iPLEDGE Allegiance to the Pill: Evaluation of Year 1 of a Birth Defect Prevention and Monitoring System

The United States Food and Drug Administration (FDA), in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin (Accutane), a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential (WCP) as it compares to the risk-benefit relationship of using isotretinoin.     

The Mills report,the Manley subsidy proposals,and the business of major‐league sport

Abstract: This article examines the debates over subsidies to professional sports teams that have been the focus of much attention and passion in Canada over the past several years, debates that led to the report by Dennis Mills,Sport in Canada: Everybody's Business, and to John Manley's ill‐fated proposals to offer subsidies to Canadian professional sports operators. The article reviews the arguments put forward by the sports industry: that major‐league hockey and baseball teams make substantial economic contributions, both directly and indirectly, to the cities in which they are located and that Canadian teams, especially those based in smaller cities, need substantial reductions in their public costs (taxes and/or rents) in order to “level the playing field” with their US. competitors. The authors argue that the commissioned studies on which these claims are based systematically overstate the economic impacts of professional sports and are not supported by independent research. The authors also argue that the difficulties facing Canada's “small market” teams are not primarily the result of higher taxes; rather, they follow from changes in the sports industry over the last decade (notably, much higher player salaries). This means that in order to remain competitive, teams must be able to generate far greater revenues than were needed only a decade ago. When one examines the new economy of professional hockey, in particular, with its heavy reliance on local television and advertising revenues and on the purchase of luxury seating by the local corporate sector, it is hard to avoid concluding that even with public subsidies teams based in provincial Canadian cities may no longer be able to compete in the major leagues. Finally, the authors consider the cultural argument that nhl hockey is a Canadian tradition and warrants support on “heritage,” as opposed to economic, grounds. However, the authors conclude that both professional sports and Canada have changed so much in recent decades that commercial sport is not an appropriate candidate for public subsidy. Sommaire: Dans cet article, on examine la question des subventions aux équipes de sports professionnels qui a fait l'objet d'un vif débat au Canada au cours de ces dern‐ières années. Ce débat avait entraîné le rapport de Dennis Mills,Sport in Canada: Everybody's Business, et les propositions soumises ans succès par John Manley pour offrir des subventions aux exploitants de sports professionnels au Canada. On y présente les arguments du secteur des sports: les équipes de hockey et de baseball des ligues majeures font un apport économique direct et indirect considérable aux villes oú elles se trouvent, et les équipes canadiennes, surtout celles basées dans des villes plus petites, ont besoin d'une réduction substantielle de leurs coûts publics (impôts et/ou loyers) afin d'égaliser le terrain de jeu par rapport à leurs concurrents américains. Selon les auteurs, les études commanditées qui justifient ces prétentions exagèrent systématiquement les retombées économiques des sports professionnels et elles ne sont pas appuyées par des recherche indépendeants. Par ailleurs, les difficultées auxquelles font face les équipes de petit marché au Canada ne découlent pas d'une forte impositoin mais plutôt de l'évolution survenue dans l'industrie du sport au cows de cette dernière décennie (notamment, la forte hausse du salaire des joueurs). Pour rester concurrentielles, les équipes doivent recueillir un revenue très supérieur à celui d'il y a dix ans. Lorsqu'on examine la nouvelle économie du hockey professionnel en particulier, fortement tributaire du revenue prodigué par la télévision et la publicité locales et de l'achat de siges au prix fort par les entreprises de la localité, il est difficile d'éviter la conclusion que, même avec des subventions publiques, les équipes basées dans des villes provinciales au Canada auront du mal à survivre dans les lques majeures. Enfin, les auteurs examinent l'argument culturel voulant que le hockey de la lnh soit une tradition canadienne qui mérite d'être appuyée à titre patrimonial plutôt qu'économique. Leur conclusion: les sports professionnels et le pays lui‐même ont tellement évolué ces dernières décennies que le sport commercial n'est pas un candidat valable pour des subventions publiques.