Ensuring the safe and effective FDA regulation of fecal microbiota transplantation

Scientists, policymakers, and medical professionals alike have become increasingly worried about the rise of antibiotic resistance, and the growing number of infections due to bacteria like Clostridium difficile, which cause a significant number of deaths and are imposing increasing costs on our health care system. However, in the last few years, fecal microbiota transplantation (FMT), the transplantation of stool from a healthy donor into the bowel of a patient, has emerged as a startlingly effective means to treat recurrent C. difficile infections. At present, the FDA is proposing to regulate FMT as a biologic drug. However, this proposed classification is both underregulatory and overregulatory. The FDA''s primary goal is to ensure that patients have access to safe, effective treatments—and as such they should regulate some aspects of FMT more stringently than they propose to, and others less so. This essay will examine the nature of the regulatory challenges the FDA will face in deciding to regulate FMT as a biologic drug, and will then evaluate available policy alternatives for the FDA to pursue, ultimately concluding that the FDA ought to consider adopting a hybrid regulatory model as it has done in the case of cord blood.     

Between Resistance and Compliance: Non-participation and the Liberal Peace

Abstract

This work is interested in the concept of non-participation in relation to international peace–support interventions. While the concept of participation has received significant attention, non-participation is under-conceptualized. A typology of non-participation is advanced, differentiating between voluntary and involuntary types of non-participation. It is argued that there is an overhasty tendency by many observers to subjectify inhabitants in post-war settings into the categories of resistance and compliance. This article rejects such a binary as too crude, and argues that non-participation needs to be examined in its own right, not automatically in relation to wider projects of liberal peacemaking or of resistance to that form of peacemaking.     

劳动者抗争行为的处罚与刑事政策研究——以我国台湾地区为视角

在任何一个国家或地区的劳资关系中,劳动争议的发生可以算是一种常态,因为在一个组织之中管理者和被管理者之间一定会有冲突和争议。劳动者为求取尊严和生存,有时会从事若干自力救济的群体性抗争活动,若当该等行为触犯刑法时,应该如何处罚?关于劳动者群体性抗争事件处罚与刑事政策,是任何一个国家或地区内部和谐稳定的重要政策之一。2011年5月1日我国台湾地区开始施行新的《劳资争议处理法》,增设了特殊刑事豁免规定,但内容颇多疑义,在施行后未必能解决现有难题,对于普遍存在的劳动者群体性抗争活动帮助不大。毕竟,劳动者抗争群体性事件问题的解决,最终仍须回归刑事政策研究。     

The Italian Mediation Explosion: Lessons in Realpolitik

Between the time that the first modern Italian mediation statutes were issued in 1993 and March 2011, when mandatory mediation procedures under Italian Legislative Decree 28/2010 went into effect, an interesting paradox emerged in Italian mediation: mediation usage was virtually nonexistent despite the high success rates of mediated cases. Clearly, the mere availability of mediation was not sufficient to attract disputants away from the courts, even though the Italian court backlog skyrocketed to 5.4 million cases during this period. Decree 28/2010 was issued by the Italian government to address this paradox through a mandatory mediation requirement, but the law has faced significant opposition from some members of the Italian bar in the form of public strikes and legal challenges. Legislators have responded to this dissent with reactionary amendments to “cure” problems in the regulatory structure, even though there has also been significant positive attention paid to the Italian mediation model at the European level. As the opposition to Decree 28/2010 now appears to be diminishing and recent data indicate that mandatory mediation is achieving its objectives (to the tune of tens of thousands of mediated cases since March 2011), two lessons in realpolitik emerge for mediation proponents. First, nothing less than compulsion can rapidly increase mediation use. Second, the legislator who compels mediation without openly engaging the opposition is not mediation savvy, for even in compelling a policy choice, one should be respectful and mindful of the opponent's position, if for no other reason than to minimize his or her opposition to the final result.     

The unlikely terrorist: women and Islamic resistance in Lebanon and the Palestinian territories

Islamic resistance groups in Lebanon and the Palestinian territories have been accused of using terrorist tactics to achieve their aims. Although some critics suggest that such groups may also have hijacked the democratic agenda in ways that disadvantage women, their supporters claim that they are promoting a model of modernity that is empowering women. This article examines the reasons why some Lebanese Shi'i and Palestinian women support the resistance against Israeli invasion and occupation that is justified in terms of religion. Far from seeing the actions of Hizbullah in Lebanon and Hamas in the Palestinian territories as acts of terrorism, many women welcome the resistance as it brings dignity and meaning to their lives and enhances feelings of national identification.     

Culture,integration and African Renaissance

ABSTRACT

This article examines the role of language in negotiating power between Sudanese Arabists and Sudanese Africanists from a critical discourse analysis perspective (henceforth CDA). The aim is to demonstrate how extreme political discourse can jeopardise national unity. The article begins by summarising the basic tenets of the CDA theory and proceeds to examine Sudanese power-related discourse. Particularly, the article assumes both top-down and bottom-up approaches to analyse the discourses corresponding to the two groups, Sudanese Arabists and Sudanese Africanists. The top-down approach examines the discourse of the ruling Arab elites who have exclusive access to institutional discourse and communication. By contrast, although the Sudanese Africanist discourse was once considered illegal and could not be conveyed through public channels, in more modern times it has found the Internet, television and radio (among others) as avenues for dissemination. A number of socio-political groups, generally referred to as marginalised affiliations, are now initiating resistance discourse (henceforth RD) which goes hand in hand with their armed struggle against the ruling elites.     

African tourist art as tradition and product of the postcolonial exotic

ABSTRACT

Figurative art made in Central and West Africa for the global market is a form of tourist art – a category that has been plagued in art historical research by misconstrued concepts such as the authenticity of traditional/precolonial art. Following its categorisation as a commodity, studies focused on the decontextualisation of the object, thus marginalising the producing culture. In this article I investigate the role of the artist in preserving tradition and the role of the trader who, as cultural broker, exoticises the object. Since it can be argued that these are acts of decolonising, African tourist art can be regarded as a product of the postcolonial exotic, as defned by Graham Huggan (2001). Accepting the inescapability of postcoloniality, tourist art can be repositioned as a successful attempt to preserve and promote African cultural traditions and identity in the new era.     

Public Finance and Capital Investment: A National Perspective on Colonial Dahomey

How, when and to whom should a woman marry, what constitutes marriage and what rights has a woman to influence the selection of her spouse? These and other questions were subjects of intense contestation between young men and women and their parents, on one hand, and, on the other, between commoners and members of the traditional elite in the Western Igbo district of Igbuzo in Southern Nigeria during the early twentieth century. Disputes over marriage rites centred on the politics of isinmo or the shaving of a woman's head. Isinmo gave the “barber” exclusive and inalienable rights to the woman. Yet, in what amounted to reversal of tradition, women seeking to end or reduce parental and patriarchal control appropriated some the rituals of isinmo to contest its use and efficacy in the hands of its erstwhile beneficiaries.     

Fighting for the rule of law: civil resistance and the lawyers' movement in Pakistan

Pakistan, sometimes referred to as ‘the most dangerous place on earth’, is not typically thought of as a place where popular nonviolent resistance could take root, much less succeed. Citizen apathy, poor governance, and fear of regime repression and terrorist violence are barriers to effective civic activism inside Pakistan. Yet, over the past two years, Pakistan's authoritarian ruler was ousted and its independent judiciary restored following a massive grassroots campaign led by lawyers. The ‘men in black’, whose insistence on the rule of law and embrace of nonviolent struggle captured the hearts and minds of millions of Pakistanis, helped transform the country's political landscape in unexpected ways. The successes tallied by this nonviolent movement, this article will argue, can be attributed to the large-scale non-cooperation and civil disobedience that pressured two successive Pakistani regimes – one authoritarian and one democratic – to yield to its demands. Unity and mass participation, nonviolent discipline, and the creative use of nonviolent tactics were three key ingredients of success. While instability and Islamist extremism continue to plague Pakistan, the lawyers' movement highlights the steadily growing strength of Pakistani civil society have a potential to influence democratic change in the country.     

DEVELOPMENT ON MY TERMS: DEVELOPMENT CONSULTANTS AND KNOWLEDGE FOR DEVELOPMENT

Consultants are an integral component of development aid. Their involvement is based on an assumption of the transferability of knowledge to clients and beneficiaries. However, this role, its efficacy and the concept of knowledge transfer have all been questioned. Although research has shown interest in northern development consultants in recent years, detailed processes and practices of southern consultants' engagement with knowledge production are less analysed. Drawing on debates about knowledge, power and managing development interventions and on extensive fieldwork exploring a Bolivian consultancy company's assignments for northern development agencies, we analyse the ‘knowledge engagements’ between clients, consultants and beneficiaries. The results suggest a novel theorisation: knowledge engagements are shaped by power relations exercised through discourses and financial aid on one hand and shared and unshared lifeworlds and backgrounds of actors on the other. They are also characterised by collusive behaviour with the discourses and practices of aid on the part of consultants and beneficiaries, which in turn influences outcomes. Southern consultants, although aware of these issues, are in a difficult position to challenge these relationships. A greater recognition of the tensions could lead to a new role for consultants if collective action were to renegotiate their terms of engagement and aim for a new mutuality. Copyright © 2013 John Wiley & Sons, Ltd.