Drug Safety Communications are used by the Food and Drug Administration to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone (...) between July 1, 2012 and June 30, 2013. Among the 594 respondents, two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited. Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep and seek out more information about the safety of their specific sleeping pill. Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications. (shrink)

A 2011 National Academies of Sciences report called for an “Information Commons” and a “Knowledge Network” to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.

This paper is the first of two in a series. In this paper, we identify mental health needs and challenges in the age of COVID-19 among Nepali-speaking, Bhutanese resettled refugees in the USA. We argue for a public health justice framework that looks critically at social determinants impacting mental health (SDIMH) barriers, which negatively impact our Bhutanese population, and serves as a theoretical foundation toward public policy and law that will inform healthcare decisions and fair treatment of resettled refugees at (...) the clinical bedside and in the community. We first describe our Bhutanese refugee population and the critical mental health issues that, for many, originated during political persecution and violent ethnic cleansing initiatives, or while living in refugee camps prior to resettlement to the USA. We present a social justice framework emerging from an extensive literature review and incorporating core social determinants specific to mental health in the age of COVID-19, which are guided by the social determinants of economic stability; neighborhoods and physical environment; education; nutrition and exercise; community and social context; healthcare system; and legal system. We illustrate specific SDIMH of our resettled Bhutanese refugees during the pandemic, followed by a second paper that details recommendations for applying the SDIMH in a collective effort to address specific barriers to mental healthcare and support. (shrink)

As much as we can be squeamish and angry over what was being done in these studies, they force us to consider how we tell these stories and the policy we make now, as so much of our research is global and the risks and benefits of experimentation always in need of recalibration.Susan M. ReverbyA growing distrust exists among Latin American populations as past abuses in medical research have rightly been publicized, and as researchers continue to intentionally and unintentionally circumvent (...) the systems of regulation and oversight. Beyond the cultural gaps between researcher and subject, the Latin American people have their own perspectives about responsible conduct of research formed by sociopolitical thought and familial and community identity, which may be overlooked or ignored by the U.S. and other foreign nations. Just as the Havasupai Tribe in Arizona have challenged us to think about the role of culture and the need for improved regulations and practices in conducting research within the United States, through past abuses in human experimentation and the emergence of discourse between our Latin American neighbors, similar challenges confront us. (shrink)

This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses.

Accessing BRCA1/2 data facilitates the detection of disease-associated variants, which is critical to informing clinical management of risks. BRCA1/2 data sharing is complex and many practices exist. We describe current BRCA1/2 data-sharing practices, in the United States and globally, and discuss obstacles and incentives to sharing, based on 28 interviews with personnel at U.S. and non-U.S. clinical laboratories and databases. Our examination of the BRCA1/2 data-sharing landscape demonstrates strong support for and robust sharing of BRCA1/2 data around the world, increasing (...) global accesses to diverse data sets. (shrink)

This paper is the second of two in a series. In our first paper, we presented a social justice framework emerging from an extensive literature review and incorporating core social determinants specific to mental health in the age of COVID-19 and illustrated specific social determinants impacting mental health (SDIMH) of our resettled Bhutanese refugee population during the pandemic. This second paper details specific barriers to the SDIMH detrimental to the basic human rights and social justice of this population during this (...) pandemic. The SDIMH, as described, further informs the need for social justice measures and cultural humility in mental healthcare, public health, law, and community engagement. This work concludes with a proposed call to action toward mental health improvement and fair treatment for refugee populations in three core areas: communication and education, social stigma and discrimination, and accessibility and availability of resources. (shrink)

This second edition of Young Children and the Environment is a practical resource that illustrates the difference that early childhood educators can make by working with children, their families and the wider community to tackle the contemporary issue of sustainable living. This second edition has been substantially revised and updated, with a new section exploring sustainability education in a variety of global contexts. Researched and written by authors recognised as leaders in their own countries, this section provides readers with international (...) resources and perspectives to further their teaching about early childhood education for sustainability. The text engages with new curriculum initiatives that have placed greater emphasis on educating for sustainability, and equips educators with the knowledge to teach this revised content. It remains accessibly written with ample case studies, vignettes and 'Provocations' to engage readers and provide insights into how early childhood education for sustainability can occur successfully in practice. (shrink)

Although bedbug infestation is not a new public health problem, it is one that is becoming more alarming among healthcare professionals, public health officials, and ethicists given the magnitude of patients who may be denied treatment, or who are unable to access treatment, especially those underserved populations living in low income housing. Efforts to quarantine and eradicate Cimicidae have been and should be made, but such efforts require costly interventions. The alternative, however, can further exacerbate the already growing problems of (...) injustice, i.e., unfair treatment of patients, inaccessibility of needed resources. In the following paper, I examine the ramifications of denying access to medical care, among other healthcare justice dilemmas surrounding bedbug infestations. I also explore the value of health, and how healthcare professionals and public officials often feel as though bedbugs are not a priority because they, themselves, are not diseases, regardless of the fact they cause physical and mental problems that affect a person’s health. I propose recommendations for improving the health and well-being of those vulnerable populations who are facing a difficult and growing public health problem that is currently being ignored in medical and public health ethics literature, regardless of increased media attention and unusual habitats of localized infestations, e.g., Statue of Liberty, New York City. (shrink)

With a shift from genetics to genomics, the study of organisms in terms of their full DNA sequences, the resurgence of eugenics has taken on a new form. Following from this new form of eugenics, which I have termed "eugenomics", is a host of ethical and social dilemmas containing elements patterned from controversies over the eugenics movement throughout the 20th century. This paper identifies these ethical and social dilemmas, drawing upon an examination of why eugenics of the 20th century was (...) morally wrong. Though many eugenic programs of the early 20th century remain in the dark corners of our history and law books and scientific journals, not all of these programs have been, nor should be, forgotten. My aim is not to remind us of the social and ethical abuses from past eugenics programs, but to draw similarities and dissimilarities from what we commonly know of the past and identify areas where genomics may be eugenically beneficial and harmful to our global community. I show that our ethical and social concerns are not taken as seriously as they should be by the scientific community, political and legal communities, and by the international public; as eugenomics is quickly gaining control over our genetic futures, ethics, I argue, is lagging behind and going considerably unnoticed. In showing why ethics is lagging behind I propose a framework that can provide us with a better understanding of genomics with respect to our pluralistic, global values. (shrink)

Neuroscience communication is increasingly taking place on multidirectional social media platforms, creating new opportunities but also calling for critical ethical considerations. Twitter, one of the most popular social media applications in the world, is a leading platform for the dissemination of all information types, including emerging areas of neuroscience such as optogenetics, a technique aimed at the control of specific neurons. Since its discovery in 2005, optogenetics has been featured in the public eye and discussed extensively on social media, but (...) little is known about how this new technique is portrayed and who the users participating in the conversation are. To address this gap, we conducted content analysis of a sample of 1000 tweets mentioning “optogenetics” over a one-year period between 2014 and 2015. We found that academic researchers are the largest group contributing to the conversation, that the tweets often contain links to third-party websites from news organizations and peer-reviewed journals, and that common thematic motifs include the applications of optogenetics specifically for the control of brain activity and the treatment of disease. We also found that the majority of the tweets are neutral in their tone regarding optogenetics. As Twitter serves as a current and dynamic forum for exchange about advances in neuroscience, the conversation about optogenetics on this engaging platform can inform socially-responsive knowledge dissemination efforts in this area. (shrink)

Background: The research community has a mandate to discover effective treatments for neurodegenerative disorders. The ethics landscape surrounding this mandate is in a constant state of flux, and ongoing challenges place ever greater demands on investigators to be accountable to the public and to answer questions about the implications of their work for health care, society, and policy. Methods: We surveyed US-based investigators involved in neurodegenerative diseases research about how they value ethics-related issues, what motivates them to give consideration to (...) those issues, and the barriers to doing so. Using the NIH CRISP database we identified 1,034 researchers with relevant, active grants and invited them to complete an online questionnaire. We received 193 responses. We used exploratory factor analysis to transform individual survey questions into a smaller set of factors, and linear regression to understand the effect of key variables of interest on the factor scores. Results: Ethics-related issues clustered into two groups: research ethics and external influences. Heads of research groups viewed issues of research ethics to be more important than the other respondents. Concern about external influences was related to overall interest in ethics. Motivators clustered into five groups: ensuring public understanding, external forces, requirements, values, and press and public. Heads of research groups were more motivated to ensure public understanding of research than the other respondents. Barriers clustered into four groups: lack of resources, administrative burden, relevance to the research, and lack of interest. Perceived lack of ethics resources was a particular barrier for investigators working in drug discovery. Conclusions: The data suggest that senior level neuroscientists working in the field of neurodegeneration (ND), and drug discovery specifically, are motivated to consider ethics issues related to their work, but the perceived lack of ethics resources thwarts their efforts. With bioethics centres at more than 50% of the institutions at which these respondents reside, the neuroscience and bioethics communities appear to be disconnected. Dedicated ethical, legal and social implications (ELSI) programs, such as those fully integrated into genetics and regenerative medicine, provide models for achieving meaningful partnerships not yet adequately realized for scholars and trainees interested in drug discovery for ND. (shrink)

Globalizing Feminist Bioethics is a collection of new essays on the topic of international bioethics that developed out of the Third World Congress of the International Association of Bioethics in 1996. Rosemarie Tong is the primary editor of this collection, in which she, Gwen Anderson, and Aida Santos look at such international issues as female genital cutting, fatal daughter syndrome, use of reproductive technologies, male responsibility, pediatrics, breast cancer, pregnancy, and drug testing.

hroughout medieval Christianity, religious works of art emerged to illustrate the teachings of the Bible for the largely illiterate population. What, then, is the significance of the psychoactive mushrooms hiding in plain sight in the artwork and icons of many European and Middle-Eastern churches? Does Christianity have a psychedelic history? -/- Providing stunning visual evidence from their anthropological journey throughout Europe and the Middle East, including visits to Roslyn Chapel and Chartres Cathedral, authors Julie and Jerry Brown document the (...) role of visionary plants in Christianity. They retrace the pioneering research of R. Gordon Wasson, the famous “sacred mushroom seeker,” on psychedelics in ancient Greece and India, and among the present-day reindeer herders of Siberia and the Mazatecs of Mexico. Challenging Wasson’s legacy, the authors reveal his secret relationship with the Vatican that led to Wasson’s refusal to pursue his hallucinogen theory into the hallowed halls of Christianity. -/- Examining the Bible and the Gnostic Gospels, the authors provide scriptural support to show that sacred mushrooms were the inspiration for Jesus’ revelation of the Kingdom of Heaven and that he was initiated into these mystical practices in Egypt during the Missing Years. They contend that the Trees of Knowledge and of Immortality in Eden were sacred mushrooms. -/- Uncovering the role played by visionary plants in the origins of Judeo-Christianity, the authors invite us to rethink what we know about the life of Jesus and to consider a controversial theory that challenges us to explore these sacred pathways to the divine. (shrink)

In light of new historical evidence regarding ethnomycologist R. Gordon Wasson’s correspondence with art historian Erwin Panofsky, this article provides an in-depth analysis of the presence of entheogenic mushroom images in Christian art within the context of the controversy between Wasson and philologist John Marco Allegro over the identification of a Garden of Eden fresco in the 12th century Chapel of Plaincourault in France. It reveals a compelling financial motive for Wasson’s refusal to acknowledge that this fresco represents Amanita muscaria, (...) as well as for Wasson’s reluctance to pursue his hypothesis regarding the entheogenic origins of religion into Christian art and artifacts. While Wasson’s view – that the presence of psychoactive mushrooms in the Near and Middle East ended around 1000 BCE – prevailed and stymied research on entheogens in Christianity for decades, a new generation of 21st century researchers has documented growing evidence of A. muscaria and psilocybin-containing mushrooms in Christian art, consistent with ethnobotanist Giorgio Samorini’s typology of mushroom trees. This article presents original photographs, taken during fieldwork at churches and cathedrals throughout Europe and the Middle East, that confirm the presence of entheogenic mushrooms in Christian art: in frescoes, illuminated manuscripts, mosaics, sculptures, and stained glass windows. Based on this iconic evidence, the article proposes a psychedelic gospels theory and addresses critiques of this theory by art historians, ardent advocates, medieval historians, and conservative Catholics. It calls for the establishment of an Interdisciplinary Committee on the Psychedelic Gospels to independently evaluate the growing body of evidence of entheogenic mushrooms in Christian art in order to resolve a controversial question regarding the possible role of entheogens in the history and origins of Christianity. (shrink)

Without a better understanding of mental disease, patients diagnosed with a mental disease may be mistreated clinically and/or socially, and caregivers and families may be wrongfully blamed for causing the disease and/or for not effectively helping and developing meaningful relationships with the patient as person. In trying to understand mental disease and why its various dimensions raise difficulties for our systems of classification and our medical models of diagnosis and treatment, a framework is required. This framework will connect metaphysical, epistemological, (...) and ethical considerations in ways that are mutually supportive and illuminating. This, in turn, will benefit those who are diseased and those persons who study, classify, diagnose, and treat disease. (shrink)

The topic of professionalism has dominated the content of major academic medicine publications during the past decade and continues to do so. The message of this current wave of professionalism is that medical educators need to be more attentive to the moral sensibilities of trainees, to their interpersonal and affective dimensions, and to their social conscience, all to the end of skilled, humanistic physicians. Urgent calls to address professionalism from such groups as the Association of American Medical Colleges, the American (...) Board of Internal Medicine, and the Accreditation Council for Graduate Medical Education, among others. In fact, at the 2004 annual meeting of the AAMC six separate presentations addressed professionalism with such titles as "Evaluating Humanism and Professionalism," Professionalism: Expectation, Education, Evaluation," or "Toward Assessing Professional Behaviors of Medical Students through Peer Observations". Professionalism, then, has become part of the current academic medicine parlance, used by administrators, clinical faculty, residency programs, and professional organizations with an expectation of shared meanings and goals. All of these stakeholders focus on what has become a consistent list of attributes deemed to be the essence of professionalism, which usually include variations on altruism, duty, excellence, honor and integrity, accountability, and respect. In fact, most of the scholarly work to date has been listing, describing, decrying, and measuring/evaluating it. In this collection of essays, we don’t argue with these attributes. Instead, we ask questions of the discourse from which they arise, how the specialized language of academic medicine disciplines has defined, organized, contained, and made seemingly immutable a group of attitudes, values, and behaviors subsumed under the label "professional" or "professionalism." This collection aims to be a critical text, one that questions the profession’s beliefs about the nature of its work and how such beliefs are enacted in medical education, particularly as they fuel the professionalism discourse. In addition, we will scrutinize how the discourse is enacted in both the formal and hidden curriculum, and in the larger medical environment. (shrink)

Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a “Medical Information Commons”. We present findings from expert stakeholder interviews aimed at understanding barriers to engagement and the appropriate role of MIC participants. Although most interviewees supported engagement, they distinguished between individual versus collective forms. They also noted challenges including representation and perceived inefficiency, prompting reflection on political aspects of engagement and efficiency concerns.

This experiment uses quantitative and qualitative measures to address the effect of two syllabus statements on academic misconduct: one based on prohibitions and one on academic integrity. Students expressed favorable attitudes toward the statements, showed an increase in guilt compared to a control group, but showed no decrease in intentions to cheat. Including only a standard academic misconduct statement in one's syllabus is not sufficient to alter behavior, which should be acknowledged by faculty.

The human major histocompatibility complex (MHC), on the short arm of chromosome 6, represents one of the most extensively characterised regions of the human genome. This ∼4 Mb segment of DNA contains genes encoding the polymorphic MHC class I and class II molecules which are involved in antigen presentation during an immune response. Recently the whole of the MHC has been cloned in cosmids and/or yeast artificial chromosomes (YACs) and large portions have been characterised for the presence of novel genes. (...) Many unrelated genes, both housekeeping and tissue specific, have been identified and the gene density in some regions is now approaching one gene every few kilobases. Some of the novel genes encode proteins involved in the intracellular processing and transport of antigens that are presented by MHC class I molecules. Others, however, have no obvious role in the immune response. The MHC is located in the chromosome band 6p21.3 which is a Giemsa (G)‐light band. The detection of such a large number of functional genes (at least 70) in this region is compatible with the idea that both housekeeping and tissue‐specific genes are localised predominantly in G‐light bands. (shrink)

A growing body of research has suggested that high levels of family functioning—often measured as positive parent–child communication and low levels of parental stress—are associated with stronger cognitive development, higher levels of school engagement, and more successful peer relations as youth age. The COVID-19 pandemic has brought tremendous disruption to various aspects of daily life, especially for parents of young children, ages 3–5, who face isolation, disconnection, and unprecedented changes to how they engage and socialize. Fortunately, both youth and parent (...) brains are plastic and receptive to change. Resilience research shows that factors such as engaging in acts of kindness, developing trusting relationships, and responding compassionately to the feelings of others can help lay new neural pathways and improve quality of life. Yet, little research has investigated the effects of brain healthy parental practices of kindness with pre-school aged children. The current study examines whether an interactive, parent–child kindness curriculum can serve as a potentiator for brain health as measured by resilience and child empathy levels. During a peak of the pandemic, mother participants between the ages of 26–46 completed questionnaires on parental resilience levels and parent-reported child empathic pro-social behaviors before and after engaging in a 4 weeks online, self-paced, kindness curriculum. Half of the group received additional brain health education explaining the principles of neuroplasticity, empathy, perspective taking, and resiliency. Mothers in both groups showed increased resilience and reported higher levels of empathic behavior in their child after completing the curriculum. There was no significant difference between groups. Comparison of mean resilience levels during COVID-19 to pre-pandemic general means indicated that mothers are reporting significantly lower levels of resilience as well as decreased empathetic behaviors in their children. These results support the notion that kindness is a powerful brain health booster that can increase resilience and empathy. This research study was timely and relevant for parents in light of the myriad of stresses brought about by the ongoing COVID-19 pandemic. There are broader public health implications for equipping individuals with tools to take a proactive and preventative approach to their brain health. (shrink)

Our senses are constantly stimulated in our daily lives but we have only a limited understanding of how they affect our cognitive processes and, especially, our autobiographical memory. Capitalizing on a public science event, we conducted the first empirical study that aimed to compare the relative influence of the five senses on the access, temporal distribution, and phenomenological characteristics of autobiographical memories in a sample of about 400 participants. We found that the access and the phenomenological features of memories varied (...) as a function of the type of sensory cues, but not their temporal distribution. With regard to their influence on autobiographical memory, an overlap between some senses was found, with on one hand, olfaction and taste and, on the other, vision, audition, and touch. We discuss these findings in the light of theories of perception, memory, and the self, and consider methodological implications of the sensory cuing technique in memory research, as well as clinical implications for research in psychopathological and neuropsychological populations. (shrink)