Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide "truthful information" to doctors about "widely accepted" off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to "widely accepted" uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks. A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.     

Competing Ontologies: A Primer for Public Administration

A growing number of public administration theorists are taking up the question of ontology—the nature of existence. This primer on the topic provides a basic explanation of ontology, describes the fundamental debates in the competing ontologies of Western philosophy, and discusses why ontology is important to social and political theory, as well as to public administration theory and practice. Using an ideal‐type approach, the author analyzes how different ontologies imply particular political forms that undergird public administration theories and practices. This ideal‐type model can be used to identify the ontological assumptions in these theories and practices. The article concludes with an invitation for personal reflection on the part of scholars and practitioners in regard to which ontology best fits their experience and beliefs and the alternatives that we might pursue for a better future.     

Detecting Spillover Effects: Design and Analysis of Multilevel Experiments

Interpersonal communication presents a methodological challenge and a research opportunity for researchers involved in field experiments. The challenge is that communication among subjects blurs the line between treatment and control conditions. When treatment effects are transmitted from subject to subject, the stable unit treatment value assumption (SUTVA) is violated, and comparison of treatment and control outcomes may provide a biased assessment of the treatment’s causal influence. Social scientists are increasingly interested in the substantive phenomena that lead to SUTVA violations, such as communication in advance of an election. Experimental designs that gauge SUTVA violations provide useful insights into the extent and influence of interpersonal communication. This article illustrates the value of one such design, a multilevel experiment in which treatments are randomly assigned to individuals and varying proportions of their neighbors. After describing the theoretical and statistical underpinnings of this design, we apply it to a large‐scale voter‐mobilization experiment conducted in Chicago during a special election in 2009 using social‐pressure mailings that highlight individual electoral participation. We find some evidence of within‐household spillovers but no evidence of spillovers across households. We conclude by discussing how multilevel designs might be employed in other substantive domains, such as the study of deterrence and policy diffusion.     

Share and Share Alike? Hedge Funds,Human Rights,and Owning Enterprise in Britain

This article explores the meanings of ownership and shareholding in the context of the 2007 run on Northern Rock, its subsequent nationalization in 2008, and the resulting legal challenge brought by former shareholders. Drawing on evidence from a range of sources outside traditional legal and official doctrine, and from original empirical research, it focuses on the perspective and voices of local small individual shareholders in relation to shareholding, bank failure, and government responses to financial crisis. It tells the story of these individual shareholders against differing conceptions of share ownership rights and responsibilities, and from various angles, to show the many different subjectivities of corporate shareholding and ownership of enterprise of which orthodox legal and economic models take scant account. It concludes on a note of historic persistence in demand for proprietary shares in banking institutions, despite the differing levels of understanding and tolerance of equity risk among shareholders that our research reveals.     

Texas Christian University (TCU) Short Forms for Assessing Client Needs and Functioning in Addiction Treatment

The TCU Short Forms contain a revised and expanded set of assessments for planning and managing addiction treatment services. They are formatted as brief (1-page) forms to measure client needs and functioning, including drug use severity and history (TCUDS II), criminal thinking and cognitive orientation (CTSForm), motivation and readiness for treatment (MOTForm), psychological functioning (PSYForm), social relations and functioning (SOCForm), and therapeutic participation and engagement (ENGForm). These instruments facilitate optically-scanned data entry, computerized scoring, and rapid graphical feedback for clinical decisions. The present study (based on 5,022 inmates from eight residential prison treatment programs) examines evidence on scale reliabilities and measurement structures of these tools. Results confirmed their integrity and usefulness as indicators of individual and group-level therapeutic dynamics.     

‘I'm going to get a job at the factory’: attitudes to women's employment in a mining community, 1945-65

This article examines how couples in mining households managed the increasing opportunities for women to work outside of the home in the period following the Second World War. Households in mining communities have regularly been characterised in research literature as operating strictly segregated gender roles and the lack of employment opportunities in mining areas appears to have accentuated the rigid division of labour. However, in some areas where the mining industry was in decline, new employment opportunities for married women increased, which inevitably placed a strain on the male provider model. This article explores these issues in relation to the ironstone mining district of East Cleveland and uses data generated from thirty-three semi-structured interviews. It will be argued that whilst the separation of the male provider and female homemaker role remained the ideal for many couples, others chose to avail themselves of the economic and psychological benefits of female employment. However, even amongst those couples where the women did undertake paid employment, the image of the male as provider was still preserved by the use of various strategies.     

new millennium’s feminine subject of feminism

This paper explores the changing feminine subject of feminism by investigating women’s sexual daydreams. Described by Rosi Braidotti following Luce Irigaray as the ‘virtual feminine’, and by Teresa de Lauretis as the ‘space-off’, the feminist subject is a mutating configuration embodying that which is not colonised from phallogocentric representations. Following Frigga Haug’s work on daydreams, the paper is informed by a study that draws on responses from nineteen women in a university setting to an anonymous online survey that asked them to write a daydream about how they would like to express their sexualities in an ideal world. The data reveal that these women of the new millennium imagine spaces of gender/sexual equity, characterised by a spirit of sexual adventure and ethical and emotionally intimate sex. I argue that these sexual imaginings are more progressive than earlier ones, filling in some of the details omitted from contemporary hegemonic representations of feminine sexuality. Arguably providing a snapshot of the feminist subject in its ongoing historical metamorphosis, the paper considers the meaning of these transformations.     

The role of inspection sequence in compliance with the US Occupational Safety and Health Administration's (OSHA) standards: Interpretations and implications

We examined the Occupational Safety and Health Administration's (OSHA) inspections in the US to identify the effects of repeated inspections and the time between inspections on non-compliance. Our sample included 549,398 inspections conducted from 1972 through 2006 in manufacturing plants in the 29 states where federal OSHA enforces the law. We controlled for inspection type, industry, establishment size, and year. The number of total violations cited fell by 28%–48% from the first to the second inspection; after that, the numbers declined much more slowly. These effects were found in every one of the four sub-periods examined. The number of violations cited increased with each additional year since the prior inspection after controlling for other variables; however, the increases were small, totaling approximately 15% over five years. OSHA should probably give higher priority to first time inspections than to repeated inspections. The current requirement that at least two years elapse between planned inspections should probably be lengthened.     

Systemic Self-Regulation: A Framework for Trauma-Informed Services in Residential Juvenile Justice Programs

Most youth detained in juvenile justice facilities have extensive histories of exposure to psychological trauma. Traumatic stress plays a key role in their mental health and behavioral problems and needs, and in their safety and rehabilitation and the security and effectiveness of detention facilities. We provide an overview of the barriers to successful provision of mental health services for youths in juvenile justice facilities, including those involving youth, parents, and juvenile justice residential facility staff and administrators. Next, we discuss the relevance and potential utility of approaching mental health needs using posttraumatic stress disorder (PTSD), and more broadly posttraumatic dysregulation, as an organizing framework. Examples of how a posttraumatic dysregulation perspective can enhance juvenile justice residential facility milieus and services are presented, with an overview of traumatic stress intervention models that have shown promise, or potentially could be deployed, in developing and sustaining trauma-informed juvenile justice facilities.