Better Regulation of Industry-Sponsored Clinical Trials Is Long Overdue

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products.     

Predators and the Public Interest — the 'Big Four' and Multi–Disciplinary Practices

This article explores the growing body of professional and academic support for Multi–disciplinary Practices (MDPs) which combine the provision of legal, accounting, financial, and other 'professional' services. In doing so, it traces the development of MDPs in the UK and assesses the leading claims which have been advanced in favour of these 'one stop' providers. It is suggested that support for MDPs is located within the emergence of a new professional paradigm which places a high premium on quality of service and the resolution of complex problems and is based on a narrow conception of the public interest which is closely if not solely associated with promoting consumer welfare. This, itself, is rooted in a deregulatory vision of the world – that is, the view that the breaking down of barriers (professional, legal, and cultural), which restrict competition and impede consumer choice, is in the 'public interest'. The article challenges these views, arguing that many of the alleged consumer benefits which are said to flow from the formation of MDPs are at best speculative and that, in any case, a proper conception of the public interest is one which extends beyond a narrow concern for consumer interests.     

Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.     

“Kind of Natural,Kind of Wrong”: Young People's Beliefs about the Morality,Legality, and Normalcy of Sexual Aggression in Public Drinking Settings

Unwelcome touching, groping, and kissing are illegal, but widely tolerated in public drinking settings. This contingency in the law's response means that patrons routinely negotiate the moral boundaries of nonconsensual sexual contact. We use 197 interviews with college‐age individuals to examine the discursive strategies young people employ when negotiating those boundaries. We find that most interviewees have experiences with sexual aggression, do not categorize it as aggression, but advocate for stronger legal punishments against offenders. In accounting for this paradox, they draw on contradictory legal and cultural narratives that both normalize and condemn men's sexual aggression. We build on legal consciousness theories and gender theories by highlighting the complex ways that gender stereotypes enshrined in law are implicated in the construction of a social problem. We also contribute to the sociology of culture by explicating the often unconscious link between culture and action revealed in young people's narratives about sexual aggression.     

Trauma Systems Therapy in Residential Settings: Improving Emotion Regulation and the Social Environment of Traumatized Children and Youth in Congregate Care

Although abundant evidence exists indicating the prevalence of trauma exposure among youth in residential care, few models exist for creating trauma-informed milieu treatment. This article outlines the problem and describes the implementation of Trauma Systems Therapy (TST) in three residential centers. TST is unique in emphasizing youth emotions and behaviors as well as the role a distressed or threatening social environment may play in keeping a traumatized youth in a dysregulated state. This dual emphasis makes TST specifically appropriate to implementation in congregate care, focusing assessment and intervention strategies on both clinical treatment and the functioning of the therapeutic milieu itself. Data are reported on incidents of the use of physical restraint; numbers of disrupted foster care placements following discharge from residential treatment; and scores on psychometric measures of children’s functioning and emotion regulation capacity. Knowledge gained through TST implementation in these three residential centers has important implications for developing a model of trauma-informed congregate care.     

Discussion of "Using Stationarity Tests in Antitrust Market Definition"

Send correspondence to: Daniel Hosken, Federal Trade Commission, 600 Pennsylvania Ave. NW, Washington, DC 20850; E-mail: dhosken@ftc.gov. The first 150 words of the full text of this article appear below.