Underwhelmed: hyperbole,regulatory policy,and the genetic revolution

Rapid advances in the field of genetics in recent years have caused some commentators to suggest the emergence of a "genetic revolution." Such advances have been both praised as the "future of medicine" and condemned for encouraging the acceptance in society of laissez-faire eugenics. Yet the effect of technological advances flowing from the science of genetics appear somewhat overstated as few products of the genetic revolution, particularly in the areas of gene therapy and genetic testing, have managed to satisfy scientists' expectations to date. Furthermore, misdirected regulation of such advances can exacerbate the social, legal, and ethical problems associated with genetics, particularly in the context of health care, where issues of human cloning and the use of premature genetic testing technologies dominate current public debate. In this article, the author criticizes the hyperbolic rhetoric surrounding the genetic revolution and calls for a more balanced and informed approach to the development of genetic policies and regulations. Such an approach should include substantial interdisciplinary debate and an active role on the part of government in the identification and communication of accurate information relating to the effects of recent technological advances in the field of genetics.     

The FDA and genetic testing: improper tools for a difficult problem

The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA''s traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA''s proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.     

Regulating medical futility: neither excessive patient's autonomy nor physician's paternalism

In the era of an aging population and escalating healthcare costs, the futility debate has become the object of extended critical attention. The issue has divided experts in relevant fields into two camps. The proponents of medical futility defend the physician's exclusive right to determine the futility of treatment and decide whether treatment should be withheld or withdrawn. On the other hand, opponents believe that a discourse of power lies at the heart of the futility debate. They believe that medical futility was constructed, in part, as a means of enhancing the physician's domination in a context wherein medical authority was threatened. This paper presents some current approaches to the futility debate and highlights positions taken by physicians and bioethicists. It concludes that establishing an operational guideline, either at hospital or national level, is a critical requirement for resolving problems posed by futility. It suggests that policies should not be based on either excessive patient's autonomy or physician's paternalism.     

The new economic credentialing: protecting hospitals from competition by medical staff members

This Article addresses hospitals' use of economic criteria to determine an individual's qualifications for staff privileges. Hospitals are resorting to economic conflict-of-interest credentialing policies in an attempt to ensure physician's loyalty and maintain their own economic viability. Physicians, however, argue that entrepreneurial activities are necessary for them to meet the economic challenges posed by declining reimbursements and rising insurance costs. The Article surveys the numerous legal theories that physicians (and, in some cases, the federal government) could employ in attacking these new types of credentialing policies and concludes that, on balance, hospitals should be able to implement their policies in ways that minimize liability in most jurisdictions. The Article concludes by discussing other issues that economic credentialing policies raise, including those implicating tax-exempt status and nonlegal considerations.     

PGTandMe: social networking-based genetic testing and the evolving research model

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.