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Abstract:
A drug called BiDil is poised to become the first drug ever approved by the Food and Drug Administration (FDA) to treat heart failure in African Americans - and only African Americans. This article explores the story of BiDil and considers some of its broader implications for the use of racial categories in law, medicine, and science. It argues that BiDil is an ethnic drug today as much, if not more because of the interventions of law and commerce as because of any biomedical considerations. The article is, first, a retrospective analysis of how law, commerce, science, and medicine interacted to produce a distinctive understanding of BiDil as an ethnic drug, shaping which questions got asked at critical junctures in its development and orienting how they were pursued. Second, it is a prospective consideration of how the science and medicine thus produced may come to affect legal and commercial understandings of the significance of race in relation to biology. The development of BiDil has profound implications for health law and policy, first, because it may be distorting current efforts to address the very real health problems associated with heart failure in America; and second because it implicates federal agencies in inappropriately giving the imprimatur of the state to conceiving and using race as a biological category.

Health, Race, Ethnicity, Genetics, Medicine, Equal Protection, Patents, Intellectual Property, Science, Drugs, FDA, PTO

Abstract:
On June 23, 2005, the U.S. Food and Drug Administration (FDA) formally approved the heart failure drug BiDil to treat heart failure in self-identified black patients. The drug itself is not actually new; it is merely a combination of two generic drugs that have been used to treat heart failure for over a decade. BiDil's newness derives primarily from its public presentation as the world's first ethnic drug.

This analysis begins with a consideration of the race-specific clinical trials that preceded the FDA approval and then moves on to elaborate upon some of the broader implications of BiDil in the context of genomic medicine and the politics of heath care. It briefly relates the story of how law and commerce played a central role in the emergence of BiDil as an ethnic drug. Then it explores the strategic reification of race as genetic in the context of BiDil and connects the drug to larger issues concerning genetics and the politics of difference in health care and perhaps beyond. In particular, the Article explores three areas in this process of reification:

1) the statistical manipulation of racial difference in drug development;
2) the conflation of racial difference with genetics; and
3) the relationship between genetic explanations of difference, market ideologies, and backlash against state action to redress racial injustice.

Race, Health, Health Disparity, Pharmaceuticals, Inequality, Markets, Genetics, Pharmacogenomics, FDA

Abstract:
Most analyses of the relationship between intellectual property and genetics have focused on important but relatively discrete policy debates about when or whether genetic information should be patented. This article aims to delve beneath the surface of such debates to unearth and interrogate unarticulated themes and assumptions that implicitly reconstruct existing understandings of personhood, citizenship, and authority in terms of genetic discourses.

Where the domains of science and the market intersect in patent law, genetic identity and property intertwine, each informing and to a degree becoming a function of the other. As experts in the natural and social sciences construct human identity at the molecular level, venture capital is making deals with these same professionals to manage and transform that identity into marketable products subject to patent rights. Genes are thus becoming sources both of identity and of property, concepts basic to historical constructions of American citizenship

Contemporary discourses of genetics and rights may be currently reshaping understandings of citizenship to the extent that the legal identity of the individual is implicated in and constructed through a relationship to her genetic material. The first step toward understanding and analyzing the nature of this relationship is to explore how genetic material itself is identified and defined within the domain of legal discourse. Intellectual property law provides a primary site for this exploration because, more than most other areas of the law, it deals explicitly with defining the nature and legal status of human genetic material.

This article explores the patenting of human genetic material as a site where science, the market, and law "situate the self" in the genome in a manner that simultaneously renders it a subject of commerce. As an entry point to this still large area of study, I choose the relatively circumscribed arena presented by the rather heated debates that emerged in 1999 and 2000 around the proposed revisions to the "Utility Examination Guidelines" used by the U.S. Patent and Trademark Office (PTO) in evaluating the validity of patent applications.

In examining the debates before the PTO, I aim to show how certain claims, supported by particular models of authoritative knowledge, gain recognition from and access to the power of the American legal and regulatory system while others are marginalized and denied. I argue that the PTO, functioning in a quasi-judicial manner, constructs distinctions between issues of policy and administration as a means to circumscribe the debates over patentability of human genetic material. The boundaries it draws, enables the PTO to bracket and dismiss concerns couched dignitary and religious discourses while recognizing and crediting the more technical arguments of scientific and economic experts.

Intellectual Property, patent, genetics, citzenship, science, regulation, DNA, dignity, self, identity, commodification

Abstract:
This article applies insights from critical race theory to examine an emerging phenomenon in biotechnology research and product development. The strategic use of race as a genetic category to obtain patent protection and drug approval. A dramatic rise in the use of race in biotechnology patents indicates that researchers and affiliated commercial enterprises are coming to see social categories of race as presenting opportunities for gaining, extending, or protecting monopoly market protection for an array of biotechnological products and services. Racialized patents are also providing the basis for similarly race-based clinical trial designs, drug development, capital raising and marketing strategies that carry the implication of constructing of race as genetic out to ever widening and consequential segments of society.

The introduction of race in the field of patent law as an adjunct to biotechnological inventions producing a new political geography of intellectual property in which the very metes and bounds of the territory covered by patents are becoming racially marked. As patents are racialized, racial identity itself is becoming a patentable commodity whose value is being appropriated to expand market control and extend the market life of their products. Generally speaking, however, the people capitalizing on race are not necessarily those who belong to the racially identified groups, but rather those corporations that are literally investing their patents and products with race to gain commercial advantage in the research, development, and marketing of new biotechnology products. Patenting race may thus have profound implications both for the equitable distribution of benefits derived from biotechnology and for broader social understandings and mobilizations of race.

Abstract:
Recent Food and Drug Administration (FDA) approval of the first drug with a race-specific indication has fueled the controversy over the meaning of race and ethnicity and raised questions over whether this move should be seen as an advance or a setback in the struggle to address disparities in health status associated with race. The drug, BiDil, combines two generics long recognized as benefiting patients with heart failure, irrespective of race or ethnicity. The push to bring these drugs to market as a race-specific treatment was motivated by the peculiarities of U.S. patent law and a willingness to exploit race to gain commercial and regulatory advantage.

Business of Health, Consumer Issues, Demography, Ethical Issues, Legal/Regulatory Issues, Minority Health, Pharmaceuticals

Abstract:
This article is a response to Gary Puckrein's paper "BiDil: From Another Vantage Point," which misrepresents rather than refutes our previously published analysis of BiDil. Puckrein claims that if our analysis were to prevail, patients would be denied life-saving therapy. Any reasonable reading of our paper suggests exactly the opposite. Indeed, based on the evidence, we urge doctors to prescribe the generics or BiDil itself as they see fit, but without regard to the race of their patient.

Business of Health, Consumer Issues, Demography, Ethical Issues, Legal/Regulatory Issues, Minority Health, Pharmaceuticals

Abstract:
This Article explores the origins of privacy law in early twentieth century America in relation to the legal solidification of Jim Crow in the aftermath of Plessy v. Ferguson. It considers some distinctively southern aspects of the origins of the right to privacy and argues that by viewing privacy, racial defamation, and Jim Crow in relation to each other, we can gain new insights into each-coming to understand that Plessy was not just about controlling space, or property, or even equality but also about controlling identity itself, and coming to see that in its origins, the right to privacy had a deeply racial component. Part II of this Article considers how Plessy implicated legal interests in the control over and construction of racial identity. Part III examines how our understanding of Plessy's treatment of identity interests can be deepened and broadened by reading Plessy in relation to Pavesich, the first American case to recognize a free standing legal interest in a right to privacy. Here, I argue that central to both cases were issues relating to an individual's access to legal means to control his identity. Part IV then elaborates on the relationship between Jim Crow laws and privacy by examining a series of racial defamation cases brought during this same period.

In drawing connections between Jim Crow laws, privacy, and racial defamation, the article brings to the foreground a fuller understanding of the status of identity in the American legal tradition. Privacy and Jim Crow share an obvious common concern for the legal management of space and community relations. Historically, they emerged together in an era beset by anxieties about the rapid social changes being wrought by modernity. These anxieties manifested themselves in deep concerns over control of individual identity and the relationship of that control to the conservative impulse to maintain the structures of an old social and economic order. As they played themselves out at the turn of the twentieth century, these concerns produced legal structures that allocated power over identity on the basis of race. Jim Crow and privacy informed each other to reinforce racial hierarchy and subordination. Nonetheless, in rereading Plessy and privacy law cases in relation to each other, I have also tried to lay out some of the unexplored potentials for using legal interests in identity to subvert racial hierarchy. By articulating control over identity as an explicit legal interest, I believe it is possible to supplement our traditional understandings of equal protection doctrine to encompass new grounds for challenging legal regimes of hierarchy and subordination.

Race, privacy, defamation, discrimination, identity, equal protection, dignity, torts, constitutional law, critical race theory

Abstract:
This article examines the implications of U.S. federal and international regulatory mandates in the construction and circulation of racial categories in biomedical research and drug development. It will focus on the interface between two regulatory mandates in particular: the International Conference on Harmonization (ICH) Guideline Document E-5 on Ethnic Factors in the Acceptability of Foreign Clinical Data, and the U.S. Food and Drug Administration (FDA) Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. The ostensible purpose of both of these guidelines is to promote more efficient and economical development of new pharmaceutical interventions. Underlying both Guidances is a presumption that race and ethnicity are relevant variables in assessing the safety and efficacy of drugs in clinical trials.

Both Guidances also implicitly cast race and ethnicity as obstacles to be managed and overcome in the course of getting new drugs to global markets as quickly and cheaply as possible.

The ICH process is transforming global drug development and marketing, and, in particular, is opening up the large Japanese market to pharmaceuticals tested in the West. The FDA Guidance similarly promises to transform the production and organization of racial and ethnic data in clinical trials for the U.S. market. As pharmaceutical development goes global, however, the social classifications of the FDA Guidance also promise to collide with the mixture of social, physiological and genetic factors elaborated in the ICH guideline. These diverse classificatory schemes cannot be easily reconciled. This paper will explore how concepts of race and ethnicity are being produced and reproduced through this collision. It will further explore how these distinct attempts to regulate race in a bureaucratic context are shaping the development of global pharmaceutical markets.

Part II of the article will set forth the background to the ICH E5 regulatory mandate and its distinct concepts of race and ethnicity. Part III will explore how the ICH guidelines have already begun to affect global pharmaceutical development. Part IV will set forth the background to the FDA guidelines on the collection of racial and ethnic data for clinical trials. It will then go on to examine the debates that arose around the adoption of the FDA guidelines, specifically as they involved considerations of how the FDA guidelines might impact global pharmaceutical development under the ICH regulatory regime. Part V will conclude the article with an examination of the broader implications of this story for the production of social and regulatory understandings of the nature of race and ethnicity.

Pharamceuticals, drug development, race, ethnicity, critical race theory, FDA, ICH, harmonization, genetics, clinical trials, regulated industries

Abstract:
The article considers how and when, if at all, is it appropriate to use race in presenting forensic DNA evidence in a court of law? This relatively straightforward question has been wholly overlooked by legal scholars. By pursuing it, this article promises to transform fundamentally the presentation forensic DNA evidence. Currently, it is standard practice for prosecutors to use race in presenting the odds that a given defendant's DNA matches DNA found at a crime scene. This article takes an interdisciplinary approach to question the validity of this widespread but largely uninterrogated practice. It examines how race came to enter the construction and presentation of forensic DNA evidence in the early 1990s and considers how its use has persisted and developed over time. It asks the basic question of what race adds as a practical matter to ability of the finder of fact to make fair and accurate decisions and weighs this against the potential dangers of bias created by introducing issues of race as genetic into the context of what is usually a violent crime. It considers how current technological advances have largely rendered the use of race irrelevant to the calculation of odds ratios necessary to establish a match between a DNA sample left at a crime scene and DNA from a suspect. It argues that in most cases such evidence should be excluded as irrelevant, or if deemed relevant it should be held inadmissible because the dangers of infecting the proceedings with racial prejudice outweigh any possible benefit that introducing the race-based statistics could provide. This is particularly the case where race is being introduced in a context that involves constructing a relationship between genetics and violent crime.

The article concludes with a brief synthesis of the arguments for ending the practice of using race frame the presentation of forensic DNA evidence. It notes this would not materially hinder the ability of prosecutors to obtain convictions using DNA evidence, nor of defendants to challenge such evidence. Yet, by removing the gratuitous introduction of race into a context of genetics and violent crime, such reform would promote a positive and significant reorientation of the relation among race, genes, and justice.

Race, Ethnicity, Forensics, Evidence, DNA, Genetics, Disrcimination. Criminal Law, Statistics

Abstract:
This article considers how existing literature on privacy recognizes, constructs and otherwise implicates something the Anglo-American legal tradition recognizes as 'identity'. Integral to this concern is approaching privacy as a regulative principle for constructing and managing relations between the individual and three primary spheres of engagement: society, the market, and the state. Contemporary analyses of privacy tend to concentrate of how privacy protects the individual from state tyranny or the prying eyes of social busy bodies. Much less attention has been paid, however, to privacy as a principle for demarcating a space beyond the reach of market forces. As privacy recognizes and protects the conditions necessary for proper individuation and realization of the self over time, it stands in stark opposition to the expansive forces of the modern market that is based on a globalizing premise of reducing all that comes within its grasp to a common medium of exchange.

The existing literature on privacy lays the groundwork for a consideration of how the law constructs and manages 'identity.' At the core of this process lies a concern to define and protect certain dignitary interests that are seen as critical to maintaining the integrity of the self in the face of modern social, economic, and political forces. Privacy, in short, provides principles for negotiating the legal management of personhood in a manner that facilitates the development and maintenance of a coherent individual identity essential to our liberal polity's commitment to human flourishing.

Among these principles are a commitment to maintaining the conditions necessary for proper individuation and realization of the self over time. In particular, this involves the legal recognition and protection of a sphere of personhood beyond the reach of market forces, a place where a person may choose to locate aspects of herself which may not be rendered fungible or commensurable with other objects through a market exchange. More generally, the literature also reveals the potential for recognizing privacy as a means through which society itself is constituted. As a principle of community maintenance, privacy casts the construction of the self as a relational, social process that implicates identities drawn from powerful historical and social affiliations. In this context, privacy challenges the notion of the bounded self and provides legal principles that construct identity as contingent, open, shifting across time and space. Yet privacy is also ultimately grounded in a concern to protect the basic dignity implicated in allowing a person to negotiate this complex terrain with a measure of autonomy and control over the process of developing an individuated self capable of human flourishing.

Abstract:
This article examines how conceptions of corporate identity are constructed in product liability law. The Article goes back to the early twentieth century to consider how the legal processes and institutions cam to endow corporations with attributes that gave it a specific type of identity. The Article focuses, in particular, on the emergence of the law of product liability and Benjamin Cardozo's path-breaking opinion in MacPherson v. Buick to illustrate how the determination of corporate responsibility and liability in tort rules implicitly, located, shaped, and bounded corporate identity and power in society. The Article further considers how the way tort law invokes concepts of agency, will, and responsiblity may work to establish the identity of a corporation as present in a product as it travels through the national market and thereby serve as a basis for imposing liability upon the corporation.

Abstract:
Over the years, the privacy-based tort of appropriation has become eclipsed by its flashier cousin, publicity. Such is perhaps to be expected in a world where seemingly everything has been turned into a saleable commodity. When celebrities are perpetually trading on their names and images in the open market, it may seem quaint, at best, to invoke a dignity as a basis for protecting personal identity. But this is exactly what happens. In case after case, even as they demand restitution for the converted monetary value of their names and images, celebrities also invoke dignitary concerns as a prime motivation in their attempt to protect and vindicate the integrity of their identities before the law. Moreover, for average citizens, the power to control the use of their name or image can be critical to maintaining the integrity of their identities. The courts recognize this, but all too frequently they subsume all such claims under the rubric of publicity. Even when acknowledging the privacy interest involved, courts tend to confuse and blur the boundary between the two causes of action, with the inevitable result being that the more prominent and tangible property-based right of publicity comes to eclipse the privacy based concerns for identity. I say eclipsed quite deliberately, because while these latter concerns persist throughout and animate much of the courts' reasoning, they remain obscured. Thus, never fully articulated, their implications are never fully explored. In this article I aim to bring the tort of appropriation back into the light. My task is to disentangle publicity and privacy, the conjoined twins of our modern media-saturated society. By examining their origins and development I will show how courts have consistently, if often obliquely, granted legal recognition to identity as a dignitary interest. In bringing such interests to the fore, I hope to revitalize our concern for and examination of intangible, noncommercial values as they inform and guide the legal management of identity. Indeed, the legal recognition of dignitary interests manifested in the jurisprudence of appropriation has created and maintained a legally sanctioned space that places control over the self beyond the reach of the market. As we choose our legal values, we locate power to interpret and enforce the law. While both publicity and appropriation involve fairly straightforward methods to determine whether someone's name or image has been used without her consent, they call upon significantly different sources of authority to assess the nature and degree of harm caused by such misuse. Publicity rights demand accountants and other relevant experts from the realm of celebrity and marketing to determine damages. Appropriation calls upon the local community to consider whether an outrage or affront to relevant social norms has occurred. The former involves the virtues and vices of expert management, the latter, the virtues and vices of local majoritarian control. My examination of the relationship between publicity and appropriation illuminates the tensions between democracy and management, even as it provides new insights into the legal relationship between the fungible and non-fungible aspects of our identities. I argue that in assessing the legal status of identity it is imperative to articulate and engage the tradition of concern for such intangible values as dignity and integrity as integral parts of our legal system. The jurisprudence of publicity and appropriation provide a unique and powerful avenue to explore such issues.