The divide so wide: Public perspectives on the role of human genome editing in the US healthcare system.

We report findings from two open-framed focus groups eliciting informed public opinion about the rapidly developing technology of human genome editing in the context of the US healthcare system. Results reveal that participants take a dim view of the present healthcare system, articulating extensive concerns about the accessibility and affordability of care. They feel that, unless these problems are resolved, they stand little chance of benefiting from any eventual human genome editing treatments. They prioritize improvement in healthcare access well above human genome editing development, and human genome editing regulation and oversight above human genome editing research. These results reveal substantial divergence between public perspectives and expert discourse on human genome editing. The latter attends primarily to the moral permissibility of technical categories of human genome editing research and how to treat human genome editing within existing regulatory and oversight systems rather than broader political-economic and healthcare access concerns. This divergence illustrates the importance of openly framed public engagement around emerging technologies.

Researching the future: scenarios to explore the future of human genome editing.

BACKGROUND: Forward-looking, democratically oriented governance is needed to ensure that human genome editing serves rather than undercuts public values. Scientific, policy, and ethics communities have recognized this necessity but have demonstrated limited understanding of how to fulfill it. The field of bioethics has long attempted to grapple with the unintended consequences of emerging technologies, but too often such foresight has lacked adequate scientific grounding, overemphasized regulation to the exclusion of examining underlying values, and failed to adequately engage the public. METHODS: This research investigates the application of scenario planning, a tool developed in the high-stakes, uncertainty-ridden world of corporate strategy, for the equally high-stakes and uncertain world of the governance of emerging technologies. The scenario planning methodology is non-predictive, looking instead at a spread of plausible futures which diverge in their implications for different communities' needs, cares, and desires. RESULTS: In this article we share how the scenario development process can further understandings of the complex and dynamic systems which generate and shape new biomedical technologies and provide opportunities to re-examine and re-think questions of governance, ethics and values. We detail the results of a year-long scenario planning study that engaged experts from the biological sciences, bioethics, social sciences, law, policy, private industry, and civic organizations to articulate alternative futures of human genome editing. CONCLUSIONS: Through sharing and critiquing our methodological approach and results of this study, we advance understandings of anticipatory methods deployed in bioethics, demonstrating how this approach provides unique insights and helps to derive better research questions and policy strategies.

Seven open questions in the futures of human genome editing.

Scholarly discussion around the governance of human genome editing (HGE) recognizes that development and application of HGE techniques could result in unexpected societal outcomes. However, it contains few to no methodological models for how to anticipate, prepare for, or shape such outcomes. This article presents early-stage results from research guided by anticipatory governance, a framework for broad expert and public consideration of innovation processes and purposes. We present and discuss key themes emerging from a set of future-oriented interviews with genome editing practitioners and experts, designed to inform broadly scoped deliberations about plausible futures of HGE. We articulate our results as seven "open questions," the answers to which will be important components of HGE's eventual shape and outcomes. Some themes are perennial in studies of science and society, and others are more novel to HGE. Each helps to reframe HGE beyond a simple comparison of risk and benefit. Such reframing opens up new and important terrain for discussion among policymakers, academics, scientists, and publics. We suggest that discussion framed around broad and reflexive questions like those presented here will help governance efforts to better acknowledge and flexibly respond to the uncertainty and complexities of HGE developments.

Toward Anticipatory Governance of Human Genome Editing: A Critical Review of Scholarly Governance Discourse.

The rapid development of human genome editing (HGE) techniques evokes an urgent need for forward-looking deliberation regarding the aims, processes, and governance of research. The framework of anticipatory governance (AG) may serve this need. This article reviews scholarly discourse about HGE through an AG lens, aiming to identify gaps in discussion and practice and suggest how AG efforts may fill them. Discourse on HGE has insufficiently reckoned with the institutional and systemic contexts, inputs, and implications of HGE work, to the detriment of its ability to prepare for a variety of possible futures and pursue socially desirable ones. More broadly framed and inclusive efforts in foresight and public engagement, focused not only upon the in-principle permissibility of HGE activities but upon the contexts of such work, may permit improved identification of public values relevant to HGE and of actions by which researchers, funders, policymakers, and publics may promote them.

Characterizing Direct-to-Consumer Stem Cell Businesses in the Southwest United States.

There are currently hundreds of businesses across the United States offering direct-to-consumer stem cell treatments that have not been through regulatory approval by the Food and Drug Administration (FDA). Here, we provide a detailed characterization of nearly 170 stem cell businesses operating in the Southwest United States. We draw specific attention to two as-yet understudied facets of these businesses. First, we identify differences in the degree to which a given business focuses their practice on stem cell treatments. Second, we compare the stated expertise of the care providers in stem cell businesses with the range of conditions they purport to treat. These findings deepen our knowledge of the growing industry around unapproved stem cell treatments, and are used here to offer suggestions for how the FDA might target its resources with respect to regulatory oversight.

Victim, perpetrator, family, and incident characteristics of infant and child homicide in the United States Air Force.

OBJECTIVE: The present study describes factors related to fatal abuse in three age groups in the United States Air Force (USAF). METHOD: Records from 32 substantiated cases of fatal child abuse in the USAF were independently reviewed for 60 predefined factors. RESULTS: Males were over-represented in young child victims (between 1 year and 4 years of age) and child victims (between 4 years and 15 years of age) but not in infant victims (between 24 hours and 1 year of age). African-American infant victims and perpetrators were over-represented. Younger victims were more likely to have been previously physically abused by the perpetrator. Perpetrators were predominantly male and the biological fathers of the victims. Infant and young child perpetrators reported childhood abuse histories, while child perpetrators reported the highest frequency of mental health contact. Victims' families reported significant life stressors. Families of young child victims were more likely divorced, separated, or single. Incidents with infants and young children tended to occur without witnesses; incidents with child victims tended to have the victim's sibling(s) and/or mother present. Fatal incidents were more frequent on the weekend, in the home, and initiated by some family disturbance. CONCLUSIONS: Differences among groups in factors related to infant and child homicide across age groups may assist in the development of more tailored abuse prevention efforts and may also guide future investigations.

ECT Treatment of Demented Elderly Patients with Major Depression: A Retrospective Study of Efficacy and Safety.

Retrospective analysis of a 4-year sample of demented patients who had major depression and who were treated with electroconvulsive therapy (ECT) showed that they responded as well to ECT as did a previously studied group of elderly depressed subjects from our institution. Cardiac side effects were no greater in this group, but some patients did have transitory increased confusion. ECT is a safe and effective therapy for the demented patient who has concomitant major depression and who has proven to be resistant to tricyclic antidepressant drug therapy, is intolerant of such medicines, or requires emergency treatment.

Efficacy and Safety of Combined ECT and Tricyclic Antidepressant Drugs in the Treatment of Depressed Geriatric Patients.

Clinical outcome of 84 elderly unipolar depressed patients who had received electroconvulsive therapy (ECT), with or without concurrent tricyclic antidepressant medication, was reviewed retrospectively to discover if predictions based on preclinical studies of increased efficacy with combined treatment would be supported. Global outcome at discharge was improved for those patients who had received tricyclic antidepressant drugs concurrent with ECT. They also required fewer ECT treatments to achieve that improvement. Total seizure times were markedly reduced for the combined therapy group, which was an unexpected finding.