The enduring psychiatric myth is that particular personal, interpersonal and social problems in living are manifestations of ‘mental illness’ or ‘mental disease’, which can only be addressed by ‘treatment’ with psychiatric drugs. Psychiatric drugs are used only to control ‘patient’ behaviour and do not ‘treat’ any specific pathology in the sense understood by physical medicine. Evidence that people, diagnosed with ‘serious’ forms of ‘mental illness’ can ‘recover’, without psychiatric drugs, has been marginalized by (...) drug-focused research, much of this funded by the pharmaceutical industry. The pervasive myth of psychiatric drugs dominates much of contemporary ‘mental health’ policy and practice and raises discrete ethical issues for nurses who claim to be focused on promoting or enabling the ‘mental health’ of the people in their care. (shrink)

Physicians who care for critically ill people with opioid use disorder frequently face medical, legal, and ethical questions related to the provision of life-saving medical care. We examine a complex medical case that illustrates these challenges in a person with relapsing injection drug use. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of life-saving care to such individuals? If so, how should such determinations be made? If not, what alternative decisionmaking (...) framework exists? We determine that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes. Instead, we are welladvised to explore each patient's situation in a holistic approach that includes the patient, family members, and care providers in the decision-making process. The scope of the problem illustrated demonstrates the urgent need to definitively improve outcomes in people who use injection drugs. Increasing access to high quality medication-assisted treatment and psychiatric care for individuals with opioid use disorder will help our patients achieve a sustained remission and allow us to reach this goal. (shrink)

In this paper, we examine the case of psychedelic medicine for Alzheimer’s disease and related dementias (AD/ADRD). These “mind-altering” drugs are not currently offered as treatments to persons with AD/ADRD, though there is growing interest in their use to treat underlying causes and associated psychiatric symptoms. We present a research agenda for examining the ethics of psychedelic medicine and research involving persons living with AD/ADRD, and offer preliminary analyses of six ethical issues: the impact of psychedelics on (...) autonomy and consent; the impact of “ego dissolution” on persons experiencing a pathology of self; how psychedelics might impact caregiving; the potential exploitation of patient desperation; institutional review boards’ orientation to psychedelic research; and methods to mitigate inequity. These ethical issues are magnified for AD/ADRD but bear broader relevance to psychedelic medicine and research in other clinical populations. (shrink)

BackgroundDrug user networks and community-based organizations advocate for greater, meaningful involvement of people with lived experience of drug use in research, programs and services, and policy initiatives. Community-based approaches to research provide an opportunity to engage people who use drugs in all stages of the research process. Conducting community-based participatory research with people who use drugs has its own ethical challenges that are not necessarily acknowledged or supported by institutional ethics review boards. We conducted a scoping review (...) to identify ethical issues in CBPR with people who use drugs that were documented in peer-reviewed and grey literature.MethodsThe search strategy focused on three areas; community-based research, ethical issues, and drug use. Searches of five academic databases were conducted in addition to a grey literature search, hand-searching, and consultation with organizational partners and key stakeholders. Peer reviewed literature and community reports published in English between 1985 and 2013 were included, with initial screening conducted by two reviewers.ResultsThe search strategy produced a total of 874 references. Twenty-five references met the inclusion criteria and were included in our thematic analysis. Five areas were identified as important to the ethics of CBPR with people who use drugs: 1) participant compensation, 2) drug user perspectives on CBPR, 3) peer recruitment and representation in CBPR, 4) capacity building, and 5) participation and inclusion in CBPR.ConclusionsWe critically discuss implications of the emerging research in this field and provide suggestions for future research and practice. (shrink)

The author raises the ethical problem of the widespread use of drugs such as Prozac, among individuals with normal mental disorders, such as nostalgia or discomfort. Referring to the work of practitioner P. Kramer, the author shows that Prozac is a psychiatric tool allowing individuals to better integrate into a society increasingly medicalized.

Providing in-utero treatments to target specific conditions in the fetus is a relatively new approach in perinatal care, with the vast majority of these treatments being used off-label. The high degree of off-label medication use in the perinatal and neonatal settings raises concern for the safety of both the fetuses and expectant mothers. This report presents two examples of intra-amniotic drug administration based on reported clinical cases. From the ethical framework of medical principlism, we examine the competing ethical duties of (...) autonomy, beneficence, and non-maleficence in this setting. We then lay out three fundamental ethical principles for obtaining informed consent and maximizing clinical benefit. (shrink)

According to several recent studies, a big chunk of college students in North America and Europe uses so called ‘smart drugs' to enhance their cognitive capacities aiming at improving their academic performance. With these practices, there comes a certain moral unease. This unease is shared by many, yet it is difficult to pinpoint and in need of justification. Other than simply pointing to the medical risks coming along with using non-prescribed medication, the salient moral question is whether these (...) practices are troubling in and of themselves. In due consideration of empirical insights into the concrete effects of smart drugs on brain and behavior, our attempt is to articulate wherein this moral unease consists and to argue for why the authors believe cognitive enhancement to be morally objectionable. The authors will contend that the moral problem with these practices lies less in the end it seeks, than in the underlying human disposition it expresses and promotes. Some might ask, what is wrong with molding our cognitive capacities to achieve excellence, get a competitive edge, or, as the whim takes us? In all of these occasions, the usage of smart drugs serves a certain goal, a telos. The goal is, broadly speaking, this: outsmarting opponents in an arms race for limited resources and thereby yielding a competitive edge. In plain words: competition is valued higher than cooperation or solidarity. What is wrong with striving for this goal? The authors submit that the question whether people really want to live in a society that promotes the mentality ‘individual competition over societal cooperation' deserves serious consideration. In developing their answer, the authors draw on an ‘Ethics of Constraint' framework, arguing that widespread off-label use of smart drugs bears the risk of negative neural/behavioral consequences for the individual that might, in the long run, be accompanied by changing social value orientations for the worse. (shrink)

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways (...) that such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making. (shrink)

Recent research in neurochemistry has shown there to be a number of chemical compounds that are implicated in the patterns of lust, attraction, and attachment that undergird romantic love. For example, there is evidence that the phenomenon of attachment is associated with the action of oxytocin and vasopressin. There is therefore some reason to suppose that patterns of lust, attraction, and attachment could be regulated via manipulation of these substances in the brain: in other words, by their use as 'love (...) drugs'. A growing bioethical literature asks searching questions about this prospect, and especially about the use of such drugs to enhance or reignite attachment in flagging relationships. This Element examines some of the central arguments on the topic, and sounds a note of caution. It urges that there are reasons to think the states of attachment produced or facilitated by the use of such drugs would not be desirable. (shrink)

Science fiction is fast becoming reality as scientists and engineers seek to develop new ways of directly accessing and controlling our brains through brain-computer and even brain-to-brain interfaces. If such research is to receive continuing public approval and support—and not invite opposition—it must anticipate the special ethical challenges it creates. By pointing to some of the acute concerns raised by neural engineering technologies—around issues of identity, normality, authority, responsibility, privacy, and justice—Eran Klein and colleagues model and stimulate the kind of (...) reflection that will be needed as new brain technologies are developed. And yet, as I read their informative discussion, I find myself asking even more questions. One concerns the ethical novelty of these technologies. For example, in terms of questions of identity, normality, responsibility, and authority, how different is deep brain stimulation from the potent psychiatric drugs that have been administered for decades? How different in terms of issues of liability associated with malfunction or misuse are brain-computer interfaces from other complex devices now routinely in use? Neither ethics nor law will have to rethink things from scratch as new neural devices and capabilities are introduced: the groundwork for answering some of these questions has already been laid in a variety of fields from bioethics, to health and product liability law. Nevertheless, I conclude that there are new questions here. It is not simply the fact that neural technologies pose questions of identity, privacy, and the like but that they do so with a degree of intensity that creates qualitatively new challenges. (shrink)

In Gustavsson et al,1 we discussed the ethical issues that arise when identifying the relevant population for disease-modifying drugs targeting Alzheimer disease. More specifically, we focused on novel immunotherapies aimed at amyloid β and tau, two relevant biomarkers. The commentaries to our paper2 3 acknowledge our conclusion: screening for AD involve ethical costs that cannot be justified unless a drug with clinically relevant effect becomes available. Since Aduhelm is the only immunotherapy targeting AD currently approved by the Food and (...) Drug Administration, we use that as a …. (shrink)

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how (...) organized psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process. (shrink)

The possibility that industry is exerting an undue influence on the culture of medicine has profound implications for the profession's public health mission. Policy analysts, investigative journalists, researchers, and clinicians have questioned whether academic-industry relationships have had a corrupting effect on evidence-based medicine. Psychiatry has been at the heart of this epistemic and ethical crisis in medicine. This article examines how commercial entities, such as pharmaceutical companies, influence psychiatric taxonomy and treatment guidelines. Using the conceptual framework of institutional (...) corruption, we show that organized psychiatry's dependence on drug firms has led to a distortion of science. We describe the current dependency corruption and argue that transparency alone is not a solution. We conclude by taking the position that the corruption of the evidence base in diagnostic and practice guidelines has compromised the informed consent process, and we suggest strategies to address this problem. (shrink)

인지 향상 약물은 안전성에 따른 위험에 대한 염려, 정의와 공정한 기회의 위협 그리고 인간 정체성과 정통성의 변화 등과 같은 윤리적 문제를 야기하고 있다. 또한 인지 향상 약물에 대한 의료 행위를 함에 있어서도 치료와 향상을 경계 짓기 위한 질병 및 정상 상태에 대한 정의가 모호하다는 한계점을 가진다. 이러한 점에서 본 논문에서는 인지 향상 약물사용을 위한 윤리적 실천 방안으로서 공동의사결정과정을 통한 자율성 존중의 강화와 선행에 근거한 위험-이익 분석 기준을 강화하는 방법을 제안하고자 한다. 구체적으로 인지향상 약물을 사용하고자 환자는 의사로부터 약물에 대한 충분한 정보를 (...) 제공받아야 하며 이를 통해 자신의 가치와 선호 따라 결정할 수 있어야 할 것이다. 또한 의사는 개별 환자의 약물 사용이 적절한지를 평가하기 위해서 동일한 약물이 다른 생명의료 중재를 위해 폭넓게 사용될 수 있으며 약물 사용의 결과 또한 다양하게 나타날 수 있다는 것을 인식하고 이를 올바르게 적용하기 위한 능력을 함양해야 할 것이다. 그리고 이에 근거하여 획일화된 기준이 아니라 개별 환자에게 적절한 위험-이익 분석 기준을 설정해야 할 것이다. 다시 말해 인지 향상 약물의 올바른 사용을 위해서는 무엇보다도 각각의 사례를 일반화시키고자 하는 것이 아니라 개별 환자의 상황에 따른 개별 단계에 초점을 맞추어 문제를 해결하고자 하는 노력이 요청된다. 또한 의사결정을 내림에 있어서도 단순히 자율성에 근거한 결정을 맹신하지 않고 환자-의사 관계의 상호성에 대한 인식을 바탕으로 개별 환자를 위한 최선의 결정을 내릴 수 있도록 하는 공동의사결정과정 체계가 구축되어야 할 것이다. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Pregnant adolescents have a higher risk of poor maternal and fetal outcomes, particularly in the setting of concomitant maternal alcohol and other drug (AOD) use. Despite numerous programmes aimed at reducing overall teen pregnancy rates and the recognition of AOD use as a risk factor for unintended pregnancy in adolescents, interventions targeting this specific group have been sparse. In adult drug-using women, financial incentives for contraception have been provided but are ethically controversial. This article explores whether a trial could (...) ethically employ monetary incentives in adolescents with AOD use to promote the use of long-acting reversible contraception (LARC), with special attention to the relevant distinctions between adults and adolescents. We conclude that a trial of incentives to promote LARC in this patient population is ethically permissible if the incentives are small, are tied to completion of an educational activity to minimise the quick fix temptation and potential for non-attendance to the risks and benefits of LARC and are provided only to the adolescent after an assessment of her reasoning to rule out coercion (eg, by guardians) as motivation. Information about treatment for AOD use and follow-up care in case of problems with the contraceptive or desire for removal should also be provided. Before implementing such a trial, qualitative research with input from providers, potential patients and their parents should be conducted to inform the programme's specific structure. (shrink)

Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research....

In this essay, I use the theological anthropology of the apostle Paul as a diagnostic lens in order to bring into focus some implicit assumptions about human personhood in the goals and methods of treatment with psychotropic medications. I argue that Paul views the body as a mode of participation in larger relational matrices in both vulnerable and vital ways. He thus sees the self as constituted relationally rather than as fundamentally isolated and self-determining. Such an understanding of personhood yields (...) an account of human agency as co-constituted and freedom as interpersonally mediated and sustained. From this perspective, the proper goal for psychiatric medication is the removal of barriers to life-giving human connections; methods of care for persons in psychological distress may include medication, but they also require embodied personal encounter. (shrink)

Background: Psychedelics are known for their powerful mental effects due to the activation of 5HT-2A receptors in the brain. During the 1950s and 1960s, research was conducted on these molecules until their criminalization. However, their clinical investigation as therapeutic tools for psychiatric disorders has revived the deontological ethics surrounding this subject. Questions arise as research on their therapeutic outcome becomes a reality. We aim to explore deontological ethics to understand the implications of psychedelics for the clinician, patient, (...) and society. Results: A total of 42 articles were considered for this review. Methods: A methodological search of psychedelic studies from 2017 to 2022 was conducted in PubMed, Scopus, EBSCOhost, and ScienceDirect to address the deontological ethics of clinical psychedelic use. Conclusion: Psychedelics need to be culturally contextualized, epistemic harm minimized and represented to ensure informed consent. Open data and commissions are needed to ensure safe and equal distribution. (shrink)

The war on drugs is widely criticized as unjust. The idea that the laws prohibiting drugs are unjust can easily lead to the conclusion that those laws do not deserve our respect, so that our only moral reason to obey them flows from a general moral obligation to obey the law, rather than from anything morally troubling about drug use itself. In this paper, I argue that this line of thinking is mistaken. I begin by arguing that the (...) drug laws are indeed unjust. However, so long as they remain prohibited, I argue that we have strong moral reasons to avoid drug use. First, drug users are partly responsible for the violent and exploitative conditions in which many drugs are produced and distributed. Second, the unequal ways in which drug laws are enforced make drug use by many an unethical exercise of privilege. These reasons do not depend on the existence of a general moral obligation to obey the law; we ought to refrain from illegal drug use even if prohibition is unjust and even if we have no general obligation to obey the law. In fact, drug laws turn out to represent an interesting exception case within the broader debate about this obligation, and I argue that it is the very injustice of the law that generates the reasons not to violate it. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Cannabis use in some individuals can meaningfully introduce de novo risk for the initiation of opioid use and development of opioid use disorder. These risks may be particularly high during adolescence when cannabis use may disrupt critical periods of neurodevelopment. Current research studying the combination of genetic and environmental factors involved in substance use disorders is poorly understood. More research is needed, particularly to identify which adolescents are most at risk and to develop effective interventions addressing contributing factors such as (...) trauma and psychiatric comorbidity. (shrink)

Undergraduates (total N = 185) were asked about performance-affecting drugs. Some drugs supposedly affected athletic performance, others memory, and others attention. Some improved performance for anyone who took them, others for the top 10% of performers, others for the bottom 10%, and finally, yet other drugs worked only on the bottom 10% who also showed physical abnormalities. Participants were asked about the fairness of allowing the drug to be used, about banning it, and about whether predictions of (...) future performance based on testing with or without the drug were better. The study found that participants appreciated the "interaction effect", that they felt it was less unfair to allow the drug if it affected the bottom 10% than if it affected everyone, and they were more eager to have the drug banned if it affected everyone. Participants were least tolerant of drugs that affected athletic performance and most tolerant of those that affected attention. (shrink)

In early 1984, the AIDS epidemic was less than four years old. Chemists at the pharmaceutical company Syntex, situated in the rolling green hills near Stanford University in Palo Alto, California, had recently synthesized a new antiviral drug (Martin et al. 1983). The drug, at first given the awkward chemical abbreviation DHPG, later came to be known by the generic name ganciclovir. Ganciclovir was a potent drug for the treatment of herpes virus infection (such as genital herpes or chickenpox), but (...) the unique characteristic of ganciclovir was that it worked against cytomegalovirus (CMV), a heretofore untreatable virus infection. Although relatively harmless in healthy individuals, CMV caused .. (shrink)

Deep brain stimulation (DBS) has been proposed as a potential treatment of drug addiction on the basis of its effects on drug self-administration in animals and on addictive behaviours in some humans treated with DBS for other psychiatric or neurological conditions. DBS is seen as a more reversible intervention than ablative neurosurgery but it is nonetheless a treatment that carries significant risks. A review of preclinical and clinical evidence for the use of DBS to treat addiction suggests that more (...) animal research is required to establish the safety and efficacy of the technology and to identify optimal treatment parameters before investigating its use in addicted persons. Severely addicted persons who try and fail to achieve abstinence may, however, be desperate enough to undergo such an invasive treatment if they believe that it will cure their addiction. History shows that the desperation for a cure of addiction can lead to the use of risky medical procedures before they have been rigorously tested. In the event that DBS is used in the treatment of addiction, we provide minimum ethical requirements for clinical trials of its use in the treatment of addiction. These include: restrictions of trials to severely intractable cases of addiction; independent oversight to ensure that patients have the capacity to consent and give that consent on the basis of a realistic appreciation of the potential benefits and risks of DBS; and rigorous assessments of the effectiveness and safety of this treatment compared to the best available treatments for addiction. (shrink)

Are universities justified in trying to regulate student use of cognitive enhancing drugs? In this article I argue that they can be, but that the most appropriate kind of regulatory intervention is likely to be voluntary in nature. To be precise, I argue that universities could justifiably adopt a commitment contract system of regulation wherein students are encouraged to voluntarily commit to not using cognitive enhancing drugs. If they are found to breach that commitment, they should be (...) penalized by, for example, forfeiting a number of marks on their assessments. To defend this model of regulation, I adopt a recently-proposed evaluative framework for determining the appropriateness of enhancement in specific domains of activity, and I focus on particular existing types of cognitive enhancement drugs, not hypothetical or potential forms. In this way, my argument is tailored to the specific features of university education, and common patterns of usage among students. It is not concerned with the general ethical propriety of using cognitive enhancing drugs. (shrink)

Illicit drug users are frequently identified as a ‘vulnerable population’ requiring ‘special protection’ and ‘additional safeguards’ in research. However, without specific guidance on how to enact these special protections and safeguards, research ethics committee (REC) members sometimes fall back on untested assumptions about the ethics of illicit drug use research. In light of growing calls for ‘evidence-based research ethics’, this commentary examines three common assumptions amongst REC members about what constitutes ethical research with drug users, and whether (...) such assumptions are borne out by a growing body of empirical data. The assumptions that form the focus of this commentary are as follows: (i) drug users do not have the capacity to provide informed consent to research; (ii) it is ethically problematic to provide financial incentives to drug users to participate in research; and (iii) asking drug users about their experiences ‘re-traumatizes’ and ‘re-victimizes’ them. (shrink)

Background Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat mental disorders and may raise different ethical concerns than other therapies such as medications or talk therapy. Yet little is known about stakeholders’ perceptions of, and ethical concerns related to, these interventions. We aimed to better understand the ethical concerns of a variety of stakeholder groups (patients with depression, caregivers of patients, members of the public, and psychiatrists) regarding four PEIs: electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (...) (rTMS), deep brain stimulation (DBS), and adaptive brain implants (ABI).Methods We conducted a national survey of these four stakeholder groups, using an embedded video vignette experiment depicting a patient with treatment-resistant depression and her psychiatrist discussing the possibility of treatment with one of the four PEIs.Results Participants’ ethical concerns varied by stakeholder group, by PEI, and by the interaction of the two. The three non-clinician groups tended to have similar ethical concerns, but to differ from psychiatrists. Similar concerns were raised with regard to the two implantable technologies, DBS and ABI. Overall, there was relatively little concern about the involuntary use of PEIs, though some expressed concern about the adequacy of information provided during the consent process. There was also significant concern that patients may not receive helpful therapies.Conclusions To our knowledge, this is the first national survey that includes multiple stakeholder groups and multiple PEI modalities. A better understanding of the ethical concerns of stakeholders can help to shape clinical practice and health care policy regarding PEIs. (shrink)

Each year, millions of individuals in the United States are treated for a variety of serious medical conditions with prescription drugs whose therapeutic benefits are well known. The vast majority of these medications are used to treat medical and psychiatric illnesses. Generally, they are used as prescribed, and contribute to a better quality of life for persons suffering from debilitating or life-threatening disorders.The fact that a small portion of these medications is diverted by those who seek their psychoactive (...) effects raises the important policy issue: how to make drugs easily available for medical use while limiting access for purposes of abuse.Such a responsibility poses challenges very different from those of the so-called “war” on illicit drugs, because this control must be achieved without impeding patients’ access to medical care. A rational public policy would attempt to achieve a balance between the need to minimize abuse and the need to provide relief. (shrink)

Each year, millions of individuals in the United States are treated for a variety of serious medical conditions with prescription drugs whose therapeutic benefits are well known. The vast majority of these medications are used to treat medical and psychiatric illnesses. Generally, they are used as prescribed, and contribute to a better quality of life for persons suffering from debilitating or life-threatening disorders.The fact that a small portion of these medications is diverted by those who seek their psychoactive (...) effects raises the important policy issue: how to make drugs easily available for medical use while limiting access for purposes of abuse.Such a responsibility poses challenges very different from those of the so-called “war” on illicit drugs, because this control must be achieved without impeding patients’ access to medical care. A rational public policy would attempt to achieve a balance between the need to minimize abuse and the need to provide relief. (shrink)

The contributions of adolescent and parent perspectives to ethical planning of survey research on youth drug use and suicide behaviors are highlighted through an empirical examination of 322 7th-12th graders' and 160 parents' opinions on questions related to 4 ethical dimensions of survey research practice: evaluating research risks and benefits, establishing guardian permission requirements, developing confidentiality and disclosure policies, and using cash incentives for recruitment. Generational and ethnic variation in response to questionnaire items developed from discussions within adolescent and (...) parent focus groups are described. The article concludes with a discussion of the potential contributions and challenges of adolescent and parent perspectives for planning scientifically valid and ethically responsible youth risk survey research. (shrink)

Cognitive‐enhancing drugs are prescribed to patients with psychiatric disorders, such as attention deficit hyperactivity disorder (ADHD) and Alzheimer's disease, to treat cognitive deficits. This chapter discusses the use of pharmacological agents to improve the cognition of both those with cognitive impairments and of the general population, as well as some of the benefits, risks, and ethical issues associated with the use of cognitive‐enhancing drugs. The chapter also talks about a survey run by the journal Nature, which was (...) prompted by a commentary by the authors of this chapter, that asked readers for their views on the issues surrounding cognitive enhancement. It can be seen that the ethical issues surrounding the use of cognitive‐enhancing drugs are complex and require discussion among different groups. With the development of new drugs and methods of enhancing cognition, such as brain stimulation, the need for further research and discussion is likely to become more pressing. (shrink)

"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is widely (...) recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (shrink)

So-called cognitive enhancing drugs are relatively common in higher education, especially among students who are white, male, and attend highly selective institutions. Using qualitative data from a diverse sample of 32 students at an elite university, the present study aims to examine whether students perceive CED use to be advantageous, equitable, and fair. Participants were either medical or nonmedical users of CEDs—primarily ADHD stimulant medications such as Adderall. Data were first coded openly, then axially into themes, and finally (...) arranged to respond to research aims around social and ethical concerns. Ethical perceptions and behavioral justifications varied by participants’ personal use frequency, class standing, and perceived social norms surrounding CEDs. Among the salient themes to emerge was the belief that CED use is a lesser or more tenable form of cheating, that the vagueness and prevalence of ADHD justifies nonmedical use, and that above all, CEDs are advantageous. Some participants expressed concern about the advantageousness of CEDs when coupled with a perceived imbalance of their use among students from traditionally underrepresented backgrounds, with one calling it “the white version of cheating.” Implications for cheating and drug use prevention are discussed, situating cognitive enhancement as an emerging ethical and social equity concern in higher education. (shrink)

Background In this qualitative analysis we aimed to explore addiction physicians’ perspectives on safer injection education for people who inject drugs, especially: (1) on possible means of introducing safer injection education in the medical environment, (2) on the compatibility of safer injection education with each physician’s core values and goals, and (3) on possible reasons for the ethical dilemma in safer injection education. Methods We conducted semi-structured interviews with eleven physicians practicing addiction medicine in France in clinical and harm (...) reduction settings. Results All participants were in favor of educational interventions for people who inject drugs. Nonetheless, these interventions varied from simple advice to injection supervision and they were seen as less acceptable when they concerned the practical and material aspects of injection. Some participants found that physicians practicing in clinical settings, where patients consult mostly to stop their drug use, should not practice safer injection education. On the contrary, other participants claimed that safer injection education was essential in all settings and was not a choice but rather a duty for addiction physicians. The ethical dilemma of such intervention when delivered by medical staff was viewed as a complex phenomenon, related to the representations of intravenous drug use and to societal expectations from physicians. Conclusion Physicians’ views on safer injection education for people who inject drugs reveal an emotionally charged subject related to the structural organization of addiction management in France. Such education is marked by an arduous history of harm reduction policies in France. IRB registration: #00011928. (shrink)

There are a number of premises underlying much of the vigorous debate on pharmacological cognitive enhancement. Among these are claims in the enhancement literature that such drugs exist and are effective among the cognitively normal. These drugs are deemed to enhance cognition specifically, as opposed to other non-cognitive facets of our psychology, such as mood and motivation. The focus on these drugs as cognitive enhancers also suggests that they raise particular ethical questions, or perhaps more pressing ones, (...) compared to those raised by other kinds of neuroenhancement. Finally, the use of these drugs is often claimed to be significant and increasing. Taken together, these premises are at the heart of the flurry of debate on pharmacological cognitive enhancement. In this article, it is argued that these are presumptions for which the evidence does not hold up. Respectively, the evidence for the efficacy of these drugs is inconsistent; neurologically it makes little sense to distinguish the cognitive from non-cognitive as separate targets of pharmacological intervention; ethically, the questions raised by cognitive enhancement are in fact no different from those raised by other kinds of neuroenhancement; and finally the prevalence rates of these drugs are far from clear, with the bulk of the claims resting on poor or misrepresented data. Greater conceptual clarity along with a more tempered appreciation of the evidence can serve to deflate some of the hype in the associated literature, leading to a more realistic and sober assessment of these prospective technologies. (shrink)

In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, (...) and human history. (shrink)

BackgroundExpanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union (EU), Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated (...) with a number of ethically relevant problems.Main textThe objective of this article is to present a coherent framework made up of eight requirements which have to be met for any treatment use of an ID to be ethical. These include a justified need for the use of an ID, no threat to clinical development of the ID, adequate scientific evidence to support the treatment, patient’s benefit as the primary goal of the use of an ID, informed decision of a patient, fair access of patients to IDs, independent review, as well as the dissemination of treatment results.ConclusionsWhile this framework is essentially consistent with the legal regulations of expanded access of the USA, the EU, Canada and Australia, it is substantially wider in scope because it addresses some important issues that are not covered by the regulations. Overall, the framework that we developed minimizes the risks and threats, and maximizes potential benefits to each of the four key stakeholders involved in the treatment use of IDs including patients, doctors, drug manufacturers, and society at large. (shrink)

We humans can enhance some of our mental and physical abilities above the normal upper limits for our species with the use of particular drug therapies and medical procedures. We will be able to enhance many more of our abilities in more ways in the near future. Some commentators have welcomed the prospect of wide use of human enhancement technologies, while others have viewed it with alarm, and have made clear that they find human enhancement morally objectionable. The Ethics (...) of Human Enhancement examines whether the reactions can be supported by articulated philosophical reasoning, or perhaps explained in terms of psychological influences on moral reasoning. An international team of ethicists refresh the debate with new ideas and arguments, making connections with scientific research and with related issues in moral philosophy. (shrink)

Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure (...) of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population. (shrink)

The United States Food and Drug Administration's recent approval of the commercial use of Deep Brain Stimulation (DBS) as a treatment for Obsessive Compulsive Disorder (OCD) will be discussed within the context of the existing USA regulatory framework. The purpose will be to illustrate the current lack of regulation and oversight of the DBS market, which has resulted in the violation of basic ethical norms. The discussion will focus on: 1) the lack of available evidence on procedural safety and efficacy, (...) 2) the numerous conflicts of interest held by research investigators, and 3) the ambiguity of both aforementioned categories due to an inherent lack of transparency in the research. It is argued that in order to address these issues, ethical analyses of DBS for psychiatric disorders must include the role of the industry forces that have become the primary impetus for this research. As such, DBS for OCD serves as an important case example in studies of neurotechnology and innovative surgery. (shrink)

A relatively healthy forty-six-year-old woman with mild hypertension receives a prescription for an antihypertensive medication. One of the medication's adverse effects is its potential to cause severe depression. Four months later, she is diagnosed with anxiety, an early manifestation of depression. An antianxiety drug is prescribed, but her anxiety worsens. Her physician then diagnoses her as having a depressive disorder, and prescribes a new antidepressant medication. She is still on the same antihypertensive.A seventy-two-year-old man is given furosemide and digoxin to (...) control a mild case of congestive heart failure and hypertension. Because furosemide deletes potassium from the body, his physician also places him on a potassium supplement. Six months later, the physician tells the patient to stop taking the furosemide and prescribes an angiotensin converting enzyme inhibitor. An effect of ACE inhibitors is to reduce the body's excretion of potassium thereby reducing the digoxin's effectiveness. (shrink)

A relatively healthy forty-six-year-old woman with mild hypertension receives a prescription for an antihypertensive medication. One of the medication's adverse effects is its potential to cause severe depression. Four months later, she is diagnosed with anxiety, an early manifestation of depression. An antianxiety drug is prescribed, but her anxiety worsens. Her physician then diagnoses her as having a depressive disorder, and prescribes a new antidepressant medication. She is still on the same antihypertensive.A seventy-two-year-old man is given furosemide and digoxin to (...) control a mild case of congestive heart failure and hypertension. Because furosemide deletes potassium from the body, his physician also places him on a potassium supplement. Six months later, the physician tells the patient to stop taking the furosemide and prescribes an angiotensin converting enzyme inhibitor. An effect of ACE inhibitors is to reduce the body's excretion of potassium thereby reducing the digoxin's effectiveness. (shrink)

Spinal muscular atrophy (SMA) is the most common genetic disease that causes infant mortality. Its treatment and prevention represent the paradigmatic example of the ethical dilemmas of 21st‐century medicine. New therapies (nusinersen and AVXS‐101) hold the promise of being able to treat, but not cure, the condition. Alternatively, genomic analysis could identify carriers, and carriers could be offered in vitro fertilization and preimplantation genetic diagnosis. In the future, gene editing could prevent the condition at the embryonic stage. How should these (...) different options be evaluated and compared within a health system? In this paper, we discuss the ethical considerations that bear on the question of how to prioritize the different treatments and preventive options for SMA, at a policy level. We argue that despite the tremendous value of what we call ‘ex‐post’ approaches to treating SMA (such as using pharmacological agents or gene therapy), there is a moral imperative to pursue ‘ex‐ante’ interventions (such as carrier screening in combination with prenatal testing and preimplantation genetic diagnosis, or gene editing) to reduce the incidence of SMA. There are moral reasons relating to autonomy, beneficence and justice to prioritize ex‐ante methods over ex‐post methods. (shrink)

As drug testing has become increasingly used to maximize corporate profits by minimizing the economic impact of employee substance abuse, numerous arguments have been advanced which draw the ethical justification for such testing into question, including the position that testing amounts to a violation of employee privacy by attempting to regulate an employee's behavior in her own home, outside the employer's legitimate sphere of control. This article first proposes that an employee's right to privacy is violated when personal information is (...) collected or used by the employer in a way which is irrelevant to the terms of employment. This article then argues that drug testing is relevant and therefore ethically justified within the terms of the employment agreement, and therefore does not amount to a violation of an employee's right to privacy. Arguments to the contrary, including the aforementioned appeal to the employer's limited sphere of control, do not account for reasonable constraints on employee privacy which are intrinsic to the demands of the workplace and implicit in the terms of the employment contract. (shrink)

A literature search was conducted on studies of new drugs used with patients with schizophrenia reported by U.S. and non-U.S. researchers from 1966–1993, yielding 41 U.S., and a total of 24 other non-U.S. studies, among them 11 British studies. Results of the U.S. and non-U.S. studies were pooled separately and compared. Among several comparable conditions discussed, the lack of any data on suicides in the U.S. studies was observed. For a second statistical analysis of suicide rates ‘person-years’ were calculated (...) to adjust for differing washout durations. The results obtained include findings that the percentage of patients relapsing in U.S. studies was slightly lower than in non-U.S. studies ; the percentage of patients dropping out in U.S. studies was higher than in non-U.S. studies ; known location of dropout patients in U.S. studies was 1.7%, compared to 2.6% in non-U.S. studies. The most interesting finding was that no suicides were reported in U.S. studies, compared to 0.6% of patients reported in British studies. Some U.S. studies used ‘challenge doses’, such as amphetamines or L-dopa; no non-U.S. studies reported their use. Compared to U.S. studies, those by non-U.S., and particularly British, researchers appeared to report adverse events in their studies. ‘Challenge’ drugs were not used; suicides were reported. It is estimated that the probability that no patients suicided who participated in the U.S. is small—one in 500. (shrink)

"Cluster randomized trials," in which groups of patients are randomly assigned to different therapeutic interventions, provide a powerful way of evaluating drugs. CRTs have not been widely used, in good part because of concerns about whether patients must give informed consent to participate in them. A better understanding of how CRTs fit into clinical practice resolves the concerns.

The use of single-use items is now ubiquitous in medical practice. Because of the high costs of these items, the practice of reusing them after sterilisation is also widespread especially in resource-poor economies. However, the ethics of reusing disposable items remain unclear. There are several analogous conditions, which could shed light on the ethics of reuse of disposables. These include the use of restored kidney transplantation and the use of generic drugs etc. The ethical issues include the (...) question of patient safety and the possibility of infection. It is also important to understand the role of informed consent before reuse of disposables. The widespread practice of reuse may bring down high healthcare costs and also reduce the huge amount of hospital waste that is generated. The reuse of disposables can be justified on various grounds including the safety and the cost effectiveness of this practice. (shrink)