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.     

Deadly divide: Malawi’s policy debate on HIV/AIDS and condoms

This paper examines the dynamics of condom policymaking in Malawi by analyzing debates, which took place in the Malawi National Assembly between the year 2000 and 2004. Using content analysis and key informant interviews, and situating the overall discussion within policy and science literature, we examine how scientific evidence is being applied in the policymaking process as it relates to the place of condoms within the context of HIV/AIDS prevention. The study not only shows the extent to which the policymaking process on condoms in Malawi largely embodies a tendency to blur the conventional divide between science and politics, but also demonstrates why controversy around condoms still persists at the highest level of government in a country with one of the highest HIV prevalence rates in the world. It was found that even when people are dying, consensus in HIV/AIDS policymaking can be difficult to achieve in a policy climate characterized by a binary perspective to social problems, and where different actors compete for control over the policy terrain. The paper makes recommendations that may be helpful in facilitating a more inclusive HIV/AIDS policymaking process in Malawi.     

The effect of incomplete information in a threshold public goods experiment

Fiscal stress and decreasing government budgets have led to renewed interest in voluntary contributions for the funding of public goods. This paper experimentally examines the Provision Point Mechanism (PPM), a voluntary contribution mechanism for the funding of lumpy public goods. Previous research has demonstrated the effectiveness of this mechanism at providing public goods, however all were conducted in an environment of complete information, which fails to capture the uncertainties of the real world. This study tests the efficacy of the PPM in informationally limited settings. We find no significant differences in the rate of successful provisions or level of group contributions when subjects have limited information about the valuations of others than when they have complete information.     

Disrupting the South African parliament: performing opposition 1994–2010

The article focuses on the most common form of institutionally punished disruption seen in South Africa's National Assembly since 1994: orders for individual MPs to withdraw from the chamber. The shifting dynamics of such “set-piece” dramatizations of opposition and their relationship with the established analyses of political opposition in post-apartheid South Africa, especially “dominant party democracy” theory are explored. There have been two main styles of disruptive performance in the National Assembly since 1994. Firstly, performances of perceived political marginalization, and secondly, performances that paradoxically lay claim to uphold parliamentary democracy through rule-breaking, which are termed performances of procedure-as-democracy. The article examines how opposition politicians have justified disruption and unpicks the symbolism of prominent incidents. The focus is upon the performance of disruption and its performative aspects, particular the articulation of race and gender. It is argued that performances of procedure-as-democracy are actually one of the principal means by which opposition political parties perform narratives of ANC dominance and as such require much more attention and critical engagement from political scholars interested in dominant party democracy.