lessons learnt. (shrink)

Development-oriented funding schemes such as the UK Global Challenges Research Fund (GCRF) have opened up opportunities for collaborations between low-middle income countries (LMICs) and high-income country (HIC) researchers. In particular, funding for medical technology research has seen a rise in previously under-represented disciplines such as physics and engineering. These collaborations have considerable potential to advance healthcare in LMICs, yet can pose challenges experienced to researchers undertaking these collaborations. Key challenges include a lack of tradition of HIC/LMIC collaborations within participating (...) departments, lack of experience with development agendas, designing contextually-appropriate technologies and ensuring long-term viability of research outputs. This paper reflects on these key challenges, using the experiences of the authors on the Open Laboratory Instrumentation (OLI) project as a focalizing lens. This project was a GCRF-funded collaboration between physicists in the UK and engineers in Tanzania to develop an open-source, 3D-printed, fully-automated laboratory microscope. The paper highlights key ethics lessons learnt. (shrink)

Development-oriented funding schemes such as the UK Global Challenges Research Fund (GCRF) have opened up opportunities for collaborations between low-middle income countries (LMICs) and high-income country (HIC) researchers. In particular, funding for medical technology research has seen a rise in previously under-represented disciplines such as physics and engineering. These collaborations have considerable potential to advance healthcare in LMICs, yet can pose challenges experienced to researchers undertaking these collaborations. Key challenges include a lack of tradition of HIC/LMIC collaborations within participating (...) departments, lack of experience with development agendas, designing contextually-appropriate technologies and ensuring long-term viability of research outputs. This paper reflects on these key challenges, using the experiences of the authors on the Open Laboratory Instrumentation (OLI) project as a focalizing lens. This project was a GCRF-funded collaboration between physicists in the UK and engineers in Tanzania to develop an open-source, 3D-printed, fully-automated laboratory microscope. The paper highlights key ethics lessons learnt. (shrink)

As the world held its breath for news surrounding COVID-19 and hunkered down amidst stay-at-home orders, medical students across the U.S. wondered if they would be called to serve on the front lines of the pandemic. Medical school administrators faced the challenge of protecting learners while also minimizing harm to their medical education. This balancing act raised critical questions in medical education as institutions reacted to changing guidelines. COVID-19 has punctuated already contentious areas of medical (...) education and has forced institutions and organizations to take quick action. From the perspectives of a recent medical school graduate and current resident and a practicing clinician-educator, we examine the pandemic’s impact on undergraduate medical education through an ethical lens. First, we explore the value of medical education, what drives this value, and how COVID-19 may alter it. We next consider student choice and how shifts toward utilitarianism in healthcare during a pandemic may affect learning and career exploration. Then, we inquire how access to technology may impact the experience of medical students from diverse backgrounds and varied institutions during a rapid shift to socially distanced learning. We identify vulnerabilities for students at several phases of the journey: premedical, preclinical, clinical, and preparation for residency. Finally, we address the hidden curriculum of COVID-19, its potential erosion of empathy among current medical students, and possible long-term consequences for future physicians and patients. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 51-52 [Access article in PDF] Congress Considers Incentives for Organ Procurement Alexander S. Curtis [Tables]During the 108th Congressional session, several bills pertaining to ethical incentives for organ donation likely will be introduced. In some cases, they will be similar to bills before the 107th Congress (see Table 1). Bills in both the House of Representatives and the Senate address the establishment and (...) maintenance of donor registries, financial reimbursements for medical and nonmedical expenses incurred by qualifying donors, the presentation of commemorative medals, and tax credits.A bill entitled "Gift of Life Congressional Medal Act" (introduced last year by Senate majority leader Bill Frist (R-TN) as Senate Bill 325), and its corresponding bill of the same title (passed in the House of Representatives last year as H.R. 708), would establish a congressional commemorative medal honoring "any organ donor, or the family or family member of any organ donor." The medal is to be designed and struck with "suitable emblems, devices, and inscriptions" by the Secretary of the Treasury. The eligible donor or donor's family member would be presented with the medal by the Secretary of Health and Human Services. This bill would establish qualifying donations as those of human kidneys, livers, hearts, lungs, pancreases, or any other organ, but excludes corneas and eyes.Another bill, introduced by Representative Michael Bilirakis (R-FL) entitled "Organ Donation Improvement Act" (H.R. 624), would award grants or contracts to states, transplant centers, and qualified organ procurement organizations for the purpose of providing travel, subsistence, and incidental nonmedical expenses to individuals who make living donations. In order to receive reimbursement, the donating individuals must reside in states other than the states in which the intended recipients reside and the annual income of those receiving the organs cannot exceed $35,000. The bill also would appropriate $15,000,000 to make grants to states and public and nonprofit entities for the purpose of carrying out studies, public education demonstrations, and outreach activities "designed to increase the number of organ donors within the state." The bill would be effective from time of enactment through 2005. [End Page 51]Two other bills proposed within the House of Representatives in 2002 called for amendment to the Internal Revenue Code. The "Gift of Life Tax Credit Act (introduced as H.R. 1872 by Representative James Hansen (R-UT)) and the "Help Organ Procurement Expand Act" (introduced as H.R. 2090 by Representative Chris Smith (R-NJ)) present a refundable credit to individuals or to the estates of those who agree either to be living donors or to donate their organs upon death. The "Gift of Life Tax Credit Act" refunds $10,000 to the estates of eligible individuals "for the taxable year which includes the date of the individual's death." The "Help Organ Procurement Expand Act" offers a refund of $2,500 to qualified persons. Donations of kidneys, livers, pancreases, islet cells, lungs, and intestines are accepted, however several conditions restrict permissible donors. The "Gift of Life Tax Credit Act" requires that the legally competent individual's death not be due to a suicide and that the intention to donate was clearly declared. The "Help Organ Procurement Expand Act" prohibits donations from individuals who were killed with physician assistance, died as a result of a suicide, have been indicted or convicted of a felony or a misdemeanor offense, or are actively under criminal investigation for a possible felony offense. The "Help Organ Procurement Expand Act" also restricts procuring organs from unborn children or human fetuses and under circumstances in which the living donor would be subject to "unacceptable levels of medical risk of death or permanent debilitation." Alexander S. Curtis is a research assistant at the Kennedy Institute of Ethics, Georgetown University, Washington, DC. He received his bachelor's degree from Miami University.... (shrink)

This article shows the organization of distance learning, particularly the idea of b-learning, combining the accomplishment of classes carried on in the traditional way and via computers. The authors present learning activities related to complementary education herein. Some of these course types may be successfully adapted to an e-learning background. The models and structure of the university virtual environment for distance learning are described. These illustrate a new approach to creating a virtual space for medical and technical studies where (...) e-learning courses are created to be used for distance education, which allows students to be taught more effectively. The projected virtual courses for different groups of students ensure individualization of students’ work, which could be a relevant element for creating the shortest path of development of professional competencies. This paper further includes a brief overview of technologies used to build interactive elements into learning mate- rials. The authors present the use of interactive elements in medical education based on examples of certain selected games and animations. (shrink)