Freedom to think – the value of multiple clinical narratives in women’s prisons†

Abstract

The merits of being multi-lingual are widely recognised. This paper considers the application of this metaphor to the conceptualisation of clinical work in a women’s prison. We suggest that sharing ‘languages’ from different theoretical orientations in open fora enables teams to build deep and nuanced understandings of clinical and systemic complexity, of particular value in secure settings. This discussion reflects the service model developed and used within HMP/YOI Holloway, a large women’s prison in London, which has recently been closed. We utilise a case example, with formulations and recommendations from several perspectives, to illustrate the value of maintaining a rich, inclusive discourse. We describe the benefits of such an approach to staff teams, to institutions and to those we serve, and consider the implications for organisation of services to maximise potential for change and recovery.     

Can the FDA improve oversight of foreign clinical trials?: Closing the information gap and moving towards a globalized regulatory scheme

Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.     

Compensation for medical injury in New Zealand: does "'no-fault" increase the level of claims making and reduce social and clinical selectivity?

The issues of patient safety and quality of care have gained policy attention with a growing appreciation of the scale and impact of medical injury in health systems. While the focus is clearly on the prevention of iatrogenic injury, the question of patient compensation is now also considered important, if only because in fault-based tort systems the fear of litigation may itself be a barrier to the disclosure and open discussion of medical error. No-fault systems, by contrast, do not require proof of culpability, and thus may both reduce barriers to compensation and increase disclosure of error. Little evidence, however, is available on the performance of such systems. This article reports on the analysis of two data sources-a sample of hospital admissions and a complete set of compensation claims for medical injury. Both are for the same year and region of New Zealand, a country that has maintained a no-fault system of accident compensation for a quarter of a century. Just over 2 percent of hospital admissions were associated with an adverse event that was potentially compensable under scheme criteria. While the claims process was well targeted, the level of claims making and receipt was low, with the ratio of successful claims to potentially compensable events being approximately 1:30. Comparison of social and clinical characteristics of the two data sets revealed a degree of selectivity. Compared with the hospital events, the typical successful claimant was younger and female and was much more likely to have experienced a surgical adverse event that, while unexpected, was not due to substandard care. It is concluded that, in interpreting these results, account needs to be taken of a number of features unique to the New Zealand system. These include: the limited payoff for a compensation claim (no pain and suffering or lump sum, free hospital care); the relative complexity of the grounds for claim (either rarity and severity or practitioner error); and a history of limited litigation for medical error. This suggests that, while the New Zealand system is well targeted, cheap, and free of financial and legal barriers, a change in legal doctrine alone has not in itself been sufficient to remove completely the selective and low level of claims making traditionally associated with patient compensation under tort.     

Drug screening in clinical or forensic toxicology: are there differences?

Legal and medical practitioners need to remember that, with respect to drug analysis, there are two distinct disciplines in analytical toxicology concerned with human biological matrices, namely clinical and forensic toxicology. Both fields use similar analytical techniques designed to detect and quantify drugs, chemicals and poisons in fluids or tissues. In clinical toxicology, analytical results help to specify the appropriate treatment of a poisoned or intoxicated patient. In forensic toxicology, the results often play a vital role in determining the possible impairment or behavioural changes in an individual, or the contribution of drugs or poisons to death in a medico-legal investigation. This column provides an overview of the similarities and differences inherent in clinical and forensic toxicology.     

Ensuring safety, implementation and scientific integrity of clinical trials: lessons from the Criminal Justice–Drug Abuse Treatment Studies Data and Safety Monitoring Board

Data and safety monitoring boards (DSMBs) provide independent oversight to bio-medical clinical trials, ensuring safe and ethical treatment of research participants, data quality, and credibility of study findings. Recently, the type of research monitored by DSMBs has been expanded to include randomized clinical trials of behavioral and psychosocial interventions in community and justice based settings. This paper focuses on the development and role of a DSMB created by the National Institute on Drug Abuse (NIDA) to monitor six multi-site clinical trials conducted within the Criminal Justice–Drug Abuse Treatment Studies (CJ-DATS). We believe this is one of the first such applications of formal DSMBs in justice settings. Special attention is given to developing processes for measuring and monitoring a range of implementation issues for research conducted within criminal justice settings. Lessons learned and recommendations to enhance future DSMB work within this area are discussed.     

Olanzapine concentrations in clinical serum and postmortem blood specimens--when does therapeutic become toxic?

The concentration of olanzapine (Zyprexa) was determined in 1653 clinical serum specimens during routine drug monitoring, and in 58 postmortem whole blood specimens as part of routine toxicological analysis. The analysis of olanzapine was performed by the solid-phase extraction of 1.0 mL of buffered serum or blood, followed by gas chromatography separation with nitrogen-phosphorus detection. The analysis of the clinical serum samples showed that 86% of positive serum values were within the range of 5 to 75 ng/mL, with a mean and median of 36 and 26 ng/mL, respectively. These data suggest that the concentrations of olanzapine expected during therapy may be higher than those previously reported. In 58 postmortem whole blood specimens the mean olanzapine concentration was 358 ng/mL with a range of 10 to 5200 ng/mL. Further, investigation of deaths involving olanzapine suggest that potential toxicity should be considered at concentrations above 100 ng/mL. Although the majority of the olanzapine-related deaths were associated with many other drugs, death primarily due to olanzapine toxicity was determined at concentrations in post-mortem blood as low as 160 ng/mL.     

The Evolution of Anti-dumping Legislation of European Union

The Course of DevelopmentJanuary 1, 1958 entry into force of the "European Econ-omic Community (EEC) Treaty", more commonly known as the"Rome Treaty," the establishment of the first European Econ-omic Community established based on the principle of the Cu…     

Above the Law? A Comparative Study of National Prosecutions of Heads of State

Official polices on the appropriate government response to crimes committed by a head of state are seldom dictated by strict principles of justice. Deciding whether to bring an errant leader to justice is often influenced by political expediency. Given the number of documented cases of official abuse, there is a need to understand why some governments choose to prosecute a former or sitting head of state while others do not. Yet, few studies have been done on this subject. This study reviews 52 cases of heads of state accused of crimes and explores how their own national governments responded to such accusations. Using data culled from various documentary sources, it employs a grounded theory approach to focus on the process that drives the decision to prosecute. Analysis indicates that political legitimacy, perception of threat, political stability, and degree of politicization of the military influence the decision to prosecute. The article concludes with a discussion of the significance and implications of these findings and suggestions for future research.     

The Feasibility of Cost of Crime Estimations in Eastern Europe – The Case of Poland

Estimates of cost of crime have gradually been introduced into the public debate on crime policy. Estimates differ in their scope and methodologies and this impedes international comparisons. This article follows the model of estimating costs of crime developed under the 6th Framework Programme and provides the comparable results of costs of crime in Poland. The total costs of crime have been estimated at 5.1% of GDP. In particular, the victimisation costs of violent crimes have been estimated at 1.94% of GDP and the costs of property crimes against individuals at 0.5% of GDP. The results are in line with estimates for other countries and provide the relevant measure for any cost-benefit analysis of a crime policy.