The goal of this article is to shed light on Deep Brain Stimulation (DBS) postoperative suicidality risk factors within Treatment Resistant Depression (TRD) patients, in particular by focusing on the ethical concern of enrolling patient with history of self-estrangement, suicide attempts and impulsive–aggressive inclinations. In order to illustrate these ethical issues we report and review a clinical case associated with postoperative feelings of self-estrangement, self-harm behaviours and suicide attempt leading to the removal of DBS devices. Could prospectively identifying and excluding (...) patients with suicidality risk factors from DBS experimental trials—such as history of self-estrangement, suicide attempts and impulsive–aggressive inclinations—lead to minimizing the risk of suicidality harm? (shrink)

Clinical cases of frontal lobe lesions have been significantly associated with acquired aggressive behaviour. Restoring neuronal and cognitive faculties of aggressive individuals through invasive brain intervention raises ethical questions in general. However, more questions have to be addressed in cases where individuals refuse surgical treatment. The ethical desirability and permissibility of using intrusive surgical brain interventions for involuntary or voluntary treatment of acquired aggressiveness is highly questionable. This article engages with the description of acquired aggressiveness in general, and presents a (...) rare clinical case to illustrate the difficulties of treating this population. To expand the debate further, this article explores the ethics related to invasive brain surgery in three parts: a) it examines coercive involuntary invasive brain surgery for the benefit of protecting others on individuals suffering from acquired aggressiveness who lack decision-making capacities to consent; b) it addresses voluntary psychosurgery on individuals suffering from acquired aggressiveness who are competent to consent; and, c) it questions whether acquired aggressive individuals, who are legally competent, have a duty to consent to invasive brain surgery, in order to maintain their autonomy by reducing or even eliminate their aggressive drives. Ensuring the safety and efficacy of surgical brain interventions could increase the ethical permissibility of voluntary treatment, but it would not necessarily entail ethical justification for proceeding with invasive brain surgery for treatment of intractable acquired aggressive behaviour. (shrink)

Although an invasive medical intervention, Deep Brain Stimulation (DBS) has been regarded as an efficient and safe treatment of Parkinson’s disease for the last 20 years. In terms of clinical ethics, it is worth asking whether the use of DBS may have unanticipated negative effects similar to those associated with other types of psychosurgery. Clinical studies of epileptic patients who have undergone an anterior temporal lobectomy have identified a range of side effects and complications in a number of domains: psychological, (...) behavioural, affective and social. In many cases, patients express difficulty adjusting from being chronically ill to their new status as ‘treated’ or ‘seizure free’. This postoperative response adjustment has been described in the literature on epilepsy as the ‘Burden of Normality’ (BoN) syndrome. Most of the discussion about DBS postoperative changes to self is focused on abnormal side effects caused by the intervention (ie, hypersexuality, hypomania, etc). By contrast, relatively little attention is paid to the idea that successfully ‘treated’ individuals might experience difficulties in adjusting to becoming ‘normal’. The purpose of this paper is (1) to articulate the postoperative DBS psychosocial adjustment process in terms of the BoN syndrome, (2) to address whether the BoN syndrome illustrates that DBS treatment poses a threat to the patient’s identity, and (3) to examine whether the current framework for rehabilitation after DBS procedures should be updated and take into account the BoN syndrome as a postoperative self-change response. (shrink)

Deep brain stimulation (DBS) is optimistically portrayed in contemporary media. This already happened with psychosurgery during the first half of the twentieth century. The tendency of popular media to hype the benefits of DBS therapies, without equally highlighting risks, fosters public expectations also due to the lack of ethical analysis in the scientific literature. Media are not expected (and often not prepared) to raise the ethical issues which remain unaddressed by the scientific community. To obtain a more objective portrayal of (...) DBS in the media, a deeper collaboration between the science community and journalists, and particularly specialized ones, must be promoted. Access to databases and articles, directly or through science media centers, has also been proven effective in increasing the quality of reporting. This article has three main objectives. Firstly, to explore the past media coverage of leukotomy, and to examine its widespread acceptance and the neglect of ethical issues in its depiction. Secondly, to describe how current enthusiastic coverage of DBS causes excessive optimism and neglect of ethical issues in patients. Thirdly, to discuss communication models and strategies to enhance media and science responsibility. (shrink)

Postmortem evidence of chronic traumatic encephalopathy (CTE) in the brains of American National Football League players who suffered concussions while playing have intensified concerns about the risks of concussion in sport.1 Concussions are frequently sustained by amateur and professional players of Australia’s three most popular football codes (Australian football, rugby league, and rugby union) and, to a lesser extent, other contact sports such as soccer. This raises major concerns about possible long-term neurological damage, cognitive impairment and mental health problems in (...) players of these sports. (shrink)

Postmortem research on the brains of American tackle football players has revealed the presence of chronic traumatic encephalopathy (CTE), a degenerative brain disease caused by repeated head trauma. Repeated concussion is a risk factor for CTE, raising ethical concerns about the long-term effects of concussion on athletes at risk for football-related concussion. Of equal concern is that youth athletes are at increased risk for lasting neurocognitive and developmental deficits that can result in behavioral disturbances and diminished academic performance. In this (...) article, we consider evidence of the effects of concussion in youth athletes, and discuss ethical duties to youth athletes and how these duties might be satisfied, given the intrinsic risks of football. Finally, we evaluate potential strategies for reducing concussions in junior football, and recommend the optimal strategy for reducing brain injury to an acceptable level while still making available the benefits of football participation for youth athletes. (shrink)

Although being generally safe, the use of Deep Brain Stimulation has been associated with a significant number of patients experiencing postoperative psychological and neurological harm within experimental trials. A proportion of these postoperative severe adverse effects have lead to the decision to medically prescribe device deactivation or removal. However, there is little debate in the literature as to what is in the patient’s best interest when device removal has been prescribed; in particular, what should be the conceptual approach to ethically (...) guide the decision to remove or maintain implants. The purpose of this article is to examine the ethical issues raised when patients refuse brain device explantation despite medical prescription. In order to illustrate these issues, we report and discuss a clinical case involving a patient suffering from treatment resistant depression who experienced forms of postoperative self-estrangement, as well as suicidal attempts, but who resists giving consent to device explantation. (shrink)

Current discussions about concussion in sport are based on a crucial epistemological question: whether or not we should believe that repetitive mild Traumatic Brain Injury causes Chronic Traumatic Encephalopathy. This epistemological question is essential to understanding the ethics at stake in treating these cases: indeed, certain moral obligations turn on whether or not we believe that mTBI causes CTE. After discussing the main schools of thought, namely the CTE-sceptic position and the CTE-orthodox position, this article examines the concussion debate in (...) sport and asks if its current articulation helps to answer whether or not we should call for responsive, ethical action. (shrink)

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute (...) incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial. (shrink)

In their paper “Deflating the neuroenhancement bubble”, more precisely in their section entitled “How New is Neuroenhancement?”, Lucke and colleagues argue that neuroenhancement is nothing new to our epoch by demonstrating that the use of psychoactive stimulants in the 19th and 20th centuries was already common. The purpose of our comment is to show that the current bubble surrounding neuroenhancement in particular, and enhancement in general, is a recasting of an even older speculative engagement that can be traced back from (...) the 16th to the 18th centuries. As a consequence, there is a high risk that bioethicists might not have captured or found new conceptual challenges related to current enhancement debate. As well, by ignoring issues related to ancient debate, we argue that modern bioethicists risk spending effort on speculative ethics. (shrink)

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical (...) issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

In their article published in Nanoethics, “Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques”, Berger et al. suggest that there may be a prima facie moral obligation to improve neuro implants with nanotechnology given their possible therapeutic advantages for patients [Nanoethics, 2:241–249]. Although we agree with Berger et al. that developments in nanomedicine hold the potential to render brain implant technologies less invasive and to better target neural stimulation to respond to brain impairments in the near (...) future, we argue against presenting the development of nanobionic clinical devices in terms of a moral obligation to conduct this research. In the first part of the paper, we consider what a duty to pursue new technologies might mean, and in the second we explore some of the negative consequences of defending such development as a moral obligation based on potential benefit. We argue that promoting the advances available to brain implants through developments in nanotechnology and bionics could contribute to medical rhetoric that indirectly increases the risk of exposing patients to harm when participating in clinical trials. We argue that rather than there being a moral obligation to improve nanobionics implants because of their potential benefit, the pursuit of improved neuro implants must be balanced against the prima facie obligations to protect patients against harm and to promote and protect patient autonomy. (shrink)

Concussion and Mild Traumatic Brain Injury affect millions of people worldwide. mTBI has been called the “signature injury” of the recent conflicts in Iraq and Afghanistan, affecting thousands of active duty service men and women, and veterans. Sport-related concussion represents a significant public health problem, with elite and professional athletes, and millions of youth and amateur athletes worldwide suffering concussions annually. These brain injuries have received scant attention from neuroethicists, and the focus of this special issue is on defining the (...) ethical considerations and developing and elucidating the neuroethical contributions to the discussion about concussion and mTBI. (shrink)

Taiwan has a population of 23 million, of which some 500,000 are Aborigines. Recent conflicts over a national biobank as part of Taiwan's biotechnological industrial development, genetic research on Aboriginal origins, and commercialization of research findings involving Aborigines have raised a number of important ethical conflicts. These ethical conflicts involve on one hand, the importance of researchers' duties, and on the other hand, Aboriginal rights. This paper will go in three steps. First, this paper describes the three cases of ethical (...) violations of Aboriginal rights committed by Taiwanese researchers in the course of their scientific duties. After having given an account of ethical conflicts between research duties and Aboriginal rights, the paper addresses larger ethical issues underlying this Taiwanese research context. Finally, the paper considers if stronger ethical regulation could reconcile Aboriginal rights and research duties. (shrink)

Despite growing evidence that a significant number of patients living with Parkison’s disease experience neuropsychiatric changes following Deep Brain Stimulation treatment, the phenomenon remains poorly understood and largely unexplored in the literature. To shed new light on this phenomenon, we used qualitative methods grounded in phenomenology to conduct in-depth, semi-structured interviews with 17 patients living with Parkinson’s Disease who had undergone DBS. Our study found that patients appear to experience postoperative DBS-induced changes in the form of self-estrangement. Using the insights (...) from patients’ subjective perceptions of postoperative self-change provides a potent explanation of potential DBS-induced self-estrangement. (shrink)

Purpose With the increasing sophistication of neuroimaging technologies in medicine, new language is being sought to make sense of the findings. The aim of this paper is to explore whether the brain-reading metaphor used to convey current medical or neurobiological findings imports unintended significations that do not necessarily reflect the genuine findings made by physicians and neuroscientists. Methods First, the paper surveys the ambiguities of the readability metaphor, drawing from the history of science and medicine, paying special attention to the (...) sixteenth through nineteenth centuries. Next, the paper addresses more closely the issue of how metaphors may be confusing when used in medicine in general, and neuroscience in particular. The paper then explores the possible misleading effects associated with the contemporary use of the brain-reading metaphor in neuroimaging research. Results Rather than breaking new ground, what we see in current scientific language is a persistence of both a constraining and expansive set of language practices forming a relatively continuous tradition linking current neuroimaging to past scientific investigations into the brain. Conclusions The use of the readability metaphor thus carries with it both positive and negative effects. Physicians and neuroscientists must resort to the use of terms already laden with abstracted meanings, and often burdened by tradition, at the risk of importing through these words connotations that do not tally with the sought-after objectivity of empirical science. (shrink)

In early 2009, President Obama overturned the ban on federal funding for research involving the derivation of human embryonic stem cells (hESC). The Food and Drug Administration (FDA) also approved Geron’s first-in-human hESC trial for spinal cord injury (SCI) patients. We anticipate an increase in both research in the United States to derive hESC and applications to the FDA for approval of clinical trials involving transplantation of hESCs. An increase of such clinical trials will require a concomitant increase in the (...) number of preceding preclinical assays. We examine important issues concerning the use of animals in SCI stem cell research that require a reevaluation of the moral permissibility of studies such as Geron’s. (shrink)

The purpose of this commentary is to address an ethical issue introduced by Walter Glannon regarding whether responsibility can be affected by the use of performance enhancing drugs. Glannon uses the example of a surgeon taking drugs to enhance her capacities. I explore whether conducting surgeries while under the influence of performance enhancing drugs will affect the surgeon’s responsibility for performing more surgeries ‘and’ the surgeon’s responsibility for assuming the consequences of performing these surgeries. Here, the ‘and’ is cumulative: one (...) is responsible for performing ‘and’ one is responsible for having taken performance enhancing drugs. Given that such accumulation could be interpreted as “more responsible”, this might challenge Glannon’s conclusion and impact the normative practices associated with enhancement drugs. (shrink)

In her article, Pascale Hess raises the issue of whether her proposed model may be extrapolated and applied to clinical research fields other than stem cell-based interventions in the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s model suggests prioritizing efficacy over safety in phase 1 trials involving irreversible interventions in the brain, when clinical criteria meet the appropriate population suffering from “degenerative brain diseases” (Hess 2012). Although there is a need to reconsider the traditional phase 1 model, especially with respect (...) to first-in-human clinical trials involving novel technologies, the question arises as to whether it is appropriate to advocate for a new model that prioritizes efficacy over safety across all phase 1 clinical research trials involving irreversible interventions in the brain. -/- . (shrink)

Taiwan has a population of 23 million, of which some 500,000 are Aborigines. Recent conflicts over a national biobank as part of Taiwan's biotechnological industrial development, genetic research on Aboriginal origins, and commercialization of research findings involving Aborigines have raised a number of important ethical conflicts. These ethical conflicts involve on one hand, the importance of researchers' duties, and on the other hand, Aboriginal rights. This paper will go in three steps. First, this paper describes the three cases of ethical (...) violations of Aboriginal rights committed by Taiwanese researchers in the course of their scientific duties. After having given an account of ethical conflicts between research duties and Aboriginal rights, the paper addresses larger ethical issues underlying this Taiwanese research context. Finally, the paper considers if stronger ethical regulation could reconcile Aboriginal rights and research duties. (shrink)