Yale journal of health policy, law, and ethics最新文献

{"title":"The origins of American health libertarianism.","authors":"Lewis A Grossman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article examines Americans' enduring demand for freedom of therapeutic choice as a popular constitutional movement originating in the United States' early years. In exploring extrajudicial advocacy for therapeutic choice between the American Revolution and the Civil War, this piece illustrates how multiple concepts of freedom in addition to bodily freedom bolstered the concept of a constitutional right to medical liberty. There is a deep current of belief in the United States that people have a right to choose their preferred treatments without government interference. Modern American history has given rise to movements for access to abortion, life-ending drugs, unapproved cancer treatments, and medical marijuana. Recently, cries of \"Death Panels\" have routinely been directed against health care reform proposals that citizens believe would limit the products and procedures covered by government health insurance. Some of the most prominent contemporary struggles for health freedom have been waged in court. But other important recent battles for freedom of therapeutic choice have taken place in other forums, from legislative hearings to Food and Drug Administration advisory committee meetings to public demonstrations. This attitude of therapeutic libertarianism is not new. Drawing mainly on primary historical sources, this Article examines arguments in favor of freedom of therapeutic choice voiced in antebellum America in the context of battles against state licensing regimes. After considering some anti-licensing arguments made before independence, it discusses the views and statements of Benjamin Rush, an influential founding father who was also the most prominent American physician of the early national period. The Article then analyzes the Jacksonian-era battle against medical licensing laws waged by the practitioners and supporters of a school of botanical medicine known as Thomsonianism. This triumphant struggle was waged in explicitly constitutional terms, even though it occurred entirely outside of the courts. The Thomsonian campaign thus offers one of the most striking examples of a successful popular constitutional movement in American history. This article shows that, at its origin, the American commitment to freedom of therapeutic choice was based on notions of not only bodily freedom, but also economic freedom, freedom of conscience, and freedom of injury. Finally, this Article considers ways in which this early history helps illuminate the nature of current struggles for freedom of therapeutic choice.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 1","pages":"76-134"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31546383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Are independent pharmacies in need of special care? An argument against an antitrust exemption for collective negotiations of pharmacists.","authors":"Danielle Beth Rosenthal","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 1","pages":"198-252"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31546385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Towards a Framework Convention on Global Health: a transformative agenda for global health justice.","authors":"Lawrence O Gostin,&nbsp;Eric A Friedman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Global health inequities cause nearly 20 million deaths annually, mostly among the world's poor. Yet international law currently does little to reduce the massive inequalities that underlie these deaths. This Article offers the first systematic account of the goals and justifications, normative foundations, and potential construction of a proposed new global health treaty, a Framework Convention on Global Health (FCGH), grounded in the human right to health. Already endorsed by the United Nations Secretary-General, the FCGH would reimagine global governance for health, offering a new, post-Millennium Development Goals vision. A global coalition of civil society and academics has formed the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) to advance the FCGH.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 1","pages":"1-75"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31546951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Affordable Care Act and the Medicare program: the engines of true health reform.","authors":"Eleanor D Kinney","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Patient Protection and Affordable Care Act and its amendments by the Health Care and Education Reconciliation Act of 2010 constitute landmark legislation known as the Affordable Care Act (ACA). The ACA has made many changes in the Medicare program as part of comprehensive health reform for the U.S. health care sector. Title III of the ACA pertains to improving the efficiency and quality of health care. Title VI calls for greater program integrity for all federally funded health insurance programs. Collectively, the changes in Medicare in these two titles address the three major problems that the Medicare program has faced since its inception: cost and volume inflation, quality assurance, and fraud and abuse. These changes, if successfully implemented, will have a dramatic impact on the reform of the American health care sector. The policy-making process in the Medicare program is exemplary of the process of \"muddling through,\" as described by the Yale economist Charles E. Lindblom. Nevertheless, these changes may also prepare the Medicare program to be transformed, through several incremental changes in upcoming years, into a single payer system.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 2","pages":"253-325"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31957702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Innovation incentives or corrupt conflicts of interest? Moving beyond Jekyll and Hyde in regulating biomedical academic-industry relationships.","authors":"Patrick L Taylor","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The most contentious, unresolved issue in biomedicine in the last twenty-five years has been how to best address compensated partnerships between academic researchers and the pharmaceutical industry. Law and policy deliberately promote these partnerships through intellectual property law, research funding programs, and drug and device approval pathways while simultaneously condemning them through conflict-of-interest (COI) regulations. These regulations have not been subjected to the close scrutiny that is typically utilized in administrative law to evaluate and improve regulatory systems. This Article suggests that the solution to this standoff in biomedical law and policy lies in an informed, empirical approach. Such an approach must both recognize such partnerships' legal and practical variations, as well as classify them based on their benefit to innovation and their harm to research biases. Ultimately, this approach must facilitate administrative reforms that would convert what is now an inherently arbitrary, yet widespread, regulatory regime into an epistemically rich mechanism for distinguishing between harmful and beneficial partnerships.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 1","pages":"135-97"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31546384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"No sisyphean task: how the FDA can regulate electronic cigarettes.","authors":"Jordan Paradise","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: \"low\" or \"light\" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed \"tobacco products\" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009 (TCA). It examines the tumultuous history of attempts at tobacco regulation by reflecting on the history of Congressional activity to regulate tobacco sales and promotion. Furthermore, this Article suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. This approach includes increased scrutiny of manufacturer and distributor claims that trigger drug and medical device provisions, utilization of new tobacco product and modified risk tobacco product provisions, and promulgation of new FDA regulations and guidance specifically directed at e-cigarettes.</p>","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 2","pages":"326-74"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31957703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"No sisyphean task: how the FDA can regulate electronic cigarettes.","authors":"J. Paradise","doi":"10.2139/SSRN.2118802","DOIUrl":"https://doi.org/10.2139/SSRN.2118802","url":null,"abstract":"The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: \"low\" or \"light\" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base. Boasting nicotine delivery and the tactile feel of a traditional cigarette without the dozens of other chemical constituents that contribute to carcinogenicity, e-cigarettes are often portrayed as less risky, as a smoking reduction or even a complete smoking cessation product, and perhaps most troubling for its appeal to youth, as a flavorful, trendy, and convenient accessory. The sensationalism associated with e-cigarettes has spurred outcry from health and medical professional groups, as well as the Food and Drug Administration (FDA), because of the unknown effects on public health. Inhabiting a realm of products deemed \"tobacco products\" under recent 2009 legislation, e-cigarettes pose new challenges to FDA regulation because of their novel method of nicotine delivery, various mechanical and electrical parts, and nearly nonexistent safety data. Consumer use, marketing and promotional claims, and technological characteristics of e-cigarettes have also raised decades old questions of when the FDA can assert authority over products as drugs or medical devices. Recent case law restricting FDA enforcement efforts against e-cigarettes further confounds the distinction among drugs and medical devices, emerging e-cigarette products, and traditional tobacco products such as cigarettes, cigars, and smokeless tobacco. This Article investigates the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009 (TCA). It examines the tumultuous history of attempts at tobacco regulation by reflecting on the history of Congressional activity to regulate tobacco sales and promotion. Furthermore, this Article suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. This approach includes increased scrutiny of manufacturer and distributor claims that trigger drug and medical device provisions, utilization of new tobacco product and modified risk tobacco product provisions, and promulgation of new FDA regulations and guidance specifically directed at e-cigarettes.","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"13 2 1","pages":"326-74"},"PeriodicalIF":0.0,"publicationDate":"2012-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67921036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PLIVA v. Mensing: generic consumers' unfortunate hand.","authors":"Stacey B Lee","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"12 2","pages":"209-63"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31068374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Updating constitutional doctrine: an extended response to the critique of compulsory vaccination.","authors":"Michael H Shapiro","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"12 1","pages":"87-170"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30677165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The right to be fat.","authors":"Yofi Tirosh","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":85893,"journal":{"name":"Yale journal of health policy, law, and ethics","volume":"12 2","pages":"264-335"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31068376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}