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 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)

The problem of inadequate pain management for both terminally ill patients and patients with chronic pain has recently been documented by a number of authors and studies. A 1997 report by the Institute of Medicine, for example, states that “a significant proportion of dying patients and patients with advanced disease experience serious pain, despite the availability of effective pharmacological and other options for relieving most pain.” There are particularly impressive data that pain associated with cancer is not adequately treated.The problem (...) has been attributed to inadequate education of physicians on approaches to pain management and an often misguided belief that prolonged therapy with certain pain medication will lead to addiction; legal obstacles, such as physicians’ fear of criminal prosecution and other disciplinary actions by state licensing boards for overprescribing narcotics; and inadequate insurance coverage as a result of narrow eligibility criteria for hospice care for Medicare beneficiaries, and inadequate reimbursement more generally for pain management and palliative care. (shrink)

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues (...) and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics. (shrink)

Uncertainty regarding potential disciplinary action may give physicians pause when considering whether to accept a chronic pain patient or how to treat a patient who may require long-term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary acrion for prescribing controlled substances and that physicians will, in some cases, inadequately prescribe opioids due to fear of regulatory scrutiny. Prescribing opioids for long-term pain management, particularly noncancer pain management, has been controversial; and boards have investigated and, in (...) some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well-publicized as news of the disciplinary actions, leaving some physicians confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of two relatively recent cases, one where a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain, and another where the physician was successfully sued for inadequate pain treatment. (shrink)

To the woman, God said, “I will greatly multiply your pain in child bearing; in pain you shall bring forth children, yet your desire shall be for your husband, and he shall rule over you.”Genesis 3:16There is now a well-established body of literature documenting the pervasive inadequate treatment of pain in this country. There have also been allegations, and some data, supporting the notion that women are more likely than men to be undertreated or inappropriately diagnosed and treated for their (...) pain.One particularly troublesome study indicated that women are more likely to be given sedatives for their pain and men to be given pain medication. Speculation as to why this difference might exist has included the following: Women complain more than men; women are not accurate reporters of their pain; men are more stoic so that when they do complain of pain, “it's real”; and women are better able to tolerate pain or have better coping skills than men. (shrink)

State medical boards are beginning to take a more balanced approach to monitoring and disciplining for prescribing of pain medications, according to this survey of state medical boards across the country. Overall, respondents indicated that they are becoming more educated and more sophisticated in their approach to complaints of opioid overprescribing. In addition, their responses reflect a heightened awareness of the appropriateness of treating chronic pain with controlled substances.Yet, despite these inroads, boards generally demonstrate a continued tolerance of pain undertreatment, (...) the survey found. There is a discrepancy in the weight given to violation of standard of care, patient harm, and gross negligence for opioid overprescribing versus undertreatment of pain. Boards appear to have a higher threshold for patient harm in cases involving pain undertreatment — particularly for chronic nonmalignant pain. (shrink)

Researchers summoned a Baltimore County woman to an office at the Johns Hopkins School of Public Health last spring to tell her the bad news. They had found a genetic threat lurking in her 7-year-old son's DNA—a mutant gene that almost always triggers a rare form of colon cancer. It was the same illness that led surgeons to remove her colon in 1979. While the boy, Michael, now 8, is still perfectly healthy, without surgery he is almost certain to develop (...) cancer by age 40.This genetic fortune-telling was no parlor trick. It was the product of astonishing advances in recent decades in understanding how genes build and regulate our bodies. And as scientists pinpoint new genes and learn to forecast the onset of more inherited disorders, millions of people are likely to demand their medical prognosis. (shrink)

Responding to a major pandemic and planning for allocation of scarce resources under crisis standards of care requires coordination and cooperation across federal, state and local governments in tandem with the larger societal infrastructure. Maryland remains one of the few states with no state-endorsed ASR plan, despite having a plan published in 2017 that was informed by public forums across the state. In this article, we review strengths and weaknesses of Maryland’s response to COVID-19 and the role of the Maryland (...) Healthcare Ethics Committee Network in bridging gaps in the state’s response to prepare health care facilities for potential implementation of ASR plans. Identified “lessons learned” include: Deliberative Democracy Provided a Strong Foundation for Maryland’s ASR Framework; Community Consensus is Informative, Not Normative; Hearing Community Voices Has Inherent Value; Lack of Transparency & Political Leadership Gaps Generate a Fragmented Response; Pandemic Politics Requires Diplomacy & Persistence; Strong Leadership is Needed to Avoid Implementing ASR … And to Plan for ASR; An Effective Pandemic Response Requires Coordination and Information-Sharing Beyond the Acute Care Hospital; and The Ability to Correct Course is Crucial: Reconsidering No-visitor Policies. (shrink)

Researchers summoned a Baltimore County woman to an office at the Johns Hopkins School of Public Health last spring to tell her the bad news. They had found a genetic threat lurking in her 7-year-old son's DNA—a mutant gene that almost always triggers a rare form of colon cancer. It was the same illness that led surgeons to remove her colon in 1979. While the boy, Michael, now 8, is still perfectly healthy, without surgery he is almost certain to develop (...) cancer by age 40.This genetic fortune-telling was no parlor trick. It was the product of astonishing advances in recent decades in understanding how genes build and regulate our bodies. And as scientists pinpoint new genes and learn to forecast the onset of more inherited disorders, millions of people are likely to demand their medical prognosis. (shrink)

The problem of inadequate pain management for both terminally ill patients and patients with chronic pain has recently been documented by a number of authors and studies. A 1997 report by the Institute of Medicine, for example, states that “a significant proportion of dying patients and patients with advanced disease experience serious pain, despite the availability of effective pharmacological and other options for relieving most pain.” There are particularly impressive data that pain associated with cancer is not adequately treated.The problem (...) has been attributed to inadequate education of physicians on approaches to pain management and an often misguided belief that prolonged therapy with certain pain medication will lead to addiction; legal obstacles, such as physicians’ fear of criminal prosecution and other disciplinary actions by state licensing boards for overprescribing narcotics; and inadequate insurance coverage as a result of narrow eligibility criteria for hospice care for Medicare beneficiaries, and inadequate reimbursement more generally for pain management and palliative care. (shrink)

This article describes the benefits of including institutional leadership in a faculty fellowship program where faculty were tasked with implementing a curricular innovation at their home institution. These benefits included: serving as an ally, advocate, and defender for the faculty fellow; seeing the bigger picture and how the fellowship can be leveraged to benefit the institution in other ways; and assisting to ensure the fellowship project will be ongoing at their institution.

During the past several years, numerous studies have been conducted regarding advance directives for health care). Studies have examined how many individuals have executed advance directives, who is more likely to execute such directives, and whether factors such as education, income, race, religiosity, or family status affect the likelihood of having executed an advance directive or one's willingness to do so. Studies have also investigated the effectiveness of different educational strategies aimed at increasing the number of individuals who execute these (...) documents. Finally, a number of researchers have looked at the implementation of advance directives.Although we now have a better understanding of some of these issues, one area that has been virtually ignored is the reliability, validity, and overall user friendliness of the advance directive forms themselves, and, in particular, of the statutory advance directive forms. (shrink)

During the past several years, numerous studies have been conducted regarding advance directives for health care). Studies have examined how many individuals have executed advance directives, who is more likely to execute such directives, and whether factors such as education, income, race, religiosity, or family status affect the likelihood of having executed an advance directive or one's willingness to do so. Studies have also investigated the effectiveness of different educational strategies aimed at increasing the number of individuals who execute these (...) documents. Finally, a number of researchers have looked at the implementation of advance directives.Although we now have a better understanding of some of these issues, one area that has been virtually ignored is the reliability, validity, and overall user friendliness of the advance directive forms themselves, and, in particular, of the statutory advance directive forms. (shrink)

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking, come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic (...) medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data. (shrink)

As national and state health care policy -making becomes contentious and complex, there is a need for a forum to debate and explore public concerns and values in health care, give voice to local citizens, to facilitate consensus among various stakeholders, and provide feedback and direction to health care institutions and policy makers. This paper explores the role that regional health care ethics committees can play and provides two contrasting examples of Networks involved in facilitation of public input into and (...) the development of health care policies and adoption of state-wide practices. (shrink)

Local health officials are called upon every day to implement the programs, enforce the regulations, and take the actions that protect the health of the citizens in their districts. These responsibilities and duties are created and regulated by a complex interplay of federal, state, and local law. Not only is an understanding of these laws necessary to carry out public health activities on a daily basis, but many public health scholars and practitioners also believe that the law can be used (...) as a tool to take proactive steps to improve public health. Unfortunately, many local public health officials do not have access to the legal assistance they need to address the various legal questions that confront them. This deficit makes it harder for them to meet their day-to-day responsibilities and makes it much more difficult for them to use the law proactively as a method to improve public health in their communities. In addition, many of the attorneys who provide legal support to public health departments do not have the time or resources to develop a thorough and up-to-date understanding of public health law. This paper examines the experience of a number of local health offices in obtaining legal advice and of attorneys who provide legal advice and assistance to local health departments and assesses different models for organizing and financing the provision of legal services to local public health officials. (shrink)

In the early days of HIV awareness, prior to universal precautions, as a local health officer, I was supervising an openly gay employee. The county executive asked me the HIV status of the employee and threatened my employment if I did not reveal it. I was reluctant to do so, believing it would be an invasion of the employee’s privacy. I contacted the county attorney who advised me that I could reveal the employee’s HIV status to the county executive but (...) he was not willing to put his guidance in writing. Ultimately, I spoke with the employee’s attorney and was given permission to reveal the employee’s HIV status. The experience, however, left a bad taste in my mouth. I felt the county attorney was acting politically in support of the county executive rather than doing what was legally appropriate. He certainly did not act as an advocate for the local health department! (shrink)

The quality of end-of-life care in this country is often poor. There is abundant literature indicating that dying individuals do not receive adequate pain medication or palliative care, are tethered to machines and tubes in a way that challenges their dignity and autonomy, and are not helped to deal with the emotional grief and psychological angst that may accompany the dying process. While this is true for individuals in many settings, it seems to be especially true for individuals in nursing (...) homes. This is somewhat puzzling given that considerable resources have been devoted to bringing public attention to this problem, we have the knowledge and expertise to provide such care, and we have a government-financed benefit that covers this type of care - the Medicare hospice benefit.While utilization of hospice care has increased during the last decade, there is considerable evidence that hospice care remains underutilized particularly in the long term care setting. (shrink)

The quality of end-of-life care in this country is often poor. There is abundant literature indicating that dying individuals do not receive adequate pain medication or palliative care, are tethered to machines and tubes in a way that challenges their dignity and autonomy, and are not helped to deal with the emotional grief and psychological angst that may accompany the dying process. While this is true for individuals in many settings, it seems to be especially true for individuals in nursing (...) homes. This is somewhat puzzling given that considerable resources have been devoted to bringing public attention to this problem, we have the knowledge and expertise to provide such care, and we have a government-financed benefit that covers this type of care - the Medicare hospice benefit.While utilization of hospice care has increased during the last decade, there is considerable evidence that hospice care remains underutilized particularly in the long term care setting. (shrink)

In June 2013, faculty from the University of Maryland Carey School of Law, along with students from the law school and several health professional schools at the University of Maryland, Baltimore, visited Malawi, in southeast Africa. While there, they met with faculty and students at the University of Malawi Chancellor College to discuss the possibility of establishing an ongoing collaboration between the two universities’ law schools. The starting point for our discussion was the potential establishment of a multi-professional, comparative health (...) law clinic that would focus on serving individuals living with HIV and AIDS. This goal would serve two objectives of the Law & Health Care Program at Maryland: to increase interprofessional education opportunities and to expose law students to more global health law issues. Establishing this clinic would also be consistent with two strategic objectives of the University of Malawi Faculty of Law: to establish links with other law schools providing clinical legal education, and to contribute to Malawi’s efforts to solve HIV/AIDS-related problems. (shrink)

In June 2013, faculty from the University of Maryland Carey School of Law, along with students from the law school and several health professional schools at the University of Maryland, Baltimore, visited Malawi, in southeast Africa. While there, they met with faculty and students at the University of Malawi Chancellor College to discuss the possibility of establishing an ongoing collaboration between the two universities’ law schools. The starting point for our discussion was the potential establishment of a multi-professional, comparative health (...) law clinic that would focus on serving individuals living with HIV and AIDS. This goal would serve two objectives of the Law & Health Care Program at Maryland: to increase interprofessional education opportunities and to expose law students to more global health law issues. Establishing this clinic would also be consistent with two strategic objectives of the University of Malawi Faculty of Law: to establish links with other law schools providing clinical legal education, and to contribute to Malawi’s efforts to solve HIV/AIDS-related problems. (shrink)

Several lines of evidence suggest that children born via Cesarean section are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of (...) babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients. (shrink)

The success of fecal microbiota transplantation as a treatment for Clostrioides difficile infection has stirred excitement about the potential for microbiota transplantation as a therapy for a wide range of diseases and conditions. In this article, we discuss vaginal microbiota transplantation as “the next frontier” in microbiota transplantation and identify the medical, regulatory, and ethical challenges related to this nascent field. We further discuss what we anticipate will be the first context for testing VMT in clinical trials, prevention of the (...) recurrence of a condition referred to as bacterial vaginosis. We also compare clinical aspects of VMT with FMT and comment on how VMT may be similar to or different from FMT in ways that may affect research design and regulatory decisions. (shrink)

This monograph consists of five parts: (1) introductory material including a conference overview; (2) papers presented at an international symposium on the topic of ethical issues in disability and rehabilitation as a section of the Annual Conference of the Society for Disability Studies; (3) responses to the symposium, prepared by four of the participants; (4) selected additional papers which offer views from perspectives or cultures not represented at the Denver conference; and (5) an annotated international bibliography. Representatives from 10 countries (...) discussed ethical issues and decision making in disability and rehabilitation. Conference papers include: "Genetic Engineering--The New Eugenics? Evolving Medical Attitudes towards the Quality of Life" (Hugh Gallagher);"Description of the Decision-Making Project" (Daryl Evans); "Treatment and Nontreatment Decisions with Respect to Extremely Premature, Very Low Birthweight Infants (500-750g)" (Ernle Young); "Allocation of Resources and Distributive Justice" (John Mather); "Quality Assurance as an Aid to Ethical Decision Making in Disability Management: Lessons from Recent Ethical Issues Involving Disadvantaged Groups in New Zealand" (Peter Gow); "Disability and Ethical Issues: A Point of View from the Netherlands" (Yolan Koster-Dreese); "Who Shall Live or How Shall They Live? Consumer and Professional Perspectives on Treatment/Non-Treatment Decisions" (Joseph Kaufert and Patricia Kaufert); and "Debates across Social Movements on Reproductive Technologies, Genetic Engineering, and Eugenics" (Theresia Degener). Conference commentaries include: "The Meeting of Disability and Bioethics: A Beginning Rapprochement" (Adrienne Asch); "A Plea for More Dialogue: Commentary on Ethics Conference" (Robert Slater); "Healing Our Wounds" (Martha Lentz Walker); "Theories and Values: Ethics and Contrasting Perspectives on Disability" (Harlan Hahn); and "Current Example of Ethical Dilemma" (Susan Lacetti). Selected additional papers include: "High-tech Medicine Is Basic Care" (Frederick Abrams); "Prevention of Disabilities as a Medical Question" (G. Schioler); "The Ethics of Disability Prevention: A Parent's Point of View" (Mrs. J. Baker); "A Reference Matrix for Issues of Life and Personhood" (Mike Miles); "Nazi Scientists and Ethics of Today" (Isabel Wilkerson); "Ethical and Policy Issues in Rehabilitation Medicine (Hastings Center Report)" (Arthur Caplan et al.); and "Differing Approaches to Prevention of Disability and Treatment of Impaired Infants Creates Controversies Worldwide" (Barbara Duncan). (JDD). (shrink)

Abstnn Eye movements were monitored while subjects performed parallel and serial sarah tasks. In Experiment la, subjects searched for an “O' among "X"s (parallel condition) and for a 'T" among "L"s (serial condition). In the parallel condition of Eqcriment lb, “q)" was the target and “O"s were distractors; in the serial condition, time..

Volume 20, Issue 7, July 2020, Page 150-152.

Generating research findings, which make sense in today's society and can be appreciated as such by both the academic and the business worlds, requires reframing not only the core of how research is being developed but also questions the relevance of organizational survival. The Imagineering Methodology developed within the framework of the NHTV University of Applied Sciences provides a complementary perspective on management research and design. This article aims to present the essence and the specifics of how research is evolving (...) today, using the aforementioned methodological stance and showing certain outcomes, already achieved in practice. (shrink)

With growing complexity in society, designers are entering the fields of organizational studies and social change with high levels of responsibility and, sometimes, little background knowledge of theories and recent evolution. Specifically in the fields of strategy, change, and transformation, the turn toward complexity science is gaining acceptance in both academia and practice. This article presents Imagineering as a complexity-inspired design approach to effectuate transformational objectives. It illustrates the method with an application on the city of Antwerp. The author concludes (...) by reflecting on the implications and perspectives of the method for transformational design and for design thinking in management. (shrink)

Emergence, the coming-into-being of new entities, new organizations, or new structures out of the interactions of individual agents in networks, is becoming a central concept in today's management literature. We are now evolving from the age of reductionism to the age of emergence, meaning that organizations in the connected society can no longer predict what is going to happen but will find themselves continuously doing things in co-evolution with their environment, things that are not necessarily in line with actions planned (...) in advance. In such a dynamic environment managers must learn to enable emergent processes in real time if an organization is to turn unpredictability to its competitive advantage. The importance of the perspective of emergence is introduced in regard to the growing complexity in society. (shrink)

Sagoff critiqued the exclusion of cultivated plants and animals from much of the body of work in ecology. However, there is a history of attempting to incorporate cultivated landscapes in ecology that goes back at least two decades, particularly in urban ecology. The subdiscipline of urban ecology has received relatively little attention in philosophy, although some of its methodologies, such as coupled human-natural systems research, have been critiqued. Here I will attempt to explicitly address the conceptual limitations in ecology for (...) studying cultivated ecosystems and evaluate these limitations in the context of coupled human-natural systems and socioecological research, urban ecosystem services frameworks, and actor-network theory. I argue that the history of cultivated organisms is highly germane to their ecology, necessitating the incorporation of human agency into ecological theory. However, human agency and nonhuman nature exist along a continuum of nature vs. culture. As a result, dualistic approaches to studying the role of human agency in ecosystem processes, such as socioecology and ecosystem services assessments—which explicitly separate humans from nature—have had limited success in cultivated landscapes. More fully integrated frameworks such as actor-network theory may better address ecological research questions in cultivated landscapes. (shrink)