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)

A significant amount of discussion in the bioethics community has been devoted to the question of whether individuals performing ethics consultations in healthcare institutions have any special expertise. In addition, articles in the lay press have questioned the “added value” that bioethicists bring to ethical dilemmas. Those at the forefront of the bioethics community have argued repeatedly that those doing ethics consults cannot simply be well-intentioned individuals, that some training in bioethics, group process, and facilitation is necessary to competently execute (...) a consult. As one bioethicist commented:if you approach any endeavor as an amateur activity, you will get, in the end, an amateurish version of the activity. Without a sufficient commitment of personnel, time, support, and financial resources, a healthcare organization will get the ‘ethics’ program … it set out to create: an inept, unskilled, inefficient, and highly risky ‘program’ in healthcare ethics and bioethics. (shrink)

A significant amount of discussion in the bioethics community has been devoted to the question of whether individuals performing ethics consultations in healthcare institutions have any special expertise. In addition, articles in the lay press have questioned the “added value” that bioethicists bring to ethical dilemmas. Those at the forefront of the bioethics community have argued repeatedly that those doing ethics consults cannot simply be well-intentioned individuals, that some training in bioethics, group process, and facilitation is necessary to competently execute (...) a consult. As one bioethicist commented:if you approach any endeavor as an amateur activity, you will get, in the end, an amateurish version of the activity. Without a sufficient commitment of personnel, time, support, and financial resources, a healthcare organization will get the ‘ethics’ program … it set out to create: an inept, unskilled, inefficient, and highly risky ‘program’ in healthcare ethics and bioethics. (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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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.

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)

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)