Advertising and promotion of medical devices

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties.     

Changing patterns of addiction and public aid receipt: tracking the unintended consequences of welfare reform

Sharp declines in welfare rolls since the passage of welfare reform legislation have led many to label it a social policy success. Using data from prereform and postreform samples of welfare applicants and recipients, as well as ethnographic data on welfare reform implementation, we examine three hypotheses based on concerns raised during the welfare reform debate about the possible effects of new policies on substance abusers and addicts: First, they would be "scared off," or discouraged from applying to aid by welfare's new requirements surrounding work and treatment. Second, they might be "weeded out," or face discrimination in the application process because of concerns about the difficulty of moving them successfully from welfare to work. Third, they might be "bumped down," or shifted to local aid programs rather than moving from welfare to self-sufficiency. Our empirical analysis finds no evidence of scaring off or weeding out, and some evidence of bumping down. Using ethnographic data, we offer some possible explanations for these findings by placing them in the context of policy change and implementation in the years following welfare reform.     

RATIONALISM VERSUS INCREMENTALISM IN CRIMINAL SENTENCING

Rationalism in management science tends to mean attempting to determine the benefits and costs of the alternative decisions under consideration, and then picking the one that is best on benefits minus costs. Incrementalism tends to mean determining the decisions that actually get made under various circumstances, and then working with those existing decision rules as the basis for making adjustments to consider special or changing circumstances. Those two approaches can be well illustrated with the problem of attempting to determine what criminal sentences should be legislated to cover given crimes and prior records. The analysis tends to show that a rationalist approach is more effective in achieving societal goals when (1) alternative policies can be meaningfully related to those goals, and (2) existing decisions reflect individual goals which are generally in conflict with societal goals. An incrementalist approach is more effective when either of those criteria is absent, which is so when seeking to arrive at legislatively determined nondiscretionary criminal sentencing.     

Citizen sampling simulations: A method for involving the public in social planning

The growth of the planning function of government raises the question of how planning can be accomplished by democratic means. A new technological device—the teaching computer—seems to be ideally suited for disscussions between experts and the public on issues of medium and long-range planning. The teaching computer can be thought of as a mass communications system with feedback.The author wishes to acknowledge research support from the Program on the Social Implications of Science and Technology at the University of Illinois under National Science Foundation grant GR-60. The research described is being carried out through the Institute of Communications Research. The facility being used is located at the Computer-based Education Research Laboratory of the University of Illinois which is supported in part by the National Science Foundation under grant GF-81 and the Advanced Research Projects Agency under grant ONR-Nonr 3985 (08). This paper was presented at the second International Future Research Conference held in Kyoto, Japan, April 10–16, 1970.     

The information content of elections and varieties of the partisan political business cycle

This event study uses economic forecasts and opinion polls to measure the response of expectations to election surprise. Use of forecast data complements older work on partisan cycles by allowing a tighter link between election and response thereby mitigating concerns of endogeneity and omitted variables. I find that forecasters respond swiftly and significantly to election surprise. I further argue that the response ought to vary across countries with different institutional foundations. In support, I find that there exist three distinct patterns in forecasters’ responses to partisan surprise corresponding to Hall and Soskice’s three varieties of capitalism.     

Campaigns and the prediction of election outcomes: Can historical and campaign-period prediction models be combined?

There are two approaches to predicting election outcomes: (1) a historical approach, which uses past election results alongside macroeconomic and political variables to forecast election results up to a year in advance, and (2) a campaign-oriented approach, which uses current campaign trends to forecast vote shares at the end of the campaign. They are in some way at odds—one approach says the campaign doesn't matter, the other focuses entirely on the campaign. This article considers whether the two approaches might be usefully combined; it considers whether the prediction errors in historical models may be related to trends during the campaign. That possibility is tested here using 17 elections in the US, UK and Canada, combining historical predictions and automated content analyses of campaign-period media content. Results suggest that campaigns do not account for errors in the historical predictions; but there may be other ways in which campaigns matter in conjunction with historical models.     

Umbilical cord blood banking and the next generation of human tissue regulation: an agenda for research

The transformation of umbilical cord blood from being a waste product to being a valuable source of stem cells has led to the emergence of significant legal, ethical and social issues. This editorial proposes an agenda for research into the regulation of umbilical cord blood banking which focuses on issues of characterisation, consent, the interplay of public and private services, and the importance of applying property concepts. It concludes by stressing the need for reform to be based on well-informed public debate.     

Adulthood animal abuse among women court-referred to batterer intervention programs

The substantial increase in the enrollment of women in batterer intervention programs (BIPs) over the past 30 years has greatly outpaced research on women who perpetrate intimate partner violence (IPV). As a result, it is unknown whether existing programs, which were originally designed to treat male perpetrators, are effective at preventing recidivism among women. Recent research shows that men who perpetrate IPV may also aggress against nonintimate partners, children, and animals, and that the reach of their aggressive tendencies has implications for treatment. Conducting similar investigations on women who perpetrate IPV may help to inform treatment delivery in BIPs. This study examined the prevalence of adulthood animal abuse perpetration and its association with psychological and physical IPV perpetration in a sample of women arrested for domestic violence (N = 87). Seventeen percent (n = 15) of the women committed at least one act of animal abuse since the age of 18, in contrast to the 0.28% prevalence rate reported in the general population. The overrepresentation of animal abuse in this sample was consistent with that of men arrested for domestic violence. Furthermore, women who reported committing animal abuse as an adult showed moderately higher rates of psychological aggression and physical assault perpetration against their partners, relative to women who did not report animal abuse. Implications for future research are discussed.