Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.     

Methodologies of election forecasting: Calling the 2010 UK “hung parliament”

Election forecasting has experienced considerable growth as a subfield within political science. Research work on United Kingdom elections has been cutting edge here. The recent 2010 general election afforded the opportunity for a trial of different forecasting methodologies. These efforts are showcased in this volume, and include standard, and not-so-standard, statistical models. Overall, these models perform well, foreseeing the unprecedented outcome of a “hung parliament”, as most pollsters and pundits did not. Moreover, they achieved this accuracy with forecasts well in advance of the election itself.     

Measuring Attitudes toward the United States Supreme Court

It is conventional in research on the legitimacy of the U.S. Supreme Court to rely on a survey question asking about confidence in the leaders of the Court to indicate something about the esteem with which that institution is regarded by the American people. The purpose of this article is to investigate the validity of this measure. Based on a nationally representative survey conducted in 2001, we compare confidence with several different measures of Court legitimacy. Our findings indicate that the confidence replies seem to reflect both short-term and long-term judgments about the Court, with the greater influence coming from satisfaction with how the Court is performing at the moment. We suggest a new set of indicators for measuring the legitimacy of the Court and offer some evidence on the structure of the variance in these items.     

Reexamining the Relationship Between Fiscal Stress and Outsourcing

The determinants of outsourcing in local government are widely studied from a variety of frameworks. One concept consistently used to explain local government outsourcing is fiscal condition, with many noting that outsourcing is more likely when a local government’s fiscal condition declines into fiscal stress. Despite the ubiquity of this expectation in the outsourcing literature, several articles reviewed suggest that the findings for this relationship remain uncertain. As a result, the research presented in this article sought to examine and extend what is known about the relationship between fiscal stress and outsourcing in U.S. municipalities. The research includes previous measures of fiscal stress and adds new measures. In addition, it tries to overcome the limited theoretical testing of the relationship between fiscal stress and outsourcing by examining both direct and indirect effects of fiscal stress on outsourcing. It finds that municipalities in the United States that are experiencing fiscal stress are more likely to engage in outsourcing, particularly municipalities that are experiencing fiscal stress and have a positive evaluation of the external market to provide services.