Do Off‐Label Drug Practices Argue Against FDA Efficacy Requirements? A Critical Analysis of Physicians' Argumentation for Initial Efficacy Requirements

The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses (“on‐label”), but does not require certification before physicians may prescribe the drug for subsequent uses (“off‐label”). Does it make sense to require FDA efficacy certification for new drugs but not for new uses of old drugs? Using a sequential online survey, we carried on a “virtual conversation” with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off‐label uses; almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most physicians said no. We then asked respondents whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response, we received hundreds of written commentaries. We organize and discuss these commentaries with an eye to understanding how the medical market certifies off‐label drug uses and how this compares to FDA certification. Does off‐label medicine use suggest that efficacy requirements should be placed on new uses of old drugs? Does it suggest that efficacy requirements on new drugs should be lifted? We explore these questions, and ask whether the response of many of the doctors exhibits the familiar behavior bias toward the status quo.     

Career concerns incentives: An experimental test

Holmström’s [Holmström, B., 1982/1999. Managerial incentive problems: a dynamic perspective. Review of Economic Studies 66, 169–182. Originally published in: Essays in Economics and Management in Honour of Lars Wahlbeck, Helsinki] career concerns model has become a workhorse for analyzing agency issues in many fields. The underlying signal jamming argument requires players to use information in a Bayesian way, which is difficult to directly test with field data: typically little is known about the information that individuals base their decisions on. Our laboratory experiment provides prima facie evidence: (i) the signal jamming mechanism successfully creates incentives on the labor supply side; (ii) decision errors take time to decrease; (iii) while subjects’ average beliefs are remarkably consistent with play, a mild winner’s curse arises on the labor demand side.     

Citizens, Autocrats, and Plotters: A Model and New Evidence on Coups D'État

We present a model of coups in autocracies. Assuming that policy choices cannot be observed but are correlated with the short-run performance of the economy we find that: (a) the threat of a coup disciplines autocrats; (b) coups are more likely in recessions; (c) increasing per capita income has an ambiguous effect on the probability of a coup. The implications of the model are consistent with the evidence. On average, one recession in the previous year increases the probability of a coup attempt by 47 percent. By contrast, the effect of the level of per capita income is weak.     

Competition and Participation in Religious Markets: Evidence from Victorian Scotland

In 1885, the largest churches in Scotland were engaged in a dispute about state funding. We use data generated in the course of that dispute to test two related hypotheses. First, as market size (proxied by population) increases, the competitiveness (or complexity) of the religious market structure will not decrease. Second, religious activity, as measured by giving per member, church income and participation, will not decrease as market competitiveness (or complexity) increases. Empirical evidence lends support to the first hypothesis, but casts doubt on the second, and the supply-side theories underpinning it, which posit a causal link between increased competitiveness (complexity) and higher levels of religious activity. In interpreting the results the importance of a rich understanding of institutional arrangements—particularly market structure, governance and financing—is underlined.     

Democracy, size of bureaucracy, and economic growth: evidence from Russian regions

This article considers the impact of sub-national political systems on economic growth by applying the case of Russian regions from 2000 to 2004. It investigates two dimensions of the sub-national systems. First, it studies the influence of democracy on economic performance, providing evidence of a non-linear relationship between democracy and economic growth. Regions with high levels of democracy, as well as strong autocracies, perform better than hybrid regimes. Second, this article considers the influence of the size of the bureaucracy on economic outcomes and confirms the ??grabbing hand?? view on bureaucracy rather than the Weberian idea. Increasing the size of the bureaucracy is associated with a decline in economic performance. In addition, this article analyzes the potential interaction between these two characteristics of sub-national politics as factors of economic growth, but does not establish any robust results.