Flaws in the U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil as a treatment for heart failure only in black patients

The U.S. Food and Drug Administration's (FDA) rationale for supporting the development and approval of BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials (V-HeFT I and II), which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial (A-HeFT) amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act.     

Protecting Marine Biodiversity in Polar Areas Beyond National Jurisdiction

Relatively little is known about polar marine biodiversity, which faces increasing threats from extractive and non-extractive activities and from the effects of climate change. The international legal regime for the protection of polar marine biodiversity in areas beyond national jurisdiction is currently inadequate, particularly in the Arctic. An important and useful outcome of this International Polar Year would be an international agreement for conservation and sustainable long-term management of marine biodiversity in the central Arctic Ocean areas beyond national jurisdiction. This agreement should incorporate the best elements of the Antarctic Treaty System together with modern conservation and management principles, and it should recognize the legitimate interests of the international community as a whole in the conservation and management of polar marine biodiversity.     

Against Legitimacy

Beetham has recently made an impressive contribution to the understanding of Legitimacy which he holds to be central to both political and social theory. As a social science concept, capable of playing a significant part in the explanation of the workings and breakdowns of political systems, however, legitimacy so defined proves difficult, sometimes impossible, to apply and runs the serious danger of misleading explanation. The case against legitimacy is argued through a combination of theoretical and empirical considerations and in place of legitimacy a case is made for the experience of government behaviour and the capacity for collective action as the more fruitful foci of social theory.     

A descriptive study of juvenile family violence: Data from intervention order applications in a Childrens Court

There is increasing recognition that family violence may be perpetrated by juveniles against their parents and siblings, however empirical research regarding the nature and causes of such violence is relatively limited. This study examines juvenile family violence in the context of an Intervention Order (IO) being sought against a relative aged 18 years or less. All cases over a 3-year period involving an IO application in a major metropolitan Children's Court in Australia were analysed (n = 438). The majority of applicants/victims were parents (78%) and to a lesser extent siblings (11%) and other relatives (9%). Most parents who sought applications were mothers (63%) and one-parent households were over-represented (66%). The majority of defendants/perpetrators were male (69%), though juvenile females constituted a significant minority (31%). Intervention orders were sought to prohibit property damage (61%), physical assaults (59%) and/or threats (53%). According to the victim reports, these behaviours emerged in the context of prolonged behavioural problems (49%), a desire to intimidate the victim (12%) or retaliation (8%). While 44% of IO applications were granted, the majority were not (56%) due to the victim discontinuing the application prior to a formal hearing. Of the orders that were granted, a third (32%) were subsequently reported as having been breached. Juvenile family violence is a serious social problem that requires more systematic research to identify the correlates of this behaviour and effective interventions to prevent or reduce its occurrence.     

Forensic Assessment of Adults Reporting Childhood Sexualized Assault: Risk,Resilience, and Impacts

Though childhood sexualized assault (CSA) increases risk for varied psychological difficulties, no single condition, syndrome, or set of difficulties is reliably associated with such experiences. CSA likely disrupts or impairs normal development in complex ways that depend on the risk and resilience factors present before, during, and after CSA. CSA characteristics that increase risk for later difficulties include young age, trauma inflicted by another person, number of occurrences, violence or intrusiveness, betrayal of trust, adverse peri-traumatic reactions, negative reactions from others following disclosure, and a context of previous sexualized assault or maltreatment. Resilience increases with positive self-esteem, better intellectual functioning, good self-control, positive social support, and early therapeutic intervention. CSA is associated with impaired psychological development, mental health disorders, behavioural and relationship difficulties, physical health problems, reduced intellectual function, lower educational achievement, lower occupational attainment, and reduced lifetime income. Any particular difficulty may be problematic in its own right and may also contribute to other difficulties in the interlocking domains of individual abilities and attributes, relationships, and significant life activities. In individual forensic assessment cases, general evidence on CSA risk/resilience and impacts can be used in combination with the lifespan developmental analysis (Barnes & Josefowitz, Psychological Injury and Law, 2014), to determine whether and how CSA contributed to psychological injuries.