Charl Els

Historical development and current status of organ procurement from death-row prisoners in China

BackgroundIn December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners.DiscussionIn the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to “voluntarily donate” organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards.ConclusionsOrgan sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with “consent” are now simply labelled as “voluntarily donations from citizens”. The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain.

Flexible and extended dosing of nicotine replacement therapy or varenicline in comparison to fixed dose nicotine replacement therapy for smoking cessation: Rationale, methods and participant characteristics of the FLEX trial

Quitting smoking is the single most effective strategy to reduce morbidity and premature mortality in smokers. Research has demonstrated the effectiveness of pharmacotherapy in smoking cessation, but few studies have directly compared varenicline and monotherapy nicotine replacement therapy (NRT) and none have examined varenicline and combinations of NRT products. The majority of smoking cessation trials involve carefully circumscribed populations, making their results less generalizable to those with severe medical conditions or psychiatric comorbidities. This paper reports on the rationale, methodology and participant characteristics of a randomized controlled trial designed to: (1) determine which pharmacotherapy - NRT, long term combinations of NRT, or varenicline - is most effective in achieving abstinence; (2) investigate the incidence of neuropsychiatric symptoms among participants over the course of their quit attempt; and (3) assess whether there is a significant difference in the incidence of neuropsychiatric symptoms in those receiving differing pharmacotherapies, and between those with and without psychiatric illnesses. The primary outcome was carbon monoxide confirmed abstinence from weeks 5-52 following a target quit date. Secondary outcomes included neuropsychiatric (i.e., depression, suicidal ideation, anxiety, anger) and withdrawal symptoms. Smokers (N=737) were randomly assigned to one of three treatment conditions, and were scheduled to attend 8 follow-up appointments over 12 months. All participants received 6-15 minute practical counseling sessions with nurse counselors experienced in treating tobacco dependence. We expect that the results will lead to an enhanced understanding of the efficacy of these pharmacotherapies, including those with a history of psychiatric illness.

Human rights violations in organ procurement practice in China

BackgroundOver 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China’s organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained.DiscussionWe have collected and analysed available evidence on human rights violations in the organ procurement practice in China. We demonstrate that the practice not only violates international ethics standards, it is also associated with a large scale neglect of fundamental human rights. This includes organ procurement without consent from prisoners or their families as well as procurement of organs from incompletely executed, still-living prisoners. The human rights critique of these practices will also address the specific situatedness of prisoners, often conditioned and traumatized by a cascade of human rights abuses in judicial structures.ConclusionTo end the unethical practice and the abuse associated with it, we suggest to inextricably bind the use of human organs procured in the Chinese transplant system to enacting Chinese legislation prohibiting the use of organs from executed prisoners and making explicit rules for law enforcement. Other than that, the international community must cease to abet the continuation of the present system by demanding an authoritative ban on the use of organs from executed Chinese prisoners.

“Decision-critical” work: a conceptual framework

Abstract“Safety-sensitive” workers, also termed “safety-critical” workers, have been subject to fitness to work assessments due to concerns that a performance error may result in worker injury, injury to coworkers or the general public, and/or disruption of equipment, production or the environment. However, there exists an additional category of “decision-critical” workers, distinct from “safety-sensitive” workers, in whom impairment may impact workplace performance, relationships, attendance, reliability and quality. Adverse consequences in these latter areas may not be immediately apparent, but a potential “orbit of harm” nevertheless exists. Workplace consequences arising from impairment in “decision-critical” workers differ from those in “safety-sensitive” personnel. Despite their importance in the occupational context, “decision-critical” workers have not previously been differentiated from other workers in the published literature, and we now outline an approach to fitness to work assessment in this group.

Task and barrier self-efficacy among treatment-seeking smokers with current, past or no psychiatric diagnosis

OBJECTIVE Individuals with a lifetime diagnosis of mental illness smoke at rates greater than the general population, and have more difficulty quitting. Cessation self-efficacy has been linked with positive cessation outcomes and can be assessed as either task (confidence to quit) or barrier self-efficacy (confidence to quit in the face of obstacles). We investigated differences in self-efficacy among smokers with a current, past or no lifetime diagnosis of psychiatric illness. METHODS 737 treatment-seeking smokers provided demographic info and smoking history, and were assessed for nicotine dependence, motivation to quit, and task and barrier self-efficacy (Smoking Self-Efficacy Questionnaire; SEQ-12) for smoking cessation. Current and past psychiatric diagnoses were assessed with the Mini International Psychiatric Interview (M.I.N.I. 6.0). ANOVA, chi-square and correlations were calculated for the smoking-related variables across the psychiatric categories. RESULTS Those with a current diagnosis smoked more cigarettes and were highly nicotine dependent. These individuals had lower barrier self-efficacy compared to those with past or no diagnosis; no differences between groups were observed on task self-efficacy. Motivation to quit was significantly correlated with task self-efficacy in all 3 groups, but with barrier-self efficacy only among those with no lifetime diagnosis of psychiatric illness. CONCLUSION Our results highlight the differences in task and barrier cessation self-efficacy in treatment-seeking smokers. Those with a current psychiatric diagnosis have less confidence in their ability to quit when confronting barriers, especially those reflecting internal states. These results highlight the need for targeted interventions to improve cessation self-efficacy, an important determinant of health behavior change.

The Quit Experience and Concerns of Smokers With Psychiatric Illness

INTRODUCTION The purpose of this study is to better understand the quit experience and concerns of smokers with psychiatric illness (i.e., major depressive, anxiety, psychotic and bipolar disorders) in comparison with those without psychiatric illness. METHODS Smokers (N=732) with (n=430, 59%) and without psychiatric illness, recruited between June 2010 and March 2013 to participate in the FLEX (Flexible and Extended Dosing of Nicotine Replacement Therapy [NRT] and Varenicline in Comparison to Fixed-Dose NRT for Smoking Cessation) smoking-cessation trial, completed questionnaires assessing previously used cessation aids and reasons for relapse, and motivation and concerns about their upcoming quit attempt. These supplementary data analyses were conducted in May 2015. RESULTS The most commonly used cessation methods during previous attempts were nicotine replacement therapy (66.4%), cold turkey (59.7%), and bupropion (34.7%); no group differences were identified. Stress was the most common precipitator of relapse during previous attempts in all groups (43.6%), particularly among participants with depression and anxiety. Health was the most common motivation for the upcoming quit attempt (91%), followed by family/social pressures (28.1%) and cost (27.9%, particularly by smokers with psychotic disorders). Common pre-cessation concerns for the complete sample included: cravings (27.6%), stress (26.7%), and fear of failure (26%); participants with psychotic and anxiety disorders were most concerned about cravings, whereas the latter two concerns were more prominent for individuals with anxiety. CONCLUSIONS Findings reveal differences in the quit histories and concerns of smokers with or without psychiatric illness. Smokers with psychiatric illness are particularly vulnerable to relapse at times of stress and negative affect; interventions that emphasize alternative coping strategies and facilitate mood management are required.

Health Care Under the Influence: Substance Use Disorders in the Health Professions

Substance use disorders are expressed within most age, economic, cultural, gender, and occupational groupings. They come to expression in individuals who may be considered vulnerable on biological, psychological, social, family, or spiritual levels. As with other mental disorders, vulnerability differs between individuals with both nature and nurture influencing their risk. Some health care professionals will also develop these chronic disorders regardless of any special knowledge or experience they may have. When substance use disorders are expressed within the health care professions, the delivery of safe, competent, compassionate, and ethical care is threatened. The health of the health care professional is also at risk as the substance use disorders typically progress in severity and may result in premature death. This is often a sensitive issue to address yet its importance demands the concerted attention of the health care professions. The following chapter begins with background on the issue of substance use disorders within the health care professions, followed by a discussion of mitigating associated risks, and an exploration of disciplinary and alternative to discipline policies. This chapter is focused primarily on literature on physicians and nurses because of the predominance of research in these disciplines. The argument will be made that creating conditions that encourage early identification, reduce barriers to treatment, and that include long-term monitoring programs provide the best conditions for ameliorating the risks resulting from substance use disorders amongst the health care professions to patient safety and health care professional health.

Workplace Functional Impairment Due to Mental Disorders

Psychiatrists are commonly expected to conduct disability assessments. These include an assessment of the worker’s functioning, putative impairment, risk, and capacity to work. Employers and other third parties, either administrative or judicial, subsequently make disability determinations based on such assessments. This assessment also forms the foundation for return-to-work determinations, or for determining the employer’s duty to accommodate to the point of undue hardship. To the extent the general psychiatrist becomes involved in assessing these occupational matters, the psychiatrist is practicing forensic psychiatry. The role and responsibilities of the treating psychiatrist, within in the context of a traditional physician-patient relationship, differ vastly from one conducting an occupational or forensic evaluation. Yet, the boundaries between these distinct and often irreconcilable roles are not always clearly delineated, properly understood, or abided by. The forensic aspects of psychiatric practice are often viewed as intrusive and challenging by non-forensically trained psychiatrists, representing a role conflict many psychiatrists find themselves poorly equipped to navigate. This chapter outlines the common psychiatric disorders encountered in clinical and occupational settings. It discusses the concepts of impairment and disability, as well as the benefits of working. The most commonly requested opinions in occupational psychiatric assessments are that of a psychiatric diagnosis, causation, impairment, fitness to work (FTW), and disability, along with recommendations for further investigations and treatment. The importance of objectively measuring impairment is outlined, along with reliably establishing a diagnosis (if any), along with the non-linear relationship between mental disorder, impairment and disability. For the purposes of this chapter, any reference to mental disorders are implied to include the broad range of disorders captured in the Diagnostic and Statistical Manual of Mental Disorders, the DSM IV-TR, which includes the substance-related disorders (i.e. Substance Abuse, Substance Dependence, or Addiction, and others). This chapter addresses the main pitfalls and risks associated with Independent Medical (i.e. Psychiatric and Addictions) Evaluations (IME), and provides a template for conducting these. The potential cost saving associated with implementing evidence-based interventions drives a sound business case for addressing mental disorders in the workplace. This chapter offers a pragmatic approach to treatment matching and disability management for workers with mental disorders (i.e. including substance-related disorders). It outlines the principles of vocational rehabilitation in the context of psychopathology, mental disorders, impairment and disability, ensuring safety, as well as optimal clinical and economic outcomes.

Nicotine metabolite ratio and smoking outcomes using nicotine replacement therapy and varenicline among smokers with and without psychiatric illness

Introduction: It has been suggested that the effectiveness of nicotine replacement smoking cessation pharmacotherapy may be enhanced by assessing rates of nicotine metabolism using the nicotine metabolite ratio – which reflects differences in the activity of the CYP2A6 hepatic enzyme – and titrating doses appropriately. To date, supporting evidence is equivocal, with little information regarding the assessment and effectiveness of the nicotine metabolite ratio among smokers with psychiatric conditions. Methods: The nicotine metabolite ratio of 499 smokers from the FLEX trial was determined using urine samples obtained at baseline. They were randomized to receive either: standard transdermal nicotine (nicotine replacement therapy); extended nicotine replacement therapy + adjunct nicotine agent; or varenicline. Primary cessation outcomes were seven-day point prevalence at 5, 10, 22, and 52 weeks post-target quit date, comparing across treatment and psychiatric status. Our principal analysis employed logistic regression (outcome: abstinence), using slow metabolizers as the reference category. Results: No differences were observed by nicotine metabolite ratio classification (slow, moderate, fast) with respect to any demographic or smoking-related variables. Nicotine metabolite ratio class did not predict smoking cessation in either the overall sample, or by treatment condition at any time-point (week 52 moderate metabolizers: odds ratio 1.34, 95% confidence interval (0.68–2.63), p=0.394; fast metabolizers: odds ratio 1.04 (0.56–1.91), p=0. 906). Conclusion: Our results did not find any associations between nicotine metabolite ratio and cessation outcomes among smokers using nicotine replacement therapy or varenicline with and without lifetime psychiatric conditions.

Factor structure of the Smoking Cessation Self-Efficacy Questionnaire among smokers with and without a psychiatric diagnosis.

Cessation self-efficacy has been shown to be a consistent predictor of smoking cessation outcomes. To date, no scale assessing cessation self-efficacy has been validated across smokers with and without a psychiatric diagnosis (current or past). Smokers with a psychiatric diagnosis are typically heavy smokers, have a more difficult time quitting, and are more prone to experience lower self-efficacy. Determining whether smoking cessation self-efficacy scores are invariant across these populations is crucial for future research and intervention strategies. Data from the Flexible and Extended Dosing of Nicotine Replacement Therapy (NRT) and Varenicline in Comparison to Fixed Dose NRT for Smoking Cessation: The FLEX Trial, a randomized control trial for smoking cessation, was used to assess the factor structure of the Smoking Cessation Self-Efficacy Questionnaire (SEQ-12), a 12-item scale assessing an individual’s confidence to refrain from smoking. Confirmatory factor analysis (CFA) was used to compare the model’s fit between the original factor structure and the present data, and to test for measurement invariance across with a current, past, or no psychiatric diagnosis. Initial support was found for both a 2- and 3-factor structure. Using CFA, only the 3-factor model displayed adequate fit indices (Global Fit Index [GFI] = 0.924). Results from the model comparisons showed no differences between those with a current, past, or no psychiatric diagnosis (cmin (30) = 38.64, p = .134). The 3 factors were highly correlated, indicative of an underlying global factor. The SEQ-12 was found to be measurement invariant across treatment-seeking smokers, with preliminary evidence suggesting it is a valid measurement scale for evaluating overall cessation self-efficacy, regardless of psychiatric status.