Flaws in the U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil as a treatment for heart failure only in black patients

The U.S. Food and Drug Administration's (FDA) rationale for supporting the development and approval of BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials (V-HeFT I and II), which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial (A-HeFT) amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act.     

Popular representations of race: the news coverage of BiDil

The BiDil story offers an ideal opportunity to explore the nature and tone of media representations of race and genetics. For example, was a biological view of race emphasized? Or was the notion of race presented in a critical fashion?     

Pharmaceutical meaning-making beyond marketing: racialized subjects of generic thiazide

In contrast to discussions of BiDil, this paper explores racial meaning-making processes around an old generic hypertension drug. By unpacking a vignette about race and thiazide outside marketing or medicine, it shows that racialization of drugs exceeds those spheres and moves in unpredictable ways.     

Genotyping the future: scientists' expectations about race/ ethnicity after BiDil

The ongoing debate about the FDA approval of BiDil in 2005 demonstrates how the first racially/ethnically licensed drug is entangled in both Utopian and dystopian future visions about the continued saliency of race/ethnicity in science and medicine. Drawing on the sociology of expectations, this paper analyzes how scientists in the field of pharmacogenetics are constructing certain visions of the future with respect to the use of social categories of race/ethnicity and the impact of high-throughput genotyping technologies that promise to transform scientific practices.     

The Use of Race and Ethnicity in Medicine: Lessons from the African-American Heart Failure Trial

Race or ethnic identity, despite its imprecise categorization, is a useful means of identifying population differences in mechanisms of disease and treatment effects. Therefore, race and other arbitrary demographic and physiological variables have appropriately served as a helpful guide to clinical management and to clinical trial participation. The African-American Heart Failure Trial was carried out in African-Americans with heart failure because prior data had demonstrated a uniquely favorable effect in this subpopulation of the drug combination in BiDil. The remarkable effect of the drug in reducing mortality in this study has illuminated an important new mechanism of therapy for heart failure. Application of these findings need not be confined to the population studied, but the observation highlights the need for more precise ways to identify individual responsiveness to therapy.     

Russia,NATO, and the "Color Revolutions"

On 12 July, while addressing people he trusted who had helped him in the elections, President Yeltsin finally said something that many people had long wanted to hear from him: Russia needed a new national idea. It may "already be needed in the next presidential elections in the year 2000," the head of state predicted, and hence its development should begin promptly, with the first results visible within a year.     

"Insanity" in civil law

The issue of "insanity" is rarely alluded to in the area of civil law. As a consequence, the legal standard for insanity is not clearly understood by many psychiatrists. The standard derives from case law and is based upon statutory law in the criminal sector. A civil case will be presented where the question of "insanity" was raised. In this case an individual committed suicide and his insurance company refused to pay the beneficiaries of his life insurance policy based upon a provision in his policy that excluded payment in situations of suicide. His beneficiaries sued, claiming that the deceased was insane at the time of his suicide and therefore not responsible for his actions. The standard for insanity in New Jersey and the reasoning of the psychiatrists will be presented.     

"It's the little things": women, trauma, and strategies for healing

Women recover and heal from traumatic violent experiences in many different ways. This study, which is part of the Franklin County Women and Violence Project, explores the healing experiences of 18 women who have histories of violence, substance abuse, and involvement in the mental health and/or substance abuse treatment system. Ethnographic interviews suggest that while professional intervention can be beneficial, it may not be adequate. In fact, it can be retruamatizing. The means of service delivery and treatment by individuals, service providers and others, may be more important than the actual service. Often women find that caring individuals and a safe environment yield the greatest benefit. It is not so much what people do to help, but how they do it.     

“司法能动”在中国的展开

原教旨意义上的“司法能动”的核心指的是司法裁判过程中的“立法性”司法。中国法学界对于什么是司法能动在理解上是极不一致的,大多数人根据自己的理解进行了阐发,其中不乏添附、歪曲之界说,甚至以讹传讹之谬误。能动司法在中国的展开,既存在理论根基不足之缺陷,又面临着司法职业化和司法能动化相冲突的尖锐矛盾。但转型社会的现实,又要求中国必须同时完成司法职业化和“中国式”的司法能动化的双重任务。虽然存在诸多不足,司法能动的倡导者提出的问题依然是值得人们认真对待的。     

"诊所式法律教育"本土化的思考

起源于美国的"诊所式法律教育"要本土化并得以在我国普遍施行,目前尚存在很多障碍,如法学教育界思想观念 上轻视实践技能的培养、诊所的经费涉及对大学有限的教育资源的重新配置、诊所指导教师的素质等等。解决障 碍,因地制宜,建立各具特色的法律诊所才能使这一教育方法在我国生长。     

"规划行政":现代行政法的时代课题与挑战

行政规划正发挥着越来越广泛的作用,有人慨叹现代行政正由"依法律行政"演变为"依规划行政"。隐藏在"规划行政"时代到来背后的是行政法理念的变迁和时代的需求。"规划行政"有其必然性并对现代行政法带来了诸多的挑战。从终极意义上的正当性视角进行考察,"依规划行政"无疑不会完全取代"依法律行政",但理性化差异的不明显显然正对后者造成挑战。     

The Idea of the "Third Reich" in the German Legal, Philosophical and Political Thinking in the 20th Century

The idea that after the Nazi takeover the German political prpaganda machinestrongly supported the naming of their land the "Third Reich" (Drittes Reich) is a misperception shared by many historians, political scientists as well as lawyers all around the world even today. It is much less know that Hitler himself was never in full support of his expression even proved qiute effective both before and after NSDAP (Nationalsozialistische Deutsche Arbeiterpartei) tekeover.     

试论"传统"中国宪政发展中的失落

一百年前的1908年,清朝政府在各种压力之下,权衡利弊,颁行了《钦定宪法大纲》,从而开创了中国立宪之路,同时也开启了中国的宪政之路。但是,宪法、宪政毕竟是舶来品,在与中国特定国情相结合过程中,产生了种种的理论上的激烈争论;亦在实现宪政之路上出现了种种的曲曲折折。当然,中国要实现宪政、必然要实现宪政,这是历史之大势,浩浩荡荡,奋勇向前,应当是毋庸置疑的。在《钦定宪法大纲》颁行一百年之际,反思清末的立宪与中国的宪政之路,无疑是一件有意义的事情。     

"Adventuring" Arts Entrepreneurship Curricula in Higher Education: An Examination of Present Efforts,Obstacles, and Best Practices

As arts entrepreneurship programs emerge in higher education, many remain idiosyncratic because of a lack of oversight by accreditation organizations. This diversity has spawned a number of philosophical and curricular trajectories in these programs; these different programs reflect the unique microcultures of theater, art, and music units. What has been lacking is a broad understanding of curricular and program development practices and techniques.

This article is the result of a national study funded by the Ewing Marion Kauffman Foundation and aims to outline best practices in arts entrepreneurship education and to gain some understanding about the curricular structure, interest in, and growth of these efforts. After interviewing decision makers and students about the topic, it is clear the interest in arts entrepreneurship education is strong, widespread, and rapidly growing.     

Infanticide, physicians, and the law: the "Baby Doe" amendments to the Child Abuse Prevention and Treatment Act

Infanticide, like most other species of homicide, is probably coeval with the human race itself. In modern Western civilization, what were formerly the most powerful incentives to infanticide have virtually disappeared. As with other social problems that affluence has seemed to solve, however, infanticide has reappeared in a new form that seems to have been made possible by affluence itself. This "new infanticide" occurs in a place whose very existence is the result of a tremendously wealthy society's devotion to its most vulnerable and least "useful" members. The modern neonatal intensive care unit, which treats, and often saves, extremely ill newborn children, who during most of history would surely have died, has proven to be a setting where many of the age-old incentives for infanticide have begun to operate again. The "new infanticide" consists of withholding food or needed medical treatment from selected infants who suffer from one or more serious, though treatable, medical problems. The national government has now enacted legislation designed to curtail the practice of infanticide by the medical profession. This paper traces the genesis of that legislation, explores the problem to which it is addressed, and evaluates its prospects for success.     

对话敌人刑法

雅科布斯教授在世纪之交提出了一个让世人震惊的观点:刑法应该把某些人当作敌人来对待!该理论自露面伊始便饱受诟病,怀疑者们几乎从所有可以想象的角度提出了批评。但是,剔除直觉和感性的因素,敌人刑法理论实际上向我们展示的是一幅更清晰、更理性的生活画卷。业已存在的实在法规范共同体如果想要更富有活力地、更健康地持续存在下去,采纳敌人刑法的主张将是相当现实的选择。     

从“先占”看中国对南沙群岛的主权

“先占”是领土取得的主要方式之一,许多国家也有相关的实践。中国是世界上最早发现、开发南沙群岛并对其进行管辖的国家,国际法学家关于“先占”的论述,无疑是中国对南沙群岛拥有主权的重要法律依据。     

Disclosing health information breaches of confidence,privacy and the notion of the "treating team"

The authors utilise cases collected during a randomised population survey to illustrate some of the legal and policy issues concerning routine transfers of information between treating practitioners. Their analysis suggests that implied consent for many routine uses of health information should not be assumed. An important part of consent to health information disclosure is the patients' ability to tailor its scope and content. This requires that they should be provided with additional information. Introducing the measures advised into the clinical setting would bring health information-gathering practices closer to compliance with the collection principles contained in Australian information privacy legislation.     

美国“一股一权”制度的兴衰及其启示

股东控制是美国公司法的基础,而"一股一权"则是该基础的核心。纽约证券交易所在20世纪初迫于政治压力,在上市公司标准中确立了一股一权原则。但在1980年代,纽约证券交易所因美国证券交易所和纳斯达克交易所的竞争压力,放弃了这一上市标准,引起了美国学者对该原则的广泛争议。一股一权原则的合理性尽管经过了学者的多次论证,但大部分国家公司法并没有将这一原则贯彻到底。实证研究表明,股权结构与公司业绩并不存在确定的关系。允许公司按实际情况设计股权结构,可能更有利于公司长远发展,但其前提是健全公司治理制度和投资者保护制度。     

Changing the law,changing the culture: rethinking the "sleepy resident" problem

Ms. Whetsell examines the Bell Regulations, which limit New York's hospital residents' work hours and require increased supervision from senior doctors, in light of the currently pending federal bill that seeks to do the same. The article argues that the federal government should draw lessons from the New York experience before proceeding with similar guidelines. The article notes that many roadblocks have prevented successful implementation of the New York policy, including a long-standing tradition of "hazing" first-year residents with long, unsupervised hours; medical community resistance to the notion of residents' sleep deprivation and dislike of government interference; and a general fear within the medical community of increased medical malpractice liability and other indicia of "blame culture." The Article concludes that the most effective approach to patient safety related to residency sleep deprivation should work within hospital culture, not against it. The proposed alternative approach would encourage patient safety strategies that value teamwork and cross-discipline collaboration, and consequently result in greater satisfaction for residents, hospitals, and patients.