Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization

Abstract

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 conditions of scarcity, prioritization approaches should minimize harm, maximize benefit, and promote fairness. To promote continued data collection, patients seeking access to unproven COVID-19 drugs should receive lower priority for allocation when they decline to participate in clinical trials, either of the requested drug or other investigational products, offering a comparable balance of risks and benefits; special attention should be paid to concerns of voluntariness and distrust. In addition, institutional treatment protocols that can contribute more robust real world data should be preferred to single patient requests for access, with priority for inclusion based on traditional clinical allocation criteria relying on available evidence. Fairness demands distribution of these protocols across a diverse range of sites, particularly those serving marginalized populations, among other protections.     

Treating Incest Survivors: Complexities,Promises, No Easy Answers

No abstract available for this article.     

No Easy Answers: Avoiding Potential Pitfalls of De‐implementation

In 2012, the Centers for Disease Control and Prevention (CDC) began to de‐emphasize and de‐implement multiple evidence‐based HIV prevention practices that had been around for 20 years, thus changing the scope of implementation across the globe. The authors provide evidence how existing interventions (e.g., CDC HIV interventions) may influence implementation of interventions that came after the program was discontinued. De‐implementation is an ecological event that influences, and is influenced by, many parts of a system, for instance, implementation of one type of intervention may influence the implementation of other interventions (biomedical and/or behavioral) after a long‐running program is discontinued. Researchers and policy makers ought to consider how de‐implementation of behavioral interventions is influenced by biomedical interventions mass‐produced by companies with lobbying power. The scientific study of de‐implementation will be inadequate without consideration of the political climate that surrounds de‐implementation of certain types of interventions and the promotion of more‐profitable ones.     

Clinical experiences during the COVID-19 pandemic

Most of the clinical experiences discussed in this article arose from monthly Zoom meetings at Rome’s Italian Centre of Analytical Psychology (CIPA). We set up a discussion group in April 2020, one month after lockdown began in Italy, and these monthly online meetings continue to this day. All senior analysts and analysts-in-training at Rome’s CIPA, whose backgrounds range from child and adolescent psychotherapy to adult psychotherapy and analysis, to sandplay therapy and medicine and psychiatry, have been participating in these meetings. The group discussions focus on the present time and its impact on us, as well as on our relationships with patients. By further developing these reflections during the lockdown in Italy (9 March - 3 May 2020), it is fair to ask whether a sense of unreality, depersonalization, or derealization has occurred, either in the therapist or patient, and if so, whether it is possible that therapists miss the human contact more than clients. We will mainly refer to clinical and personal experiences as our most precious guidelines.     

Examining the Ethics of Clinical Use of Unproven Interventions Outside of Clinical Trials During the Ebola Epidemic

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease (EVD), debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical trials. Those engaged in the debate have responded rapidly to a complex and evolving crisis, however, and this debate has not provided much opportunity for in-depth analysis. Additionally, the existing literature on access to unproven therapies has focused on contexts like HIV/AIDS and oncology, which are very different than the Ebola epidemic. In this paper, we examine the ethical issues surrounding access to unproven therapies in the context of the recent Ebola outbreak to yield new insights about this controversial and unsettled issue. We argue first that, in this context, the interests of patients in obtaining access to unproven therapies are not fully aligned with the interests of their providers and drug developers. Second, we focus on the resource constraints facing providers, funders, and patients and conclude that they often counsel against the use of unproven interventions against EVD.     

Clinical Supervision of Couple and Family Therapy during COVID-19

This paper addresses the need for a swift transition from in-person clinical supervision to telesupervision during the time of the COVID-19 global pandemic. Five specific areas will be discussed in the effort to enhance the quality of clinical supervision provided to couple and family therapists in training at this time including the following: (1) COVID-19 and the structural changes and technological adaptation of supervision; (2) culturally and contextually sensitive guidelines for clinical supervision during COVID-19; (3) the supervisee’s competence and the clinical supervisory process; (4) the new set of boundaries and the supervisory role; (5) and the supervisory alliance and supervisees’ vulnerabilities in the face of COVID-19.     

FDA儿童药物临床试验规范化对我国的启示

对美国食品药品监督管理局（Food and Drug Administration,FDA）儿童药物临床试验的规范化进行界定,发现我国面临儿童用药方面存在安全隐患、儿童药物临床试验存在需求缺口、儿童药物临床试验审查不够规范等现实困境,引发规范儿童药物临床试验的关键性思考。借鉴FDA对儿童药物临床试验的规范化实践,总结FDA儿童药物临床试验相关法案、临床试验指南文件以及对伦理审查委员会的监管措施,得出完善儿童药物临床试验专门法规和指南、加强相关伦理委员会监管和指导、规范儿童药物临床试验伦理审查、加大儿童受试者保护力度等对我国的启示。

     

Infidelity in the Time of COVID-19

Infidelity occurs in approximately 25% of marriages and is associated with various negative consequences for individuals (e.g., depression, anxiety, and post-traumatic stress), the couple relationship (e.g., financial loss, increased conflict, and aggression), and the couple's children (e.g., internalizing and externalizing behaviors). Infidelity is also one of the most frequently cited reasons for divorce. The increased stress brought on by the pandemic may be putting couples at an increased risk for experiencing infidelity, and data collected during the pandemic have shown that people across the United States are engaging in behaviors that are associated with a high likelihood of experiencing infidelity. The negative consequences of infidelity are also likely to be exacerbated for couples during the pandemic due to the intersection with the social, emotional, and financial consequences of COVID-19. Furthermore, couples are likely to experience disruptions and delays to the affair recovery process during the pandemic, which can negatively impact their ability to heal. Therefore, recommendations for navigating affair recovery during the pandemic, including adaptations for therapy, are also discussed.     

新药临床试验中的反安慰剂效应

新药在临床试验中设立安慰剂对照需要患者知情同意,有违安慰剂暗示治疗的本意.在一种新药Ⅱ期临床试验中,发现告知与隐瞒设立安慰剂对照的事实,疗效差异明显.表明告知患者可能使用到安慰剂,会产生反安慰剂效应,影响疗效判定.提出疗效判定尽量使用客观指标、采用叠加设计、采用暂时隐瞒法、心理医生介入等4项对策.     

临床试验的科学性和伦理问题

提出了临床试验中7种不符合伦理的情况,并以实例说明.同时介绍了符合伦理的临床试验的一种新的设计方法--动态设计以及实施动态设计所需要建立的独立数据检查委员会.最后讨论了动态设计的中文译名.     

新药临床试验中的反安慰剂效应

新药在临床试验中设立安慰剂对照需要患者知情同意,有违安慰剂暗示治疗的本意。在一种新药Ⅱ期临床试验中,发现告知与隐瞒设立安慰剂对照的事实,疗效差异明显。表明告知患者可能使用到安慰剂,会产生反安慰剂效应,影响疗效判定。提出疗效判定尽量使用客观指标、采用叠加设计、采用暂时隐瞒法、心理医生介入等4项对策。     

Essential anxiety: COVID-19 in analytic practice

This paper explores the impact of the COVID-19 pandemic on my relationship with analysands and my inner world. I reflect on the role of the archetypal Self during times of existential anxiety that may lead to an experience of ‘essential anxiety’. This term refers to a meeting by a fearful ego with an inward recognition of the Self, when faced with threat. The efforts to curb the spread of the pandemic changed our ways of life, while the virus itself threatened our existence in debilitating or outright destructive ways. But what also came into view, in sessions of analysis and supervision, was the creative instinct, and a celebration of life. The soul-to-soul relationship, and the connection with images of the archetypal Self, made the experience of existential anxiety at times an essential experience that facilitated psychological growth. I discuss some advantages of on-line Jungian analysis where, despite distance and partial view, the body still serves as container to hold important psychological material, conferring a sense of wholeness for analyst and analysand. The COVID-19 crisis is terrible and terrifying but it also provides an opportunity for self-regulation and individuation.     

Helping Couples in the Shadow of COVID-19

The pandemic caused by the SARS-CoV-2 virus (coronavirus) and the associated illness, COVID-19, has caused a level of worldwide upheaval unlike any most people now living have seen in their lifetimes. This crisis affects people in their most important, committed, and intimate relationships. Although this crisis has damaged the health and well-being of individuals, crushed economies, and led to an extensive period of uncertainty about the future, there may also be positive outcomes in the motivation people have to protect their relationships. In this paper, we focus on strategies that therapists and relationship educators can use to help couples preserve and protect their relationships during such a time. We describe four foundations of safety that allow relationships to thrive: physical, emotional, commitment, and community. We then highlight three keys from our body of work that can help guide individuals and couples in protecting their relationships on a day-to-day and moment-to-moment basis: (1) decide, don’t slide; (2) make it safe to connect; (3) do your part.     

反安慰剂效应在临床试验中的研究

临床工作中,患者在服药后有时会出现一些不良反应,其中有些是由于药物的特殊药理作用导致的,但也有一些属于非特异性的不良反应.近些年来,随着对安慰剂效应研究的逐步深入,人们越来越注意到,“意识”在不良反应的发生中也起到了重要的作用,即反安慰剂效应的作用.本文将从几个不同方面阐述反安慰剂效应的作用及影响因素,并讨论应如何认识、处理临床冶疗和临床试验中反安慰剂效应的问题.     

Changes in loneliness and coping strategies during COVID-19

The social distancing measures implemented to slow the spread of COVID-19 impacted many aspects of people's lives. Previous research has reported negative consequences of these measures for people's psychological well-being, and that people differed in the impact on their psychological well-being. The present study aimed to describe the different coping strategies Dutch people used to deal with these measures and to link these strategies to loneliness. In addition, the study aimed to examine mean-level changes in loneliness and to explore individual differences in loneliness change. We used data from 2009 participants of a panel study of representative Dutch households. We assessed coping strategies used during the first wave of the COVID-19 pandemic in May 2020 and examined changes in loneliness between October 2019 (before COVID-19) and May 2020 (during the first wave of COVID-19). First, results showed that most people employed specific coping strategies. The most frequently used social strategies were chatting and (video)calling; the most frequently used non-social strategies were going outside, doing chores, watching TV, reading and self-care. Second, people who used more coping strategies reported lower levels of loneliness. Third, analyses revealed an average increase in loneliness between October 2019 and May 2020. Fourth, we observed two significant interaction effects, showing a stronger positive link between the number of social coping strategies and initial loneliness levels among those with a partner or living with others than for those who were single or lived alone. Yet, no moderating effects on changes in loneliness were found: people using more coping strategies did not differ in loneliness changes from people using fewer coping strategies. Together, findings suggest that loneliness increased in the Netherlands during the first phase of COVID-19 and that, while people's coping strategies were related to loneliness levels, they did not buffer against loneliness increases.