Jonathan D. Kahn

Race and ancestry in biomedical research: exploring the challenges.

The use of race in biomedical research has, for decades, been a source of social controversy. However, recent events, such as the adoption of racially targeted pharmaceuticals, have raised the profile of the race issue. In addition, we are entering an era in which genomic research is increasingly focused on the nature and extent of human genetic variation, often examined by population, which leads to heightened potential for misunderstandings or misuse of terms concerning genetic variation and race. Here, we draw together the perspectives of participants in a recent interdisciplinary workshop on ancestry and health in medicine in order to explore the use of race in research issue from the vantage point of a variety of disciplines. We review the nature of the race controversy in the context of biomedical research and highlight several challenges to policy action, including restrictions resulting from commercial or regulatory considerations, the difficulty in presenting precise terminology in the media, and drifting or ambiguous definitions of key terms.

The OHRP and SUPPORT - Another view

A group of physicians, bioethicists, and scholars in allied fields agrees with the Office for Human Research Protections about the informed-consent documents in SUPPORT.

Genes, Race, and Population: Avoiding a Collision of Categories

A wide array of federal mandates have a profound impact on the use of racial and ethnic categories in biomedical research, clinical practice, product development, and health policy. Current discussions over the appropriate use of racial and ethnic categories in biomedical contexts have largely focused on the practices of individual researchers. By contrast, our discussion focuses on relations between the daily practices of biomedical professionals and federal regulatory mandates. It draws upon the legal doctrine of equal protection to move beyond such debates and to propose guidelines to address the structural forces imposed by federal regulations that mandate how data about race and ethnicity are used in biomedical research. It offers a framework to manage the tension involved in using existing federally mandated categories of race and ethnicity alongside new scientific findings about human genetic variation.

Race, Pharmogenomics, and Marketing: Putting BiDil in Context

This article endeavors to place into context recent developments surrounding the United States Food and Drug Administration recent approval of BiDil® (isosorbide dinitrate/hydralazine hydrochloride) (NitroMed, Inc., Lexington, MA) as the first ever race-specific drug—in this case to treat heart failure in African Americans. It focuses in particular on both commercial incentives and statistical manipulation of medical data as framing the drive to bring BiDil to market as a race-specific drug. In current discourse about pharmacogenomics, targeting a racial audience is perceived as necessary because at this point the technology and resources do not exist to scan efficiently every individuals genetic profile. The article argues that medical researchers may say they are using race as a surrogate to target biology in drug development, but corporations are using biology as a surrogate to target race in drug marketing. Pharmacogenomics may hold great promise, but on our way to that Promised Land, it is imperative to review such short cuts with a critical eye.

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 Administrations (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 FDAs 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.

Patenting Race in a Genomic Age1

In the growing field of biotechnology research and development, a new phenomenon is emerging – the strategic use of race as a genetic category to obtain patent protection and drug approval. The imbrication of race in the field of patent law as an adjunct to biotechnological inventions is producing new racialized spaces of intellectual property that may have profound implications for broader social understandings and mobilizations of race. When the federal government grants a patent to an invention that is based on an asserted or implied genetic basis for a particular racial group, it gives the imprimatur of the federal government to the construction of race as genetic. Moreover, once granted, such patents may provide the basis for similarly race-based clinical trial designs, drug development, capital raising and marketing strategies that carry the construction of race as genetic out to ever widening and consequential segments of society.

Mandating race: how the USPTO is forcing race into biotech patents

A recent review of select patent prosecutions before the United States Patent and Trademark Office indicates a troubling dynamic at work.

Re-Presenting Government and Representing the People: Budget Publicity and Citizenship in New York City, 1908-1911

Governmental budget systems do not only allocate public resources, they also influence the way in which people interact with their government and conceive of their role as citizens. The contemporary politics of budget making tends to mask this influence. As originally conceived, however, public budgets in America were meant to serve as a tool to reshape democratic citizenship. This article explores the history of governmental budget reform and the impounding effect on citizens from before the twentieth century. The author highlights publicity and political discourse surrounding the topic as well as governmental advertisements.

The Two (Institutional) Cultures: A Consideration of Structural Barriers to Interdisciplinarity

C. P. Snow’s famous Two Cultures essay has become a foil for decades of discussions over the relation between science and the humanities. The problem of the “two cultures” is often framed in terms of how the particular epistemological claims or general intellectual orientations of particular individuals on either side of this purported divide obstruct interdisciplinary dialogue or cooperation. This formulation, however, fails to consider the institutional frameworks within which such debates occur. This article examines the broader structural constraints that provide incentives, erect barriers, or otherwise shape the potential for interdisciplinary research and practice, with particular attention to work involving the life sciences. It argues that in order to understand the nature and scope of the problems facing interdisciplinary work, we must focus on the institutional constraints that shape how individuals frame questions, pursue investigations, develop careers, and collaborate.

Enslaving the Image: The Origins of the Tort of Appropriation of Identity Reconsidered

This article looks back to the origins of the tort of appropriation in turn-of-the-century America to understand better how principles of privacy law were first used to define and confront questions of the legal status of identity. It argues that the first advocates of privacy law used the concept of appropriation of identity to define and promote a way of life and an entire scheme of social relations that stood in opposition to the rising tide of modernity as represented on the one hand by an unfettered capitalism that threatened to commodify all aspects of human experience, and on the other hand by the flood of immigrants perceived as a teeming urban mass that threatened to debase the more “refined” and individualistic culture of the genteel bourgeois elite. The battle to protect individual privacy reflects and illuminates deeper conflicts over negotiating the terms by which America was to enter the twentieth century. In the origins of the tort of appropriation we see the anti-modern bourgeois using law to adapt ideals of civility and deference to a rapidly changing world of giant trusts and immigrant masses.