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The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests.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.     

HMO enrollment: a study of market forces and regulations

This paper investigates the influence of market forces and state regulations on enrollment in prepaid group practices (PGPs)--the dominant form of HMO. Using data at the metropolitan-area level, the paper estimates a lagged-adjustment model in two stages. The first stage estimates the determinants of the existence of a PGP of viable size. Using a technique appropriate for censored samples, the second stage estimates the determinants of enrollment given viability. The result of greatest relevance for policymakers is that restrictions on corporate employment of physicians hinder the growth of PGPs.     

Genetic testing,genetic medicine,and managed care

As modern human genetics moves from the research setting to the clinical setting, it will encounter the managed care system. Issues of cost, access, and quality of care will affect the availability and nature of genetic testing, genetic counseling, and genetic therapies. This Article will explore such issues as professional education, coverage of genetic services, privacy and confidentiality, and liability. It will conclude with a series of recommendations for the practice of genetic medicine in the age of managed care.     

Between market forces and knowledge based motives: the governance of defence innovation in the UK

The purpose of this contribution is to examine the evolutionary transformations that have characterised the UK defence innovation system since the mid 1980s. It focuses on the central and challenging issue faced by the Ministry of Defence (MoD) in implementing effective governance mechanisms emerging from the continuous trade-off between short-term market driven measures motivated by efficiency arguments, and more long term and relational considerations in terms of knowledge economics. Furthermore, in terms of technology transfer, this evolution has been accompanied by a gradual shift from an initial logic of spin-off to society expected from government driven military projects, to a logic of spin-in where the main concern of the military sector is to broaden its industrial and R&D base.

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.     

Barcelona 2002: law, ethics, and human rights. HIV testing for peacekeeping forces: legal and human rights issues

In 2001, the United Nations Security Council established an Expert Panel to study the issue of whether the UN should institute HIV testing of peacekeeping personnel. This article, based on a 9 July 2002 presentation to the XIV International AIDS Conference (abstract TuOrG1173), reports on the findings of a paper prepared for the Expert Panel by the Canadian HIV/AIDS Legal Network. The paper examined whether it is permissible for the UN to implement mandatory HIV testing of its peacekeeping personnel, and whether HIV-positive UN peacekeeping personnel should be excluded or restricted from service on the basis of their HIV status or HIV disease progression. The article describes some of the court cases in which these issues have been considered; discusses the importance of analyzing such issues in the context of a human rights-based approach to the pandemic; and formulates a series of key principles for guiding UN decision-making. The article concludes that a policy of mandatory HIV testing for all UN peacekeeping personnel cannot be justified on the basis that it is required in order to assess their physical and mental capacity for service; that HIV-positive peacekeeping personnel cannot be excluded from service based on their HIV status alone, but only on their ability to perform their duties; and that the UN cannot resort to mandatory HIV testing for all UN peacekeeping personnel to protect the health and safety of HIV-negative personnel unless it can demonstrate that alternatives to such a policy would not reduce the risk sufficiently. In the end, the Expert Panel unanimously rejected mandatory testing and instead endorsed voluntary HIV counselling and testing for UN peacekeeping personnel.     

Prenatal genetic testing and screening: constructing needs and reinforcing inequities

This Article considers the influence and implications of the application of genetic technologies to definitions of disease and to the treatment of illness. The concept of "geneticization" is introduced to emphasize the dominant discourse in today's stories of health and disease and the social construction of biological phenomenon is described. The reassurance, choice and control supposedly provided by prenatal genetic testing and screening are critically examined, and their role in constructing the need for such technology is addressed. Using the stories told about prenatal diagnosis as a focus, the consequences of a genetic perspective for and on women and their health care needs are explored.     

Regulatory policy and information deficiencies in the market for mental health services

This paper addresses issues related to the regulation of the delivery of mental health services. The focus is primarily on regulations that are aimed at dealing with the consequences of imperfect information in the marketplace. The paper reviews and assesses what is known about the impact of regulations on efficiency and equity. One conclusion is that we know a fair amount about impacts of regulation on prices for mental health service and very little about effects on quality of care. A research agenda is proposed based on the knowledge available in 1988.