If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious (...) wrongdoing by physicians. (shrink)

We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose (...) unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Credibility, Persuasiveness, and EffectivenessPatricia A. King (bio)Since the early 1970s, complex ethical, social, legal, and scientific controversies generated by biomedicine have been referred to governmentally created commissions, committees, boards, and panels that are commonly referred to as “ethics” committees. The Advisory Committee on Human Radiation Experiments is the most recent example of such a group. Although it is too early to know the full impact of the Committee’s work, (...) it is important to reflect on aspects of its deliberations that shed light on the public policy role of ethics bodies. Specifically, I will reflect on matters that go to the credibility, persuasiveness, and effectiveness of these committees.The point should be made at the outset that these ethics committees are, first and foremost, public policy groups. Governmentally created bodies of all types, including ethics committees, are established to provide pragmatic advice to governments about specific problems and controversies or to complete specified tasks on behalf of governments. What distinguishes ethics committees from other advisory groups is that the issues assigned to them are presumed to be primarily ethical, as opposed to, say, economic, in nature. It is expected that ethical analyses and premises will play a significant, albeit not exclusive, role in the committee’s deliberations. 1 As with other advisory groups, the primary responsibility of ethics committees is to respond to the branches of government that were instrumental in their creation as well as to the public at large. Since political concerns undoubtedly play a role in the creation of these groups, it is understandable that political concerns have some impact on the committee’s work. Thus, ethics committees are generally cognizant of the need to ensure that their processes and substantive conclusions are credible, persuasive, and effective.In my experience, members of ethics commissions understand the need to offer principled arguments that are factually accurate to justify their recommendations and conclusions. They also appreciate the need for consensus and rightly worry about disagreement among members. I believe, however, that committee members are less attentive than they should be to the social and political contexts in which they operate. This is not surprising. Members of these committees, and often their staffs as well, are typically experts drawn from the academy. [End Page 313] Scholars traditionally offer advice or influence policy through articles and scholarly work undertaken individually or in cooperation with like-minded individuals who do not need to be persuaded about the merits of a specific position. Moreover, scholarly articles are often pitched at a level of abstraction that may be of limited utility in the context of concrete decision making.Scholarly efforts are important. Particularly in bioethics, these scholarly efforts often have furnished the conceptual frameworks that are critical to the efforts of those who grapple with complex matters, the appropriate resolution of which pose moral disagreement and genuine perplexity. Policy formulation by its very nature, however, requires more. Attention must be paid to competing moral and social frameworks. Logical, rational arguments and risk/benefit assessments are important, but emotion, passion and values grounded in experience also demand consideration. Policy formulation as a result can be a quite messy process.Members of the academy are often uncomfortable in this environment. Pursuing the messy details can be threatening and at times at odds with values that academics prize highly. I believe this discomfort was evident in the reluctance of several Advisory Committee members to obtain security clearances that were required in order to see classified material related to the Committee’s work. Secrecy may have seemed at odds with cherished values of openness. As a result the perusal of classified materials was left to those with clearances. Fortunately, the Committee was successful in having relevant information declassified so all committee members read and deliberated about the same information. Committees needing to see more contemporaneous classified information might not be so fortunate.Ethics commission members correctly worry about disagreement. The ability to reach consensus helps to give recommendations a compelling quality. Morris Abram, chairman of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, makes this point powerfully. He states that “a commission requires agreement that is as... (shrink)