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The controversy over patients' access to stem cell interventions is familiar to scholars of the drug regulatory system and the politics of evidence-based medicine. What counts as evidence of a biomedical intervention's safety and effectiveness? Who should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions and the legal challenge to the agency's actions. Next, we place the debate about patients' access to stem cell interventions in the broader context of efforts in the US to promote and implement health technology assessment and the debate about standards of evidence. We then review several proposed initiatives to get stem cell and other new biomedical interventions into the clinic faster and consider the extent to which these policies can resolve the underlying conflicts about evidentiary standards for clinical use. Finally, we consider whether efforts to expedite access to biomedical technologies may undermine countervailing efforts to improve the safety and effectiveness of stem cell interventions. [ABSTRACT FROM AUTHOR]

There has been growing tension at the intersection of health and economic policy making as global governance has increased across sectors. This tension has been particularly evident between tobacco control and trade policy, as the international norms that frame them—particularly the Framework Convention on Tobacco Control and the World Trade Organization (WTO)—have continued to institutionalize. Using five case studies of major tobacco-related trade disputes from the principal multilateral system of trade govemance—the WTO/General Agreement on Tariffs and Trade—we trace the evolution of these interacting norms over nearly twenty-five years. Our analytic framework focuses on the actors that advance, defend, and challenge these norms. We find that an increasingly broad network, which includes govemments, intergovemmental organizations, nongovemmental organizations, and members of the epistemic community, is playing a more active role in seeking to resolve these tensions. Moreover, key economic actors are beginning to incorporate health more actively into their messaging and activities. We also demonstrate that the most recent resonant messages reflect a more nuanced integration of the two norms. The tobacco control example has direct relevance to related policy areas, including environment, safety, access to medicines, diet, and alcohol. [ABSTRACT FROM AUTHOR]

Health care in the United States is fragmented, inefficient, and rife with quality concerns. These shortcomings have particularly serious implications for adults with disabilities and functionally impaired older adults in need of long-term services and supports (LTSS). Three strategies have been commonly pursued by state governments to improve LTSS: expanding noninstitutional care, integrating payment and care delivery, and realigning incentives through market-based reforms. These strategies were analyzed using an evaluation framework consisting of the following dimensions: ease of access; choice of setting/provider; quality of care/life; support for family caregivers; effective transitions among multiple providers and across settings; reductions in racial/ethnic disparities; cost-effectiveness; political feasibility; and implementability. Although the analysis highlights potential benefits and drawbacks associated with each strategy, the limited breadth of the evidentiary base precludes an assessment of impact across all nine dimensions. More importantly, the analysis exposes the interdependent, complex system of care within which LTSS is situated, suggesting that policy makers will require a holistic and long-term perspective to achieve needed changes. Addressing the nation's LTSS needs will require a multipronged strategy incorporating a range of health and social services to meet the complex care needs of a diverse population in a variety of settings. [ABSTRACT FROM AUTHOR]

Tobacco control advocates began to use ballot initiatives to enact tobacco control measures in the late 1970s. In response, the tobacco industry worked for over two decades to change laws governing initiative and referendum processes to prevent passage of such measures. In 1981 the tobacco industry's political lobbying arm, the Tobacco Institute, created a front group that presented itself as a neutral initiative research clearinghouse to effect changes in state initiative and referenda laws. In 1990 the Tobacco Institute began creating an in-house team and worked with third-party groups to try to change state initiative laws. While the industry ultimately abandoned both efforts when neither achieved immediate success, over time the industry's goals have penetrated legitimate discourse on the initiative and referendum process in the United States, and many specific ideas it advocated have garnered mainstream support. Direct democracy advocates, as well as public health advocates and policy makers, need to understand the tobacco industry's goals (which other industries adopted) of limiting the direct democracy process to ensure that any changes do not inadvertently increase the power of the special interests that direct democracy was developed to counterbalance. [ABSTRACT FROM AUTHOR]

The international community, under the auspices of the World Health Organization, developed the landmark Framework Convention on Tobacco Control (FCTC) to curb the global tobacco epidemic. As an internationally binding convention about global best practices on tobacco control, the FCTC has become an overriding source of policy transfer for developing countries in the fight against smoking. However, since its ratification of the first global norm over tobacco governance and against the grim background of the widespread tobacco-induced public health devastation within its borders, China has failed to genuinely pursue FCTC policies because of domestic political and social factors. The empirical findings of this article point to the dominance of political-social dynamics for China's nontransfer of FCTC policies, arguing that the government's GDPism, its sovereignty-first mentality, and hostility to NGOs as well as widespread social acceptability of tobacco consumption and high smoking prevalence are fundamental causes of China's nontransfer of FCTC policies. The article explicates how these variables correspond to FCTC policies in an analytic framework of policy transfer. [ABSTRACT FROM AUTHOR]

Efforts to support and use comparative effectiveness research (CER), some more successful than others, have been promulgated at various times over the last forty years. Following a resurgence of interest in CER, recent health care reforms provided substantial support to strengthen its role in US health care. While CER has generally captured bipartisan support, detractors have raised concerns that it will be used to ration services and heighten government control over health care. Such concerns almost derailed the initiative during passage of the health care reform legislation and are still present today. Given recent investments in CER and the debates surrounding its development, the time is ripe to reflect on past efforts to introduce CER in the United States. This article examines previous initiatives, highlighting their prescribed role in US health care, the reasons for their success or failure, and the political lessons learned. Current CER initiatives have corrected for many of the pitfalls experienced by previous efforts. However, past experiences point to a number of issues that must still be addressed to ensure the long-term success and sustainability of CER, including adopting realistic aims about its impact, demonstrating the impact of Patient-Centered Outcomes Research Institute (PCORI) and communicating the benefits of CER, and maintaining strong political and stakeholder support. [ABSTRACT FROM AUTHOR]

Recently the medical profession has faced increased outside pressure to reform postgraduate medical training programs to better equip young doctors for changing health care needs and public expectations. In this article we explore the impact of reform on professional self-governance by conducting a comparative historical-institutional analysis of postgraduate medical training reform in the United Kingdom and the Netherlands. In both countries the medical training regime has shifted from professional self-regulation to coregulation. Yet there are notable differences in each country that cannot be explained solely by diverging institutional contexts. They also result from the strategic actions by the actors involved. Based on an assessment of the recent literature on institutional transformation, this article shows how strategic actions set negotiating authority processes into motion, producing new and sometimes surprising institutional arrangements that can have profound effects on the distribution and allocation of authority in the medical training regime. It stresses the need to study the interactions among political context, the properties of institutions, and negotiating authority processes, as they are crucially important to understanding institutional transformation. [ABSTRACT FROM AUTHOR]

We are at the beginning of an era in which the pressure to secure the biggest possible "bang" for the health care "buck" is perhaps higher than it ever has been, on both sides of the Atlantic, and within the health policy discourse, incentives, for both professionals and patients, are occupying an increasingly prominent position. In this article, we consider issues related to motivating the professional and the patient to perform targeted actions, drawing on some of the evidence that has thus far been reported on experiences in the United Kingdom arid the United States, and we present an admittedly somewhat speculative taxonomy of hypothesized effectiveness for some of the different methods by which each of these two broad types of incentives can be offered. We go on to summarize some of the problems of, and objections to, the use of incentives in health and health care, such as those relating to motivational crowding and gaming, but we conclude by positing that, following appropriate consideration, caution, and methodological and empirical investigation, health-related incentives, at least in some contexts, may contribute positively to the social good. [ABSTRACT FROM AUTHOR]