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.     

Rise and decline of mass culture?

He is author of Roots of Radicalism; The Media Elite; The IQ Controversy: The Media and Public Policy; Watching America;and The Mass Media in Liberal Democratic Societies.     

Preventing the Use of Deadly Force: The Relationship between Police Agency Policies and Rates of Officer‐Involved Gun Deaths

Killings of civilians by police officers have become a matter of intense public concern in the United States. High‐profile deaths, especially those of black citizens, have caused outrage and sparked the Black Lives Matter movement with calls for dramatic changes in how police agencies operate. However, little systematic research exists to answer questions about which policies should be ended or put in place to reduce these deaths. The authors leverage a large data set of gun deaths by police officers in the United States, combined with agency‐level policy data and community demographic data, to examine whether certain policies are associated with lower or higher rates of officer‐involved gun deaths. Findings show that one policy—the requirement that officers file a report when they point their guns at people but do not fire—is associated with significantly lower rates of gun deaths.     

The no-win Mom: motherland in twentieth-century America

The cultural contradictions of motherhood SHARON HAYS, 1996 New York: Yale University Press     

Perceptions and Satisfaction with Father Involvement and Adolescent Mothers’ Postpartum Depressive Symptoms

This study examined the associations between adolescent mothers’ postpartum depressive symptoms and their perceptions of amount of father care giving and satisfaction with father involvement with the baby. The sample included 100 adolescent mothers (ages 13–19; mainly African-American and Latina) whose partners were recruited for a randomized study for fathers only. Controlling for prenatal depressive symptoms and other prenatal and postpartum variables, we found that higher levels of mothers’ satisfaction with father involvement rather than perception of amount of fathers’ care giving was significantly associated with fewer postpartum depressive symptoms. The relationship between satisfaction with father involvement and depressive symptoms was partially mediated by mothers’ sense of parenting competence and not by mothers’ parenting stress. Policy and programs should place greater emphasis on early support for adolescent mothers and their partners, particularly when mothers desire the involvement of the father with his child.     

The third age of political communication

The author discusses the historical development of political media communication. The first age was a time of relatively easy access to the media; the second age showed the growing power of the media through access to television; and the third suggests an increasing proliferation of information channels within and beyond the mainstream mass media. Four current trends are analysed, with speculation of the subject of their future development. Copyright © 2001 Henry Stewart Publications